MN Physician January 2017 by Minnesota Physician Publishing

MINNESOTA

JANUARY 2017

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXX, No. 10

Family medical accounts A potential solution to Minnesota Medicaid problems BY ROBERT W. GEIST, MD

he Minnesota Medicaid program has problems. Its costs have risen inexorably and patients may not be able to find a personal doctor they want. Instead these patients often seek care in hospital emergency rooms, which is not an ideal way to access health care.

Pharmacogenomics Understanding precision medicine

A new snag arose for some 300,000 Medicaid families in December 2016 when the Medica HMO announced that it would not bid at the next auction to service Medicaid families because low state capitation rate fees would ruin their business. This means that after May 1, 2017, one-third of the Medicaid population must choose another HMO. Is this really a choice? What if the folks enrolled in Medicaid could choose something other than an HMO for their care— perhaps an opportunity that enabled them to handle their own health care dollars and choose their own doctor? What if the state of Minnesota simply decided to pay people’s Medicaid bills? Connecticut has already tried this and reduced its Medicaid overhead costs by more than 50 percent. Family medical accounts to page 184

BY WILLIAM S. OETTING, PHD, AND PAMALA A. JACOBSON, PHARMD

hat if a patient’s response to an SSRI was known before prescribing and efficacy could be maximized? What if we could predict who will not achieve sufficient analgesic with pain medications? What if we could accurately predict if someone is at higher risk of a severe cutaneous reaction to phenytoin or allopurinol? A goal of pharmacogenomics is to answer these types of questions. Precision medicine is the field of disease diagnosis, treatment, and prevention that takes into account individual variability in environment, lifestyle, and genetic sequence. Pharmacogenomics (also known as pharmacogenetics) is the science of determining how genetic variation affects a person’s Pharmacogenomics to page 164

JANUARY 2017 MINNESOTA PHYSICIAN

JANUARY 2017 • Volume XXX, Number 10 WWW.MPPUB.COM

COVER FEATURES Pharmacogenomics Understanding precision medicine

Family medical accounts A potential solution to Minnesota Medicaid problems

By William S. Oetting, PhD, and Pamala A. Jacobson, PharmD

By Robert W. Geist, MD

DEPARTMENTS CAPSULES

MEDICUS

By Gregory Maurer, CPA, CMPE, and James Reimann, CMPA

INTERVIEW

CARDIOLOGY

By Nate Mussell, JD

Heterotopic tricuspid valve replacement A novel solution

Greg Simon, JD, White House Cancer Moonshot Task Force

The 2017 Minnesota legislative preview With change comes uncertainty

High-deductible health plans Mitigating a physician’s risk

The war on cancer

HEALTH CARE POLICY

ADMINISTRATION

By Mudassar Ahmed, MD

RISK MANAGEMENT

Prescribing pain medications Minimizing a physician’s risk

By Solveig Dittmann, RN, BA, BSN, CPHRM

MINNESOTA HEALTH CARE ROUNDTABLE Value-Based Reimbursement A new way to pay for health care

PUBLISHER

______________________________________________________________

Mike Starnes, mstarnes@mppub.com

EDITOR________________________________________________ Lisa McGowan, lmcgowan@mppub.com ASSOCIATE EDITOR_____________________________ Richard Ericson, rericson@mppub.com ART DIRECTOR_______________________________________Sunshine Sevigny, sunny@mppub.com OFFICE ADMINISTRATOR______________ Amanda Marlow, amarlow@mppub.com

Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; email mpp@mppub.com; phone 612.728.8600; fax 612.728.8601. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

MINNESOTA PHYSICIAN JANUARY 2017

JANUARY 2017 MINNESOTA PHYSICIAN

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

Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy that offers unbeaten A1C reduction* 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

MINNESOTA PHYSICIAN JANUARY 2017

Mean A1C change from ba

-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.

JANUARY 2017 MINNESOTA PHYSICIAN

Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

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

MINNESOTA PHYSICIAN JANUARY 2017

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)

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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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)

DG HCP BS 20APR2015

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Mayo Clinic Publishes Plan for Physician Burnout Researchers at Mayo Clinic have outlined strategies for health care organizations to combat the rise of physician burnout. The nine-point plan comes after more than a decade of documentation by Mayo Clinic researchers. “Research has shown that more than half of U.S. physicians are experiencing symptoms of burnout, and the rate is increasing,” said Tait Shanafelt, MD, director of the Mayo Clinic’s Program on Physician Well-Being and first author of the article. “Unfortunately, many organizations see burnout as a personal problem to be addressed by the individual physician. It is clear, however, that burnout is a system issue, and addressing it is the shared responsibility of both the individuals and health care organizations.” Physician burnout can have an impact on organizations, including lower productivity, staff turnover, decreased quality of care, and malpractice suits. It can impact the individual

physicians by leading to broken relationships, alcoholism, and suicide. The strategies Mayo Clinic researchers recommend for organizations to resolve physician burnout are: acknowledging and assessing the problem; recognizing the behaviors of leaders that can increase or decrease burnout; using a systems approach to develop targeted interventions to improve efficiency and reduce clerical work; cultivating community at work; using rewards and incentives strategically; assessing whether the organization’s actions are aligned with the stated values and mission; implementing organizational practices and policies that promote flexibility and work-life balance; providing resources to help individuals promote self-care; and supporting organizational sciences (study the factors in your own institutions that contribute to the problem and invest in solutions). The authors conclude that “deliberate, sustained, and comprehensive efforts by the organization to reduce burnout and promote engagement can make a difference.”

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PTSD Added as Qualifying Condition for Medical Cannabis Post-traumatic stress disorder (PTSD) has been added as a qualifying condition for Minnesota’s medical cannabis program. The Minnesota Department of Health (MDH) announced the decision on Dec. 1. Throughout June and July, Minnesotans were invited to submit petitions to add qualifying conditions to the state’s medical cannabis program. Nine conditions were put forward for consideration—PTSD, schizophrenia, acquired absence of limb (phantom limb syndrome), arthritis, autism, depression, diabetes, Ehlers Danlos Syndrome, and insomnia. MDH received 50 public comments, heard from a citizen’s review panel, and reviewed a set of research summaries for each condition that was prepared by MDH staff. “This decision was made after careful deliberation of available evidence, consultation with experts in

the field, and public input,” said Ed Ehlinger, MD, Minnesota commissioner of health. “While the process of reviewing these potential additions was difficult due to the relative lack of published scientific evidence, PTSD presented the strongest case for potential benefits. PTSD also has few effective treatment alternatives available for some patients with the condition.” Patients with PTSD will be eligible to receive medical cannabis beginning Aug. 1, 2017, with advance certification from a Minnesota health care provider. Petitions were also submitted for new delivery methods for medical cannabis, including topical, edible, and vaporizing the whole plant. MDH made the decision to begin allowing manufacturers to develop and provide topical formulations of medical cannabis. According to Ehlinger, evidence suggests that patches, lotions, creams, gels, and ointments could offer a safe, effective, and low-risk method for providing medical cannabis in known dosages to qualified patients.

Courage Kenny Researchers Present Results Researchers at Courage Kenny Rehabilitation Institute recently presented results from two studies at the American Congress of Rehabilitation Medicine 93rd Annual Conference. The first study showed how new gait guidelines have improved the walking speed of stroke patients. Courage Kenny implemented more aggressive guidelines based on best practices during physical therapy sessions in 2015 and found that on average, patients doubled their improvement in speed during therapy compared to results under the previous guidelines. “Gait speed has a big impact on how people do in the community. The gains patients made in gait speed meant that, on average, patients were now walking at community walking speeds,” said Nancy Flinn, PhD, senior scientific advisor at Courage Kenny. “If they went to the mall or grocery store, they would be able to move at the speed of others, so they are safer, because they are less likely to get bumped by others who are passing them.” The second study showed that for patients with cancer-related cognitive dysfunction (chemobrain), occupational therapy can improve everyday functioning as well as the ability to manage issues with mood, stress, and fatigue. The study included 28 patients being treated for breast cancer. Mary Vining Radomski, PhD, senior scientific advisor at Courage Kenny reported that cancer survivors may be able to improve their cognitive fog by learning strategies to manage some of these factors.

Acupuncture Improving Mastectomy Recovery A new study at Abbott Northwestern Hospital has shown that women who had acupuncture treatments after breast cancer surgery had a greater reduction in pain, nausea, and anxiety and were better able to cope on the first day after surgery compared to those who received traditional care. Researchers focused on pain, nausea, anxiety, and the ability to cope based on results of an Oncology Nursing Society survey given to

members that asked them to report the symptoms that are the most distressing and difficult to manage. Patients that participated in the study entered their levels of these variables on a scale of zero to 10 into a tablet immediately before and after receiving an acupuncture treatment. The treatments were delivered up to two times after surgery at least 12 hours apart. Patients in the group that received traditional care after surgery were visited two times after surgery at least 12 hours apart to report their levels on the same variables for comparison. “The results of this study demonstrate that acupuncture reduced patients’ perception of pain, anxiety, and nausea by about 1.5 units, which is both clinically and statistically significant,” said Jeffery Dusek, PhD, director of research at Allina’s Penny George Institute for Health and Healing. “For comparison, it is known that opioid medications reduce patients’ perception of pain by 1.9 units, which is comparable to the decrease for acupuncture in this study.”

Minneapolis VA Offers Same-Day Appointments Veterans will now be able to receive same-day service when they need it at the Minneapolis VA Medical Center’s primary care and mental health clinics. The service, called MyVA Access, is part of a nationwide initiative by the U.S. Department of Veterans Affairs to improve veterans’ health care experiences. “When you contact us, we will either address your need that day or schedule appropriate follow up care, depending on the urgency,” said Patrick Kelly, director of the Minneapolis VA Medical Center. “We may provide a face-to-face visit, return a phone call, arrange a telehealth or video care visit, respond by secure email, or schedule a future appointment.” The medical center has added staff and increased space in order to offer veterans same-day service when they require primary care assistance during regular business hours, and next-day service when they require care after regular business hours. If a veteran is in crisis, they will receive immediate attention from a MINNESOTA PHYSICIAN JANUARY 2017

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Minneapolis VA Medical Center health care professional. If they are new to mental health and have a non-urgent care need, they will receive an initial screening evaluation by the next calendar day.

MHA Accepts Award for Reducing Patient Harm The Minnesota Hospital Association was one of 16 Hospital Improvement Innovation Networks across the U.S. to be recognized at the 2016 Centers for Medicare & Medicaid Services (CMS) Quality Conference, Aligning for Innovation and Outcomes. The networks were recognized for their diligent work; authentic collaboration with patients, clinicians, and partners; and unprecedented national impact on patient safety in all U.S. hospitals. They received a total of $347 million from CMS to continue their efforts. Improvement efforts have resulted in saving more than 87,000 lives, preventing 2.1 million instances of

patient harm, and yielding $19.8 billion in cost savings nationwide from 2010 to 2014, as well as substantial reductions in the 30-day Medicare feefor-service all-cause readmission rate. According to CMS, the focus of the Hospital Improvement Innovation Networks’ work going forward will be to sustain and accelerate national progress and momentum toward continued harm reduction in the Medicare program. In addition, they commit to improving health equity, and giving specific attention to identifying and reducing health care disparities.

Alternative Sedation Method Used for Ear Tube Procedures Fairview Health Services has started using a device by Preceptis Medical, the Hummingbird TTS, as an alternative to anesthesia for children undergoing ear tube procedures for persistent ear infections. It is the most common pediatric surgery in the U.S.

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Previously, these procedures required the use of general anesthesia in the operating room because children tended to have difficulty sitting still or tolerating the procedure without sedation. This device allows physicians the option to use conscious sedation to keep the child awake but comfortable during the procedure.

St. Jude Improving Heart Failure Treatment First-quarter results for St. Jude Medical Foundation’s $1 million, two-year grant to address heart failure in Minnesota show significant quality improvements. The goal of the pilot initiative is to implement the American Heart Association’s Get With The Guidelines–Heart Failure program in 12 Minnesota hospitals and seven Texas hospitals. At six months, results show that more than 2,400 Minnesota patients with heart failure have been impacted. Patients who were prescribed beta blockers at discharge increased from 78 percent to 92 percent and patients

who received follow-up appointments increased from 44 percent to 88 percent. Participating Minnesota hospitals include Fairview Southdale Hospital; University of Minnesota Heart Care at Fairview Ridges Hospital; University of Minnesota Medical Center; Hennepin County Medical Center; Fairview Lakes Hospital; Fairview Northland Hospital; Fairview Range Hospital; Park Nicollet Methodist Hospital; Regions Hospital; St. John’s Hospital–HealthEast Care System; St. Joseph’s Hospital– HealthEast Care System; and Woodwinds Health Campus.

New Design With this edition, we are pleased to present a graphic redesign for Minnesota Physician. We hope the updated type treatment and layout will provide easier access to the varied and meaningful editorial content we work to present each month. As always, we welcome your submissions of articles and suggestions for topics to cover.

MEDICUS

MINDY BENTON, DPM, doctor of podiatric

medicine and surgery at Allina Health Clinics, has been named president of the American Board of Foot and Ankle Surgery (ABFAS). Previously, Benton has held roles on several ABFAS committees and served as president of the National Board of Podiatric Medical Examiners. She earned her doctor of podiatric medicine degree from the Dr. William M. Scholl College of Podiatric Medicine in Chicago and completed an internship and surgical residency training program at Hennepin County Medical Center. In addition to seeing patients at Allina’s Bandana Square and Inver Grove Heights clinics, she serves as the director of Podiatric Medical Education and as section chairperson of Podiatric Medicine and Surgery at HCMC. ROBERT KRATZKE, MD, associate professor at the

University of Minnesota Medical School and lung cancer researcher at the Masonic Cancer Center, has been named the inaugural chair of the Big Ten Cancer Research Consortium Steering Committee (BTCRC), where he will serve a one-year term. Kratzke has served as the University of Minnesota steering committee representative since 2014 and is a member of the BTCRC’s Thoracic Clinical Trial Working Group. Kratzke earned his medical degree at the University of Washington School of Medicine and completed his residency training in internal medicine at the University of Wisconsin Hospital and Clinics. KAI-NAN AN, PHD; ALBERT CZAJA, MD; JAMES EISENACH, MD; AND DAVID FELICIANO, MD,

have received Mayo Clinic’s 2016 Distinguished Alumni Award, which acknowledges and shows appreciation for the exceptional contributions of alumni to the field of medicine. An is an emeritus professor of orthopedics and biomedical engineering and emeritus consultant in the department of orthopedic surgery at Mayo Clinic. He began working at Mayo Clinic in 1975 and retired in 2014. He led the Biomechanics Laboratory at Mayo Clinic, which became one of the leading orthopedic research centers in the world under his leadership. Czaja is an emeritus professor of medicine and emeritus consultant in the division of gastroenterology and hepatology at Mayo Clinic. He retired in 2007. Czaja is a leading authority on autoimmune liver disease and has made contributions to the understanding of autoimmune hepatitis. Eisenach is the FM James III Professor of Anesthesiology and vice chair for research in the department of anesthesiology at Wake Forest School of Medicine in Winston-Salem, N.C., as well as the president and CEO of the Foundation for Anesthesia Education and Research. He is largely responsible for the introduction and development of intrathecal clonidine as an analgesic and made significant contributions to the understanding of chronic pain mechanisms. Feliciano is the J. Stanley Battersby Professor of Surgery and chief emeritus in the division of general surgery at Indiana University Medical Center in Indianapolis. He is widely regarded as a leading authority in trauma care and has made significant contributions to surgery in the U.S. He built trauma units in hospitals at Baylor University, the University of Rochester, Emory University, and Indiana University. MINNESOTA PHYSICIAN JANUARY 2017

INTERVIEW

The war on cancer Greg Simon, JD, White House Cancer Moonshot Task Force

Please tell us about Cancer Moonshot. uring his 2016 State of the Union Address, President Obama called on Vice President Biden to lead a Cancer Moonshot focused on making a decade of progress in preventing, diagnosing, and treating cancer in five years, ultimately striving to end cancer as we know it. As Kennedy said about his Moonshot, this Moonshot is a mission for humankind we are “unwilling to postpone,” and represents the harnessing of technology in the service of humankind. A Presidential Memorandum established the Cancer Moonshot Task Force, which was directed to unite the government in achieving the mission through a focused effort to leverage Federal investments, targeted incentives, private sector efforts, and patient initiatives, among other mechanisms. To organize the research areas of focus, the Memorandum also directed the National Cancer Institute (NCI) at the National Institutes of Health (NIH) to form the Cancer Moonshot Blue Ribbon Panel (BRP) to bring together experts in a variety of disciplines to identify key areas of science for new investment at NCI. Keeping the patient journey at the heart of its mission, the Cancer Moonshot is focused on outcomes important to patients and, in its first year, is catalyzing new actions, collaborations, and system changes inside the Federal government and in the private, academic, and philanthropic sectors. The Vice President has spoken with heads of state and generated memoranda of understanding (MOUs) with a number of countries to solidify greater international coordination and cooperation. In addition to jumpstarting these new actions in 2016, the Task Force produced a “road map,” to guide progress on the goals in the coming years with programs and policies in the Federal agencies. This included a visionary statement from the Vice President in his Executive Report, describing the goals, the progress made this year, and the issues that still need to be addressed. How do you work with other elements of President Obama’s Precision Medicine Initiative? Based on coordination and alignment of goals, a number of the first-year successes of the Cancer Moonshot were made in collaboration with and because of the foundation laid by the President’s

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Precision Medicine Initiative. For example, the NCI Genomic Data Commons (GDC) was released in June, a first-of-its-kind public data platform for storing, analyzing, and sharing genomic and associated clinical data on cancer that was initiated as part of Precision Medicine oncology. This resource allows researchers to freely access raw genomic and clinical data for more than 32,000 patients, with patient privacy and data security safeguards in place, and more records to follow. We know that people

A certain “...”level of risk needs to be taken in order to investigate new drug paths.

“...”

find this resource valuable, with more than 5 million users and more than 50 million data downloads worldwide since June. At the Cancer Moonshot Summit this summer, the Department of Veterans Affairs (VA) and the Department of Energy (DOE) announced a new collaboration to apply the most powerful computational assets at the DOE’s National Labs to nearly half a million veterans’ records from one of the world’s largest research cohorts—the Million Veteran Program, a cornerstone of the Precision Medicine Initiative. What is the role of the Cancer Moonshot Task Force? The Principals of the Task Force are agency leaders directed to unite the Federal government in

achieving our mission through a focused effort to leverage Federal investments and targeted initiatives. President Obama charged the Task Force with leveraging Federal investments, targeted incentives, private sector efforts, and patient engagement initiatives to support cancer research and enable progress in prevention, diagnosis, and treatment. Tell us about Cancer Moonshot funding. The funding began with $195 million in new cancer activities at the NIH in Fiscal Year 2016. The Fiscal Year 2017 Budget proposed to continue this initiative with $755 million in funds for new cancerrelated research activities at both NIH and the Food and Drug Administration. The Departments of Defense and the VA are increasing their investments in cancer research, including through funding Centers of Excellence focused on specific cancers, and conducting large longitudinal studies to help determine risk factors and enhance treatment. The 21st Century Cures bill passed Congress and was signed into law. It includes a total of $1.8 billion in Cancer Moonshot funding to be appropriated over several years. How can physicians and research centers become involved with Cancer Moonshot? One way is for the cancer community to consider how they impact a patient’s journey through prevention, diagnosis, treatment, and beyond, and to speed up what they planned and to do it in half the time. Many have responded, resulting in the formation of a new collaboration to further the development of effective ways to detect and track cancer progression. Individual research institutions can do their part by finding new ways to advance cancer research, by supporting team science to develop new and innovative approaches to battling cancer, by collaborating with other institutions to share best practices, and by sharing research data with other institutions and researchers sooner. This allows us to learn collectively and move forward faster to find new cures and develop improved detection. Research institutions can work with patients to develop clinical trials that work better for them and to better support each patient through their care. And individual physicians should communicate a patient’s options to them and their family in ways they can understand and feel informed to make the care decision that is right for them.

Will there be a way for patients to become involved with Cancer Moonshot? Individuals are encouraged to get involved by volunteering on the local level. To learn how you can volunteer, please visit Cancer.Serve.Gov. If research conducted by Cancer Moonshot produces new therapies, what kind of patent issues will this raise? Government funded, university conducted research is governed for intellectual property purposes by the Bayh-Dole Act. This act made it possible for universities and their employees to own and license the intellectual property resulting from government funded research. Some people have criticized Cancer Moonshot claiming that the goals and funding are out of balance by several measures. How do you respond? Criticism is expected and welcome but there is no denying that the initiative has captured the attention of the nation and the world. It is difficult to argue with a goal of doubling our rate of progress in preventing, diagnosing, and successfully treating cancer. And while some believe that we need to double our expenditures on cancer research, the $1.8 billion contained in the 21st Century Cures Act represents the largest increase in our national cancer budget in years.

What needs to happen for Cancer Moonshot to produce results? When President Nixon started the war on cancer, there was no army, no weapons, and no strategy. Today, 45 years later, we have the army and the weapons to fight the war and we are changing the way we conduct our scientific research. Agencies need to work collaboratively and share data so the research community at large can learn from past successes and failures. This helps avoid replication of failed experiments. Significant results and therapies are surfacing, as opposed to being buried due to journals keeping data proprietary for a year or universities refusing to share their data or biological material for use, study, and validation. The Vice President encourages bold thinking and, a certain level of risk needs to be taken in order to investigate new drug paths, etc. Digital databases that store large groups of genetic data and research are being developed and channeled into environmental causes. The application of computing power to massive amounts of medical data that can identify new targets for treating cancer and help predict the emergence and the path of cancer are very encouraging.

in achieving the ambitious mission and moved by its national call to action. Companies, universities, institutions, patients, and foundations have taken up the challenge to accelerate progress, turning the Cancer Moonshot into a movement not just a program. This will only grow with time. Because over 200 types of cancers exist, there are inevitably a myriad of cures and approaches, which is why we are so focused on sharing data. The more we share, the more we know. Acquiring a rich knowledge base and deep understanding of the complexities of cancer is essential to destroying this disease.

What do you see as the best-case scenario for the success of Cancer Moonshot? We have been successful, in part, because the agencies and individuals involved are deeply invested

Solutions, a center of the Milken Institute. He

Greg Simon, JD, is Executive Director of the Vice Presidentâ&#x20AC;&#x2122;s Cancer Moonshot Task Force. He returns to the White House after serving as Vice President Al Goreâ&#x20AC;&#x2122;s Chief Domestic Policy Advisor between 1993 and 1997. Previously, Mr. Simon was the CEO of the financial firm Poliwogg Holdings and Senior Vice President of Worldwide Policy at Pfizer Inc. Prior to that, he was the founding President of FasterCures/The Center for Accelerating Medical received his BA in history from the University of Arkansas and his Juris Doctorate from the University of Washington, Seattle.

MINNESOTA PHYSICIAN JANUARY 2017

3Pharmacogenomics from cover

differences in the DNA sequences coding for drug metabolizing enzymes. Variation in other proteins including drug transporters and drug targets can also alter an individualâ&#x20AC;&#x2122;s response. The cytochrome (CYP) P450 enzyme response to drug treatment and is one component of precision medicine. system is the most predominant drug metabolism system and is involved in Advances in the field of genetics have allowed us to associate specific genetic metabolism of 50 percent or more of FDA approved variants with drug treatment response resulting in drugs. The genes that encode these enzymes are more precise drug-response predictions. However, highly genetically polymorphic and carriers of these advances in genetic technologies have surpassed our genetic variants that alter the rate of metabolism ability to interpret the vast amounts of knowledge may result in altered efficacy and/or toxicity. With In clinical practice being generated and clinical implementation of these knowledge of the presence of these genetic variants, discoveries lags behind. these drugs improve individuals can be placed in metabolism phenotypes the health condition Precision in drug therapy (for example poor, intermediate, rapid, or ultrain the best of situations In a paper published in the April 30, 2015 issue rapid metabolizers). Depending on the agent, these in 1 of 5 patients. of Nature, Nicholas Schork, of the University of genetic variants can place a patient at higher risk California, San Diego, evaluated the top 10 grossing of therapeutic failure, side effects, or even serious drugs prescribed in the U.S. He concluded that adverse drug reactions. For example, the SSRIs, in clinical practice these drugs improve the health citalopram and escitalopram, are dependent on the condition in the best of situations in 1 out of 5 patients enzyme CYP2C19 for metabolism. Individuals who are (Abilify) and the worst in only 1 out of 25 patients (Nexium). It was a call to ultra-rapid metabolizers (5â&#x20AC;&#x201C;30 percent of the population) have an increased action to improve the precision in which we provide drug therapy. Some may probability of failing therapy, due to low serum drug levels, and an alternative say that these drugs are a failure, but this is not true for those who appropriately SSRI should be considered. Patients who carry genetic variants that result in respond to these treatments. Our reaction to this should not be to remove these a poor metabolism phenotype (2â&#x20AC;&#x201C;15 percent of the population) are at much drugs from clinical practice, but to identify those individuals who will respond higher risk of adverse drug reactions and a 50 percent dose reduction or an appropriately and provide alternative therapy to those who will not. alternative agent should also be considered for these patients. Variation in how individuals metabolize drugs is a major reason for why Accounting for race we see such differences in response. This variation results in large part from Most drug treatments have been studied and approved using primarily European ancestry research participants. Hence most classical clinical trials provide the most effective treatment and dose for the Caucasian population but may not for other populations. Although this provides the clinician with a starting point for treatment, for some individuals the presence of variants in genes, found more frequently in other populations, impacts drug dynamics and toxicity risk. For many of the pharmacogenomic genes, there are significant differences in allele frequencies between populations such as African Americans and Asians. The cytochrome P450 enzyme CYP3A5 provides an example of significant differences between races. CYP3A5 is involved in the metabolism of many commonly used drugs and some individuals carry a variant (CYP3A5*3) that results in a non-functional enzyme. Individuals who have two copies of the CYP3A5*3 variant do not have CYP3A5 activity and are poor metabolizers. The frequency of European Americans with two copies of the CYP3A5*3 variant is over 85 percent, but for African Americans the frequency of individuals with two copies of CYP3A5*3 is only 20 percent resulting in African Americans having faster metabolism of drugs that are substrates for CYP3A5. Some African Americans may inherit different loss of function variants, such as CYP3A5*6 and CYP3A5*7, which do not occur in the Caucasian population. There are several variants in HLA loci associated with StevensJohnson syndrome/toxic epidermal necrolysis (SJS/TEN) when certain drugs are taken. Some of these associated alleles (e.g., HLA-B*58:01 and HLA-B*15:02) are found mainly in the Asian population.

Problems with genetic variants By genotyping the individual, potential differences in metabolism or response can be identified and used to provide more informed care. Though it has now become inexpensive to determine the presence of genetic variants, our ability to correctly utilize this information in clinical practice is still in its infancy. Problems include the lack of research identifying the relationship

JANUARY 2017 MINNESOTA PHYSICIAN

between genetic variants and response to treatment, which will be needed in Minnesota minority populations, to better understand the impact of for all drug treatments. An additional problem is the understanding of genetic variation on disease treatment, prevention, and diagnosis. We are the functional effects of a genetic variant that has never been observed. also training health profession students how to use genetic information This will occur with greater frequency as individuals have their DNA in the care of patients. In the College of Pharmacy, pharmacogenomics sequenced and novel or rare variants are identified. is a required part of the curriculum. An advanced elective course in pharmacogenomics is also offered. On average an individual has over 3.5 million single nucleotide variants (SNVs) and identifying those Ultimately there are many factors that contribute that are important for predicting drug response to an individual’s health. In this era of big data, presents a major challenge. Other variants include Variation in how information from the electronic health record, copy number variants (CNVs), insertion/deletions individuals metabolize genetic sequencing, environmental and social (indels), and rearrangements. Additionally, how this drugs is a major reason determinants are being combined to create a more information is presented in the medical record and robust profile of an individual. An individual’s full for why we see such the education necessary for clinicians to understand genome will someday be available in the electronic differences in response. and utilize this information to better treat their health record and these data will be routinely used patients is also a challenge. in wellness, risk assessment, diagnosis, and delivery A viewpoint from the National Academy of Medicine, published in the Oct. 25, 2016 issue of the Journal of American Medical Association, stated that “Precision medicine has the potential to transform medicine by tailoring treatments to individuals. By providing the right treatment at the right time, healthcare could be delivered with greater accuracy and efficiency, while providing better quality of care.” To achieve these goals, we need to create research programs that can help us understand the variability observed between individuals who undergo identical treatments. The National Precision Medicine Cohort (All of Us) is an NIH funded initiative with the goal of building a national, large-scale research cohort with 1 million or more volunteers (www.nih.gov/research-training/allofusresearch-program). This initiative will produce knowledge that will help us develop more effective ways to prolong health and treat disease. Central to this initiative is the collection of genetic, health, lifestyle, and environment information from cohort participants. The Veterans Administration has also launched a national, voluntary research program (Million Veterans Program) to study how genes affect health (http://www.research.va.gov/ mvp/).

of care. The era of precision medicine has arrived. William S. Oetting, PhD, is a professor in the Department of Experimental and Clinical Pharmacology in the College of Pharmacy at the University of Minnesota.

Pamala A. Jacobson, PharmD, is a professor in the Department of Experimental and Clinical Pharmacy and Director of the Institute of Personalized Medicine in the College of Pharmacy at the University of Minnesota.

Pharmacogenomics in clinical practice Additional national efforts are underway to assist clinicians in adopting the use of genomic information in clinical practice. The Implementing Genomics in Practice (IGNITE) consortium, an NIH supported initiative, is working to develop methods to incorporate genomic information into clinical care and develop systems for effective implementation in the clinical setting. The Clinical Pharmacogenetics Implementation Consortium (CPIC), supported by the NIH Pharmacogenomics Research Network, evaluates and rates the strength of clinical studies and publishes pharmacogenomic guidelines (https://www.pharmgkb.org/page/cpic). There are now 86 drug guidelines encompassing genetic variants in 16 genes with ratings and recommendations for genetic guided dosing and toxicity risk, and the number continues to grow. Health care systems such as the Mayo Clinic, the University of Florida, and the NorthShore University HealthSystem in Chicago have established pharmacogenomic services for their patients. They believe that genetic testing will improve the quality of care they deliver to their patients.

Getting the word out So what can we do now to bring about a more precise utilization of genetic information? Here at the University of Minnesota we have begun a Precision Medicine Initiative. Major goals include expanding research, particularly MINNESOTA PHYSICIAN JANUARY 2017

3Family medical accounts from cover

funds would be placed on a debit card. The money would belong to the family and could only be used to pay for medical Medicaid goods and services.

This article will explore how to empower Medicaid families with a proposed Family Medical Account (FMA) program, like account-based plans in the private sector where they can choose their doctors and hospital.

Account-based insurance

The Minnesota FMA program would cover Medicaid families with children, who have incomes less than 138 percent of the Federal Poverty Level (FPL). These folks rarely have money for even minor medical care after paying for food, shelter, clothing, and the heating bill. If family FMA money is ever used up after paying for outpatient medical services, the state would continue to insure all further care, as it does If family ownership of for all Medicaid enrollees. After one year, unused health care dollars ... [works] FMA money would be transferred to a family-owned investment account. If a family were no longer in the private sector, eligible to receive Medicare (most often because why wouldn’t it work in someone got a better paying job), any remaining the public Medicaid sector? investment account money would be an FMA debit card available only for future medical expenses.

In 2003, Congress passed a law allowing American families to keep money tax-free in family controlled accounts called Health Savings Accounts or HSAs. This money covers affordable and expected (“first dollar”) medical costs. The combination of an HSA with relatively inexpensive high-deductible insurance that protects against the risk of a catastrophic financial loss from illness is called a Consumer Directed Health Plan (CDHP). According to David Randall et al., HSA-CDHP insurance has reduced medical spending “between 18 percent and 22 percent without tangible negative health outcomes.” In addition, they found that the greater the employer contribution to the HSA, the greater employee satisfaction and the greater the decreased use of services. Is this a paradox? Maybe not. If family ownership of health care dollars results in careful use of its medical budget in the private sector, why wouldn’t it work in the public Medicaid sector?

FMAs for Minnesota Medicaid The proposed Minnesota Family Medical Account program would mimic the private sector’s HSA-CDHP combination. FMA money from Medicaid

Could the Minnesota FMA program create savings? First, FMA money for first-dollar care on a debit card would most likely eliminate high corporate overhead costs for transactions. In 2012 for example, Connecticut fired its Medicaid HMOs after an independent audit (by the Milliman Company) showed gross overpayments compounded by initial difficulty gaining access to Medicaid HMO company books for audit. Costs were rising, as were patient complaints of barriers to services. Three years later in an interview with Connecticut’s director of Medicaid and staff by Melinda Beck of the Wall Street Journal, they said that the state’s total Medicaid administrative costs were trimmed to 5 percent compared with the average 12 percent overhead cost of its managed care plans—a more than 50 percent reduction. Connecticut’s Medicaid program directly pays clinic provider and hospital fees. Physicians welcomed the change of direct payments and additional pay for coordinating care. This was followed by a 7 percent increase in available Medicaid physicians and a decrease in hospital emergency room (ER) use. By 2016, Connecticut state officials said that the average cost per patient, per month was down 9.3 percent. Costs decrease when doctors are happy to see Medicaid patients. Patients are happy when freed from nuisance corporate referral barriers. A barrier-free market is how other market sectors work smoothly. Second, Minnesota Medicaid families owning FMA money for expected and affordable care would think twice about visiting an expensive hospital ER for a minor complaint. It is possible that savings from prudent use of FMA money could result in savings even greater than Connecticut’s 9.3 percent. In Minnesota, the proposed FMA program would include only nondisabled families with children. These families make up about 64 percent of the Medicaid population and incur about 26 percent of total Medicaid expenses. If the FMA program did save money, it could be expanded to include working adults without children with incomes up to 200 percent of the FPL; they already pay income-related premiums. It could also be expanded to include the disabled, who make up about 17 percent of the Medicaid population and account for almost 46 percent of total costs.

What about other states? The Minnesota FMA program would differ from Connecticut Medicaid by limiting eligibility to non-disabled families with children, and as noted before, by funding an FMA debit card for first-dollar care. The Minnesota

JANUARY 2017 MINNESOTA PHYSICIAN

program would avoid the greater complexity of different account-based programs found in three other states. For example, Indiana, Arkansas, and Michigan charge premiums (often called “contributions”), copayments for services, and penalties for not paying premiums, which in the long run might prove to be counterproductive, if their programs are costly through sheer complexity. In contrast, the simplicity of the Minnesota FMA debit card would eliminate such nuisance administrative costs and uncollectible nuisance charges from folks with little, if any money. States fear huge expenses from Medicaid beneficiary overuse of hospital ERs for nonemergency minor services. The Minnesota FMA program would depend on prudent family control of frivolous ER visits and better access to their own doctor. There would also be an FMA deduction of $25 if the participant did not contact the nurse hotline before going to the ER—the charge would be eliminated if treatment were required.

The commissioner of health would have a mandate to furnish an ombudsman to deal with complaints and an education division to provide important information to each beneficiary to ensure that they could make informed medical decisions and have an informed free choice when choosing either the FMA or HMO Medicaid programs.

Medicaid HMO corporations and managed care social engineers …may not welcome an FMA system.

Extra FMA program benefits The Minnesota FMA program would differ from other state programs, since it would give each non-disabled Medicaid family with children a free choice of either the FMA program or the traditional Medicaid HMO program. The FMA program would also cover federally mandated health prevention services as well as medications for hypertension, diabetes, and epilepsy without tapping into FMA money.

It is true that poverty and low status are poor for your health. For this reason, the Minnesota FMA debit card would be generously funded; the benchmark would be based on 2016 dollars allowed in federally qualified HSA programs indexed for inflation. The FMA debit card would be strictly limited to payments for approved medical services from willing licensed providers. The Minnesota FMA debit card money would follow that family when they leave Medicaid.

Are there political barriers to FMAs? New Medicaid programs require federal waiver approval—sometimes an arduous process. The political shift in Washington D.C. might make the FMA waiver process easier and approval more likely. Medicaid HMO corporations and managed care social engineers, who planned today’s huge and expensive merged medical factory-like system, may not welcome an FMA system where families can choose to manage their own money for care and where the state Family medical accounts to page 424

MINNESOTA PHYSICIAN JANUARY 2017

HEALTH CARE POLICY

The 2017 Minnesota legislative preview With change comes uncertainty BY NATE MUSSELL, JD

he passing of every new year brings change, and the beginning of Minnesota’s 2017 legislative session (which started January 3) will certainly exemplify a year of change at our state’s capitol. The new year also brings uncertainty at the Legislature, because of the hurdles legislators will face with the most uncertain health care environment both in Washington, D.C. and in Minnesota since the passage of the Affordable Care Act (ACA) in 2010.

Minnesota’s 2017 legislative session will usher in a new majority in the Senate as the Republicans regained control for the first time since 2012 and House Republicans expanded their majority in a presidential election for the first time in over a decade. While Republicans will control the Legislature, Democratic Governor Mark Dayton will serve the last two years of his final term. The health insurance crisis continues to loom large in St. Paul and passing a two-year budget and getting the Governor’s signature will certainly impose significant challenges in the upcoming year.

New faces at the Capitol The November general election results in Minnesota certainly surprised many not only nationally, but in Minnesota as well. The House Republicans picked up three additional seats to increase their majority to 76–57. This is the first year since 2008 that the House majority has stayed with the same party going into and following the election. The 19 vote majority will likely increase to 20 following a special election for incumbent Rep. Bob Barrett’s seat in February. The larger surprise of the election was the Republican Senate Caucus narrowly flipping a deficit to regain the majority 34–33. Senate Democrats failed to win and keep almost all of the competitive rural races including two losses by longtime incumbent members—Senate Tax Chair Rod Skoe and Sen. Tom Saxhaug. The election also painted a very stark contrast throughout the state as rural areas in greater Minnesota became increasingly more Republican and Democrats saw their base shrink into major metropolitan areas throughout the state. For health care issues, the November elections also ushered in new chairs in the Senate and a new Health Policy Chair in the house. Third-term senator Michelle Benson (R–Ham Lake) will chair the Senate Health and Human Services (HHS) Finance Committee in the upcoming session. Sen. Benson is well versed on health policy and budget issues having served on both the health policy and finance committees throughout her first two terms in office. Sen. Jim Abeler (R–Anoka) will serve as Chair of the Senate Human Services Reform Finance and Policy Committee. Sen. Abeler will be serving his first full term in the Senate after serving a brief term in 2016 following a special election last February. Sen. Abeler is also no stranger to health finance and policy issues having served as the HHS Finance Chair during his previous stint in the House during the 2011–2012 legislative biennium. In the House of Representatives, Rep. Matt Dean (R–Dellwood) will maintain his chairmanship of the HHS Finance Committee, but following the retirement of Rep. Tara Mack (R–Apple Valley), four-term Rep. Joe Schomacker (R–Luverne) will take over as chair of the House Health and Human Services Reform Committee. Schomacker had previously served as chair of the Aging and Long-Term Care and Policy Committee. For the first time in 33 years, the 2016 election also saw two physicians, Sen. Scott Jensen (R–Chaska) and Sen. Matt Klein (D–Mendota Heights), elected to the Legislature. Sen. Jensen is a family practice physician practicing in the West Metro, while Sen. Klein works as a hospitalist at Hennepin County Medical Center.

Health care right out of the gate Based on some early indications from both House and Senate leadership, the Legislature will waste little time in the upcoming session trying to address the current health insurance crisis in the state. While many House Republicans have been clamoring for changes to MNsure (the state insurance exchange program) for years, the current cost crisis really started coming to a head this past summer and fall—first with the announcement that Blue Cross and Blue Shield of Minnesota was largely exiting the individual market, and then the subsequent release of double-digit individual market rate increases in early October.

JANUARY 2017 MINNESOTA PHYSICIAN

The looming question facing lawmakers in January when the session percent of the state’s budget. Minnesota’s November budget forecast showed begins will be how to address the individual market in 2018 and beyond. a surplus of $1.4 billion for the state, but that number is largely preliminary One can expect the first bill introduced in January in both the House and until the release of an updated budget forecast in February. The surplus Senate to be a framework of potential solutions to the individual market rate also accounts for a balance of over $675 million that remains from the last increase issues, along with other health reforms. Some potential solutions legislative session. The new Senate Republican majority has made it clear that being discussed include bringing back the state’s high risk pool—the their number one budget priority is likely to be tax relief and the returning Minnesota Comprehensive Health Association House Republican majority is likely to follow suit. (MCHA)—that was phased out following passage Aside from tax and transportation packages, which of the ACA, or a potential reinsurance program are likely to take top billing in 2017, considerable to help offset the costs of a narrowing risk pool. For the first time in 33 years, attention will be focused on the state’s Health and Restoring MCHA may help shift some of the risk Human Services budget. Much of what happens in that the 2016 election in the narrowing individual market by moving the budget—particularly with Medical Assistance (MA), also saw two physicians higher cost individuals—many of whom have very which is Minnesota’s Medicaid program—will hinge … elected to the Legislature. expensive medical conditions—back into a separate on potential changes to Medicaid and the ACA at the risk pool. Major questions remain though about federal level. Some of the buzz around Washington how to structure and pay for these reforms. Those includes a potential move toward more state control questions are further complicated by the uncertainty of Medicaid through block grant programs. In at the federal level with the future of the ACA, which Minnesota, both the House and Senate are likely to consider reforms to is on very thin ice under the new Republican Congress and Republican the existing MA and MinnesotaCare programs that could include potential presidential administration. waivers and other eligibility changes. Hospitals may be hit particularly hard

Federal uncertainty creates budget uncertainty There is uncertainty around how Congress and the new administration in Washington, D.C. will revise Medicaid and other state/federal programs. This particularly affects how Minnesota’s Legislature will prepare its new state budget, where Health and Human Services still accounts for almost 30

if the state and federal government moves away from the Medicaid expansion that Minnesota was an early adopter of as part of the ACA. Some of the smaller, but still very significant budget issues that might come up based 2017 Minnesota legislative preview to page 404

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MINNESOTA HEALTH CARE ROUNDTABLE 46TH SESSION

Value - Based Reimbursement

A new way to pay for health care

Value-based reimbursement (VBR) is not a new idea, but solving the problems it poses, most significantly measuring quality in health care, has been very elusive. Addressing this problem, to date, has involved fine-tuning best practice guidelines, improving electronic health records, developing better data analytics, addressing diversification of care teams, adjusting for health care disparities, and many other related considerations. We are now at a significant crossroads in health care delivery— moving from paying for volume to paying for value—that will be tied to better outcomes and prevention. Today we will look at the steps that must be taken to make VBR deliver on its potential. Let’s start by defining what is meant by value-based reimbursement. MS. LAVALLEY: Value-based reimbursement is intended to incentivize physicians and care teams to deliver higher quality care at lower cost. It’s essentially a different way of contracting. Instead of a set fee schedule, physicians will be reimbursed for the care they deliver, based on both the quality and the cost of that care. Fee-for-service payments will start to decline, and other forms of payment—such as per-member, per-month [PMPM] payments; bonus payments; incentive

payments; and shared saving payments—will start to make up a larger contribution of the revenue for both physicians and health systems. MR. FLOTT: This new value-based reimbursement

environment challenges providers to examine everything they are doing. It has different meanings depending on the lens you look through. The patient is saying, “I want wellness if I get sick, I want you to make me better, I want that done in a respectful manner, and I want it to be affordable.” The employer providing a group plan is saying, “I want to have a relevant company, I want to retain the best employees possible, and I want to do it affordably.” Payers also have their own perspectives. MR. MELLOH: Value-based reimbursement is one example of a larger trend that is putting providers at financial risk for the delivery of care, the cost of care, and the quality of care. It is one example of a larger industry trend that is influencing activity in the marketplace.

because the patients have one perspective of what “value-based” means, while providers and insurers have another. If we can reimburse providers for keeping their patients healthy and for doing a good job, as opposed to just reimbursing for the numbers of tests and procedures they do, then we are taking the right direction. MR. D’EMANUELE: It is a process; it is not an event. We are not going to be in a value-based purchasing world tomorrow. At this point, reimbursement from most payers, and certainly from Medicare, is around the margins of the current basic reimbursement system. In the physician world, there is a fee schedule, and value-based elements— cost, outcomes, population health, or use of EHRs [electronic health records]—will impact that by a few percentage points, rising to 9 percent in a few years. Where it goes after that, whether it gets to 25 or 30 percent, we will have to see. MS. SIMM: We are at the infancy in even defining

changing us from counting the number of widgets we put through the system to actually taking care of patients and doing so in a quality fashion. It really does matter whose perspective you take,

what “value” is in health care. I encourage both patients and physicians to be at the table to help us define this, because the devil is in the details. In Minnesota, there has been work done with some coalitions at the state level to define value. Hopefully this will push us even further.

DON FLOTT

LISA SIMM, MBA

ROSS D’EMANUELE, JD

Don focuses on the value of laboratory diagnostics and its impact on a patient’s total cost of care. Together with pathologists, scientists, and clinicians, he has developed data-driven methodologies for producing validated diagnostic clinical evidence that can drive out waste. He examines how laboratory diagnostic data will contribute to high-quality, effective personalized medical care with lower costs.

Lisa has served as a “Pathways to Excellence Committee” member with the Maine Health Management Coalition, a purchaser-led, multi-stakeholder partnership. Her risk management experience includes work in hospitals, outpatient settings, physician office practices, and long-term care settings. She manages a staff of risk management consultants in Coverys’ Boston office.

Ross is committed to translating a complex health care regulatory environment into practical and concrete advice for his clients in the health care provider, payer, and drug and medical device segments of the health care industry. His areas of expertise include health care fraud and abuse, Stark and anti-kickback laws, HIPAA, accountable care organizations, and valuebased reimbursement.

Mayo Medical Laboratories

JANUARY 2017 MINNESOTA PHYSICIAN

DR. KLEEBERG: It is turning a battleship. It is

Coverys

Dorsey & Whitney, LLP

Value-based reimbursement, as driven by Medicare, includes three important acronyms, beginning with MACRA [Medicare Access and CHIP Reauthorization Act of 2015]. Let’s define MACRA’s two tracks: MIPS [Merit-Based Incentive Payment System] and APMs [Advanced Alternative Payment Models].

MIPS program track next year. There are a limited number of alternative payment models that are eligible under this program in 2017, but CMS has said it will expand models to encourage more physicians and groups to transition to alternative payment models. DR. KLEEBERG: At first we thought we were going

Medicare & Medicaid Services] payment program will encourage physicians to transition away from fee-for-service and into alternative payment models like ACOs [Accountable Care Organizations] or bundled payments. CMS responded to concerns that multiple quality programs were confusing and burdensome, so they introduced a new program. Unfortunately, it essentially just took three existing programs—meaningful use, physician quality reporting system, and valuebased payment modifier—then added another component. The new program still follows a feefor-service payment structure, but physicians or their groups are at risk for a penalty or eligible for a bonus based on a score of their use of EHR technology, submission of quality data, and practice improvement activities. CMS forecasts that a majority of physicians will go through the

to have to go into it full force as of January 1, but there are a couple of tracks that allow you to adapt more slowly. You can go into an alternative payment model and avoid the MIPS process if there is a dual-sided risk. The dual-sided risk had been prohibitive for independent practitioners and small practices that wanted to do an advanced alternative payment model, but with one new proposed rule, they are only going to be at risk for their portion of their Medicare payments. In 2018, under a proposed new ACO Track 1+ model, there is a possibility that some primary or smaller practices will want to be on dual risk. Right now most of them are still on Track 1, which means they also need to be in MIPS. Hopefully this will bring all of these programs together and make it coherent, and not squash independent practitioners that want to participate in alternative payment models.

PAUL KLEEBERG, MD

ALLISON LAVALLEY, MBA

DAVID MELLOH, JD

Paul is a regional medical director with Aledade, Inc., focused on enabling primary care providers to succeed in value-based payment systems and accountable care. Board-certified in family medicine, he has played key roles in EHR implementations in integrated delivery systems in small hospitals and clinics, and has represented the information technology needs of rural providers.

Allison is responsible for quality performance and value-based care delivered by athenahealth, setting the vision and priorities for future product development and for high quality, patient-centered care. She has also launched patient outreach programs focused on evidence-based chronic and preventive care, clinical data imports from other EHRs, and efficiency gains.

David advises hospitals and integrated delivery systems, physician group practices, surgery centers, and dental group practices. His background includes hospital-physician integrations and health system acquisitions, ACOs, clinically integrated networks, and other provider organizations designed to share economic risk and furnish high-quality health care services.

MS. LAVALLEY: The new CMS [Centers for

Aledade, Inc.

athenahealth

ABOUT THE ROUNDTABLE Minnesota Physician Publishing’s 46th Minnesota Health Care Roundtable focused on the topic of Value-Based Reimbursement: A new way to pay for health care. Six panelists and our moderator, Minnestoa Physician Publisher Mike Starnes, met on November 3, 2016 to discuss this topic. The next roundtable on April 20, 2017 will address Precision Medicine: A new approach to care.

Lindquist & Vennum, LLP

MINNESOTA PHYSICIAN JANUARY 2017

MINNESOTA HEALTH CARE ROUNDTABLE 46TH SESSION

MS. SIMM: One of the resources I use is CMS’s

Practice Transformation Networks. Their main purpose is to help individual physician office groups survive in this new payment model and to transform care in order to meet their new obligations. I use that and other resources on a weekly basis to touch base and learn solutions. We also partner with a company that helps organizations with bundled payments. MR. D’EMANUELE: This is a new Medicare payment

system, and it will have a big impact on physician reimbursement. There could be a reimbursement swing of up to 9 percent, depending on whether you perform well or poorly. Most physicians will be judged based on their data and reporting around four different categories—quality, clinical process improvement, use of EHRs, and resource use. The data will go into CMS in early 2018, and then they will tell you in 2019 what the impact is on your reimbursement. Your scoring in the quality category will be, I believe, 60 percent in the first year, and resource use that first year is 0 percent, but that will shift later to 30 percent of your total score. What that means is you are going to be judged with your peers on the cost and the resource use of treating patients. It will be an assessment based on claims data, not anything you report. CMS will come up with a score of how you treated a patient with a certain condition and what it cost the Medicare program, versus an analogous physician of an analogous specialty. How can we differentiate between expensive care being high quality or a waste of resources?

at the table to develop and to vet some good risk adjustment systems that take into account social determinates and genetic predispositions, which can be part of what predicts your medical outcome. What are the positive elements of value-based reimbursement? MR. FLOTT: Even in a closed practice like Mayo

that is 152 years old, we are seeing new clinician work groups develop. Along with other things such as bundled payments and accepting shared risk, this will ultimately benefit the patient.

MS. SIMM: Some risk adjustment systems have been around almost 30 years. They were developed by some of the best research institutions in the country, but they do not begin to encompass what we capture today in EHRs or on paper. Physicians need to be

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JANUARY 2017 MINNESOTA PHYSICIAN

DR. KLEEBERG: The message really has to come from the top, but it also has to be very clear. For the whole system to turn to value-based care, even when it’s not 100 percent of your bottom line, you need to be dedicated to it, because it’s going to be costly in the beginning, just as it always is to do something new. Strong leadership can help people understand it and keep their eye on the prize.

What should health care leadership be doing to implement value-based reimbursement? MS. LAVALLEY: It is going to be costly at first,

I see an opportunity for improved collaboration between providers and payers. —Allison LaValley, MBA

especially if most of your contracts are still in a feefor-service world. It is tough to maintain a positive revenue stream, but CMS and some other payers are starting to offer fee-for-service reimbursements for things like chronic care management or transitional care management, and those are definitely the types of care delivery that you are going to need to be successful in an alternative payment mode. Another aspect of that is looking at the physicians in your practice and in your network and looking at your patient panels to determine, as you transition into an ACO or join an ACO, whether you have the right mix of staffing to take care of your patients and remain profitable. MR. FLOTT: Many payers measure a PMPM basis,

MS. SIMM: There is much more we can do to engage

people. Employee health plans often incentivize employees to take advantage of access to care, to become more in command of their own health. There really is no other form of insurance out there where the person covered doesn’t have some skin in the game. If you have homeowners insurance, you can lower your premiums with smoke detectors and chimney inspections. It may sound radical, but part of me believes the insurer needs to have a little skin in the game, too, but I don’t know how you’d do that with populations of people that might struggle in any event.

based models of care, and I think that in order to effectively manage against the resource use and other aspects of value-based reimbursement, there will have to be a lot of effort put into rethinking and reshaping the way in which patients are seen and care is delivered.

who can sift through the reporting and the types of quality measures that fit with the particular organization, you can help physicians understand how it is going to apply to them. Right now everyone thinks it’s an abstract, and it seems overwhelming. I think it is incumbent upon all organizations to break through that, make it more concrete, and set out an initial strategy. Part of that might be financial incentives to physicians who do certain things. None of us knows the perfect formula for motivating individuals. That is more art than science. MR. MELLOH: It will be incumbent on providers

to rethink the way in which care is delivered and to redesign that. We talked earlier about the team-

which I believe is $300 per patient. How do we use services to lower that overall PMPM? In many organizations, including Mayo, that’s a new type of vernacular and a new type of thinking. Every step of the way, we need to ask how we deal with these patients, and how we hand off in order to bring that value back on the commercial side. MS. LAVALLEY: A number of our practices go through

patient-centered medical home transformation and want to get recognized by a group like NCQA [National Committee for Quality Assurance]. There are creative solutions or lower cost ways to implement things. A great example is one of our clients, a small practice single physician, with a total staff of about five employees. They wanted to be able to provide after-hour patient access to

care, but doing so would be very costly. So they found three other physicians in their community who were interested in doing the same thing, and developed an after-hour triage. Health care is increasingly utilizing teams of medical professionals with different levels of training, often working in different locations for unrelated organizations, so how is value-based reimbursement going to be adjusted to compensate the right caregivers for providing the right care? DR. KLEEBERG: When primary care practices get

the savings, they divide it up among the small practices, based on a formula that they all agree to in their board meeting. Each practice gets a certain amount for the number of patients they see, the quality of their service, and their participation in ACO activities. But how it’s divvied up within the practice is totally up to the practice itself. In a multispecialty clinic, there could be issues with how it gets divvied up between the specialist and the primary care providers. That was also an issue when we figured out the fee-for-service payment scale, because there had been only one or two primary care providers on the fee scale board, and specialists wound up getting more money, but we now recognize that primary care really has more value when it comes to keeping people healthy. I don’t have a magic answer regarding how much a nurse practitioner or how much the front desk should get, either, but it should be equitable across the group, and the decisions have to come in advance, not when the check arrives. MS. SIMM: Every specialty has at least a couple of agenda items in the Choosing Wisely campaigns that patients need to be more educated about. Even in radiology, patients feel that there are some unnecessary tests. When we pulled together our specialists in a large provider group, they were serious about it, long before Choosing Wisely. Employees at health care institutions are some of the heaviest utilizers of medical services in the country. Some of their premiums can be astronomical. It’s hard for physicians to say “no” for an MRI to that group, because they work hand in hand with them. MR. MELLOH: The likelihood is that specialist’s

incomes will decline over time. Diagnostic testing has been a large contributor to a specialist’s income, and diagnostic testing, generally speaking, declines in a value-based model. It’s inevitable that the glory

days for radiology, cardiology, even orthopedics have likely come and gone. We’ll see a drop in income immediately and for the foreseeable future. MR. D’EMANUELE: I think that’s true, not only

for value-based purchasing, but for CMS. Payers are going after that and will continue to go after that, even if we didn’t have value-based purchasing on a number of different levels. A corollary is that some specialty groups are most eager to get into ACOs and to share the savings with hospitals. They replace the income, or at least part of the income, that they are losing on the ancillaries.

in its entirety immediately, but we must develop foundations to successfully execute it. There is time, 3–5 years, probably, before it becomes applicable in a meaningful, material, and financial way. MS. LAVALLEY: It’s really about whether we are able

to achieve better outcomes at a lower cost, and, if so, whether we are able to demonstrate that this transformation of care is possible. As we start to see more proof points, we will continue to demonstrate that there is potential, and that will help to create more momentum to change the rest of the industry. DR. KLEEBERG: It is critically important for us to

exchange data across different EHRs and to notify primary care providers when patients have been discharged from the hospital. We have large systems that are very good at communicating within themselves, and also pretty good at communicating with other providers that have the same EHR product, but we need true interoperability, where data can flow from one place to another and patient data goes where they go. Minnesota is so far ahead in many aspects of care, but we’re behind in terms of health information exchange, primarily because we’ve got larger systems. MR. D’EMANUELE: There are a lot of challenges,

More physicians should have a voice at the table [even though] that means taking time away from the practice. —Lisa Simm, MBA, CPHQ, CPPS, CPHRM

Let’s say that CMS can prove that value-based reimbursement saves money and improves care. How can we transpose the success onto health insurance plans in a way that is transparent and translates into lower premiums and higher provider reimbursements? MR. MELLOH: We need a foundation to deliver care that is both efficacious and cost effective. That means having appropriate data analytics, appropriate models of care delivery, and appropriate teams of providers. I don’t suggest that this is an easy process, but we do, of course, have time. We’ve acknowledged that MACRA is around the margins, and, by and large, we’re still in a fee-for-service world. This isn’t something that has to be tackled

and they are all important to success. To be successful, clinicians have to be excited by the opportunity and the prospects, but sober and patient in facing the challenges. In my law firm, if we have a new document or management system, my first instinct is, “I hate this.” You have to hit the desk twice before you understand the reason for the new, more efficient system, and then you get on with it. MS. SIMM: The interoperability and the ability to

look at patients across the continuum is hugely important for this, and I think that physician leadership is hugely important. MR. FLOTT: We must keep the patient at the center. I’ve essentially grown up in an integrated system, and I’ve watched how integration works with family members, including myself. I couldn’t imagine any other way of delivering care where all the caregivers are working together on your behalf, and the information is available at your fingertips. There are systems around the country that are truly integrated beyond Mayo, and I think others are working very hard for that, but I think that is going to be one of the absolute keys.

Mayo Medical Laboratories MINNESOTA PHYSICIAN JANUARY 2017

ADMINISTRATION

High-deductible health plans Mitigating a physician’s risk BY GREGORY MAURER, CPA, CMPE, AND JAMES REIMANN, CMPA

the costs of the product being offered. In addition to monthly premiums, the patient’s cost of the product includes office visits and prescription copays, coinsurance amounts, and deductibles. Excluding premiums, these costs constitute the patient’s maximum annual out-of-pocket costs. With respect to HDHPs, providers are responsible for collecting payment from the patient or responsible party up to the annual out-of-pocket cost maximum limit. MNsure reported in December 2015 that since open enrollment started in November, 50 percent of those buying private plans through the Exchange selected Bronze plans, which was up from 34 percent a year ago. With Bronze Level plans, the deductibles range from approximately $4,500–$7,000.

The ABCs of high-deductible health plans

While health plans can protect their bottom line by raising and collecting premiums or cancelling coverage if premiums are not paid, health care providers are left trying to collect higher and higher deductibles, which the patient or responsible party often cannot afford. Health plans consider deductibles, copays, and coinsurance “cost sharing” with patients, to discourage unnecessary care and reduce the health plan’s costs. An example of Minnesota health plans using premium increases to protect their bottom lines occurred in November 2016 when health insurance exchange enrollees (MNsure) received their 2017 premium increase notice. The premiums in 2017 for the individual market in the health insurance exchange went up an average of between 50 percent (Bronze Level products) to 67 percent (Platinum Level products) over 2016.

lthough the future of the Affordable Care Act and health care legislation is unknown, high-deductible health plans (HDHPs) continue to increase in popularity and appear to be here to stay. Patients are opting for premium affordability over financial risk. Simply stated, they are rolling the dice. With respect to the health insurance products being sold in Minnesota, there has been a dramatic increase in the level of premiums and deductibles that individuals, families, and small employer groups are being asked to accept. As more and more of these high-deductible products are offered by the health plans doing business in Minnesota, providers need to take the necessary steps to limit the risks that are being placed on their clinics and staff. This article addresses a number of the issues that are associated with HDHPs and the steps providers can take to mitigate those risks. Health plans enter into contractual agreements with patients. Within these contractual agreements are explanations of which services are covered (covered benefits), which providers are in-network (provider network), and

In the journal Health Affairs, the Kaiser Foundation reports that between 2006 and 2015, a patient’s out-of pocket-costs rose 230 percent. HDHPs now make up 24 percent of health plans offered to both small and large employer groups throughout the country. Compared to HDHPs that were offered back in 2006 (6 percent), this is a fourfold increase that has passed on a huge obligation to providers to collect these deductibles as a part of doing business. Further, the same study showed that 46 percent of the health plans sold in the U.S. have a deductible of at least $1,000. Many providers have had to address this obligation by training front desk staff to collect these monies up front or be faced with uncollectible debt that could result in serious financial hardship or business failure.

Health care access These high deductible plans do more than just pass the cost of health care to the patient, they also affect the patient’s choice to access health care. A study done by the Rand Corporation in 2011, “Healthcare Spending and Preventive Care in High-Deductible and Consumer Directed Health Plans,” published in the American Journal of Managed Care, showed that the addition of a $1,000 deductible to a health plan policy was enough to limit the patient from accessing preventive care. When the first line of cost sharing is several thousand dollars, many patients choose to forego care for chronic conditions, allowing health issues to escalate into acute problems before seeking help. The argument made by health plans that sell HDHPs is that they lower the rising trend of health care consumption by making their members (your patients) more “cost conscience” when accessing care. However, as the Rand study showed, out-of-pocket costs influenced a patient’s decision to access preventive care, thereby affecting a patient’s decision on whether or not to access care when needed as well as follow up on the care recommended by a health care professional.

JANUARY 2017 MINNESOTA PHYSICIAN

Until there is pushback from the patient market on paying high premiums and high deductibles for care they can’t afford, or until legislation is passed to stop this cost shifting to patients by HDHPs that are sold in the Minnesota market, HDHPs are here to stay. So, what steps can you take now to lessen the financial risks being passed onto your clinic and help your patients adhere to the follow-up care that you recommend?

here to stay. By addressing the shortcomings of HDHPs now, your patients will be more informed should they be in the position to elect or purchase a health care product in the future. Gregory Maurer, CPA, CMPE, is the executive director of Health Billing Systems, Inc. His responsibilities include payer contracting, reimbursement

Recommendations analysis, compliance, and operations. Gregory has more than 30 years of 1. Support legislation that limits the practice of passing financial risk to health care experience including 21 years in clinic administration. He is a past your patients and your clinic. In the 2017 Minnesota legislative session, a bill president of Minnesota Medical Group Management Association (MMGMA) will be introduced that would put the financial burden of collecting highand is currently an active member of the MMGMA Payer Relations and deductible costs back where they belong, with the Government Affairs Committees. health plan. The legislation would provide a “safety net” for patients and clinics. The legislation would James Reimann, CMPA, is president of Physician also require that if repeated attempts by a provider to Out-of-pocket costs Advocates of Minnesota, Inc. His responsibilities collect outstanding deductibles are not successful, the influenced a patient’s health plan would have to make the provider whole. include payer negotiations and contracting, decision to access Covered benefits and associated costs are actuarially reimbursement analysis, health care policy and preventive care. determined for every health plan product sold to the implementation. James has more than 30 years of patient market and it is the duty of every health plan health care experience including 15 years in health to make sure that the financial risk of those products plan administration and 18 years representing sold are the health plan’s—not the providers that clinics in health plan relations. He is a past chair of participate in the health plan’s network. 2. Make sure your clinic has the staff and latest technology available to ensure collections are made at the point of service. Minnesota law does not allow physicians to withhold patient care before payment; therefore, it is paramount that your clinic staff collects any required copays, deductibles, or prepayments necessary for both covered and non-covered services. At a bare minimum, your clinic should incorporate the practice of having patients sign an acknowledgement and/or an Advanced Beneficiary Notice (ABN) stating that they are responsible for all services that are not paid in full by their health plan.

the Minnesota Medical Group Management Association (MMGMA) Payer Relations Committee and is currently an active member of the MMGMA Payer Relations and Government Affairs Committees and also a member of HFMA (Healthcare Finance Management Association).

3. If patients are not purchasing prescriptions because of the out-ofpocket costs associated with their HDHP, determine if there are generic alternatives that are covered. If certain medications do not have a cheaper generic equivalent, are not available, or do not provide the efficacy of the non-generic medication, the health plan should be informed. 4. Make sure your staff follows up with all of your patients to ensure your orders are being carried out. As noted earlier, as these costs are shifted to the patient, there is reluctance on the part of the patient to follow up on the recommended care. Your clinic should have “patient navigators” within your care team that help patients not only access the right care at the right time, but also the care recommended after they leave your clinic. Have your staff keep track of those patients who are not following through and their reasons for not doing so. This information should be shared with the health plan to demonstrate the problems associated with the HDHPs they are selling to their members. If the problems continue, they should be shared with the Minnesota Department of Health for further review and follow up. Stay current with medical literature on the proliferation of HDHPs 5. in the market. There are many studies now underway that are trying to ascertain if HDHPs are actually saving health care costs or whether they are more expensive in the long run if patients are not accessing the care they need when they need it. HDHPs do not need to become a barrier to the physician/patient relationship if providers and patients discuss the affordability of various recommended treatment options. As stated earlier, HDHPs appear to be MINNESOTA PHYSICIAN JANUARY 2017

CARDIOLOGY

Heterotopic tricuspid valve replacement A novel solution BY MUDASSAR AHMED, MD

he treatment of valvular heart disease has undergone a paradigm shift over the past decade. This has had the most impact in the treatment of aortic valve disease, where transcatheter aortic valve replacement (TAVR) has now become the therapy of choice for many patients with aortic stenosis. In many patient populations (specifically those at intermediate to high risk with surgery), TAVR has been shown to be superior to surgical aortic valve replacement; with lower morbidity and mortality rates and better valve outcomes. There are still questions about transcatheter valve durability, which will likely be addressed with longer-term follow-up studies. Similarly, many patients with mitral regurgitation can now be treated with transcatheter repair, using the MitraClip device, a procedure that often allows for discharge in a day or two, with outcomes equivalent to surgery in terms of freedom from heart failure as well as overall survival. There are also novel devices under investigation that will allow for mitral valve replacement via the transcatheter approach.

Pathology of the tricuspid valve, specifically tricuspid regurgitation, is common as well, and is often underappreciated as a cause of significant associated morbidity, as well as mortality. A Veterans Affairs study from 2004, for example, showed a 36 percent mortality rate at one year in patients with severe tricuspid regurgitation. The most common treatment of tricuspid regurgitation remains medical management of the associated congestive heart failure. It is uncommon for patients to undergo surgery primarily for tricuspid valve disease, both because of inherent difficulties with surgical tricuspid valve replacement as well as the fact that their primary disease condition that led to severe tricuspid valve disease or clinical deterioration secondary to the valve disease, often makes them poor candidates for surgery. There is therefore, a need for percutaneous and transcatheter solutions for tricuspid valve regurgitation. While there are devices under investigation, they are several years away from clinical approval.

A case study We were able to treat a patient with severe tricuspid regurgitation using existing technologies in an innovative way. As far as we know, this represented the first use of this type of therapy in Minnesota. The patient is a 76-year-old female with severe tricuspid regurgitation for several years. The tricuspid regurgitation resulted in hepatic as well as renal failure, with the onset of cirrhosis as well as the need for dialysis. Both of these developed secondary to downstream venous congestion from her valve disease. Another consequence of that was the need for weekly paracentesis, with several liters of fluid drained at each visit. She had had prior bypass surgery, and that along with her liver disease, as well as the underlying complexity of tricuspid valve surgery, made her a poor candidate for surgical tricuspid valve repair.

At least in the short term, this procedure can improve quality of life and clinical symptoms.

Her condition progressed to the point that hospice was being considered as her likely destination. She was referred at this point to HealthEast Heart Care to look for any potential solutions. After a thorough multidisciplinary evaluation, our heart team agreed that surgery carried prohibitive risk but that she may be a candidate for heterotopic tricuspid valve replacement, i.e., implanting a tricuspid valve outside of its usual location. This was a procedure that was first described in 2011, and has been performed at a few centers both outside and within the United States.

The problem Among the many problems with transcatheter orthotopic tricuspid valve replacement (i.e., deploying a new valve in the existing tricuspid location) is

JANUARY 2017 MINNESOTA PHYSICIAN

Figure 1. Angiogram, CTA, and 3D-TEE showing measurements and the relationships of the various structures at the IVC-RA junction. Source: HealthEast

the lack of effective fixation for the new valve. Heterotopic tricuspid valve replacement gets around this problem by deploying a new valve in the central venous system, in our patient’s case at the junction of the inferior vena cava (IVC) and right atrium (RA). This has no impact on the native tricuspid valve regurgitation, but the hemodynamic effects of the regurgitation on the downstream venous system are eliminated by the presence of the new valve. Careful review of the imaging studies is key to determining whether a patient would be a good candidate for heterotopic tricuspid valve replacement. An important measurement is the size of the inferior vena cava close to the right atrium as this is the site where the new transcatheter valve will be deployed. The IVC itself is too pliable and does not allow for fixation of a transcatheter valve. The IVC is therefore treated with a stent that serves as an “anchor” for the subsequent deployment of the valve. If the IVC is much larger than 35mm, deploying a valve even with a stent as an anchor will be difficult. In addition to IVC size, the relationship of the hepatic veins to the IVC-RA junction needs to be assessed to prevent closing of the hepatic vein ostia with the new valve.

After the “stent scaffolding” was in place, a 29mm Sapien 3 valve was successfully deployed at the IVC-RA junction, positioned at the proximal edge of the IVC stent. Following valve deployment, angiography showed minimal regurgitation into the IVC, while still maintaining good antegrade flow from the IVC into the right atrium (see Figure 2). The patient was discharged from the hospital in two days, and at her two-week follow-up appointment noted an improvement in her breathing and overall functional capacity. She had required weekly paracentesis prior Heterotopic tricuspid valve replacement to page 384

Assessing our patient In our patient, we assessed the IVC-RA anatomy with computerized tomography, transesophageal echocardiography as well as angiography (see Figure 1). These studies showed the proximal IVC, close to the RA, measuring at 30mm. This was felt to be of a sufficient size to accommodate a 29mm Edwards Sapien 3 valve, especially with a stent placed first to anchor the valve. However, the hepatic veins entered the IVC very close to the right atrium. Therefore, to prevent closing the hepatic veins, the Sapien valve would have to be deployed relatively high, with most of the valve in the right atrium. To provide fixation to the valve at such a high position, the anchoring stent would have to be deployed high as well with approximately 20mm in the right atrium. More distally, the IVC was measured larger at approximately 35mm. To prevent migration of the proximal IVC stent, it was felt that a second larger stent would have to be deployed distally.

The solution Based on these imaging measurements, the procedure was performed with access in the right femoral vein (RFV) as well as the right internal jugular (RIJ) vein. A wire passed from the RIJ was externalized through the RFV and the delivery system for a 30mm Cook-Z stent was taken up from the RFV over this wire. To prevent migration of the self-expanding Z stent on deployment, a Coda Balloon was inflated in the right atrium. The 30mm stent was successfully deployed at the IVC-RA junction with 20mm of the stent extending into the right atrium. A 35mm Z stent was then successfully deployed more distally overlapping with the proximal stent by 5mm. MINNESOTA PHYSICIAN JANUARY 2017

RISK MANAGEMENT

Prescribing pain medications Minimizing a physician’s risk BY SOLVEIG DITTMANN, RN, BA, BSN, CPHRM

anaging chronic pain in the primary care setting has increased in volume and complexity over the last two decades. According to a recent Institute of Medicine (IOM) report, approximately 100 million Americans suffer from pain. The IOM estimates the costs associated with treating pain to be more than half a trillion dollars per year. The Centers for Disease Control and Prevention (CDC) estimates that health care providers wrote 259 million prescriptions for painkillers in 2012, enough for “every American adult to have a bottle of pills.” Pain is one of the most common reasons people see a physician, yet it is frequently treated inappropriately. From 1999 to 2014, more than 165,000 people died from overdose related to opioid pain medication in the U.S. Accordingly, prescribing pain medications should be approached with a measure of caution. As Manubay, Muchow, and Sullivan wrote in the March 2011 issue of Primary Care: “Navigating the complexity of treatment guidelines provided by the FSMB

(Federation of State Medical Boards), the U.S. DEA (Drug Enforcement Administration), and other health organizations can be confusing and intimidating. The difficulties in measuring pain, fear of regulatory issues, and legal risks are additional barriers to providing appropriate pain management.” A 2014 American Board of Family Medicine original research study concluded that: “It seems that primary care physicians care for a complicated group of patients with chronic pain that rivals the complexity of those seen in specialized tertiary care pain management facilities.” Unfortunately, many providers, especially in rural areas, do not have ready access to pain management clinics or specialists for referrals. Fortunately, telemedicine options have become available to help fill this gap.

Physician risk Prescribing pain medications can be a significant risk for physicians. As prescription drug overdoses rise nationwide, attorneys are seeing more physicians being held liable for negligence. Michael Moroney, a New Jersey health law attorney, remarks that, “Doctors make easy targets for lawsuits because they often are seen as placing would-be weapons into patients’ hands” when prescribing opioids. In one documented case, a patient with a history of depression taking prescription opioids attempted suicide. The patient was on an antidepressant, and unbeknownst to his psychiatrist, was also taking narcotics prescribed by an orthopedist. In a drug-induced haze, the man threw himself down a flight of stairs, breaking his neck. The family sued the psychiatrist for negligence and the case was ultimately settled. Some keys to avoiding the risk of litigation include conducting a complete assessment of the patient prior to prescribing and coordinating the care with the patient’s other providers. For example, a patient with a history of substance abuse may not be a good candidate for opioid therapy, so nonnarcotic pain control measures should be considered. Patients should not be prescribed medication without a complete reconciliation of all medications prescribed by all of his/her providers.

Patient risk In addition to accidental or intentional overdoses, other opioid-related causes of death include respiratory depression caused by the drug itself or by the concomitant use of other neuro-depressive drugs, such as benzodiazepines, and/or alcohol. Physicians must be aware of these risks and patients need to be educated about them. There are absolute contraindications for prescribing opioids. These include severe respiratory instability, acute psychiatric instability or uncontrolled suicide risk, diagnosed non-nicotine substance abuse disorder, and true allergy to opioid products. Relative contraindications include having substance abuse disorder that has been or is being treated, obstructive apnea not using CPAP, chronic obstructive pulmonary disease, paralytic ileus, and cognitive impairment.

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Another contributing factor is the challenge that physicians face when These significant risks should prompt both providers and patients trying to identify patients who may be at risk for abusing prescription drugs to raise many questions about the optimal treatment of chronic pain, or inappropriately sharing them. Manubay, Muchow, and Sullivan identify particularly since the long-term use of opioids has not been clearly several “red flag” behaviors in an article in the journal, Primary Care: demonstrated to provide greater pain relief and/or a return to functional capacity for most patients. Opioids should never • Refusal to grant permission to obtain old be the first line of therapy for the management of records or communicate with previous physicians chronic pain. Alternative therapies such as physical • D emonstrated reluctance to undergo therapy, transcutaneous electrical nerve stimulation comprehensive histories, physical (TENS), and acupuncture or acupressure are examinations, or diagnostic testing, Prescribing pain medications examples of therapies that have been successful for especially urine drug screenings can be a significant many patients. • R equests for specific drugs (often because of risk for physicians. A recent survey of physicians conducted by the the higher resale value of brand names) Health Management Academy found that only 30 • P rofessing to have multiple allergies to percent of respondents believe that they have effective recommended medications practice protocols in place to promote non-opiate analgesics. The survey revealed strong agreement that guidelines designed to increase the use of non-opiate analgesics should have a high priority for development. The same respondents saw chronic pain management as being fragmented across clinical services and modes of care, such as outpatient, inpatient and emergency departments, clinics, and hospice programs. There is also a perceived need for pain management training and education for physicians, nurses, and other health care providers. Although multiple tools and guidelines associated with managing chronic pain exist, the majority of opioid abuse stems from prescribed medications that patients obtained for chronic pain relief. Physicians need to reflect upon their prescribing practices and make sure that they are not contributing to opioid abuse. On the other hand, misunderstanding addiction and mislabeling patients as addicts may result in unnecessary withholding of opioid medications from patients with significant pain and inadequate pain control. In all cases, the physician must balance the possibility of addiction against the benefits of the therapy, striving always to reduce the risk of the former.

• T hreatening the doctor or displaying anger during visits • C onsistently targeting appointments at the end of the day or during off hours • Repeatedly “losing” prescriptions • Requesting escalation in dosages Prescribing pain medications to page 364

The pain medication epidemic On one hand, providers have been admonished to take complaints of pain as genuine and to consider pain as the “fifth” vital sign to be assessed. On the other hand, the U.S. is in the midst of a prescription pain medication use epidemic. The vast majority (71.3 percent) of the deaths related to pharmaceutical overdose in the U.S. involve opioid analgesics. According to the CDC, “Drug overdose death rates in the United States have more than tripled since 1990 and have never been higher.” According to the National Institute of Health’s (NIH) National Institute on Drug Abuse, the number of prescriptions for opioids has escalated from approximately 76 million in 1991 to nearly 207 million in 2013, with the United States being the biggest prescription opioid consumer globally, accounting for almost 100 percent of the world total for hydrocodone and 81 percent for oxycodone. The NIH identifies several contributing factors to the current prescription drug abuse problem, including drastic increases in the number of prescriptions written and dispensed, greater social acceptability for using medications for different purposes, and aggressive marketing by pharmaceutical companies. MINNESOTA PHYSICIAN JANUARY 2017

3Prescribing pain medications from page 35 How to minimize opioid abuse Clearly, evidence of opioid abuse suggests a “disconnect” between the management of chronic pain guidelines and current opioid prescribing practices. A recent study by Krebs, Bergman, and Coffing, et al., published in The Journal of Pain, found that one of several barriers to prescribers complying with recommendations was a sense that supervising pain management regimens is akin to “law enforcement.” The study also found “that patients believed opioid adherence monitoring and ground rules for opioid prescribing to be acceptable when they trusted that the physician had their best interests in mind.” This evidence suggests that providers can

anticipate some patients will willingly comply with guidelines designed to protect against opioid abuse. Current recommendations for the safe prescribing and use of pain medications are based on the “cumulative weight of evidence [which] suggests that routine monitoring during treatment, use of structured opioid therapy, and appropriate opioid selection may decrease the risk of abuse in patients requiring ongoing analgesia.” In addition to observing for the “red flags” noted earlier, Volkow and McLellan suggest the following mitigation strategies against opioid diversion and abuse in The New England Journal of Medicine (March 31, 2016): 1. Use screening tools to identify patients with a substance-use disorder. 2. Use data from a prescription monitoring program (available in Minnesota at http://pmp.pharmacy.state.mn.us/prescriber-rxsentry-access-form). 3. Conduct urine drug screens prior to prescribing opioids and periodically thereafter. 4. Develop a doctor/patient agreement on adherence that outlines the patient’s responsibilities for taking medication and complying with a drug-testing plan. A free online program for physicians on safe opioid prescribing is now available on the American College of Physicians website at: https://www.acponline.org/gsearch/Opioid%2Bprescribing.

Identify patients who may be at risk for abusing prescription drugs.

The importance of documentation Finally, comprehensive medical record documentation is essential from risk management and continuity of care perspectives. Documentation must reflect a thorough history and physical, the failure of non-opioid therapies in controlling the pain, the indications for opioid prescribing, the overall pain management plan, any consultations received, and periodic reevaluations of the patient’s status. Providers should be aware of the dangers of opioid prescribing practices and employ strategies to minimize the risk of opioid abuse for patients who require long-term pain management. The consistent use of the risk prevention strategies noted in this article may better identify patients who could become opioid abusers and help quell this national epidemic.

Solveig Dittmann, RN, BA, BSN, CPHRM, is a Senior Risk Specialist at Coverys with more than 30 years of experience in behavioral health risk management, patient safety, accreditation management and performance improvement.

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MINNESOTA PHYSICIAN JANUARY 2017

3Heterotopic tricuspid valve replacement from page 33 to the procedure. After her valve implant, she was able to go a month before needing paracentesis.

Transcatheter valve therapies have dramatically changed the treatment algorithms for aortic and mitral valve disease.

The prognosis It is uncertain how long the improvement she has had thus far will last, but it appears that at least in the short term, this procedure can improve quality of life and clinical symptoms. Transcatheter valve therapies have dramatically changed the treatment algorithms for aortic and mitral valve disease, and this case underscores the need for better transcatheter solutions for the tricuspid space. Mudassar Ahmed, MD, is a fellow of the American College of Cardiology and is part of the cardiology team at HealthEast Heart Care. He is the director

Figure 2. Angiogram showing no reflux into the IVC from the right atrium after

of the Cardiac Cath Lab and the Structural Heart Program at HealthEast.

valve deployment. Source: HealthEast

JANUARY 2017 MINNESOTA PHYSICIAN

MINNESOTA PHYSICIAN JANUARY 2017

32017 Minnesota legislative preview from page 21

attention in Minnesota as well. Consumers in many states are sharing stories of showing up at an emergency room in what they believe is an “in-network” on changes at the federal level are the future of graduate medical education hospital and then receiving bills for physician services that were not paid funding both through Medicare as well as Minnesota’s long-standing Medical by their insurance company. The issue has received considerable media Education and Research Costs (MERC) program funding. attention and focus following a New England Journal of Medicine study published this past November. While it is unclear what proposals, if any, Also playing a significant role in state budget discussions is the future of the will be brought forward in Minnesota around this current 2 percent provider tax. Last time Republicans held majority control in both the House and Senate issue, it certainly has further highlighted the growing (in 2011), the final budget agreement reached after challenges physicians, hospitals, and consumers The November general a lengthy special session included a phase out and are facing across the country with narrowing and election results eventual repeal of the provider tax by Dec. 31, 2019. tiered provider networks amidst rising insurance Fast forwarding to the 2017 session, Republicans will in Minnesota certainly premiums. again be faced with the question about whether to surprised many. Get involved keep the provider tax repeal in place or whether they Every legislative session is different with new issues will direct some or all of those funds toward other coming up and old issues lingering on, but it remains ongoing health reforms. Other areas of the state’s important for physicians to stay involved throughout budget that will likely generate significant interest include further efforts to increase funding for mental health, and an effort the process. With two physicians newly elected to the Minnesota Senate to implement a COLA (cost-of-living adjustment) increase for disability and there is no better time to share the issues that are most pressing to your waivered service providers. No matter what budget comes out of the House profession, your practice, and your patients. and Senate at the end of April, the Governor’s office still holds considerable influence through a potential veto, which only further muddies the waters.

“Surprise billing”

Nate Mussell, JD, is with the Minnesota law firm of Lockridge Grindal Nauen,

Another issue that has been gaining considerable attention in other states includes “surprise” or balance billing. We may see this gather additional

health care providers.

JANUARY 2017 MINNESOTA PHYSICIAN

PLLP. The firm provides legal and government relations services to a variety of

MINNESOTA PHYSICIAN JANUARY 2017

3Family medical accounts from page 19 chooses to use a less expensive administrator to pay the bills. FMA program legislation may also be opposed by those who think that a program that saves money might reduce federal funding obligations and “cost” the state money. Such bizarre thinking has guided recent “fair share” Minnesota state policy and policies in other states when reporting expenses to the Centers for Medicare & Medicaid Services. Taxpayers eventually lose at this game.

The FMA goal The Minnesota FMA program adopted its goal from Joseph V. Kennedy, one of Minnesota’s most distinguished economists who has studied poverty. He wrote in 2008 that, “Government policy is far more effective when it channels market forces than when it overrides them….Ownership of resources is the path to a decent life free of poverty and dependency: a goal for all Americans.” One doctor I know, whose clinic population is made up of over 50 percent of Medicaid patients, said that an FMA-like program would mean dignity for these families because they would be handling their own health care money and making choices.

Will the FMA program work? If family ownership of money works in the private sector, why not in the public Medicaid sector? Can the savings in Connecticut be replicated in Minnesota? In 2015, David Randall, the executive director of the American Research and Policy Institute, speculated that states would cut costs by enrolling even “a small portion of people in a Health Savings Account for Medicaid.”

JANUARY 2017 MINNESOTA PHYSICIAN

Imagine that all 70 percent of non-disabled Medicaid beneficiaries chose the Minnesota FMA program instead of an HMO. This population accounts for about 25 percent of Minnesota Medicaid spending. If Connecticut’s total administrative costs without HMOs and without an account-based program were reduced by more than 50 percent, similar decreased overhead costs would most likely be the biggest savings from a Minnesota FMA program.

Conclusion Minnesota Medicaid Managed Care corporations have failed on promises of cost control, have restricted patient access with more restrictions to come, and have accrued much money and power over the public Medicaid sector. The state can arrange payment of provider bills with less expense. In contrast, changing to an account-based FMA program would give Medicaid families control of money for first-dollar outpatient care, and would show promise of real savings from reduced program overhead costs and from prudent use of services. FMA money would also allow sicker patients greater flexibility in doctor and hospital choice to meet their complex health needs.

Robert W. Geist, MD, is a retired physician and former president of the Ramsey Medical Society, United Hospital Medical Staff, and Minnesota Urologic Society.

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