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MINNESOTA

APRIL 2017

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXI, No. 1

High-cost patients and insurance options High-risk pools or reinsurance BY DOUGLAS L. WOOD, MD, FACC, FACP

F

Genetic counselors Board licensure and an expanding role BY ASHLEY M. DECKMAN, MS, CGC, AND MELISSA R.F. TRUELSON, MS, CGC

F

or almost half a century, genetic counselors have been utilizing their extensive training and expertise to provide personalized information to individuals and families regarding inherited disease. Genetic counselors play an integral role on health care teams and an expanding role in genetics and genomic medicine. The recently passed Occupational Licensing of Genetic Counselors law in Minnesota, overseen by the Minnesota Board of Medical Practice, will impact this growing medical profession and the provision of patient care significantly. Genetic counselors to page 164

ive percent of patients account for about half of the total health spending in the U.S. and about 1 percent of health care claims are highdollar claims. High-cost beneficiaries are usually people with chronic health conditions and it is not uncommon that mental illness and physical illness are found together in this population. As you can imagine, heart disease, diabetes, lung disease, and musculoskeletal disorders are common. The high and rapidly rising costs of advanced biological therapies also mean that people with cancer, hematologic disorders, inflammatory bowel disease, and orphan diseases will incur very high health care costs. And, of course, those who suffer catastrophic acute illnesses or trauma can have extremely high costs. High-cost patients and insurance options to page 184


rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

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

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

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APRIL 2017 MINNESOTA PHYSICIAN


APRIL 2017

|

Volume XXXI, Number 1

COVER FEATURES Genetic counselors Board licensure and an expanding role

High-cost patients and insurance options High-risk pools or reinsurance

By Ashley M. Deckman, MS, CGC, and Melissa R.F. Truelson, MS, CGC

By Douglas L. Wood, MD, FACC, FACP

DEPARTMENTS CAPSULES

10

MEDICUS 

13

INTERVIEW

14

The Health Professionals Services Program

Preexposure prophylaxis for HIV prevention What physicians should know

GASTROENTEROLOGY 20

Medicare enrollment Increasing complexity in program compliance

By Jesse Berg, JD, and Julia Reiland, JD

32

The Minnesota Reflux and Heartburn Center Comprehensive care under one roof

By Paul A. Severson, MD, FACS

By Malini B. DeSilva, MD, MPH, and Japhet M. Nyakundi, MSW

MEDICINE & THE LAW

26

Congenital infections with cytomegalovirus An unsolved challenge in pediatric health

By Mark R. Schleiss, MD

Sheila Specker, MD, University of Minnesota Department of Psychiatry

PUBLIC HEALTH

INFECTIOUS DISEASES

22

FETAL CARE

34

Minnesota’s Newborn Screening Program An evolving safety net

By Jessica Cavazos, and Maggie Dreon, MS, CGC

PROFESSIONAL UPDATE: OPHTHALMOLOGY Advances in cataract surgery A new option for patients

28

By Elizabeth A. Davis, MD, FACS

WWW.MPPUB.COM PUBLISHER

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Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; 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.

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APRIL 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 APRIL 2017

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Mean A1C change from ba

-0.6

-0.6

-0.8 -1.0 -1.2

-0.8

-1.1 * Unbeaten A1C reduction across 6 head-to-head trials -1.4

-1.6

Lantus® (100 mg) (n=262; Baseline A1C: 8.1%)

Trulicity® (0.75 mg) (n=272; Baseline A1C: 8.1%)

Trulicity® (1.5 mg) (n=273; Baseline A1C:1,3 8.2%)

Data represent least-squares mean ± standard error.

*In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.

A1C reduction from baseline

MeanA1C A1Cchange change from from baseline Mean baseline(%) (%)

0.0

Add-on to metformin (26 weeks)

Add-on to metformin (52 weeks)

Add-on to metformin and Actos® (26 weeks)

Add-on to metformin and Amaryl® (52 weeks)

Compared to Victoza®3

Compared to Januvia®1,5,6

Compared to Byetta®1,7

Compared to Lantus®1,8-10

-0.2 -0.4

-0.39

-0.6

-0.46

-0.63

-0.8 -1.0

-0.87

-1.2

-0.99

-1.10

-1.4

-1.51

-1.8 Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)

Januvia (100 mg) (n=273; Baseline A1C: 8.0%)

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

Lantus (n=262; Baseline A1C: 8.1%)

Trulicity® (1.5 mg) (n=299; Baseline A1C: 8.1%)

Trulicity® (0.75 mg) (n=281; Baseline A1C: 8.2%)

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

Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%)

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

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

Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%)

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

Data represent least-squares mean ± standard error.

26-week, randomized, open-label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

104-week, randomized, placebocontrolled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis)

Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met

-1.08

-1.30

-1.36 -1.42

-1.6

-0.76

Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

Key secondary objectives of superiority of both dulaglutide doses vs Januvia were met

Superiority was only demonstrated in the studies versus Byetta and Januvia.

Additional study results Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy. In a 52-week randomized, double-blind phase 3 study, adult patients with type 2 diabetes were treated with monotherapy. Baseline A1C=7.6% for each of metformin (n=268), Trulicity 0.75 mg (n=270), and Trulicity 1.5 mg (n=269). At the 26-week primary endpoint, mean A1C reductions were metformin: 0.6%; Trulicity 0.75 mg: 0.7%; Trulicity 1.5 mg: 0.8%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (-0.8% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,11

78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)

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

Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met

• Starting dose of Lantus was 10 units daily.

Key secondary objectives of superiority of both dulaglutide doses vs Byetta were met

Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of insulin glargine was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met

In a 52-week randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients, Trulicity was studied in combination with Humalog® with or without metformin ≥1500 mg/day. Humalog was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose; 36% of patients randomized to glargine were titrated to the fasting glucose goal at the 26-week time point. Baseline A1C=8.5% for Lantus (n=296), baseline A1C=8.4% for Trulicity 0.75 mg (n=293), and baseline A1C=8.5% for Trulicity 1.5 mg (n=295). At the 26-week primary endpoint, mean A1C reductions were Lantus: 1.4%; Trulicity 0.75 mg: 1.6%; Trulicity 1.5 mg: 1.6%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 26 weeks (-1.6% vs -1.4%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,12,13

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

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APRIL 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

©Lilly USA, LLC 2016. All rights reserved.

MINNESOTA PHYSICIAN APRIL 2017

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TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. • Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS

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

Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a doserelated and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with

Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5  mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg

TrulicityTM (dulaglutide)

TrulicityTM (dulaglutide)

Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied. CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. WARNINGS AND PRECAUTIONS

Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75

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APRIL 2017 MINNESOTA PHYSICIAN

DG HCP BS 20APR2015

DG HCP BS 20APR2015

PRINTER VERSION 1 OF 2


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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Synthetic Drug Adding Danger to Opioid Epidemic Officials from across Minnesota have gathered to discuss the public safety risk of a new synthetic opioid that has already caused at least five overdose-related deaths in the state in 2017. “This is not something that’s just affecting the inner city,” said Jon Rechtzigel, Apple Valley police chief. “It’s everywhere throughout the state of Minnesota. We also want to offer assurance that we’ll all be collaborating on this threat.” The synthetic drug, called carfentanil, is used as a tranquilizer for elephants and other large animals. It is 10,000 times more potent than morphine and 100 times more powerful than fentanyl. It has caused deaths across the U.S., but these are the first confirmed cases in Minnesota. “We have at least four to five additional fatal cases in which we suspect the possibility of carfentanil, but the confirmatory testing is still pending,” said Andrew Baker, Hennepin County’s chief medical examiner. Routine drug and alcohol screenings don’t currently detect carfentanil, so officials send the samples to a specialized

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lab for testing. So far those tests have confirmed that the drug caused three deaths in Minneapolis, one in Dakota County, and one in Rice County. “A 900-kilogram elephant can be immobilized by just two milligrams of carfentanil,” said Jon Cole of Hennepin County Medical Center and the Minnesota Poison Control Center. “This drug is ultra-potent.” “The use of opioids like carfentanil is a health crisis for Minnesota. It is a law enforcement crisis and it is a crisis for all Minnesotans,” said Drew Evans of the Minnesota Bureau of Criminal Apprehension. “We need to work together to address the crisis with information, education, and enforcement.” The bureau has investigated 11 cases involving carfentanil in the last six months. There is a concern that the strong new synthetic drug could cause a large increase in overdoses as opioid-related deaths continue to rise in Minnesota. “We’ve had three of the confirmed deaths in Minneapolis,” said Bruce Folkens of the Minneapolis Police Department. “One of our homicide detectives is assigned to all three cases. He is going to be collaborating with Faribault and Apple Valley to deep

APRIL 2017 MINNESOTA PHYSICIAN

dive on any information they have.” Carfentanil comes in several forms, including powder, blotter paper, tablets, patches, and sprays. Some of these can be absorbed through the skin or accidentally inhaled, so there is concern for first responders and law enforcement personnel who are exposed to the drug as well. “The Medical Examiner’s Office felt it important not just to inform the public of this new hazard, but to ensure that our colleagues on the front lines of saving lives were aware that carfentanil has now been confirmed to be in Minnesota,” said Baker.

Gastric Acid Suppression Medications May Cause Higher Risk of Recurrent C-Diff Infection Patients who use gastric suppression medications are at a higher risk for recurrent Clostridium difficile (C-diff) infections, according to results of a Mayo Clinic study. Researchers conducted a systematic review and meta-analysis of 16 studies with 7,703 patients who had C-diff

and found that 1,525 developed recurrent C-diff. The rate of recurrent C-diff in patients with gastric acid suppression was 22.1 percent, compared to 17.3 percent in patients who did not have gastric acid suppression. “In our study, we found that use of gastric acid suppression medications are associated with a statistically significant increased risk of development of recurrent C-diff in patients with a prior episode of C-diff,” said Sahil Khanna, MBBS, gastroenterologist at Mayo Clinic and senior author of the study. Gastric suppression medications that were studied include proton pump inhibitors such as omeprazole and histamine 2 blockers such as ranitidine, which are standard prescription and over-the-counter medications for gastroesophageal reflux disease, peptic ulcer disease, or dyspepsia. “It may be reasonable to re-evaluate the need for these medications in patients with C-diff,” said Khanna. However, Khanna notes to use caution when reviewing the results because of variables that were not considered in the study, such as the underlying reason why patients needed gastric acid suppressant to begin with.


Minnesota Hospitals Contributed $4.5 Billion in Services Minnesota’s hospitals and health systems contributed more than $4.5 billion in programs and services in 2015, an increase of 3.6 percent from 2014, according to the new Community Benefit Report from the Minnesota Hospital Association (MHA). Of that amount, hospitals provided $440 million in proactive services that respond to specific community health needs such as health screenings, health education, health fairs, immunization clinics, and other community outreach in the areas of fitness, weight loss, mental health, and diabetes prevention. They also provided $536 million in uncompensated care; $408 million in education and workforce development; and $239 million in research. The largest area of spending was $2.4 billion in government underfunding as a result of treating Medicare and Medicaid patients and receiving government reimbursements that were less than the cost of providing care (a 7.6 percent increase from 2014). “Minnesota’s hospitals and health systems partner with their communities to promote physical and mental health and well-being beyond the physical walls of the hospital,” said Lawrence Massa, president and CEO of MHA. “We know that much of what influences our health happens outside of the doctor’s office—in our schools, workplaces, and neighborhoods. Just as our care teams devote themselves to meeting the needs of patients in the hospital, our hospitals and health systems are driven to address their own community’s needs.” The report includes data that was self-reported by Minnesota hospitals and health care systems as well as data from the Minnesota Department of Health.

Summit Orthopedics Opens Eagan Location Summit Orthopedics has opened a new orthopedic treatment and surgery center in Eagan. The existing Eagan clinic and therapy locations have closed and moved all their services to the new facility. The 65,000-square-foot facility is nearly identical to the recently opened Vadnais Heights location. Summit Orthopedics hopes its new facilities will enhance the state’s medical tourism industry.

“Minnesota has several positive attributes when it comes to medical tourism, including our worldwide reputation for quality healthcare, our lower healthcare costs, and the breadth of our advanced medical technology community,” said Adam Berry, CEO of Summit Orthopedics. “Summit has built many relationships for those looking to come to Minnesota for advanced orthopedic care. We are excited to expand this reputation and capability.” The facility offers physician consultations, advanced imaging, therapy, braces, orthotics, surgical care, and overnight recovery suites. It is open seven days a week for walk-in patients. Summit Orthopedics’ Vadnais Heights location was recently the second ambulatory surgery center in the U.S. to receive The Joint Commission’s Gold Seal of Approval for Advanced Certification for Total Hip and Total Knee Replacement. The new Eagan location will pursue that same certification.

Fairview to Open Urgent Care Location in Edina Fairview Health Services opened a new urgent care location in Edina on March 28. It is located within Fairview Clinics–Edina, across from Fairview Southdale Hospital. Physicians Urgent Care, an independently owned provider, previously offered urgent care services at Southdale— but that clinic closed in August 2015. “Our patients want the convenience of an urgent-care center that can take care of their bumps, bruises and colds without the time and expense of going to an emergency room,” said Ben Wasserman, RN, clinic administrator. “Urgent care centers play an important role in keeping up with the everyday needs of our growing patient population.” The Edina location is Fairview’s ninth urgent care facility.

IHP Program Expands After Saving $156M The Minnesota Department of Human Services’ (DHS) Integrated Health Partnerships (IHP) program has added two new provider groups and renewed participation contracts with four existing participants for another three-year cycle. IHP, formerly called the Health Care Delivery Systems (HCDS) demonstration, was established by the MINNESOTA PHYSICIAN APRIL 2017

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Legislature in 2010 to test alternative health care delivery models, encouraging a focus on delivering efficient and effective health care and preventive services instead of paying providers for the volume of care they provide rather than the quality, like the traditional payment system. It began adding participating providers on Jan. 1, 2013. From then to 2015, the program savings totaled more than $156 million. The two new participants are Fairview Physicians Associates Network, which has 74 sites in the greater metropolitan area of the state, and Community Health Network, a partnership between HealthEast Care System, Entira Family Clinics, and other independent specialty providers that has more than 50 care sites in the east metro region. In addition, Mayo Clinic, Hennepin Healthcare System, Hennepin County Medical Center (HCMC), and Southern Prairie Community Care renewed their participation for another threeyear cycle, with Mayo and HCMC expanding the services that are included in the accountable care arrangement. A total of 21 provider groups are participating in 2017, covering more than 462,000 Medical Assistance

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enrollees. DHS’ goal is to extend the program and comparable value-based reforms to half of all Medical Assistance and MinnesotaCare enrollees, a total of about 500,000 people, by the end of 2018. This goal is supported by Gov. Mark Dayton, who included enhancing the IHP model in his budget for the 2018–2019 biennium. “Through Integrated Health Partnerships, we have proven that it is possible to reduce the cost of health care while maintaining—and even improving— the quality of care that patients receive,” said Emily Piper, DHS commissioner. “We are pleased that this nation-leading initiative continues to grow.”

Rates of Secondary Cancer in Survivors Falling Researchers from the University of Minnesota’s Masonic Cancer Center and St. Jude Children’s Research Hospital have found that survivors of childhood cancers now have fewer secondary cancers. Patients diagnosed with a childhood cancer after 1990 are experiencing better outcomes than those that were diagnosed in the 1970s. Researchers

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believe this is due to a reduction in exposure to therapeutic radiation. “It’s quite exciting. We’ve known for several years that radiation therapy puts survivors at high-risk for secondary cancers, and treatments have been modified to reduce radiation exposure,” said Lucie Turcotte, MD, assistant professor of pediatrics at the University of Minnesota Medical School and lead researcher on the study. “Still, no one has shown reducing the exposure has reduced subsequent cancer risk. That’s what we’ve done in this paper.” The study used data from the Childhood Cancer Survivor Study, which was the largest cohort of cancer survivors in North America. The research team examined data for more than 23,000 survivors with a first cancer diagnosis between 1970 and 1999 and looked at radiation exposure to determine the 15-year incidence of subsequent cancers. They found that the rate decreased in each decade of the initial diagnosis—those diagnosed in the 1970s had a 2.1 percent rate of subsequent cancers and those diagnosed in the 1990s had a 1.3 percent rate. “This study is unique because we were able to look comprehensively at

treatment exposure data and validated subsequent cancer data,” said Joseph Neglia, MD, MPH, head of the department of pediatrics at the University of Minnesota Medical School and senior author of the study. “This level of in-depth and longitudinal data allows us to make a much clearer analysis.” The researchers plan to continue researching the issue with a focus on increasing understanding of specific cancer therapy agents and their effects and look more closely at chemotherapy-radiation interactions impacting secondary cancer risks. They will also continue to follow the patients from the Childhood Cancer Survivor Study to see how the more recent survivors fare as they age. “All the efforts to modify treatment of pediatric cancer in order to reduce late effects while maintaining or improving cure rates are paying off,” said Gregory Armstrong, MD, of St. Jude Children’s Research Hospital and principal investigator of the study. “This study shows that for the most ominous late effect of treatment, second cancers, the risk has been reduced for childhood cancer survivors from the modern treatment era.”


MEDICUS

Steven Bradley, MP, MPH, associate cardiologist at the Minneapolis Heart Institute and associate medical director at the Minneapolis Heart Institute Center for Healthcare Delivery Innovation, has received the 2017 Douglas P. Zipes Distinguished Young Scientist Award from the American College of Cardiology. Previously, Bradley served as the associate director of the VA National Clinical Assessment Reporting and Tracking Program. He also has provided his expertise as a volunteer in the American Heart Association Get With the Guidelines Program, where he continues to serve as an active leader. Bradley earned a master’s of public health degree at the University of Washington and a medical degree at the Medical College of Wisconsin. Julie Mayers Benson, MD, of Lakewood Health System in Staples, has received the 2017 Family Physician of the Year award from the Minnesota Academy of Family Physicians. The award is presented to a family physician who represents the highest ideals of the specialty of family medicine including caring, comprehensive medical services, community involvement, and service as a role model. Benson is recognized as an expert in palliative care and has special interests in pediatrics and hospice care. She earned her medical degree from the University of Minnesota Medical School. Thirty-one Minnesota physicians were nominated for the award by patients, community members, and colleagues. Paul Severson, MD, a surgeon from Deerwood, Minn., has received the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Award for Excellence in Humanistic Clinical Care. Severson is the co-founder and co-director of the Minnesota Institute for Minimally Invasive Surgery; director of the Minnesota Reflux and Heartburn Center; and program director for Advanced GI MIS/ Bariatric and Flexible Endoscopy Fellowship. He is the founder and CEO of Project Haiti, through which he has made over 70 trips to Haiti to teach laparoscopic and endoscopic surgery, and played a significant role in building a state-of-the-art hospital with full minimally invasive surgery capabilities in a town with few resources. He is also a member of SAGES Global Affairs committee, which provides tele-education to residents, faculty, and private practice surgeons in Haiti. Severson has been a member of the medical staff at Cuyuna Regional Medical Center in Crosby and Riverwood Healthcare Center in Aitkin since 1984. He earned his medical degree at the University of Minnesota. Matthew A. Hunt, MD, has been named the 2017 president of Twin Cities Medical Society. He succeeds Carolyn McClain, MD. Hunt is an associate professor, neurosurgery residency program director, and joint orthopedic/neurosurgery spine fellowship co-director at the University of Minnesota. He earned his medical degree at the University of Louisville School of Medicine, Kentucky, completed a surgery internship, neurosurgery residency, and fellowship in neurosurgical oncology at Oregon Health & Science University in Portland, and served as a clinical fellow in neurosurgery at The National Hospital for Neurology and Neurosurgery, London, UK.

Osmo Vänskä /// Music Director

DAVID ZINMAN

ALSO SPRACH ZARATHUSTRA

INSIDE THE CLASSICS: DVOŘÁK

INGRID FLITER

DAVID ZINMAN RETURNS

STRAUSS’ ALSO SPRACH ZARATHUSTRA Jun 1 | SYMPHONY IN 60 Come early for happy hour, enjoy a shorter performance and stay late for a post-concert onstage gathering with Minnesota Orchestra musicians. Tickets $30 / $20 for patrons under the age of 40

Jun 2-3 | Full Performance Enjoy this program of sweeping orchestral classics including Strauss’ Also sprach Zarathustra made famous by Stanley Kubrick’s 2001: A Space Odyssey.

MOZART AND DEBUSSY Jun 8–11

Juano Menya, Conductor / Ingrid Fliter, piano

Mozart is the ultimate “classical” composer whose every bar of music is perfectly proportioned, balanced and beautiful, while Debussy’s revolution a century later was to build a whole new world of sound.

INSIDE THE CLASSICS

BECOMING LEGEND: DVOŘÁK SYMPHONY NO. 7 Jul 15 Dvořák’s Symphony No. 7 is his most thrilling—the music that put a Prague butcher’s son on the international music map. Tickets $30 / $20 for patrons under the age of 40 Please note: first half is conversation and orchestral excerpts, second half is a full performance

minnesotaorchestra.org 612.371.5656 Ã Orchestra Hall Photo credits available online. All sales final. All artists, dates, programs, prices and times are subject to change.

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MINNESOTA PHYSICIAN APRIL 2017

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INTERVIEW

The Health Professionals Services Program Sheila Specker, MD, University of Minnesota Department of Psychiatry Tell us about the mission of the Health Professionals Services Program (HPSP) and how it originated.

The program originated from a task force assembled in approximately 2002 by the Minnesota Board of Medical Practice (BMP) in conjunction with the Minnesota Board of Nursing. I was a member of that task force. The discussion in 2002 was about providing a non-disciplinary and confidential way for physicians and nurses to be monitored for substance use disorders that would both protect the public and promote recovery. A strong proponent of this program was H. Leonard Boche, the executive director of the Minnesota BMP at the time. The HPSP began in 2004 after the Legislature established it by statute. Programs such as HPSP are incredibly effective in obtaining and sustaining recovery. Rates of recovery for physicians from substance use disorders through monitoring are 75–80 percent in contrast to general population rates of 40 percent. The mission of the program has not changed: it is to protect the public by providing monitoring services to licensed health care professionals whose illnesses may impact their ability to practice safely. With this in mind, the goals are to promote early intervention, diagnosis, and treatment of physicians and other health care professionals by providing monitoring services as an alternative to board discipline. As with other chronic illnesses, early intervention increases the likelihood of positive outcomes and avoids damaging effects on career or compromised patient care. What kinds of services does HPSP provide?

HPSP is comprised of a program manager and five other case managers, all of whom have clinical expertise in the areas of substance use and mental health disorders. The program receives reports from individuals, employers, the boards, or treatment providers. The case manager interviews potential participants to determine if they have an illness and obtains information from various sources including treating providers to determine if monitoring is indicated. The case manager then creates a monitoring plan appropriate to the health condition. The case manager coordinates the services that the participant receives to ensure they are able to obtain treatment and services and communicates with the

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patient’s place of employment and with treating providers. HPSP also has an outreach program that educates various groups and societies about illnesses such as substance use disorders in physicians and the services they can provide. It is important to note that HPSP is not a treatment program; treatment is obtained in the community. HPSP provides a service

Of the total number of health professionals that you serve, what percentage are MDs and percentage-wise, how do they compare to the general population in terms of the issues you address?

The program has enrolled over 6,000 licensed health care professionals, of which 900 have been physicians. Nurses represent the largest number of participants because they comprise the largest number of health care providers in the state. The percentage of nurses and physicians in the program are representative of the number of individuals in their professions, with neither profession being overrepresented by percentage. Rates of substance use disorders in physicians are comparable to that of the general population; however the choice of substances may vary depending on access to those substances. Currently, the program monitors 70 physicians and of these, 49 have a substance use disorder. Fortytwo physicians claim alcohol as their substance of choice, while the rest use opioids, cocaine, cannabis, or amphetamines.

Rates“...” of substance use disorders in physicians are comparable to that of the general population.

What are the benchmarks for self-reporting and why are physicians reluctant to do so?

Physicians may be fearful to report because of their unfamiliarity with the program, the program requirements such as random urine drug screens in the case of substance use disorders, the concern that the BMP could “find out,” and that the program is not confidential. It is important to note that the program cannot release information to the Board unless there is non-compliance, harm, or if a physician is already under Board direction.

“...”

to the licensing boards; if the Board receives reports about a practitioner, often they will be referred to HPSP for monitoring. Disciplinary action will not be taken as long as the practitioner is compliant with the monitoring plan. How do you work with the Board of Medical Practice?

I am the medical consultant to the HPSP and do not have any ties with the BMP. I have, however, been involved with education or presentations regarding physician health and outcomes to board staff. The oversight of the HPSP is through the Program Committee, which is comprised of representatives from the licensing boards.

Please tell us about reporting a colleague. What are the signs that this may be the right thing to do?

Most physicians and health care professionals in the program are not “impaired.” The term “impairment” specifically refers to not being able to practice safely and this is uncharacteristic of most individuals being monitored. A colleague may choose to report when there is concern about patient safety, evidence of being under the influence of a substance, or if the practitioner is not cooperative with a plan to manage their illness. Reports are confidential as long as they are made in good faith. Reporting a colleague


can be very difficult and people often wrestle with questions such as, “Is it necessary? Will it affect my relationship with this individual? Will this person be angry with me?” The colleague can always contact HPSP to discuss the situation. It is also important to note that there is a physician recovery support organization, Physicians Serving Physicians, that can also be contacted as a resource and is confidential. What can health care employers do to support employees returning to work following treatment for a substance or psychiatric disorder?

Employers can provide flexibility in work schedules to allow for treatment and other program requirements such as time to participate in drug screens. Employers also complete quarterly work site reports to aid in the monitoring process. Providing a confidential, encouraging, supportive outlook will greatly reduce employee concern about re-entering their job setting. What is the best way to address the stigma associated with having a substance or psychiatric disorder?

It is important to understand that these disorders are chronic illnesses, similar to hypertension or diabetes and as such require management and treatment. Use of

appropriate, professional language is important, such as having a substance use disorder, rather than being an alcoholic. How we speak about these conditions reflects our attitudes and conveys messages. Physician burnout is a topic of increasing concern. Can you discuss how this has impacted referrals to HPSP?

Burnout can create a disenchantment with obtaining help and fuel apathy. With that in mind, taking the step to contact the program may seem to take too much effort. Physicians who have participated in programs like HPSP are invariably thankful for how the process has made them better doctors. Please tell us about this.

There may be initial reticence in participating, however, physicians who complete the program are grateful for the additional support and focus on their daily maintenance of recovery. Through treatment and programs such as HPSP, physicians develop humility, concern for the well-being of others, and honesty. I recall a patient who was in recovery for substance use and required surgery. She insisted that her anesthesiologist be someone in recovery as well, because she could trust that person to be caring, empathic, and honest.

Sheila Specker, MD, is an addiction psychiatrist and associate professor in the Department of Psychiatry at the University of Minnesota and director of the Minnesota Addiction Medicine Fellowship Program. She attended medical school at the University of Minnesota, and completed a residency in family medicine at the University of Wisconsin and a psychiatry residency and fellowship in addiction medicine at the University of Minnesota. She is boardcertified in psychiatry, addiction psychiatry, and addiction medicine. She has been HPSP’s medical consultant since its inception. Dr. Specker has a clinical practice at the University of Minnesota that focuses on addiction and co-occurring disorders, as well as health professionals with substance use disorders. Her research is in the areas of adolescent substance use prevention and treatment; brain imaging and relapse; and pharmacotherapies for addiction. She recently participated in a White House Symposium on furthering treatment and physician training in addiction. She presents at various CME events both locally and nationally.

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3Genetic counselors from cover

Similar to physicians, nurses, and other health care providers, genetic counselors work in both clinical and non-clinical settings. These include university-based medical centers, private hospitals, private practices, Scope of practice diagnostic laboratories, health maintenance organizations, non-profit While the role of a genetic counselor is ever-evolving, an official scope of organizations, and governmental organizations. Genetic counselors also practice was established by the National Society of Genetic Counselors specialize and provide focused services based on their unique interests. (NSGC) in June of 2007 and includes three primary sections: 1) clinical Data from the NSGC Professional Status Survey 2016, show the majority genetics, 2) counseling and communication, and 3) professional ethics and of genetic counselors specialize in cancer, prenatal, and pediatric genetics; values. To illustrate this, a typical genetic counseling session involves the however, many genetic counselors work in more highly counselor obtaining and interpreting individual specialized fields such as cardiology, metabolic disease, and family medical histories and using the ART/IVF, hematology, pharmacogenetics, public provided information to discuss the inheritance, health, psychiatry, and biobanking. Additionally, features, natural history, means of diagnosis, a growing number of genetic counselors practice in and management of the relevant conditions. There are almost 50,000 non-clinical settings including research, clinical trials, Depending on the outcome of these discussions different genetic tests laboratory support, teaching, supervision, utilization and the informed decision-making process, the currently available. management, and scientific writing. genetic counselor may identify appropriate genetic laboratory tests, facilitate testing, and explain the clinical implications of these test results. Genetic counselors also focus on assessing psychosocial factors including social, educational, and cultural issues that may impact the patientâ&#x20AC;&#x2122;s understanding or interpretation of the discussion and outcomes. Depending on the area of practice, genetic counseling sessions can last anywhere from 20 minutes to over two hours.

The path to licensure The path to becoming a genetic counselor is rigorous. In order to become a certified genetic counselor (CGC), one must obtain a Masterâ&#x20AC;&#x2122;s degree in Genetic Counseling from one of over 35 highly competitive accredited programs throughout the U.S. and Canada. These two-year training programs typically consist of didactic classroom training, clinical rotations, and an original research thesis project. Minnesota is home to a well-established graduate program of study in genetic counseling at the University of Minnesota, Twin Cities, which was founded in 1989 and has graduated over 175 students since its inception. Once a candidate has met all requirements of the training program, he or she may apply to sit for the American Board of Genetic Counseling (ABGC) Certification Examination. The need to license genetic counselors has been apparent to genetics providers for the past decade or so. This need has become increasingly evident to the broader medical community as advancements in genetic testing technology and marketing have been widely implemented. The role of genetic testing in health care grows more predominant and complex every day, illustrated by the dramatic increase in the number of genetic tests available in recent years. The Genetic Testing Registry from the National Center for Biotechnology Information (NCBI) reports that there are almost 50,000 different genetic tests currently available for over 16,000 genes, and upwards of 10,000 conditions. Technological advancements have also contributed to this rapid growth of genetic test availability. For example, next generation sequencing (NGS) is a testing method that enables laboratories to test many genes simultaneously at much lower costs, according to the National Human Genome Research Institute (May 2016). NGS has led to increased access to genetic testing, which in many ways is beneficial to patients and physicians. The general public has also become more educated and involved in its individual health care needs, which has led to public demand for quality genetic services. Increasing public interest has led to the emergence of the direct-to-consumer (DTC) genetic testing marketplace, essentially bypassing physicians and genetic counselors altogether. DTC marketing of genetic tests is of growing concern to physicians and genetic counselors, alike, leading to policy statements from the American College of Medical Genetics

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and Genomics; the American Society of Human Genetics; NSGC; and a resolution by the Minnesota Medical Association in 2010. According to the NSGC, as attention to DTC genetic tests increases, so does the risk that inappropriate tests may be requested or test results may be misinterpreted.

third-party payers, so patients calling insurance companies to identify local genetic counselors are often told that none exist, leaving patients to either go without counseling and testing or hop from clinic to clinic until they find a provider who is comfortable ordering and interpreting their test results. Finally, and perhaps most important, this law will protect Minnesotans by prohibiting unlicensed practice and putting regulatory enforcement into place. This law allows recourse if a patient receives poor quality of care from a genetic counselor through a complaint investigation process initiated by the Board of Medical Practice.

Given the limited regulation of genetic testing, it is not surprising that the methods, accuracy, and reporting of genetic testing varies greatly from laboratory to laboratory. Test menus include increasing numbers of modifier genes, genes associated with only reduced disease penetrance, and genes with limited (or even no) data on the significance of alterations identified within In addition, licensing of genetic counselors them. This environment is ripe for patients to receive will likely result in health care cost savings for misinformation and misinterpretation of test results, Minnesota. Multiple studies, such as a 2011 study by ARUP Laboratories, have shown that utilization ultimately leading to harm, as documented in Minnesota DTC marketing of of genetic counselors decreases unneeded spending (Bensend et al., Journal of Genetic Counseling, 2014) genetic tests is of growing on genetic testing. Additional cost savings have and across the country (Brierley et al., The Cancer concern to physicians. been realized due to disease prevention, as in Journal, 2012). In addition to concern about potential the case of Lynch syndrome-associated cancers harm, the Minnesota Genetic Counselors Association as published by Järvinen et al. in the Journal of (MNGCA) realized that patients were not only lacking Clinical Oncology (2009). This law will not alter the means to identify a qualified genetic counselor how genetic counselors bill insurance companies, as but also a mechanism to hold genetic counselors genetic counselors have for years successfully billed accountable for the care they provide. Thus, the effort and received reimbursement for services by independent payers using the to obtain licensure for genetic counselors in Minnesota was initiated. specified genetic counseling code here in Minnesota. The MNGCA was formed as a chapter of the NSGC in 2007, and its membership includes the majority of practicing genetic counselors in the state. Initial work by the MNGCA’s Public Policy Committee began with grassroots work in 2009 and involved identifying a chief author for the licensing bill, being accepted by a health licensing board, and completing the Council of Health Boards Review in 2010. While the bill had several bipartisan authors since 2010, it failed to make it to a committee hearing, although it was introduced in the Minnesota Senate by chief author Sen. Melissa Wiklund (D–East Bloomington) in 2014. In 2015, MNGCA secured legislative counsel from Matthew Bergeron with Larkin Hoffman by way of NSGC and MNGCA grant funding, and Rep. Nick Zerwas (R– Big Lake/Elk River) became chief author of the licensing bill in the House of Representatives. During the short 2016 legislative session, the genetic counselor licensing bill passed successfully out of all 11 required committee hearings and was included in the omnibus supplemental budget bill, which was signed into law by Governor Dayton in June 2016 (HF 2749; SF 2356). With the passage of this bill, Minnesota joined 19 other states in requiring licensure for genetic counselors. Two additional states are currently involved in the rulemaking processes.

Genetic counselors to page 424

The importance of licensure The licensure statute is important for a number of reasons. First, it defines the scope of practice for genetic counselors who, until now, have been unregulated health care providers. Second, it offers title protection for genetic counselors. Using any title, such as “genetic consultant,” “genetic assistant,” or “gene counselor” that may represent someone as a genetic counselor without being licensed as a genetic counselor is considered grounds for disciplinary action. Third, the statute will increase access to care for patients by enabling them to identify qualified genetic counselors. The public currently has no way of determining who is legitimately trained and qualified to provide such care. As unlicensed providers, genetic counselors are not typically credentialed by

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3High-cost patients and insurance options from cover Obtaining coverage

been advanced for reinsurance mechanisms. But, what are the merits of each approach in stabilizing insurance markets and does either approach make it easier for people to obtain affordable coverage?

Before the passage of the Affordable Care Act (ACA), most people with highThe cost of care cost medical conditions found it impossible to obtain any health insurance Minnesota used a high-risk pool approach until the passage of the ACA. Data because of their medical condition, much less affordable coverage. Some available from the Minnesota Department of Health Economics Program states, including Minnesota, had developed highdescribes the details of the Minnesota Comprehensive risk pools to provide coverage for people with highHealth Association (MCHA) high-risk pool for 2012. cost conditions. The ACA, however, barred insurers The program served 26,241 Minnesotans (0.4 percent from excluding anyone from coverage because of of the population). The average monthly premium pre-existing medical conditions and eliminated was $403 and cost at least 20 percent more for the caps for lifetime spending in addition to providing Minnesota used a high-risk consumer than a commercial plan would have cost. subsidies for those purchasing insurance through pool approach until the But the $977 average monthly claim cost was more exchanges. The entry of people with costly health passage of the ACA. than double the premium, requiring subsidies from care conditions into the insurance marketplace the state to make up the difference. The program created difficulty for some insurers when claim costs served people of all ages: 8.7 percent of people exceeded estimates and resulted in financial losses. were under 20 years old; 16 percent of people were Some insurers elected to exit the market while between 20 and 40; 44 percent were between 40 and others raised their rates significantly. These events 60; and 31 percent were 60 years or older. But, was likely contributed to some of the instability of markets the cost of the MCHA program substantially greater than costs for other in at least some states. Consequently, insurers, regulatory agencies, policy public insurance programs? In comparison, General Assistance Medical makers, and legislators have been seeking solutions to stabilize insurance Care (for low income childless adults aged 21â&#x20AC;&#x201C;64 who did not qualify for markets. Two ideas that have attracted interest to resolve the problem of other programs) served 19,540 people with average monthly spending of high-cost beneficiaries are the re-creation of high-risk pools and the use of $325. Medicaid served 727,390 people with an average monthly spending per reinsurance methods. Debate about the relative costs and benefits of each enrollee of $944. In 2012, 863,205 Minnesotans were enrolled in Medicare approach has intensified in the Minnesota Legislature as proposals have with an average monthly spending of $761. Although the average monthly spending for people in the high-risk pool was higher than monthly spending for any other public assistance program, it was not significantly different than spending in the Medicaid program. The total annual spending for 2012 in the high-risk pool was $307 million, while total Medicaid spending was $8.24 billion. If the entire cost of the high-risk pool was added to Medicaid, the total Medicaid spending would have increased by 3.7 percent. However, if the 2012 high-risk premiums were deducted from the total spending, the increase in Medicaid spending would have only been $180 million (only 2 percent). Therefore, when taken in context of total Medicaid spending in Minnesota, the costs in the high-risk pool are quite modest in comparison. It is easy to see that spreading the cost of the high-cost beneficiaries across Medicaid would not substantially increase total spending. If we were to pool larger groups of beneficiaries, including those buying on the exchange and MinnesotaCare, it becomes easier to manage the risk related to high-cost conditions.

High-risk pools The approach of using a high-risk pool to segment a small part of the insured population, based on the Minnesota experience, is costly and may not serve people or taxpayers very well at all. The subsidies that would be required from the state may be substantially higher than anticipated given rapidly rising costs of care, especially expensive drugs and hospital care. Therefore, sustainable state funding may be difficult to achieve. A larger insurance market with a stable risk population and sustainable funding will be much better for everyone. High-cost beneficiaries do pose a risk to stable markets, especially when the total risk pool is segmented into smaller parts. Removing high-cost beneficiaries can be accomplished by removing them from the pool by using a high-risk pool or reinsurance methods to cap the high-dollar cases. In a high-risk pool, expenses from one year to the next may be very difficult to estimate and since the pool must cover the entire cost incurred,

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having even a few more very high-cost cases may have a profoundly negative effect on actual spending, thus requiring more state spending to subsidize the high-dollar claims. This results in greater volatility in the high-risk pool making it difficult for insurers, consumers, and the state to provide sustainable coverage that is affordable for all.

Reinsurance

market reforms,â&#x20AC;? by Shubham Singhal, Erica Coe, and Patrick Finn from the McKinsey Center for U.S. Health System Reform, published online Feb. 2, 2017, accessed at healthcare.mckinsey.com) suggests that reinsurance methods are less costly than using high-risk pools. Based on 1 percent of the total number of health care cases being judged as high cost, a high-risk pool approach would cost 250 percent more than a reinsurance approach.

A reinsurance approach may be easier to use and Conclusion more sustainable. Actuaries have used medical stopThe approach of combining the very small number of loss methods for years in other insurance markets. high-cost beneficiaries with larger groups of low-cost By combining high-cost beneficiaries into larger beneficiaries and reinsurance could provide considerable pools of low-risk people, it becomes easier to predict In a high-risk pool, benefits for Minnesota. Other states (Arkansas and total health care spending, which would result in Alaska) have adopted this approach or are considering expenses from one year greater pricing accuracy and lower risk for insurers. (such as Michigan) this method of stabilizing insurance to the next may be very Consumers would benefit from being able to buy the markets. Careful actuarial analysis should tell us what difficult to estimate. same plans at the same price as lower-risk people. the cost would be for the state of Minnesota. Then we The state would not face unpredictable and possibly can make a more informed decision about what would unaffordable subsidies as in a high-risk pool. With a be the right choice for us; reinsurance or a high-risk reinsurance method combined with merging highpool. cost beneficiaries with low-cost groups, year-to-year premium changes should be less volatile than in the past few years. Douglas L. Wood, MD, FACC, FACP, is a cardiologist and medical director The ultimate question is how much it would cost to mitigate the effects for the Center for Innovation at Mayo Clinic. Dr. Wood has served on federal of high-cost beneficiaries. This depends on the number of beneficiaries and state advisory committees and task forces relating to health policy and considered to be high cost and the total cost of the claims as well as the cut health reform. He has also served as chair of the Division of Health Care point or cap for reinsurance benefits to be paid to the insurer. The cap, of Policy and Research at Mayo. Dr. Wood is currently chairman of the Board of course, is arbitrary and could range from $250,000 to $1,000,000 or more. Trustees of the Minnesota Medical Association. An analysis by McKinsey & Company (â&#x20AC;&#x153;Potential impact of individual

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PUBLIC HEALTH

Preexposure prophylaxis HIV prevention Preexposure prophylaxis for for the prevention of HIV What physicians should know BY MALINI B. DESILVA, MD, MPH, AND JAPHET M. NYAKUNDI, MSW

D

espite ongoing, successful behavioral interventions including abstinence-only education, consistent condom use, HIV testing and counseling, testing for other sexually transmitted diseases (STDs), needle-syringe exchange services, and riskreduction counseling, the number of new HIV diagnoses in Minnesota has remained relatively stable at around 300 cases per year since 2000. Certain populations are disproportionately affected. Male-to-male sexual activity is the leading risk factor for acquiring HIV in Minnesota. In 2015, the estimated rate of HIV diagnosis among men who have sex with men (MSM) was 168.1 per 100,000 population, more than 40 times the rate among non-MSM men. People of color are also disproportionately affected. Although non-Hispanic African-American and black African-born Minnesotans make up only 5 percent of Minnesota’s population, together these groups accounted for 44 percent of the newly diagnosed HIV cases in 2015. Forty-one percent of all newly diagnosed HIV cases in 2015 were reported among individuals under 30 years of age.

What is PrEP? Preexposure prophylaxis for HIV (PrEP) is a way to help prevent HIV by taking a daily pill that contains two medicines used to treat HIV, with the goal of reducing the number of new HIV infections. When taken consistently, PrEP has been shown to be more than 90 percent effective at decreasing sexual transmission and more than 70 percent effective at decreasing injection drug use transmission of HIV infection. In July 2012, the U.S. Food and Drug Administration (FDA) approved the daily combined medication tenofovir 300mg and emtricitabine 200mg (TDF/FTC, trade name Truvada) for use as PrEP in HIV-negative adults who are at substantial risk for becoming HIV-infected. If a person takes PrEP every day, the presence of TDF/FTC in the person’s bloodstream can stop infection from taking place when exposed to HIV. However, if a person does not take PrEP as prescribed, there may not be enough medicine in their bloodstream to block the virus.

Who should take PrEP? PrEP is recommended for adults who are at substantial risk for HIV infection; it is not for everyone and is not a solitary HIV prevention strategy. According to the U.S. Centers for Disease Control and Prevention (CDC), there are about 1.2 million people in the U.S. who are eligible for PrEP. However, only a fraction of these are currently receiving prescriptions. Groups at substantial risk of HIV include anyone who is in an ongoing sexual relationship with an HIV-infected partner, MSM, heterosexual women and men who have specific sexual risk behaviors, and injection drug users exhibiting certain behaviors. See Table 1 for a summary of patient characteristics that classify an individual as being at substantial risk for HIV-infection as well as basic guidance for initiation of PrEP. Patients should work with their health care provider to determine if PrEP is a good prevention option for them by conducting a comprehensive risk assessment.

Monitoring PrEP use In 2014, the CDC published a guidance document for clinicians’ use that details how to determine eligibility, initiate, follow-up, and discontinue PrEP. If a patient meets criteria for PrEP, it is important to make sure they do not have any contraindications to using the medication such as 1) documentation of HIV infection (use of TDV/FTC alone may lead to drug resistance in HIV-infected individuals); 2) creatinine clearance <60mL/min; or 3) inability or lack of readiness to adhere to a daily PrEP regimen (effectiveness of PrEP is related to medication adherence). Additional considerations to take into account when determining if a patient is a candidate for PrEP include whether they have chronic hepatitis B infection; if the patient is attempting to become pregnant; patient age; risk of chronic kidney disease and use of other nephrotoxic medications; and history of osteopenia, osteomalacia, or osteoporosis. Full discussion of these risk factors can be accessed in the U.S. Public Health Service’s clinical practice guidelines for PrEP (https://www.cdc.gov/hiv/pdf/ prepguidelines2014.pdf). An HIV test should be obtained prior to starting PrEP to ensure the patient is HIV-negative. It is important to stress to patients that the

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effectiveness of PrEP is dependent on adherence; PrEP should only be prescribed to those who are able to adhere to the daily medication regimen.

risk category. In Parker’s qualitative study, three-fourths of study participants engaged in condomless anal sex or had multiple sexual partners before PrEP initiation. Although participants did not report an increase in number of If the physician and patient agree to start PrEP, the patient should be sexual partners or decrease in condom use during the counseled about common side effects of PrEP that study period, their risk of HIV infection was decreased include headache, abdominal pain, and weight loss. through use of PrEP. For patients at substantial risk These side effects usually resolve or improve after of HIV infection who do not take part in other riskthe first month of use. The first prescription for reduction strategies, PrEP provides an important HIV PrEP (TDF/FTC 1 tablet by mouth daily) should PrEP therapy in Minnesota prevention method that can dramatically reduce HIV be limited to a 30-day prescription and the patient remains underutilized and acquisition. Hojilla and colleagues noted that most should schedule a 30-day follow-up visit to assess under-prescribed. patients use PrEP in conjunction with other riskadherence and tolerance. At the 30-day visit, a reduction strategies including condoms and asking prescription for 60 days may be given. After the first about HIV status of their sex partners. three months, patients receiving PrEP should then be monitored every three months for HIV and other PrEP use in Minnesota STD testing, medication adherence, and side effects. The Minnesota Department of Health (MDH) Patients should be reminded that use of PrEP is only one part of a comprehensive HIV prevention plan. Medical providers should counsel patients about the other components of HIV prevention and provide patients with education about the following:

sponsors five PrEP programs in the Twin Cities metro area and is working to expand PrEP programs throughout Minnesota. PrEP programs are comprehensive clinical programs where individuals can be assessed, tested for HIV, and prescribed PrEP when they enroll in the clinic’s program. All

• Consistent and correct condom use • Safer-sex practices and risk-reduction counseling • Importance of frequent HIV testing and screening for other STDs that can facilitate HIV transmission; remind patients that PrEP does not protect against transmission of other STDs • For individuals in serodiscordant relationships, the importance of ensuring the HIV-infected partner is taking their anti-HIV medications as prescribed PrEP should be discontinued if a patient becomes HIV-infected, develops chronic kidney disease defined as a creatinine clearance <60 mL/ min, is found to be non-adherent to PrEP, repeatedly misses follow-up appointments, or has a change in their risk behaviors so that PrEP is no longer indicated.

Men Who Have Sex with Men

Heterosexual Women & Men

Injection Drug Users

Detecting substantial risk of acquiring HIV infection:

•S  exual partner with HIV • R ecent bacterial STD •H  igh number of sex partners* •H  istory of inconsistent or no condom use •C  ommercial sex work

• Sexual partner with HIV • Recent bacterial STD • High number of sex partners* • History of inconsistent or no condom use • Commercial sex work • Lives in high-­ prevalence area or network

• HIV-positive injecting partner • Sharing injection equipment • Part of a methadone, buprenorphine, or suboxone treatment program and use of injection drugs not prescribed by a clinician in last 6 months

Clinically eligible:

• • • •

Prescription

Once daily oral doses of TDF/FTC (Truvada), ≤ 90 day supply

Other Services:

• Follow-­up visits at least every 3 months to provide: o HIV test, medication-­adherence counseling, behavioral risk-­reduction support, side effect assessment, STD symptom assessment o At 3 months and every 6 months after, assess renal function o Every 6 months test for bacterial STDs

Insurance coverage Most public and private insurance providers cover the majority of PrEP costs. However, coverage for both the medication and clinical and laboratory services associated with use of PrEP vary. There are patient assistance programs to help offset some of these costs. Gilead, the maker of Truvada, has various patient assistance programs listed on their website: https://start.truvada.com/paying-for-truvada. PrEP is not meant to be used lifelong. Rather, it is a method to further augment HIV prevention effectiveness during periods when people are at greatest risk of acquiring HIV. As such, the costs associated with the use of PrEP should also be for a limited duration.

Risky sexual behavior Several studies have shown that use of PrEP does not increase risky sexual behaviors of individuals who are prescribed it. Marcus and colleagues, showed that in the iPrEx study, a double-blind, placebo controlled trial of FTC/ TDF which enrolled 2,499 MSM and transgender women at risk for HIV infection at 11 sites in Peru, Ecuador, South Africa, Brazil, Thailand, and the U.S. during 2007–2009, there was no evidence of increases in receptive anal intercourse with no condom among participants believing they were receiving FTC/TDF. It should also be noted that PrEP is considered a harm-reduction strategy and is targeted towards individuals who already fall into a substantial

Documented negative HIV test before prescribing PrEP No signs/symptoms of acute HIV infection Normal renal function, no contraindicated medications Documented hepatitis B virus infection and vaccination status

• Do oral/rectal STD testing

• Assess pregnancy intent • Pregnancy test every 3 months

•A  ccess to clean needles/syringes and drug treatment services

Table 1. Summary of guidance for PrEP use (U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV in the United States–2014: A clinical practice guideline. May 14, 2014. Available at: http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf). *“High number of sexual partners” not specifically defined by CDC, but may be interpreted as greater than 1. There is a MSM risk index provided in Section 6 of the U.S. Public Health Service Preexposure Prophylaxis for HIV Prevention in the United States–2014. Clinical Provider’s Supplement (https://www. cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf) which assigns a score based on the number of sexual partners in the last 6 months.

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MEDICINE AND THE LAW

Medicare enrollment Increasing complexity in program compliance BY JESSE BERG, JD, AND JULIA REILAND, JD

F

or many physicians, Medicare enrollment is challenging yet necessary for a successful practice. There are many benefits to participation: the Medicare fee schedule amount is higher than that of a non-participating provider, collections from patients are easier, reimbursement can be more reliable, and perhaps most important, it is the only way for doctors to obtain access to the largest segment of the insured population. The trouble is these benefits come at a significant cost—and as the health care industry evolves, this cost continues to increase. One example of this is the increasing complexity associated with simply enrolling in Medicare. Until the late 1990s, Medicare enrollment meant completing the HCFA1513 form, a document with one page of instructions and eight questions. By comparison, the current CMS-855A form is 59 pages long and includes dozens of complex questions. The Centers for Medicare & Medicaid Services (CMS) has also become vigilant about enrollment accuracy and revalidation, pursuing verification of

not only reasonable provider information (such as licensure status) but also extremely technical requirements. And unfortunately, physicians and other Medicare “providers” and “suppliers” may find themselves easily enmeshed in CMS’ program integrity efforts. The good news is that, by avoiding common pitfalls with Medicare enrollment and claims submission, providers can greatly reduce the risk of CMS knocking on their door.

Medicare program integrity Medicare “program integrity” initiatives are designed to prevent and detect Medicare fraud and abuse. Starting in the early part of the 2000s, CMS’ program integrity activities have grown in scope and scale and regulators have tacked on ever more significant penalties for physicians and other parties who fail to meet applicable requirements. Some of the more important initiatives have included the following: • Enrollment and revalidation efforts. In what is CMS’ most significant new initiative to stop health care fraud, physicians and all other providers and suppliers are required to provide significant detail about their ownership, operations, and past history as a condition of enrolling in Medicare. The revalidation policy reflects CMS’ desire to ensure parties confirm the accuracy of their enrollment record every few years. The failure to respond in time to a revalidation request, a trap that has befallen many organizations, is a basis for deactivation of billing privileges. • Reimbursement suspension. CMS may suspend reimbursement in the event of a “credible allegation of fraud” (while an investigation of those allegations occurs) and impose broad moratoria on enrollment in defined geographic areas and for defined categories of providers and suppliers. • Risk screening. Use of “risk-based” enrollment screening that scrutinizes providers and suppliers based on CMS’ view of how much fraud and abuse risk they pose to Medicare and the ability to change risk level associated with specific parties. • Enrollment revocation. CMS can revoke a physician’s enrollment for a range of different reasons. This authority was expanded in 2015 to include revocation based on a “pattern or practice” of submitting claims that do not meet Medicare requirements. The term “pattern or practice” was not defined in the 2015 rulemaking. CMS contracts with a number of private entities to conduct these program integrity activities. Although combating fraud and abuse is certainly important from a public policy perspective, the federal government recoups a lot of money through program integrity efforts. According to CMS, in 2015 the Fraud Prevention System (FPS) helped identify or prevent $654.8 million in inappropriate payments. These savings are approximately 44 percent higher than the identified savings from 2014, with a nearly $11.5 to $1 return on investment.

Moving from a “pay and chase” system to proactive efforts Historically, CMS focused its efforts on recovering money for claims that

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should not have been paid in the first place. This approach is known as the “pay and chase” system. Following payment of a Medicare claim, CMS would review the claim to verify accuracy of information, appropriateness, medical necessity, and other requirements. If CMS determined that the payment was inappropriate it would pursue (or “chase”) providers and seek reimbursement.

Physicians beware: issues to watch for There are four types of enrollment actions: 1) new enrollments; 2) revalidations; 3) changes of information; and 4) changes of ownership. Each of these actions is subject to its own specific requirements and deadlines. It is unfortunately fairly easy for physicians to get crosswise with some of the deadlines and demands that apply to particular situations.

This system turned out to be hard, slow, and For example, physicians, like other Medicare more expensive because bad actors often just suppliers and providers, are required to keep their disappeared. As a result, CMS has shifted away enrollment information up to date and must notify The trend toward making from this model toward more proactive efforts. CMS of any changes. One of the easiest ways for enrollment more rigorous shows For example, the agency has increased its focus on physicians to run into trouble is if they own or no signs of abating. maintaining correct enrollment efforts with the manage supplier types that are subject to different goal of keeping “bad actors” out of the Medicare reporting requirements than the physicians program to begin with. In addition to making the themselves. The reason is that the Medicare enrollment applications themselves increasingly rules establish different timeframes that apply to different supplier categories and different types of complex, CMS has also taken steps to compel changes. This is not always very clear because the physicians to enroll even if they do not desire to same enrollment form (the CMS-855B) is used by physicians to enroll their see Medicare patients. For instance, physicians who order or refer Medicare group practice and also by many of the supplier types that physician often patients to other organizations for services (but do not themselves bill own or control (such as independent diagnostic testing facilities [IDTFs] Medicare) are required to enroll using the CMS-855O form. and ambulatory surgery centers [ASCs]). For example, physicians themselves The trend toward making enrollment more rigorous shows no signs of generally have the most leeway to report enrollment changes. General changes abating. For example, in February 2016, CMS issued a proposed rule that to physician enrollment record (such as a change in practice location) must would make the provider enrollment process even more onerous. One of be reported within 90 days of the effective date of the change, and physician the changes from that rule is that providers would be required to disclose affiliations (going back five years) with individuals that owe money to Medicare enrollment to page 244 Medicare, Medicaid, or the Children’s Health Insurance health care programs. In addition, OIG (Office of Inspector General) is utilizing its Medicare program exclusion authority as a way to enforce Medicare program requirements. On Jan. 12, 2017, OIG issued a final rule that expanded its permissive exclusion authority. Most importantly, OIG now has the authority to exclude individuals or entities that are convicted of an offense that involves the obstruction of an audit related to any criminal offense that is the basis for mandatory or permissive exclusion. In addition, OIG has authority to exclude any individual or entity that knowingly makes, or causes to be made, any false statement, omission, or misrepresentation of a material fact in any application, agreement, bid, or contract, to participate or enroll as a provider of services or supplier under a federal health care program. There has also been an increasing focus on excluding individuals (e.g., owners, officers, managing employees) from Medicare as opposed to simply excluding the organization those individuals were running. In late 2010, the OIG began to emphasize the use of its permissive authority to exclude individuals who have ownership or control interests in a sanctioned entity if those individuals knew or should have known of the conduct that led to the sanction or who were officers or managing employees at the entity. Individuals in these roles may be excluded based solely on their position within the entity. The OIG guidance also established a regulatory presumption that an owner, officer, or managing employee of a sanctioned entity who knows or should know of the excluded conduct giving rise to the sanction will be excluded. The implications of program exclusion are profound; among other things, exclusion means that with very limited exceptions, no payment will be made by any federal health care program for any service furnished, ordered, or prescribed by an excluded party. By targeting individuals in this way, the OIG is trying to force physicians to take ownership of the claims being submitted to Medicare and ultimately improve compliance with Medicare rules. MINNESOTA PHYSICIAN APRIL 2017

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3Medicare enrollment from page 23 changes of ownership or control must be reported within 30 days. However, if a physician owns another type of supplier different timeframes will apply. An IDTF is required to report certain specific changes, such as change in the physician charged with supervising the facility, within 30 days. Durable medical equipment suppliers, meanwhile, are required to use a different enrollment form altogether (the CMS-855S) and must report all changes within 30 days. And while a physician can file his or her 855B group practice enrollment up to 60 days in advance of the date the practice will begin operations, a physician who owns an ASC can file the ASCs’ enrollment (also on the CMS-855B) 180 days in advance. Taking advantage of this extra time to file for an ASC enrollment is very important because that type of supplier cannot begin operating until the state conducts a licensing survey. However, a physician who tries to enroll their group practice more than 60 days in advance will likely have the enrollment forms returned. Other common enrollment pitfalls that physicians often encounter include the following: • Misstating the legal business name (LBN). This can be challenging for groups that have a name on file with the Secretary of State that differs from their LBN on file with the IRS. • Issues with IRS documentation. Issues in this area can include disconnects between the LBN on file with the IRS and the name the group wants to use with CMS as well as documentation regarding tax-exempt status.

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• Not supplying adequate personal information for board members, officers, and managing employees. Note that while board membership may change frequently, that does not mean providers/suppliers are exempt from reporting changes via their 855S within the relevant timeframes. It may also be important to have talking points ready so that you can explain to board members and other organizational leaders why they need to provide sensitive information, such as their social security numbers, as part of the enrollment process. • Ignoring some of the technical details requested in these forms, such as failing to provide full 9-digit ZIP codes or paying insufficient attention to how CMS expects ownership interests to be calculated and disclosed. • Failing to disclose adverse actions. This often results from confusion around what CMS means by “adverse.” For example, one physician group failed to report a 20-day license suspension because that period was less than the 30-day deadline under the Medicare enrollment regulations for reporting adverse actions. The court found the physicians had not interpreted the regulation correctly. To avoid these pitfalls, providers should do the following: • Get to know PECOS (Provider Enrollment, Chain, and Ownership System), the online Medicare enrollment system, before it is time to enroll or revalidate. Physicians working with PECOS for the first time sometimes express confusion about the system, the questions it asks, and its various prompts for submitting information. One helpful way to minimize this confusion is to take advantage of CMS’ PECOS’


webinars, a series of free, easy-to-use tools that physicians and their staff can use to walk through common Medicare enrollment scenarios. Spending a little bit of time learning about how the system works in advance will save stress when physicians find themselves struggling to meet tight enrollment deadlines. • Always use the most up-to-date CMS-855 Medicare Enrollment Application. They can be downloaded from the “CMS Forms List” on the CMS website. These forms change frequently and changes are not always widely publicized. In fact, there are many out-of-date versions floating around the internet. The publication date for all of the CMS-855 forms can be found on the lower left-hand corner of the document.

• Compile a work plan for each provider/supplier category relevant to your practice and use it every time you have an enrollment filing. This is a helpful way of making sure important steps, such as including all of the required attachments, are not overlooked.

Always use the most up-to-date CMS-855 Medicare Enrollment Application.

• Verify that the National Plan & Provider Enumeration System data matches the IRS data and data submitted on the relevant CMS-855 Application. • Some provider and supplier categories are subject to site visits as part of their enrollment. If you fall into these groups, be sure that you are operational during normal business hours, that you have the appropriate signage for your provider/supplier category, and that you have accurately described your address and other contact information on your enrollment forms.

• Avoid the danger of simply filling out your paperwork and waiting for an answer. Tracking the application as it moves through the process is much safer and lends itself to fewer unpleasant surprises. One helpful tool for doing this can be through building relationships with contacts at the Medicare Administrative Contractor for purposes of getting questions answered accurately.

Medicare program integrity will be a topic at Gray Plant Mooty’s 21st Annual Health Law Seminar, to be held on July 20, 2017. Please contact Jesse (jesse.berg@gpmlaw.com) or Julia (Julia. reiland@gpmlaw.com) if you would like to attend or have questions about Medicare program integrity issues. Jesse Berg, JD, is a principal at Gray Plant Mooty and a member of its Health & Nonprofit Organization Practice Group.

Julia Reiland, JD, is an associate at Gray Plant Mooty and a member of its Health & Nonprofit Organization Practice Group.

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INFECTIOUS DISEASES

Congenital infections with cytomegalovirus An unsolved challenge in pediatric health BY MARK R. SCHLEISS, MD

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ytomegalovirus, or CMV, is a virus that is a member of the human Herpesviridae family. This family of viruses includes varicella-zoster virus (the cause of chickenpox), Epstein-Barr virus (the cause of mononucleosis), and herpes simplex virus. CMV infections are common, and most individuals acquire the virus over the course of a lifetime. However, CMV infections are hard to “catch”—they are not transmitted by casual contact, like the common cold or the flu, but instead require fairly intimate contact. CMV is transmitted by saliva, urine, breastfeeding, sexual contact, and, rarely, blood transfusion. Like all Herpesviridae infections, CMV causes life-long, permanent (so-called “latent”) infection, but typically is of medical consequence only if an individual is immune suppressed, such as in the context of organ or bone marrow transplantation or after acquiring HIV infection.

CMV and pregnancy Pregnancy is another uniquely high-risk situation. If a pregnant woman acquires a CMV infection, there is risk to the unborn infant. The risk is highest when a woman acquires her first CMV infection during pregnancy. Under these circumstances, CMV may be transmitted to the developing fetus in up to one-half of all pregnancies. Even if a woman has had previous CMV infections prior to becoming pregnant, up to 1 to 2 percent of fetuses become infected if that pregnant woman acquires a new strain of CMV infection during pregnancy. The consequences for the newborn infant, if infected in utero, can be devastating. Although many infants develop normally, up to 65 percent of newborns suffer disabilities, depending on the timing of infection and the maternal immune status (whether the mother had a first-time infection or recurrent infection). Disabilities and sequelae can include microcephaly, cerebral palsy, mental retardation, seizures, developmental delay, and hearing loss. More infants are injured by congenital CMV infection than the more commonly recognized syndromes of fetal alcohol syndrome, Down’s syndrome, and neural tube defects— combined. Congenital CMV occurs in >40,000 infants in the U.S. every year—a number vastly greater than the total number of Zika virus-infected newborns. In addition to brain injury induced by this virus, CMV is also the most common infectious disease in the U.S. that causes hearing loss. Up to one-third of all hearing loss in infants and children is caused by congenital CMV infection.

Treating CMV If a woman is known to have an active CMV infection during her pregnancy (particularly a primary infection), she should be monitored by ultrasound examination and, in some circumstances, amniocentesis should be considered to attempt to confirm fetal CMV infection. If the fetus is infected with CMV, experimental therapies for the pregnant patient could include infusion of high-titer CMV immune globulin (the IgG antibody is capable of neutralizing CMV virus), or therapy with anti-viral medications such as valacyclovir. The value of these therapies remains unproven. For the newborn infant with symptomatic congenital CMV disease, it is known that treatment with valganciclovir, a nucleoside analog similar to valacyclovir, improves neurodevelopmental and audiological outcomes. Most infants are treated for the first six months of life. Unfortunately, there is no vaccine licensed to prevent congenital CMV. A number of vaccines are currently in clinical trials. A recent study in the Schleiss laboratory yielded promising results employing a two-antigen combination vaccine, consisting of a humoral immune target combined with a T-cell target (http://www.healthtalk.umn.edu/2017/01/11/ cytomegalovirus-vaccination/). In this study in experimentally infected guinea pigs, the two-antigen combination vaccine resulted in a greater than ten-fold reduction in CMV-associated mortality in newborn pups. It is hoped that a CMV vaccine can be licensed in humans within the next 10 years.

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What to tell your pregnant patients

newborns who do not pass their newborn hearing screen for congenital CMV infection. A second study, being performed in collaboration with the Minnesota Department of Health and funded by the Centers for Disease Control, is performing universal screening for congenital CMV infection in all newborns. A third study, funded in collaboration with the Minnesota Vikings Childrens’ Fund (“If You Don’t Pass, Screen!”) is providing for advocacy for CMV research. These diverse programs share the common goal of improving recognition of congenital CMV infection through education and screening.

The key issue in pregnancy is the issue of education. In spite of the common nature of CMV, most women (and men) have never heard of the virus. It is of critical importance to educate women who are pregnant or may be pregnant of ways to avoid CMV infection during pregnancy (see the sidebar). Indeed, many states, including Utah, Connecticut, Illinois, Texas, Tennessee, and Hawaii have passed legislation that directs state health officials to implement CMV educational programs targeting women of childbearing age. Providing this information to pregnant patients Early recognition of congenital CMV—with Most women (and men) have may help reduce the risk of congenital CMV diagnosis being made in the immediate newborn never heard of the virus. infection. Women at particularly high risk period—is of critical importance. The finding of include attendants at group day-care centers, an active CMV infection in an older infant or and mothers of young children attending group toddler who presents with hearing loss or another day-care. Screening women by blood serology neurological disability cannot with certainty be testing, in order to identify their CMV status ascribed to congenital CMV infection, since that (and level of risk) during pregnancy, may also be child’s infection could have been acquired after useful. CMV seronegative pregnant women are at the highest risk, and birth. Early identification, in addition to increasing diagnostic certainty, educational measures (and in some cases, serological monitoring for serocan facilitate the use of antiviral therapy in the infected infant, which in conversion) are particularly important in these women. Increasingly, turn can improve the neurological and audiological outcomes. Thus, there women are asking their health care providers to obtain such CMV testing is considerable interest in moving newborn screening programs forward. At before or during their pregnancies.

The importance of early newborn screening

Congenital infections with cytomegalovirus to page 384

In addition to screening women during their pregnancies for CMV antibodies, there is a role for screening newborn infants for congenital CMV infection. This is not yet standard-of-care, but is being looked at in several studies in Minnesota. One study, funded by the Children’s Hospitals and Clinics of Minnesota Internal Research Grant Program, has been testing

STRATEGIES FOR PREVENTING ACQUISITION OF CMV INFECTION 4

Avoidance of infectious secretions • Urine • Saliva • Nasal discharge • Breast milk • Blood • Semen, cervical secretions

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Hand-washing • Diaper changes • Wiping nasal discharge of young children

4 4 4

Avoid sharing eating and drinking utensils

4

Determination of serological status • Seronegative women—highest risk • Monitor for seroconversion during pregnancy

Sexual transmission Kissing • Toddlers in group day care

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PROFESSIONAL UPDATE: OPHTHALMOLOGY

Advances in cataract surgery A new option for patients BY ELIZABETH A. DAVIS, MD, FACS

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Cataracts

Cataracts are a common condition, with almost 4 million cataract surgeries performed each year, and that number is expected to increase (2016 n July 15, 2016, Abbott Medical Optics announced Comprehensive Report on the Global IOL Market). By age 80, more than that the U.S. Food and Drug Administration (FDA) half of all Americans either have a cataract or have had cataract surgery. approved the use of Tecnis Symfony Intraocular Lenses However, cataracts do not just impact seniors. In 2016, it was estimated during surgery for cataracts. that nearly one in four cataract surgeries were Minnesota Eye Consultants performed on people younger than 65. Many was the first in the Minneapolis–St. Paul market people who have cataracts experience other to offer this new lens to patients. problems with their vision, such as presbyopia By age 80, more than half The first in a new category of intraocular and astigmatism, which the Symfony lenses also lenses (IOLs), the Tecnis Symfony lenses are the of all Americans either address. Presbyopia, which affects most people only lenses in the U.S. that provide an extended have a cataract or have had over age 40, means people have lost the ability depth of focus of continuous high-quality vision cataract surgery. to focus on objects up close and often require following cataract surgery, while also mitigating glasses to perform near visual tasks. Astigmatism the effects of presbyopia by helping people focus is when the cornea is misshapen, which causes on near objects. The FDA approval includes a blurry or distorted vision. version of the lens for people with astigmatism, Cataracts often develop slowly, causing a the Tecnis Symfony Toric IOL. decline in visual acuity and visual quality. Occasionally they develop rapidly. Regular visits to the eye doctor are important for catching changes in vision, but primary physicians can also watch out for several symptoms, such as: • Cloudy vision • Halos around lights • Light sensitivity • Difficulty seeing at night • Double vision in one eye • Poor night vision • Seeing faded colors • Frequent changes in glasses or contact lens prescriptions When cataracts are in their early stages, they may be managed with an updated prescription to glasses or contact lenses. But as they develop, loss of vision may start to interfere with everyday activities like reading or driving.

Candidates for the lens An eye doctor will help determine candidacy for cataract surgery. They will assess current eye health and review medical history to determine whether there are other contributory factors. During cataract surgery, the natural lens of the eye is removed, and an artificial lens, called an intraocular lens, or IOL, is inserted. The IOL most commonly used in cataract surgery is a monofocal lens, which only allows the person to see at one focal point without glasses, with objects at other distances being out of focus. In contrast, the Symfony lens was specifically developed with features to improve both the range and quality

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of vision. The lens has a diffractive echelette design that results in an extended depth of focus. Rather than having two distinct focal points (as occurs with multifocal IOLs), there is a range of clear vision from distance to closer focal points. The lens is also made of a proprietary material that reduces something called chromatic aberration (the dispersion of light of different wavelengths) and this enhances the quality of vision and contrast sensitivity. This new lens is ideal for patients who desire enhanced uncorrected visual acuity and it doesnâ&#x20AC;&#x2122;t affect the way that cataract surgery is performed. The lens is inserted exactly the same way as any other IOL is inserted. Instead, it only changes the way that light is focused. With the Symfony, there is a greater range of vision in focus without glasses or contact lenses (see Table 1). Other IOL solutions for treating presbyopia include multifocal IOLs that split light into two distinct foci, and accommodative IOLs that change the eyeâ&#x20AC;&#x2122;s overall power when the ciliary muscle contracts. The cataract surgeon will determine which IOLs the patient is a candidate for.

About the new lens It is important to note that the Symfony lens is not a multifocal IOL but an EDOF (extended depth of focus IOL), thus there is a continuum of vision from the distance to the proximal focal point (see Figure 1).

DEFOCUS CURVE: 3-MONTH ADJUSTED DATA

Table 1. Defocus curve that shows the greater depth of focus of the Symfony IOL compared to a monofocal IOL. The FDA clinical trial results showed that patients who received the Symfony IOL, on average, maintained 20/20 acuity through 1.5 D of defocus and 20/40 acuity through 2.5 D of defocus.

Advances in cataract surgery to page 304

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3Advances in cataract surgery from page 29 • Near focal point may not be as close as certain multifocal lenses, so some reading glasses may be required for small print. • Low incidence glare and halos. Patients may have some scattered light rays at night, but not as significant as other multifocal lenses. • Diffractive technology. • The lens is made of an acrylic material, is foldable, and fits through a small incision.

MONOFOCAL IOLs

Monodical IOLs are used to restore vision in one area of focus—usually distance. Glasses may still be needed for near and intermediate distance activities.

• High-quality vision due to aspheric technology and low chromatic aberration. The lens is approved in more than 50 countries around the world, and has been widely studied, with data from numerous clinical studies involving over 2,000 eyes. In clinical studies, the lens: • Provided seamless, day-to-night vision. Patients could see objects sharply and clearly at a proximal focal point and far away distances, as well as points in between.

EXTENDED DEPTH OF FOCUS IOL

An Extended Depth of Focus IOL provides a continuous range of high-quality vision—from near to far and points in between—and may reduce the frequency of wearing glasses.

Figure 1. Monodical IOLs typically require glasses for most distances whereas extended depth of focus IOLs can reduce dependence on glasses for certain distances.

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• Provided high-quality vision. Some IOLs may leave patients with an inability to focus clearly due to competing wavelengths of light passing through the lens at different angles (known as chromatic aberration), or with vision that is not completely focused because of the shape of the cornea (known as spherical aberration). The Symfony lens has been engineered to mitigate these issues. • Demonstrated a low incidence of halo and glare, which may be perceived as rings or blurring around bright lights. Glare and halo can sometimes affect an individual’s ability to drive at night or to perform other visual tasks.

house, and he enjoys sports. Prior to the surgeries on both of his eyes, all of these activities were affected by his vision. He was the perfect candidate to receive the Symfony lens.

Gary notes that the new lens has improved his quality of life quite a bit. He can read the newspaper without reading glasses, view trees 100 yards from his house, and see the sun glistening on each leaf. He is amazed at the detail he can see now. After cataract surgery he didn’t want to wear glasses, Almost 4 million cataract and now he doesn’t have to. He has clear vision surgeries [are] near and far, and doesn’t rely on glasses at all performed each year. now.

Case study Patient Gary Way, 67, from Grand Rapids, Minn., recently had cataract surgery with me, and he selected the Symfony lens after we discussed all of the options. Gary had the Symfony lens put in both eyes. One of the most important things for him was his inability to read street signs or highway signs. That made things very difficult. He is retired, but does a bit of woodworking and other things around the

Many of the IOL options we have for treating cataracts are excellent, and result in high patient satisfaction, but each have their own distinct advantages and disadvantages. A good surgeon will help each patient choose the IOL that is best suited for their desires, lifestyle, preferences, and unique eye anatomy.

Elizabeth A. Davis, MD, FACS, is a partner at Minnesota Eye Consultants, and served as an advisor with Abbott on the Symfony lens.

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GASTROENTEROLOGY

The Minnesota Reflux and Heartburn Center Comprehensive care under one roof BY PAUL A. SEVERSON, MD, FACS

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ERD is the most common gastrointestinal problem diagnosed in outpatient clinics, affects an estimated 20 million Americans, and can lead to Barrett’s esophagus and esophageal adenocarcinoma. Cuyuna Regional Medical Center in Crosby and Riverwood Healthcare Center in Aitkin, along with surgeons from the Minnesota Institute for Minimally Invasive Surgery, have assembled a team of health care professionals to provide comprehensive care to patients with gastroesophageal reflux disease (GERD), and established the Minnesota Reflux and Heartburn Center (MRHC) where patients can be evaluated and treated at the same location. Modeled after other emerging reflux centers across the United States, and with lessons learned from our bariatric and cancer center experience, we are now positioned to offer an excellent patient-centered, comprehensive evaluation and treatment experience, not only for our regional patients, but also for those patients seeking help throughout Minnesota.

Avoiding further complications According to Dr. Howard McCollister, an endoscopic specialist at MRHC, esophageal adenocarcinoma remains highly lethal, has increased 600 percent over the last three decades, and is the fastest growing cancer in the United States. We have instituted state-of-the-art protocols for esophageal cancer screening that include the introduction of confocal laser endomicroscopy (Cellvizio, Mauna Kea Technologies, Paris, France). A multi-center trial at MRHC (along with six other centers nationally) has compared this novel technology to the traditional biopsies that most physicians utilize. The study results are very promising and groundbreaking, and demonstrate a dramatic improvement in our ability to screen and identify Barrett’s intestinal metaplasia. Hopefully, this will translate into saving many more lives from the ravages of cancer of the esophagus. According to MRHC reflux specialist Dr. Tim LeMieur, “What this means for patients is that we can visualize the inside of their cells in real time, and diagnose precancerous Barrett’s or esophageal cancer immediately during an endoscopy. At this time, Cellvizio is being used in only a few specialized centers in the U.S., so being able to offer this innovative technology in Minnesota is a huge benefit for reflux patients.”

Treating GERD The primary cause for GERD is a weakening of the lower esophageal sphincter (LES), which cannot be tightened by medications. While it is widely known that the LES pressure required to maintain competence can be overcome during pregnancy or worsening obesity, the LES can also be weakened with certain chemicals such as alcohol, nicotine, and caffeine. Certain lifestyle changes, which include elimination of contributory chemicals and weight loss, as well as a trial of proton pump inhibitor medications, remain the mainstay of GERD treatment for the vast majority. Of the 20 million people who take proton pump inhibitor medications, an estimated 7 million are not happy with the results, primarily because symptom relief is usually not possible for patients who experience regurgitation symptoms. These symptoms may not commonly be typical GERD symptoms such as heartburn and chest pain, but may present with atypical symptoms such as cough, hoarseness, chronic sore throat or throat-clearing, increased mucous or phlegm production, burning tongue, bitter taste, or frank regurgitation. Medications are usually not effective in relieving these frequently incapacitating regurgitation symptoms. The amount of refluxate is not altered by medications, only the acid composition of the gastric contents. Bilious gastric contents continue to reflux in GERD patients, and proton pump inhibitor medications have never been shown to decrease the risk of esophageal cancer, nor do they control regurgitation symptoms. For patients such as these, surgery or “barrier” technologies are necessary.

Controlling gastric juices One new technology that MRHC has offered patients and successfully utilized over the last three years is the LINX magnetic sphincter augmentation procedure. This tiny implant is a bracelet of titanium-coated

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rare-earth magnets, positioned around the weakened LES via laparoscopy performed in same-day surgery. It is ingeniously designed to open only during swallowing, and magnetically close as soon as the bolus of food passes into the stomach. Once in position, it effectively controls reflux of gastric juice back up into the esophagus. Dr. Shawn Roberts is one of several MRHC surgeons to have performed the procedure. He says that the procedure is a game changer for patients suffering from severe GERD that has not responded to medical therapy. Its durability is every bit as good as previous anti-reflux procedures, but offers the advantages of minimal side effects by preserving the natural ability to belch and vomit. While this new procedure offers great hope to many patients, traditional procedures such as Nissen, Toupet, and Collis-Nissen fundoplication procedures are sometimes still indicated. In addition, patients who also suffer from morbid obesity as well as GERD can be cured simultaneously with a gastric bypass procedure, also performed by minimally invasive surgical technique.

Patients who have been treated with long-term proton pump inhibitor medication, who experience breakthrough symptoms, are concerned about the side effects, or have failed results from previous procedures, are appropriate candidates for a comprehensive evaluation at MRHC. For more information, visit www.mnheartburn.org. Paul A. Severson, MD, FACS, is director of the Minnesota Reflux and Heartburn Center and chief of surgery at Riverwood Health Care Center and past chief at Cuyuna Regional Medical Center. He is a professor in the Rural Physician Associate Program at the University of Minnesota and is the program director for the Fellowship in Advanced GI MIS, Bariatric Surgery, and Flexible Endoscopy at MIMIS (Minnesota Institute for Minimally Invasive Surgery).

MRHC surgeons have served as educators in both reflux and bariatric surgery for over 20 years, including hosting a post-graduate fellowship in Advanced Minimally Invasive Surgery, Bariatric Surgery, and Flexible Endoscopy. MRHC is a referral center for the evaluation of complicated reflux problems, and its surgeons perform revisional procedures on patients referred from the five state area.

Determining the course of treatment In order to determine which procedures are advisable, a comprehensive evaluation is performed. This consists of a complete endoscopic evaluation, which includes enhanced imaging technologies to identify abnormal and potentially pre-cancerous lining at the esophago-gastric junction, confocal laser endomicroscopy, increased tissue biopsies, and installation of one of three different outpatient pH monitoring methods. In addition, highresolution manometry is performed in one of MRHC’s two GI Labs to evaluate the muscular function of the esophagus and identify any esophageal conditions that might masquerade as, or coexist with, GERD. Nurse coordinators can conveniently arrange all studies in a single day for patients traveling a long distance. Finally, a comprehensive consultation with the

GERD is the most common gastrointestinal problem diagnosed in outpatient clinics.

reflux specialist summarizes the results, and a “lifeplan” is developed based on the scientific data obtained. We are dedicated to providing a highly personalized “concierge” level service to our patients from their first phone call through their definitive procedure. Nurse practitioners who assist patients through their GI Lab testing and clinic experience are thrilled to find a new diagnosis, or offer a new treatment, that allows them to finally help someone who has been suffering—often for many years. MRHC has grown rapidly since its inception two years ago, and our exciting dedication to GERD has inspired our last two surgical fellow graduates to start similar reflux centers in Seattle, Wash., and Coeur d’Alene, Idaho. There are now over 50 reflux centers in the U.S., with MRHC being the first in Minnesota.

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FETAL CARE

Minnesota’s Newborn Screening Program An evolving safety net BY JESSICA CAVAZOS, AND MAGGIE DREON, MS, CGC

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ince 1965, newborn screening has been available to all Minnesota newborns shortly after birth. What started with one screen, for a single condition (PKU), has now grown into a three-component (blood spot, hearing, and pulse oximetry) program that screens for over 50 serious, congenital disorders.

All components of the newborn screening program are best completed between 24 and 48 hours of life. Screening during this timeframe allows for the most accurate results, while also enabling early detection and treatment for affected infants prior to symptoms. Most important, all disorders screened for have a treatment, intervention, or cure that improves health outcomes of affected children when identified early. The availability of treatment is a hallmark of newborn screening conditions and a key reason why the CDC has named newborn screening one of the greatest public health achievements of the 21st century.

Physician involvement The success of newborn screening programs relies heavily on the involvement of physicians throughout the state. Physicians are the first line of contact for

the program when an at-risk infant is detected. In the case of an abnormal lab result, MDH (Minnesota Department of Health) genetic counselors and follow-up staff first contact the infant’s physician to alert them to the result, provide just-in-time information about the disorder, and help coordinate further follow up and family communication. Given the potential urgency of some of the conditions on the newborn screening panel, the Newborn Screening Program strives to have screening results available when the infant is between three and seven days old. Abnormal screening results will be called to the infant’s physicians and normal screening results should be made available to physicians by the infant’s birth hospital. It is important to note that newborn screening is, indeed, just screening. Any clinical suspicion of a disorder on the newborn screening panel should be followed up on regardless of the screening results.

Additions to the Minnesota screening panel Since the introduction of PKU testing in the 1960s, newborn screening programs across the country have continued to evolve—in terms of number or disorders screened, technology advancements, education, and timeliness. This year will mark another period of evolution as the Minnesota newborn screening panel will grow by three new disorders: X-linked adrenoleukodystrophy (X-ALD), mucopolysaccharidosis type I (MPS-I), and Pompe disease. In Minnesota, disorders are added to the newborn screening panel by the Commissioner of Health through the recommendation of the Newborn Screening Advisory Committee on Heritable and Congenital Disorders. Legislative action is not needed to add conditions in Minnesota unless an associated increase to the newborn screening fee is needed to cover costs of implementation. The Newborn Screening Advisory Committee is charged with examining potential conditions and assessing whether it makes sense for the state to require universal population screening. Federal guidance, in the form of a recommended uniform screening panel, for state programs have set criteria that conditions should meet prior to inclusion on the newborn screening panel. These criteria are: • Availability of inexpensive and reliable large-scale testing methodologies. • The condition is unlikely to have clinically identifiable presentation. • Significant disease burden and onset occurs during the newborn period. • Availability of diagnostic confirmation and efficient treatment. • Public health programs are able to test and manage the condition. After a thorough review by experts throughout the state, the Advisory Committee recommended that X-ALD, MPS-1, and Pompe disease be added to the Minnesota panel. Since receiving the Commissioner’s approval of this recommendation, the Newborn Screening Program has been preparing to begin screening for these new conditions. This preparation required the development and validation of new testing methods, creation of educational materials, and establishment of a robust follow-up infrastructure. On Feb. 6th, 2017, we began testing all blood spots for X-ALD. Validation for the

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remaining two disorders, MPS I and Pompe, is ongoing and MDH expects to begin screening for these two disorders later this summer. The addition of these conditions present several novel issues for newborn screening and providers alike because they have variable severity, age of onset, and treatment efficacy. Because of these challenges, the role of providers in screening follow-up will be increasingly vital and ongoing. A review of the three conditions will help highlight some novel challenges.

waiting, will be lost to follow-up, and then miss the key features of the disorder that show onset has occurred. Once onset occurs, the impact of the disease is irreversible, making the goal of catching symptoms early essential and the relationship between the family and PCP critical. X-ALD treatment may include adrenal hormone replacement and/or hematopoietic stem cell transplantation. The expected incidence of X-ALD is 1 in 21,000 males.

Mucopolysaccharidosis type I MPS I is a lysosomal disorder, caused by an enzyme deficiency leading X-linked adrenoleukodystophy to accumulation of glycosaminoglycans. MPS I was X-ALD is a genetic disorder, primarily found previously identified as three separate disorders: 1) in males, that affects the nervous system. There Hurler, 2) Hurler-Scheie, and 3) Scheie syndromes. are three types of X-ALD and screening cannot Given the overlap between these three syndromes, distinguish between them: 1) childhood cerebral, 2) The success of newborn they are now recognized to be variations of MPS adrenomyeloneuropathy, and 3) Addison’s disease. screening programs relies I. MPS I has two forms (severe and mild) and Even individuals who have the most severe type with heavily on the involvement again, screening is unable to distinguish between the earliest onset, childhood cerebral, may not show of physicians. the two, however additional testing from specialists symptoms prior to four years of age. Primary care can determine which form a child has. Severe MPS physicians (PCPs) will have to monitor their patients I is associated with multi-system involvement, to identify the onset symptoms, a critical point for including progressive and rapid neurocognitive treatment initiation, to ensure the most optimal impairment. Onset is typically within the first or outcomes for these children. This requires a new second year of life. Mild (or attenuated) MPS I can occur anytime between level of vigilance and again reiterates the critical nature of the relationship three years of age and adulthood, and typically progresses more slowly than between the PCP and the family. This later age of onset puts families— the severe form. Children diagnosed with MPS I can be treated with enzyme and PCPs—in a “sit and wait” situation. In order to most effectively treat replacement therapy and/or a hematopoietic stem cell transplant. While X-ALD, treatment must be initiated at the onset of the disorder’s features, but not before. The risk is that families will become complacent with the Minnesota’s Newborn Screening Program to page 364

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3Minnesota’s Newborn Screening Program from page 35 there is no cure, these treatments have shown some promise in slowing or stabilizing the disease progression. The approximate incidence of MPS I is 1 in 100,000 births. Pompe disease Pompe disease is another lysosomal disorder caused by a deficiency in an enzyme leading to accumulation of glycogen, primarily in cardiac and skeletal muscle. Pompe disease has a wide variability in severity and age of onset. There are three types: 1) classic infantile-onset, 2) non-classic infantile-onset, and 3) late-onset. Classic infantile-onset Pompe is the most severe type and begins within a few months of birth. Infants develop profound weakness and cardiomyopathy, leading to death in the first year of life if untreated. Nonclassic infantile-onset Pompe typically appears by age one and is characterized by delayed motor skills and progressive muscle weakness. Late-onset Pompe is associated with progressive muscle weakness and respiratory failure, with highly variable onset and progression. Pompe can be treated with enzyme replacement therapy, with earlier treatment showing better outcomes. However, children with either form of infantile-onset usually have shortened lifespans. Pompe occurs in approximately 1 in 28,000 births.

Conclusion Based on screening data from other states, the Minnesota Newborn Screening Program expects to identify 5 to 15 newborns each year with one of these three disorders. Early identification of these conditions can lead to earlier intervention. In many cases with these conditions, if symptoms have

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progressed the damage is irreversible thereby supporting the idea that earlier identification is beneficial. Additionally, early identification also reduces the diagnostic odyssey that families might otherwise undergo. The landscape of newborn screening is indeed changing. The conditions that are now being added sometimes go beyond the newborn period, and even after diagnostic work-up these conditions can have an unpredictable age of onset. Genetic sequencing is being added more to testing algorithms and treatment efficacy is variable. However, the goal remains for newborn screening in Minnesota to continue to evolve in a rapidly-changing medical world. Providers have always played a key role in newborn screening awareness and follow-up, and that role has never been more important. Jessica Cavazos joined the Minnesota Department of Health’s Newborn Screening Program in 2014 as a Health Educator and is responsible for creating and developing much of the external image for the Newborn Screening Program. She leads efforts for the development of educational materials for parents and providers, crafting social media posts, and assisting in the Newborn Screening Program’s various initiatives.

Maggie Dreon, MS, CGC, joined the Minnesota Department of Health’s Newborn Screening Program in 2014 and is engaged with result notification, quality improvement initiatives, and project leadership to advance newborn screening in Minnesota. Sickle cell has become a passion of hers since she joined the MDH team and she leads efforts to address the disparities within this community.


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3Congenital infections with cytomegalovirus from page 27

patients, and may eventually prove to be valuable in prevention of injury in infants. Antiviral therapy is available for symptomatic congenitally this time, itâ&#x20AC;&#x2122;s unknown what the optimal screening test(s) might consist of. infected newborns, and improves developmental and audiological outcome. Mouth swabs to test for CMV in saliva, urine samples, and blood samples Until an effective vaccine is licensed, prevention is key. Education about are all potential sources to test for the presence of CMV viral DNA. Since CMV among women of childbearing age may help prevent transmission nearly all newborns have blood spots collected at birth in order to test for a during pregnancy. Newborn screening programs can help quantify the variety of genetic and metabolic diseases, there is magnitude of the disease burden and identify interest in expanding dried blood spot screening infants who may benefit from treatment and to congenital CMV testing. For accurate early intervention. Advocacy for CMV research diagnosis, congenital CMV must be identified in is critical and opportunities abound for clinical the first 21 days of life. Infants who screen positive research for this underappreciated but unsolved Congenital CMV is the most for CMV at birth should be monitored closely for challenge in pediatric health! common congenital viral development of hearing loss, which may occur infection in the U.S. any time in the first approximately three years. Mark R. Schleiss, MD, is a professor of pediatrics Neurological and ophthalmologic examinations at the University of Minnesota Medical School. He are often warranted. For some infants, antiviral joined the university in 2005 when he was named therapy (valganciclovir) is indicated. Ongoing to the prestigious American Legion and Auxiliary consultation with a pediatric infectious diseases Heart Research Foundation Endowed Chair in Pediatric Infectious Diseases. provider is recommended.

Summary Congenital CMV is the most common congenital viral infection in the U.S., and possibly globally. It is the most common infectious disease responsible for developmental disabilities in newborns, in particular hearing loss. Antiviral interventions are being studied in pregnant

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He is also the director of the Division of Pediatric Infectious Diseases. He has been engaged in the study of the biology of cytomegalovirus (CMV) since the 1980s and is a world-class expert in CMV infections in infants and children. He leads several NIH-funded projects dedicated to the study of CMV vaccines. More details about the laboratory and the CMV screening programs can be found at https://www.cmvscreening.org/about-us.


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3Preexposure prophylaxis for HIV prevention from page 21 programs include basic education about PrEP and health care navigation to help individuals without adequate health insurance connect to insurance resources. To date, 272 patients have been enrolled in MDH-sponsored PrEP programs. Anecdotally, one patient reported that use of PrEP prompted him to be more active in other self-care measures. PrEP provided a serodiscordant couple in which the HIV-negative female partner became pregnant with a sense of relief; both she and the infant remained HIV-negative. Other patients have noted that use of PrEP has provided them with a sense of empowerment. MDH provided a grant to the Minnesota AIDS Project (MAP) to help with creation of a PrEP navigation system focused on assisting patients determine their risk of HIV infection, assessing their insurance for coverage of PrEP, and helping schedule an appointment with a doctor who prescribes PrEP. Patients are encouraged to contact MAP’s PrEP Navigator at (612) 373-2411 to take advantage of these services. Similar to the rest of the U.S., PrEP therapy in Minnesota remains underutilized and under-prescribed. Increases in provider prescriptions for and patient utilization of PrEP in Minnesota is critical to achieving reductions in the number of new HIV infections in the state. Our goal is to increase clinicians’ awareness of PrEP, their ability to conduct comprehensive sexual histories to identify patients at elevated risk of acquiring HIV infection, and to prescribe PrEP along with offering other HIV prevention services to their patients. PrEP is a powerful HIV prevention tool, and should be combined with condoms and other prevention methods to provide greater protection to individuals at substantial risk of HIV infection.

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Malini B. DeSilva, MD, MPH, is board-certified in both internal medicine and pediatrics and works for the Minnesota Department of Health in the Infectious Disease Epidemiology, Prevention, and Control Division. She was previously an Epidemic Intelligence Service Officer working for the Oregon Health Authority.

Japhet M. Nyakundi, MSW, has worked at the Minnesota Department of Health as grant manager for nearly 20 years. His current roles and responsibilities focus on promoting PrEP services to both health care providers and consumers in Minnesota. He is currently pursuing a doctorate degree in public administration.

HELPFUL RESOURCES 14 U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV in the United States–2014: A clinical practice guideline. May 14, 2014. Available at: http://www.cdc.gov/ hiv/pdf/guidelines/PrEPguidelines2014.pdf)

24 U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV in the United States–2014: Clinical Providers’ Supplement. Available at: https://www.cdc.gov/hiv/pdf/ guidelines/PrEPProviderSupplement2014.pdf

34 Minnesota AIDS Project: http://www.mnaidsproject.org/


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3Genetic counselors from page 17 Disciplinary action by the Board

important members of health care teams. As such, genetic counselors need to be held accountable for the care they provide to patients, just as physicians, nurses, and other health care providers are held accountable. The Occupational Licensing of Genetic Counselors law is one important step toward protecting Minnesotans, while increasing access to the highest quality genetic counseling services available and using health care dollars responsibly.

Effective Jan. 1, 2018, practicing as a genetic counselor in Minnesota without a license will be considered a misdemeanor offense. In addition, genetic counselors will be subject to disciplinary action for failing to meet the minimum requirements set forth by the law. Examples of conduct that could result in disciplinary action include: competency matters of all kinds, failure to maintain appropriate continuing education, providing care while impaired or abusing chemicals, sexual misconduct, failure to maintain adequate medical records, improper management Methods, accuracy, and of medical records, disciplinary action against the reporting of genetic genetic counselor’s license in another state, and revealing a privileged communication from or testing varies greatly from relating to a patient. laboratory to laboratory.

The impact of licensure The purpose of this bill is not to alter the genetic counselors’ scope of practice, but to protect the public from harm and to hold genetic counselors legally accountable for the quality of care they provide. The only significant change to the duties and scope of practice for genetic counselors is the added ability to order laboratory genetic testing. This includes genetic testing, karyotype analysis, microarray, and exome or genome sequencing. Orderable tests are limited to the defined scope of practice for genetic counselors and would not include testing that falls under the practice of medicine, such as imaging or tests for disease monitoring. Most importantly, the licensing statute will not prevent other health care providers from performing genetic counseling or ordering genetic testing, as long as it is within their scope of practice. Many physicians appreciate that the liability for ordering the correct testing can now be placed on the genetic counselor. Interpreting genetic test results in the context of a patient’s personal and family history is rarely straightforward. The implications of a positive test result are numerous not only for the patient but also for his or her entire family. Even patients with negative genetic testing are often at increased risk of disease and need to have a solid understanding of this in order to manage their health care appropriately going forward. As panel genetic tests analyzing upward of 20 or 30 genes become the norm, increasing numbers of patients will be identified with “variants of uncertain significance”—DNA alterations that may or may not be disease causing. Genetic counseling targeted toward patients’ personal and family histories in conjunction with these test results is time consuming, multifaceted, and often emotionally charged. Having access to licensed genetic counselors who are dedicated not only to identifying the most efficient and appropriate genetic test but also to explaining complex results in an understandable and sensitive manner will be advantageous for physicians less familiar with rapidly changing genetic testing menus and insurance requirements for testing coverage.

Summary As medicine continues to incorporate genetic and genomic analysis toward truly personalized medicine, genetic counselors will be increasingly

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Ashley M. Deckman, MS, CGC, is vice chair of the Minnesota Genetic Counselors Association and has served as co-chair of the public policy committee for the Minnesota Genetic Counselors Association for the past three years, focusing her efforts on securing licensure for genetic counselors. She is a board-certified genetic counselor specializing in variant interpretation and reporting for Ambry Genetics.

Melissa R.F. Truelson, MS, CGC, has served as co-chair of the public policy committee for the Minnesota Genetic Counselors Association for the past three years, focusing her efforts on securing licensure for genetic counselors. She is a board-certified genetic counselor specializing in variant interpretation and reporting for Ambry Genetics.


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