Vo l u m e X X X , N o . 7 O c t o b e r 2 016
Understanding the “public option” It’s still just a concept By Kip Sullivan, JD
I
n July 2015, Hillary Clinton announced her support for a “public option.” In an article in the Aug. 2, 2016 edition of The Journal of the American Medical Association, President Obama endorsed the “public option,” but only for Americans who buy health insurance on the exchanges established by the Affordable Care Act (ACA). By late August, Jacob Hacker, the inventor of the “public option,” had published several articles extolling the “option” as a solution to the ACA’s woes. Hacker, like Obama, seems to think the “option” should be available only to people shopping on the exchanges.
The CREATES Act
If I were writing this article in 2008, I could describe the “public option” (PO) in considerable detail. But since the summer of 2009, when congressional Democrats unveiled legislation including a PO, it has been impossible to define the PO. All we can say about the concept at this date is that it would be run by some level of government (state or federal) and subsidized to some degree by taxes. All the other
Assuring access to generic prescription drugs By Senator Amy Klobuchar, JD
T
he high cost of prescription drugs is a major issue for American consumers and with good reason. The United States spent more than $297 billion on prescription drugs in 2014—that is a 12.2 percent increase over 2013 and the largest increase since 2002. According to a recent study, 1 out of 4 Americans whose prescription drug costs went up said they were unable to pay their medical bills. And 1 out of 5 were forced to skip doses of their medication. High prescription drug costs are
not only a pocketbook issue, but also a quality of care issue. This is unacceptable and it is why I have worked hard to find bipartisan solutions to help lower the cost of prescriptions. One solution to the high cost of prescription drugs is to promote competition, particularly from generic alternatives that give consumers the
The CREATES Act to page 16
Understanding the “public option” to page 18
is for Cardiology.
University of Minnesota Health Heart Care specialists have a deep understanding of academic medicine and clinical research. Leaders in heart-care interventions for over a generation, we make innovative care our mission. This expert knowledge translates into advanced clinical care tailored for each patient. Through our clinic trials, our patients are at the forefront of groundbreaking care and treatment options. We’ve transformed lives with major breakthroughs in valve replacements, transplants, cardiac resuscitation and other pioneering techniques to treat heart disease. With multiple centers and clinic locations throughout the region, some of the best heart care providers are just a heartbeat away. Learn more about our expert, innovative care at mhealth.org/heartcare The University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. Š 2016 University of Minnesota Physicians and University of Minnesota Medical Center
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MINNESOTA PHYSICIAN OCTOBER 2016
OCTOBER 2016 • VOLUME XXX, NUMBER 7
MINNESOTA HEALTH CARE ROUNDTABLE
COVER FEATURES THE CREATES ACT Assuring access to generic prescription drugs By Senator Amy Klobuchar, JD
UNDERSTANDING THE “PUBLIC OPTION”
FORTY-SIXTH SESSION
It’s still just a concept By Kip Sullivan, JD
Value - Based Reimbursement:
DEPARTMENTS CAPSULES 10
MEDICUS
13
INDIVIDUALIZED MEDICINE
28
A new way to pay for health care
The Precision Medicine Initiative Transforming our approach to disease By Keith Stewart, MB, ChB, MBA
SURGERY 32 INTERVIEW 14 Helping the most vulnerable Misty Tu, MD
Evaluating surgical outcomes Tools for making comparisons By Daryll C. Dykes, MD, JD, PhD, and Jim Chase, MHA
SPECIAL FOCUS: PUBLIC HEALTH Web-based patient education 20 A look at two successful efforts By Ruth Seabaugh, PharmD, BCPS, and William Nersesian, MD The Quality Measurement Enhancement Project (QMEP) 22 Accounting for social determinants of health By Michael Scandrett, JD; Jonathan Rose, PhD; Nancy Garrett, PhD; and David Satin, MD, ABFM Comunidades Latinas Unidas En Servicio (CLUES) 26 Serving the Twin Cities Latino community By Mauricio Cifuentes, PhD, LICSW, and Carla Kohler
PROFESSIONAL UPDATE: TRANSPLANT SURGERY Total pancreatectomy with islet autotransplantation 30 Treating intractable chronic pancreatitis By Mariya Skube, MD, and Gregory Beilman, MD
Thursday, November 3, 2016 • 1:00-4:00 PM
The Gallery (lobby level), Downtown Minneapolis Hilton and Towers Background and Focus: As initiatives driven by federal health care reform move forward, the term “Value-Based Reimbursement” (VBR) is being applied to a wide spectrum of issues. But what does this mean? CMS is developing measurements, well over 150 to date, to define what “value” means in health care. It is proposed that these metrics will be used to create incentives that pay more for better care in every element of health care delivery. Hospitals, physician practices, home care, and long-term care will all be reimbursed by an emerging new math. Objectives: We will explore the motivations behind this changing approach to purchasing health care. We will examine what is being measured and what value really means. We will discuss the arguments that claim VBR is a bad idea and those that believe it is the best solution. We will discuss how a collaborative, transparent system, that integrates care teams, health information technology and improved reimbursement methods will help achieve increased access to high-quality, cost-effective care for patients. Panelists include: • Don Flott, Director of Utilization and Integration Services, Mayo Medical Laboratories • Allison LaValley, MBA, Executive Director, athenahealth • David Melloh, JD, Chair, Health Law Practice Group at Lindquist & Vennum LLP • Ross D’Emanuele, JD, Co-Chair, Health Care Industry Group at Dorsey & Whitney LLP • Lisa Simm, MBA, Manager of Risk Management, Coverys Sponsors include: • athenahealth • Lindquist & Vennum LLP • Mayo Medical Laboratories • Dorsey & Whitney LLP • Coverys
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OCTOBER 2016 MINNESOTA PHYSICIAN
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MINNESOTA PHYSICIAN OCTOBER 2016
It clicked when my doctor and I discussed Trulicity ÂŽ1,2
Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy that offers unbeaten A1C reduction* in 6 head-to-head trials, once-weekly dosing, and the Trulicity pen.1,3 If you have patients who struggle with the idea of adding an injectable, consider Trulicity as an option for the next step in their care.1,4 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3
For more information on 6 head-to-head trials, see the following page.
Trulicity is a GLP-1 RA that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.
Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on inside spread and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
Learn about unbeaten A1C reduction at Trulicity.com
OCTOBER 2016 MINNESOTA PHYSICIAN
5
Mean A1C change from ba
-0.6
-0.6
-0.8 -1.0 -1.2
-0.8
-1.1 * Unbeaten A1C reduction across 6 head-to-head trials -1.4
-1.6
Lantus® (100 mg) (n=262; Baseline A1C: 8.1%)
Trulicity® (0.75 mg) (n=272; Baseline A1C: 8.1%)
Trulicity® (1.5 mg) (n=273; Baseline A1C:1,3 8.2%)
Data represent least-squares mean ± standard error.
*In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.
A1C reduction from baseline
MeanA1C A1Cchange change from from baseline Mean baseline(%) (%)
0.0
Add-on to metformin (26 weeks)
Add-on to metformin (52 weeks)
Add-on to metformin and Actos® (26 weeks)
Add-on to metformin and Amaryl® (52 weeks)
Compared to Victoza®3
Compared to Januvia®1,5,6
Compared to Byetta®1,7
Compared to Lantus®1,8-10
-0.2 -0.4
-0.39
-0.6
-0.46
-0.63
-0.8 -1.0
-0.87
-1.2
-0.99
-1.10
-1.4
-1.51
-1.8 Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)
Januvia (100 mg) (n=273; Baseline A1C: 8.0%)
Placebo (n=141; Baseline A1C: 8.1%)
Lantus (n=262; Baseline A1C: 8.1%)
Trulicity® (1.5 mg) (n=299; Baseline A1C: 8.1%)
Trulicity® (0.75 mg) (n=281; Baseline A1C: 8.2%)
Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=280; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Data represent least-squares mean ± standard error.
•
26-week, randomized, open-label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
•
104-week, randomized, placebocontrolled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
•
Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis)
•
Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met
•
-1.08
-1.30
-1.36 -1.42
-1.6
-0.76
Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met
•
Key secondary objectives of superiority of both dulaglutide doses vs Januvia were met
Superiority was only demonstrated in the studies versus Byetta and Januvia.
Additional study results Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy. In a 52-week randomized, double-blind phase 3 study, adult patients with type 2 diabetes were treated with monotherapy. Baseline A1C=7.6% for each of metformin (n=268), Trulicity 0.75 mg (n=270), and Trulicity 1.5 mg (n=269). At the 26-week primary endpoint, mean A1C reductions were metformin: 0.6%; Trulicity 0.75 mg: 0.7%; Trulicity 1.5 mg: 0.8%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (-0.8% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,11
78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)
•
52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)
•
•
Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met
• Starting dose of Lantus was 10 units daily.
Key secondary objectives of superiority of both dulaglutide doses vs Byetta were met
•
•
Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of insulin glargine was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met
In a 52-week randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients, Trulicity was studied in combination with Humalog® with or without metformin ≥1500 mg/day. Humalog was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose; 36% of patients randomized to glargine were titrated to the fasting glucose goal at the 26-week time point. Baseline A1C=8.5% for Lantus (n=296), baseline A1C=8.4% for Trulicity 0.75 mg (n=293), and baseline A1C=8.5% for Trulicity 1.5 mg (n=295). At the 26-week primary endpoint, mean A1C reductions were Lantus: 1.4%; Trulicity 0.75 mg: 1.6%; Trulicity 1.5 mg: 1.6%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 26 weeks (-1.6% vs -1.4%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,12,13
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on the following page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
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MINNESOTA PHYSICIAN OCTOBER 2016
Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS
In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.
diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%). Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefit outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.
Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.
Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages. Please see Instructions for Use included with the pen. DG HCP ISI 20APR2015 Trulicity® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Actos® is a registered trademark of Takeda Pharmaceutical Company Limited. Byetta® is a registered trademark of the AstraZeneca group of companies. Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis. Januvia® is a registered trademark of Merck & Co., Inc. Victoza® is a registered trademark of Novo Nordisk A/S. Other product/company names mentioned herein are the trademarks of their respective owners. References 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. 2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. 3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357. 4. Polonsky WH, Hajos TR, Dain MP, Snoek FJ. Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. Curr Med Res Opin. 2011;27(6):1169-74. doi: 10.1185/03007995.2011.573623. Epub Apr 6, 2011. 5. Data on file, Lilly USA, LLC. TRU20150203A. 6. Data on file, Lilly USA, LLC. TRU20150203B. 7. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167. 8. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625. 9. Data on file, Lilly USA, LLC. TRU20140912A. 10. Data on file, Lilly USA, LLC. TRU20150313A. 11. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176. 12. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066. 13. Data on file, Lilly USA, LLC. TRU20150313B.
The most common adverse reactions reported in ≥5% of Trulicitytreated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%),
PP-DG-US-0393
01/2016
©Lilly USA, LLC 2016. All rights reserved.
OCTOBER 2016 MINNESOTA PHYSICIAN
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TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. • Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS
INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a doserelated and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with
Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg
TrulicityTM (dulaglutide)
TrulicityTM (dulaglutide)
Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied. CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. WARNINGS AND PRECAUTIONS
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
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MINNESOTA PHYSICIAN OCTOBER 2016
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and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree. USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicitytreated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). TrulicityTM (dulaglutide)
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
DG HCP BS 20APR2015
No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis. OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and nonsevere hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.
Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved. Additional information can be found at www.trulicity.com DG HCP BS 20APR2015 TrulicityTM (dulaglutide)
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CAPSULES
North Memorial Opens First Pediatric Clinic North Memorial Health Care has opened its first pediatric clinic in its North Memorial Health Care Medical Office Building at Maple Grove Hospital. It has five pediatricians on staff and offers urgent care services and easy access to acute pediatric hospital care at the hospital. “Through our partnership with the University of Minnesota Masonic Children’s Hospital, children receive expert care from hospital-based pediatricians and bridge communications with primary care physicians when they’re admitted,” said Andy Cochrane, CEO of Maple Grove Hospital.
Minneapolis VA Opens Surgery Center The Minneapolis Veterans Affairs Health Care System opened a new, 28-bed surgery center on its campus on Sept. 6. The new center has expanded to more than 7,000 square feet of patient care space and has 17 additional private pre-procedure and post-procedure
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patient rooms. It also has additional space for special procedures, physician consults, equipment storage, and staff work areas. The health care system also recently completed a satellite outpatient pharmacy, though an opening date is still pending. The surgery center will support the current 18 operating rooms in addition to the two hybrid operating rooms scheduled to open in January 2017.
Care Model Effective for Complex Patients Results of the COMPASS (Care of Mental, Physical, and Substance-Use Syndromes) initiative have shown that the large-scale multisite collaborative care model is effective in helping patients with depression and diabetes and/ or cardiovascular disease. “Complex patients with both depression and diabetes or heart disease are more likely to have their diseases improved or controlled through an initiative like COMPASS,” said Leif Solberg, HealthPartners Institute investigator. Through COMPASS, care managers at clinics help these complex
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patients by conducting systematic outreach and reviewing patient cases in weekly consultations with a psychiatrist and primary care doctor when patients are not showing signs of improvement. The Institute for Clinical Systems Improvement (ICSI) provided direct implementation coaching and support, including the development of an implementation guidebook. Patient registry and outcomes reporting were led by the Advancing Integrated Mental Health Solutions (AIMS) Center at the University of Washington. “Many health care programs focus on single diseases,” said Claire Neely, chief medical officer at ICSI. “The COMPASS focus on integrating care for both behavioral health conditions and medical conditions, in partnership with a patient’s primary care physician, is an effective way to help patients achieve multiple health goals.” The initiative was conducted at 172 clinics representing 18 medical groups in eight states from February 2013 through March 2015. More than 3,800 patients were part of the report, including those with a variety of income levels and care systems. Of the patients with uncontrolled disease at their time of
enrollment, 40 percent were reported to have achieved depression remission or response; 23 percent glucose control; and 58 percent blood pressure control during an average follow-up period of 11 months. That reached and exceeded COMPASS’ goals of improving depression symptoms in 40 percent of patients and improving diabetes and hypertension control rates by 20 percent. “COMPASS demonstrates that an evidence-based collaborative care model can be effectively implemented across diverse systems to successfully treat medically complex patients with uncontrolled disease,” said Rebecca Rossom, MD, investigator at HealthPartners Institute. “In this sense, COMPASS may serve as a model for future real-world collaborative care implementation.”
Opioid Prescriptions Common Among Medicare Recipients at Hospital Discharge A study from the University of Minnesota School of Public Health has found that new opioid use
after hospitalization is common among Medicare beneficiaries. Researchers analyzed a 20 percent random sample of pharmacy claims from Medicare beneficiaries hospitalized in 2011 who did not have an opioid prescription claim in the 60 days before hospitalization. They found that among 623,957 hospitalizations, 92,882 (14.9 percent) were associated with a new opioid claim. Among 2,512 hospitals, the average adjusted rate of new opioid use within seven days of hospitalization was 15.1 percent. Results also showed that the likelihood of post-discharge opioid prescribing varied widely across hospitals even after accounting for patient characteristics, severity, and diagnoses. “We know that even short-term opioid prescriptions can lead to long-term use,” said Pinar Karaca- Mandic, PhD, associate professor in the School of Public Health and senior author of the study. “We must try to understand why hospitals vary in their post-discharge opioid prescriptions. It’s concerning that very large variations in post-discharge prescribing remain, especially with abuse so prevalent today.” Among hospitalizations with an opioid claim within seven days of hospital discharge, 32,731 (42.5 percent) of 77,092 were associated with an opioid claim 90 days after discharge. “One of the more glaring and possibly problematic findings was nearly 40 percent of patients with a new opioid prescription filled the prescription 90 days after their discharge, suggesting longterm use,” said Karaca-Mandic. She added that current hospital incentives to promote adequate pain control could be used with other measures that aim to target and promote appropriate opioid use in order to reduce large variations in rates of opioid prescribing after hospital discharge. There is a system that offers incentives for better pain management in place currently, however there are no measures on appropriateness of opioid prescribing.
Mayo Clinic Expands Converged Emergency Telemedicine Practice Mayo Clinic has announced a new strategy for a converged emergency telemedicine practice, which serves more than 45 hospitals in nine states. One change within the new strategy will enable Mayo Clinic to work with one vendor for
standardized services across the health system’s nationwide telemedicine enterprise, instead of the multiple vendors it has worked with as it grew its emergency telemedicine practice. “By combining the breadth and depth of Mayo Clinic knowledge and expertise with a standardized technology across the enterprise, we will be able to create a comprehensive, integrated, multidisciplinary emergency telemedicine program,” said Bart Demaerschalk, MD, neurologist at Mayo Clinic and medical director of synchronous (telemedicine) services for the Mayo Clinic Center for Connected Care. “Through this program, we can provide specialty consults and guidance for medical and surgical emergencies in adults and children.” According to Demaerschalk, the strategy will provide more opportunity for Mayo Clinic to grow its clinical services lines. Initially, the telemedicine services lines that will participate in the convergence are telestroke and teleneonatology. “This is an exciting milestone for connected care at Mayo Clinic,” said Christopher Colby, MD, chair of the Pediatrics Neonatal Medicine Division and telehealth director for pediatrics at Mayo Clinic. “We will now offer a technology platform specifically designed to deliver emergent telemedicine consultation. Perhaps equally as important is that this will bring expertise from the Mayo Clinic enterprise together to develop world-class telemedicine across many service lines.” The first phase of the convergence is scheduled to continue through the beginning of 2017.
MN’s Obesity Remains Lowest in Region The adult obesity rate in Minnesota shows a statistically significant drop from 2014 to 2015, according to new data released from the Centers for Disease Control and Prevention (CDC). The rate fell from 27.6 percent in 2014 to 26.1 percent in 2015. Other states in the region, which includes North Dakota, South Dakota, Wisconsin, and Iowa, all had adult obesity rates above 30 percent, with rates ranging from 30.7 percent to 32.1 percent. “Minnesota’s obesity rate is markedly lower than our Capsules to page 12 OCTOBER 2016 MINNESOTA PHYSICIAN
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surrounding states and we were still able to achieve a greater decrease in 2015 than our neighboring states,” said Ed Ehlinger, MD, Minnesota commissioner of health. “Achieving healthy weight for all Minnesotans is one of the key objectives for our Statewide Health Improvement Program (SHIP) and its community and private sector partners. By working together we’ve been able to increase opportunities for healthy eating and physical activity for all Minnesotans.” The South showed the highest adult obesity rates. Four states in the region had obesity rates of at least 35 percent—Alabama, Louisiana, Mississippi, and West Virginia. Louisiana had the highest rate at 36.2 percent. The lowest rates were found in the West (25.2 percent), followed by the Northeast (26.4 percent), and the Midwest (30.7 percent). Colorado had the lowest rate at 20.2 percent. The adult obesity rate in Minnesota had held steady since SHIP was enacted in 2008, until it rose from 25.5 percent in 2013 to 27.6 percent in 2014. SHIP spends about $17.5 million each year to fund
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grants and support local community partners across the state to expand healthy eating habits and active living opportunities, as well as with tobacco prevention efforts. The CDC’s report includes 2015 state- and territory-specific data on adult obesity. It used self-reported data from the Behavioral Risk Factor Surveillance System. Every state showed an adult obesity rate of at least 20 percent.
Health Centers Funded for IT Improvements The U.S. Department of Health and Human Services (HHS) has awarded $868,860 in funding for health information technology enhancements at 15 Minnesota health centers. Minnesota’s award is part of a total of $87 million that will fund improvements at 1,310 health centers located in all 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, and the Pacific Basin. “Health centers across the country are instrumental in providing high-quality, comprehensive primary health care to millions of people,” said HHS Secretary Sylvia Burwell. “This
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investment will help unlock health care data and put it to work, improving health outcomes and building a better health care system for the American people.” Funds will be used to accelerate health centers’ transition to value-based models of care, improve efforts to share and use information to support better decisions, and increase engagement in delivery system transformation. All purchases or upgrades of electronic health record systems made with the grant funds must use technology certified by the Office of the National Coordinator for Human Information Technology. “These awards will allow health centers to deliver higher quality of care to patients and spend health care dollars in a smarter way,” said Jim Macrae, acting administrator of HHS’ Health Resources and Services Administration.
St. Luke’s Recognized for Heart Attack Care St. Luke’s has earned the 2016 Mission: Lifeline Gold Plus Receiving Quality Achievement Award from the American Heart Association for implementing specific
quality improvement measures for the treatment of patients who suffer from severe heart attacks. It is the only hospital in Minnesota to earn this level of the award so far. Previously, St. Luke’s received a silver award in 2014 and a gold award in 2015. Each year, about 25,000 people in the U.S. experience an ST elevation myocardial infarction (STEMI), which is caused by a complete blockage of blood flow to the heart. It is the most deadly type of heart attack. To prevent death, providers must immediately restore blood flow either by surgically opening the blocked vessel or by giving the patient clot-busting medication. The goal of the American Heart Association’s Mission: Lifeline program is to reduce system barriers to prompt treatment for heart attacks, beginning with the 911 call and continuing through hospital treatment. The Gold Plus award recognizes St. Luke’s for having an 85 percent composite adherence and at least 24 consecutive months of 75 percent or higher compliance on all Mission: Lifeline STEMI Receiving Center quality measures to improve quality of care for STEMI patients.
MEDICUS DAVID MASOPUST, PHD, associate professor in the University of Minnesota Medical School’s department of microbiology and immunology, has been named to the inaugural class of Howard Hughes Medical Institute (HHMI) Faculty Scholars in recognition of his dedication to creative and innovative solutions in science. The program is a new initiative led by HHMI along with the Simons Foundation and the Bill & David Masopust, Melinda Gates Foundation that targets early career PhD researchers running their own laboratories in order to provide flexible funding resources. Masopust’s research focuses on immunosurveillance and how memory T cells control infections and cancer. With this new opportunity, he hopes to resolve major gaps in the understanding of T cell migration and how it relates to immunological memory and protection. His most recent work includes a new model of mice, called “dirty mice,” which are designed to better mimic the adult human immune system, as well as investigations into how the immune system patrols the body for detection of infected and cancerous cells. PATRICIA LINDHOLM, MD, a family medicine physician at Lake Region Healthcare in Fergus Falls, has received the Minnesota Medical Association’s (MMA) Distinguished Service Award for her outstanding contributions to medicine, the MMA, and Minnesota physicians throughout her career. Lindholm served as president of MMA in 2010–2011 and currently serves as president of the MMA Foundation Board Patricia of Directors. She is also serving a four-year term on Lindholm, MD the Board of Medical Practice. In her 25 years with the MMA, she has served on the Board of Trustees, testified at the Capitol, represented the MMA on the MN Community Measurement Board, and served on the Professionalism Advisory Team. MARNI FELDMANN, MD, has joined Northwest Eye as an ophthalmologist specializing in the diagnosis and treatment of retinal diseases. She has a particular interest in age-related macular degeneration, diabetic retinopathy, and retinal vascular diseases and specializes in retinal angiography and ocular imaging as well as office treatments, including lasers and intravitreal injections. She has been practicing Marni Feldmann, ophthalmology for 10 years. Feldmann earned MD her doctor of medicine degree at the University of Wisconsin–Madison and completed a residency in ophthalmology at the University of Wisconsin Hospitals and Clinics as well as the Diseases of the Retina fellowship at Northwestern University in Chicago. She serves as a member of several medical professional societies, including the Minnesota Academy of Ophthalmology and the American Society of Retina Specialists. Previously, Feldmann was on staff with Park Nicollet for seven years and worked in private practice for two years. KAREN LLOYD, PHD, LP, senior director of behavioral health programs and resiliency at HealthPartners, has received the award for Program Excellence and Innovation from the Minnesota Association of Community Mental Health Programs for advancing behavioral health care. Lloyd has been working to create programs to improve mental health for more than a decade, including establishing programs to Karen Lloyd, prevent repeat hospital visits; prevent emergencies; PhD, LP raise awareness; direct addiction treatment; promote well-being; reduce stigma; and provide online therapy. She created the behavioral health department at HealthPartners in 2002 and the following year, HealthPartners was the first health plan in the state to begin offering disease management services to people with depression. Her team now consists of 65 staff members who provide phone coaching and support to 48,000 members each year. OCTOBER 2016 MINNESOTA PHYSICIAN
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INTERVIEW
Helping the most vulnerable
Misty Tu, MD Blue Cross and Blue Shield of Minnesota As senior medical director for psychiatry and behavioral health, Dr. Tu serves as Blue Cross and Blue Shield of Minnesota’s clinical leader for the company’s psychiatry and behavioral health management functions. She has extensive experience in direct patient care in psychiatric crisis stabilization, inpatient psychiatric care, detoxification, and substance abuse treatment. She has been involved in establishing psychiatric services in emergency room settings, tele psychiatry, and partial hospitalization program care. Her work has extended across several patient populations, including the active military. Immediately prior to Blue Cross, Dr. Tu served as the associate medical director for utilization management at Magellan Louisiana CMC, where she worked to produce quality and cost effective behavioral health care for more than 10,000 recipients. She holds a doctor of medicine degree from Texas Tech Health Sciences Center and she completed her psychiatric residency at the University of Southwestern Medical Center.
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What are some of your responsibilities as senior medical director of psychiatry and behavioral health at Blue Cross and Blue Shield of Minnesota (Blue Cross)? The most important things I do at Blue Cross is listening and teaching. I have to listen and understand the challenges facing our members, our providers, and ourselves as a company and translate that into the strategic journey we have to take. Teaching is a large component of my responsibilities. I collaborate with my staff, other divisions, and outside stakeholders to take the things we have learned and put them into use in a meaningful way.
at the top of their license, but that doesn’t mean every member of the team needs the same type of licensure.
It is projected that 1 out of 5, or even more individuals suffer from some form of behavioral health disorder. What kind of provider shortage issues does this present? Due to this high prevalence of mental illness, most patients are treated in the primary care setting. For many individuals, this is the appropriate level of care. Health plans can assist primary care providers by making guidelines, consults, and other entry points to seeing a provider, such as telemedicine, available. There are shortages of mental health care Data suggests an increase in youth substance providers and there are variations in the quality of abuse. What can you tell us about this and what do providers that present barriers to care that we work you think is the core issue driving this trend? diligently to minimize. It is hard to talk about a core issue, because I think that it is multifactorial. Medications such as Untreated behavioral health issues can lead stimulants and opioids have rampant use in our to higher overall health costs. Can you give us society and our kids see that physicians prescribe some examples? them. They often think they are safe to take Actually, if treatment for a behavioral health and don’t understand the risks involved such as issue is not optimized, there are overall increases addiction, overdose, and intoxication. Treatment in health care costs. Patients need to be identified for substance use disorders cannot be done in the and then provided with appropriate treatment. vacuum of a facility. Parents, schools, communities, There are many factors as to why individuals with and providers all need to be engaged to educate, mental illness may experience increased cost. Their watch for signs of substance abuse, and seek help providers may not coordinate services well so their when needed. psychiatrist could increase a particular medication that adversely affects an individual’s diabetes. Depression can increase an individual’s perception Please tell us about the pilot program you are working on with primary care doctors that involves of pain, which can lead to worse outcomes. The increase in cost often translates into poor quality asking teens about potential substance abuse. Primary care physicians are the gateway to of life so we have many interests in ensuring that reaching many of our youth and transition age patients get the best care possible. adults. There are screens for risky behavior that can help predict substance use disorder potential and Individuals with behavioral health issues may be help us identify individuals for early intervention. reluctant to seek care due to social stigma. What We are collaborating with a pediatric clinic in the can health care providers do to address this? Metro area. The collaboration includes mental One of the most important things that we can do health assessments and interventions in the clinic is ask questions. We need to ask people when they along with care coordination and follow up. A teen come in to see us if there are other things that they can see their doctor and be referred for a consult want to talk about such as: Are you feeling okay? Is with a mental health professional that day in the your life fulfilling and do you feel happy? Do you same office. We are looking at putting in the right feel scared? When? Why? Do you have questions reimbursement methodology, determining key about substance abuse or any of the medications metrics for success, and figuring out how to work you are taking? We have to ask these questions and with each other and not be at odds. listen to the answers. It isn’t always about having all the solutions, but really listening to the patient and engaging them. Current trends in behavioral health treatment involve creating teams of health care professionals with different levels of training. What can you tell As a nation, we now face an epidemic of us about this? prescription-based opioid addiction. Currently, I work with a diverse staff at Blue What can be done to reverse this? Cross because individuals with different levels of This isn’t a problem that developed suddenly, training all bring different strengths to help find nor is there one driving factor that can be tackled. a solution. We encourage all providers to work Medical professionals will have to be trained
MINNESOTA PHYSICIAN OCTOBER 2016
differently on how to address pain. We need to give providers the power to make appropriate care decisions without fear of a bad rating on a website or from regulatory agencies. We need to educate and engage patients and their families in taking control of their health and directing their care appropriately. We need to be able to share information so that providers have the entire picture of the patient without privacy laws tying our hands. We need to work on evidence-based treatment approaches that allow members to enter the continuum of care at whatever their need dictates. There is a lot to be done and there are groups doing some of this work. We need to continue pushing this issue and not accept the current state. Individuals experiencing severe episodes of mental illness who are treated by first responders often end up in emergency departments or jails where proper care is not available. What can be done to address this? Jails and sometimes even emergency departments are not the correct point of entry into care for individuals with mental illness. For those with behavioral health
issues who encounter a first responder, there our members receive. We don’t have enough needs to be a crisis network available that can mental health care inpatient beds or a robust take physical responsibility of the individual enough outpatient and safety network. There is more funding than ever available, but that won’t help if we aren’t offering the right services at the right time. People with behavioral health issues are very vulnerable and are often given treatment involuntarily This is a very exciting time so they need us to do the best job we can for for mental health care. them.
and provide assessment and start treatment. From there the individual can be transferred to the appropriate level of care or discharged with follow up. The most critical part of this is that we need an environment that is safe so that an assessment and treatment can take place. What do you see as the biggest problems facing behavioral health care? There are many problems facing mental health care, but that can give way to many opportunities. We don’t have enough quality measures and controls over the care that
What lies ahead for behavioral health care? This is a very exciting time for mental health care even though it is difficult. There is true interest from a legislative and public policy standpoint that can help drive momentum for change. We have to be willing to be courageous and try new solutions. We have to look at enacting best practices and integrating with primary care so that we treat the individual as a whole. Correct assessment and treatment has to take place in a timely manner and we need to utilize the knowledge we have to help identify those at risk. Technology and innovations in physical medicine are moving ahead every day and we can learn from these advances.
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The CREATES Act from cover
option to purchase the same product at a much lower price. Typically, the first generic product is 20 percent cheaper than its branded counterpart. As more generic competitors launch products, the generic price can be as much as 90 percent lower than the branded price. The Food and Drug Administration (FDA) estimates that consumers saved over $217 billion in 2012 alone through using generics, and $1.68 trillion from 2005 to 2014. More competition means lower prices, improved medication adherence, and better health care for consumers. I joined with Republican Senator Chuck Grassley of Iowa to introduce legislation that would prevent collusive agreements where branded pharmaceutical companies pay their potential generic competitors not to manufacture their generic product. And recently, I worked with
my Judiciary Committee colleagues—Senator Patrick Leahy of Vermont, Senator Grassley, and Senator Mike Lee of Utah— to introduce the bipartisan Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), which would put an end to two strategies that delay generic competition and cost American consumers billions of dollars. Generic vs. branded drugs In the 1980s, Congress revamped the approval process for prescription drugs, creating two types of approvals: one for branded products and one for generic products. To receive FDA approval for a branded product, a company must establish that the product is safe and effective. In contrast, a generic company must test its product against the branded version and establish that the two products are bioequivalent. Typically, patents expire 20 years after the date of filing.
However, drug companies can have some time added to account for the FDA’s review process or if they obtain pediatric exclusivity. The generic approval process generally works well, but there is always a danger that a branded
The CREATES Act allows innovation and competition to drive the pharmaceutical market.
firm might try to manipulate the system to delay the approval of a generic alternative, which delays competition. Even a few months delay in the introduction of a generic alternative to a blockbuster drug can mean hundreds of millions of dollars in additional revenue. Delay tactics can be enticing to a branded firm, but if those tactics raise drug costs, it is consumers who pay the price. Denying access to branded samples It has become more common in the pharmaceutical industry for branded companies to deny generic companies access to the samples they need by limiting distribution. For a long time, branded companies sold their products to large wholesalers, and a generic company would simply buy the branded samples from a wholesaler. To stop this, a few branded companies have forbidden distributors from selling to anyone besides a pharmacy, while some companies even distribute the product directly to the pharmacy. As the only source for the product, the branded firm can then refuse to sell to the generic company. Without access to branded samples, there can be no FDA
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approval and no generic competition. This practice is becoming more common. • As of January 2016, the FDA received over 100 inquiries from generic companies unable to obtain the necessary samples to conduct testing. • The chairwoman of the Federal Trade Commission (FTC), Edith Ramirez, testified before the antitrust subcommittee that the FTC is “very concerned” about potential abuses of drug distribution systems to impede generic competition. • An increasing number of drugs have no generic available even after branded patents expire. Some companies cite the FDA’s requirement that the drug is subject to a Risk Evaluation and Mitigation Strategy, or REMS, as a justification for their refusal to sell to the generic firm. REMS are safety protocols that the FDA requires for drugs that pose significant dangers or that are likely to be abused. When generic competition occurs, the FDA, by statute, requires the branded and generic firms to negotiate a single, shared REMS system. REMS systems vary from product to product. Some require the manufacturer to provide patient education materials on the risks of the drug. The most serious REMS systems limit distribution of a product. That was never the intent REMS systems are important for patient safety, but they are not intended to prevent generic approval. When Congress created the REMS requirements, the statute specifically stated that a REMS system should not be used to delay generic competition. Generic companies often obtain FDA approval of their testing protocols, but branded firms continue to refuse to sell the product. If one company can sell a product safely in the marketplace, others should be able to also, as long as they meet the safety protocols established by the FDA. A few branded
companies have found a second way to abuse the REMS system by delaying the negotiations of the shared-REMS system. All the while, the branded company already has approval of its product and continues to sell without generic competition. Until there is an agreed-upon shared REMS, the generic company cannot receive approval from the FDA, and consumers canâ&#x20AC;&#x2122;t benefit from competition and the lower prices generics bring to the marketplace. Some companies have been known to drag the process out for years. The importance of the bill The solution is an impartial referee to prevent manipulation of the regulatory process, which is the goal of our CREATES Act. Under the bill, a generic company can appeal to a neutral arbitrator if it believes the branded company is manipulating the process. First, if a generic cannot obtain samples in the marketplace and the
branded company refuses to sell the samples, a generic company can ask a federal judge to require the sale. Second, if the brand and the generic cannot reach an agreement on a sharedREMS system, the court decides
Delay tactics can be enticing to a branded firm, but â&#x20AC;Ś it is consumers who pay the price.
if the branded firm is being unreasonable. Importantly, the bill maintains the FDAâ&#x20AC;&#x2122;s role in ensuring patient safety. By eliminating unnecessary delays in competition, our bill
would reduce the federal deficit by $3.2 billion over 10 years according to the Congressional Budget Office (CBO). Consumers, employers, and others who pay for prescription drug benefits would save even more. This bill has already gained broad support from AARP, the American College of Physicians, the American Hospital Association, Blue Cross and Blue Shield, and Consumers Union to name a few. Often, prescription drug pricing issues break down along partisan lines. However, the CREATES Act is a commonsense solution developed by a bipartisan group of senators. Abusing the regulatory process at the expense of patients should not be a profit stream for a company. The CREATES Act allows innovation and competition to drive the pharmaceutical market. Our bill will lower prescription drug costs and improve the quality of health care. When people get sick, their focus should be on
getting well, not on how to pay for their prescriptions. I look forward to continuing to work with my colleagues on both sides of the aisle to pass this important piece of legislation.
has earned a reputation as an effective, results-driven legislator willing to reach across the aisle to get things done. In the Senate, she has supported efforts to reduce the cost of health care for families and businesses and reward efficient, cost-effective results like those achieved in Minnesota. She has also been an outspoken advocate for the importance of science in advancing new medical breakthroughs. She has consistently pushed to maintain strong federal funding for the National Institutes of Health, supported the bipartisan Stem Cell Research Enhancement Act, and authored successful legislation to promote early detection in breast cancer patients.
Senator Amy Klobuchar, JD,
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Understanding the “public option” from cover
vital details—who would be insured, who among the insured would receive subsidies, which clinics and hospitals would provide care, how much providers of medical goods and services would be paid, whether the PO’s premiums would be lower than those of existing insurers—are unknown at this point. The best way to understand the PO is to trace its history from a specific proposal put forth by Jacob Hacker in 2001 to its current status as a political Rorschach blot—a concept that can mean pretty much whatever you want it to mean if you’re in the mood to project hopes or fears onto it. The original proposal When Jacob Hacker was still a graduate student working on a degree in political science, he wrote a proposal designed to insure nearly all Americans.
This proposal was published in 2001 as part of a project funded by the Robert Wood Johnson Foundation called Cover America. Hacker published a slightly different version of this proposal in 2007, by which time he was a professor of political science at Berkeley. In his 2001 article
the phrase “Medicare-like” to describe the HCAP proposal to drive home their claim that HCAP would enjoy the advantages of Medicare’s traditional fee-for-service program—large size, low payment rates to doctors and hospitals, and low overhead (Medicare’s administrative costs
It has been impossible to define the PO.
he called his program “Medicare Plus.” In his 2007 paper he called it “Health Care for America Plan.” I will call it HCAP for short although he did not. In both papers Hacker proposed that Congress create a “Medicare-like” program that would sell health insurance to the non-elderly. Hacker and his followers repeatedly used
eat up only 2 percent of its expenditures versus 20 percent on average for the insurance industry). Because it had those advantages, Hacker predicted HCAP would be able to set its premiums far below those of the insurance companies and thereby induce at least half of the non-elderly to enroll in HCAP. In his 2001 paper he stated that, “approximately 50 to 70 percent of the non-elderly population would be enrolled in Medicare Plus.” In his 2007 paper, Hacker stated: For millions of Americans who are not uninsured or lack…affordable work place coverage, the Health Care for America Plan would be an extremely attractive option. Through it, roughly half of non-elderly Americans would have access to a good public insurance plan. (p. 5). These predictions were confirmed by the Lewin Group, a consulting firm. In its October 2003 report on Hacker’s 2001 paper, Lewin concluded that Hacker’s “Medicare Plus” program would enroll 113 million people (or 46 percent of the non-elderly) and leave 5 million uninsured. In its February 2008 report on Hacker’s 2007 paper, Lewin concluded that HCAP would enroll 129 million people (50 percent of the nonelderly population) and leave 2 million uninsured.
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The Democrats’ version compared with Hacker’s But something happened to HCAP between 2007 when Hacker published his second paper and the summer of 2009 when House and Senate Democrats announced their versions. According to the Congressional Budget Office (CBO), the PO announced by the House Democrats in June 2009 would insure 10 million people at most, and the PO unveiled by the Senate Health, Labor and Pension (HELP) Committee in July 2009 was unlikely to insure anyone. How was HCAP transformed from a program that would insure 115 to 130 million people into one that would insure zero to 10 million people? The answer: The Democrats stripped Hacker’s HCAP of every feature that would have given it the power to set its premiums below those of the insurance industry. Hacker had laid out these five criteria for HCAP: 1. It had to be pre-populated with tens of millions of people, that is, on the day it opened for business it had to represent a large pool of people. (Hacker proposed automatically enrolling the uninsured as well as Medicaid and SCHIP enrollees into his public program.) 2. Only HCAP enrollees could get subsidies. 3. HCAP had to be available to all nonelderly Americans (not just the uninsured and employees of small employers). 4. HCAP had to be given authority to use Medicare’s provider reimbursement rates. 5. The insurance industry had to be required to offer the same minimum level of benefits HCAP had to offer. According to the Lewin Group’s 2008 report, a PO meeting these criteria would have (as of 2007): • Enrolled 129 million enrollees (or 50 percent of the non-elderly)
• Enjoyed overhead costs equal to 3 percent of expenditures • Paid hospitals 26 percent less and doctors 17 percent less than the insurance industry • Set its premiums 23 percent below those of the average insurance company But the POs in the House and Senate HELP Committee bills met only one of those five criteria: Both bills required the insurance industry to cover the same benefits the PO had to cover. None of the other four criteria were met. The PO was not pre-populated; the subsidies to employers and to individuals were available to the PO and the insurance industry; employees of large employers could not buy insurance from the PO in the first few years after the plan opened for business and possibly never; and the PO was not authorized to use Medicare’s provider payment rates (the House bill authorized Medicare’s rates plus 5 percent). Neither Hacker nor any other prominent PO advocate ever publicly objected to the weakened version of HCAP proposed by the Democrats. Thus, at this date we can only assume Hacker and his disciples thought the Democrats’ PO would succeed even though the CBO had doubts. The PO’s biggest obstacle Thanks primarily to opposition to the PO by Senator Joe Lieberman (D-CT), the PO was dropped from the Senate version of the legislation that eventually became the Affordable Care Act. So we will never know how the weak PO proposed by the Democrats would have performed. But we may predict with some confidence that any PO that doesn’t meet Hacker’s original criteria for HCAP will probably fail, especially if it is restricted to selling only on exchanges as the co-ops have been. The number one reason to predict the failure of a weak
PO is the high concentration of the health insurance industry and the spread of managed care cost-control tactics, notably the use of closed or preferred panels of doctors and hospitals. A brief review of Minnesota’s insurance market illustrates this statement.
Scholars at George Washington University confirmed this assessment. After visiting the Twin Cities in 1991, they reported, “There is now little chance of market entry by a small newcomer plan unless it is sponsored by one of [the] giants” (Where Does Marketplace Com-
It simply is not true that any co-op program is better than no co-op program.
M i n n e s o t a’s i n s u r a n c e industry began to consolidate in the 1980s as the managed care tactics pioneered by HMOs spread. HMOs and the first traditional insurers to adopt managed care tactics used their ability to shift large pools of patients from one clinic or hospital to another to force providers to give them steep discounts that non-managed insurers could not extract. Those discounts allowed the managed care plans to lower their premiums, which brought them more enrollees, gave them more market power to demand discounts, and the cycle continued. This dynamic drove some insurance companies out of business, and caused others to merge with each other.
petition in Health Care Take Us? June 1991, p. 5). The “giants” referred to were Blue Cross Blue Shield and the four HMOs that dominated the Twin Cities by 1991. According to a letter published in the New England Journal of Medicine in 1993, those HMOs were extracting discounts equal to 38 percent from Minneapolis hospitals. Even Medicare,
at 36 percent, couldn’t extract discounts as big as the HMOs could. The average discount for all other private-sector insurers was just 3 percent. Several well established insurance companies responded to this new market by leaving it or shutting down. Prudential and American Family Insurance left Minnesota in 1994. The Mayo Clinic shut down its HMO in 2001. First Plan, a co-op with 18,000 members, shut its doors in 2009. A vice president for First Plan explained to the Star Tribune, “Our size makes it very difficult for us to compete.” It should be obvious to anyone familiar with this history that it is now extremely difficult for any company, be it publicly or privately owned, to crack the Minnesota market today. If that company has the advantages that Hacker
Understanding the “public option” to page 42
C onsolidation a nd the spread of managed care made Minnesota’s insurance market almost impregnable to newcomers by the late 1980s. In 1988, the Minnesota Department of Health reported, “It is becoming increasingly difficult to ‘crack’ the Minnesota health plan market.” (Minnesota Health Plan Markets, 1987, February 1988, p. 18). The reason, said the Department, was that new entrants found it very difficult to assemble the critical mass of enrollees and providers needed to compete with the largest insurance companies in Minnesota.
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SPECIAL FOCUS: PUBLIC HEALTH
N
early 2,000 Minnesotans die each year from chronic lower respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma, according to the Minnesota Department of Health. COPD is the fifth leading cause of death in the state, and 17 percent of people with COPD had at least one emergency room visit or hospitalization in the last 12 months. Many patients return to the hospital multiple times each year in our state, often for complications that are preventable with correct use of medication therapy. The Agency for Healthcare Research and Quality (AHRQ) estimated that in 2004 (most recent data available), asthma cost to Minnesotans was $240 million directly in hospitalizations, emergency room visits, office visits, and medications; the indirect costs of lost work and school days accounted for an additional $181 million dollars. Access the Asthma Care Quality Improvement: A
Web-based patient education A look at two successful efforts By Ruth Seabaugh, PharmD, BCPS, and William Nersesian, MD
Resource Guide for State Action at: http://www.ahrq.gov/sites/ default/files/publications/files/ asthqguide.pdf Leveraging a community health perspective Because of the scope of this opportunity, in 2010 the Fairview Physician Associates (FPA) Network Quality Improvement committee decided to tackle COPD from a community health perspective. This physician-led group wanted to address the issues related to quality, patient
experience, and cost of care—following the Institute for Healthcare Improvement’s Triple Aim for population health. We hoped to create an education tool free to any user—patients, providers, and the public; accessible from anywhere at any time, while providing clear, consistent, and compelling information. FPA Network is a providerand practice administrator-led nonprofit organization of 2,500 health care providers and nearly 400 primary and specialty clinic locations. Member practices are independent, owned by Fairview Health Services or by University of Minnesota Physicians. Using a variety of initiatives, FPA Network has worked for more than 20 years to improve quality and experience, while reducing cost of care to improve the health of the communities we serve. Based on a literature review and needs expressed by care providers and pharmacists across our network, we developed a three-pronged approach to improve quality of COPD care: 1. Encourage appropriate use of spirometry. 2. Facilitate primary care referrals to network pulmonology specialists based on established criteria. 3. Improve appropriate patient use of medication. Inhaler variation, complexity creates confusion We began work to determine how to improve COPD medication use across our network’s population of approximately 36 0,0 0 0 p e ople . E duc at i n g
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patients on correct inhaler technique had become more difficult with market introduction of dry powder inhalers and the variety of metered dose inhalers driven by the switch in 2008 from chlorofluorocarbon (CFC) to hydrofluoroalkanes (HFA) propellants. At that time, patients had to sort through 10 different devices representing 22 branded inhalers on the market. A literature search found that studies documented high rates of incorrect inhaler technique. For example, Molimard, et al. showed that incorrect inhaler use reached as high as 76 percent (Journal of Aerosol Medicine and Pulmonary Drug Delivery, 2003.) Incorrect technique can reduce therapeutic effect, contributing to exacerbations and avoidable hospitalizations. Our pharmacy and patient education staff realized they needed device-specific resources organized in an easy-to-use for mat to help physicians, nurses, and pharmacists educate patients during the encounter. We explored printed options such as flip charts, posters, and pocket cards, but found that printed tools would be expensive, difficult to disseminate, and hard to maintain. We realized that an Internet-based tool would support broad access at minimum cost, while allowing users to interact with information anywhere at any time. There were plenty of online resources available at the time, including manufacturer and independent resources from such organizations as the American Lung Association. However, no web-based source organized information about all inhalers on the market, including video demos, in one convenient location. An Internet-based tool allows providers to incorporate training into the workflow of the clinic, pharmacy, or hospital easily, while providing a reference for patients to practice and review inhaler instructions at home. Web-based video demonstrations of pharmacists
modeling proper inhaler technique became the cornerstone of our project as the most effective teaching method. We also realized that an internet-based tool had the potential to further improve the health of our COPD population by providing information on living with COPD, to include proper nutrition and energy conservation. We worked with network patient education and pharmacy staff to incorporate printable information on these topics. We planned to add information on asthma after we launched the website. Overcoming hurdles What began as a relatively small project expanded rapidly into a comprehensive website. We addressed several barriers along the way, including issues of copyright and access to internal development resources. We worked to make a case for the project in order to secure system IT resources by working together with multiple system departments including patient education, pharmacy, marketing, and legal staff. Inhaler manufacturers were non-responsive to our requests to use product images or to link to their demo videos. As a result, we created our own demo videos and product photographs, working with our system’s medication therapy management pharmacists who provided expert product demonstrations. Although developing our own materials increased the complexity of the project and time to completion, taking control of the process allowed us to offer information completely without manufacturer bias. Promoting the site across the network After many tweaks and additions, “Maximize Your Inhaler” (fpanetwork.org/inhalers), went live in July 2013, three years after we began planning. Costs for in-house development were limited to staff time. The site navigation allows users to scroll through and click photos of an inhaler product, which links to
a corresponding product video on a carousel, as well as associated printable information sheets and prescribing details for providers. Prior to launch, we knew we needed a plan to promote
Sy monds, Pha r m D, BCACP, Fairview medication therapy management pharmacist. “Many people are visual learners, so having a video resource for patients to reference back to on proper inhaler technique is
“Inhaler technique tends to be very poor for many patients.” —Brittany Symonds
the website throughout our health system, independent network clinics, and beyond. We began promotion with our own large and complex network, introducing the site through demonstrations at leadership meetings, in-network communication, employee intranet, social media, clinic posters, and patient handouts for network clinics and pharmacies. We also worked with system care teams and medical specialty providers to include the website in the system COPD care package, as well as link it to our electronic medical record. Initial feedback from providers and patient educators was very favorable. “The instruction is good and very necessary from an education and treatment standpoint,” said Susan L. Burton, MD, assistant professor of medicine, pulmonary, allergy, critical care, and sleep medicine at the University of Minnesota Medical School. Dr. Burton commented that she has seen patients misuse inhalers in “just about every way” possible, including spraying the medication into the air. Other network clinical staff recognized the value of consistent and accurate inhaler patient education. “Studies have shown that inhaler technique tends to be very poor for many patients, which means they may not be getting optimal benefits from their medication,” said Brittany
helpful for patient education.” In response to requests, we added asthma educational materials to the website that fall and launched the asthma portion of the website in Spring 2015. Because information on the inhaler website can affect patient care, we developed a regular review process to keep the material current, adding new
inhalers as they come on the market. Diabetes product education website launch Due to the popularity of the inhaler website, our medication therapy management pharmacists and certified diabetes educator team asked us to develop a diabetes website in partnership with their departments. We incorporated user feedback into a new, parallel diabetes site that features video demos of injectable medications and creates a more streamlined user experience. We launched the diabetes website (fpanetwork.org/diabetes), in May 2016 and followed a similar promotional strategy. While awareness of the diabetes site is still growing, early feedback is positive. Spencer, a 23-year-old male who has had Type 1 Diabetes since he was 7 years old, shared
Web-based patient education to page 25
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SPECIAL FOCUS: PUBLIC HEALTH
The Quality Measurement Enhancement Project (QMEP) Accounting for social determinants of health By Michael Scandrett, JD; Jonathan Rose, PhD; Nancy Garrett, PhD; and David Satin, MD, ABFM
T
he State of Minnesota’s goal is to enroll more than half of the state’s Medicaid population in Integrated Health Partnerships (IHPs, aka accountable care organizations) and similar alternative value-based payment (VBP) arrangements by 2018. Under these new VBP models, health care providers are held accountable for the costs and quality of care of their patients, using standardized statewide measures. Early experience in Minnesota has raised concerns that existing measures and the way they are used have the
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unintended effect of causing potential financial harm to clinics due to their location or the populations of patients they serve rather than their clinical expertise. One important reason for this is that existing measures and VBP payment methods do not account for the importance of and impact on patients of social determinants of health (SDH). How SDH impacts health SDH are socio-economic, racial, and cultural factors such as poverty, homelessness, place of residence, language barriers,
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ethnic differences, and other factors that have a substantial impact on a patient’s health, access to care, treatment outcomes, and health care costs (Health Equity of Care Report, 2014). Because of SDH barriers, some patients need additional or different types of services to achieve the same level of health and treatment outcomes as others. For these patients, the clinical expertise of a doctor or clinic is essential, but may not be sufficient to achieve the best health outcome. For a clinic that treats homeless patients with chronic medical conditions, the first priority might be helping patients achieve stable housing before they can effectively treat and manage a patient’s health conditions. Another example is a clinic serving new immigrant patients who do not speak English. Providers at that clinic will need to spend more time with each patient to allow for communication and explanation of the American health care system. Research has demonstrated that there is a direct link between SDH and patients’ health and access to and quality of care. Increasingly we are learning that SDH factors typically have a greater impact on patients’ health than medical services. Despite this evidence, Minnesota’s existing health care quality measures do not identify and take into account patients’ SDH barriers, and existing provider payment methods do not pay for the additional services patients need. The University of Minnesota Medical School recently established enhanced education about the impact of
SDH as a curricular priority. This is not just a Minnesota issue but is receiving growing attention nationally. A recent Medicare report sets forth a plan for incorporating SDH into Medicare payment and measurement methods (Accounting for Social Risk Factors in Medicare Payment, 2016). An Institute of Medicine report calls for changes to health education programs so that health care professionals and providers are better prepared to identify and address SDH in their patient populations (A Framework for Educating Health Professionals to Address Social Determinants of Health, 2016.) Accounting for SDH In health care, as in other areas, “That which is measured improves.” Unless quality measures and payment methods measure and account for SDH barriers, the emerging care delivery and payment models have the potential to accelerate the widening health disparities that are of great concern to providers, communities, policymakers, employers, and health insurance plans. Under existing pay-for-performance programs, clinics serving large numbers of patients with high SDH complexity often score as lower quality providers, and receive payments that do not adequately cover the additional costs of services needed to achieve optimal health and treatment outcomes for their patients. Under the emerging VBP payment models, these clinics face a strong financial penalty for serving patients experiencing health and health care disparities. This, in turn, results in patients with SDH
barriers having less access to the additional services they need to overcome the barriers and achieve the same level of health outcomes as other patients. Even though many societal factors contribute to health disparities, unless the health system places a much stronger emphasis on SDH through payment and measurement incentives, the system itself will be perpetuating or even exacerbate the disparities that exist due to SDH. A good example of the unintended penalty on clinics because of where they are located or the types of patients served is the statewide measure for optimal diabetes care. One component of the measure is whether a diabetic patient smokes. If the patient smokes, the clinic receives a failing score on the entire diabetes care measure without regard for how well a patient’s diabetes is managed. This measure is intended as an incentive for clinics to reduce the smoking rates of its patients, but it directly penalizes clinics serving communities with high overall smoking rates. This includes many rural clinics and urban clinics that serve populations, such as Native American communities with smoking rates of over 50 percent. We all know how difficult it can be for an individual to break the addiction to tobacco, especially if many of their friends, neighbors, and coworkers are smokers. A doctor who does a stellar job of providing best practices to help patients quit could be a “bad doctor” when practicing in some rural areas or serving some patient populations, and a “good doctor” when serving patients and populations with low smoking rates. Even further, these clinics and doctors will be financially penalized under VBP payments even though they may actually need to spend more time and resources on smoking cessation services because so many more of their patients smoke. The QMEP Project The Quality Measurement Enhancement Project (QMEP) is an alliance of health care clinics,
consumer groups, racial and ethnic communities, academic and research institutions, and state agencies that have been working together to develop better methods to account for the impact of SDH in the health care system. The QMEP project exists because of the leadership, expertise and advocacy of people from the affected communities who experience disparities partnering with the health care
possible changes to SQRMS that are mandated by the legislation. QMEP initially set out to develop socioeconomic risk adjustment tools for existing SQRMS measures, but after reviewing the research and discussing the issues and options further, it is now assessing whether new or different measures and payment methods are needed. Existing primary care clinic quality indicators relate pri-
Quality measurement should include what patients and communities consider to be important.
providers who provide services to them. QMEP has supported improvements in how quality of care is reported through Minnesota Community Measurement in Minnesota so that the health profiles of racial, ethnic, and low economic status communities, and the specific challenges that these health profiles present, are accounted for in assessing and reporting quality of care (Health Equity Quality Report, 2016). Efforts also resulted in the enactment of legislation in 2015 that requires the Minnesota Department of Health (MDH) to change Minnesota’s Statewide Quality Reporting and Measurement System (SQRMS) to account for SDH. The legislation also requires that the Department of Human Services (DHS) develops new payment methods for Minnesota’s Medicaid and MinnesotaCare programs that will account for the additional services and resources needed to serve patients with SDH barriers. Because of these successes, we can see more clearly that disparities do exist, and we have support of policymakers and state agencies to implement improvements in the health care measurement and payment system to address health disparities. QMEP is now working with MDH and DHS to develop
marily to expertise in managing a small number of chronic diseases, but do not measure many other facets of quality of care that are important to patients, providers, and the community.
For example, even though the goal of health care reform is the Triple Aim of improving population health and patient experience and reducing total cost of care, SQRMS does not include an overall measure valuing a clinic’s health, wellness, and prevention efforts to improve population health. Another example suggested by the Institute of Medicine is categorizing quality measures into those that are and are not SDH-sensitive, so that payers and others who use the measures can design programs that direct resources where they are most needed to reduce disparities. A core principle of QMEP is that initiatives intended to reduce disparities and address SDH in the measurement system should be done through authentic partnerships with affected communities in which
QMEP to page 24
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QMEP from page 23
the communities play a lead role in developing the strategies. The current measures do not necessarily reflect the perspective of patients and communities and what is important to them and how they define quality. Our measurement system should be true to the goal of patient-centered care, which means that quality measurement should include what patients and communities consider to be important. Leadership and the engagement of communities experiencing disparities is essential in every part of the health care system—policy, education, practice, and financing—including defining quality of care, and which services and resources are needed to overcome SDH barriers and achieve a more equitable health care system (Principles of Authentic Community Engagement). As the QMEP alliance continues its work, attention is being paid to the new Medicare quality measures and payment methods that are being established under the Medicare Access and CHIP Reauthorization Act (MACRA). MACRA measures will become the new national standard for provider quality measurement and value-based payment, raising questions about what is needed to align Minnesota’s SQRMS measures with the federally mandated MACRA measures. These emerging developments give us even more reason to assess our current measurement strategy and consider what changes need to be made. Improving health care quality measurement QMEP’s goal is to improve health care quality measurement but not add to the measurement burden already experienced by Minnesota’s clinics. We cannot measure all of the facets of quality care but do need to reassess which measures are most important for statewide reporting and use in VBP payment
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methods. The measurement burden is of special concern in light of the additional new measures coming from the federal government. Because QMEP believes some important facets of quality are missing from the current system, its goal is to reassess measurement priorities and consider eliminating some existing measures. QMEP believes it is possible to reduce the overall measurement bur-
and community barriers that affect community health, such as lack of housing or nutritious food, and work with others to find solutions. Physicians have a role in shaping public health policy. They can participate in policy advocacy through their professional associations and other organizations for improvements in the current statewide quality measurement system and government pro-
Clinics face a strong financial penalty for serving patients experiencing health and health care disparities.
reimburse physicians who are serving patients who face substantial non-clinical socio-economic barriers that affect their health, access to, and “quality of care.”
Michael Scandrett, JD, is executive director of the Minnesota Health Care Safety Net Coalition. Jonathan Rose, PhD, is board chair of the Sierra Leone Community in Minnesota (SLCM), an organization that promotes the well-being of the Sierra Leone community and a fellow of the Leadership and Advocacy Institute to Advance Minnesota’s Parity for Priority Populations (LAAMPP Institute). Nancy Garrett, PhD, is chief analytics
den for Minnesota clinics by aligning Minnesota’s measures with the new federal measures and then refocusing the remaining Minnesota-specific measures on those that are most important to improving the health and quality of care for all Minnesotans and reducing the health disparities experienced by some. Regardless of which measurements are used, they must take SDH into account or the system will itself contribute to perpetuating or even exacerbating health disparities by not adjusting for the external SDH that have such a strong influence on patient health, access to care, and provider scores on quality measures. What can physicians do? Physicians can contribute to improving health equity for those Minnesotans who are experiencing disparities today. They can learn more about the importance of social determinants of health that affect their patients, use internal systems and resources to better identify those non-clinical factors that affect their patients and communities, and use that knowledge to develop skills for improved treatments and outcomes. They can also provide expertise and leadership to draw attention to the societal
MINNESOTA PHYSICIAN OCTOBER 2016
vider payment methods. They can advocate and work for an improved and more effective measurement system and payment method—one that would more fairly value and adequately
officer at Hennepin County Medical Center. David Satin, MD, ABFM, is an assistant
professor in the Department of Family Medicine and Community Health at the University of Minnesota.
Web-based patient education from page 21
his experience with the tool. “The FPA diabetic webpage will be very helpful to individuals and their families when they are first diagnosed, as well as for those who have had diabetes for a long time, like me,” he said. “I found the glucagon video to be a good refresher and liked that resources, such as carb counting and sick day review, were listed in one area and easy to find,” he added. A network physician also saw benefit for his patients. “The ability of my patients to access demonstration videos specific to their inhalers or diabetes devices is very beneficial to my practice,” said Kevin Nelson, MD, family medicine physician, Richfield Medical Group. Measuring our impact Use of both the inhaler and diabetes websites continue to grow as part of an overall menu
of population health tools, to include care packages, care coordination, patient education, transitions of care work, classes for people with chronic disease, and other resources.
doubled over the past year. Our video demos also are available on YouTube and have dramatically increased from about 680 views per month in 2015 to more than 3,200 per month in 2016.
Web-based training for complex patient-initiated therapies offers multiple advantages.
E x a m i n at ion of website analytics shows that the inhaler website is among the most f requently visited pages on fpanetwork.org. We have been surprised to receive requests to link to our site from around the U.S. and Europe. We have seen steady growth in our website analytics for our inhaler and diabetes web pages. The number of pa ge s v iewe d h a s ne a rly
Conclusion Future plans for the project include developing content in multiple languages, possible new sites featuring other diseases or devices, and converting to a new operating platform that will allow for better mobile device and video use. Web-based training for complex patient-initiated therapies offers multiple advantages
to support population health. Examples include: • Demonstration of product use techniques clearly in detail • No cost to the patient • Availability any time, any place • Generally affordable to develop • Ability to maintain and update rapidly Improving the health of the communities we serve requires coordinated efforts throughout the health care system. We found that our Internet-based tools have become a valuable part of educating patients with chronic disease.
Ruth Seabaugh, PharmD, BCPS, is a pharmacy specialist for Fairview Physician Associates Network. William Nersesian, MD, is chief medical officer for Fairview Physician Associates Network.
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SPECIAL FOCUS: PUBLIC HEALTH
I
t is a summer morning at Comunidades Latinas Unidas En Servicio (CLUES) Minneapolis. Many people are coming into the building to attend English as a Second Language (ESL) classes, while others wait in the reception area asking questions, requesting services, or waiting for a staff person to meet with them. It is a vibrant environment that includes people of all ages. They belong to different communities, mostly Latino, though it is clear that languages other than English and Spanish are also spoken. Thirty-five years ago a group of Latino social work students at the University of Minnesota were concerned by the pervasive, unmet emotional needs of the small yet growing Latino community in the Twin Cities. They decided to join efforts and use their professional training to create a social service agency focused on providing mental health services in Spanish.
Comunidades Latinas Unidas En Servicio (CLUES) Serving the Twin Cities Latino community By Mauricio Cifuentes, PhD, LICSW, and Carla Kohler
These pioneers were full of passion and enthusiasm. They were part of the community they wanted to serve and knew firsthand the impact they wanted to make. Over time, their awareness about the complex needs of the Latino community led them to expand services beyond mental health. Their vision and dedication as well as the hard work of many others transformed the original small agency into what
it is today. From the time CLUES was founded in 1981, the Latino community in Minnesota has grown significantly, presenting new and urgent challenges. Most of the current staff identify as Latino and/or have close ties to someone such as a Latino spouse. Some staff members identify with other immigrant and/or refugee communities, such as the Somali population. Providing social services CLUES acknowledges that issues of inequity, inequality, oppression, and discrimination disproportionally affect the Latino and other immigrant and refugee communities. The agency also recognizes that the lack of culturally responsive and linguistically appropriate services affects the access and effective delivery of services to these communities. At the same time, we recognize the strengths and contributions these communities and their individual members bring society. This awareness shapes our programmatic response to the needs of the Latino community. As the largest social service agency in the state of Minnesota focused on serving primarily the Latino community, we provide a broad range of services in Spanish and with cultural sensitivity in mind. Services are delivered through programs organized around four pillars: 1) economic vitality, 2) educational achievement, 3) cultural and
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civic engagement, and 4) health and family services. Overall, CLUESâ&#x20AC;&#x2122; programs reflect Latino cultural values, and are client-centered, strength-based, multigenerational, and follow a comprehensive and integrative approach. The ultimate goal of all these programs is to provide access to resources and opportunities for Latinos to be healthier, prosperous, and engaged.
MINNESOTA PHYSICIAN OCTOBER 2016
Economic vitality The economic vitality pillar focuses on asset and credit building, employment and workforce development, and community resources navigation. These programs address some of the most pressing issues facing Latino families, especially if they are undocumented or have very low income. Accessing available resources in the community, facilitating the process of establishing a credit history, and obtaining and retaining jobs with fair salaries open the door for financial prosperity and are key to breaking the cycle of poverty, which are major stressors for many Latinos. Educational achievement The educational achievement pillar focuses on community education as a way to achieve community transformation. It addresses the needs of children, by offering early childhood literacy and elementary tutoring; the needs of youth through academic support, college preparation, and professional mentors; the needs of parents through adult education training and workshops on a variety of subjects. All community members may receive the benefits of programs such as ESL, computer skills for English-language learners, financial literacy, and computer literacy. Education is highly valued in the Latino culture, and for many immigrants the desire to provide a better level of education for their children is the main reason they immigrate and/or remain in the United States.
Cultural and civic engagement The cultural and civic engagement pillar promotes and supports specific public policy issues such as immigration reform, offers civics classes for English-language learners, promotes voter engagement and registration, encourages Latino youth to volunteer, facilitates access to citizenship through the citizenship loan project, and furthers Latino culture and art through partnerships and events such as Fiesta Latina. Health and family services The health and family services pillar understands health as a broad concept and a continuum rather than a static idea. It recognizes the intimate connection that Latinos ascribe to their bodies and minds. This connection between body and mind explains, at least partially, why Latinos are the ethnic minority group in the United States with the highest levels of somatization. It is very common for Latinos to express emotional stress in the form of physical ailments. The health and family services pillar includes behavioral health services such as individual, couples, family, and group psychotherapy onsite and also in schools. We also provide mental health assessments for immigration-related cases, chemical health assessments (rule 25), treatment groups, early intervention educational programs, family well-being (domestic violence, sexual assault, parenting support and education, and case management), and health promotion and disease prevention through our Community Health Services program. Community Health Services (CHS) focuses on addressing health disparities affecting the Latino community not only in the metro area of Minneapolisâ&#x20AC;&#x201C;St Paul, but also in some rural areas in southern Minnesota. Through the utilization of the Community Health Worker model, it offers education and promotes healthy behaviors among Latino communities,
families, and individuals. Community health workers promote health and wellness concerning tobacco cessation, exposure to second-hand smoke, dia-
exists in communities of color and LGBTQ populations. In Minnesota, the two communities with the highest rates of smoking include American In-
There [is] a high prevalence of chronic (and often multiple chronic) diseases in the U.S. Latino population.
betes prevention, chronic disease self-management, healthy eating, active living, and teen pregnancy prevention. Specific interventions within Community Health Services range from community engagement at large cultural, ethnic, and religious events to one-to-one direct services through home visit education, tobacco cessation, and health care access.
dian (38.3 percent) and Latinos (28.2 percent). To address these disparities and complement other existing work, CLUES began the DEJALO YA! Program. This is a seamless integration of services that provides one-to-one education on the harm of tobacco use and second-hand smoke. The program also connects smokers with resources to help them quit.
The Centers for Disease Control and Prevention (CDC) note that Latinos are disproportionately obese or overweight (75 percent compared to 67 percent of the general U.S. population) and are at a higher risk of developing chronic diseases such as asthma, cancer, diabetes, heart disease, and hypertension. Not only is there a high prevalence of chronic (and often multiple chronic) diseases in the U.S. Latino population, but also a majority of Latinos living with chronic disease self-report feeling that their diseases are inadequately managed. In response to this reality, CLUES has implemented a Stanford evidenced-based chronic disease self-management workshop for Latinos. The Tomando Control de Su Salud workshop has been adopted to help Twin Cities Latinos with chronic disease enjoy healthier
CLUES to page 40
Preventing chronic disease CLUES has a long history and a strong background in working with the Latino community on chronic disease prevention and policy systems and environmental (PSE) change. CLUES leads a strong coalition of Latino leaders, local churches, community groups, colleges, and local institutions committed to implementing local PSE changes among Latino communities. CHS aims to reduce the number of Latino children, young adults, families, and communities exposed to tobacco influences, focusing on the implementation of private PSE changes to eliminate tobacco use and exposure to second- and third-hand smoke through the adoption of tobacco-free policies by Latino multi-unit managers, business owners, church leaders, and event organizers. Minnesotaâ&#x20AC;&#x2122;s Adult Tobacco Survey revealed that the statewide smoking rate is 14.4 percent; however, a significant disparity
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INDIVIDUALIZED MEDICINE
P
resident Barack Obama launched the Precision Medicine Initiative (PMI) in 2015 “to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” As director of the Center for Individualized Medicine (CIM) at Mayo Clinic, my goal is for every patient to benefit from the promise of precision medicine. CIM is transforming health care through research using new genomic-based tests and treatments that address the unmet needs of patients worldwide. Precision medicine leads to earlier diagnoses, and safer drug therapies and treatment plans customized to the patient’s individual genetic code. Individualized medicine— also known as precision medicine—will continue to transform how we manage health and disease. By taking into account differences in each person’s
The Precision Medicine Initiative Transforming our approach to disease By Keith Stewart, MB, ChB, MBA
lifestyle, environment, and genes, precision medicine gives us the tools to shape treatment to the individual’s needs for the best possible care. This personalized approach can help physicians diagnose, treat, and eventually even prevent illness. That could mean a higher quality of care at a lower cost, because we’re not spending time and effort on needless tests or drugs that might not work. The PMI Cohort Program, launched in early 2016, aims
to lay the foundation for using precision medicine in clinical practice. The goals of the PMI Cohort Program are to engage a group of 1 million or more U.S. research participants who will share biological samples and information about their health, lifestyles, and environmental exposures—all linked to their electronic health records. This data may enable researchers to develop more precise treatments and prevention strategies for many diseases and conditions. However, to illuminate differences and similarities in health all the way down to the level of an individual patient,
The PMI Cohort Program biobank To meet this need of developing more precise treatments for many diseases and conditions and extending healthy life through prevention, the National Institutes of Health (NIH) awarded Mayo Clinic $142 million in funding over five years to serve as the national PMI Cohort Program biobank. We relied on its existing infrastructure and biobank experience when applying for this highly competitive funding award. Indeed, the existing 50,000-participant Mayo Clinic Biobank is similar in study design, biospecimen collection, processing, and storage. The only difference is Mayo currently holds approximately 1,000,000 samples versus more than 35 million samples that will be stored through the PMI Cohort Program biobank. Mayo Clinic’s ability to harness the resources of Mayo Medical Laboratories (MML) is also key to accomplish the goals of the biobank. The MML nationwide network covers all 50 states, with more than 300 couriers and longstanding relationships with
Today, Mayo Medical Laboratories receives 35,000–40,000 specimens per day and performs 23 million tests per year.
researchers have to find data connections from a variety of sources. Some of those sources are physical, such as blood or urine samples, and some, such as electronic health records, mobile health data, and vital signs, are informational data. Linking these disparate datasets will accelerate research. One step in that process is the creation of a centralized and coordinated biorepository that safely and privately hosts biological samples. Linking to informational and health-related datasets facilitates timely research.
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major logistic providers that ensure the shortest transit time possible for specimens. Today, MML receives 35,000–40,000 specimens per day and performs 23 million tests per year. What is a biobank? A biobank is a facility designed to store biological samples linked to health information safely and privately, and in optimal conditions to ensure accurate research. The PMI Cohort Program biobank will hold a research repository of biologic samples, known as
biospecimens, to help improve our understanding of individual differences that contribute to health and disease to advance precision medicine. The PMI Cohort Program expects to enroll 1 million volunteers and may store up to 35 million physical or biological samples in the PMI Cohort Program biobank at Mayo Clinic. Participants will also provide data from electronic health records to the Program, allowing researchers to compare biological samples with patient outcomes over long periods of time. By establishing a research resource study of the size and scope proposed by the NIH, we hope to accelerate our understanding of disease onset and progression, treatment response, and health outcomes. The PMI Cohort Program biobank will reflect the diversity of the U.S. population, including volunteers from diverse social, racial/ethnic, and ancestral populations. The range of participants will come from a variety of geographies, social environments, and economic circumstances, and from all age groups and health statuses. This comprehensive range will help us gain better insights into the biological, environmental, and behavioral influences on health and disease. Stephen Thibodeau, PhD, co-director of the Mayo Clinic Center for Individualized Medicine Biorepositories Program and co-principal investigator, and Mine Cicek, PhD, director of the Mayo Clinic Biospecimens Accessioning and Processing Core Laboratory and co-principal investigator, will oversee the PMI Cohort Program biobank and administer the award. The highly automated Mayo Clinic Bioservices facility serves as an active, vital research resource for the biospecimen collection of 1 million participants. The facility allows for efficient and accurate handling and processing of specimens, which includes robotic systems to separate, label, and store biospecimen components, including automated DNA extraction. These samples are cataloged and stored in
automated, secured freezer complexes primarily on Mayo Clinic’s campus in Rochester. The Biospecimens Accessioning and Processing Core laboratory site on Mayo Clinic’s Florida campus will provide sample storage for 20–25 percent (8–10 million samples) of the collection to protect the national resource in the case of a natural disaster affecting the primary storage facility. Mayo Clinic will increase
1 million volunteers within four years. The Biobank will allow Mayo Clinic to seek new medical knowledge and share that knowledge with others. This effort also complements the Destination Medical Center initiative and Discovery Square at Mayo Clinic, which is designed for global research innovation and collaboration. Whether we’re gathering data to find the right answers or identifying the right treatments,
The PMI Cohort Program biobank is expected to be a major force in advancing precision medicine.
the size of its existing Minnesota biobank by 25,000 square feet and its Florida biobank by 5,000 square feet including advanced automation technology, state-of-the-art robotic freezers, and personnel. Construction began in the summer of 2016 and is anticipated to be complete by March 2017 in Minnesota and December 2016 in Florida.
will bring. With new technologies, federal funding, nationwide participation, and health care organizations such as the Mayo Clinic Center for Individualized Medicine, the concept of individualized treatment will quickly be a reality. About Mayo Clinic’s Center for Individualized Medicine The Center for Individualized Medicine discovers and integrates the latest in genomic, molecular, and clinical sciences into personalized care for each Mayo Clinic patient. For more information, visit http://mayoresearch.mayo.edu/center-for-individualized-medicine/. Keith Stewart, MB, ChB, MBA, is the
Mayo Clinic’s goal is to meet the unmet medical needs of all patients. We are excited for the tremendous opportunities this
Carlson and Nelson Endowed Director of the Mayo Clinic Center for Individualized Medicine, for Mayo Clinic’s campuses in Arizona, Florida, and Rochester. He is also a consultant hematologist at Mayo Clinic and recognized as the Vasek and Anna Maria Polak Professor of Cancer Research.
Maintaining data security and privacy Participants will have access to their personal data as well as summarized results from across the cohort. The PMI Cohort Program will ensure this is done ethically and responsibly. The White House developed the Data Security Policy Principles and Framework to incorporate in all PMI activities, including the PMI Cohort Program. Maintaining data security and privacy is paramount to maintaining participants’ trust and engagement. The future of the PMI Cohort Program biobank The PMI Cohort Program biobank is expected to be a major force in advancing precision medicine and contributing to research and improved health care. NIH aims to begin enrolling participants in 2016 and reach
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PROFESSIONAL UPDATE: TRANSPLANT SURGERY
K
ira’s first episode of pancreatitis occurred at the age of four years. She had multiple family members with pancreatic issues as well, and she was found to have hereditary disease secondary to a PRSS1 mutation. The frequency of her pancreatitis episodes increased in her late teens. In addition to approximately two hospitalizations per year, she suffered from epigastric pain on an almost daily basis that affected her ability to continue her college studies and sometimes required narcotic pain medication. Medical and endoscopic interventions to control her pain were unsuccessful. The patient was therefore referred to the University of Minnesota for consideration of a total pancreatectomy with islet autotransplantation (TPIAT), a procedure her brother had undergone in the past at another institution. CT imaging of her pancreas revealed calcifications consistent with chronic pancreatitis, however her endocrine
Total pancreatectomy with islet autotransplantation Treating intractable chronic pancreatitis By Mariya Skube, MD, and Gregory Beilman, MD pancreatic function remained preserved with a normal mixed meal test. After consultation with the chronic pancreatitis team, she elected to undergo the procedure, hoping to get back on track with her educational and life objectives. The history of TPIAT The first TPIAT was performed at the University of Minnesota in 1977 by two pioneering transplant surgeons, Drs. John Najarian and David Sutherland. Total pancreatectomies had previously
been utilized for treatment of chronic pancreatitis, however this procedure alone results in brittle diabetes with the inherent complications of increased insulin sensitivity and dramatic hypoglycemic episodes. Islet autotransplantation was developed in order to circumvent these issues by maintaining a component of beta cell mass for insulin production. To date, over 650 patients have received TPIAT at the University of Minnesota. There are approximately 30 other centers in the world that perform this operation, with most of them located in the U.S. Candidates for TPIAT include patients with chronic pancreatitis, recurrent acute pancreatitis, or documented hereditary disease (PRSS1, SPINK1, or CFTR
coordinators. The patient’s clinical course must indicate disease refractory to optimal medical management including endoscopic therapies such as stenting of strictured ducts. These patients often also present with evidence of pancreatic endocrine and exocrine insufficiency— such as altered glucose tolerance and digestive abnormalities— given their severe disease. As noted in a 2012 article by Sutherland, et al. in the Journal of the American College of Surgeons, approximately 20 percent of the TPIAT patient population at the University of Minnesota had undergone a previous surgical drainage procedure or partial pancreatic resection such as a Puestow, Whipple, or distal pancreatectomy. Performing TPIAT on patients with active alcoholism or illicit drug use, pancreatic cancer, inability to comply with the post-operative care regimen, or co-morbidities not compatible with the physical demands of the operative course is contraindicated. Evaluation Patients presenting for consideration of surgical intervention receive multidisciplinary evaluation by a team of providers including experts in gastroenterology,
The recovery process after surgery requires six to 12 months. genetic mutations) with clinical significance (see Figure 1 for complete selection criteria). These patients suffer from severe abdominal pain and often require frequent health care visits and hospitalizations to manage symptoms and disease sequelae. This results in a decreased quality of life, escalating pain management regimens, and significant time away from school and work. Given the gravity of this procedure, a careful and thorough approach to patient selection is employed by a multidisciplinary team including surgeons, endocrinologists, gastroenterologists, and care
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endocrinology, surgery, pain, psychology, and nutrition. This evaluation is capped by a weekly conference in which each patient is discussed individually to develop a care plan. About half of evaluated patients are determined to be appropriate for TPIAT. Other interventions include medications, dietary modification, endoscopic or pain therapies, and other surgical procedures. Surgical options Not all patients with chronic pancreatitis should undergo TPIAT. For patients with marked pancreatic duct dilation—especially
FIGURE 1
University of Minnesota selection criteria for TPIAT I. Definitions (must have one of A, B, or C) A. Chronic pancreatitis (CP) Patients with chronic abdominal pain, lasting greater than 6 months, features consistent with that of pancreatitis, and evidence of chronic pancreatitis as evidenced by at least one of the following: 1. M orphologic/functional evidence of CP (CT of abdomen with evidence of chronic pancreatitis [calcifications] or ERCP evidence of pancreatitis) 2. EUS of ≥6/9 criteria positive for CP 3. At least two of the following three findings: a. Secretin MRCP or ERCP with findings suggestive of CP (abnormal duct/side branch) or MRI T2 evidence of fibrosis b. EUS with ≥ 4/9 criteria positive for pancreatitis c. Abnormal exocrine pancreatic function tests (peak bicarbonate <80) B. Relapsing acute pancreatitis (AP) (must have both 1 and 2) 1. ≥3 episodes of documented AP with ongoing episodes >6 months 2. N o evidence of current gallstone disease or other correctible etiology such as autoimmune pancreatitis C. Documented hereditary pancreatitis with compatible clinical history II. Indications for TPIAT (must have 1–5 below) A. Documented CP or relapsing AP with chronic or severe abdominal pain, directly resulting in at least one of the following: 1. C hronic narcotic dependence (patient requires narcotics on a daily or nearly daily basis for >3 months) 2. Impaired quality of life, defined by at least one of the following: a. Loss of job b. Inability or significantly reduced ability to work or attend school c. Frequent absences from school d. Frequent hospitalizations e. And/or ability to participate in usual, age-appropriate activities 3. C omplete evaluation with no reversible cause of CP or relapsing AP present or untreated 4. U nresponsive to maximal medical therapy and endoscopic therapy with ongoing abdominal pain requiring routine narcotics for CP or relapsing AP 5. A dequate islet cell function (non-diabetic or non-insulin requiring diabetes with C-peptide positive) Source: Authors created the figure from the following references (Bellin, et al., Clin Gastroenterol Hepatol 2010; Dudeja, et al., Ann Surg, 2013; Sutherland, et al., J Am Coll Surg 2012).
FIGURE 2 The image on the left depicts the usual pre-TPIAT anatomy; the grey portions represent the components resected during TPIAT. The image on the right is the typical post-surgical anatomy.
Source: artist Bonnie Maxwell
older patients or those with diabetes—a drainage procedure is an appropriate option. In patients with diabetes and small duct disease or with severe pancreatic necrosis in the past, a resection procedure with removal of the affected portion of the pancreas is reasonable. The pancreatectomy The operative plan is formulated dependent on each patient’s particular situation with special consideration of preoperative imaging and previous pancreatic procedures. Peritoneal access is typically laparotomy, however laparoscopic and robotic approaches are other potential options. Pancreatic dissection is carried out with special attention to vascular preservation (namely of the gastroduodenal artery, splenic artery, and splenic vein) until the specimen is fully mobilized in order to minimize ischemic time thereby avoiding unnecessary loss of islet cell mass. Patients typically undergo partial duodenectomy and splenectomy with preservation of the pylorus. Bowel continuity is restored after the specimen has been removed and sent for processing. Reconstruction is typically accomplished with a gastro- or duodenojejunostomy and choledochojejunostomy via a Roux-en-Y limb (see Figure 2). A gastrostomy or jejunostomy tube is usually placed to allow enteral access for medications and nutrition while the patient recovers. Islet isolation After operative removal of the pancreas, the specimen is delivered to a specialized facility that isolates the islet cells from the pancreas through a complex process involving enzymatic, mechanical, and thermal processing. This can take four to eight hours, which is particularly significant considering that at our center, the patient remains on the operating table under general anesthetic until the processed
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SURGERY
F
or the first time, patients, health care providers, and payers have access to information on patient outcomes following knee replacement and spine surgeries across the state. Minnesota is the first state in the nation to collect and publicly release Patient Reported Outcome (PRO) data for orthopedic knee and spine surgeries. The first round of outcome data, which was released in March 2016, provides quality information about the degree to which these procedures have helped to alleviate pain and improve mobility and function. The surgical outcome data that was released in March (and is posted on MNHealthScores.org) was based on three new measures developed by MN Community Measurement (MNCM) as part of the Minnesota Department of Health’s Statewide Quality Reporting and Measurement System (SQRMS): • Total knee replacement— functional status • Spinal surgery: lumbar fusion—functional status
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Evaluating surgical outcomes Tools for making comparisons By Daryll C. Dykes, MD, JD, PhD, and Jim Chase, MHA
• Spinal surgery: discectomy/ laminotomy (herniated disk)—functional status The measures include the change in functional status reported by patients before and after each procedure. The data are collected from patients using standardized survey tools. The results from providers who submitted data show most patients improve in their ability to perform activities such as sitting, walking, and getting out of bed after surgery, for all three procedures. Spine surgeries were measured on a 100-point scale.
MINNESOTA PHYSICIAN OCTOBER 2016
Patients on average saw a 16.7-point improvement after lumbar fusion surgeries and a 22-point improvement after herniated disk surgery. A higher number of points indicated reduced pain and greater improvement in function and mobility after surgery. Knee replacement outcomes were measured on a 48-point scale, in which the top score represented a fully functioning knee. The statewide average change in score after knee surgery was 17.1 points. Again, a higher number of points indicated greater improvement after surgery. Although most patients reported increased mobility following knee and spine surgeries, the degree of improvement varied across medical groups. While this variability may be attributable to differences in surgical technique, post-surgical rehabilitation methods, appropriateness of the procedure for a given patient, or other clinically-significant factors, some or all of the variability in these data could be attributable to inherent limitations of the measure instruments, variability in patient factors across medical groups as discussed below, or incomplete data submission. As MNCM has found with other measures, reporting this comparative data can help clinicians learn from other practices and identify opportunities for changes in care that can improve patient outcomes. Most important, public reporting of outcome data can get patients more engaged in their own health care and assist them with making better decisions about their own treatment options.
Patient-reported outcomes provide important perspective Historically, patients themselves have been a largely untapped resource in assessing the quality of health care. Patients are an extremely valuable, and arguably, the authoritative source of information on outcomes beyond experience with care. For the spine and knee procedures, Minnesota’s statewide quality reporting system uses measures based on PRO tools. These measures, developed by MNCM, use the patients’ own accounts of changes in their physical and mental health status before and after surgery, including their ability to perform normal household and job-related activities. These measures improve the ability of providers to assess function, pain, and quality of life from the best source of the information—their patients. Measures based on PROs are increasingly sought-after because they can assess what is most important to patients.
Sharing information on outcomes with the public is a relatively new concept.
According to the National Quality Forum (NQF), patient and family engagement is a key component of a comprehensive strategy to achieve a high quality, affordable health system, since evidence shows that patients who are engaged in their care experience better outcomes and choose less costly, but equally effective interventions. Why PROs are an important measure PROs have become recognized as a systematic and validated way to hear from patients. PROs measure changes in an individual’s physical and/or mental health status, including their ability to perform normal
household functions and job duties, resulting from medical treatments or procedures. PROs are typically measured using standardized patient surveys, which exist for asthma, depression, back pain, and a variety of other conditions and procedures. According to the ConsumerPurchaser Alliance, a collaboration of consumer, employer, and labor groups working to promote the use of performance measurement in health care, consumers and providers should care about PROs, because they: • Measure what is important to patients—the effect of medical care on their overall quality of life and daily activities • Address many issues that providers should be discussing with their patients that ultimately will affect their clinical outcomes • Give consumers essential information for provider choice • Represent a key element of patient-centered care
Minnesota leads the nation in the development of high-value PRO measures. MNCM has developed and implemented multiple PRO measures, which will continue to be a focus of the organization’s measure development work in the future. We believe that these measures provide meaningful information and immense value. Collecting data Over the past 10 years, MNCM has developed, implemented, or publicly reported more than 75 measures that are widely accepted by payers and providers. Through ongoing testing, auditing, refinement, and collaboration with a wide variety of stakeholders, MNCM works to assure that the measurement development and data collection process is: • Meaningful • Evidence based • An opportunity for improvement • Actionable • Credible • Feasible
MNCM’s PRO measures now include: • Patient experience of care • Depression care • Asthma control • Total knee replacement • Spinal surgery: lumbar fusion • Spinal surgery: discectomy/ laminotomy (herniated disk)
to measure symptom control (pain, nausea, and constipation) during chemotherapy. Integrating patient-reported outcome tools into existing cancer care practices provides an opportunity to make that care more patient-centered and enhance communication between patients and providers.
Patients themselves have been a largely untapped resource in assessing the quality of health care.
MNCM also collects patient-reported race, Hispanic ethnicity, preferred language, and country of origin data that are used to stratify a variety of quality measures in our effort to identify and eliminate racial and ethnic health disparities. Another measure currently under development aims
In July 2015, MNCM’s spinal surgery—lumbar fusion functional status and total knee replacement functional status became MNCM’s newest PRO measures endorsed by the NQF.
Evaluating surgical outcomes to page 34
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Evaluating surgical outcomes from page 33
The need for state-wide participation Not all eligible providers submitted data this year, even though the measures were included by the Minnesota Department of Health in the set of mandatory measures. As reported by MNCM, a total of 31 medical groups submitted data for total knee replacements, 13 medical groups for lumbar
fusion surgeries, and 16 medical groups for herniated disk surgeries. While this represents approximately 80 percent of the total knee replacements performed in Minnesota, only one-quarter of knee replacement patients completed the required pre- and post-procedure Oxford Knee Score questionnaires, a patient-completed survey describing their knee function as it relates to daily activities. Because we cannot determine procedure volumes for Minnesota spine procedures based on currently available data, we
cannot determine the proportion of spine surgery patients that completed the component questionnaires. However, it is
Patient and family engagement is a key component of a comprehensive strategy to achieve a high quality, affordable health system
likely that a significant reporting gap exists for spine surgery reporting, as well. Although the primary care community has been measured for more than a decade, for specialties like orthopedics and neurosurgery, sharing information on outcomes with the public is a relatively new concept. While submitting this data takes considerable effort, groups who donâ&#x20AC;&#x2122;t participate leave their patients with incomplete information about how well they might function after having surgery. Also, given the increase in accountable care contracts with payers, where the referring physician is responsible for all the care their patients receive, referring providers have a much greater incentive to review standardized outcome information on their patients than in the past. The demand for this level of performance information is likely to expand across all medical specialties in the near future. Conclusion The demand for specialized procedures like knee and spine surgery has far outpaced our ability to measure and report the effectiveness of the procedures. By 2030, total knee replacement surgeries are projected to grow from approximately 700,000 procedures per year to 3.5 million procedures
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MINNESOTA PHYSICIAN OCTOBER 2016
per year, according to the American Association of Orthopedic Surgeons. Spine procedures also will see increased demand,
particularly among patients older than 65, where surgical rates are expected to rise 59 percent by the year 2025. The systematic measurement and public reporting of health care measures is a relatively new concept for surgical subspecialties, like orthopedics and neurosurgery. We believe, however, that surgeons, their patients, and referring providers will come to value these and other specialty measures as important supplements to primary care measures in our effort to meet the growing demand for services, and to improve health care outcomes for all patients.
Daryll C. Dykes, MD, JD, PhD, is a board-certified orthopedic spine surgeon and health law researcher based in the Twin Cities. He served on the MN Community Measurement Board of Directors and Quality Audit Committee between 2012 and 2016. He is currently on sabbatical in Washington, DC, working with members of Congress and the administration as a Robert Wood Johnson Foundation Health Policy Fellow. Jim Chase, MHA, has been the president of MN Community Measurement since 2004 and has worked for Minnesota Department of Human Services, health plans, and provider organizations in the state. Jim serves on the boards of the National Quality Forum, the Institute for Clinical Systems Improvement, and Apple Tree Dental.
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Total pancreatectomy with islet autotransplantation from page 31
cells are returned for infusion. The ducts of the pancreas are cannulated, and an enzymatic solution is infused to separate the endocrine and exocrine components of the pancreas. The specimen is sectioned into small segments. Through the mechanical and enzymatic means, the tissue is dissociated. The resultant suspension is then filtered resulting in a suspension of islet cells. Further purification is carried out depending on tissue volume and islet count. The islets are then packaged and returned to the operating room for infusion.
A critical determinant in the endocrine outcome for the patient is the islet cell mass. While 1 to 2 million islet cells are present in a healthy pancre-
(IEQ) per kilogram of patient weight results in improved rates of at least partial graft function. Once the islet cells are returned to the operating room,
Patients also report significantly improved quality of life on standardized surveys.
as, islet yield in this population is significantly lower than this due to chronic inflammation, previous pancreatic operations, and loss during islet isolation. Our institutional experience has found that an islet infusion of at least 2,500 islet equivalents
the infusion process begins. After anticoagulation, the portal venous system is accessed through cannulation of a major branch such as the splenic vein or superior mesenteric vein. Intraportal pressures are monitored during the infusion;
generally, if the portal venous pressure persistently rises above 30 centimeters of water, the infusion is aborted. If aborted, the remaining islets are placed in an alternative location such as the peritoneal cavity. Recovery Postoperatively, patients are admitted to the hospital for approximately two weeks. An insulin infusion is utilized to maintain strict glucose control in the early postoperative period to avoid excessive stress on the islet cells as engraftment Total pancreatectomy with islet autotransplantation to page 38
Online Resources for Physicians or Patients with Chronic Pancreatitis 4 4 4 4
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https://www.pancreasfoundation.org/patient-information/chronic-pancreatitis/ http://www.pancreapedia.org/reviews/total-pancreatectomy-and-islet-auto-transplantation-for-chronic-pancreatitis https://www.youtube.com/watch?v=XFxFnKpmH3k https://www.youtube.com/watch?v=hM2S2mR77s8
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progresses. Insulin is weaned over the following months as the islet cells engraft and recover function. Most adults require short-term enteral access such
procedure to meet both their acute perioperative as well as their chronic pain needs. Some of the potential complications in the postoperative period include bleeding, portal vein thrombosis, anastomotic leaks, bowel obstruction, and intra-abdominal and/or wound infections.
Appropriate patient selection remains a key component to the success of this procedure.
TABLE 1 Patient outcomes after TPIAT (insulin independence rate is after 18 months and narcotic independence rate is after one year). 80 70
66%
60 50
Percentage of Patients
Total pancreatectomy with islet autotransplantation from page 36
40
40%
30 20 10 0
Insulin Independence
Narcotic Independence
Outcomes as a gastrostomy and/or jejunostomy tube due to delayed gastric emptying that can arise after duodenectomy. Enzyme replacement is provided to supplant exocrine pancreatic function lost with pancreatic resection. Patients often have significant preoperative narcotic pain medication requirements given the severe pain associated with pancreatitis. Their pain regimen is tailored and weaned after the
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The recovery process after surgery requires six to 12 months. Outcomes Our long-term data reveals that most of our patients do benefit from the procedure (see Table 1). On average, two-thirds of patients have some islet function with one-third of patients being completely insulin dependent. Patients also report significantly improved quality of life
MINNESOTA PHYSICIAN OCTOBER 2016
Source: Authors created the table from the following references (Bellin, et al., Am J Transplant, 2016; Chinnakotla, et al., Ann Surg, 2015).
on standardized surveys (Bellin, et al., Clinical Gastroenterology and Hepatology, 2016). Approximately 50 percent of patients no longer require narcotic pain medications two years after the operation. Nonetheless, appropriate patient selection remains
a key component to the success of this procedure as it is a significant undertaking that is not the optimal choice for every patient. Kira is now one year out from her TPIAT. Her glucose is managed with two units of long-acting insulin daily, and she does not require ongoing narcotic pain medication. She is studying engineering psychology and plans to pursue graduate school as well. Kira reports that although the recovery process after the operation was admittedly very challenging, she is satisfied with the results and would recommend the procedure to other patients in similar situations. Mariya Skube, MD, is a fourth-year
general surgery resident at the University of Minnesota collaborating with Dr. Beilman. Gregory Beilman, MD, is the Owen H. and Sarah Wangensteen Chair in Experimental Surgery and Deputy Chair of Surgery at the University of Minnesota. He practices as a general and critical care surgeon and has been involved in the TPIAT program since 2001.
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CLUES from page 27
lives by supporting them to better care for themselves. CLUES is part of a national organization, the Nuestras Voces (Our Voices): National Network to Reduce Tobacco-Related and Cancer Health Disparities Program. It seeks to increase Hispanic community infrastructure and build regional and national partnerships with existing tobacco and cancer control networks, their membership, and other stakeholders to decrease tobacco use and exposure to second-hand smoke. The program also increased cancer prevention strategies and disease management for those living with cancer. We also partnered with Blue Cross and Blue Shield to conduct a quantitative study measuring tobacco use in the Latino community. The report, titled
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“Tobacco Use in Minnesota: A Quantitative Survey of Members of Minnesota’s Latino Communities,” found that the overall rates of tobacco use among
a community action plan that aims to improve the health and well-being of the Latino community in Ramsey County. Several partners who serve
Overall rates of tobacco use among Latinos are lower than Minnesota’s general adult population.
Latinos are lower than Minnesota’s general adult population, however young adults and men have greater rates comparatively. These findings are important in establishing a plan on how to address tobacco use in the Latino community. Recently, we collaborated with Ramsey County to develop
MINNESOTA PHYSICIAN OCTOBER 2016
Latino community members in Ramsey County came together to reduce health disparities that impact communities of color, specifically addressing healthy eating, active living, and tobacco use, significant indicators that impact health and lead to chronic disease.
Conclusion Even though we have described CLUES’ different programs and activities as separate entities, it is important to understand that they have been designed and implemented as a cohesive strategy by a multidisciplinary group of stakeholders, experts from different fields, and community members. As a not-for-profit organization, CLUES values partnerships as a powerful tool to help us achieve our goals. We welcome collaboration in the design, implementation, evaluation, and research of our services, which benefits our Latino community.
Mauricio Cifuentes, PhD, LICSW, is senior director of Health and Wellness at Comunidades Latinas Unidas En Servicio (CLUES). Carla Kohler is the manager of Community Health at CLUES.
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Understanding the “public option” from page 19
conferred upon HCAP, including subsidies not available to private insurers plus pre-population, then it is reasonable to agree with the Lewin Group that such a company would succeed, possibly so well it could eventually seize half the non-Medicare market. But if the company does not have those advantages, then we should accept the CBO’s prediction that it would enroll few people. We might even predict that, like the ACA’s health insurance co-ops, it won’t survive. Failure of the ACA co-ops does not bode well The 23 co-ops authorized to sell insurance on the ACA exchanges closely resembled the Democrats’ weak version of HCAP. The co-ops were not pre-populated and the subsidies they received were available to insurance companies as well. In a September
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2009 letter to Senator Max Baucus (D-Mont.), the CBO said the co-ops “seem unlikely to establish a significant market presence in many areas of the country.” That, as we all know now, was an accurate prediction. Sixteen of the co-ops have gone under as of this date. There is a
exchanges, underestimated how costly their enrollees would be. Other factors that contributed to the co-ops’ demise almost certainly included small size (and a concomitant inability to extract large discounts from providers) and naivete about how to game the risk-adjust-
[The public option must] … be pre-populated with tens of millions of people.
lesson here for PO proponents: If a PO is not pre-populated and given subsidies that its competitors do not receive, it may not survive. We do not yet have a complete accounting of why the 16 co-ops failed, but it seems clear at this point that they, like nearly every other insurer that sold on the
MINNESOTA PHYSICIAN OCTOBER 2016
ment mechanism used by CMS to determine which insurers got more than their share of healthy enrollees. (Many co-ops claimed that risk-adjustment payments they had to make to other insurers were a major factor in their demise.) The failure of the co-op program should provide PO
proponents with a lesson in how not to write legislation. If you’re going to entertain the fantasy that a brand new insurance company can crack the insurance market today, you better write clear criteria into the enabling legislation that guarantees large size and an adequate supply of capital. And you better resolve at the opening of each session of Congress that if at any point those criteria are stripped out of the authorizing legislation, you will pull the plug. You will oppose the bill. It simply is not true that any co-op program is better than no co-op program. Similarly, it is not true that any PO program is better than no PO program.
Kip Sullivan, JD, writes frequently
about health policy. His articles have appeared in peer-reviewed journals such as the New England Journal of Medicine and Health Affairs. His formal training is in law and economics.
rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. Thatâ&#x20AC;&#x2122;s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.
To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.
The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. Š 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
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