Minnesota Physician July 2015

Hospitals, health plans, local public health departments, and community groups are

working together to improve the men-tal health of Minnesotans. The need to take action to address mental health is important and the momentum to do so is growing.

According to a 2011 survey by the Behavioral Risk Factor Surveillance

System (BRFSS), more than 9 percent of Minnesotans report that they have poor mental health. When surveying Minnesota adults by telephone, BRFSS found that respondents reported at least 14 of the last 30 days as bad men-tal health days. Nationally, nearly one in five adults (43.7 million) had a form of mental illness in 2012.

The Center for Community Health to page 16

Compassionate use exemption to page 18

Vo lum e X X IX , N o. 4J u l y 2 015

Expanded access to investigational drugs

By Richard Klein; Deborah Miller, PhD, MPH, MSN, RN; Colleen LoCicero, RPh;

and Peter Lurie, MD, MPH

The Food and Drug Administration (FDA) has a long history of allowing access to potentially promising new therapies for

patients with few therapeutic options. Physi-cians can submit expanded access requests to FDA concerning the treatment of a specific pa-tient. This article will explain how this process works and describe proposed changes that will facilitate access.

The purpose of expanded accessThe purpose of expanded access, sometimes called “compassionate use exemption,” is to pro-vide an investigational drug (or biologic) outside of a clinical trial for treatment purposes. FDA may permit expanded access only when there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat a serious disease or condition, and when the probable risk to the person from the investiga-tional product is not greater than the probable risk from the disease or condition. Because the purpose of expanded access is treatment, rather than research, it does not require the systematic collection of data necessary to determine the safety and efficacy of the drug.

Compassionate use exemption

The Center for Community Health

Maintaining the zone of mental health stability

By Janny Brust, MPH, and Bonnie Brueshoff, DNP, RN, PHN

L ife. We help people get back to it!

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 (866) GSS-CARE or visit www.good-sam.com/minnesota.

An approach to consider for type 2 diabetes therapy starts here

WARNING: RISK OF THYROID C-CELL TUMORSIn male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies.

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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

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

Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.

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

Select Important Safety Information

JULY 2015 MINNESOTA PHYSICIAN 3

*In clinical trials, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1

Trulicity may be a good option for adult patients with type 2 diabetes who need more control than oral medications are providing.1

To learn more about Trulicity and the savings card for patients, talk to your Lilly sales representativeor visit Trulicity.com.

DG95134 02/2015 PRINTED IN USA ©Lilly USA, LLC 2015. All rights reserved.

Important Safety Information

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

Limitations of Use: Not recommended as fi rst-line therapy for patients inadequately controlled on diet and exercise. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.

Trulicity™ offers proven A1C reduction* and once-weekly dosing in the Trulicity pen1

WARNING: RISK OF THYROID C-CELL TUMORSIn male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies.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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with elevated serum calcitonin (if measured) and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation.

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 confi rmed. Consider other antidiabetic therapy in patients with a history of pancreatitis.

Please see Important Safety Information continued on following page.

4 MINNESOTA PHYSICIAN JULY 2015

6.2

6.4

6.6

6.8

7.0

7.2

7.4

7.6

7.8

8.0

8.4

8.2

Week 13 Week 26Baseline

-1.3*†

‡

-1.5*†

-1.0

-0.5

93% fewerinjections3

LS m

ean A

1C (%

)

Once-weekly Trulicity 1.5 mg showed signifi cant A1C reduction1

Important Safety Information,continued

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

Hypersensitivity Reactions: Systemic reactions were observed in clinical trials in patients receiving Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice.

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

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

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.

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

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

Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefi t outweighs potential risk to fetus.

Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity taking into account the importance of the drug to the mother.

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

Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages. Please see Instructions for Use included with the pen.

DG HCP ISI 12NOV2014

Trulicity™ is a trademark of Eli Lilly and Company and is available by prescription only.

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

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

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity- adjusted 1-sided P value <.001; analysis of covariance using last observation carried forward); primary objective met

References

1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2014.

2. Data on file, Lilly USA, LLC. TRU20140910A.3. Data on file, Lilly USA, LLC. TRU20140919C.4. American Diabetes Association. Standards

of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14-S80.

Data represent least-squares mean ± standard error.* Multiplicity-adjusted 1-sided P value <.025 for superiority of Trulicity vs Byetta for A1C. † Multiplicity-adjusted 1-sided P value <.001 for superiority of Trulicity vs placebo for A1C.

Mixed model repeated measures analysis. After 26 weeks, placebo-treated patients were switched in a blinded fashion to Trulicity 1.5

mg or Trulicity 0.75 mg. ‡ American Diabetes Association recommended target goal. Treatment should be

individualized.4

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control.

A1C reduction from baseline1-3

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

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

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

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


TrulicityTM (dulaglutide) DG HCP BS 12NOV2014 TrulicityTM (dulaglutide) DG HCP BS 12NOV2014

TrulicityTM (dulaglutide)

Brief Summary: Consult the package insert for complete prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS

INDICATIONS AND USAGE

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

Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied.CONTRAINDICATIONS

Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.WARNINGS AND PRECAUTIONS

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 medullary thyroid carcinoma (MTC), in humans, as the human relevance of this signal could not be determined from the clinical or nonclinical studies. 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). Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the 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). The role of serum calcitonin monitoring or thyroid ultrasound monitoring for the purpose of early detection of MTC in patients treated with Trulicity is unknown. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin as a screening test for MTC and a high background incidence of thyroid disease. Very 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 referred to an endocrinologist for further evaluation. Patients with thyroid nodules noted on physical examination or neck imaging should also be referred to an endocrinologist for further evaluation. 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.

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. Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice.

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

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.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.ADVERSE REACTIONS

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.

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 43% 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 :

Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), TRULICITY 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg 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 patient 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 patient treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) TRULICITY-treated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies


TrulicityTM (dulaglutide) DG HCP BS 12NOV2014 TrulicityTM (dulaglutide) DG HCP BS 12NOV2014

against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions : In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block : A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7% and 2.3% for placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5% and 3.2% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebo-treated patients had mean increases of up to 3%. DRUG INTERACTIONS

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

Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis. OVERDOSAGE

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

the human relevance of this finding is unknown. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician.

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

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

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

during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions

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

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

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

for Use before starting Trulicity therapy and review them each time the prescription is refilled.

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, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com

DG HCP BS 12NOV2014



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The 2015–2016 Season

Features

July 2015 Minnesota Physician 9

july 2015 • Volume XXIX, No. 4

www.mppub.com

Publisher Mike Starnes | [email protected]

editor Lisa McGowan | [email protected]

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office AdministrAtor Amanda Marlow | [email protected]

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DePARTmeNTS

Barrett’s esophagus 32By Jose Vega-Peralta, MD

The new face of health care 22By MPP Staff

PRofeSSIoNAl uPDATe: GASTRoeNTeRoloGy

mINNeSoTA HeAlTH cARe RouNDTAble

cAPSuleS 10

meDIcuS 13

INTeRVIeW 14

PublIc HeAlTH 20Chronic pain treatment By Tami Swenson, MA and

Stefan Gildemeister, MA

oRTHoPeDIc SuRGeRy 30Cubital tunnel syndromeBy Yesenia M. Rodriguez-

Alvarez, MD

meDIcINe AND THe lAW 34The 2015 legislative wrap-upBy Nate Mussell, JD

The Center for Community Health 1Maintaining the zone of mental health stabilityBy Janny Brust, MPH, and Bonnie

Brueshoff, DNP, RN, PHN

Compassionate use exemption 1Expanded access to investigational drugsBy Richard Klein; Deborah Miller, PhD,

MPH, MSN, RN; Colleen LoCicero, RPh; and Peter Lurie, MD, MPH

Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs.

Objectives: We will review numerous initiatives that support the development of new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring.

Panelists include:

• Lee Beecher, MD, President, Minnesota Physician-Patient Association

• Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services

• L. Read Sulik, MD, Chief Integration Officer, PrairieCare

Sponsors include: • MN Dept. of Human Services • PrairieCare

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail, call in, or fax your registration by 11/5/2015.

Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub.com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable.

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Thursday, November 12, 2015 • 1:00-4:00 PMDowntown Minneapolis Hilton and Towers

FORTy-FOURTH SESSION

Behavioral Health IntegrationNew pathways to care

Debra DeBruin, PhD

Center for Bioethics, University of Minnesota

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

CAPSULES


Respiratory Illnesses Impact Mortality in Minnesota The most distinctive cause of death in Minnesota is respi-ratory illnesses, according to a new report from the U.S. Centers for Disease Control and Prevention (CDC). This means it is the cause of death that has the most elevated impact on mortality in Minnesota com-pared to the national average.

Researchers analyzed deaths in each state from 2001 to 2010 using data from the CDC’s National Center for Chronic Disease Prevention and Health Promotion, to determine which cause of death out of 113 was the most distinctive to each state. They also classified underlying causes of death, taking into ac-count secondary causes that may impact a main cause of death.

“Other and unspecified acute lower respiratory infec-tions,” according to the report,

was the most distinctive cause in Minnesota and its neigh-boring states of Wisconsin and Iowa, as well as Kansas, Ne-braska, and Ohio. Minnesota’s other neighbors, North Dakota and South Dakota, had pneu-monia, also a lower respiratory infection, as its most distinctive cause of death.

Researchers developed the map in response to a 2014 so-cial media trend that had users creating their own maps of the most distinctive or character-istic value of some variable at the state or country level. They wanted to create a map that had a “more nuanced view of mortality variation within the United States than what can be seen by using only the ten most common causes of death.”

The authors note that the map has its limitations, such as the fact that that some of the states’ distinctive causes of death are still very rare—fewer than 100 for 22 states. In addi-tion, there is only one distinc-

tive cause of death noted per state, but there were others that were significantly higher than national averages that are not shown on the map.

According to the authors, “Although chronic disease pre-vention efforts should continue to emphasize the most common conditions, an outlier map such as this one should also be of interest to public health pro-fessionals, particularly insofar as it highlights nonstandard cause of death certification practices within and between states that can potentially be addressed through education and training.”

New Wound Center Opens in WaconiaRidgeview Medical Center has opened its new Wound & Hyperbaric Healing Center in Waconia. It features two hy-perbaric oxygen chambers that surround patients with pure ox-

ygen at increased atmospheric pressure to promote healing, including the growth of new small blood vessels and skin, and fighting infections.

“We are pleased to expand out wound care services and bring improved local access to nationally recognized, best-practice wound care proto-cols to our patients and com-munities,” said Mike Phelps, MBA, COO of Ridgeview Med-ical Center. “The addition of two hyberbaric oxygen therapy chambers—in Waconia—is especially exciting for patients who previously had to travel up to 30 miles or more to receive these services.”

According to Ridgeview, this will benefit patients seeking care for diabetic and pressure ulcers, infections, radiation injuries, and patients with compromised skin grafts or wounds that have not healed within 30 days.

The center is partnered with Healogics, which provides wound care and consulting


services to almost 800 hospitals across the U.S. It was funded in part by the Waconia Rotary, which donated $5,000.

Early Antiretroviral

PatientsResults from a major interna-tional clinical trial have shown that people with HIV have a much lower risk of develop-ing AIDS and other serious illnesses if they begin taking antiretroviral drugs earlier, ac-cording to the National Insti-tutes of Health (NIH).

Currently, World Health Organization guidelines recom-mend that people with HIV be-gin antiretroviral therapy when their CD4+ cell count, which is used to measure immune system health, reaches 500 cells per cubic millimeter or less, while U.S. HIV treatment guide-lines recommend that all people infected with HIV begin antiret-roviral treatment immediately, regardless of CD4+ cell count.

The trial, called the Stra-tegic Timing of AntiRetrovi-ral Treatment (START) study, began in March 2011 and was scheduled to conclude in late 2016. However, the results were deemed already conclusive by an independent Data and Safety Monitoring Board (DSMB), which recommended that the results be released early.

“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” said Anthony Fauci, MD, director of the Na-tional Institute of Allergy and Infectious Diseases (NIAID), a part of NIH that provided primary funding for the START trial. “Moreover, early ther-apy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others. These findings have global implica-tions for the treatment of HIV.”

The study is the largest ran-domized clinical trial of the ef-fect of early antiretroviral treat-ment on people with HIV. It was conducted by the Interna-tional Network for Strategic Ini-tiatives in Global HIV Trials at 215 sites in 35 countries where researchers enrolled a total of 4,685 adult male and female participants who were infected with HIV and had not taken antiviral therapy. All had CD4+ T-cell counts in the normal range (above 500 cells per cubic millimeter). Half were ran-domly chosen to start treatment immediately, while half would not start treatment until their CD4+ cell count dropped to 350 cells per cubic millimeter.

The DSMB found that the group who started treatment early had significantly fewer in-stances of serious AIDS events, other major health issues, and death. The group that received early treatment had 41 in-stances of these major health events or death, compared to 86 events in the group that received later treatment. The DSMB’s interim analysis found that those who received early treatment had a 53 percent lower risk of developing a seri-ous illness or dying.

The University of Minne-sota was the trial’s regulatory sponsor and statistical and data management center. Partici-pants are being informed of the interim results and will be offered antiretroviral treatment if they are not already on it. Investigators will continue to follow their progress through 2016 when the trial would have originally concluded.

Involved in Surgical Mistakes, Study FindsResults from a study at Mayo Clinic have shed some light on the prevalence and causes of surgical “never events,” defined by Leapfrog Group as adverse events that are serious, largely preventable, and of concern to both the public and health care

Capsules to page 12

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Researchers analyzed data from 1.5 million invasive pro-cedures performed at Mayo Clinic over a five-year period and found that among those, 69 never events occurred—a rate of about one never event for every 22,000 procedures. These included 24 instances of per-forming the wrong procedures, 22 instances of performing sur-gery on the wrong site or wrong side of the body, 18 instances of leaving an object in the patient, and five instances of putting in the wrong implant, none of which were fatal.

Researchers then used hu-man factors analysis, a system originally designed to investi-gate military plane accidents, to determine environmental, organizational, job, and individ-ual factors that were involved in the never events. They found a total of 628 human factors that

contributed to the never events, and determined that four to nine of these were involved in each error on average.

The errors were grouped into one of four levels: 1) pre conditions for action, which includes distractions, overconfidence, stress, mental fatigue, and inadequate com-mu nica tion; 2) unsafe actions, which includes not following or not understanding rules and perceptual errors such as confirmation bias; 3) over sight and supervisory factors, which includes in adequate supervision, not enough staffing, and planning issues; and 4) organizational influences, which includes problems with organizational culture or operational processes.

“What it tells you is that multiple things have to happen for an error to happen,” said Juliane Bingener, MD, a gastroenterologic surgeon at Mayo Clinic. Mayo Clinic is

using the research to add to and improve its prevention efforts. Full results of the study were published in Surgery, the official journal of the Society of University Surgeons, the Central Surgical Association, and the American Association of Endocrine Surgeons.

PrairieCare to Open Clinic in MaplewoodPrairieCare has announced plans to expand its psychiatric services to Maplewood, where it will build a new, almost 14,000- square-foot outpatient clinic. Once completed, this will be PrairieCare’s eighth location in the metro area.

The clinic will staff about 10 clinicians, individual and family therapists, psychiatrists, and psychologists and will have the capacity to treat about 2,000 patients each year. In ad-dition, the clinic will house a

partial hospitalization program that will treat about 350 child-ren each year. PrairieCare determined a need in the northeast metro area for this program, as many children who are discharged from hospital-ization face traveling across the metro area to receive tran si-tional services, which can cause transportation and scheduling difficulties for families.

Like PrairieCare’s other lo-cations, the Maplewood clinic will partner with a local school district to enhance services for its special education students. A school will be co-located in the clinic so children will be able to come to PrairieCare for a full day of treatment, includ-ing about five hours of intense clinical care and two hours of education, allowing for less disruption in their schoolwork while they receive treatment.

The clinic is expected to open in February 2016.

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William Davis, MD, family practitioner and chief medical information officer at Winona Health, has received the Cerner Physician Community Lifetime Achievement Award from the Cerner Corporation for 15 years of work advancing elec-tronic medical records. Winona Health was one of the first health care organizations to develop an integrated electronic medical record system. Davis implemented a system using COSTAR in 1991, which he replaced with Cerner PowerChart in early 2002 after partnering with Cerner Corporation. Earlier this year, Winona Health was named among the top 7 percent of health care systems in the U.S. for utilizing information technology to improve health care quality, safety, and outcomes. Davis earned a medical degree at the University of Min-nesota where he also completed a residency in family medicine. He has been with Winona Health since 1991 and became the health system’s first chief medical information officer in 2001. Davis also serves as chair of the Winona Health Ethics Committee.

Janice Sinclair, MD, has been elected president of the Minnesota Academy of Ophthalmology. Sinclair earned her medical degree at the Uni-versity of Minnesota Medical School, completed an internship at Hennepin County Medical Center, and completed a residency at the Uni-versity of Minnesota. Prior to this position, she practiced with Northwest Eye Clinic since 2000. She is certified by the Board of Ophthalmology and is a member of the American Academy of Ophthalmology, Minnesota Academy of Oph-

thalmology, International Society of Refractive Surgery, Contact Lens Association of Ophthalmologists, American Medical Associa-tion, Minnesota Medical Association, Twin Cities Medical Society, and Physicians for Social Responsibility.

Martin Kaplan, MD, practitioner at Southdale Eye Clinic, has received the 2015 Budd Appleton Award for Service to Ophthalmology from the Minnesota Academy of Ophthalmology in recognition of his service to the field. Kaplan earned his medical degree from the University of Minnesota Medical School and is active in community service, including appearing each year at the Special Olympics, working with the Diabetes Expo, and performing community glaucoma screenings. Kaplan is a Fellow of the American Academy of Ophthalmology, a member of the American Society of Cataract and Refractive Surgery, and a clinical associate professor at the University of Minnesota Medical School’s depart-ment of ophthalmology.

David McKee, MD, has been elected chief med-ical officer of Integrity Health Network. McKee is a neurologist at Northland Neurology and Myology, PA, a practice he founded in 1993. He also maintains outreach clinics in Cloquet, Grand Rapids, Hibbing, and Virginia, and serves as Integrity Health Network’s medical director of specialty services. He earned his medical degree at the University of Wisconsin School of Medicine in Madison, completed a residency in

neurology at Oregon Health & Science University in Portland, and completed a fellowship in neuromuscular diseases at the Montreal Neurological Institute at McGill University in Quebec.

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The importance of ethics

Debra DeBruin, PhD

Center for Bioethics at the University of

Minnesota

Dr. DeBruin is director of the Center for Bioethics at the

University of Minnesota. She also served as a health policy fellow for Sen. Edward Ken-nedy in the Democratic of-

fice of the Health, Education, Labor and Pensions Com-mittee of the United States Senate. She has worked as a consultant to the Institute of Medicine and the National Bioethics Advisory Com-

mission on research ethics issues. Dr. DeBruin has been a member of a number of working groups relevant

to public health in Minne-sota, and co-directed the

Minnesota Pandemic Ethics Project. She teaches and conducts research on the

ethics of research and public health policy.

What is bioethics?Bioethics addresses ethical issues in biomedical research and the health and life sciences. It attends to questions that arise in clinical settings. It also, for example, encompasses public health ethics issues such as health disparities, environmental ethics issues such as those concerning approaches to mitigating climate change, and ethical issues in the life sciences such as those related to genetically modified organisms. It is an interdisciplinary field; this diversity of voices promotes rich engagement with issues and really enhances our understanding of them.

Why do we need bioethicists?Bioethicists address issues that affect everyone. We research and analyze ethics questions and work with students, professionals, policy makers, and the public to promote understanding of these issues. We offer consultation to clinical and research teams when they encounter difficult ethical issues in their work. We advise policy makers, as with recent ques-tions about how to manage the Ebola response in Minnesota. We also engage the public—for exam-ple, we might lead a discussion with a community group about the importance of advance directives for care at end of life, or about debates over the Affordable Care Act.

What are the ethical issues to consider when breaking bad news to a patient?

It may seem odd to think about good commu-nication as an ethical issue, but it is essential to respecting patients and promoting their well-being. Providers should be compassionate but clear, and explain the significance of clinical results for the pa-tient’s prognosis. Uncertainties should be acknowl-edged, and patients should have an opportunity to reflect and ask questions. When teams of providers are involved in care, there should be a process for coordinating information rather than providing it to the patient in a piecemeal fashion. Patients need to be supported as they develop an understanding of what this news means for their lives, and should be encouraged to discuss their wishes for how their care should be managed. Of course, there are com-plexities to consider for pediatric patients or adults who have compromised capacities to understand such information and make decisions.

What are the latest thoughts in the ethics community around end of life issues?

There is increasing concern about cases involving disagreement between clinicians and patients or their families about whether continued treatment of

a patient’s condition will benefit the patient. These disagreements can be wrenching for all involved and very challenging to resolve. It is important that patients be supported with appropriate comfort care and compassionate interactions no matter what decision is made about continued treatment.

There has also been a great deal of atten-tion paid to physician aid in dying. Oregon, Washington, Montana, Vermont, and New Mexico have legal-ized physician aid in dying, and bills to do

so have been introduced in another 26 states plus the District of Columbia during the 2015 legislative session. Minnesota is one of these states, bringing the debate very close to home.

Dr. X believes his ethics are right. Dr. Y believes her ethics are right, but they differ completely on the same issue. Who is right?

There is definitely room for disagreement among thoughtful, morally sensitive individuals. This does not mean that anything goes, though. We may find common ground if we move discussions about ethical issues beyond a clash of moral intuitions to an exploration of our reasons for our views. Such discussion can promote respectful understanding. There are some ethical values that are fundamental to the profession of medicine even though tensions may arise with clinicians’ personal moral views. For example, clinicians who disapprove of particular lifestyle choices may not abandon patients who make those types of choices.

What are some of the ethical issues faced by medical researchers?

Increasingly, community clinicians collaborate on research projects, so these issues don’t concern only academic physicians. Overall, researchers must promote the rights and well-being of people participating in research. Participants’ informed consent is required before they can be enrolled in research, and they should be allowed to withdraw from the study at any time without pressure or penalty (or their continued involvement is not voluntary). Privacy and confidentiality should be protected. Risks should be minimized and reason-able in relation to potential benefits from the study. If we are not likely to learn something important in a study, we should not expose human volunteers to risk in that research. Researchers need to be fair about who they recruit into studies. They should not target people simply because they may be easy to recruit—for example, people who would find it hard to refuse the opportunity to use a study to

INTERVIEW

There are some ethical values that are fundamental to the

profession of medicine.


access care. Researchers should also not arbitrarily exclude certain populations from research—for example, studies of conditions that affect both men and women should include both groups. Conflicts of interest also pose significant concerns.

How do ethics factor into issues around social determinants of health?

A person’s health status can be significantly affected by social factors such as access to good educational and employment oppor-tunities, availability and affordability of healthy foods and safe housing, discrim-ination and stigma, among others. Some groups tend to suffer from poorer health related to social and economic inequalities, and not simply due to barriers in access to care. For example, we know that members of certain racial and ethnic groups tend to suffer disproportionately in infectious dis-ease outbreaks such as influenza pandemics. How should pandemic plans respond to this disparity? Some groups have more difficulty complying with complex treatment regimens given their social realities. How should they be appropriately supported? Health dispari-ties pose critical social justice issues.

Please tell us about some of the work you did with President Clinton.

I worked as a consultant to President Clin-ton’s National Bioethics Advisory Commis-sion. I worked on a report that evaluated how well our oversight system protects the rights and welfare of human participants in research and made recommendations for reform. I researched and drafted analyses of a number of ethical issues in research, including how to manage risk/benefit assess-ments and how to implement appropriate safeguards for vulnerable populations in re-search. I have continued to work on a num-ber of these issues in my faculty position at the University of Minnesota, especially issues concerning vulnerable populations.

What is the Minnesota Pandemic Ethics Project?

Beginning in 2007, the Minnesota Depart-ment of Health (MDH) sought ethics guid-ance for influenza pandemic planning efforts in the state. The University’s Center for Bio-ethics worked on this project in partnership with the Minnesota Center for Health Care Ethics; I led the team from the university. MDH was especially interested in how to ethically ration scarce resources during an influenza pandemic. We developed an ethics framework to guide rationing, as well as a wide-reaching ethical analysis of challenges

that the state would likely encounter in applying that framework, including health disparities and access barriers, the use of age in rationing decisions, concerns about liability, and management of palliative care in pandemic, among others. To develop the ethics framework and implementation guid-ance, we consulted extensively with stake-holders specializing in infectious diseases, public health, law, public safety, community advocacy, and so on. Then, in addition to a public comment period, we led a series of community engagement meetings across the state to make sure that diverse citizens could give input on the draft guidance. The project’s main reports can be found on the MDH website.

In the physician/patient relationship what are some of the ethical issues incumbent on both parties?

The goal is to have clinicians and patients work together to promote shared decision-making. This requires that they talk honestly and openly about problems and treatment possibilities; again, good communication is critical here. Shared decision-making is best supported when all parties demonstrate mutual respect and there is a foundation of trust from which to work.


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Addressing mental healthIn 2012, health plans, local public health agencies, and hospitals formed the Center for Community Health (CCH) to improve health in the sev-en-county Twin Cities met-ropolitan area. CCH has two goals that are addressed by two committees:

The CCH Assessment and Alignment Committee was charged with identifying common processes for Community Health Needs Assessments (CHNAs) that would fulfill state and federal requirements.

The CCH Collective Action Committee was charged with addressing one or more public health priority areas—we chose to work on one—based on CHNAs. In 2014, this committee focused its expertise and resources on mental health because it was considered to be one of

the most important issues. We also used criteria to help hone down a list of four pos-sibilities that made the list based on CHNAs.

Because mental health was a key public health priority area identified by an analysis of CHNAs statewide, the CCH Collective Action Committee agreed to align its actions, resources, and knowledge toward addressing this issue. Mental health can be ad-

dressed in a number of ways along a continuum of care that includes promotion, preven-tion, treatment, and recovery. CCH Collective Action Com-mittee members chose to focus on areas that generally do not get a lot of attention:

Engaging community members to help reduce the stigma associated with mental illness.

Educating Minnesotans to identify and seek help for people who are expe-riencing mental health issues. CCH recommend-ed specific training and resources after consulting with the National Alliance on Mental Illness (NAMI) of Minnesota. The training and resources are avail-able to the public.

The zone of mental health stabilityThe CCH Collective Action Committee’s ultimate goal is to support programs and activities that keep people in the zone of mental health stability, which recognizes that individuals, both those with and without mental health diagnoses, have ups and downs in their daily lives (see Figure 1 on page 17). A person’s zone of mental health stability can be disturbed by personal events such as a death, illness, loss of employment, or by community trauma such as a devastation resulting from a tornado or gun violence. Recognizing that a person is struggling (which constitutes the pre-crisis stage) and then knowing how to

intervene are important skills for anyone to have. The goal is to avert a crisis that would typically require extensive professional intervention.

The recommended programs focus on keeping people in the zone by being supportive, offering constructive advice, providing information, and encouraging professional help, if needed.

As the Collective Action Committee members discussed how people stay in the zone of mental health stability, the critical role that community support plays was repeatedly mentioned. Community support includes both the social condi-tions and social connectedness that sustain mental wellness. Social conditions that support mental health may include hav-ing stable, safe housing; income security; access to affordable, quality health care; and edu-cation. Social connectedness points to relationships that provide emotional, physical, economic, and social support. While social conditions and so-cial connectedness were not the focus of the committee’s charge, they are critically important toward maintaining mental health stability.

Using criteria and expert support from NAMI of Min-nesota, the committee recom-mended three programs: Make It OK; Psychological First Aid; and Mental Health First Aid.

Make It OK (MIO) www.makeitok.org: MIO is aimed at increasing public awareness of positive mental health practic-es. The Make It OK campaign is designed to encourage people to talk more openly about men-tal illness and ask for help. In addition to raising awareness about the need to improve conversations about mental health and wellbeing, MIO pro-vides concrete steps for how to effectively discuss these issues in a productive, non-confronta-tional way. MIO has a number of resources, including a free 45-minute, in-person workshop on how to talk about mental illnesses, what to say, and how to spread the word.

Nine percent of Minnesotans report that they have poor mental health.

The Center for Community Healthfrom cover

NOW OPEN!


Psychological First Aid (PFA) www.health.state.mn.us/oep/responsesystems/pfa.html: PFA is an evidence-informed approach that can be used by interested individuals to assist children and adults who are experiencing immediate mental trauma as the result of a traumatic event, public health emergency, or other disaster. PFA, sponsored by the Minnesota Department of Health Office of Emergency Preparedness, has a number of resources including an online tutorial that teaches PFA’s recommended post-disaster interventions.

Mental Health First Aid (MHFA) www.mentalhealth-firstaid.org/cs: MHFA teaches interested individuals how to assist people who are experi-encing a mental health problem or crisis. Two types of training are offered—for adults who work with youth and for adults who work with adults. This eight-hour course aims to im-prove mental health literacy by teaching individuals to identify signs of addiction and mental illness, and to implement a five-step action plan to assess the situation and provide timely assistance. MHFA also provides trainees with local resources

and connects them to local professionals who can help in severe situations.

Mental health awarenessIn addition to supporting three programs, the committee asked members to publicize May Mental Health Month. The committee provided talking points for newsletters or press releases and provided a proc-lamation that asks for support for the three recommended programs. The initial response to this request has been impressive and the committee will evaluate these efforts to measure collective impact:

Pledges to Make It OK went up dramatically— a 32 percent increase in one month.

Proclamations were signed by organizational lead-ers from metro hospitals, public health agencies, and health plans.

Articles appeared in internal and external publications.

Recommended programs were discussed via social media.

Training and workshops were offered.

In the next few months, the committee will begin planning activities for Mental Illness Awareness Week, Oct. 4–10, 2015. The committee will also investigate and then recommend other mental health programs that support community awareness and engagement.

Figure 1. The zone of mental health stability

Source: Center for Community Health

Zone of Stability

Pre-Crisis

Crisis Point

The Center for Community Health to page 38

For more information: Email: [email protected]

Telephone: 651-426-6995

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A brief history of expanded accessFDA has allowed access to investigational therapies in areas such as cardiovascular disease, AIDS, and cancer since the 1970s. From the beginning, FDA has sought to maintain a delicate balance between pro-viding access for seriously ill patients without effective treat-ments, while minimizing undue exposure to risk and ensuring that expanded access does not interfere with the conduct of clinical trials. It is the clinical trial process that offers the promise of generating scientific data to demonstrate safety and effectiveness, which then leads to approval, marketing, and ac-cess to the drug for all patients.

In 1987, when AIDS activists demanded early access to unap-proved drugs outside of clinical trials, FDA revised its regula-tions to permit some forms of

expanded access. In 2009, FDA published new regulations that clarified the existing expanded access regulations and added new types of expanded access (see 21 CFR Part 312 Subpart I–Expanded Access to Investi-gational Drugs for Treatment Use). The regulations describe three distinct tiers of expanded access to investigational drugs based on the number of patients to be treated. Expanded access

can be used for individual pa-tients, including: 1) emergency situations when there is not sufficient time to submit paper-work in advance of providing treatment; 2) intermediate-size

patient populations for several to about 100 patients; and 3) larger patient populations when more than 100 patients may be involved in the program.

Seeking individual patient expanded accessThe best approach for a patient to obtain access to an investiga-tional drug is through partici-pation in a clinical trial of the drug. This is important because

clinical trials can generate the data that may lead to approv-al of the drug. Information about clinical trials is avail-able at www.clinicaltrials.gov, a website maintained by the U.S. National Library of Med-icine at the National Institutes of Health. If a patient with a serious or life-threatening dis-ease or condition is not eligible for ongoing clinical trials, or there are no ongoing clinical trials for the patient’s disease or condition, a physician might consider treatment with an investigational drug through expanded access for that patient if there are no comparable or satisfactory alternative thera-pies (e.g., if the patient is intol-erant of available therapies). If the physician and patient are interested in pursuing expand-ed access, the physician may submit an individual patient investigational new drug (IND) application.

The treating physician who submits an individual patient IND takes on the role of spon-sor/investigator. The physician must comply with the outlined responsibilities for sponsors and investigators to the extent they are applicable to the ex-panded access use (see 21 CFR Part 312 Subpart D– Responsibilities of Sponsors and Investigators for the com-plete list of responsibilities).

These responsibilities include:

Submitting a protocol and consent form to an Institutional Review Board (IRB) for approval

Monitoring the patient under treatment

Accounting for the remaining drug after treatment is completed

Providing FDA with a brief, written treatment outcome summary at the end of treatment, includ-ing any adverse effects experienced

Submitting appropriate IND reports

The application processThere are several parties involved in the decision to treat a patient through expanded access—the treating physician, the patient, the drug developer, and FDA. The treating physician must determine that the prob-able risk to the patient from the investigational drug is not greater than that from the dis-ease or condition. The treating physician should contact the drug developer to determine whether they are willing to provide their investigational drug for treatment of the patient under expanded access. FDA cannot compel a drug developer to provide expanded access to an investigational drug. Sometimes the drug developer denies the request for reasons that include insufficient drug on hand, inadequate safety information, or concern that distribution of the drug through expanded access could interfere with clinical development. For more details regarding the application process for an individual patient see: http:// www.fda.gov/ Drugs/ Development Approval Process/ How Drugs are Developed and Approved/ Approval Applications/ Investigational New Drug IND Application/ ucm107434.htm.

Once FDA receives a com-pleted individual patient IND from the physician, FDA staff will review and decide whether treatment may proceed. FDA must determine, among other things, that the patient cannot


Compassionate use exemption from cover

The purpose of expanded access is treatment, rather

than research.

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obtain access to the drug under another IND. Since Oct. 13, 2009, on average, FDA has allowed over 99 percent of indi-vidual patient INDs it received to proceed (see Figure 1 on this page). However, there may be patients who were denied access to an investigational drug by the drug’s developer for the reasons already outlined.

An individual patient IND would generally include the following:

1. Date of the request and the patient’s initials (not the full name, to preserve confidentiality).

2. A brief clinical history of the patient, including disease status, prior therapy and response, and rationale for this treatment.

3. Proposed treatment plan, including the dose, route, planned duration, monitor-ing procedures, and modifi-cations for toxicity.

4. If applicable, a letter of authorization (LOA) from the commercial developer allowing the physician to refer to information already submitted to FDA by the commercial developer.

5. Information about the investigator’s qualifications, including training, experi-ence, and licensure (or the first few pages of a curricu-lum vitae).

6. Physician’s contact infor-mation, including telephone number, email address, and facsimile number.

7. Statement that informed consent and IRB approval will be obtained prior to initiating the treatment. (See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm? fr = 50.20&Search Term-Informed%20con.)

8. Completed FDA Form 1571 as a cover letter.

FDA has a 30-day regulatory timeframe to review and decide on individual patient IND re-quests. However, in many cases, a decision is communicated to the physician much fast-er. In an emergency situation that requires the patient to be treated before a written submis-sion can be made, the request to use the investigational drug for individual patient expanded access may be made via tele-phone or other rapid means of communication. Authorization to ship and use the drug may be given by the FDA official over the telephone, and shipment of and treatment with the investi-gational drug may begin prior to FDA’s receipt of the written submission. The physician must submit an expanded access IND to FDA within 15 working days of FDA’s authorization of the treatment use. If there is not sufficient time to obtain IRB approval in an emergency situation, treatment may begin without prior IRB approval, provided the IRB is notified by the physician of the emergency treatment within five working days of initiating treatment.

Recent proposed changes to FDA’s expanded access processFDA has proposed a number of significant changes to the individual patient IND process. In February 2015, FDA proposed a new form that distills from FDA Form 1571 the information specific to the individual patient IND and is estimated to take approximately 45 minutes to complete. It also would reduce the number of attachments. FDA is currently reviewing public comments on the new form and is looking forward to finalizing it as expeditiously as possible. For additional information, please see FDA’s revised ex-panded access web page at http://www. fda.gov/NewsEvents/Public HealthFocus/ Expanded AccessCompassionate Use/default.htm.

ConclusionFDA has a long history of flex-ible expanded access to inves-tigational drugs for treatment

of serious illnesses for patients without approved treatment options. In 2009, FDA final-ized new regulations to clarify requirements for expanded access. Currently, the agency is working to streamline and sim-plify the application process, and make promising investi-gational therapies available to patients with serious conditions and unmet medical needs.

Richard Klein is director of FDA’s Pa-tient Liaison Program, the agency’s primary interface with patient com-munities, in the Office of Health and Constituent Affairs. Deborah Miller, PhD, MPH, MSN, RN, works in FDA’s Office of Health and Constituent Affairs in the Cancer Patient Liaison Program. She trains new patient ad-vocates and assists patients seeking access to investigational medical products through clinical trials or expanded access programs. Colleen LoCicero, RPh, is associate director for regulatory affairs in the Office of Drug Evaluation I in the Center for Drug Evaluation and Research. Peter Lurie, MD, MPH, is a family physician and FDA’s associate commissioner for Public Health Strategy and Analysis.

Figure 1. Individual patient expanded access requests, 2009–2014

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Chronic pain is a substan-tial public health concern affecting both the qual-

ity of life of individuals and their families, and imposing an economic burden on society through lost productivity and public and private health care expenditures. The Institute of Medicine estimates about 100 million Americans are affected by chronic pain, more than those affected by heart disease, diabetes, and cancer combined.

In January, the Minnesota Department of Health (MDH) released Minnesota’s first ever estimate of the number of chronic pain procedures performed within the state. The report also marked the first time that MDH used Minnesota’s All Payers Claims Database (MN APCD) to answer an important research question on the health and health care utilization of Minnesotans. Using the unique capabilities of data in the MN APCD, MDH found that about 83,000 Minnesotans per year re-ceived chronic pain procedures.

Study methodsIn 2014, the Minnesota Leg-islature directed the MDH to conduct a study about the delivery of procedures used to treat chronic pain by phy-sicians, doctors of osteopathy, and certified registered nurse anesthetists (CRNAs). The study included developing an algorithm to 1) identify chronic pain procedures within medical claims data, 2) examine the geographic variation within the state in the provision of pain management services, 3) iden-tify the place of service or the types of facilities where chronic pain services are provided, and 4) examine what types of health

care professionals, in terms of their specializations and profes-sional license, perform chronic pain treatment procedures.

To fulfill the legislative re-quirements, MDH took advan-tage of existing knowledge by examining published studies on the provision of chronic pain therapy, consulting experts in the insurance industry on mat-ters of billing and coding prac-tices, and obtaining feedback from the professional organi-zations representing Minnesota physicians and nurse anesthe-tists. In addition, MDH con-ducted empirical research using the MN APCD to analyze the volume, distribution, and types of chronic pain management procedures performed between Jan. 1, 2010 and Dec. 31, 2012.

The MN APCD is a large data repository that contains Minnesota health insurance in-formation, including diagnosis, treatment, and provider details, from medical and pharmacy claims. The data are collected from Medicaid, Medicare, and commercial insurance payers as required by the Minnesota Legislature. While the study used a subset of the data from 2010 through 2012, the MN APCD is updated continuously and currently includes histor-ical enrollment, claims, and price data starting in 2009. It represents medical care trans-actions for approximately 4.6 million insured Minnesotans or about 85 percent of the state’s population and is, as such, the most comprehensive dataset about health care transactions in Minnesota.

In reviewing the literature on the delivery of chronic pain procedures, we noticed an absence of consistent definitions of chronic pain and a lack of clearly specified interventional

pain procedures used to treat these conditions. To ensure that the scope of chronic pain procedures identified for this study was carefully selected and clinically meaningful, we sought input from professional associations of physicians and certified registered nurse anesthetists on the selection methodology and drew on the literature, including published clinical guidelines.

Broadly speaking, our selection approach started with a broad selection of pain procedures that we then refined to exclude procedures limited to treatment of acute pain. Consistent with the legislative direction, our focus was on services that are exclusively provided by medical doctors (MDs), doctors of osteopathy (DOs), and certified registered nurse anesthetists (CRNAs). Our approach generally took the following steps:

We identified a broad set of pain procedures by studying clinical guidelines specific to MDs, DOs, and CRNAs.

We complemented this information by adding procedures identified by national chronic pain asso-ciations and other federal agency research initiatives that focused on investigat-ing chronic pain.

We excluded the following procedures from our list, because they are either not primarily used to treat chronic pain or are exclu-sively used as diagnostic procedures: discography, fluoroscopic guidance, arthrography, epidurogra-phy, myelography, catheter placement, diagnostic spi-nal puncture, arthrocente-sis, and acupuncture.

In order to appropriately differentiate chronic pain procedures from treatment for acute pain conditions, we excluded professional claims with place of service settings in inpatient hospitals, emergency departments, urgent care centers, and birthing cen-ters; and we also excluded

PUBLIC HEALTH

Chronic pain treatment

The volume of procedures is increasing

By Tami Swenson, MA, and Stefan Gildemeister, MA


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Chronic pain treatment to page 42


any professional claim with perioperative modifier codes or with a code that the Medicare Hospital Outpatient Prospective Payment System indicated as inpatient hospital provision.

A final exclusion category was any professional claim with a diagnosis for ICD-9 v338.18 for acute pain following surgery or v338.1 for acute pain.

The final group of pain in-tervention procedures includes those commonly used to treat the majority of chronic pain patients, especially those with musculoskeletal and neurologic causes of pain.

Major findingsOverall the major findings from our study on chronic pain management show that for the period of 2010 to 2012 a total of 660,728 procedures were

performed, and the procedures increased 13.2 percent. Approx-imately 83,000 Minnesotans per year received chronic pain procedures, with most (44.4 percent) receiving one proce-dure and about one-third (30.9 percent) with three or more pro-cedures. Almost 63 percent of these procedures were delivered by providers in the seven-county Metro area of the Twin Cities. The majority of chronic pain procedures (58.9 percent) were provided within a physician office or clinic setting.

Travel distance to providers delivering chronic pain pro-cedures varies, with patients seeing rural providers traveling an average of 53 miles and pa-tients seeing providers in urban centers traveling an average of 28 miles for treatment. Figure 1 on this page shows the distance patients travel to obtain pain management services by the geographic location of the pro-vider and patient. While average travel distance for provider caseload in a non-rural area

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Figure 3. Place of service distribution of chronic pain management procedures delivered in Minnesota by provider type, 2010–2012

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Figure 2. Distribution of chronic pain management procedures delivered in Minnesota by provider type, 2010–2012

Epidural Injections Somatic Nerve Blocks Facet Joint Injections Trigger Point or Tendon Injections Other Chronic Pain Procedures

Pain Specialist Physicians

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Source: All from Minnesota Department of Health

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Figure 1. Average travel distance in miles for chronic pain procedures delivered in Minnesota by provider geography compared to patient residence, 2010–2012

Note: Distance is calculated between ZIP code centroids for provider ZIP code and patient ZIP code.

Metro (more than 50,000

persons)

Micropolitan (10,000-49,999

persons)

Small Town (2,500-9,999

persons)

Rural (less than 2,500 persons)

Provider Location Patient Residence

M I N N E S O T A H E A L T H C A R E R O U N D T A B L E

About the RoundtableMinnesota Physician Publishing’s forty-third Minnesota Health Care

Roundtable examined the topic of The New Face of Health Care: Expanding medical professional

relationships. Seven panelists and our moderator met on April 23, 2015 to

discuss this topic. The next roundtable, on Nov. 12, 2015, will address Behavioral health integration:

New pathways to care

Mr. Starnes: Today we will talk about ex-panding medical professional relationships, which can take many forms. In some—an oncologist working with a radiologist, for example—there is a well-defined protocol for communication and continuity of patient care. We want to focus more on medical doctors working with medical professionals who are not MDs. Let’s start with a defini-tion. What is a medical professional?

Dr. Hu: It has to do with a degree of specif-ic medical training in some specific field as well as professional interest. It has to involve some aspect of medicine, however broadly you want to define that.

Dr. Sawyer: In our institution, we not only train chiropractic doctors but acupunc-turists and massage therapists, and our definition of massage therapy is therapeutic massage. We very much consider them to be medical professionals.

Dr. Desai: When you define a medical pro-fessional, you get into a lot of political dis-cussions, and some people get their hackles up. Folks who have gone through medical school or dental school or chiropractic school sometimes show an ingrained defen-siveness based on the school they’ve attend-ed and the education they’ve had. I’m part of a multidisciplinary practice, so I work very closely with behavioral health special-ists, psychologists, licensed social workers, physical therapists, and others. Oftentimes I work with chiropractors or other medical professionals, as well as with acupunctur-ists. The value of that is undeniable.

Mr. Hustvet: I like the term “health care pro-fessional.” Our current discipline is really pushing to alleviate some of the problems of having a limited number of physicians. Would I take it personally if I were called a “mid-level provider?” I would really look more at what I’m able to do for the patient. Am I able to meet a need in a timely fash-ion? Am I able to assist and provide care where maybe there would have been a delay?

Mr. Starnes: As science and training expands, many health care professionals have the ability to make frontline diagnoses of conditions that could be shared with physicians. Any examples of the ways in which these individuals could work with physicians?

Dr. Gulon: Dental schools now include the team-based approach to care as part of the

curriculum. Dentists are trained to not only work on prevention, but disease treatment as well—and, like our physician colleagues, to deliver care over the lifetime of our patients. It’s obvious that everything that goes into the mouth pretty much enters all the pathways of all the basic systems of the body. Understanding that and applying dis-ciplines and approaches to care that impact and/or prevent it are going to be useful in at least the teamwork process in health care.

Mr. Starnes: Let’s talk about expanding the relationships between health care professionals and the benefits this can bring. What are some of the existing barriers to this more collabora-tive approach?

Dr. Sawyer: The biggest barriers really have to do with payment and the incentives in

payment. When a patient walks in our door we manage that patient in a silo, and we aren’t thinking of other providers that might be able to have a better impact or an additional impact on that patient.

Mr. Wingrove: A lot of us are still getting to know each other, and I think that is one of the keys to having successful interdisciplin-ary approaches. We’re being forced now to look outside of our own box and collabo-rate with other people. In the long run, I think that’s going to serve the patients well. It’s probably something we should have done a decade ago.

Dr. Desai: Patient ownership is an area that we tend to ignore. It’s the most uncomfort-able of the areas to discuss. The cultural issues surrounding patient ownership are the ones that are the hardest conversations to have.

Dr. Gulon: I see this as an opportunity, not as a barrier. First of all, 40 percent of the population seeks dental care in any given year. Fifteen percent of those people don’t see a physician, and that’s a problem. If we’re presented with conditions in which we could be a source of referral to the physicians through appropriate screening, whether it’s hypertension, which we do rou-tinely, oral cancer screening examinations, diabetes screening, or sleep apnea screen-ing, there are windows and/or opportuni-ties to collaborate at a higher level with our physician colleagues.

Mr. Starnes: Are we are going to foster better relations between provider types if the consumers themselves broaden their approach to health?

Mr. Hustvet: Changing a patient’s view on taking ownership of their health isn’t going to happen in a five-minute conversation at a physician’s office. It probably won’t happen even after three or four five-minute conver-sations at the physician’s office.

Dr. Hu: Say you need to get a CT scan and an MRI. Each costs different amounts at different places, whether it’s inpatient, outpatient, or in hospitals. There’s very little transparency, so even if they want to be involved in making those decisions in a cost-effective manner based on their insur-ance or deductible, they can’t do it.


The new face of health care

Expanding medical professional relationships


Mr. Johnson: We all need to provide education to our patients about preven-tive care and following up with pre-ventive checkups, because it can’t be a burden for just one profession.

Dr. Hu: I’m a specialist, a vascular surgeon, so my view may be skewed towards specialty care. Again, we’ve been siloed for a long time. We have radiologists who do angiograms and surgeons who do surgery, but those barriers have changed, and everyone wants to protect their turf. I think the financial barriers are the first hurdle and probably the biggest hurdle in order to build a multidisciplinary team with a common goal.

Mr. Starnes: We need to better understand the levels of training of different kinds of providers. How early in one’s health care career should this learning begin?

Mr. Johnson: In the physical therapy program it happens early, and for good reason. Everybody is in learner mode. I think it needs to be a little bit more robust, actually, so training would con-tinue beyond those initial few years.

Mr. Starnes: What about health care pro-fessionals who are well into their careers and well removed from the academic or school environment?

Mr. Hustvet: Sometimes it’s directed by a physician above everyone who pulls teams together to promote exposure and greater comfort levels with the different fields. Being outside the facility, it’s really a challenge for us. We spend a lot of effort trying to track

people down and explain what kinds of services and offerings we have, asking questions about their needs, and where we can fill in the gaps.

Mr. Wingrove: I represent the profes-sion that will literally decide for about 80 percent of you in the room today at least once whether you live or die. That’s about 10 percent of what we do. We have another 30 percent that deals with your urgent care needs, and about 60 percent that involves your social needs. Until recently, we weren’t train-ing our professionals in how to deal with your social issues beyond some of the safety issues. That’s one of the real promises of the new generation of community paramedics. It’s taking a professional that is super-sharp in life-saving skills and retraining them to do the majority of the work they actually perform each day, which involves more psychosocial skills.

Mr. Starnes: How can reimbursement mechanisms further collaboration?

Dr. Desai: There’ll be a shortage of 90,000 physicians within the next two to five years, and certain states are suffering from it more acutely than others. If we formed a care team with seven health care professionals and we all saw the patient together, only one of us could get reimbursed. We need to create incentives for people to want to be part of that team. If you come to see me as a patient, I will almost always refer you to a physical therapist, possibly a behavioral health specialist, an acupuncturist, or a surgeon.

Mehul Desai, MD, MPH, practices at the Maple Grove and Fridley offices of Medical Advanced Pain Specialists (MAPS). Board-certified in pain medicine and physical medicine and rehabilitation (PMR), he has served as an assistant professor in the Depart-ment of Anesthesiology and Critical Care Medicine and of neurosurgery at George Washington Univer-sity (GWU) Medical Center, Washington, DC.

John Gulon, DDS, has served at Eden Prairie-based Park Dental since 1987. In addition to seeing pa-tients at the group practice’s Roseville clinic, he has served as the president and CEO of Park Dental and its 37 practice locations since 2005. He graduated from the University of Minnesota School of Dentistry.

Michael Hu, MD, practices at Hennepin County Medical Center. He completed his medical degree and general surgery training at the University of Minnesota and his vascular surgery fellowship at Washington University in St. Louis. His professional interests include aneurysm disease, peripheral arterial and venous disease, carotid disease, and dialysis access.

Derek Hustvet, RRT-NPS, LRT, is director of respi-ratory service at Pediatric Home Service (PHS). He earned a bachelor’s degree in respiratory therapy from North Dakota State University, Fargo, and is a licensed respiratory therapist and a neonatal/pediatric respiratory care specialist.

Craig Johnson, PT, MBA, is president of the Minne-sota Physical Therapy Association (MNPT), where he is active in government affairs and payer relations as well as strategic repositioning efforts, association payer forums, and payer relation meetings. He is also a partner and director of clinical integration at Therapy Partners.

Charles Sawyer, DC, is senior vice president at Northwestern Health Sciences University in Bloom-ington, Minnesota. During his 35-year career, he has been a leader in the chiropractic profession and a member of the faculty and administration at Northwestern Health Sciences University.

Gary Wingrove is director of government relations and strategic affairs for Gold Cross Ambulance/Mayo Clinic Medical Transport in Minnesota and Western Wisconsin. He is a former Minnesota state EMS director who was awarded the Minnesota De-partment of Health’s Jim Parker Leadership Award for Community Health Services.

ABOUT THE MODERATORMike Starnes has been the publisher at Minnesota Physician Publishing since 1986. His duties include the production of MedFax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.


“ You want to do the best thing for the patient.”

Michael Hu, MD

M I N N E S O T A H E A L T H C A R E R O U N D T A B L E sponsored by


“ We are trying to promote innovative clinical pathways.”

Craig Johnson, PT, MBA

Dr. Sawyer: Right now, with the fee-for-service reimbursement formula, we don’t have any incentive to talk about team-based care. If and when the payment shifts to focus on the value that the team provides, it will be more productive.

Dr. Desai: In 2018 it shifts, as Medicare makes the majority of payments based on value as opposed to fee-for-service.

Mr. Starnes: What could be gained by better relationships between health care professional relationships?

Dr. Desai: Low-back pain is the single most expensive medical condition, with costs approaching around $100 billion annu-ally in the United States. It’s three times more expensive than cardiac care services, and it’s more expensive than diabetes and cardiac care combined. Eighty percent of Americans will have an episode of low-back pain. However, it turns out that 7 percent of those patients—around 15 to 25 million Americans—are using up 85 to 97 percent of that $100 billion. If the different health care professionals treating these patients operated more collaboratively, there could be huge cost savings.

Mr. Johnson: I think that many of our current outcome measurements are really process measurements. They’re not quality-

of-life measurements, like those used in Europe, and they’re not functionally based either. An outcome that’s worth measuring, in my mind, one that moves the health of the population higher, requires a functional measure and a quality-of-life measure. I think we do need to address that and not go with just process measures or measuring whether we get the person from point A to point B and they’re happy and out the door, but, rather, on their ability to function in society and their quality of life.

Dr. Hu: In the large medical groups I’ve worked in, patient satisfaction is different from measuring the real outcomes—for example, that they’re functioning better, they’re able to walk, and they’re pain free. At the same time, you’re getting these little management metrics—for example, what would you as a physician do? Is the pa-tient satisfied and happy? All of those are not necessarily the same as treating the problem. I think that trying to have patient satisfaction is a tremendous problem that a lot of physicians complain about in these large care systems, but it doesn’t necessarily correlate with better care.

Dr. Desai: I agree with you, because when you look at the HCAHPS (Hospital Consum-er Assessment of Healthcare Providers and Systems) scores, patients who are more like-ly to be satisfied are more likely to die ear-lier. Patient satisfaction and outcomes are not correlated. You’re more likely to provide more tests, more medications, more inter-ventions for someone because then they feel

as if something happened to them and they report being more satisfied—but that’s not the same as actually getting better.

Dr. Hu: At HCMC (Hennepin County Medical Center), we’re working on a so-called Limb Salvage Center, where we have people from different specialties—radiology, vascular surgery, hyperbaric oxygen, dietary—try-ing to save limbs. All of us bring different perspectives, and maybe we have different tools. The whole goal is not to have two different ideas about how to treat this, but to have one consensus idea of how to treat the patient.

Dr. Gulon: Certainly we’d see some ad-vantages of interoperability between the medical record and the dental record. That doesn’t exist today. Instead we do it the old-fashioned way, with a call or paper referral. One challenge is to follow up to ensure that the patient did follow through with the referral with the physician. The other challenge is getting the results of that referral and/or the tests or evaluation back to the dentist.

Mr. Starnes: Any other thoughts on how we could improve care by improving relationships between provider types?

Dr. Gulon: One, for example, is periodon-tal disease. It’s present in roughly half the population today, and there are certain clear associations between periodontal disease and its management and cardio-vascular health. Today, roughly 80 million people have some form of hypertension and 14.5 million people go undiagnosed or are unaware of the associated risks.

Mr. Starnes: Are there examples from within your own organizations of how expanded rela-tionships between different kinds of health care providers are producing good results?

Mr. Wingrove: Within paramedic service, we have some high-utilizer groups of patients. The people that abuse our system tend to call on different days and at different times, so they’ll see nurse Judy on Monday and nurse Tammy on Wednesday and nurse Steve on Friday. North Memorial’s com-munity paramedics now follow patients at home who have 10 or more medications, three or more comorbidities, and time-sen-sitive medications. The paramedics use the same electronic medical record, so they can see all the hospital visits, all the clinic visits, and can issue a request for a physical




“ We are trying to have more proactive team involvement.”

Derek Hustvet, RRT-NPS, LRT

therapy service or a secure message to the physician. It’s part of a Medicaid shared savings ACO (Accountable Care Organiza-tion), so the state gave them a significant portion of shared savings last fall. Of course, 80 percent of it should go to the paramedic and 20 percent be shared by the rest of you, but that model is a shining star in the country.

Dr. Sawyer: The Hennepin Health initiative is extremely novel. It combines the clinical services that we all think about, but then it adds social services, and throws a big net over the most complicated, vulnerable population of patients where the costs are high and the access is not good. They’re bringing mental health professionals and social workers in and dealing with poverty and homelessness.

Mr. Hustvet: We are trying to have more pro-active team involvement. We are also trying to prevent emergency room visits and the expense of Medicare dollars. We do this not just with asthma and obesity but also with our general patient population. The bigger challenge is when we have to communicate with four different physicians from two dif-ferent hospitals, with one to four involved parents, and three, four, or five different primary nurses. Care conferences are probably a great example as well. We get to sit with the physicians, with the family, with everybody involved and have a conver-sation. These meetings can sometimes raise really important, crucial questions. If the discharge is tomorrow, what happens, how do we fix this, do we rush through things? If the team does save dollars, it’s hospi-tal-based versus home care versus maybe an extended living facility, that determines where that benefit goes.

Mr. Johnson: What’s going well? Here are a few examples. One is a primary spine pro-gram in Mankato. The primary care clinic is a medical home, and they’re using a tool to risk-adjust patients in terms of the risk of accessing services and making referrals to physical therapy. Another therapy clinic in our network is working with a primary care clinic, and when a patient is identified with prediabetes based on blood work, they refer them to physical therapy for education. They’ve shown very good results in reducing blood sugar levels over a six-month period. Finally, Courage Kenny set up a pilot program a couple of years ago as a medical

home with about 200 patients. The patient population was essentially defined as dual eligible, which means they are eligible for Medicaid and Medicare. By being very preventive- focused and helping manage their health, I believe they saved the state about $2 million.

Mr. Starnes: Why are health plans so unwilling to offer fair compensation to non-physician health care professionals?

Dr. Sawyer: It’s all about coding and chasing the money. We’re starting to ditch the terms complementary and alternative because they don’t mean anything. If acupuncture is the best early treatment to use, along with reasonable medication management for a patient with acute or chronic pain, then that should be put into effect right from the start. Typically, to qualify for reim-bursement for acupuncture the pain has to be four months of chronicity or longer. This delays the use of a therapy that has no downside to it whatsoever. Then, once pay-ment is approved, reimbursement is so low that it’s not feasible to provide the care in a pain clinic or large health system.

Mr. Johnson: In our current fee-for-service system it’s obvious that the current pathway for most disease processes is too costly. We’ve done a fair amount of research into payer data of delivery partners and timing of care in relation to physical therapy and particularly musculoskeletal conditions, and there’s a huge amount of care that’s provided upstream. There have been a couple of very good research articles from Spine magazine and Health Affairs demonstrating that early access to physical therapy for low back pain—within 14 days of seeing a primary or a medical provider—has reduced the total episode cost for that back episode by 40 percent.

Mr. Starnes: Dental insurance reimbursement seems to differ from other reimbursement models. Why is this?

Dr. Gulon: I’m not sure that dental is doing it any better. In fact, in dental we get paid by procedures. In the dental world, we don’t operate with diagnostic codes, but that world is evolving. On the other hand, we’re working on a couple of novel projects with integrated physician networks, including some sleep studies right in our practice. We’ve worked out some reimbursement mechanisms between the physician network and our group.

Mr. Starnes: One of the biggest challenges comes from corporate culture and senior leadership. In some systems individuals won’t change regardless of evidence that suggests they should, and in some systems senior leadership is very proactive about change but it somehow gets bogged down in mid-level management. Any comments on this?

Dr. Desai: We do have progressive-thinking leadership, and we’re doing some things that are progressive and innovative on the training level. People who have been trained already and have been out of school, for five, 10, or 15 years, is where the gap is. What we really need is to identify and mentor and support great clinical leaders. What I mean is that health care is not going to change until health care providers buy in. You can have a great administrator, you can force it down someone’s throat, but you need a foil to that with great health care




leadership. Getting folks who are mid-ca-reer to change their practice patterns, as we’ve all been talking about, is a signifi-cantly greater challenge because they’re set in their ways. Those are the folks running the show, so to speak.

Dr. Gulon: I’m really optimistic that the ears are open from the medical administrators’ point of view. Many of us have been proud that in Minnesota, overall, we’re pretty progressive with regards to health care. Unfortunately, when it comes to the pedi-atric dental benefit, Minnesota is dead last, 50th out of 50, in terms of reimbursement. Switching gears for a moment, from the conversations we’ve had with chief med-ical officers, there’s a significant amount of waste in terms of the access for dental care through emergency departments, with roughly $50 million each year being spent on dental care in emergency rooms. Inter-estingly enough, we’ve been able to partner with a physician group to leverage some of the synergies so that we can actually have those patients access the care through the dental practice rather than through the emergency room.

Mr. Wingrove: When we encounter a patient who has congestive heart failure and has significant breathing difficulty, we have two choices. We can intubate them, or we can put them on CPAP (continuous positive airway pressure). If we intubate them, what do you suppose happens to the hospital-

acquired infection rate? It has nothing to do with the hospital, but it’s in an unsterile environment, and it’s an invasive proce-dure. On the other hand, if we use CPAP and maybe even get a better result than intubation, we can drive the hospital score into a better position. Those are some of the things that have value to patients as well as to the payers.

Mr. Starnes: Under the Accountable Care Act (ACA), reimbursement for health care services will migrate from a volume- to a value-based methodology. How does expanded collabora-tion between health care professionals respond to this migration?

Mr. Johnson: The whole notion of collabora-tion has been spurred on by the ACA. The Centers for Medicare & Medicaid Services (CMS) has announced that they’re moving towards 50 percent of their payment being value-based by 2018, and that will certainly foster innovation around collaboration. I am a firm believer that we should manage what we measure, so measuring outcome is going to be very critical in this collab-oration. Financial incentives, when they are aligned, will also drive collaboration, and financial incentives really do drive our provider behavior.

Mr. Starnes: Part of the health care reform is going to deal with attempts to reduce rehospi-talization. How can penalties for rehospitaliza-tion drive better collaboration?

Mr. Hustvet: From a home care perspective, we actually have some incentive right now to keep patients out of the hospital. We can’t bill for our equipment, and we can’t bill for the pieces or parts or supplies they use if they’re in the hospital. We have a clinical piece that often does not get reimbursed. If it does get reimbursed, it’s not a full reim-bursement, but that piece of equipment is necessary to keep that patient out of the hospital. We’ve noticed, in the last three years, more focus from the hospital facility level at care management and discharge planning. There’s a lot more focus on providing 24-hour, 7-day-a-week support. There used to be just a daily discharge plan, after which you didn’t have a lot of com-munication and cooperation. I think from our perspective, we’ve been trying to do this because it’s good for our business model and it’s good for our patients.

Mr. Starnes: Can an increased emphasis on prevention foster improved collaborations?

Dr. Desai: It’s very unlikely that prevention can be achieved with just one provider. It’s unlikely that just one specialist or one primary care provider could achieve pre-vention. I think that in itself provides the foundation for greater collaboration. One of the things I tell patients all the time is, I don’t have to be the one to fix you, I don’t have to be the one to make you better, but if I can get you to the right person, it still makes me look good.

Dr. Sawyer: I’m not sure who is able, by virtue of their training and experience, to actually provide preventive services. I’m not talking about pap smears and mammo-grams, I’m talking about the discussions, the coaching, and visiting with the patient. We’ve got a mixed bag, and I think it’s too early to know for sure how that’s going to work, but we certainly have to put that in place because it’s now mandated.

Mr. Starnes: Are there future legislative actions at the state or federal level that might drive collaboration?

Mr. Johnson: It can be demonstrated that silo management mentality is ineffective. From our association’s standpoint, we are trying to promote innovative clinical path-ways, and research has shown that early access to physical therapy is key to saving dollars throughout that whole episode. We have a very innovative national association.


“ Everybody ought to be right at the top of their license.”

Charles Sawyer, DC



I applied for a grant from them to run a pilot study around worker’s compensation patients directly accessing physical therapy. We have had discussions with stakehold-ers at high levels including the Chamber of Commerce, the Department of Labor, brokers, and the worker’s compensation in-surer for the state. I think this is definitely beginning to show up on their radar. I think that will obviously affect future legislation and the way that the worker’s compensa-tion fee schedule works. Ultimately, we are hoping to change legislation.

Mr. Starnes: We recently had landmark approval from the House and Senate on new Medicare reform. Is Medicare reform going to help foster better relationships between health care professionals?

Mr. Hustvet: I think it’s a good start. I think anytime you’re getting physicians involved with alternative providers, there’s going to be more collaboration. There’s a push right now on both physicians and even physician assistants to see how much work they can get done. If we can spend 10 minutes, 20 minutes, or a half hour with the patient and then have a five-minute conversation with the physician—versus the physician only getting five minutes with the patient— I think that’s going to drive a little more col-laboration, and offer a little more exposure. The physician, I think, will end up ultimate-ly being more of a coordinator and manag-er of the other therapies and services.

Mr. Starnes: In every legislative session, there are bills introduced that redefine the scope of practice for specific provider types, and there are always “turf-war” conflicts over their pas-sage. How do we best address this?

Mr. Wingrove: Sometimes that’s healthy tension, and sometimes that’s not healthy tension. We’re in a time when change is here and it’s being made everywhere, and I think we just have to recognize there have been changes over time in all of our professions, and those are cyclic. This is a new time when the professions will change. Technology also plays a role in how safely different providers can do different things. The professional protection, I don’t think, will ever go away, but we’ll have to respond to it based on what the payment system forces on us.

Mr. Johnson: We don’t really like this licen-sure turf battle, but it does happen. There’s

a filter that describes scope and helps leg-islators make decisions. Legislators make decisions about scope for every profession in this state, and they’re not really the experts most of the time. They’ve actually appreciated that here’s something that you can measure when somebody comes to you and they want to expand in a certain area. I think we need to get beyond that as well and be very proactive, because the time that it takes and the resources it takes to fight those battles are pretty wasted. I think we need to recognize that and try to maximize the training level of each provider on the care team and not have legislative turf bat-tles about scope.

Dr. Sawyer: The real issue is that everybody ought to be right at the top of their license, and if these care models can change and the reimbursement can change, then the commercial payers will follow what Medi-care is doing. Getting this shift to value would allow clinicians like Gary and me to sit down at the table and say, well, if we’re in the shop together, if we’re in the same practice together, what can we do to elevate the model of care and the delivery of it and the efficiency of it and go right to a payer, along with nurse practitioners, pain spe-cialists, and acupuncturists and say, we’ve got a proposal from you and it’s too good to turn down.

Dr. Gulon: Dentistry, as I mentioned earlier, has added mid-level practitioners in the form of dental therapists and advanced dental therapists with expanded functions. Dentistry was not un-like other professions that were slow to recognize the shortag-es that we are encoun-tering. We have to be more creative, and I think that’s driving a lot of the behaviors out there.

Dr. Hu: If you can get the collaborations to work, is it going to be revenue neutral? If it’s revenue neutral, basically you’re redistributing income from one group to another group. From a practical stand-

point, I believe that fee-for-service can be a very powerful motivator sometimes just to do the work. Will people work as hard when you take away some of that financial incentive? I know that under different health care models and within different health care groups, when you incentivize doing a procedure and you’re a subspecial-ist, you do make your people work harder. When you take that incentive away, they don’t work as hard.

Dr. Sawyer: I do worry a little bit about the fact that maybe we’re over-vilifying fee-for-service reimbursement. If we shift into value-based reimbursement and shared savings and shared risk, I wonder if there’s going to be another perverse incentive. If I do less, the team that I’m on, the hospital that I practice in, and the system that I’m a health care provider in, is going to do bet-ter, and by extension I will do better if my contract shows some performance.

Mr. Hustvet: I think there’s also potential for cost savings. If I’m a respiratory therapist and I’m allowed to manage an asthma pa-tient, more than likely I’m going to get reim-bursed less than the pulmonologist would. I could be working for a pulmonologist or a physician or a primary pediatrician through their office. I’m getting reimbursed less but they’re seeing three times as many asthma patients because I’m there as well. I think there’s some potential to shift some


“ We’re in a time when change is here.”

Gary Wingrove



of the work to me, or other folks that aren’t billing quite as much, and still see quali-ty patients and allow the physician to see the higher-needs patients that maybe are getting delayed or pushed off or even going into the hospital.

Mr. Starnes: An emerging model involves com-munity-based initiatives, many of which could be duplicated and expanded. Can you give some examples?

Mr. Wingrove: Our state got a grant from CMS to work on different sorts of models, and one of the ones they’ve chosen is to create opportunities to expand three emerg-ing professions: community paramedics, community health workers, and dental therapists. They are contracting now for each of these to create tool kits for potential employers. The goal is to speed the adop-tion of the professions by employers. It will set the stage for the employer to learn about the training they come in with, the sorts of things you can expect them to do, and how reimbursement works—if it works at all. They are also, at least in our case, subsidiz-ing the employment of a handful of pro-fessionals so that employers can test it out and make sure it works and learn about the intricate details of actually putting the pro-fession into practice.

Dr. Sawyer: I’m not sure that the innova-tions would have happened in either the state innovation model initiative or the Hennepin Health initiative if there hadn’t been legislation and direct involvement by state agencies with provider groups. In other words, I’m not sure that would have evolved or happened if the payers weren’t the ones responsible for it, and I don’t think they would’ve taken the initiative.

Mr. Johnson: Under one community-based program that, in its original form, our asso-ciation worked on, we developed an educa-tion program that assessed seniors for their risk of falling. Reducing the number of falls has an impact on that individual’s health as well as on the health of those in the com-munity. The program was first developed for assessment and then for intervention, and oftentimes the assessment revealed that a community-based strengthening program would help to reduce the risk of falls. This was a grant-funded initiative with a train-the-trainer model, which trained commu-nity health nurses and others to assess and then to address the issue. Now the Depart-ment of Health is reviving this initiative, with about a dozen health care providers and community organizations working on reducing falls by seniors in the community.

Mr. Starnes: How could a value-based care model promote interprofessional relationships or address the turf or silo mentality?

Dr. Desai: The greatest advantage of a value-based reimbursement model is that, for the most part, the value of a person’s contribution to the care team gets equalized a little bit better. The traditional system is quite hierarchal, with certain people on the top and others along the way. By bundling care and by providing reimbursement in a value-based system, long-term manage-ment becomes more important than inci-dent-based management, which also then shifts away from the silo effect.

Mr. Starnes: If we increased the focus on the patient experience, might we break down some of that silo mentality?

Dr. Hu: I think so. Like anything, you want to do the best thing for the patient, and it’s rare that you’re the only one who can do it. I think centering on the patients, giving them the best experience, requires you to seek out all the other things that they need. I think, yes, that will help break down some of the silos.

Dr. Gulon: Patients who go through different levels of care—whether it’s with a dentist or a physician or a chiropractor or whom-ever—will benefit if there’s a high level of transparency, communication, and coordi-nation within the care team. Certainly we recognize the challenges of achieving that, but also it’s pretty obvious how that might feel to the patient.

Mr. Starnes: Even though different types of providers have similar goals, they may not talk to each other. Why not?

Dr. Desai: Synergies are often unrealized because of time and malaligned financial incentives. Those are the two primary rea-sons. Right now there’s no incentive to learn what the other guys do. He might be the specialist in this, I might be the specialist in that. In order to get that 360-degree view or that spherical view of what the patient’s going through, you need to get all partners involved. If you do that, then the value of your partnership increases and your incen-tive to learn about what others do, at least to some extent, increases.

Dr. Sawyer: If we’re in the same practice business together, we sit down at the table and figure out how are we going to be


“ I see this as an opportunity, not a barrier.”

John Gulon, DDS



successful, because we’d like to approach this particular payer, public or private, with a proposal to do X for a new model of care and delivery. We’ve got to get to know each other, on both a professional level and a personal level, so we have some trust and assurance that we’re watching each other’s backs. Being in business together is a big deal.

Mr. Hustvet: We lack easy communication and easy access tools. Just because I’m only free at noon and you’re only free at one doesn’t mean I couldn’t have gone into a shared system and put in a note or a com-ment for you. That’s better than a system in which one physician calls, one emails, and one faxes or leaves a note on the nurse’s desk. I can’t communicate with three or four of the hospitals that use different electronic records, and one physician who prefers to use a pager and calls me back when I’m already out on the road seeing somebody else.

Mr. Starnes: Do patients need to be educated not to fear being part of a collaborative process?

Dr. Desai: I think so. I think, increasingly, you have patients who have been exposed to advocacy groups. Also, patients are increas-ingly more educated about their disease states. Patients come to me all the time and say, well, PT (physical therapy) doesn’t work for me, or chiropractic doesn’t work for me, or acupuncture doesn’t work for me. That ties back into that initial conversation we had about training and understanding what your collaborators bring to the table. I say to the patient, well, it’s not that PT doesn’t work for you, but it’s that therapist.

Mr. Johnson: I think that’s exactly right. We have a joke in physical therapy about a patient making a comment to the doctor: “I tried physical therapy, and it didn’t work.” The comeback is, “Have you tried doctoring?” It’s the individual. There is a provider in town that is absolutely selective about which therapist he sends his patients to because he’s taken the time to build a relationship. Understanding the person who’s delivering the care is really critical, and I think that’s a great point.

Dr. Desai: A lot of us who believe in multidis-ciplinary or interdisciplinary care have tak-en the time to create our own networks. I have already identified the folks I’m going to

send people to. I have preferred providers, and those are the only people I’m interested in sending patients to if I have a choice. I know at the end of the day, the patients are going to get better, and it’s going to make me look good, and everyone, so to speak, is happy at the end of that experience.

Mr. Starnes: What must be done to expand interprofessional relationships in health care delivery?

Mr. Wingrove: I think it centers on the people and the relationships between the professionals. It will go faster if we spend time on the front end managing that process well.

Mr. Hustvet: I think the most basic piece is just increased communication, whether that involves meetings, discussions, or elec-tronic communications. That’s really going to be the main driver.

Dr. Desai: In my estimation, it’s financial misalignment. Until we align the financial incentives to collaborate, there’s going to be some resistance. I think that with the Accountable Care Act and with value-based reimbursement, we’re moving in the right direction, and I think there are some really creative ideas with regards to that, but finances need to be aligned.

Dr. Sawyer: I think it has to be initiative and motivation. In other words, when I’ve got a reason to reach out, I should make that phone call or send that email and ask if we can have lunch so we can start talking about some different ways of working together.

Dr. Gulon: From the consumer point of view, I would ask patients to continue to access the system and to understand how relation-ships and overall health are interconnected and to continue to demand from the med-ical care system that which seems obvious but which may be more difficult to achieve. I think that with continued persistence, that will happen.

Dr. Hu: If I had to pick one, I would say good communication between the different specialties and the different providers. Concurrent with that would be a good understanding of the capabilities of every-one on the team and what they can do for the patient.

Mr. Johnson: I would echo those. It’s a long list, but I believe that aligning the financial incentives and relationships and under-standing what each provider does are most important.


“ I tell patients all the time, ‘I don’t have to be the one to fix you.’”

Mehul Desai, MD, MPH

Entrapment of the ulnar nerve at the elbow, or cu-bital tunnel syndrome, is

the second most common com-pression neuropathy, second only to carpal tunnel syndrome. In fact, most patients who present with symptoms of hand numbness and tingling believe their symptoms are related to carpal tunnel syndrome. Like carpal tunnel syndrome, cubital tunnel syndrome can cause extensive disability if left untreated.

Anatomy of the ulnar nerveThe ulnar nerve contains branches from the C8 and T1 nerve roots. As the terminal branch of the medial cord of the brachial plexus, it contin-ues between the medial head of the triceps and the brachi-alis muscles. Then, it becomes more superficial and enters the sulcus between the medial epicondyle and the olecranon into the cubital tunnel. The

roof of the cubital tunnel is the arcuate ligament of Osbourne or Osbourne’s ligament. The nerve then courses deep into the forearm between the ulnar and humeral heads of the flexor carpi ulnaris (FCU).

The ulnar nerve stretches and slides through the cubital tunnel when the elbow moves. As it crosses the elbow, there are several potential areas for nerve compression:

Arcade of Struthers: A band of fascia connecting the medial head of the triceps and the intermus-cular septum, about 8 cm

proximal to the medial epicondyle

Medial intermuscular septum

Medial epicondyle

Cubital tunnel: The most common area of nerve entrapment

Anconeus epitrochlearis: The anomalous muscle arises from the medial border of the olecranon and inserts into the medial epicondyle. This is found in 10 percent of patients undergoing cubital tunnel release

Deep flexor pronator apo-neurosis: Four centimeters distal to the cubital tunnel

Research has shown that maximum elbow flexion dou-bles the pressure within the ulnar nerve. Also, the anatomy of the cubital tunnel changes in shape from extension to flexion, significantly increasing the pressure within the cubital tunnel.

Subluxation of the ulnar nerve is common. About 16.2 percent of the population has ulnar nerves that subluxate over the medial epicondyle past 90 degrees of elbow flex-ion, most of them bilaterally. Subluxation does not appear to cause cubital tunnel syndrome, but the friction generated with repeated subluxation may cause intraneural inflammation. The superficial position of the nerve on the medial side of the elbow also increases the risk of injury by direct compression.

ORTHOPEDIC SURGERY

Cubital tunnel syndrome

Diagnosis and treatment

By Yesenia M. Rodriguez-Alvarez, MD


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Diagnosis of cubital tunnel syndromeAfter obtaining a thorough medical history, including in-formation about comorbidities (like diabetes, thyroid disease, or peripheral neuropathy), a physician should probe into the onset of symptoms, whether they are constant or intermit-tent and whether they get better or worse with changes in posi-tion. He or she also should ask about any subjective weakness or problems with activities of daily living, like buttoning, typing, or opening bottles. Symptoms commonly occur in patients who hold extended positions of elbow flexion (like holding a phone or sleeping with the arm crooked under the pillow) as well as in those who lean repeatedly on the medial side of the elbow on a hard surface.

Patients with intermittent symptoms experience normal nerve function at times or during certain positions. Those with constant symptoms find less predictable results of treatment.

Most patients present with numbness and tingling of the ring and small fingers. Pain is less common. In some cases, patients can’t identify the location of the symptoms but complain of trouble gripping objects or clumsiness. Often weakness and muscle atrophy are found on presentation. Patients with cubital tunnel syndrome are four times more likely to present with muscle at-rophy than patients with carpal tunnel syndrome.

Long-standing or severe disease may develop into muscle weakness or wasting. Common findings on physical exam include:

Froment’s sign: Key pinch-ing by flexing the interpha-langeal joint of the thumb to compensate for weak thumb adduction

Wartenberg’s sign: Ulnar deviation of the small finger due to interosseous muscle weakness

First dorsal interosseous muscle atrophy

Loss of finger abduction/adduction

Duchenne’s sign: Clawing of the ring and small fin-

gers due to paralysis of the lumbrical and interosseous muscles

Masse’s sign: Flattening of the dorsal metacarpal arch due to hypothenar muscle paralysis

Provocative tests for cubital tunnel syndrome include the Tinel test and the elbow flexion test. The Tinel test detects irri-tated nerves by gently tapping on a patient’s nerve to provoke a pins and needles sensation and has the highest negative pre-dictive value (98 percent). The elbow flexion test tries to repro-duce symptoms by increasing the tension of the ulnar nerve with prolonged elbow flexion. It’s also important to inspect the elbow through a full range of motion to make sure the ulnar nerve does not subluxate over the medial epicondyle with elbow flexion.

Other possible causes of elbow pain need to be ruled out, such as chronic valgus stress (in athletes with elbow instability) or signs of previous fracture, like childhood su-pracondylar fracture or adult elbow fractures. X-rays should be obtained in all patients to evaluate for elbow arthritis, as it can lead to osteophytic impingement of the nerve.

High-resolution ultrasound is being used more frequently today to visualize enlargement of the ulnar nerve as it’s seen with cubital tunnel syndrome. Ultrasound also may be helpful in peripheral nerve trauma, tu-mors within the cubital tunnel, and revision surgery.

Electrodiagnostic testing can confirm a clinical diagnosis and localize the compression site. Conduction velocities across the elbow below 50 m/s are considered positive for cubital tunnel syndrome. Other

diseases, such as peripheral neuropathy or upper motor neu-ron disease, can be ruled out.

The best way to diagnose cubital tunnel syndrome is to combine clinical data with electrodiagnostic tests. How-ever, electromyography and nerve conduction studies have a false negative rate of more than 10 percent. Recent studies have suggested that electrodi-agnostic testing is unnecessary to predict surgical outcomes, although in patients with

advanced findings, the testing can be used for prognosis and to help predict expectations for nerve and muscle recovery.

Nonoperative treatment optionsPatients with mild and/or inter-mittent cases of cubital tunnel syndrome can often be treated nonsurgically. It is important to identify provocative causes of symptoms, as avoidance of these may help eliminate symptoms. Activity avoidance or modification, splints that block maximum or repetitive flexion, and physical therapy that involves nerve mobilization techniques are the most com-monly described methods of conservative treatment.

Studies have shown that the intraneural and extraneural pressures within the cubital tunnel are lowest at 45 degrees of flexion. As a result of these studies, 45 degrees of flexion is

Cubital tunnel syndrome to page 40


Cubital tunnel syndrome, is the second most common compression neuropathy.

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Barrett’s esophagus (BE) is a potentially precancer-ous condition that results

from chronic gastroesophageal reflux disease (GERD). In BE, the normal mucosa of the distal esophagus (stratified squamous epithelium) after continued injury from reflux may not be repaired with squamous epithe-lium, instead it is replaced by metaplastic columnar mucosa which is similar to the small intestine, therefore called intestinal metaplasia. First described by Norman Barrett, an Australian-born British tho-racic surgeon in 1950, Barrett’s esophagus has generated great clinical interest because of the rapid rise in rates of esophageal adenocarcinoma (EAC), which is the ultimate complication of BE.

There have been significant advancements in the diagnosis, surveillance, and treatment of all the stages of BE. These de-velopments have led to the need for highly specialized multidis-ciplinary teams with expertise in esophageal disorders and

with a particular interest in BE. These teams commonly in-clude pathologists, radiologists, gastroenterologists, and sur-geons; their main objective is to provide a consensus on diagno-sis and treatment especially on complex cases.

PathogenesisThe prevalence of BE is estimat-ed to be around 5 to 20 percent of the general population, de-pending on the study you look at. It is difficult to ascertain a more precise prevalence, since BE does not have any specific symptoms. Once a person with BE experiences symptoms such as difficulty swallowing, pain upon swallowing, or weight loss, there is great concern that it might already have

progressed to EAC. Since there are no specific symptoms that would alert the person or the physician of BE, it carries the risk of being diagnosed late when there has already been progression to EAC.

There are many well-known risk factors that help guide the physician in deciding who needs evaluation for BE, with the ultimate goal to treat and avoid progression to EAC. BE is most commonly diagnosed in mid-dle-aged Caucasian males. It affects men two to three times more often than women. It is more common in Caucasians and Hispanics, and is uncom-mon in Blacks and Asians. GERD is considered to be the most important risk factor. Other risk factors include smok-ing, obesity (more importantly intra-abdominal fat distribution with central obesity), metabolic syndrome, hiatal hernia, erosive esophagitis, and consumption of red meat and processed meat.

Diagnosis BE is diagnosed by obtaining biopsies of the esophagus dur ing upper endoscopy. Biopsies should be taken of the columnar epithelium-appearing tissue in the distal esophagus. In the U.S., the presence of intestinal metaplasia in the biopsies is required to diagnose BE. In tes tinal metaplasia has been a well-established risk factor for development of adenocarcinoma.

Once the diagnosis of BE has been made, the patient should be evaluated by a gas-troenterologist who specializes in BE. This field has advanced greatly in recent years, allowing specialists to appropriately clas-sify the disease and effectively prevent the ultimate complica-tion of EAC.

New techniques have been developed, such as endoscop-ic mucosal resection (EMR), which allows the appropriately trained gastroenterologist to

safely resect large specimens endoscopically. This is particu-larly important when there are nodules, ulcerations, or other concerning findings that require a larger biopsy specimen for accurate staging.

In the last decade, the endoscopic equipment used to evaluate Barrett’s disease has greatly improved. High-reso-lution endoscopes with special focus systems and image pro-cessing techniques have enabled the physician to better target the biopsies and obtain a more accurate classification of BE.

StagingAccurate staging or classifi-cation of Barrett’s disease is essential and dictates the type of treatment needed. BE can be classified as nondysplastic, low-grade dysplasia, high-grade dysplasia, and EAC. The high-er the degree of dysplasia, the higher the risk of progression into EAC.

The annual cancer incidence in patients with BE ranges from 1 to 2 percent, but the risk of de-veloping EAC compared to the general population is thought to increase thirtyfold. Specifically for patients with high-grade dysplasia, the rate of develop-ment of cancer is 4 to 8 percent per year.

The extent of BE or co-lumnar metaplasia is another important distinction. A major-ity of patients with short-seg-ment BE less than 3 cm will not have classic GERD symptoms or esophagitis. Patients with long-segment BE commonly have a history of severe GERD and erosive esophagitis. The risk of developing high-grade dysplasia or cancer is higher in long-segment BE compared to short-segment BE.

TreatmentOver the past decade, there have been great advancements in the treatment of Barrett’s esophagus. Guidelines have been developed to determine the appropriate treatment and also to prevent overtreatment of BE, as not every patient with BE will develop EAC. Current guidelines recommend that all patients with symptomatic reflux should receive medical treatment to

Barrett’s esophagusA look at significant therapeutic advances

By Jose Vega-Peralta, MD

PROFESSIONAL UPDATE: GASTROENTEROLOGY


Read usonlineWherever you are!

www.mppub.com

control reflux symptoms. This is most commonly achieved with a proton pump inhibitor. It is still not recommended to proceed with antireflux surgery on every patient with BE as current data do not show surgery to be superior to medical therapy at preventing EAC. However, in patients who have medication refractory reflux or patients who have BE that cannot be eradi-cated, antireflux surgery has to be considered.

Treatment of BE is deter-mined by the degree of dyspla-sia present on the biopsies. In patients with nondysplastic Bar-rett’s, no endoscopic treatment is currently recommended and a surveillance endoscopy should be repeated in three to five years with appropriately protocolized biopsies. Low-grade dysplasia should be confirmed by a second pathologist and a repeat surveil-lance endoscopy can be done in six to 12 months where repeat biopsies or endoscopic treatment can be offered to treat and erad-icate the Barrett’s tissue. For high-grade dysplasia, endoscop-ic treatment is strongly encour-aged to eradicate the intestinal metaplasia. If the patient does not want to undergo treatment, then a repeat surveillance en-doscopy with biopsies should be done in three months’ time.

Treatment options for BE with high-grade dysplasia range from esophagectomy to endo-scopic treatment. Due to the high morbidity and the risk for complications from esophagec-tomy and the efficacy of the new endoscopic treatments, esophagectomy is rarely done for high-grade dysplasia. Endo-scopic treatment is the preferred treatment modality for high-grade dysplasia. Endoscopic treatments include ablation techniques or endoscopic resec-tion of the Barrett’s tissue. The current available endoscopic ablation techniques are radio-frequency ablation (RFA), pho-todynamic therapy (PDT), and endoscopic spray cryotherapy.

RFA, using the Barrx catheters (previously known as HALO), is the most com-monly-used technique to treat BE as it has been extensively studied and found to be safe

and effective at eradicating BE. Eradication of BE with RFA has been shown to reduce the inci-dence of EAC. The procedure is done during an upper endosco-py using catheters that can be attached or passed through the scope. These catheters contain closely-spaced electrodes that generate a controlled thermal injury, ablating the precancer-ous tissue. It takes an average of three to four RFA ablation

procedures, three months apart, to completely eradicate the BE.

PDT is a technique in which chemical agents are intrave-nously administered to the patient. Approximately 24 to 48 hours after injection, a catheter is used to emit a specific light and the agent is stimulated to produce cytotoxicity in the pres-ence of oxygen, which leads to the destruction of the BE. PDT carries higher esophageal stric-ture rates and is less frequently utilized now that less toxic methods are available.

Endoscopic spray cryo-therapy is another ablation technique. Cold nitrogen or carbon dioxide are endoscopi-cally delivered to the BE. This freezes the tissue and ablates the BE. Cryotherapy is a newer and promising technique, but it remains unproven due to the small number of studies con-ducted at this point.

Not every BE with high-grade dysplasia should be treated the same way. Nodules or ulcerations represent early EAC and should not be ablat-ed. Instead the tissue should be endoscopically removed en bloc for further evaluation, as it could be early cancer.

Endoscopic resection tech-niques to treat BE include endo-scopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The main difference between both tech-niques is the depth and size of resection. During EMR, the mu-cosa is resected but not always the submucosa. This procedure is faster and has lower risks of perforation and bleeding. ESD

resects the mucosa and submu-cosa but carries a higher risk of perforation and bleeding. Both techniques lead to resection of large segments of mucosa, which can be therapeutic and also provide a larger specimen to the pathologist, resulting in improved staging. After eval-uation by a multidisciplinary esophageal group, early intra-mucosal adenocarcinoma can be treated with EMR or ESD.

The multidisciplinary Esophageal GroupAt the University of Minnesota, the Esophageal Group holds a weekly multidisciplinary esophageal conference devoted solely to esophageal disorders, attended by gastroenterologists, esophageal/thoracic surgeons, minimally invasive surgeons, radiologists, and pathologists. At this conference, challenging cases are co-managed by this

multidisciplinary team. Such collaboration has enabled the development of novel mini-mally invasive methods of treating esophageal diseases, particularly complications of esophageal surgery and endoscopic procedures.

ConclusionsBarrett’s esophagus is a complex disease for which significant advances have been made and are ongoing. The diagnosis, surveillance, and treatment of all stages of BE has greatly evolved to the point that cancer can potentially be prevented or detected and treated at an early stage in a minimally invasive way. Barrett’s esophagus should be managed by a multidisci-plinary team with expertise in esophageal disorders.

Jose Vega-Peralta, MD, is an inter-ventional gastroenterologist. He is assistant professor of medicine and the medical director of the Multidis-ciplinary Esophageal Program at the University of Minnesota.


BE does not have specific symptoms.

Join our teamAt Allina Health, we’re here to care for the millions of patients we see each year throughout Minnesota and western Wisconsin.

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MEDICINE AND THE LAW


As seems to be the case every year, no legislative session ever plays out the

same way, and the 2015 legisla-tive session was no exception. For the second time in the last five years, the Minnesota Legis-lature went to a special session to complete work on putting together a budget. But the 2015 special session had a far differ-ent feel and dynamic than the one in 2011, both in terms of the political divide and the fact that the special session met outside of the Capitol building for the first time in over 110 years. Di-vided control of the Legislature with a Republican-controlled House and a DFL-controlled Senate, and interesting dynam-ics with the governor, saw com-peting spending philosophies and budget proposals despite a $1.8 billion surplus. The last few days of this session proved to be the most interesting witnessed by Capitol watchers in years.

At the beginning of the session and up until late April, many expected the Legislature

to focus on a long-term trans-portation funding package and a tax package. Yet by the end of session, the prospects of pass-ing either became a victim of necessity as budget negotiations broke down and the final tenu-ous agreement left a significant portion of the surplus on the bottom line for the 2016 session. The vastly different approaches taken by the House and Senate in providing transportation funding and tax relief were just a preview of the differences in many of the other budget bills, including the Health and Human Services (HHS) budget bill—which appeared to be in the most peril in early May.

During the final weeks, the gap that existed between the House and Senate HHS budgets topped $1.4 billion. In spite of this drastic divide, the final budget proved to be relatively uncontroversial. In a welcome change from more recent budget years, the HHS budget bill was not one of the issues hanging in the balance as the Legislature headed to a special session in June.

Provider tax hangs in the balanceThe final target for the HHS budget was a $329 million cut, which at first glance seemed rather daunting in the face of a very large surplus. Legislative leaders and the respective Health and Human Services Finance Committee chairs—Rep. Matt Dean (R–Dellwood) and Sen. Tony Lourey (D–Ker-rick)—used existing provider tax revenues or more specifically al-most $450 million that remained in the Health Care Access Fund to make up for the cut. One of the concerns of the provider community for years now has been the constant raiding of the Health Care Access Fund to pay for other general fund spending. This year there seemed to be less overt concern, in large part because the Health Care Access Fund revenues were used to fund other priorities in health care. Ultimately, the HHS budget maneuvering might have been the easiest part of the Health Care Access Fund and provider tax discussion this session.

As each legislative session passes, the scheduled repeal of the provider tax in 2019 gets closer and closer and the question of what to do with the MinnesotaCare program be-comes more of a reality. House Health and Human Services Finance Committee Chair Rep. Dean and other House Republi-

cans attempted to move up the discussion on the provider tax by proposing a repeal of the cur-rent MinnesotaCare program, citing the uncertain future of the program’s funding source. The governor’s administration and the Senate Democrats made it very clear throughout the ses-sion that they would not agree to a repeal, but it certainly raised a number of issues that a new Health Care Finance task force and future Legislatures will ad-dress. Some of these questions include: 1) Will the provider tax in fact be repealed? 2) Will current eligibility in Minneso-taCare be trimmed back in the future? 3) Will those individuals enrolled in MinnesotaCare be moved to the private market for health coverage if need be? 4) Will the state continue to make use of MinnesotaCare as a basic health plan qualifying for federal matching dollars? Each of these issues will only become more difficult to address for leg-islators as 2019 creeps closer.

What else was in the budget?As a result of using one-time money in the Health Care Access Fund, the HHS budget actually made a number of important investments this session. The largest amount of new spending came in the form of significant rate reforms to the state’s nurs-ing homes. The rate reforms had broad bipartisan support and are politically very important—particularly for many of the newly-elected rural members. Mental health funding was also a major focus of the HHS budget this session. In total, just under $30 million in new spending was dedicated to stabilizing mental health payments, increasing capacity for community mental health treatment options, and improving access to mental health crisis services. This new spending is only the beginning of what will likely be a multi-year effort to reform the state’s mental health system, including difficult decisions that will have to be made in future years about potentially closing state-operat-ed facilities in Fergus Falls and Willmar and the future of the security hospital in St. Peter.

The 2015 legislative wrap-up

Another special session

By Nate Mussell, JD

The 2015 legislative wrap-up to page 36

Allergy/Immunology

Dermatology

EmergencyMedicine

Medicine

Hospitalist

Hospice

Med/Peds

Ob/Gyn

Psychiatry

Rheumatology

April 2015 Minnesota Physician 37

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For many physicians and medical students, some of the new funds to help alleviate future health-care workforce shortages might be the most im-portant new spending to come out of this session. The HHS budget included just over $2 million for loan forgiveness pro-grams; an additional $1 million per year for the state’s Medical Education and Research Costs program; $1.5 million for a new primary care physician residen-cy program; and $1 million for a foreign-trained physician res-idency program. Many of these issues came from the Health Care Workforce task force rec-ommendations. You can expect to see continued focus on some of these programs in the future.

MNsure—lots of talk, little actionAnother issue that many ex-pected to receive considerable attention during this session wasMNsure—the state’s health

insurance exchange. MNsure had been the target of signifi-cant criticism during the fall and winter months as many around the Capitol eagerly

awaited the Legislative Auditor’s evaluation. The Senate Demo-crats proposed elimination of the current MNsure board and centralization of the adminis-tration of the exchange in a new state agency—a recommenda-tion that was front and center in the Legislative Auditor’s report that came out midway through the session. That change gained little support among House Re-publicans who favored either a move to the federal exchange or a change to allow subsidies for coverage purchased outside of the exchange. Ultimately, neither

the House nor the Senate could agree to any of these changes so little of consequence actually happened with MNsure.

Other bills of interestThe Legislature passed an al-most historically low number of bills this year—a trend seen in recent years due to divided gov-ernment. Some bills were com-bined into larger omnibus bills, while others were passed as standalone bills. Even with the small number of bills passed, a few are important to point out.

The Interstate Physician Licensure Compact Minnesota was one of a num-ber of states to introduce and eventually pass the Interstate Medical Licensure Compact this session. This legislation allows for states entering into the compact to provide an expedited licensure process for physicians who practice in multiple states, while at the same time maintaining each state’s existing requirements for licensure and oversight. In total, seven states needed to pass the compact before it became effective. Alabama became the seventh state to pass the com-pact while Minnesota followed shortly thereafter. Since the end of session, Nevada also passed the compact, while a number of other states continue to debate the issue in their respective legislatures.

TelemedicineContinuing with the theme of improving access to health care, legislation was passed this session creating parity in the payment for telemedicine services. Beginning in January of 2017, health plans sold in Minnesota will be required to pay for telemedicine services at the same rate at which they would pay for the same service if it was delivered in person. Medical Assistance and Medicare both currently

cover telemedicine services, but language was added this session to limit the number of telemed-icine services to three times per week. There was certainly some pushback from the health plans throughout the process most notably concerning a fee for the site of origination, which was not included in the final language. The broad bipartisan support for the importance of telemedicine helped bring about these important changes for health care providers across the state this session.

Prior AuthorizationOne of the high profile health care bills that did not pass this session was brought forward by the physician community to reform the current process for prior authorization of pre-scription drugs. The legislation would have made changes to the transparency of prescription drug coverage, limit changes made to prescription drugs during a coverage year, and improve access to necessary prescription drugs by removing some of the barriers in prior approval. Although the bill saw progress in the Senate following a number of hearings, the bill did not move forward in the House largely due to significant objections by health plans and pharmacy benefit companies. This will certainly be an issue to watch in 2016.

What’s Ahead?If the 2015 legislative session was unique in its political dy-namics and space limitations, the 2016 session will almost assuredly top it. The Capitol building will be closed for the entire year, leaving the Legisla-ture to meet in the newly-con-structed Senate office building. On top of that, the Legislature will not meet until the first week in March, in large part because of the Capitol closure, so you can brace for a very fast-paced two months where just about anything could happen.

Nate Mussell, JD, is with the Minne-sota law firm of Lockridge Grindal Nauen, PLLP. The firm provides legal and government relations services to a variety of health care providers.

The Legislature passed an almost historically low

number of bills this year.

The 2015 legislative wrap-up from page 34

Family Medicine

St. Cloud/Sartell, MN

We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an outpatient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals.

Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal.

HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefi t package, paid malpractice and a commitment to providing exceptional patient-centered care.

Apply online at healthpartners.com/careers orcontact [email protected]. Call Diane at 952-883-5453; toll-free:800-472-4695 x3. EOE

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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

The VAHCS is currently recruiting for the following healthcare positions in the following location.

EndocrinologistENT (part-time)Emergency MedicineGeriatrician (part-time) HospitalistNeurologistOncologist/Hematologist

Orthopedic SurgeonPrimary Care (Family Practice or Internal Medicine)PsychiatristPulmonologistUrologist (part-time)

Urgent Care

We have part-time and on-call

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medicine pediatric (Med-Peds)

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Family or Internal Medicine Physician

An ideal balance between your professional and personal life. Provide comprehensive care in a clinical and hospital practice. ER coverage available, but not required.

GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cites.

For more informationCall Kirk Stensrud, CEO320.634.4521

Mail CV to:Kirk Stensrud, CEO10 Fourth Ave SEGlenwood, MN 56334

Email CV to:[email protected]

For additional information, contact Dr. Kathy Brandli, President, at [email protected] or

Eric Nielsen, Administrator, at [email protected] or 218.485.2000

www.gatewayclinic.com

Physician-owned Gateway Clinic seeks a family medicine physician to join our new Hinckley clinic. 3 or 4-day week practice with shared hospital call. Full-scope primary care and clinic OB practice (prenatal and postpartum care in clinic, option for colleagues to cover OB call and deliveries). Generous salary with sign-on and retention bonus, outstanding benefit package, 15% retirement contribution. Shareholder opportunities available.Gateway Clinic has locations in Moose Lake, Sandstone and Hinckley. Centrally located between Mpls/St. Paul and Duluth, the area provides an excellent family focused, quality of life opportunity in a rural setting with good public schools and abundant with lakes, rivers, state parks, and ideal hunting - all within an hour to metropolitan conveniences.

Family Medicine with Clinic OB


Resources for physicians Mental health issues and illnesses affect people of all ages, socio-economic classes, and racial and ethnic groups. Stigma continues to be a significant barrier across the groups, which prevents individuals with mental health concerns from seek ing help or appropriate medical care. Physicians play a critical role in help-ing people experiencing mental health crises or issues. Often a physician is the first professional that an individual may confide in. Assuring individuals that mental health issues are common and treatable, especially when caught early, is an important first step.

If patients are concerned about their insurance coverage, the best advice is to tell them to call the customer service number on the back of their

health insurance card. Custom-er service representatives will be able to answer questions about specific coverage, infor-mation about deductibles, and whether providers are in or out of network. They’ll even help schedule an appointment with a behavioral health provider.

NAMI Minnesota (www.namihelps.org) is a good source of information. NAMI provides free classes to families and professionals, has a helpline, provides free peer-led support groups, offers presentations to

the public to raise awareness on mental illnesses, and has great written resources on their website.

The Institute for Clinical Systems Improvement (ICSI) (www.icsi.org/for_patients/depression_care/) has advice on screening and care for those

with depression. ICSI uses a short questionnaire (PHQ-9) to identify depression and offers a protocol, based on medical evidence, to support care and recovery. ICSI also provides information on the use of

SBIRT, a screening and early intervention tool to reduce risky alcohol and drug use. SBIRT includes a way to identify people at risk for substance use disorders, a brief intervention to raise awareness of the risks, and referrals to treatment for those who need additional care.

For more infor-mation about CCH or the Collective Action Committee, please visit our website at www.mnmetrocch.org.

Janny Brust, MPH, is director of medical policy and community affairs at the Minnesota Council of Health Plans. She is on the Executive Committee for the Center for Community

Health and serves as co-chair of its Collective Action Committee. Bonnie Brueshoff, DNP, RN, PHN, is director for the Dakota County Public Health Department in West St. Paul. She is a committee member of the Center for Community Health and the Collective Action Committee.

Physicians play a critical role in helping people experiencing mental health crises

or issues.

www.olmstedmedicalcenter.org

Olmsted Medical Center, a 220-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital,

Opportunities available in the following specialties:

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

Spring Valley Clinic

Communities

OB/GYNHospital – New Women’s Adolescence

Hospital

The Center for Community Healthfrom page 17


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

US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Applicant(s) selected for a position

may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction

Program. Possible recruitment bonus. EEO Employer.

For more information:

Human Resources4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

Compensation &

Primary Care

Applicants must be BE/BC.

St. Cloud VAHealth Care SystemBrainerd | Montevideo | Alexandria

MAYO CLINIC HEALTH SYSTEM is a family of clinics, hospitals, and other health care facilities serving more than 60 communities in Minnesota, Iowa, and Wisconsin. Mayo Clinic Health System links the expertise of Mayo Clinic in practice, education and research with the health-delivery systems of our local communities.

The Northwest Wisconsin Region opportunities include:

Dermatology Occupational Medicine Emergency Medicine Ophthalmology (General & Glaucoma) Family Medicine Orthopedics General Surgery Pediatrics Hospitalist Psychiatry (Adult & Child) Internal Medicine Pulmonary/Critical Care Nephrology Urgent Care Neurology Urology Neuropsychology

Mayo Foundation is an affirmative action and equal opportunity employer and educator.

If you wish to learn more or to express interest in these positions, please contact us at 800-573-2580; email

[email protected]; or apply at http://www.mayoclinic.org/jobs/physicians-scientists

Please contact or fax CV to:

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

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Join the top ranked clinic

in the Twin CitiesA leading national consumermagazine recently recognizedour clinic for providing the bestcare in the Twin Cities based on quality and cost. We are currently seeking new physicianassociates in the areas of:

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considered to be the optimum position for immobilization of the elbow to decrease pressure on the ulnar nerve. Because of this, either a splint that keeps the elbow extended or one that blocks more than 45 degrees of flexion can be used to help prevent nerve inflammation due to tension and increased pressures. This is why it is so important to advise patients to avoid positions or activities that involve repetitive or persistent elbow flexion over 45 degrees. Also, it is important to advise patients about the need to avoid positions that may cause direct compression of the ulnar nerve against hard surfaces.

Operative treatment optionsSurgery is indicated if symp-toms are constant, there is mus-cle atrophy or motor weakness, or if conservative treatments fail to bring relief. There is

no gold standard for surgical treatment of cubital tunnel syn-drome, but six techniques are more commonly used:

In situ decompression: An incision is made along the ulnar nerve to release Os-bourne’s ligament and the FCU superficial and deep fascia. The ulnar nerve is retained in its bed, and it is not dissected from the sur-rounding connective tissue.

Subcutaneous anterior transposition: This surgery moves the nerve in front of the elbow axis of flexion, decreasing tension on the nerve. It also decreases pressure caused when the cubital tunnel volume is decreased.

Intramuscular trans po-si tion: This technique is sometimes used along with anterior transposition of the nerve. The nerve is placed within the flexor-pronator muscle mass.

Submuscular transposition: This surgery is the most extensive and requires the largest incision. The nerve is placed beneath the flexor-pronator mass.

Medial epicondylectomy: The nerve is decom-pressed as in in situ decompression, but the medial epicondyle is also partially resected to decrease inflammation in subluxating nerves.

Endoscopic decompres-sion: An endoscope is used to cut any fascial constrictions over the ulnar nerve. Many different techniques are described and permit the use of smaller incisions.

The most common com-plications seen with surgical treatment are injury to cutane-ous nerves and nerve scarring. The posterior branch of the medial antebrachial cutaneous nerve should be protected to

avoid injury. Subluxation is sometimes seen after simple decompression.

OutcomesCubital tunnel syndrome is a common nerve compression syndrome with a variety of treatment options. Multiple sur-gical options exist for patients who fail non-surgical treatment or those with severe disease. Selection of a surgical approach is based on the etiology of the nerve compression, anatomic variations, and surgeon’s choice. Good results can be obtained with complete decom-pression of the nerve, with or without transposition.

Yesenia M. Rodriguez-Alvarez, MD, is an orthopedic surgeon at Summit Orthopedics, specializing in hand, wrist, and elbow inju-ries. She sees patients in St. Paul, Eagan, Hastings, and at the Apple Valley Medical Center.

Cubital tunnel syndrome from page 31


Physician Practice Opportunities

www.averamarshall.org

For details on these practice opportunities go to http://www.avera.org/marshall/physicians/For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691 [email protected]

Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership.

Currently we are seeking to add the following specialists:PsychiatristPsychologistOrthopedic SurgeonGeneral Surgeon

Family MedicineInternal MedicineOBGYN

Avera Marshall Regional Medical

Center300 S. Bruce St.

Marshall, MN 56258


The perfect matchof career and lifestyle.

www.acmc.com |

FOR MORE INFORMATION:

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

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

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Renville County Hospital & Clinics is looking for a BC/BE Family Medicine Physician. RCHC is

25-bed Critical Access Hospital with three clinics committed to quality, evidence-based care and

exceptional patient satisfaction. Current call is 1:4.

Excellent compensation. Enhanced physician

included with this position.

Contact: Lynette Bernardy611 East Fairview Avenue, Renville, MN 56277

[email protected]

Family Medicine & Emergency Medicine Physicians

Great Opportunities

[email protected]

www.lakewoodhealthsystem.com

Lakewood Health System is seeking to expand the care team for its progressive and patient-focused clinics and hospital. Located in Staples, Minnesota, Lakewood is an independent, growing healthcare system

facilities. Practice consists of 14 family medicine physicians and 10 advanced practice clinicians, as well as a variety of on-staff specialists.

Visit www.lakewoodhealthsystem.com, or contact Brad Anderson at 218-894-8587 or [email protected].

POSITIONS AVAILABLE:INTERNAL MEDICINE– No call

EMERGENCY MEDICINEFAMILY MEDICINE– Full-scope practice avail.

SURROUNDED BY LAKES

Erik Dovre, OB/GYN


is similar, providers in rural settings see patients who have traveled an average of 53 miles. From a patient perspective, patients in less populated areas travel two to three times the distance to their provider than patients within metropolitan areas. Average travel distance is an imperfect way to measure the degree to which patients travel to obtain certain care. It has the potential to mask a large dis-tribution in the burden of travel faced by patients. For instance, while average travel distance for patients receiving care from rural providers is calculated at 53 miles (the distance between patient to provider ZIP code cen-troids), some patients between 2010 and 2012 traveled as far as 118 miles. Average travel dis-tance is provided in this study to provide general context.

According to provider detail reported on billing data, pain specialists and physicians with pain-related specialties provided the vast majority (86.1

percent) of all chronic pain procedures. Physician pain spe-cialists have additional training and certification in pain med-icine. Physicians without this additional certification but who practice within fields primarily treating patients with acute and chronic pain are classified as pain-related specialties for this analysis and these specialties include: anesthesia, neurology, physical medicine, orthopedic and neurological surgery, and radiology. Primary care physi-cians, internal medicine, family practice, or general medicine specialties, delivered 8.2 percent, and CRNAs provided 1.6 percent. Figure 2 on page 21 shows that physicians who are pain specialists delivered primarily paravertebral facet

joint injections, (28.7 percent) and epidurals (34.1 percent). Primary care physicians mainly performed tendon injections or trigger point injections (68.6

percent) and somatic nerve blocks (16.3 percent). Chronic pain services provided by CRNAs were composed of 57.6 percent epidural in-jections, 15.7

percent somatic nerve blocks, and 18.1 percent trigger point injections.

Physician providers of chronic pain management services deliver care predomi-nantly in physician office settings, ranging from 53.9 percent to 84.1 percent of all chronic pain procedures by physician specialty, as shown in Figure 3 on page 21. In contrast, 97.4 percent of pain management services delivered by CRNAs are provided in outpatient hospital settings.

As noted earlier, the volume of chronic pain procedures between 2010 and 2012 rose by about 13.2 percent. Primary Care physicians saw the highest growth in the volume of ser-vices provided over this period (22.2 percent). Physicians who are pain specialists or prac-tice in a pain-related specialty saw in aggregate double-digit growth in chronic pain man-agement services they provided (15.8 percent and 11.3 percent respectively). In contrast, the volume of these procedures delivered by CRNAs declined 5 percent from 2010 to 2012. There are a variety of possible reasons for this decline, in-cluding retirement of certain CRNAs that provided high volumes of services, a refocus on delivering other procedures, and scope-of-practice barriers. To some extent, changes in billing or coding practices could also contribute to this trend.

ConclusionsTaken together, the findings from the study provide a

descriptive analysis of the vol-ume and distribution of chronic pain procedures provided in Minnesota. Relying on the most comprehensive available administrative claims data for Minnesota, the MN APCD, the study shows that the volume of chronic pain procedures has increased over the three-year period studied. The study also shows the fastest volume growth occurred among pri-mary care physicians, followed by pain specialists. CRNAs, who account for a small share of the volume of chronic pain proce-dures delivered (1.6 percent), in part because few focused on delivering these services, saw an actual decline in delivering chronic pain management services.

Despite the increase in the volume of chronic pain pro-cedures delivered by primary care physicians, access to pain procedures and pain special-ists varies by geography across the state. For example, rural patients accessing pain proce-dures faced travel times nearly twice as long as urban patients. Potential geographic challenges in access to services might be particularly significant for patients requiring chronic pain management procedures, be-cause of the challenges associ-ated with traveling while in pain or in treatment for pain. The 2015 Minnesota Legislature has shown an interest in engaging on health care workforce issues. Stay tuned to see if it reaches to the delivery of chronic pain management services!

The full report on chronic pain pro ce dures in Min ne-so ta is available at http:// www. health. state. mn. us/ divs/ hpsc/ hep/ 20150120 Chronic Pain Procedures Mn. pdf. Ad di tion al in for ma tion about the MN APCD may be examined at http:// www. health. state. mn.us/ healthreform/ allpayer.

Tami Swenson, MA, is a senior re-search scientist in the Health Econom-ics Program (HEP) at the Minnesota Department of Health (MDH). Stefan Gildemeister, MA, is the state health economist and director of the Health Economics Program at MDH.

One Hundred million Americans

are affected by chronic pain.

Chronic pain treatment from page 21

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Documents

Minnesota Physician July 2015