Minnesota Physician July 2015 by Minnesota Physician Publishing

Vo l u m e X X I X , N o . 4 J u l y 2 015

Compassionate use exemption Expanded access to investigational drugs By Richard Klein; Deborah Miller, PhD, MPH, MSN, RN; Colleen LoCicero, RPh; and Peter Lurie, MD, MPH

he Food and Drug Administration (FDA) has a long history of allowing access to potentially promising new therapies for patients with few therapeutic options. Physicians can submit expanded access requests to FDA concerning the treatment of a speciﬁc patient. This article will explain how this process works and describe proposed changes that will facilitate access.

The Center for Community Health Maintaining the zone of mental health stability By Janny Brust, MPH, and Bonnie Brueshoff, DNP, RN, PHN

ospitals, health plans, local public health departments, and community groups are working together to improve the mental 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 mental 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

The purpose of expanded access The purpose of expanded access, sometimes called “compassionate use exemption,” is to provide 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 investigational 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 to page 18

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.

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An approach to consider for type 2 diabetes therapy starts here

Trulicityâ&#x201E;˘ 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.

Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance 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.

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. JULY 2015 MINNESOTA PHYSICIAN

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

*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 representative or visit Trulicity.com.

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.

Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance 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.

DG95134

02/2015 PRINTED IN USA

MINNESOTA PHYSICIAN JULY 2015

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 conﬁrmed. Consider other antidiabetic therapy in patients with a history of pancreatitis. Please see Important Safety Information continued on following page.

Important Safety Information, continued

Once-weekly Trulicity 1.5 mg showed signiﬁcant A1C reduction1

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.

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. A1C reduction from baseline

8.4

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.

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.

8.2 8.0 7.8

LS mean A1C (%)

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.

7.6

Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential beneﬁt outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

-0.5

7.4 7.2 7.0

‡

-1.0

6.8

-1.3* † -1.5*

†

6.6 6.4

93% fewer injections3

6.2 Baseline

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%).

1-3

Week 13

Week 26

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%) 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

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.

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.

JULY 2015 MINNESOTA PHYSICIAN

TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS @ 5 4)3- )5, .-4)3- 8):9 ,;3)/3;:1,- +);9-9 ) ,69- 8-3):-, )5, :8-):4-5: ,;8):165 ,-7-5,-5: 15+8-)9- 15 :0- 15+1,-5+- 6. :0?861, +-33 :;4689 ),-564)9 )5, +)8+1564)9 ).:-8 31.-:14- ->769;8- : 19 ;5256=5 =0-:0-8 $8;31+1:? +);9-9 :0?861, +-33 :;4689 15+3;,15/ 4-,;33)8? :0?861, +)8+1564) $ 15 0;4)59 )9 0;4)5 8-3-<)5+- +6;3, 56: *- ,-:-8415-, .864 +3151+)3 68 565+3151+)3 9:;,1-9 @ $8;31+1:? 19 +65:8)15,1+):-, 15 7):1-5:9 =1:0 ) 7-8965)3 68 .)413? 019:68? 6. $ )5, 15 7):1-5:9 =1:0 ;3:173- 5,6+815- -673)91) 9?5,864- :?7- "6;:15- 9-8;4 +)3+1:6515 68 :0?861, ;3:8)96;5, 4651:6815/ 19 6. ;5+-8:)15 <)3;- 15 7):1-5:9 :8-):-, =1:0 $8;31+1:? 6;59-3 8-/)8,15/ :0- 8192 .)+:689 )5, 9?47:649 6. :0?861, :;4689 INDICATIONS AND USAGE Trulicityâ&#x201E;˘ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 141:):1659 6. %9- 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 "192 6. $0?861, +-33 $;4689 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 peptideÂ (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 MTCÂ 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 >50Â 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. !)5+8-):1:19 In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitisrelated 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 5Â cases of confirmed pancreatitis inÂ 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. ?76/3?+-41) =1:0 65+641:)5: %9- 6. 59;315 #-+8-:)/6/;-9 68 59;315 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. ?7-89-591:1<1:? "-)+:1659 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. "-5)3 47)184-5: 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 )9:8615:-9:15)3 19-)9- 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. TrulicityTM (dulaglutide) DG HCP BS 12NOV2014

MINNESOTA PHYSICIAN JULY 2015

)+86<)9+;3)8 ;:+64-9 There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS 3151+)3 #:;,1-9 >7-81-5+- 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 â&#x2030;Ľ60mL/min/1.73 m2) in 96.0% of the pooled study populations. ,<-89- "-)+:1659 15 !3)+-*6 65:8633-, $81)39 "-768:-, 15CB 6. $8;31+1:? $8-):-, !):1-5:9 Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5Â mgÂ (N=834) (listed as placebo, 0.75 mg, 1.5 mg) nausea (5.3%, 12.4%, 21.1%), diarrheaaÂ (6.7%,Â 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%,Â 9.4%),Â decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%,Â 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 ReactionsÂ : In the pool of placebo-controlled trials, gastrointestinal adverse reactionsÂ occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75Â mg 31.6%, 1.5Â mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5Â 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 â&#x20AC;&#x153;mildâ&#x20AC;? in 58% and 48% of cases, respectively, â&#x20AC;&#x153;moderateâ&#x20AC;? in 35% and 43% of cases, respectively, or â&#x20AC;&#x153;severeâ&#x20AC;? in 7% and 11% of cases, respectively. In addition to the adverse reactions Â â&#x2030;Ľ5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75Â mg; 1.5Â 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 56Â 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 8.2Â years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renalÂ function was normal or mildly impaired (eGFR â&#x2030;Ľ60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and activecontrolled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as â&#x2030;Ľ5% above. Other Adverse Reactions: HypoglycemiaÂ : 5+1,-5+- 6. 6+;4-5:-, #?47:64):1+ A C4/ , 3;+69- $08-9063, )5, #-<-8- ?76/3?+-41) 15 !3)+-*6 65:8633-, $81)39 C Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75Â 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%Â 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 ReactionsÂ : 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 0.75Â mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of â&#x2030;Ľ15 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.Â ImmunogenicityÂ : 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 dulaglutideneutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies 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 K "=5>A< ?0C84=CB C70C +AD;828CH 20DB4B 14=86= 0=3 <0;86=0=C C7HA>83 24;; CD<>AB 8= A0CB 0=3 C70C 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. K "=5>A< ?0C84=CB C70C ?4AB8BC4=C B4E4A4 013><8=0; ?08= C70C <0H A0380C4 C> C74 102: 0=3 F7827 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 B4E4A4 013><8=0; ?08= >22DAB K +74 A8B: >5 7H?>6;H24<80 <0H 14 8=2A40B43 F74= +AD;828CH 8B TrulicityTM (dulaglutide) DG HCP BS 12NOV2014

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 C74A0?H ?0AC82D;0A;H F74= 2>=2><8C0=C;H 03<8=8BC4A43 F8C7 0 BD;5>=H;DA40 >A 8=BD;8= K (0C84=CB 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 A4=0; 508;DA4 >22DAB K "=5>A< ?0C84=CB C70C B4A8>DB 7H?4AB4=B8C8E8CH A402C8>=B 70E4 144= A4?>AC43 during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions >22DA ?0C84=CB <DBC BC>? C0:8=6 +AD;828CH 0=3 B44: <43820; 03E824 ?A><?C;H K 3E8B4 ?0C84=CB C> 8=5>A< C748A 740;C720A4 ?A>E834A 85 C74H 0A4 ?A46=0=C >A 8=C4=3 C> 142><4 ?A46=0=C K (A8>A C> 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 8;;DBCA0C8>=B K "=5>A< ?0C84=CB >5 C74 ?>C4=C80; A8B:B 0=3 14=458CB >5 +AD;828CH 0=3 >5 0;C4A=0C8E4 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 <0H 270=64 0=3 03E8B4 ?0C84=CB C> B44: <43820; 03E824 ?A><?C;H K 027 F44:;H 3>B4 >5 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 C74 =4GC A46D;0A;H B2743D;43 3>B4 K 3E8B4 ?0C84=CB CA40C43 F8C7 +AD;828CH >5 C74 ?>C4=C80; A8B: >5 60BCA>8=C4BC8=0; B834 45542CB K "=BCAD2C ?0C84=CB C> A403 C74 %43820C8>= D834 0=3 C74 "=BCAD2C8>=B for Use before starting Trulicity therapy and review them each time the prescription is refilled. KP"=BCAD2C ?0C84=CB C> 8=5>A< C748A 3>2C>A >A ?70A<028BC 85 C74H 34E4;>? 0=H D=DBD0; BH<?C>< >A 85 0=H :=>F= BH<?C>< ?4AB8BCB >A F>AB4=B K "=5>A< ?0C84=CB C70C A4B?>=B4 C> 0;; 38014C82 C74A0?84B 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 TrulicityTM (dulaglutide)

DG HCP BS 12NOV2014

JULY 2015 MINNESOTA PHYSICIAN

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MINNESOTA PHYSICIAN JULY 2015

july 2015 • Volume XXIX, No. 4

Features The Center for Community Health 1 Maintaining the zone of mental health stability

MINNESOTA HEALTH CARE ROUNDTABLE

By J anny Brust, MPH, and Bonnie Brueshoff, DNP, RN, PHN

Compassionate use exemption Expanded access to investigational drugs

By R ichard Klein; Deborah Miller, PhD, MPH, MSN, RN; Colleen LoCicero, RPh; and Peter Lurie, MD, MPH

DEPARTMENTS CAPSULES

MEDICUS

INTERVIEW

Debra DeBruin, PhD Center for Bioethics, University of Minnesota

Public Health

Chronic pain treatment By Tami Swenson, MA and Stefan Gildemeister, MA

Orthopedic surgery

Medicine and the Law

Cubital tunnel syndrome By Yesenia M. RodriguezAlvarez, MD

The 2015 legislative wrap-up By Nate Mussell, JD

Professional Update: Gastroenterology Barrett’s esophagus 32 By J ose Vega-Peralta, MD

Minnesota Health care Roundtable The new face of health care 22 By M PP Staff

FORTy-FOURTH SESSION

Behavioral Health Integration New pathways to care

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

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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 mpp@ mppub.com. 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 replace 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.

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CAPSULES

Respiratory Illnesses Impact Mortality in Minnesota The most distinctive cause of death in Minnesota is respiratory 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 compared 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 account secondary causes that may impact a main cause of death. “Other and unspeciﬁed acute lower respiratory infections,” according to the report,

was the most distinctive cause in Minnesota and its neighboring states of Wisconsin and Iowa, as well as Kansas, Nebraska, and Ohio. Minnesota’s other neighbors, North Dakota and South Dakota, had pneumonia, also a lower respiratory infection, as its most distinctive cause of death. Researchers developed the map in response to a 2014 social media trend that had users creating their own maps of the most distinctive or characteristic 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 addition, there is only one distinc-

MINNESOTA PHYSICIAN JULY 2015

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.

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

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

“We are pleased to expand out wound care services and bring improved local access to nationally recognized, best-practice wound care protocols to our patients and communities,” said Mike Phelps, MBA, COO of Ridgeview Medical 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.”

New Wound Center Opens in Waconia

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.

Ridgeview Medical Center has opened its new Wound & Hyperbaric Healing Center in Waconia. It features two hyperbaric oxygen chambers that surround patients with pure ox-

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 7KHUDS\ %HQHÀWV +,9 Patients Results from a major international clinical trial have shown that people with HIV have a much lower risk of developing AIDS and other serious illnesses if they begin taking antiretroviral drugs earlier, according to the National Institutes of Health (NIH). Currently, World Health Organization guidelines recommend that people with HIV begin 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 guidelines recommend that all people infected with HIV begin antiretroviral treatment immediately, regardless of CD4+ cell count. The trial, called the Strategic Timing of AntiRetroviral 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 National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH that provided primary funding for the START trial. “Moreover, early therapy 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 implications for the treatment of HIV.”

The study is the largest randomized clinical trial of the effect of early antiretroviral treatment on people with HIV. It was conducted by the International Network for Strategic Initiatives 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 randomly 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 instances of serious AIDS events, other major health issues, and death. The group that received early treatment had 41 instances 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 serious illness or dying. The University of Minnesota was the trial’s regulatory sponsor and statistical and data management center. Participants 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.

+XPDQ %HKDYLRUV Involved in Surgical Mistakes, Study Finds Results 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

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

providers for the purpose of public accountability. Researchers analyzed data from 1.5 million invasive procedures performed at Mayo Clinic over a ďŹ ve-year period and found that among those, 69 never events occurredâ&#x20AC;&#x201D;a rate of about one never event for every 22,000 procedures. These included 24 instances of performing the wrong procedures, 22 instances of performing surgery on the wrong site or wrong side of the body, 18 instances of leaving an object in the patient, and ďŹ ve instances of putting in the wrong implant, none of which were fatal. Researchers then used human factors analysis, a system originally designed to investigate military plane accidents, to determine environmental, organizational, job, and individual factors that were involved in the never events. They found a total of 628 human factors that

The errors were grouped into one of four levels: 1) preconditions for action, which includes distractions, overconďŹ dence, stress, mental fatigue, and inadequate communication; 2) unsafe actions, which includes not following or not understanding rules and perceptual errors such as conďŹ rmation bias; 3) oversight and supervisory factors, which includes inadequate supervision, not enough stafďŹ ng, and planning issues; and 4) organizational inďŹ&#x201A;uences, which includes problems with organizational culture or operational processes. â&#x20AC;&#x153;What it tells you is that multiple things have to happen for an error to happen,â&#x20AC;? said Juliane Bingener, MD, a gastroenterologic surgeon at Mayo Clinic. Mayo Clinic is

partial hospitalization program that will treat about 350 children each year. PrairieCare determined a need in the northeast metro area for this program, as many children who are discharged from hospitalization face traveling across the metro area to receive transitional services, which can cause transportation and scheduling difďŹ culties for families.

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

PrairieCare to Open Clinic in Maplewood PrairieCare has announced plans to expand its psychiatric services to Maplewood, where it will build a new, almost 14,000square-foot outpatient clinic. Once completed, this will be PrairieCareâ&#x20AC;&#x2122;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 addition, the clinic will house a

Like PrairieCareâ&#x20AC;&#x2122;s other locations, 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, including about ďŹ ve 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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MEDICUS William Davis, MD, family practitioner and chief medical information ofďŹ cer at Winona Health, has received the Cerner Physician Community Lifetime Achievement Award from the Cerner Corporation for 15 years of work advancing electronic medical records. Winona Health was one of the ďŹ rst health care organizations to develop an integrated electronic medical record system. William Davis, Davis implemented a system using COSTAR in MD 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 Minnesota where he also completed a residency in family medicine. He has been with Winona Health since 1991 and became the health systemâ&#x20AC;&#x2122;s ďŹ rst chief medical information ofďŹ cer 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 University of Minnesota Medical School, completed an internship at Hennepin County Medical Center, and completed a residency at the University of Minnesota. Prior to this position, she practiced with Northwest Eye Clinic since 2000. Janice Sinclair, She is certiďŹ ed by the Board of Ophthalmology MD and is a member of the American Academy of Ophthalmology, Minnesota Academy of Ophthalmology, International Society of Refractive Surgery, Contact Lens Association of Ophthalmologists, American Medical Association, 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 ďŹ eld. Kaplan earned his medical degree from the University of Minnesota Medical School and is active in community service, including appearing each Martin Kaplan, year at the Special Olympics, working with the MD 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 Schoolâ&#x20AC;&#x2122;s department of ophthalmology. David McKee, MD, has been elected chief medical ofďŹ cer 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 Networkâ&#x20AC;&#x2122;s medical director of specialty services. He earned his medical David McKee, MD 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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JULY 2015 MINNESOTA PHYSICIAN

INTERVIEW

The importance of ethics a patient’s condition will benefit the patient. These What is bioethics? disagreements can be wrenching for all involved Bioethics addresses ethical issues in biomedical research and the health and life sciences. It attends and very challenging to resolve. It is important that patients be supported with appropriate comfort to questions that arise in clinical settings. It also, care and compassionate interactions no matter for example, encompasses public health ethics what decision is made about continued treatment. issues such as health disparities, environmental ethics issues such as those There has also been concerning approaches to a great deal of attenmitigating climate change, tion paid to physician There are some ethical values and ethical issues in the aid in dying. Oregon, life sciences such as those that are fundamental to the Washington, Montana, related to genetically profession of medicine. Vermont, and New modified organisms. It is Mexico have legalan interdisciplinary field; ized physician aid in this diversity of voices dying, and bills to do promotes rich engagement with issues and really so have been introduced in another 26 states plus enhances our understanding of them. the District of Columbia during the 2015 legislative

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 Kennedy in the Democratic ofﬁce of the Health, Education, Labor and Pensions Committee of the United States Senate. She has worked as a consultant to the Institute of Medicine and the National Bioethics Advisory Commission on research ethics issues. Dr. DeBruin has been a member of a number of working groups relevant to public health in Minnesota, and co-directed the Minnesota Pandemic Ethics Project. She teaches and conducts research on the ethics of research and public health policy.

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 questions about how to manage the Ebola response in Minnesota. We also engage the public—for example, 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 communication 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 patient’s prognosis. Uncertainties should be acknowledged, 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 complexities to consider for pediatric patients or adults who have compromised capacities to understand such information and make decisions.

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 reasonable 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 What are the latest thoughts in the ethics about who they recruit into studies. They should community around end of life issues? not target people simply because they may be easy There is increasing concern about cases involving to recruit—for example, people who would find disagreement between clinicians and patients or their families about whether continued treatment of it hard to refuse the opportunity to use a study to

MINNESOTA PHYSICIAN JULY 2015

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 opportunities, availability and affordability of healthy foods and safe housing, discrimination 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 disease 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 disparities 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 Clinton’s National Bioethics Advisory Commission. 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 assessments and how to implement appropriate safeguards for vulnerable populations in research. I have continued to work on a number 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 Department of Health (MDH) sought ethics guidance for influenza pandemic planning efforts in the state. The University’s Center for Bioethics 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 guidance, we consulted extensively with stakeholders 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 decisionmaking. 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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intervene are important skills for anyone to have. The goal is to avert a crisis that would typically require extensive professional intervention.

The Center for Community Health from cover

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

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

UÊ 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. UÊ 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 possibilities 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-

NOW OPEN!

dressed in a number of ways along a continuum of care that includes promotion, prevention, treatment, and recovery. CCH Collective Action Committee members chose to focus on areas that generally do not get a lot of attention: UÊ Engaging community members to help reduce the stigma associated with mental illness. UÊ Educating Minnesotans to identify and seek help for people who are experiencing mental health issues. CCH recommended speciﬁc training and resources after consulting with the National Alliance on Mental Illness (NAMI) of Minnesota. The training and resources are available to the public. The zone of mental health stability The 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

MINNESOTA PHYSICIAN JULY 2015

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 conditions and social connectedness that sustain mental wellness. Social conditions that support mental health may include having stable, safe housing; income security; access to affordable, quality health care; and education. Social connectedness points to relationships that provide emotional, physical, economic, and social support. While social conditions and social 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 Minnesota, the committee recommended 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 practices. The Make It OK campaign is designed to encourage people to talk more openly about mental illness and ask for help. In addition to raising awareness about the need to improve conversations about mental health and wellbeing, MIO provides concrete steps for how to effectively discuss these issues in a productive, non-confrontational 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.

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 OfďŹ ce of Emergency Preparedness, has a number of resources including an online tutorial that teaches PFAâ&#x20AC;&#x2122;s recommended post-disaster interventions.

Mental Health First Aid (MHFA) www.mentalhealthďŹ rstaid.org/cs: MHFA teaches interested individuals how to assist people who are experiencing a mental health problem or crisis. Two types of training are offeredâ&#x20AC;&#x201D;for adults who work with youth and for adults who work with adults. This eight-hour course aims to improve mental health literacy by teaching individuals to identify signs of addiction and mental illness, and to implement a ďŹ ve-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.

UĂ&#x160; Pledges to Make It OK went up dramaticallyâ&#x20AC;&#x201D; a 32 percent increase in one month.

Mental health awareness In 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 proclamation 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:

UĂ&#x160; Proclamations were signed by organizational leaders from metro hospitals, public health agencies, and health plans.

Figure 1. The zone of mental health stability Crisis Point Pre-Crisis Zone of Stability

UĂ&#x160; Articles appeared in internal and external publications. UĂ&#x160; Recommended programs were discussed via social media. UĂ&#x160; Training and workshops were offered. In the next few months, the committee will begin planning activities for Mental Illness Awareness Week, Oct. 4â&#x20AC;&#x201C;10, 2015. The committee will also investigate and then recommend other mental health programs that support community awareness and engagement. The Center for Community Health to page 38

Source: Center for Community Health

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Compassionate use exemption from cover

A brief history of expanded access FDA 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 providing access for seriously ill patients without effective treatments, 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 scientiďŹ c data to demonstrate safety and effectiveness, which then leads to approval, marketing, and access to the drug for all patients. In 1987, when AIDS activists demanded early access to unapproved drugs outside of clinical trials, FDA revised its regulations to permit some forms of

expanded access. In 2009, FDA published new regulations that clariďŹ ed the existing expanded access regulations and added new types of expanded access (see 21 CFR Part 312 Subpart Iâ&#x20AC;&#x201C;Expanded Access to Investigational 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

Seeking individual patient expanded access The best approach for a patient to obtain access to an investigational drug is through participation in a clinical trial of the drug. This is important because

The purpose of expanded access is treatment, rather than research.

can be used for individual patients, including: 1) emergency situations when there is not sufďŹ cient time to submit paperwork in advance of providing treatment; 2) intermediate-size

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

MINNESOTA PHYSICIAN JULY 2015

clinical trials can generate the data that may lead to approval of the drug. Information about clinical trials is available at www.clinicaltrials.gov, a website maintained by the U.S. National Library of Medicine at the National Institutes of Health. If a patient with a serious or life-threatening disease or condition is not eligible for ongoing clinical trials, or there are no ongoing clinical trials for the patientâ&#x20AC;&#x2122;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 therapies (e.g., if the patient is intolerant of available therapies). If the physician and patient are interested in pursuing expanded 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 sponsor/investigator. The physician must comply with the outlined responsibilities for sponsors and investigators to the extent they are applicable to the expanded access use (see 21 CFR Part 312 Subpart Dâ&#x20AC;&#x201C; Responsibilities of Sponsors and Investigators for the complete list of responsibilities).

These responsibilities include: UĂ&#x160; Submitting a protocol and consent form to an Institutional Review Board (IRB) for approval UĂ&#x160; Monitoring the patient under treatment UĂ&#x160; Accounting for the remaining drug after treatment is completed UĂ&#x160; Providing FDA with a brief, written treatment outcome summary at the end of treatment, including any adverse effects experienced UĂ&#x160; Submitting appropriate IND reports The application process There are several parties involved in the decision to treat a patient through expanded accessâ&#x20AC;&#x201D;the treating physician, the patient, the drug developer, and FDA. The treating physician must determine that the probable risk to the patient from the investigational drug is not greater than that from the disease 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 insufďŹ cient 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 ApprovalProcess/ HowDrugsareDevelopedand Approved/Approval Applications/ InvestigationalNewDrugIND Application/ucm107434.htm. Once FDA receives a completed 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

NUMBER OF REQUESTS

Figure 1. Individual patient expanded access requests, 2009â&#x20AC;&#x201C;2014 1800 1600

Not allowed to proceed

1400 1200

Allowed to proceed

1000 800 600 400 200 0

10/13/09 to 10/12/10

10/13/10 to 10/12/11

FY 12

FY 13

FY 14

YEAR Source: U.S. Food and Drug Administration

obtain access to the drug under another IND. Since Oct. 13, 2009, on average, FDA has allowed over 99 percent of individual 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 drugâ&#x20AC;&#x2122;s developer for the reasons already outlined. An individual patient IND would generally include the following: 1. Date of the request and the patientâ&#x20AC;&#x2122;s initials (not the full name, to preserve conďŹ dentiality). 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, monitoring procedures, and modiďŹ 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 investigatorâ&#x20AC;&#x2122;s qualiďŹ cations, including training, experience, and licensure (or the ďŹ rst few pages of a curriculum vitae). 6. Physicianâ&#x20AC;&#x2122;s contact information, 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&SearchTermInformed%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 requests. However, in many cases, a decision is communicated to the physician much faster. In an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made via telephone or other rapid means of communication. Authorization to ship and use the drug may be given by the FDA ofďŹ cial over the telephone, and shipment of and treatment with the investigational drug may begin prior to FDAâ&#x20AC;&#x2122;s receipt of the written submission. The physician must submit an expanded access IND to FDA within 15 working days of FDAâ&#x20AC;&#x2122;s authorization of the treatment use. If there is not sufďŹ cient time to obtain IRB approval in an emergency situation, treatment may begin without prior IRB approval, provided the IRB is notiďŹ ed by the physician of the emergency treatment within ďŹ ve working days of initiating treatment.

Recent proposed changes to FDAâ&#x20AC;&#x2122;s expanded access process FDA has proposed a number of signiďŹ cant changes to the individual patient IND process. In February 2015, FDA proposed a new form that distills from FDA Form 1571 the information speciďŹ c 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 ďŹ nalizing it as expeditiously as possible. For additional information, please see FDAâ&#x20AC;&#x2122;s revised expanded access web page at http://www.fda.gov/NewsEvents/ PublicHealthFocus/ Expanded AccessCompassionateUse/ default.htm. Conclusion FDA has a long history of ďŹ&#x201A;exible expanded access to investigational drugs for treatment

of serious illnesses for patients without approved treatment options. In 2009, FDA ďŹ nalized new regulations to clarify requirements for expanded access. Currently, the agency is working to streamline and simplify the application process, and make promising investigational therapies available to patients with serious conditions and unmet medical needs. Richard Klein is director of FDAâ&#x20AC;&#x2122;s Pa-

tient Liaison Program, the agencyâ&#x20AC;&#x2122;s primary interface with patient communities, in the OfďŹ ce of Health and Constituent Affairs. Deborah Miller, PhD, MPH, MSN, RN, works in FDAâ&#x20AC;&#x2122;s OfďŹ ce of Health and Constituent Affairs in the Cancer Patient Liaison Program. She trains new patient advocates 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 OfďŹ ce of Drug Evaluation I in the Center for Drug Evaluation and Research. Peter Lurie, MD, MPH, is a family physician and FDAâ&#x20AC;&#x2122;s associate commissioner for Public Health Strategy and Analysis.

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PUBLIC HEALTH

hronic pain is a substantial public health concern affecting both the quality 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.

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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 received chronic pain procedures.

Chronic pain treatment The volume of procedures is increasing By Tami Swenson, MA, and Stefan Gildemeister, MA Study methods In 2014, the Minnesota Legislature directed the MDH to conduct a study about the delivery of procedures used to treat chronic pain by physicians, 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) identify the place of service or the types of facilities where chronic pain services are provided, and 4) examine what types of health

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MINNESOTA PHYSICIAN JULY 2015

care professionals, in terms of their specializations and professional license, perform chronic pain treatment procedures. To fulfill the legislative requirements, MDH took advantage of existing knowledge by examining published studies on the provision of chronic pain therapy, consulting experts in the insurance industry on matters of billing and coding practices, and obtaining feedback from the professional organizations representing Minnesota physicians and nurse anesthetists. In addition, MDH conducted 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 information, 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 historical enrollment, claims, and price data starting in 2009. It represents medical care transactions 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: UÊ We identified a broad set of pain procedures by studying clinical guidelines specific to MDs, DOs, and CRNAs. UÊ We complemented this information by adding procedures identified by national chronic pain associations and other federal agency research initiatives that focused on investigating chronic pain. UÊ We excluded the following procedures from our list, because they are either not primarily used to treat chronic pain or are exclusively used as diagnostic procedures: discography, fluoroscopic guidance, arthrography, epidurography, myelography, catheter placement, diagnostic spinal puncture, arthrocentesis, and acupuncture. UÊ 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 centers; and we also excluded

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

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

UÊ 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.

Major ﬁndings Overall 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

Figure 1. Average travel distance in miles for chronic pain procedures delivered in Minnesota by provider geography compared to patient residence, 2010–2012 70

Provider Location

performed, and the procedures increased 13.2 percent. Approximately 83,000 Minnesotans per year received chronic pain procedures, with most (44.4 percent) receiving one procedure and about one-third (30.9 percent) with three or more procedures. 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 procedures varies, with patients seeing rural providers traveling an average of 53 miles and patients 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 provider and patient. While average travel distance for provider caseload in a non-rural area Chronic pain treatment to page 42

Patient Residence

50 40 30 20 10 0

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)

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

Figure 2. Distribution of chronic pain management procedures delivered in Minnesota by provider type, 2010–2012 100 80 60 40 20 0

Pain Specialist Physicians

Pain-Related Physician Specialties

Pain Care Physician

Other Physician Specialties

Certiﬁed Registered Nurse Anesthetist

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

Figure 3. Place of service distribution of chronic pain management procedures delivered in Minnesota by provider type, 2010–2012 100 80 60 40 20 0 Pain Specialist Physicians

Pain-Related Physician Specialties

Pain Care Physician

Other Physician Specialties

Certiﬁed Registered Nurse Anesthetist

Ofﬁce Outpatient Hospital Ambulatory Surgical Center Other Source: All from Minnesota Department of Health

JULY 2015 MINNESOTA PHYSICIAN

MINNESOTA HEALTH CARE ROUNDTABLE

Mr. Starnes: Today we will talk about expanding 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 deﬁnition. What is a medical professional?

Dr. Hu: It has to do with a degree of specific 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.

About the Roundtable Minnesota 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

Dr. Sawyer: In our institution, we not only train chiropractic doctors but acupuncturists 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 professional, you get into a lot of political discussions, and some people get their hackles up. Folks who have gone through medical school or dental school or chiropractic school sometimes show an ingrained defensiveness based on the school they’ve attended and the education they’ve had. I’m part of a multidisciplinary practice, so I work very closely with behavioral health specialists, psychologists, licensed social workers, physical therapists, and others. Oftentimes I work with chiropractors or other medical professionals, as well as with acupuncturists. The value of that is undeniable. Mr. Hustvet: I like the term “health care professional.” 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 fashion? 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

MINNESOTA PHYSICIAN JULY 2015

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 interdisciplinary approaches. We’re being forced now to look outside of our own box and collaborate 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 uncomfortable of the areas to discuss. The cultural issues surrounding patient ownership are the ones that are the hardest conversations to have.

The new face of health care Expanding medical professional relationships 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 disciplines 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 collaborative approach? Dr. Sawyer: The biggest barriers really have to do with payment and the incentives in

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 routinely, oral cancer screening examinations, diabetes screening, or sleep apnea screening, there are windows and/or opportunities 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 conversations 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 insurance or deductible, they can’t do it.

MINNESOTA HEALTH CARE ROUNDTABLE Mr. Johnson: We all need to provide education to our patients about preventive care and following up with preventive 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 continue beyond those initial few years. Mr. Starnes: What about health care professionals 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

“You want to do the best thing for the patient.” Michael Hu, MD

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 profession 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 training 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 lifesaving 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 Department of Anesthesiology and Critical Care Medicine and of neurosurgery at George Washington University (GWU) Medical Center, Washington, DC. John Gulon, DDS, has served at Eden Prairie-based Park Dental since 1987. In addition to seeing patients 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 respiratory 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 Minnesota 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 Bloomington, 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 Department of Health’s Jim Parker Leadership Award for Community Health Services.

A BO U T T H E M O D E R ATO R Mike 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.

JULY 2015 MINNESOTA PHYSICIAN

MINNESOTA HEALTH CARE ROUNDTABLE Dr. Sawyer: Right now, with the fee-forservice 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 annually 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 patient 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 Consumer Assessment of Healthcare Providers and Systems) scores, patients who are more likely to be satisﬁed are more likely to die earlier. Patient satisfaction and outcomes are not correlated. You’re more likely to provide more tests, more medications, more interventions for someone because then they feel

“We are trying to promote innovative clinical pathways.” Craig Johnson, PT, MBA

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—trying 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 advantages 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 periodontal disease. It’s present in roughly half the population today, and there are certain clear associations between periodontal disease and its management and cardiovascular 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 relationships 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 community paramedics now follow patients at home who have 10 or more medications, three or more comorbidities, and time-sensitive 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

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MINNESOTA HEALTH CARE ROUNDTABLE therapy service or a secure message to the physician. It’s part of a Medicaid shared savings ACO (Accountable Care Organization), 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 proactive 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 different 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 conversation. 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 hospital-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 program 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 preventivefocused and “We are trying to helping manage have more proactive their health, I believe they team involvement.” saved the state Derek Hustvet, RRT-NPS, LRT 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 reimbursement 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 payment 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

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“Everybody ought to be right at the top of their license.” Charles Sawyer, DC

leadership. Getting folks who are mid-career to change their practice patterns, as we’ve all been talking about, is a significantly 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 pediatric 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 medical 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. Interestingly 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 procedure. 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 collaboration between health care professionals respond to this migration? Mr. Johnson: The whole notion of collaboration 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 collaboration. 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 rehospitalization. How can penalties for rehospitalization 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 reimbursement, 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 communication 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 prevention. 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 mammograms, 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 pathways, 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.

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MINNESOTA HEALTH CARE ROUNDTABLE 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 stakeholders at high levels including the Chamber of Commerce, the Department of Labor, brokers, and the worker’s compensation insurer 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 compensation 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 collaboration, and offer a little more exposure. The physician, I think, will end up ultimately being more of a coordinator and manager 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 passage. 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 licensure turf battle, but it does happen. There’s

a filter that describes scope and helps legislators 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 battles 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 Medicare 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 specialists, and acupuncturists and say, we’ve got a proposal from you and it’s too good to turn down.

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 subspecialist, 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 feefor-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 better, 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 patient, more than likely I’m going to get reimbursed 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

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 unlike other professions “We’re in a time that were slow to when change recognize the shortagis here.” es that we are encountering. We have to be Gary Wingrove 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-

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

Dr. Sawyer: I’m not sure that the innovations 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. 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 emerging 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 adoption 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, subsidizing the employment of a handful of professionals so that employers can test it out and make sure it works and learn about the intricate details of actually putting the profession into practice.

Mr. Johnson: Under one community-based program that, in its original form, our association worked on, we developed an education 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 community. 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 trainthe-trainer model, which trained community health nurses and others to assess and then to address the issue. Now the Department 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.

of the work to me, or other folks that aren’t billing quite as much, and still see quality 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.

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

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 management becomes more important than incident-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 whomever—will benefit if there’s a high level of transparency, communication, and coordination 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 reasons. 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 incentive 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

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MINNESOTA HEALTH CARE ROUNDTABLE 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.

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

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 comment 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 increasingly 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 multidisciplinary or interdisciplinary care have taken 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 electronic 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 relationships and overall health are interconnected and to continue to demand from the medical 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 everyone 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 understanding what each provider does are most important.

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ORTHOPEDIC SURGERY

ntrapment of the ulnar nerve at the elbow, or cubital tunnel syndrome, is the second most common compression 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 nerve The ulnar nerve contains branches from the C8 and T1 nerve roots. As the terminal branch of the medial cord of the brachial plexus, it continues between the medial head of the triceps and the brachialis muscles. Then, it becomes more superﬁcial and enters the sulcus between the medial epicondyle and the olecranon into the cubital tunnel. The

UÊ Deep ﬂexor pronator aponeurosis: Four centimeters distal to the cubital tunnel

Cubital tunnel syndrome

Research has shown that maximum elbow flexion doubles 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.

Diagnosis and treatment By Yesenia M. Rodriguez-Alvarez, MD 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).

proximal to the medial epicondyle

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 flexion, 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.

UÊ Medial intermuscular septum UÊ Medial epicondyle UÊ Cubital tunnel: The most common area of nerve entrapment

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:

UÊ 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

UÊ Arcade of Struthers: A band of fascia connecting the medial head of the triceps and the intermuscular septum, about 8 cm

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Diagnosis of cubital tunnel syndrome After obtaining a thorough medical history, including information about comorbidities (like diabetes, thyroid disease, or peripheral neuropathy), a physician should probe into the onset of symptoms, whether they are constant or intermittent and whether they get better or worse with changes in position. 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 atrophy than patients with carpal tunnel syndrome. Long-standing or severe disease may develop into muscle weakness or wasting. Common findings on physical exam include: UÊ Froment’s sign: Key pinching by flexing the interphalangeal joint of the thumb to compensate for weak thumb adduction UÊ Wartenberg’s sign: Ulnar deviation of the small finger due to interosseous muscle weakness

UÊ First dorsal interosseous muscle atrophy UÊ Loss of ﬁnger abduction/ adduction UÊ Duchenne’s sign: Clawing of the ring and small ﬁn-

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

Cubital tunnel syndrome, is the second most common compression neuropathy. gers due to paralysis of the lumbrical and interosseous muscles

diseases, such as peripheral neuropathy or upper motor neuron disease, can be ruled out.

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

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

Provocative tests for cubital tunnel syndrome include the Tinel test and the elbow flexion test. The Tinel test detects irritated nerves by gently tapping on a patient’s nerve to provoke a pins and needles sensation and has the highest negative predictive value (98 percent). The elbow flexion test tries to reproduce 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 supracondylar 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, tumors within the cubital tunnel, and revision surgery.

advanced findings, the testing can be used for prognosis and to help predict expectations for nerve and muscle recovery. Nonoperative treatment options Patients with mild and/or intermittent 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 commonly 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

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JULY 2015 MINNESOTA PHYSICIAN

PROFESSIONAL UPDATE: GASTROENTEROLOGY

arrett’s esophagus (BE) is a potentially precancerous 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 epithelium, 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 thoracic 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 developments have led to the need for highly specialized multidisciplinary teams with expertise in esophageal disorders and

Barrett’s esophagus A look at significant therapeutic advances By Jose Vega-Peralta, MD with a particular interest in BE. These teams commonly include pathologists, radiologists, gastroenterologists, and surgeons; their main objective is to provide a consensus on diagnosis and treatment especially on complex cases. Pathogenesis The prevalence of BE is estimated to be around 5 to 20 percent of the general population, depending 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

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MINNESOTA PHYSICIAN JULY 2015

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 middle-aged Caucasian males. It affects men two to three times more often than women. It is more common in Caucasians and Hispanics, and is uncommon in Blacks and Asians. GERD is considered to be the most important risk factor. Other risk factors include smoking, 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 during 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. Intestinal 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 gastroenterologist who specializes in BE. This ﬁeld has advanced greatly in recent years, allowing specialists to appropriately classify the disease and effectively prevent the ultimate complication of EAC. New techniques have been developed, such as endoscopic mucosal resection (EMR), which allows the appropriately trained gastroenterologist to

safely resect large specimens endoscopically. This is particularly 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-resolution endoscopes with special focus systems and image processing techniques have enabled the physician to better target the biopsies and obtain a more accurate classification of BE. Staging Accurate staging or classification 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 higher 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 developing EAC compared to the general population is thought to increase thirtyfold. Specifically for patients with high-grade dysplasia, the rate of development of cancer is 4 to 8 percent per year. The extent of BE or columnar metaplasia is another important distinction. A majority of patients with short-segment 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. Treatment Over 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

and effective at eradicating BE. Eradication of BE with RFA has been shown to reduce the incidence of EAC. The procedure is done during an upper endoscopy 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 precancerous tissue. It takes an average of three to four RFA ablation

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

resects the mucosa and submucosa 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 evaluation by a multidisciplinary esophageal group, early intramucosal adenocarcinoma can be treated with EMR or ESD.

Conclusions Barrett’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 multidisciplinary team with expertise in esophageal disorders.

BE does not have speciﬁc symptoms. procedures, three months apart, to completely eradicate the BE. PDT is a technique in which chemical agents are intravenously 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 presence of oxygen, which leads to the destruction of the BE. PDT carries higher esophageal stricture rates and is less frequently utilized now that less toxic methods are available. Endoscopic spray cryotherapy is another ablation technique. Cold nitrogen or carbon dioxide are endoscopically 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 conducted at this point. Not every BE with highgrade dysplasia should be treated the same way. Nodules or ulcerations represent early EAC and should not be ablated. Instead the tissue should be endoscopically removed en bloc for further evaluation, as it could be early cancer. Endoscopic resection techniques to treat BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The main difference between both techniques is the depth and size of resection. During EMR, the mucosa is resected but not always the submucosa. This procedure is faster and has lower risks of perforation and bleeding. ESD

The multidisciplinary Esophageal Group At 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

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

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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 eradicated, antireflux surgery has to be considered. Treatment of BE is determined by the degree of dysplasia present on the biopsies. In patients with nondysplastic Barrett’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 surveillance endoscopy can be done in six to 12 months where repeat biopsies or endoscopic treatment can be offered to treat and eradicate the Barrett’s tissue. For high-grade dysplasia, endoscopic treatment is strongly encouraged to eradicate the intestinal metaplasia. If the patient does not want to undergo treatment, then a repeat surveillance endoscopy with biopsies should be done in three months’ time. Treatment options for BE with high-grade dysplasia range from esophagectomy to endoscopic treatment. Due to the high morbidity and the risk for complications from esophagectomy and the efficacy of the new endoscopic treatments, esophagectomy is rarely done for high-grade dysplasia. Endoscopic treatment is the preferred treatment modality for highgrade dysplasia. Endoscopic treatments include ablation techniques or endoscopic resection of the Barrett’s tissue. The current available endoscopic ablation techniques are radiofrequency ablation (RFA), photodynamic therapy (PDT), and endoscopic spray cryotherapy. RFA, using the Barrx catheters (previously known as HALO), is the most commonly-used technique to treat BE as it has been extensively studied and found to be safe

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physicianjobs.allinahealth.org JULY 2015 MINNESOTA PHYSICIAN

MEDICINE AND THE LAW

s seems to be the case every year, no legislative session ever plays out the same way, and the 2015 legislative session was no exception. For the second time in the last ﬁve years, the Minnesota Legislature went to a special session to complete work on putting together a budget. But the 2015 special session had a far different 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. Divided control of the Legislature with a Republican-controlled House and a DFL-controlled Senate, and interesting dynamics with the governor, saw competing 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

Another special session By Nate Mussell, JD to focus on a long-term transportation funding package and a tax package. Yet by the end of session, the prospects of passing either became a victim of necessity as budget negotiations broke down and the ﬁnal tenuous 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.

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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 balance The 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–Kerrick)—used existing provider tax revenues or more specifically almost $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 becomes 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 current 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 session 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 address. Some of these questions include: 1) Will the provider tax in fact be repealed? 2) Will current eligibility in MinnesotaCare 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 legislators 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 nursing 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 multiyear 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-operated facilities in Fergus Falls and Willmar and the future of the security hospital in St. Peter. The 2015 legislative wrap-up to page 36

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The 2015 legislative wrap-up from page 34

For many physicians and medical students, some of the new funds to help alleviate future health-care workforce shortages might be the most important new spending to come out of this session. The HHS budget included just over $2 million for loan forgiveness programs; 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 residency program; and $1 million for a foreign-trained physician residency program. Many of these issues came from the Health Care Workforce task force recommendations. You can expect to see continued focus on some of these programs in the future. MNsure—lots of talk, little action Another issue that many expected to receive considerable attention during this session wasMNsure—the state’s health

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

The Legislature passed an almost historically low number of bills this year. awaited the Legislative Auditor’s evaluation. The Senate Democrats proposed elimination of the current MNsure board and centralization of the administration of the exchange in a new state agency—a recommendation 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 Republicans who favored either a move to the federal exchange or a change to allow subsidies for coverage purchased outside of the exchange. Ultimately, neither

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MINNESOTA PHYSICIAN JULY 2015

Other bills of interest The Legislature passed an almost historically low number of bills this year—a trend seen in recent years due to divided government. Some bills were combined 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 number 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 compact 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. Telemedicine Continuing 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 telemedicine 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 Authorization One 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 prescription 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 dynamics and space limitations, the 2016 session will almost assuredly top it. The Capitol building will be closed for the entire year, leaving the Legislature to meet in the newly-constructed 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.

Urgent Care

Family Medicine with Clinic OB

We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We are seeking BC/BE fullrange family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice.

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.

For consideration, apply online at healthpartners.com/careers and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact diane.m.collins@healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

For additional information, contact Dr. Kathy Brandli, President, at kbrandli@gatewayclinic.com or Eric Nielsen, Administrator, at enielsen@gatewayclinic.com or 218.485.2000

www.gatewayclinic.com

healthpar tners .com

Sioux Falls VA Health Care System Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable EHQHÀWV SDFNDJH The VAHCS is currently recruiting for the following healthcare positions in the following location.

Sioux Falls VA HCS, SD Endocrinologist

Orthopedic Surgeon

ENT (part-time)

Primary Care (Family Practice or Internal Medicine)

Emergency Medicine Geriatrician (part-time) Hospitalist

Psychiatrist Pulmonologist

Neurologist Oncologist/Hematologist

Urologist (part-time)

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 information Call Kirk Stensrud, CEO 320.634.4521 Mail CV to: Kirk Stensrud, CEO 10 Fourth Ave SE Glenwood, MN 56334 Email CV to: kirk.stensrud@glacialridge.org

(605) 333-6852 www.siouxfalls.va.gov Applicants can apply online at www.USAJOBS.gov

www.glacialridge.org JULY 2015 MINNESOTA PHYSICIAN

The Center for Community Health from page 17

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 signiďŹ cant 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 helping people experiencing mental health crises or issues. Often a physician is the ďŹ rst professional that an individual may conďŹ de in. Assuring individuals that mental health issues are common and treatable, especially when caught early, is an important ďŹ rst 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. Customer service representatives will be able to answer questions about speciďŹ c coverage, information about deductibles, and whether providers are in or out of network. Theyâ&#x20AC;&#x2122;ll even help schedule an appointment with a behavioral health provider.

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

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

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

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

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.

Janny Brust, MPH, is

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

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.

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

Opportunities available in the following specialties: -HTPS` 4LKPJPUL Spring Valley Clinic

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

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www.olmstedmedicalcenter.org 38

MINNESOTA PHYSICIAN JULY 2015

St. Health Cloud VA Care System

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 Emergency Medicine Family Medicine General Surgery Hospitalist Internal Medicine Nephrology Neurology Neuropsychology

Occupational Medicine Ophthalmology (General & Glaucoma) Orthopedics Pediatrics Psychiatry (Adult & Child) Pulmonary/Critical Care Urgent Care Urology

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 euphysicianrecruitment@mayo.edu; or apply at http://www.mayoclinic.org/jobs/physicians-scientists

Brainerd | Montevideo | Alexandria

Opportunities for full-time and part-time staff are available in the following positions: Â&#x2021; $VVRFLDWH &KLHI RI 6WDII Â&#x2021; 2SKWKDOPRORJLVW Â&#x2021; 'HUPDWRORJLVW Â&#x2021; +HPDWRORJ\ 2QFRORJ\ Â&#x2021; ,QWHUQDO 0HGLFLQH )DPLO\ 3UDFWLFH

Â&#x2021; 3K\VLFLDQ 3DLQ &OLQLF 2XWSDWLHQW Primary Care Â&#x2021; 3V\FKLDWULVW

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Applicants must be BE/BC.

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

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.

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

Please contact or fax CV to:

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

763-504-6600 Fax 763-504-6622

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For more information: 9LVLW ZZZ 86$-REV JRY RU FRQWDFW 1ROD 0DWWVRQ 67& +5#9$ *29 Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301 www.NWFPC.com JULY 2015 MINNESOTA PHYSICIAN

Cubital tunnel syndrome from page 31

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.

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

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

Operative treatment options Surgery is indicated if symptoms are constant, there is muscle atrophy or motor weakness, or if conservative treatments fail to bring relief. There is

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

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

UÊ 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. UÊ Intramuscular transposition: This technique is sometimes used along with anterior transposition of the nerve. The nerve is placed within the ﬂexorpronator muscle mass.

UÊ Endoscopic decompression: 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 complications seen with surgical treatment are injury to cutaneous 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. Outcomes Cubital tunnel syndrome is a common nerve compression syndrome with a variety of treatment options. Multiple surgical 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 decompression 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 injuries. She sees patients in St. Paul, Eagan, Hastings, and at the Apple Valley Medical Center.

Physician Practice Opportunities 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.

Avera Marshall Regional Medical Center 300 S. Bruce St. Marshall, MN 56258

Currently we are seeking to add the following specialists: UÊ Psychiatrist

UÊ Family Medicine

UÊ Psychologist

UÊ Internal Medicine

UÊ Orthopedic Surgeon

UÊ OBGYN

UÊ General Surgeon

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 U Dave.Dertien@avera.org

www.averamarshall.org 40

MINNESOTA PHYSICIAN JULY 2015

Family Medicine & Emergency Medicine Physicians

Great Opportunities Â&#x2021; ,PPHGLDWH 2SHQLQJV Â&#x2021; &DVXDO ZHHNHQG RU HYHQLQJ VKLIW FRYHUDJH Â&#x2021; 6HW \RXU RZQ KRXUV Â&#x2021; &RPSHWLWLYH UDWHV Â&#x2021; 3DLG 0DOSUDFWLFH

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

/ Hospitalist / Infectious Disease / Internal Medicine / OB/GYN / Oncology / Orthopedic Surgery / Pediatrics

/ Psychiatry / Psychology / Pulmonary/ Critical Care / Rheumatology / Sleep Medicine / Urgent Care

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

_ michelle@whitesellmedstaff.com ZZZ ZKLWHVHOOPHGVWDII FRP

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

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Erik Dovre, OB/GYN

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

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 EHQHĂ&#x20AC;WV ZLWK 3(5$ UHWLUHPHQW EHQHĂ&#x20AC;W included with this position.

ZLWK Ă&#x20AC; YH SULPDU\ FDUH FOLQLFV D FULWLFDO DFFHVV KRVSLWDO DQG VHQLRU OLYLQJ facilities. Practice consists of 14 family medicine physicians and 10 advanced practice clinicians, as well as a variety of on-staff specialists. &RPSHWLWLYH VDODU\ DQG EHQHĂ&#x20AC; WV 5HORFDWLRQ DQG VLJQ RQ ERQXV DYDLODEOH

Visit www.lakewoodhealthsystem.com, or contact Brad Anderson at 218-894-8587 or bradanderson@lakewoodhealthsystem.com.

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3OXV :HÂˇUH EXLOGLQJ D QHZ PHGLFDO FHQWHU SURMHFWHG FRPSOHWLRQ Contact: Lynette Bernardy 611 East Fairview Avenue, Renville, MN 56277

www.lakewoodhealthsystem.com

bernardyl@rchospital.com 3KRQH Â&#x2021; 7ROO IUHH JULY 2015 MINNESOTA PHYSICIAN

Chronic pain treatment from page 21

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 distribution 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 centroids), some patients between 2010 and 2012 traveled as far as 118 miles. Average travel distance 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

joint injections, (28.7 percent) percent) of all chronic pain and epidurals (34.1 percent). procedures. Physician pain spePrimary care physicians mainly cialists have additional training performed tendon injections and certification in pain medor trigger point injections (68.6 icine. Physicians without this percent) and additional somatic nerve certification blocks (16.3 but who percent). practice One Hundred Chronic within fields pain services primarily million Americans provided by treating are affected by CRNAs were patients chronic pain. composed of with acute 57.6 percent and chronic epidural inpain are jections, 15.7 classified as percent somatic nerve blocks, pain-related specialties for this and 18.1 percent trigger point analysis and these specialties injections. include: anesthesia, neurology, physical medicine, orthopedic Physician providers of and neurological surgery, and chronic pain management radiology. Primary care physiservices deliver care predomicians, internal medicine, family nantly in physician office practice, or general medicine settings, ranging from 53.9 specialties, delivered 8.2 percent to 84.1 percent of all percent, and CRNAs provided chronic pain procedures by 1.6 percent. Figure 2 on page physician specialty, as shown 21 shows that physicians who in Figure 3 on page 21. In are pain specialists delivered contrast, 97.4 percent of pain primarily paravertebral facet management services delivered

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MINNESOTA PHYSICIAN JULY 2015

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 services provided over this period (22.2 percent). Physicians who are pain specialists or practice in a pain-related specialty saw in aggregate double-digit growth in chronic pain management 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, including 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. Conclusions Taken together, the ﬁndings from the study provide a

descriptive analysis of the volume 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 primary care physicians, followed by pain specialists. CRNAs, who account for a small share of the volume of chronic pain procedures 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 procedures delivered by primary care physicians, access to pain procedures and pain specialists varies by geography across the state. For example, rural patients accessing pain procedures 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, because of the challenges associated 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 procedures in Minnesota is available at http://www. health.state.mn.us/divs/hpsc/ hep/20150120ChronicPain ProceduresMn.pdf. Additional infor mation 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 Economics 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.

Physicians, are you SICK of: Feeling like you work for insurance companies instead of patients? Declining reimbursements while your patients pay higher premiums? Hospitals dictating where you refer patients? Patients delaying or avoiding much needed care because of high deductibles?

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