Vo l u m e X X V I I I , N o . 7
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Psychiatric consultations for children Practical, convenient, and free resources for primary care By Todd Archbold, LSW, MBA, and Linda Vukelich
Chronic kidney disease A call to action for defeating a silent epidemic By Surabhi Thakar, MD; Marc Weber, MD; and Gail Torres, MS, RD, RN
hronic kidney disease (CKD) is a devastating diagnosis that is increasing in prevalence, and is associated with a high rate of morbidity and mortality. Approximately 26 million Americans are living with CKD, and this is primarily due to diabetes and hypertension, the two most common causes of the disease. CKD is the ninth-leading cause of death in the United States, and according to
the United States Renal Data System (USRDS) 2013 Annual Data Report, there is nearly a fivefold reduction in life expectancy for dialysis patients compared to the general population. Of the four most serious cancers, only lung cancer has a worse mortality rate than CKD. In the 2004 landmark study by Go et al., it also was demonChronic kidney disease to page 20
or decades, the shortage of child and adolescent psychiatrists (CAPs) and other specialized mental health practitioners has resulted in the challenge of meeting the overwhelming mental health needs in communities all over the country. These needs include managing chronic illnesses like depression, anxiety, and other mood disorders; to triaging and treating acute disorders, like suicidality, that rise to the level of a psychiatric emergency. The CAP shortage has shifted the burden of providing mental health care to primary care clinicians, many of whom feel ill-equipped to manage complex psychiatric illnesses during brief office appointments with little support. Psychiatric consultations for children to page 10
Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin. Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.
- ZERO ALCOHOL FOR NINE MONTHS.
October 2014 • Volume XXVIII, No. 7
Features Chronic kidney disease A call to action for defeating a silent epidemic
MINNESOTA HEALTH CARE ROUNDTABLE
By S urabhi Thakar, MD; Marc Weber, MD; and Gail Torres, MS, RD, RN
Psychiatric consultations for children Practical, convenient, and free resources for primary care
By T odd Archbold, LSW, MBA, and Linda Vukelich
Mary Chesney, PhD, RN, CPNP
Diabetes education By L aurel Reger, MBA, and Mary Beth Dahl, RN
Health care Policy 32
Minnesota Advanced Practice Registered Nurse Coalition
Coverage impacts of the ACA By Julie Sonier, MPA, and Elizabeth Lukanen, MPH
Influenza vaccinations By Edward Ehlinger, MD, MSPH
Systematic case review By Jim Trevis
Professional Update: Ob-GYN Pelvic organ prolapse By Vanessa Knoedler, MD
Background and focus: As tools and techniques for treating chronic illness have expanded, so have methods and mechanisms of provider reimbursement. More people now have access to care, and with this comes a heightened awareness of the impact of social determinants on health. The transition to rewarding physicians for maintaining a healthier population is slow but the promise is clear. Treating chronic illness remains an area of high-volume use and, improperly managed, quickly becomes an area of high cost. Objectives: We will evaluate changes that health care reform is bringing to chronic illness care. We will examine new community-based partnerships that are forming to address prevention, compliance, and better identification of risk. We will look at specific diseases and how workplace solutions, insurance companies, clinics, hospitals, long-term care facilities, and home care providers are working together to lower costs and improve outcomes.
Panelists include: • Kari Benson, MPA, Minnesota Board on Aging • Durand Burns, MD, Minneapolis Heart Institute Foundation • Crystal Twynham, MD, FACS, Bariatric Surgery • L. Read Sulik, MD, PrairieCare Please send me ____ tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, Inc., 2812 East 26th Street, Minneapolis, MN 55406. Tickets may also be ordered by phone 612.728.8600 or fax 612.728.8601. Publisher Mike Starnes | email@example.com Senior Editor Janet Cass | firstname.lastname@example.org Editor Lisa McGowan | email@example.com Art Director Alice Savitski | firstname.lastname@example.org Office Administrator Amanda Marlow | email@example.com
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Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@ mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.
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Personal Care Provider Sentenced For Fraud A jury has found Charles Kwadzo Sokpa-Anku, guilty on three counts of Medicaid fraud. Ramsey District County Court sentenced Sokpa-Anku to pay $20,791 in restitution, serve 30 days in the Ramsey County Workhouse, and forfeit any employment where he could have access to Medicaid funds. He also must pay $300 in fines and serve 5 years of probation after he is released from the county jail. Investigators completed an on-site review of Sokpa-Anku’s agency, Carelinks Home Care, Inc., after receiving a fraud report from a third-party witness. They found that Carelinks had billed for more than 24 hours of services in a day by a qualified professional in more than one instance. Because Carelinks had one qualified professional on staff during those times, it was impossible for the agency to legitimately bill for more than 24 hours in one day. The investigation also showed
that Carelinks regularly submitted bills for services that had no supporting documentation. DHS officials ultimately determined that Carelinks had overbilled the state a total of $23,729.67 for services it supposedly provided in 2009 and 2010. According to Jerry Kerber, DHS inspector general, this represents a heightened effort to crack down on cases of fraud against state programs that use public funding. DHS also has started investigating child care providers who commit fraud by falsely billing the state for childcare assistance funds. “When providers fail to perform the job they are paid to do, they not only fail the program participants, but they violate the public trust they promised to respect,” said Kerber. “The punishment imposed on Mr. Sokpa-Anku should put everyone on notice that DHS is serious about pursuing providers and recipients who commit fraud against our publicly funded programs.” According to state data, DHS’ financial fraud department con-
Minnesota Physician October 2014
ducted 356 investigations in 2013, 38 of which it referred for prosecution. Those numbers increased from 2012, when it conducted 254 investigations and referred 30 for prosecution.
Olmsted County Multimorbidity Studied A new study has determined which combinations of medical conditions are more prevalent by age, sex, and race/ethnicity in a geographically defined Midwestern population. Researchers from Mayo Clinic, Olmsted Medical Center, and Johns Hopkins University collaborated to measure multimorbidity—multiple diseases or medical conditions occurring simultaneously in a patient—using a list of 20 medical conditions developed by the U.S. Department of Health and Human Services. The team used records from the Rochester Epidemiology Project to access data for more than
138,000 individuals who lived in Olmsted County in 2010 and concluded that multimorbidity is reasonably common among the general population. They also discovered that it increases greatly with age and differs between men and women, and with race and ethnicity. Of the residents in the study, 39 percent had at least one condition, 23 percent had two or more conditions, and almost 5 percent had five or more conditions. Those under the age of 65 had a higher rate of multimorbidity than those 65 and older, and most condition combinations in those under 60 included mental disorders like depression and substance abuse. The rate of multimorbidity was higher in blacks than in whites, and higher in whites than in Asians. Women were more likely to have combinations of two or three conditions that included arthritis and osteoporosis, while men were more likely to have combinations that included cancer. Mayo officials say that the study is regional, but that the results are close to those from
the Medicare database as well as a recent, similar study from Scotland. They say the findings are important because of the aging population and the need to rethink the way we provide health care. “This is the first comprehensive assessment of combinations of medical conditions in our community,” said Walter Rocca, MD, Mayo Clinic neurologist and epidemiologist. “Clinical guidelines that focus on a single chronic disease should be reconsidered to include multiple risk factors and combinations of diseases. Attention to multiple morbidities may mean changing treatment approaches, the use of medications, or the organization of medical services.”
Cardiac Life-Saving Devices Implemented Statewide Automated chest compression devices will be placed in ambulance services and hospitals across Minnesota at no cost to providers, according to the Minnesota Department of Health. The initiative is being funded with a $4 million grant from the Leona M. and Harry B. Helmsley Charitable Trust. The project will include training on how to use the device, called Physio-Control LUCAS 2 Chest Compression System. It was made available in the metro area about five years ago, but a need in Greater Minnesota was identified, as 80 percent of ambulances and hospitals lack access to the device. “This is part of our effort to ensure quality health care for all Minnesotans,” said Minnesota Commissioner of Health Ed Ehlinger, MD. “Our goal is to improve cardiac arrest survival rates by installing these devices in every ambulance and hospital in the state.” The survival rate from cardiac arrest is 14 percent in Minnesota, while the national rate is less than 5 percent.
Midwest Prescription Painkiller Overuse Hospitalization Rises The rate of adult inpatient hospitalizations involving prescription opioid overuse in the U.S. increased more than 150 percent between 1993 and 2012, according to a new report from the Healthcare Cost and Utilization Project (HCUP). The report only included instances of prescription opioid overuse; those that involved illegal drug use were excluded. In 1993, the national rate of opioid-related hospital stays was 116.7 per 100,000. By 2012, that reached a rate of 295.6 per 100,000, with a total of 709,500 incidents of hospitalization from opioid overuse in the U.S. The largest rates of increase from 1993 to 2012 were found among people living in the Midwest, women, and people 85 years of age and older.
Pediatric Orthopaedic Experts for 91 Years
The Midwest had a total of 163,700 total hospitalizations from opioid overdoses in 2012. While that number is the second-lowest of the regional subgroups, the Midwest’s average increase rate is 9.1—a much higher rate than other regions. The Northeast region had a considerably higher rate than other regions in 1993, but its average increase rate has been much lower than other regions. There is no longer a blatant disparity between regions in 2012 rates. Rates for hospitalization from opioid overdoses were nearly equal for men and women in 2012, compared with 1993, when men had a staggeringly higher rate. Rates for age groups were far more similar in 2012 than they were in 1993, when the rate for people ages 25 to 44 was more than double that of any other age subgroup. From 1993 to 2012, that age group’s rate increased an average of 2.7 percent each year. Because the rate for adults aged 45 and older has increased an average of 9 percent each year, the age groups are almost equally likely to be hospitalized due to an opioid overdose. In 1993, Medicaid had the largest proportion of stays involving opioid overuse. However, Medicare had the largest annual
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increase over time, and by 2012, Medicaid and Medicare were both billed for about one-third of all opioid-related hospital stays.
Mayo Clinic Square Financing Arranged More than $43 million in financing has been secured for renovating Block E into Mayo Clinic Square. The 217,354-square-foot space has been under construction for
months and is on schedule to open in 2015, according to Don Kohlenberg, who represents Provident Real Estate Ventures, the asset manager of Block E owner Camelot LLC. “For a project in the throes of construction, activity is better than expected,” said Kohlenberg. “From the architecture standpoint, this building is creating visually a clean break, a reboot if you will, from Block E.” The newly renovated space will house the Minnesota Timberwolves, Minnesota Lynx, and Mayo Clinic Sports Medicine
Center on the third floor, putting into effect a partnership made earlier this year that makes Mayo Clinic the teams’ preferred medical provider. Mayo Clinic is expected to move into the newly renovated space this fall with a full staff of athletic trainers, physical therapists, rehabilitation physicians, and strength and conditioning specialists. The Minnesota Timberwolves will move in the first half of 2015. Space for restaurants, retailers, and office space is available for more potential tenants. “Typically when one company commits the others fall in line, because they realize this is a limited resource,” said Kohlenberg. Minneapolis-based RSP Architects is handling the building’s interior and exterior renovations. AECOM, a California-based firm, handles Mayo Clinic’s market analysis and economic-fiscal duties and is heading up the Mayo Clinic Sports Medicine Center part of the renovation. Mayo Clinic has said it expects to pay between $5 million and $7 million to develop its portion.
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Minnesota Physician October 2014
“As far as how the central business district is taking the news that Mayo Clinic has naming rights for the building, we’ve had nothing but positive comments,” Kohlenberg said. “Fast-forward a year from now, this block is going to have an entirely different vibe and feel and appeal. Hopefully, we see that it’ll be something that’ll be a positive reflection on Mayo Clinic.”
HealthPartners Honored for Employee Culture HealthPartners has been named the best workplace among large companies in the Minneapolis/ St. Paul Business Journal’s 16th annual Best Places to Work awards. This is the fourth time HealthPartners has been included on the list as a top performer and the first time it has been ranked No. 1. More than 200 organizations competed for a place on the list. The rankings are based on data from an employee survey conducted by a third-party organization.
CentraCare Announces New President/CEO CentraCare Health has named Kenneth D. Holmen, MD, as its president and CEO. Holmen will assume responsibilities Jan. 1, 2015, replacing Terry Pladson, MD, who will retire after 12 years in the position. Currently, Holmen serves as vice president of physician strategies and business development for HealthPartners, a position he has held since 2004. He also was chief medical officer and vice president for medical affairs for Regions Hospital during that time.
AMA Issues HCP Rule Change Fact Sheet The American Medical Association (AMA) has published a new fact sheet to help physicians comply with new federal regulations for prescribing hydrocodone. The new rule, which goes into effect on Oct. 6, reschedules hydrocodone combination products (HCPs) into Controlled Substance Schedule II. This change from the Drug Enforcement Administration (DEA) will affect millions of patients, according to the AMA. Officials hope the fact sheet will help prevent disruptions in patient care and medication access. “The AMA is strongly committed to combating prescription drug abuse and diversion while at the same time preserving patient access to medically necessary treatments for pain,” said Robert M. Wah, MD, president of the AMA. “This new fact sheet explains how new regulatory changes impact both physicians and pharmacists, which will help ensure patients continue having access to the care they need under the new federal rule.” According to the AMA, HCP prescriptions that were issued before Oct. 6 and are authorized for refills can be dispensed with current DEA rules until April 8, 2015. But, the agency warns that state laws and other limitations may cause some denials of refill requests beginning Oct. 6. The AMA is encouraging physicians to provide prescriptions to patients rather than depending on existing refills, in order to avoid disruptions in medication access.
Medicus Jan Buckner, MD, board-certified in hematology/oncology and a professor of oncology at the Mayo Clinic, has received a five-year, $47.5 million NCI grant to lead the NCI’s National Community Oncology Research Program research base for the Alliance for Clinical Trials in Oncology. The Alliance is part of a national clinical trials network sponsored by NCI and comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. Buckner completed medical school at the University of North Carolina, Chapel Hill; an internal medicine residency at Butterworth Hospital, Grand Rapids, Mich.; and a medical oncology fellowship at the Mayo Clinic, Rochester. He is deputy director for cancer practice at the Mayo Clinic Cancer Center in Rochester, where the Alliance research base will be located.
Dionne Hart, MD
Dionne Hart, MD, board-certified in psychiatry, has been named Psychiatrist of the Year for 2014 by the Minnesota Psychiatric Society. She received the award for her efforts in psychiatric education and ending health care disparities, and for excellence in patient care. She graduated from Rush Medical College, Chicago, and completed a residency in adult psychiatry at the Mayo Clinic. Hart provides advocacy services through Care From The Hart, Rochester.
Nancy A. Henry-Socha, MD, MEd, has joined St. Croix Orthopaedics. She completed medical school and a residency in physical medicine and rehabilitation at the University of Minnesota, and a fellowship in pain medicine at the University of Washington, Seattle. She is board-certified in physical medicine and rehabilitation and board-eligible in pain medicine.
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Ameer Khowaja, MD, board-certified in internal medicine, has joined the Division of Diabetes and Endocrinology at Hennepin County Medical Center (HCMC), Minneapolis. He graduated from Aga Khan University in Karachi, Pakistan; completed an internal medicine residency at HCMC; and served a fellowship in diabetes, endocrinology, and metabolism at the University Ameer Khowaja, of Minnesota. Rosemary Quirk, MD, DTMH, MD board-certified in internal medicine, has been named director of HCMC’s internal medicine residency program. She completed medical school at the University of Wisconsin–Madison and an internal medicine residency at HCMC, and earned a diploma in tropical medicine from the University of Liverpool, England. Rachel Sandler, Rosemary Quirk, MD, MPH, board-certified in MD, DTMH internal medicine, has joined Rachel Sandler, HCMC to provide primary care in several clinics. MD, MPH She earned a medical degree from the University of Iowa Carver College of Medicine, Iowa City, and served an internal medicine residency at Tulane University, New Orleans. Terri Peterson, MD, board-certified in physical medicine and rehabilitation, has joined Courage Kenny Rehabilitation Institute, Minneapolis. Peterson earned a medical degree from the University of Minnesota and served a residency in physical medicine and rehabilitation at the Mayo Clinic, Rochester. Terri Peterson, MD October 2014 Minnesota Physician
Expanding the role of advanced practice registered nurses Tell us about the work you do at the University of Minnesota. I serve as director of the Doctor of Nursing Practice (DNP) program at the University of Minnesota School of Nursing. My responsibilities include program oversight and quality control to ensure that we meet all national standards and accreditation requirements to ensure student success. I am also a clinical associate professor, certified pediatric nurse practitioner, and member of the faculty.
Mary Chesney, PhD, RN, CPNP Cofounder and recent president of the Minnesota Advanced Practice Registered Nurse Coalition (APRN) Dr. Chesney is a clinical associate professor and director of the Doctor of Nursing Practice (DNP) program at the University of Minnesota School of Nursing. She is a certified pediatric nurse practitioner and current president of the National Association of Pediatric Nurse Practitioners (NAPNAP). She chaired NAPNAP’s national Health Policy Committee from 2010–2013. Dr. Chesney is a cofounder of the MN APRN Coalition and served as its chair (2010–2011) and as president from (2011–2014).
Please discuss the work of the Minnesota Advanced Practice Registered Nurse Coalition. The Minnesota Advanced Practice Registered Nurse Coalition (MN APRN Coalition) is a professional organization representing APRNs, including clinical nurse specialists (CNSs), nurse anesthetists (CRNAs), nurse midwives (CNMs), and nurse practitioners (CNPs) from all of the APRN professional associations in Minnesota. The coalition’s mission is to improve patient access and choice to safe, high-quality, cost-effective health care by removing statutory, regulatory, and institutional barriers that prevent APRNs from practicing to the fullest extent of their education and training. Educating consumers, health care administrators, and provider groups about all four roles of APRN practice, educational standards, clinical preparation, and expertise is also an important part of our work. The coalition’s first priority was to advance legislation to remove barriers from the Minnesota Nurse Practice Act and adopt the National APRN Consensus Model. This model ensures standardization in APRN requirements for state licensure, national certification, education, and accreditation. The bill was introduced during the 2013 legislative session and successfully passed into law during the 2014 session. What does the new APRN legislation accomplish? The APRN legislation requires that all four APRN roles obtain a second licensure in addition to the primary RN licensure, graduate from a nationally accredited graduate nursing education program, pass a national certification examination, and maintain active certification status in his/her specific APRN role and population focus. The new law grants APRNs full practice authority to practice and prescribe. Specifically, the law removes two barriers: (1) the requirement that the APRN practice in a setting that allows for collaborative management of patients with a specific physician or group of physicians, and (2) the requirement to maintain a written prescriptive agreement with a physician in order to prescribe. The legislation requires that new CNPs and CNSs complete a transi-
Minnesota Physician October 2014
tion-to-practice period that includes 2,080 hours of practice under a collaborative agreement with either a physician or an experienced CNP or CNS within an integrated practice setting that includes physicians and APRNs. Prior to this law, the ability of Minnesota’s APRNs to practice or prescribe could be prevented by inaccessibility to a physician willing to enter into a collaborative arrangement (e.g., in rural or underserved areas), or immediately stopped by a physician leaving the collaborative arrangement. Some CNSs and CNPs paid as much as 10 percent of their annual salaries to employ physicians to serve as their collaborating and prescriptive agreement physician. A number of physicians were concerned about liability issues and were reluctant to enter into these agreements. Unfortunately, the people caught in the middle in these cases were the patients who experienced gaps in their medication management and care. Why is the bill important? Our coalition viewed this legislation as an important means to increase access to care and widen the choice of health care providers for Minnesota’s citizens. As of June 2014, Minnesota has 118 federally designated primary care health provider shortage areas and 59 mental health provider shortage areas. Many more Minnesotans now have access to health insurance coverage through MNsure and Medicaid expansion. Going forward, we need everyone to practice to the top of his/her scope, and license and leverage their unique strengths in order to efficiently and cost-effectively deliver the quality health care Minnesotans deserve. From my perspective as an APRN educator, this bill is enormously important for keeping our best and brightest APRN graduates in Minnesota. Prior to passing this legislation, Minnesota was ranked in the bottom third of states for APRN practice environments. This bill improves the APRN practice environment in Minnesota and removes barriers that previously limited employment opportunities, reduced employment security, and prevented full utilization of APRNs. hat do you want doctors to know W about the bill? I think one of the big misunderstandings about this bill is that some physicians believed APRNs were seeking autonomy so that we could hang up our shingles for competitive solo practice of “medicine” and move away from collaborative practice with physicians or other health care providers. This simply isn’t the case. In most cases, APRNs will continue to work within integrated practices with physicians. I want physicians to know that APRNs have enormous
respect for the medical education and training that physicians complete. We recognize our physician colleagues as possessing unique and highly developed expertise in differential diagnosis and management of patients with complex, fragile, or unstable conditions. This bill doesn’t in any way diminish our desire to collaborate, consult with, or refer our patients to our physician colleagues. The legislation allows APRNs to practice in underserved or rural areas that may lack physician access. However, like physicians, APRNs also place great value on team-based care and believe that, when possible, patient-centered, team-based care is optimal for patients with chronic or complex conditions. Our opinion differs from some medical associations in that we do not believe teams should automatically be led by a physician. At the University of Minnesota Academic Health Center, we are moving toward a nonhierarchical, collegial model of interprofessional teams led by the provider whose knowledge and unique expertise best match the priority needs of the patient. Our patients will be best served when we all move beyond turf and hierarchy to focus on developing high performance, collegial, patient-centered interprofessional teams. How does the bill affect certified registered nurse anesthetists? Of the 1,760 CRNAs in Minnesota, approximately 20 CRNAs have completed advanced
coursework and clinical hours to perform a limited repertoire of interventional pain management procedures. These procedures include certain types of regional anesthetic blocks or lumbar epidural steroid injections to relieve chronic or acute pain that is not related to surgical, obstetrical, or procedural anesthesia care. During the legislative session, these limited interventional pain management procedures performed by CRNAs became a controversial focal point for opposition to the bill. The law includes compromise language that allows autonomous practice and prescribing by CRNAs engaging in routine anesthesia practice. However, the small number of Minnesota’s CRNAs who are prescribing for or managing acute and chronic pain that is not related to perioperative, procedural, or obstetrical care must do so under a collaborative agreement with a physician. W hy is the new legislation especially important for rural and underserved communities? Prior to passing this legislation, Minnesota APRNs’ practices were tied to physician practices under all circumstances, limiting care options in rural or remote areas of Minnesota. The new law opens new possibilities. For example, the new law would allow a group of CNPs to form a primary care practice in a rural area that doesn’t have physician access. The CNPs will be able to serve about 60 to 80
percent of the primary care needs, dramatically reducing the need for citizens to drive longer distances to see a physician. Prior to this legislation, nurse midwives were not able to set up practice unless they could find obgyn or family practice physicians willing to serve as collaborating physicians. The new law paves the way for increased consumer access to nurse-midwife maternity care. Two-thirds of Minnesota’s counties rely on CRNAs as their sole source of anesthesia care. Prior to this legislation, CRNAs in counties without anesthesiologists worked under collaborative arrangements with primary care physicians or surgeons. In reality, most of these physicians and surgeons have limited education or experience with anesthetic agents or induction of, or recovery from, anesthesia. It is illogical to think that patient safety was enhanced by requiring a physician-CRNA collaborative agreement in this type of scenario. hat steps need to be taken to make W this law operational? The Minnesota Board of Nursing is charged with the responsibility for operationalizing the new law. The process for issuing a second APRN license to the more than 6,800 APRNs in Minnesota will need to be completed by Jan. 1, 2015. As this interview goes to press, the details of the requirements and processes for licensure and documentation of the CNP/ CNS transition to practice hours are still in development.
University of Minnesota - Continuing Professional Development (formerly the Office of CME) Education is essential to achieving and sustaining quality healthcare. Through partnership with healthcare leaders, our educational activities help advance quality improvement and patient care initiatives.
2014 -15 CPD Activities (All courses in the Twin Cities unless noted)
LIVE COURSES Got Your Shots Immunization Conference (St. Cloud, MN) October 27-28, 2014 Internal Medicine Review November 12-14, 2014 Emerging Infections November 21, 2014
Bakken Symposium: Heart & Lung Transplant December 2, 2014 Geriatric Orthopaedic Fracture Conference December 5-6, 2014 Maintenance of Certification in Anesthesiology (MOCA) Training January 10 & April 18, 2015
Pediatric Dermatology February 20, 2015 Integrated Behavioral Healthcare Conference: Building Partnerships & Teams for Better Care March 13, 2015 Cardiac Arrhythmias: An Interactive Update for Internal Medicine, Family Medicine & Pediatrics April 3, 2015
www.cmecourses.umn.edu ONLINE COURSES (CME credit available) www.cme.umn.edu/online • Adolescent Vaccination - AVAILABLE NOW! • Nitrous Oxide for Pediatric Procedural Sedation • Global Health - To include Travel Medicine & Refugee Health - Family Medicine Specialty - Pediatric Specialty For a full activity listing, go to www.cmecourses.umn.edu
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October 2014 Minnesota Physician
Psychiatric consultations for children from cover
The truth is that nearly one out of five children will suffer from symptoms of a diagnosable mental illness, and nearly 70 percent of those symptoms will begin before the age of 14. A vast majority of these illnesses are highly treatable with appropriate evaluation and intervention. However, many complex situations exist that involve comorbid diagnosis, neurodevelopmental complexities, and family or situational dysfunction. Nationwide, hospital emergency rooms are becoming more crowded with patients in psychiatric emergencies. Many of these emergencies could have been prevented if early access to psychiatric resources had been available to patient and clinician. Alarmingly, more than 15 percent of patient visits
to hospital emergency departments are a result of a psychiatric crisis and this number has risen steadily over the last decade. Numerous research studies have shown that the lack of access to care or early identification can result in fur-
The Minnesota Collaborative Psychiatric Consultation Service In 2010, the Minnesota Legislature authorized the Department of Human Services (DHS) to form the Minnesota Collaborative Psychiatric Consultation
One out of five children will suffer from symptoms of a diagnosable mental illness. ther social developmental problems and significant worsening of symptoms, not to mention high financial costs for families, hospitals, and taxpayers. Studies also have found that only one out of every four youth identified with a mental illness actually receives treatment.
Minnesota Physician October 2014
Service. This collaborative gave primary care clinicians access to child and adolescent psychiatric consultations. The initial group included Essentia Health, Mayo Clinic, PrairieCare, and Sanford Health, with Allina joining the second year. The collaborative was tasked with providing: 1. Voluntary and mandatory consultations to primary care
physicians by board-certified child and adolescent psychiatrists 2. Clinical mental health triage by a licensed clinical social worker 3. Training to the primary care community The initial contract period was for two years lasting from August 2012 to May 2014. During this time the Minnesota Collaborative Psychiatric Consultation Service was the provider of services, fulfilling the stateâ€™s legislative responsibilities. The service received nearly 1,800 phone calls from primary care clinicians and others seeking advice and consultation for psychiatric patients. The service provided training in pediatric psychopharmacology to nearly 80 primary care providers statewide to support assessment and management of mental illness Psychiatric consultations for children to page 18
Covered for more than 80% of commercially insured patients without prior authorization1
The recommended starting dose of INVOKANA® (canagliflozin) is 100 mg once daily.2 INVOKANA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. INVOKANA® is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS >> History of a serious hypersensitivity reaction to INVOKANA® >> Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis WARNINGS and PRECAUTIONS >> Hypotension: INVOKANA® causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA®, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system, or patients with low systolic blood pressure. Before initiating in patients with ≥1 of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating Please see additional Important Safety Information and brief summary of full Prescribing Information on the following pages.
October 2014 Minnesota Physician
DIFFERENCE INVOKANA® 300 mg vs Januvia® 100 mg
at 52 weeks, each in combination with metformin + a sulfonylurea2
Greater reductions in A1C2 LSLSMean inin A1C From Baseline (%) MeanChange Change A1C From Baseline (%) Mean baseline:
–1.03 Januvia® (sitagliptin) 100 mg + metformin and a sulfonylurea (n=378)
INVOKANA® 300 mg + metformin and a sulfonylurea (n=377)
*95% CI: –0.50, –0.25; P<0.05. LS=least squares.
INVOKANA® (canagliflozin) starting dose: 100 mg once daily. In patients tolerating the starting dose who have an eGFR ≥60 mL/min/1.73 m2 and require additional glycemic control, the dose can be increased to 300 mg once daily.2 Indicated trademarks are registered trademarks of their respective owners.
IMPORTANT SAFETY INFORMATION (cont’d) >> Impairment in Renal Function: INVOKANA® increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiation. More frequent renal function monitoring is recommended in patients with an eGFR <60 mL/min/1.73 m2 >> Hyperkalemia: INVOKANA® can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia. Monitor serum potassium levels periodically in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions
Minnesota Physician October 2014
9/19/14 5:32 PM
INVOKANA® 300 mg demonstrated greater reductions in A1C vs Januvia® 100 mg... ...as well as greater reductions in body weight† and systolic blood pressure 2†
Greater reductions in body weight2*† Difference from Januvia® 100 mg: –2.8%; P<0.001
Greater reductions in systolic blood pressure3*† Difference from Januvia® 100 mg: –5.9 mm Hg; P<0.001 INVOKANA® is not indicated for weight loss or as antihypertensive treatment. *LS mean.
†Prespeciﬁed secondary endpoint.
Incidence of hypoglycemia2 INVOKANA® 300 mg: 43.2%; Januvia® 100 mg: 40.7% The incidence of hypoglycemia increases when used in combination with insulin or an insulin secretagogue.
Adverse reactions (ARs)3 Incidences of ARs were similar between groups except for: Male/female genital mycotic infection, INVOKANA® 300 mg: 9.2%/15.3%; Januvia® 100 mg: 0.5%/4.3% Increased urine frequency/volume, INVOKANA® 300 mg: 1.6%/0.8%; Januvia® 100 mg: 1.3%/0%
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A randomized, double-blind, active-controlled, 52-week study of patients with type 2 diabetes inadequately controlled on maximum doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated) and near-maximally or maximally effective doses of a sulfonylurea.3 >> Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: INVOKANA® can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA® >> Genital Mycotic Infections: INVOKANA® increases risk of genital mycotic infections. Patients with history of these infections and uncircumcised males were more likely to develop these infections. Monitor and treat appropriately >> Hypersensitivity Reactions: Hypersensitivity reactions (eg, generalized urticaria), some serious, were reported with INVOKANA®; these reactions generally occurred within hours to days after initiation. If reactions occur, discontinue INVOKANA®, treat per standard of care, and monitor until signs and symptoms resolve Please see additional Important Safety Information and brief summary of full Prescribing Information on the following pages.
October 2014 Minnesota Physician
IMPORTANT SAFETY INFORMATION (cont’d)
>> Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA® or any other antidiabetic drug DRUG INTERACTIONS >> UGT Enzyme Inducers: Rifampin: Coadministration of INVOKANA® with rifampin decreased INVOKANA® area under the curve (AUC) by 51% and therefore may decrease efficacy. If an inducer of UGT enzymes must be coadministered with INVOKANA®, consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA® 100 mg once daily, have an eGFR ≥60 mL/min/1.73 m2, and require additional glycemic control. Consider other antihyperglycemic therapy in patients with an eGFR <60 mL/min/1.73 m2 who require additional glycemic control >> Digoxin: There was an increase in the AUC and mean peak drug concentration of digoxin (20% and 36%, respectively) when coadministered with INVOKANA® 300 mg. Monitor appropriately >> Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose test results. Use alternative methods to monitor glycemic control >> Interference With 1,5-Anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control USE IN SPECIFIC POPULATIONS >> Pregnancy Category C: There are no adequate and well-controlled studies of INVOKANA® in pregnant women. During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters >> Nursing Mothers: It is not known if INVOKANA® is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, discontinue INVOKANA®
with the 300-mg dose, compared to younger patients; more prominent increase in the incidence was seen in patients who were ≥75 years. Smaller reductions in HbA1c relative to placebo were seen in patients ≥65 years (‒0.61% with INVOKANA® 100 mg and ‒0.74% with INVOKANA® 300 mg) compared to younger patients (‒0.72% with INVOKANA® 100 mg and ‒0.87% with INVOKANA® 300 mg) >> Renal Impairment: Efficacy and safety were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2). These patients had less overall glycemic efficacy and a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR ≥60 mL/min/1.73 m2); patients treated with 300 mg were more likely to experience increases in potassium. INVOKANA® is not recommended in patients with severe renal impairment (eGFR <30 mL/ min/1.73 m2), with end-stage renal disease, or receiving dialysis >> Hepatic Impairment: INVOKANA® has not been studied in patients with severe hepatic impairment and is not recommended in this population OVERDOSAGE >> In the event of an overdose, contact the Poison Control Center and employ the usual supportive measures, eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as needed ADVERSE REACTIONS >> The most common adverse reactions associated with INVOKANA® (5% or greater incidence) were female genital mycotic infections, urinary tract infections, and increased urination Please see brief summary of full Prescribing Information on the following pages. References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014. 3. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial [published correction appears in Diabetes Care. 2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515.
>> Pediatric Use: Safety and effectiveness in patients <18 years of age have not been established >> Geriatric Use: 2034 patients ≥65 years and 345 patients ≥75 years were exposed to INVOKANA® in 9 clinical studies. Patients ≥65 years had a higher incidence of adverse reactions related to reduced intravascular volume (eg, hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly
Janssen Pharmaceuticals, Inc.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. © Janssen Pharmaceuticals, Inc. 2014
Minnesota Physician October 2014
>> Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C can occur with INVOKANA® (canagliflozin). Monitor LDL-C and treat per standard of care after initiating
(canagliflozin) tablets, for oral use Brief Summary of Prescribing Information. IndIcatIons and Usage INVOKANA™ (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) in full Prescribing Information]. Limitation of Use: INVOKANA is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. contraIndIcatIons • History of a serious hypersensitivity reaction to INVOKANA [see Warnings and Precautions]. • Severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage renal disease or patients on dialysis [see Warnings and Precautions and Use in Specific Populations]. WarnIngs and PrecaUtIons Hypotension: INVOKANA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA [see Adverse Reactions] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensinaldosterone system (e.g., angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), or patients with low systolic blood pressure. Before initiating INVOKANA in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy. Impairment in renal Function: INVOKANA increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating INVOKANA [see Adverse Reactions]. More frequent renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2. Hyperkalemia: INVOKANA can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion, such as potassium-sparing diuretics, or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia [see Adverse Reactions]. Monitor serum potassium levels periodically after initiating INVOKANA in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions. Hypoglycemia with concomitant Use with Insulin and Insulin secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INVOKANA can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue [see Adverse Reactions]. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA. genital Mycotic Infections: INVOKANA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections [see Adverse Reactions]. Monitor and treat appropriately. Hypersensitivity reactions: Hypersensitivity reactions (e.g., generalized urticaria), some serious, were reported with INVOKANA treatment; these reactions generally occurred within hours to days after initiating INVOKANA. If hypersensitivity reactions occur, discontinue use of INVOKANA; treat per standard of care and monitor until signs and symptoms resolve [see Contraindications and Adverse Reactions]. Increases in Low-density Lipoprotein (LdL-c): Dose-related increases in LDL-C occur with INVOKANA [see Adverse Reactions]. Monitor LDL-C and treat per standard of care after initiating INVOKANA. Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA or any other antidiabetic drug. adverse reactIons The following important adverse reactions are described below and elsewhere in the labeling: • Hypotension [see Warnings and Precautions] • Impairment in Renal Function [see Warnings and Precautions] • Hyperkalemia [see Warnings and Precautions] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions] • Genital Mycotic Infections [see Warnings and Precautions] • Hypersensitivity Reactions [see Warnings and Precautions] • Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions] clinical studies experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Pool of Placebo-Controlled Trials: The data in Table 1 is derived from four 26-week placebo-controlled trials. In one trial INVOKANA was used as monotherapy and in three trials INVOKANA was used as add-on therapy [see Clinical Studies (14) in full Prescribing Information]. These data reflect exposure of 1667 patients to INVOKANA and a mean duration of exposure to INVOKANA of 24 weeks. Patients received INVOKANA 100 mg (N=833),
INVOKANA™ (canagliflozin) tablets INVOKANA 300 mg (N=834) or placebo (N=646) once daily. The mean age of the population was 56 years and 2% were older than 75 years of age. Fifty percent (50%) of the population was male and 72% were Caucasian, 12% were Asian, and 5% were Black or African American. At baseline the population had diabetes for an average of 7.3 years, had a mean HbA1C of 8.0% and 20% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 88 mL/min/1.73 m2). Table 1 shows common adverse reactions associated with the use of INVOKANA. These adverse reactions were not present at baseline, occurred more commonly on INVOKANA than on placebo, and occurred in at least 2% of patients treated with either INVOKANA 100 mg or INVOKANA 300 mg. table 1: adverse reactions From Pool of Four 26−Week Placebo-controlled studies reported in ≥ 2% of InvoKana-treated Patients* InvoKana InvoKana Placebo 100 mg 300 mg Adverse Reaction n=646 n=833 n=834 Female genital mycotic 3.2% 10.4% 11.4% infections† 4.0% 5.9% 4.3% Urinary tract infections‡ Increased urination§ 0.8% 5.3% 4.6% 0.6% 4.2% 3.7% Male genital mycotic ¶ infections Vulvovaginal pruritus 0.0% 1.6% 3.0% Thirst# 0.2% 2.8% 2.3% Constipation 0.9% 1.8% 2.3% Nausea 1.5% 2.2% 2.3% * The four placebo-controlled trials included one monotherapy trial and three add-on combination trials with metformin, metformin and sulfonylurea, or metformin and pioglitazone. † Female genital mycotic infections include the following adverse reactions: Vulvovaginal candidiasis, Vulvovaginal mycotic infection, Vulvovaginitis, Vaginal infection, Vulvitis, and Genital infection fungal. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=312), INVOKANA 100 mg (N=425), and INVOKANA 300 mg (N=430). ‡ Urinary tract infections include the following adverse reactions: Urinary tract infection, Cystitis, Kidney infection, and Urosepsis. § Increased urination includes the following adverse reactions: Polyuria, Pollakiuria, Urine output increased, Micturition urgency, and Nocturia. ¶ Male genital mycotic infections include the following adverse reactions: Balanitis or Balanoposthitis, Balanitis candida, and Genital infection fungal. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=334), INVOKANA 100 mg (N=408), and INVOKANA 300 mg (N=404). # Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. Abdominal pain was also more commonly reported in patients taking INVOKANA 100 mg (1.8%), 300 mg (1.7%) than in patients taking placebo (0.8%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients participating in placebo- and active-controlled trials. The data combined eight clinical trials [see Clinical Studies (14) in full Prescribing Information] and reflect exposure of 6177 patients to INVOKANA. The mean duration of exposure to INVOKANA was 38 weeks with 1832 individuals exposed to INVOKANA for greater than 50 weeks. Patients received INVOKANA 100 mg (N=3092), INVOKANA 300 mg (N=3085) or comparator (N=3262) once daily. The mean age of the population was 60 years and 5% were older than 75 years of age. Fifty-eight percent (58%) of the population was male and 73% were Caucasian, 16% were Asian, and 4% were Black or African American. At baseline, the population had diabetes for an average of 11 years, had a mean HbA1C of 8.0% and 33% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 81 mL/min/1.73 m2). The types and frequency of common adverse reactions observed in the pool of eight clinical trials were consistent with those listed in Table 1. In this pool, INVOKANA was also associated with the adverse reactions of fatigue (1.7% with comparator, 2.2% with INVOKANA 100 mg, and 2.0% with INVOKANA 300 mg) and loss of strength or energy (i.e., asthenia) (0.6% with comparator, 0.7% with INVOKANA 100 mg, and 1.1% with INVOKANA 300 mg). In the pool of eight clinical trials, the incidence rate of pancreatitis (acute or chronic) was 0.9, 2.7, and 0.9 per 1000 patient-years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In the pool of eight clinical trials with a longer mean duration of exposure to INVOKANA (68 weeks), the incidence rate of bone fracture was 14.2, 18.7, and 17.6 per 1000 patient years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Upper extremity fractures occurred more commonly on INVOKANA than comparator.
October 2014 Minnesota Physician
INVOKANA™ (canagliflozin) tablets In the pool of eight clinical trials, hypersensitivity-related adverse reactions (including erythema, rash, pruritus, urticaria, and angioedema) occurred in 3.0%, 3.8%, and 4.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Five patients experienced serious adverse reactions of hypersensitivity with INVOKANA, which included 4 patients with urticaria and 1 patient with a diffuse rash and urticaria occurring within hours of exposure to INVOKANA. Among these patients, 2 patients discontinued INVOKANA. One patient with urticaria had recurrence when INVOKANA was re-initiated. Photosensitivity-related adverse reactions (including photosensitivity reaction, polymorphic light eruption, and sunburn) occurred in 0.1%, 0.2%, and 0.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Other adverse reactions occurring more frequently on INVOKANA than on comparator were: Volume Depletion-Related Adverse Reactions: INVOKANA results in an osmotic diuresis, which may lead to reductions in intravascular volume. In clinical studies, treatment with INVOKANA was associated with a dose-dependent increase in the incidence of volume depletion-related adverse reactions (e.g., hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration). An increased incidence was observed in patients on the 300 mg dose. The three factors associated with the largest increase in volume depletion-related adverse reactions were the use of loop diuretics, moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2), and age 75 years and older (Table 2) [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Use in Specific Populations]. table 2: Proportion of Patients With at Least one volume depletion-related adverse reaction (Pooled results from 8 clinical trials) comparator InvoKana InvoKana group* 100 mg 300 mg Baseline characteristic % % % Overall population 1.5% 2.3% 3.4% 75 years of age and older† 2.6% 4.9% 8.7% eGFR less than 2.5% 4.7% 8.1% 60 mL/min/1.73 m2† Use of loop diuretic† 4.7% 3.2% 8.8% * Includes placebo and active-comparator groups † Patients could have more than 1 of the listed risk factors Impairment in Renal Function: INVOKANA is associated with a dosedependent increase in serum creatinine and a concomitant fall in estimated GFR (Table 3). Patients with moderate renal impairment at baseline had larger mean changes. table 3: changes in serum creatinine and egFr associated with InvoKana in the Pool of Four Placebo-controlled trials and Moderate renal Impairment trial
Pool of Four PlaceboControlled Trials
Baseline Week 6 Change End of Treatment Change*
Baseline Moderate Week 3 Renal Impairment Change Trial End of Treatment Change*
Placebo n=646 0.84
eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL)
87.0 0.01 -1.6 0.01
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2)
InvoKana InvoKana 100 mg 300 mg n=833 n=834 0.82 0.82 88.3 0.03 -3.8 0.02
88.8 0.05 -5.0 0.03
-2.3 -3.4 InvoKana InvoKana Placebo 100 mg 300 mg n=90 n=90 n=89 1.61 1.62 1.63 40.1 39.7 38.5 0.03 0.18 0.28 -0.7 -4.6 -6.2 0.07 0.16 0.18 -1.5
* Week 26 in mITT LOCF population In the pool of four placebo-controlled trials where patients had normal or mildly impaired baseline renal function, the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR below 80 mL/min/1.73 m2 and 30% lower than baseline, was 2.1% with placebo, 2.0% with INVOKANA 100 mg, and 4.1% with INVOKANA 300 mg. At the end of treatment, 0.5% with placebo, 0.7% with INVOKANA 100 mg, and 1.4% with INVOKANA 300 mg had a significant renal function decline. In a trial carried out in patients with moderate renal impairment with a baseline eGFR of 30 to less than 50 mL/min/1.73 m2 (mean baseline eGFR 39 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information], the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR 30% lower than baseline, was 6.9% with placebo, 18% with INVOKANA 100 mg, and 22.5% with
Minnesota Physician October 2014
INVOKANA™ (canagliflozin) tablets INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with INVOKANA 100 mg, and 3.4% with INVOKANA 300 mg had a significant renal function decline. In a pooled population of patients with moderate renal impairment (N=1085) with baseline eGFR of 30 to less than 60 mL/min/1.73 m2 (mean baseline eGFR 48 mL/min/1.73 m2), the overall incidence of these events was lower than in the dedicated trial but a dose-dependent increase in incident episodes of significant renal function decline compared to placebo was still observed. Use of INVOKANA was associated with an increased incidence of renalrelated adverse reactions (e.g., increased blood creatinine, decreased glomerular filtration rate, renal impairment, and acute renal failure), particularly in patients with moderate renal impairment. In the pooled analysis of patients with moderate renal impairment, the incidence of renal-related adverse reactions was 3.7% with placebo, 8.9% with INVOKANA 100 mg, and 9.3% with INVOKANA 300 mg. Discontinuations due to renal-related adverse events occurred in 1.0% with placebo, 1.2% with INVOKANA 100 mg, and 1.6% with INVOKANA 300 mg [see Warnings and Precautions]. Genital Mycotic Infections: In the pool of four placebo-controlled clinical trials, female genital mycotic infections (e.g., vulvovaginal mycotic infection, vulvovaginal candidiasis, and vulvovaginitis) occurred in 3.2%, 10.4%, and 11.4% of females treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections on INVOKANA. Female patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrence and require treatment with oral or topical antifungal agents and anti-microbial agents [see Warnings and Precautions]. In the pool of four placebo-controlled clinical trials, male genital mycotic infections (e.g., candidal balanitis, balanoposthitis) occurred in 0.6%, 4.2%, and 3.7% of males treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Male genital mycotic infections occurred more commonly in uncircumcised males and in males with a prior history of balanitis or balanoposthitis. Male patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrent infections (22% on INVOKANA versus none on placebo), and require treatment with oral or topical antifungal agents and anti-microbial agents than patients on comparators. In the pooled analysis of 8 controlled trials, phimosis was reported in 0.3% of uncircumcised male patients treated with INVOKANA and 0.2% required circumcision to treat the phimosis [see Warnings and Precautions]. Hypoglycemia: In all clinical trials, hypoglycemia was defined as any event regardless of symptoms, where biochemical hypoglycemia was documented (any glucose value below or equal to 70 mg/dL). Severe hypoglycemia was defined as an event consistent with hypoglycemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained). In individual clinical trials [see Clinical Studies (14) in full Prescribing Information], episodes of hypoglycemia occurred at a higher rate when INVOKANA was co-administered with insulin or sulfonylureas (Table 4) [see Warnings and Precautions]. table 4: Incidence of Hypoglycemia* in controlled clinical studies Monotherapy (26 weeks) Overall [N (%)] In combination with Metformin (26 weeks) Overall [N (%)] Severe [N (%)]† In combination with Metformin (52 weeks) Overall [N (%)] Severe [N (%)]† In combination with sulfonylurea (18 weeks) Overall [N (%)] In combination with Metformin + sulfonylurea (26 weeks) Overall [N (%)] Severe [N (%)]† In combination with Metformin + sulfonylurea (52 weeks) Overall [N (%)] Severe [N (%)]†
Placebo (n=192) 5 (2.6) Placebo + Metformin (n=183)
InvoKana 100 mg (n=195) 7 (3.6) InvoKana 100 mg + Metformin (n=368)
InvoKana 300 mg (n=197) 6 (3.0) InvoKana 300 mg + Metformin (n=367)
3 (1.6) 0 (0) glimepiride + Metformin (n=482) 165 (34.2) 15 (3.1) Placebo + sulfonylurea (n=69) 4 (5.8) Placebo + Metformin + sulfonylurea (n=156) 24 (15.4) 1 (0.6) sitagliptin + Metformin + sulfonylurea (n=378) 154 (40.7) 13 (3.4)
16 (4.3) 1 (0.3) InvoKana 100 mg + Metformin (n=483) 27 (5.6) 2 (0.4) InvoKana 100 mg + sulfonylurea (n=74) 3 (4.1) InvoKana 100 mg + Metformin + sulfonylurea (n=157) 43 (27.4) 1 (0.6)
17 (4.6) 1 (0.3) InvoKana 300 mg + Metformin (n=485) 24 (4.9) 3 (0.6) InvoKana 300 mg + sulfonylurea (n=72) 9 (12.5) InvoKana 300 mg + Metformin + sulfonylurea (n=156) 47 (30.1) 0 InvoKana 300 mg + Metformin + sulfonylurea (n=377) 163 (43.2) 15 (4.0)
INVOKANA™ (canagliflozin) tablets table 4: Incidence of Hypoglycemia* in controlled clinical studies (continued) In combination with Metformin + Pioglitazone (26 weeks) Overall [N (%)] In combination with Insulin (18 weeks) Overall [N (%)] Severe [N (%)]†
Placebo + Metformin + Pioglitazone (n=115) 3 (2.6)
InvoKana 100 mg + Metformin + Pioglitazone (n=113) 3 (2.7)
InvoKana 300 mg + Metformin + Pioglitazone (n=114) 6 (5.3)
Placebo (n=565) 208 (36.8) 14 (2.5)
InvoKana 100 mg (n=566) 279 (49.3) 10 (1.8)
InvoKana 300 mg (n=587) 285 (48.6) 16 (2.7)
* Number of patients experiencing at least one event of hypoglycemia based on either biochemically documented episodes or severe hypoglycemic events in the intent-to-treat population † Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained) Laboratory Tests: Increases in Serum Potassium: Dose-related, transient mean increases in serum potassium were observed early after initiation of INVOKANA (i.e., within 3 weeks) in a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information]. In this trial, increases in serum potassium of greater than 5.4 mEq/L and 15% above baseline occurred in 16.1%, 12.4%, and 27.0% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. More severe elevations (i.e., equal or greater than 6.5 mEq/L) occurred in 1.1%, 2.2%, and 2.2% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In patients with moderate renal impairment, increases in potassium were more commonly seen in those with elevated potassium at baseline and in those using medications that reduce potassium excretion, such as potassium-sparing diuretics, angiotensinconverting-enzyme inhibitors, and angiotensin-receptor blockers [see Warnings and Precautions]. Increases in Serum Magnesium: Dose-related increases in serum magnesium were observed early after initiation of INVOKANA (within 6 weeks) and remained elevated throughout treatment. In the pool of four placebo-controlled trials, the mean change in serum magnesium levels was 8.1% and 9.3% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to -0.6% with placebo. In a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information], serum magnesium levels increased by 0.2%, 9.2%, and 14.8% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Serum Phosphate: Dose-related increases in serum phosphate levels were observed with INVOKANA. In the pool of four placebo controlled trials, the mean change in serum phosphate levels were 3.6% and 5.1% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to 1.5% with placebo. In a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information], the mean serum phosphate levels increased by 1.2%, 5.0%, and 9.3% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Low-Density Lipoprotein Cholesterol (LDL-C) and non-HighDensity Lipoprotein Cholesterol (non-HDL-C): In the pool of four placebocontrolled trials, dose-related increases in LDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in LDL-C relative to placebo were 4.4 mg/dL (4.5%) and 8.2 mg/dL (8.0%) with INVOKANA 100 mg and INVOKANA 300 mg, respectively. The mean baseline LDL-C levels were 104 to 110 mg/dL across treatment groups [see Warnings and Precautions]. Dose-related increases in non-HDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in non-HDL-C relative to placebo were 2.1 mg/dL (1.5%) and 5.1 mg/dL (3.6%) with INVOKANA 100 mg and 300 mg, respectively. The mean baseline non-HDL-C levels were 140 to 147 mg/dL across treatment groups. Increases in Hemoglobin: In the pool of four placebo-controlled trials, mean changes (percent changes) from baseline in hemoglobin were -0.18 g/dL (-1.1%) with placebo, 0.47 g/dL (3.5%) with INVOKANA 100 mg, and 0.51 g/dL (3.8%) with INVOKANA 300 mg. The mean baseline hemoglobin value was approximately 14.1 g/dL across treatment groups. At the end of treatment, 0.8%, 4.0%, and 2.7% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively, had hemoglobin above the upper limit of normal. drUg InteractIons Ugt enzyme Inducers: Rifampin: Co-administration of canagliflozin with rifampin, a nonselective inducer of several UGT enzymes, including UGT1A9, UGT2B4, decreased canagliflozin area under the curve (AUC) by 51%. This decrease in exposure to canagliflozin may decrease efficacy. If an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) must be co-administered with INVOKANA (canagliflozin), consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA 100 mg once daily, have an eGFR greater than 60 mL/min/1.73 m2, and require additional glycemic control. Consider other
INVOKANA™ (canagliflozin) tablets antihyperglycemic therapy in patients with an eGFR of 45 to less than 60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer and require additional glycemic control [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information]. digoxin: There was an increase in the AUC and mean peak drug concentration (Cmax) of digoxin (20% and 36%, respectively) when co-administered with INVOKANA 300 mg [see Clinical Pharmacology (12.3) in full Prescribing Information]. Patients taking INVOKANA with concomitant digoxin should be monitored appropriately. Positive Urine glucose test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-ag) assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Use In sPecIFIc PoPULatIons Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of INVOKANA in pregnant women. Based on results from rat studies, canagliflozin may affect renal development and maturation. In a juvenile rat study, increased kidney weights and renal pelvic and tubular dilatation were evident at greater than or equal to 0.5 times clinical exposure from a 300 mg dose [see Nonclinical Toxicology (13.2) in full Prescribing Information]. These outcomes occurred with drug exposure during periods of animal development that correspond to the late second and third trimester of human development. During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters. INVOKANA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nursing Mothers: It is not known if INVOKANA is excreted in human milk. INVOKANA is secreted in the milk of lactating rats reaching levels 1.4 times higher than that in maternal plasma. Data in juvenile rats directly exposed to INVOKANA showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from INVOKANA, a decision should be made whether to discontinue nursing or to discontinue INVOKANA, taking into account the importance of the drug to the mother [see Nonclinical Toxicology (13.2) in full Prescribing Information]. Pediatric Use: Safety and effectiveness of INVOKANA in pediatric patients under 18 years of age have not been established. geriatric Use: Two thousand thirty-four (2034) patients 65 years and older, and 345 patients 75 years and older were exposed to INVOKANA in nine clinical studies of INVOKANA [see Clinical Studies (14.3) in full Prescribing Information]. Patients 65 years and older had a higher incidence of adverse reactions related to reduced intravascular volume with INVOKANA (such as hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300 mg daily dose, compared to younger patients; more prominent increase in the incidence was seen in patients who were 75 years and older [see Dosage and Administration (2.1) in full Prescribing Information and Adverse Reactions]. Smaller reductions in HbA1C with INVOKANA relative to placebo were seen in older (65 years and older; -0.61% with INVOKANA 100 mg and -0.74% with INVOKANA 300 mg relative to placebo) compared to younger patients (-0.72% with INVOKANA 100 mg and -0.87% with INVOKANA 300 mg relative to placebo). renal Impairment: The efficacy and safety of INVOKANA were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to less than 50 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information]. These patients had less overall glycemic efficacy and had a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR greater than or equal to 60 mL/min/1.73 m2); patients treated with INVOKANA 300 mg were more likely to experience increases in potassium [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Adverse Reactions]. The efficacy and safety of INVOKANA have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD, or receiving dialysis. INVOKANA is not expected to be effective in these patient populations [see Contraindications and Clinical Pharmacology (12.3) in full Prescribing Information]. Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment. The use of INVOKANA has not been studied in patients with severe hepatic impairment and is therefore not recommended [see Clinical Pharmacology (12.3) in full Prescribing Information].
October 2014 Minnesota Physician
INVOKANA™ (canagliflozin) tablets
Minnesota Physician October 2014
in the primary care setting. While many of the calls to the service were pediatricians voluntarily seeking advice on a case, a majority were providers calling about patients who were prescribed a treatment protocol that required a CAP consultation for state-funded health plans to fill certain prescriptions. We learned through this service that most prescribers were providing excellent care and making appropriate medication recommendations. We also learned that cases requiring mandatory consultations represented a subset of some of the most highly complex youth psychiatric cases, and that those patients were being seen by child and adolescent psychiatrists. While the service was
Foundation. Fast-TrackerMN. org is a free online searchable database of providers and resources designed to easily and quickly locate and connect providers, care coordinators, and patients alike. It adds value to the entire system as a referral tool for providers, a search tool for patients and families, and an information resource for the mental health community through its blog, calendar, and live information links. Fast-TrackerMN.org remains available for free online searches, and currently contains over 650 clinics offering a variety of resources. With the help of the entire Minnesota mental health provider community, Fast-TrackerMN.org offers providers, advocates, and consumers a single site to find information and services and get connected.
More than 15 percent of patient visits to hospital emergency departments are a result of a psychiatric crisis and this number has risen steadily over the last decade. S:9.5”
overdosage There were no reports of overdose during the clinical development program of INVOKANA (canagliflozin). In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status. Canagliflozin was negligibly removed during a 4-hour hemodialysis session. Canagliflozin is not expected to be dialyzable by peritoneal dialysis. PatIent coUnseLIng InForMatIon See FDA-approved patient labeling (Medication Guide). Instructions: Instruct patients to read the Medication Guide before starting INVOKANA (canagliflozin) therapy and to reread it each time the prescription is renewed. Inform patients of the potential risks and benefits of INVOKANA and of alternative modes of therapy. Also 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. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change. Instruct patients to take INVOKANA only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time. Inform patients that the most common adverse reactions associated with INVOKANA are genital mycotic infection, urinary tract infection, and increased urination. Inform female patients of child bearing age that the use of INVOKANA during pregnancy has not been studied in humans, and that INVOKANA should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Instruct patients to report pregnancies to their physicians as soon as possible. Inform nursing mothers to discontinue INVOKANA or nursing, taking into account the importance of drug to the mother. Laboratory Tests: Due to its mechanism of action, patients taking INVOKANA will test positive for glucose in their urine. Hypotension: Inform patients that symptomatic hypotension may occur with INVOKANA and advise them to contact their doctor if they experience such symptoms [see Warnings and Precautions]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake. Genital Mycotic Infections in Females (e.g., Vulvovaginitis): Inform female patients that vaginal yeast infection may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions]. Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis): Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions]. Hypersensitivity Reactions: Inform patients that serious hypersensitivity reactions such as urticaria and rash have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction or angioedema, and to take no more drug until they have consulted prescribing physicians. Urinary Tract Infections: Inform patients of the potential for urinary tract infections. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur. Active ingredient made in Belgium Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Finished product manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 Licensed from Mitsubishi Tanabe Pharma Corporation © 2013 Janssen Pharmaceuticals, Inc. 10282403 020588-140827
Psychiatric consultations for children from page 10
valuable in many ways, the requirement for mandatory consultations proved to be demanding and arduous for the primary care community. Due to the unpopularity of the mandatory consultations, the consortium providing the service did not apply for renewal at the end of the contract period in May 2014. At that point, there was no longer any enforcement of mandatory consultations. However, the voluntary consultations were seen as incredibly positive. Fast-TrackerMN.org The Minnesota Collaborative Psychiatric Consultation Service used Fast-TrackerMN.org, an online tool developed by the Minnesota Psychiatric Society’s foundation, which is the Minnesota Mental Health Community
Psychiatric Assistance Line (PAL) In June 2014, PrairieCare Medical Group received a 12-month grant from the Minnesota Department of Human Services to offer free clinical triage, and child and adolescent psychiatric phone consultations to health care providers, via a service called the Psychiatric Assistance Line (PAL). The new PAL service does not require primary care to have any mandatory consultations for medical approval. PAL is available strictly on a voluntary basis for providers. This service is augmented by the Fast-TrackerMN.org online mental health database and funded by DHS. The service is available Monday through Friday from 8:00 a.m. to 5:00 p.m. via a toll-free number; online options for access are avail-
able as well. The purpose of both PAL and Fast-TrackerMN. org is to support primary care providers treating youth with psychiatric illness and assisting with triage and referral when necessary. PAL was designed to be convenient by offering both phone and online services. Primary care providers can submit online inquiries that will be answered by email. They also can schedule their own appointment times online, and a PAL social worker will call them when most convenient. PAL is beneficial to patients and families by allowing the assessment and management of mental illness to take place in their primary care provider’s office. This means more kids are getting help sooner and avoiding the cost and trauma of untreated mental illnesses. In the first month, PAL provided almost daily consulta-
bat ADHD worsened the sleeplessness. The patient had been started on a trial of 5 mg of short-acting Ritalin in the morning and at lunch. The pediatrician called PAL for advice on other medications that
tions to a variety of health providers on cases ranging from referrals to psychotherapists, to consulting on complex management of medications for comorbid diagnosis. Some examples of specific cases:
The child and adolescent psychiatrist shortage has shifted the burden of providing mental health care to primary care clinicians. • A 7-year-old female presented with ADHD, mild fetal alcohol syndrome, and sleep problems. The pediatrician had already tried clonidine and melatonin to combat the sleep issues but did not have success. A recent trial of 18 mg of Concerta taken in the morning to com-
could help the patient sleep, and for referrals to a therapist. • A 4-year-old male presented with a history suggestive of intrauterine exposure and/or perhaps reactive attachment disorder. The patient exhibited progressively aggressive
behavior. A psychiatric referral had been made, but the appointment was weeks away. The pediatrician sought advice from PAL on referrals to support the family, and suggestions for medications while waiting for the psychiatric appointment. Shifts in psychiatric care The culture of health care, significantly influenced by federal legislation, is shifting toward integrating psychiatric services into primary care. These efforts are certainly valuable in preventing the progression of symptoms, but also are necessary as the percentage of psychiatric patients and degree of severity only seem to increase over time. Until this integration is logistically feasible, financially viable, and embraced by health systems, PAL is an Psychiatric consultations for children to page 42
Bach’s Brandenburg Concertos Handel’s Messiah Thursday, December 11, 7:30pm Temple Israel, Minneapolis Friday, December 12, 7:30pm Wayzata Community Church, Wayzata Saturday, December 13, 7:30pm Saint Paul’s United Church of Christ, Saint Paul Sunday, December 14, 3:00pm Trinity Lutheran Church, Stillwater Bach: Brandenburg Concertos Nos. 1-6
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Thursday, December 18, 7:30pm Friday, December 19, 8:00pm Saturday, December 20, 1:00pm Basilica of Saint Mary, Minneapolis Paul Agnew, conductor Sarah Brailey, soprano John Holiday, countertenor David Portillo, tenor Colin Ramsey, bass SPCO Chorale Dale Warland, artistic director Handel: Messiah
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October 2014 Minnesota Physician
Chronic kidney disease from cover
Table 1. Criteria for CKD (either of the following present for >3 months) Markers of kidney damage (one or more)
Albuminuria (AER ≥30 mg/24 hours; ACR ≥30 mg/g [≥3mg/mmol]) Urine sediment abnormalities Electrolyte and other abnormalities due to tubular disorders Abnormalities detected by histology Structural abnormalities detected by imaging History of kidney transplantation
GFR <60 ml/min/1.73 m2 (GFR categories G3a-G5)
Abbreviations: CKD, chronic kidney disease; GFR, glomerular filtration rate Table courtesy of KDIGO
strated that CKD increases the risk for cardiovascular events, acute kidney injury, and allcause mortality. In addition to these dire endpoints, the signs and symptoms of the later stages of CKD, especially end-stage renal disease (ESRD), lead to a drastically reduced quality of life. But like the early stages of hypertension and diabetes, the early stages of CKD can present with few or no symptoms, thus making screening in primary care the key to reducing the progression of disease. And once CKD is detected, the qual-
ity of care received will directly affect the course of the disease and quality of life. Because of the silent nature of early CKD, primary care physicians (PCPs) are at the forefront of identifying and implementing evidence-based care for preserving kidney function and forestalling ESRD. According to Shahinian and Saran in 2010, the evidence now clearly shows that early intervention can slow or prevent the progression of CKD. They also note that because of the large number of patients either at
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Minnesota Physician October 2014
risk for CKD or with early-stage disease, PCPs will need to take the primary role in caring for most of these patients. Even patients with later-stage CKD should be co-managed by both the nephrologist and PCP. Barriers to care A major barrier to improved CKD care is lack of awareness on the part of both PCPs and patients. In the 2005 RADAR study by Singh et al., PCPs were only aware about 33 percent of the time that their patients had CKD. According to Plantinga et al. in 2010, patient awareness of their disease, even with stage 4 CKD, was approximately only 40 percent. According to the USRDS 2013 Annual Data Report, the probability of a patient at any stage of CKD having both creatinine and urine albumin tests done in the prior year was under 40 percent even with the risk factors of known diabetes and hypertension. In a study by Allen et al. in 2010, it was found that PCPs did not generally recognize the underlying presence of CKD, and the majority of patients at high risk for complications of CKD did not receive annual urine protein testing. Additionally, few patients were managed with nephrology involvement as the disease progressed to later stages. Not surprisingly, they also found that PCP recognition of CKD and nephrology co-management led to improved quality of care. Inadequate screening and early identification of CKD then leads to late referrals to nephrology. USRDS data show that the probability of being seen by a nephrologist in the
year following a diagnosis of CKD is only about 30 percent. In a study by Stack in 2003, about 30 percent of CKD patients were referred to nephrology less than four months prior to needing dialysis, which was associated with a higher risk of death. One major factor leading to the higher mortality rate observed in this study was a greater use of dialysis catheters as opposed to fistulas, and subsequent catheter-related infections. When CKD progression enters the later stages, timely referral to a nephrologist allows for the necessary preparation and maturation of an arteriovenous fistula, the preferred type of vascular access. But
The early stages of CKD can present with few or no symptoms.
when CKD is identified too late, emergency dialysis must be performed with a catheter, thus exposing patients to a sevenfold higher rate of infection than for patients with a fistula. This lack of lead time also negates the possibility of placing a catheter for peritoneal dialysis, which often is preferable to hemodialysis. And finally, late referral to nephrology also precludes a
Table 2. GFR categories in CKD GFR category
GFR (ml/min/1.73 m2)
Normal or high
Mildly to moderately decreased
Moderately to severely decreased
Abbreviations: CKD, chronic kidney disease; GFR, glomerular filtration rate *Relative to young adult level In the absence of evidence of kidney damage, neither GFR category G1 nor G2 fulfill the criteria for CKD.
Table 3. Albuminuria categories in CKD ACR (approximate equivalent) Category
AER (mg/24 hours)
Normal to mildly increased
Abbreviations: AER, albumin excretion rate; ACR, albumin-to-creatinine ratio; CKD, chronic kidney disease *Relative to young adult level **Including nephrotic syndrome (albumin excretion usually >2200 mg/24 hours [ACR > 2220 mg/g; >220 mg/mmol]) Tables courtesy of KDIGO
preemptive kidney transplant, the optimal treatment for kidney failure. According to Vassalotti et al. in 2010, utilization of CKD tests for patients at risk and interpretation of those tests by PCPs is improving. And through the work of the National Kidney Foundation’s Kidney Early Evaluation Program (KEEP), more knowledge is being gained regarding factors that influence access to care and quality of care. KEEP data, along with collaboration between nephrologists and PCPs, are central to improving care. It also has been shown (Boulware, 2006) that PCPs who were aware of existing guidelines regarding referral to nephrology were 14 times more likely to refer. Therefore, research, collaboration, and exposure to guidelines will further promote these positive trends. Guidance on evaluating and managing CKD The National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) U.S. commentary on the Kidney Disease Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of CKD helps the PCP
make meaningful interventions to forestall the progression of CKD. NKF-KDOQI convenes a work group to write commentaries on KDIGO guidelines in order to assist U.S. practitioners in interpreting the global KDIGO guidelines and determining their applicability to U.S. practice. Proper evaluation begins with a clear definition of CKD, as well as an understanding of the most recent information for staging of the disease. CKD is defined as abnormalities of kidney structure or function, present for >3 months, with implications for health (see Table 1 on page 20 for specific criteria). Numerous studies in recent years have provided convincing evidence that both lower GFR and greater levels of albuminuria are independently related to mortality, cardiovascular events, and the rate of ESRD. Therefore, grading criteria for the categories of GFR and albuminuria are included in Table 2 and Table 3 (on this page), respectively. Using these categories, KDOQI has stratified relative risk based on the heat map from the KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease in Table 4 (page 22).
The crucial role of the PCP As noted by Vassalotti et al. in a guidance paper for PCPs in 2008, the tremendous demands
on the PCP’s time in addressing a wide array of patient issues requires streamlined guideChronic kidney disease to page 22
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Table 4. Prognosis of CKD by GFR and albuminuria categories: KDIGO 2012 Persistent albuminuria categories Description and range
GFR categories (ml/min/1.73m2) Description and range
Normal to mildly increased
<30 mg/g <3 mg/mmol
30–300 mg/g 3–30 mg/mmol
>300 mg/g >30 mg/mmol
Normal or high
Mildly to moderately decreased
Moderately to severely decreased
Green: low risk (if no other markers of kidney disease, no CKD); Yellow: moderately increased risk; Orange: high risk; Red: very high risk Table courtesy of KDIGO
Chronic kidney disease from page 21
lines. The following may serve to guide and highlight the crucial role and unique expertise of the PCP in addressing CKD.
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1. Identify risk factors for CKD such as diabetes,
hypertension, and a family history of kidney disease, and then screen with estimated glomerular filtration rate (eGFR) and albumin-to-creatinine ratio (ACR). Many labs now include eGFR as part
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Minnesota Physician October 2014
of the basic metabolic panel, but if not, creatinine can be used in a simple calculation (visit www.kidney.org to access the eGFR calculator). ACR also is done easily with an albumin-specific dipstick. Both tests are not costly and should be covered by insurance. 2. D iagnose and classify CKD using Tables 1–4 in order to guide testing and treatment, as described in the NKF-KDOQI guidelines. 3. Refer to nephrology for: • A KI or sustained fall in GFR • GFR <30 ml/min/1.73 m2 (GFR categories G4-G5) • A consistent finding of significant albuminuria (ACR >300 mg/g), depending on the specific needs of the patient and the provider’s capacity to deliver specialty care • Questions about the etiology of albuminuria • Difficulty with decreasing level of albuminuria despite institution of ACE inhibitor or ARB therapy
• Side effects or contraindications to ACE-inhibitor/ARB therapy, but with albuminuria >300 mg/g or nephrotic-range proteinuria or albuminuria • Progression of CKD • Urinary red cell casts, RBC >20 per high power field sustained and not readily explained • CKD and hypertension refractory to treatment with four or more antihypertensive agents • Persistent abnormalities of serum potassium • Recurrent or extensive nephrolithiasis • Hereditary kidney disease • Planning for renal replacement therapy (RRT) in patients with progressive CKD in whom the risk of kidney failure within 1 year is 10 percent to 20 percent higher, as determined by validated risk prediction tools. The goal is to avoid late referral, defined as less than 1 year before the start of RRT. 4. B egin coordinated and focused treatment of modifiable risk factors to prevent CKD progression.
to a nephrologist, then factor management, these Controlling blood presan elective fistula can be conditions require a sure and glucose levels in placed prior to the start multidisciplinary appatients with diabetes can of hemodialysis, thus proach to care. Proper prevent cardiovascular eliminating the need for nutrition is central to disease and delay or slow the loss of kidney function. Proteinuria also can be A major barrier to improved mitigated by conCKD care is lack of awareness trolling hypertenon the part of both primary sion and diabetes, thus delaying care physicians and patients. CKD progression. Timely treatment of acidosis a central venous catheter the control of bone and through dietary modiand its attendant risk for electrolyte disorders, as fications or bicarbonate infection. well as problems such as therapy has been found to obesity, malnutrition, and be beneficial in preserving 8. P roper management of fluid overload. kidney function. Key elelate stage CKD (stage 4–5), ments for risk factor manincluding evaluation for 6. Avoid nephrotoxic and agement include lifestyle preemptive transplant, edcontraindicated medicachanges such as quitting ucation on RRT options, tions such as NSAIDs and smoking, losing weight if and proper access (“fistula contrast dyes. indicated, and exercising. first”). 7. P reserve vascular access 5. Treat CKD complications CKD is a growing U.S. since many patients will that can affect quality of eventually need dialysis. If public health problem. Inlife, such as anemia, bone creased awareness and impleveins in the nondominant mineral disorders, elecarm can be preserved, and mentation of the NKF-KDOQI trolyte abnormalities, and evidence-based guidelines for there is timely referral depression. As with risk
CKD by PCPs could delay the progression of disease, reduce mortality, and improve the quality of life for patients There are many online provider resources available such as the KDOQI guidelines, which provide evidence-based clinical practice standards for all stages of CKD and related complications www.kidney.org/Professionals/kdoqi/ Surabhi Thakar, MD, is a nephrology fellow at the University of Minnesota Medical School. Marc Weber, MD, is board-certified in internal medicine and nephrology and is director of the nephrology fellowship program at the University of Minnesota Medical School. He is the chair of the Minnesota chapter’s National Kidney Foundation Medical Advisory Board. Gail Torres, MS, RD, RN, is the nurse program director for Kidney Learning Solutions at the National Kidney Foundation.
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october 2014 Minnesota Physician
ccording to the Minnesota Department of Health’s (MDH’s) summary report on the 2013–2014 flu season, Minnesota hospitals treated 1,539 people with laboratory-confirmed influenza during the 2013–2014 influenza season. In addition, there were 93 influenza-like illness (ILI) outbreaks in schools, 27 influenza outbreaks in long-term care facilities, and two confirmed pediatric influenza-related deaths. These numbers occurred in a relatively mild influenza season. In comparison, the 2012–2013 season saw more than 3,000 hospitalizations, 463 outbreaks of influenza-like illness in schools, and 209 influenza outbreaks in long-term care (MDH summary report on the 2012–2013 flu season). We have no way of predicting what the 2014–2015 influenza season will bring, but we can take action to prevent as many cases of influenza as possible by getting vaccinated and urging our patients and fellow health care workers to get vaccinated as well.
Influenza vaccinations Why all health care workers need one By Edward Ehlinger, MD, MSPH
Who should be vaccinated against influenza? In August 2014, the Centers for Disease Control and Prevention (CDC) published the Advisory Committee on Immunization Practices (ACIP) recommendations for influenza vaccination for the 2014–2015 season. As has been standard the last several years, ACIP recommended that everyone 6 months of age and older get vaccinated against influenza unless they have a medical contraindication—this recommendation includes all health care personnel, not just those working directly with patients.
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Minnesota Physician October 2014
There was a time when physicians recommended annual influenza vaccinations only for certain groups with a higher risk of complications from influenza. Those included seniors, young children, people with chronic illnesses, and pregnant women. The more recent recommendation for everyone to receive an influenza vaccine each year reflects an understanding that influenza can be a serious disease even for healthy people. As clinicians, we know this better than anyone. We care for individuals suffering from severe respiratory illnesses made worse by influenza. We also care for patients living with chronic illnesses or battling cancer and patients who are pregnant or immunocompromised—not to mention infants, young children, and the elderly—all susceptible to severe complications from influenza. Influenza is a highly contagious disease that is easily spread by both symptomatic and asymptomatic individuals. Even when you may not feel sick, you could unknowingly spread the virus to vulnerable patients in your care. As physicians, our first priority is to “do no harm.” One way we do that is by employing best practices and following optimal standards of care. That’s why it is the ethical responsibility of all clinicians to protect themselves and their patients by getting their annual influenza vaccine and encourage others in their organization to do the same. Influenza vaccination rates for health care personnel Nationally, vaccination rates among health care personnel have lagged far below the Healthy People 2020 goal of
90 percent. For the 2013–2014 influenza season, CDC data showed 75.2 percent of health care providers reported receiving an influenza vaccination (a slight increase from 72 percent in the 2012–2013 season). Coverage was highest for health care personnel in hospitals, at 89.6 percent, and lowest for health care personnel in longterm care facilities, at 63 percent. Long-term care facilities often don’t have the same infection prevention resources as hospitals, which may be why their rates are lower. On a positive note, the CDC data also showed that physicians had the highest vaccination coverage in 2013–2014 at 92.2 percent. Nurses, nurse practitioners and physician assistants, and pharmacists were close behind with rates between 85 percent and 91 percent. While it is good that clinicians have these high vaccination rates, the rates should be even higher. All personnel working in a health care facility should be vaccinated to protect the health of staff and patients. CDC data for 2013–2014 showed that medical assistants and aids had a vaccination rate of just 57.7 percent and nonclinical personnel had a rate of 68.6 percent. Some of these individuals may not have direct patient contact, but they breathe the same air, touch the same door knobs, and share the same elevators with everyone in the facility. Given what we know about the ease with which influenza viruses can spread, it is the responsibility of all staff in health care facilities to get vaccinated to help protect patients and staff from influenza. A rule published by the Centers for Medicare & Medicaid Services (CMS) in August 2011 requires acute care hospitals participating in its Hospital Inpatient Quality Reporting (IQR) Program to report influenza vaccination for health care providers. For the first year in which these data were reported (2013–2014), 4,254 acute care hospitals reported figures for three groups: employees, licensed independent practitioners, and adult student/train-
These surveys have different methods of collecting data, so we aren’t able to directly compare rates. The bottom line, however, is clear: We can do better. We need to do better.
the benefits of health care personnel vaccination for staff and patients; vaccination of senior staff or opinion leaders; removal of barriers like cost; and monitoring and reporting rates all have been successful strategies for increasing health care personnel influenza vaccination rates (Immunization of HealthCare Personnel; CDC 2011).
How can we achieve higher vaccination rates? Health care providers’ barriers to getting vaccinated aren’t that different from barriers in the general population. Health care providers have reported fear of vaccine side effects; not having enough time or having vaccinations offered in inconvenient locations; perceived ineffectiveness of the vaccine; low perceived risk of getting influenza; and fear of needles as reasons for not getting vaccinated. Studies have shown that strategies to provide convenient times and locations for vaccination; campaigns to emphasize
MDH’s FluSafe program helps hospitals and nursing homes achieve higher influenza vaccination rates among their health care personnel. Through FluSafe, health care facilities monitor and track influenza vaccination for health care personnel and report their rates to MDH. Facilities reaching vaccination rates of 70 percent, 80 percent, or 90 percent are publicly recognized for their achievement. The program also provides facilities with resources for promoting the benefits of influenza vaccination. For the 2013–2014 season, 213 health care facilities participated. However, with approxi-
ees and volunteers. Nationally, the vaccination rate for the employees group was 86.1 percent. Minnesota’s rate for employees was 79.4 percent.
mately 375 nursing homes and 145 hospitals in the state, that leaves plenty of room to expand the reach of the strategies and best practices provided by the FluSafe program. I urge you to see if your hospital or nursing home can participate in FluSafe (www.mdhflu.com), or make use of some of the free resources to implement your own campaign to track immunizations, set goals, and celebrate achieving them. Some states have taken steps to mandate influenza vaccination for all health care providers. While this is one approach to increasing vaccination rates, Minnesota is not moving toward a mandate at this time. Instead, we are relying on clinicians and health care facilities to voluntarily implement this best practice of infection control. Be an immunization champion We rely on the hard work and dedication of our clinicians and health care professionals to help
Minnesota maintain its status as one of the healthiest states in the nation. Getting vaccinated to prevent the spread of influenza is an important step for protecting those we serve. The high vaccination rates reported by physicians show we are practicing what so many of us preach. I encourage you to take the next step by sharing your story and urging people in your organization to take action as well. Educate them on the benefits of influenza vaccines and work with administrators to establish immunization clinics for staff. Help us protect our state from this serious but preventable health risk. Edward Ehlinger, MD, MSPH, was appointed by Gov. Mark Dayton in 2011 to serve as the commissioner of the Minnesota Department of Health, the state’s lead public health agency. Commissioner Ehlinger is boardcertified in both internal medicine and pediatrics.
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October 2014 Minnesota Physician
an a collaborative care management model implemented in primary care improve the outcomes and lower the cost of care for patients with multiple mental and medical chronic diseases? That is what the COMPASS (Care Of Mental, Physical And Substance-use Syndromes) model is striving to discover. Funded by a three-year Center for Medicare & Medicaid Innovation grant, and led by the Institute for Clinical Systems Improvement (ICSI), the initiative is being implemented by 17 medical groups through 187 clinics in eight states. Entira Family Clinics, Essentia Health, Mayo Clinic Health System, North Memorial Health Care, and Stillwater Medical Group are implementing the model in Minnesota.
Systematic case review Improving treatment for complex mental and medical conditions By Jim Trevis
ity and assess the patient’s readiness for self-management 2. A computerized registry to track and monitor the patient’s progress
The COMPASS model includes the following components:
3. A care manager to provide patient education and self-management support, coordinate care with the primary care physician and consultants, and provide active follow-up
1. A n initial evaluation to measure condition sever-
4. A consulting psychiatrist and consulting medical
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Minnesota Physician October 2014
physician to review cases with the care manager and recommend changes in treatment to the primary care physician 5. Treatment intensification when there is a lack of improvement 6. Relapse and exacerbation prevention Complex patients Patients eligible for COMPASS have suboptimally managed depression (PHQ-9 >9), and treatable suboptimally managed diabetes or cardiovascular disease (including patients over age 65 with uncontrolled hypertension), with an option to include substance misuse based on AUDIT ≥7 for females or ≥8 for males, and/or DAST10 ≥2. The medical groups implementing COMPASS have found it more complicated and challenging than anticipated to find appropriate high-risk patients. “The biggest surprise for me was discovering how complex these patients are and how many issues they have,” says Faris Keeling, MD, medical director, Integrated Behavioral Health, Division of Community Clinics, Essentia Health, and COMPASS consulting psychiatrist. “These patients are fewer in number but are our most expensive to treat.” Adds Emilie Hedlund, MHA, outpatient care coordination manager, North Memorial, “These patients typically are not served well in the fastpaced, visit-oriented primary care system.”
Systematic case reviews The COMPASS model addresses the complexity of these chronically ill patients through its Systematic Case Review (SCR). The core SCR team is composed of a care manager, consulting psychiatrist, and consulting physician. This team meets weekly for two hours to review the registry of COMPASS patients, focusing on creating care plans for new patients and recommending treatment changes to the primary care physician (who makes the final decisions) for patients not progressing. Minnesota medical groups designed their SCR teams differently. Stillwater assigned a single doctor to the physician consulting role, believing regular involvement in the SCR would improve patient outcomes faster. The team also includes a diabetes educator and medical home care managers. Entira initially rotated many physicians into the consulting role to expose more providers to the model for eventual spread across their clinics, according to Ruth Herman, MBA-H, director of clinical practice. Entira now is rotating fewer physicians onto the SCR team to address the importance of having ongoing knowledge of the patient’s condition to achieve results. North Memorial brings in its care managers from 13 clinics to attend the SCR team meeting. They do extensive prep on their patients to efficiently use the SCR team’s two-hour window. Representatives from pharmacy, plus a diabetic program director and vascular consultant, join the discussions. In addition to core players, Essentia Health involves clinic management on its SCR team. An Essentia psychiatrist now devotes part of his/her time to COMPASS patients who need face-to-face time not provided by the SCR consulting psychiatrist.
Collaborative care models Some of the clinics offering COMPASS were familiar with team-based care through programs like DIAMOND (Depression Improvement Across Minnesota, Offering a New Direction). Most primary care physicians liked the input of the consulting psychiatrist in this model because many patients with depression present with much complexity.
SCR roles Clinicians consulting in SCRs report that the team approach provides a deeper dive to uncover health and social issues of complex patients that are real barriers to patient improvement. Many express their satisfaction with their role on the SCR team. Says Martha Sanford, MD, medical director of quality at Stillwater, “I was hesitant to serve as the consulting medical provider. Now it is one of my favorite parts of the week. Hearing about patients who had been receiving ‘usual care’ and not getting better was an eye-opener in terms of under-
The COMPASS model added a consulting medical physician, usually a family practitioner or internal medicine physician. For clinics less familiar with team-based care, this addition required cultural changes. Primary care physicians with long-term relationI can very efficiently … ships with COMPASS make a positive impact patients sometimes did not agree with the on the patients’ health. SCR medical physician’s recommendations because he or she was standing these patients’ strugnot aware of the context for the gles. Now we all work together proposed change in care. This and these patients are benefithighlighted the importance of ting from the model.” having good, strong care manDr. Keeling says that the agers, as they are the commuSCR meeting is the most nications conduit between the rewarding part of his week. “I primary care physician and the can very efficiently give input SCR team. on five to 10 cases that make a Many clinics report that they are seeing the value of the SCR process. The consulting physicians often have more expertise in addressing depression, diabetes, and/or cardiovascular disease and can focus on a “treat-to-target” strategy for nonprogressing patients. As SCR teams better understand this patient population, some have added diabetic educators, pharmacists, and endocrinologists. The results: Primary care physicians are seeing improvements in long-term, highutilizer patients. “The patient benefits by getting expert input that focuses on a particular condition, such as diabetes, whereas in usual care, the primary care physician might be faced with a half a dozen issues at once, making it nearly impossible to concentrate and improve just one ailment,” says Dr. Keeling.
positive impact on the patients’ health.” Leveraging data Patient outcome data now is being supplied to participating medical groups. Clinics are seeing how the model and the SCR component are impacting care. If they are missing the initiative’s target goals, they can focus on “treating to target” with their care plans. The data also help care managers to uncover patient barriers to improvement, and then use motivational interviewing to address patient desires for self-management. Through July 2014, 3,239 patients nationally were enrolled in COMPASS. Among those enrolled for more than four months (2,316), very preliminary results are as follows: Sixty percent have seen their
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Systematic case review to page 40 October 2014 Minnesota Physician
iabetes is complicated. Managing diabetes well takes a lot of skill and practice. Yet many people with diabetes—43 percent according to the Centers for Disease Control and Prevention—have never had any formal training on how to manage their illness. For Medicare beneficiaries, the number of those who have never received diabetes education may be as high as 98 percent.
This lack of training could explain why many of your diabetes patients appear to be “noncompliant,” “nonadherent,” or “difficult.” It also might answer the question of why your clinical performance measures for diabetes care are not improving. Diabetes education may be the solution to both. What is diabetes education? Diabetes education, also called diabetes self-management education (DSME) or diabetes self-management training
Diabetes education Helping your patients help themselves By Laurel Reger, MBA, and Mary Beth Dahl, RN (DSMT), aims to help people with diabetes or prediabetes gain the knowledge and skills needed to make behavior changes and to successfully manage their disease. Self-management education is an ongoing process that requires support and training for a lifetime. The overall purpose of DSME is to support informed decision-making; teach self-care behaviors; promote problem solving; encourage active collaboration with the health care team; and improve clinical outcomes, health status, and quality of life. Behavior change is a key outcome of DSME. Diabetes education focuses on changing behaviors in ways that will
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Minnesota Physician October 2014
improve people’s health and quality of life. They learn skills for eating healthfully, being physically active, monitoring their blood glucose, taking medications, solving problems, coping with stress, and reducing risk factors while building a community support system during group classes. DSME must be tailored to each patient. Differences in culture, health beliefs, economic and literacy levels, life experiences, and the patient’s emotional response to having diabetes all influence how each person understands and manages his/her disease. The most effective DSME programs employ a multidisciplinary team to help the patient learn how to make informed self-care choices. DSME centers A DSME center is a patient education provider in a nonacute care setting, from physicians’ offices to multispecialty clinics, pharmacies, or hospital outpatient clinics. These centers typically involve a multi-disciplinary team that might include a certified diabetes educator, registered dietitian, behavioral health specialist, and others. Some are small, independent practices; others are complex education centers affiliated with larger care systems. To be covered by health insurance, a DSME center must be recognized by the American Diabetes Association (ADA) or accredited by the American Association of Diabetes Educators (AADE). All must demonstrate that they adhere to the National Standards for DSME, which outlines the 10 essential elements of high quality DSME. The DSME centers must additionally offer an evidence-based training curriculum; have experienced and credentialed educators; convene
an advisory group; collect and review data about their patient population; practice continuous quality improvement; and achieve specific patient self-management goals and health outcomes. Currently, there are approximately 241 accredited DSME programs across the state of Minnesota. Why do you and your patients need DSME? Numerous studies show that DSME delivered by an accredited or recognized provider improves health outcomes, significantly lowers costs, and has a positive impact on clinical quality of care measures. For example, a recent study demonstrated a positive correlation between the number of diabetes education claims in the population and adherence to the Healthcare Effectiveness Data and Information Set (HEDIS) process measures compared to the population that did not receive diabetes education. Here are some of the benefits of DSME to the health care team: • Improved clinical quality of care and performance measures from: o Substantially improved glycemic control, even among those with diabetes-related complications o Improved treatment adherence o Improved knowledge of nutrition and anthropomorphic measures o Increased use of appropriate preventive services o Hospitalization rates reduced by more than one-third • Reduced costs due to fewer hospitalizations and emergency department visits and lower incidence of longterm complications • Sustainment of these benefits for up to two years Here are some of the patient benefits of DSME: • Patients will learn basic coping skills and how to
make lifestyle changes that will make them feel better and more confident in managing their disease.
hydrate intake, and account for exercise, sickness, and anything else that could affect your metabolism.
• Patients will learn how to get their A1C to goal, how to manage their cardiovascular risk factors, and how to avoid other complications.
• If you are overweight, monitor the calories and fat grams you eat.
• Patients will be better able to understand their disease and be more willing to make decisions with their health care team.
• Dispose of your sharps appropriately.
Why is diabetes education needed? It’s quite difficult to organize and manage all of the things that a diabetic has to keep track of without a plan: • Count all the carbohydrates you eat every day and figure out patterns so you can make changes to medications, activities, or eating. • Manage multiple medications and insulin with a delivery system of syringes, pens, or a pump. • Adjust your meal insulin dose based on your carbo-
• Include 30 minutes of physical activity daily.
• K now how to recognize and treat hypoglycemia. • Check your skin and feet daily. • Remember all of your routine preventive care visits and lab work. These are just the basics. It gets even more complex if you have cardiovascular disease (as with 70 percent of people with diabetes), arthritis (50 percent), depression (20 percent), or other complications. What can you do to ensure that your patients get DSME? Patients need more than just
a referral, they need to be convinced that DSME will be a good use of their time and money. In Minnesota, DSME is a covered benefit by nearly all health insurance providers. Medicare covers 10 hours of DSME instruction for the initial visit and two hours of training annually thereafter. Medicaid also covers DSME. Coverage for DSME is mandated for commercial health insurance plans operating in Minnesota. Even those plans not mandated by law (such as self-insured programs) typically cover DSME because they recognize the benefits of diabetes education in improving health and reducing costly complications and hospitalizations. Even with broad insurance coverage for DSME, copays and insurance deductibles can pose a financial barrier to some patients. They need to understand that attending a DSME program can ultimately save them money—possibly a lot of money. DSME is a proven means of
Three patients. Who is at risk for diabetes?
lowering treatment costs, staying out of the hospital, and having fewer sick days. Attending a DSME program can more than pay for itself. It can lead to better health outcomes that will benefit their quality of life for a lifetime. Referrals are still essential. It is most important that you refer all your newly diagnosed diabetes patients to a recognized or accredited diabetes education center or to a local certified diabetes educator (CDE). Developing good selfcare behaviors early in the course of the disease will have the greatest impact. Some practices are building automatic referrals into their EHRs for new diabetes diagnoses to ensure that this step is not overlooked. Contact Stratis Health if you are a Minnesota provider interested in implementing automatic referrals for DSME from your EHR. Most people with type 2 diDiabetes education to page 38
When there are no signs or symptoms, you may not know until it’s too late. Act now. Screen your patients for type 2 diabetes. It’s easy. It’s covered. It will reduce their risk. • Refer your at-risk patients to a proven lifestyle change program and help cut their risk of developing type 2 diabetes in half.
1 in 3 adults are at risk!
• For patients who already have diabetes, send them to a quality diabetes self-management program to improve control and reduce complications. Find groups in Minnesota at www.health.mn.gov/diabetes/programs
Minnesota Department of Health DIABETES PROGRAM
October 2014 Minnesota Physician
Professional Update: Ob-gyn
elvic organ prolapse affects as many as 35 percent of adult women worldwide and can drastically affect their quality of life. Unfortunately, it is a problem that women rarely talk about and for which they rarely seek treatment. Given its strong association with age and obesity, however, pelvic organ prolapse soon will become a larger public health issue as the population ages and grows more obese. Postmenopausal women have rates of prolapse above 40 percent, and women who are obese have a 40 percent to 75 percent increased risk of prolapse. Etiology and scope Prolapse stems from a laxation of the pelvic support system. The support of the vagina and its nearby organs is sustained by the cardinal and uterosacral ligaments at the vaginal apex. The endopelvic fascia connects to the arcus tendineus fascia pelvis that, in turn, attaches to the aponeurosis of the levator
Pelvic organ prolapse
4) in relation to the hymen. Prolapse above the hymen is a 1, to the hymen is 2, past the hymen is 3, and maximum descent is 4. This system is still often used for quick office visits.
A quiet problem
The POP-Q system has become the gold standard for describing prolapse, especially by pelvic floor specialists and in current research. This method is more complex and describes the descent of each compartment (anterior, posterior, and apical) and the combination of prolapsing compartments present. The POP-Q system currently is favored, as it gives a more detailed, if less straightforward, description of the issue.
By Vanessa Knoedler, MD
ani, supporting the mid-vagina. The perineal body and connective tissue attachment of the urethra to the pubic bone and laterally to the levator muscle support the introitus. The resting tone of the pelvic floor creates a valve-like mechanism that surrounds the pelvic outlets of the urethra, vagina, and rectum. When this resting tone is damaged, the pelvic organs can prolapse through the genital hiatus. Female pelvic organ prolapse is a set of conditions within pelvic floor disorders. It includes herniation of the anterior
or posterior vaginal walls, the apex of the vaginal vault, or the uterus itself. In addition to age and weight, there are multiple factors that predispose women to prolapse. These include Caucasian race; pregnancy; vaginal birth and its complications (especially damage to the muscle bundles of the levator muscles and pelvic floor nerves); pelvic surgery; pelvic radiation; inherent tissue weakness; and previous accidents or pelvic damage. Chronic constipation, smoking, and heavy lifting also can contribute to prolapse. Women may present with a variety of symptoms, including a bulge or protrusion from the vagina, urinary symptoms, colorectal symptoms, sexual dysfunction, and discomfort when exercising. Urinary symptoms can range from incontinence to obstruction, with stress incontinence affecting 40 percent of patients with prolapse. Fecal symptoms may include the need for splinting (placing a finger in the vagina to aid in defecation) and incontinence. Physicians should examine prolapse with a single-bladed speculum to evaluate anterior and posterior vaginal defects as well as descent of the apex of the vagina (after a hysterectomy) or of the uterus itself. A single-bladed speculum can be created by unscrewing the two blades and simply removing the top half. Evaluation of the level of prolapse descent and any concomitant incontinence, including a post-void residual, make up the bulk of the exam. Classification or gradation of prolapse was previously accomplished by the BadenWalker System, which describes prolapse by type (anterior, posterior, or apical) and grade (1 to
Minnesota Physician October 2014
Managing pelvic organ prolapse Management includes a variety of options that range from conservative therapyâ€”lifestyle modification, physical therapy, and Kegel exercisesâ€”to pessaries or surgery. All patients deserve a nonsurgical discussion even if they come in requesting surgery. The goal of conservative management is to improve symptoms, reduce progression, and avoid or delay surgery. Weight loss in an obese woman cannot undo the damage already causing prolapse, but it can reduce symptoms. Smoking cessation and constipation treatments also can improve the symptoms. The InTone device and biofeedback have potential for improving symptoms associated with prolapse, including muscle strengthening in the pelvic floor and decrease in concomitant symptoms such as urinary incontinence. InTone is a biomedical device used for home biofeedback therapy that strengthens the pelvic floor musculature. The device inserts into the vagina and sends small electrical pulses used in conjunction with a teaching video to provide active at-home physical therapy. Pessaries are very useful for patients who are irritated by their symptoms and want nonsurgical treatment. These devices come in a variety of
shapes and sizes, and the many options almost always yield a functional fix for these patients within one or two visits for appropriate sizing of the pessary. Risks include erosion of the vaginal wall, but this complication occurs mainly with the larger space-filling pessaries. These devices can be used as a lifelong solution to prolapse. Prolapse can be maintained at its current stage, but it rarely improves over time unless surgically corrected. The symptoms may improve, but the actual defect does not. Surgical advances designed to restore anatomy are coming to the forefront of prolapse, but they must be approached cautiously and with fully informed consent. Currently a woman has an 11 percent to 20 percent lifetime risk of undergoing surgery for pelvic floor disorders. Surgical repairs are the most common inpatient surgical procedure performed in women over 70 and carry an annual U.S. cost of more than $300 million. Traditional prolapse repairs such as sacrospinous ligament fixation, uterosacral ligament fixation, laparoscopic repair of paravaginal defects, and anterior/posterior colporrhaphy lead to recurrence rates as high as 58 percent. These repairs are used infrequently, such as when a patient requests surgery and declines mesh or if a surgeon uses them in conjunction with another surgery to augment the repair. This might include an anterior repair in conjunction with a sacrocolpopexy if there is residual anterior compartment prolapse after the sacrocolpopexy mesh is put in place. Plication procedures use the patient’s own ligaments as support material to suspend the prolapsing organs. These surgeries tend to degrade over time, enabling the prolapse to return. The mesh controversy Synthetic mesh devices gained popularity with surgeons who attempted to reduce the high recurrence rate of traditional prolapse repairs. The rates did drop to between 2 percent and 5 percent, but considerable controversy arose with the use
of mesh devices. The sacrocolpopexy with polypropylene mesh is the gold standard for surgical repair of prolapse in women with a uterine descent or apical prolapse after a hysterectomy. This mesh carries the least amount of controversy with its use. Robotics seem to offer an improvement over laparoscopic or open techniques due to the amount of stitching and dissection needed along the pelvic sidewall during surgery. The highly debated drawbacks of robotics include increased cost and operating time, mostly when a surgeon is learning, but surgeons often favor the robotic approach due to the improved ergonomics and ease of completing the procedure. Erosion rates into the vagina, bladder, or bowel are very low for this procedure, as the vagina is never entered. Vaginally placed mesh slings, on the other hand, have produced some unacceptable results. Correction of an anterior or posterior compartment defect requires transecting the vaginal mucosa and anchoring a mesh between the mucosa and the underlying fascia. The mesh is suspended through natural connective tissue structures. These particular meshes are the central portion of the recommendation by the U.S. Food and Drug Administration that mesh be labelled “high-risk” and have certain guidelines as to who should place them and what patient counseling is necessary. Overall, transvaginal mesh yields decent outcomes in the short term for anterior compartment prolapse. They are no longer considered acceptable for posterior compartment prolapse. The main risks of this procedure appear to be erosion into the vagina, pelvic pain, and dyspareunia. Erosion can usually be treated fairly successfully with mesh excision, but the pain is more difficult to manage. In reality, mesh devices are not inherently flawed. They are just overused or used by the wrong people. Physicians consulting with women interested in a mesh device should
always mention the possibility of dyspareunia, pelvic pain, fistulae, repeat surgeries, mesh erosion, and revision. Physician training is very important, as is familiarity with the exact mesh being placed. It has come to light, with the recent American Urogynecologic Society (AUGS) stance, that many gynecologists simply are not equipped to place transvaginal prolapse repair mesh. In many practices, a specialist in female pelvic medicine and reconstructive surgery, or other professionals with similar levels of experience, will perform these procedures. Patients who already have undergone multiple prolapse procedures and request another require the attention of a highly trained specialist. Guidelines currently are being devised for recommendations regarding all mesh repairs for prolapse. The last recourse in prolapse is for a patient to choose to fix her prolapse at the expense of
future sexual function. A colpocleisis corrects the prolapse, but obliterates the vagina, thus holding up the uterus or vaginal apex. The importance of follow-up Whichever method of treatment (or lack thereof) a patient decides upon, close follow-up is necessary to monitor the condition of the prolapse over time. Repairs can degrade, mesh can become exposed, and conservative treatments can fail. Close follow-up ensures that the patient is well evaluated for her prolapse and treatment efficacy, and it ensures that the patient knows she is in the right hands. As physicians, we all should try our best to help our patients with this poorly understood and vastly undertreated problem. Vanessa Knoedler, MD, is board-certified in obstetrics and gynecology, and practices with Metro OBGYN in its St. Paul, Maplewood, and Woodbury offices.
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Complex Wound Care
Introducing the newest member of our TCU team: Cristina Presbitero, BSN, RN, WCC
Cristina Presbitero is a Med-Surg and Wound Care Certified RN with over eight years of experience in complex wound care and enterostomal nursing and consulting. This means: • More wounds managed in house versus out patient, reducing total care cost and rehospitalization. • Wound vac management. • Track healing rates on hospital and house-acquired wounds, incident bases on diagnosis and risk factors, reducing hospitalization. Questions? Please contact our Admissions Coordinator Kelly Emerson at 651-632-8842
October 2014 Minnesota Physician
Health care policy
n Jan. 1, 2014, Minnesotans gained access to new health insurance coverage options through the Affordable Care Act (ACA). These options included an expansion of Medicaid coverage for adults with annual incomes of up to 138 percent of the federal poverty level (or up to $16,105 for a single-person household) and new premium tax credits and cost-sharing subsidies for the purchase of private coverage through Minnesota’s new health insurance marketplace, MNsure. These new options, along with an in-
Coverage impacts of the ACA Implications for our health-care delivery system By Julie Sonier, MPA, and Elizabeth Lukanen, MPH dividual mandate to have health insurance coverage, have led to shifts in Minnesota’s health insurance coverage landscape. These shifts have implications
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651-292-9292 | saintpaulhotel.com | 800-292-9292
Minnesota Physician October 2014
for all sectors of the health care market, including physicians and other health care providers. Changes in the size and composition of the insured population have the potential to change the composition of providers’ typical patient population (e.g., age and health status), alter demand for services, and transform the system capacity needs. There is great interest in having timely information to understand how the ACA has affected Minnesota so far. Historically, population surveys have been used to monitor state-level changes in health insurance coverage. However, given lags in data collection, relevant estimates from these surveys will not be available until the fall of 2015. Information on national-level impacts is beginning to be available, but there are many reasons to believe that the law’s impacts on health insurance coverage will vary by state: different policy choices that states have made about implementing the law, variation in prior uninsurance rates across states, and variations in state demographic and economic characteristics. To assess the state-level impacts of the ACA in a more timely way, the State Health Access Data Assistance Center (SHADAC) at the University of Minnesota published an analysis using a unique method to estimate how patterns of health insurance coverage in Minnesota have shifted since the fall of 2013. The analysis and report were prepared at the request of MNsure, Minnesota’s state-based health insurance exchange, and the work was funded through a grant from the Robert Wood Johnson Foundation’s State Health Re-
form Assistance Network. This article provides a brief summary of the SHADAC research and discusses its implications for the health care system. The full report is available at (www. shadac.org/MinnesotaCoverag e Report). Methods and data Although some piecemeal information has been available about the ACA’s impacts in Minnesota, such as the number of people who have enrolled in coverage through MNsure, this information only tells part of the story. An accurate assessment of the ACA’s impacts needs to account for shifts between coverage sources—for example, some people who signed up for coverage through MNsure may have previously had other coverage. To accurately assess the statewide impacts of the ACA, SHADAC measured the health insurance coverage status of the entire population of Minnesota at two points in time: Sept. 30, 2013, and May 1, 2014 (see Fig. 1 on page 33). We chose these dates to provide a snapshot of coverage in the state immediately before MNsure’s first open enrollment period and one month after the end of open enrollment. This allowed us to account for enrollments that had been started but not completed prior to the official end of open enrollment on March 31. This method of measuring population-wide changes in the number of people with each type of coverage provided a complete picture of how health insurance coverage in Minnesota has changed, rather than the partial picture based on the limited data that were previously available. We gathered information from private and public payers on the number of Minnesota residents enrolled in their health plans on these two dates. The data for our study came from the following sources: U.S. Census Bureau (for population totals); the Minnesota Council of Health Plans (reporting for private health plans); MNsure; the Minnesota Department of Human Ser-
vices; the federal government’s Centers for Medicare & Medicaid Services; the Minnesota Comprehensive Health Association; and the 2013 Minnesota Health Access Survey (a biannual health insurance survey of Minnesota households that is conducted jointly by the Minnesota Department of Health and SHADAC). We calculated the net increase or decrease in the number of people with each type of coverage listed in Figure 1, and used this information to estimate the change in the number of uninsured Minnesotans. Additional details about our data, methods, and assumptions are included in the full report on the SHADAC website. Results Our study results are shown in Figure 2 (see page 34) and Figure 3 (see page 36). We estimate that there were approximately 180,500 fewer uninsured Minnesotans on May 1, 2014, compared to the number of uninsured on Sept. 30, 2013. In other words, the size of the uninsured population in Minnesota declined by 40.6 percent. The vast majority of the increase in insurance coverage is attributable to enrollment growth in Minnesota’s public insurance programs, Medical Assistance and MinnesotaCare. Combined, these two programs exhibited enrollment growth of more than 155,000 people. This result was not particularly surprising to us, given previous research from the Minnesota Department of Health showing that an estimated two-thirds of Minnesota’s uninsured population was eligible for public coverage but not enrolled. The number of people with private insurance coverage also increased, by about 30,000 statewide (an increase of 36,000 in nongroup coverage offset by a decline of 6,000 in group coverage). While the private group market remained relatively stable (a decline of about 0.2 percent), the distribution of enrollment shifted slightly from fully-insured to self-insured plans. The private nongroup
health insurance market grew by 12.5 percent and was driven by enrollment in MNsure, but also included enrollment growth in the nongroup market outside of MNsure (direct purchase).
Figure 1. Minnesota health insurance market
• Fully-Insured, Non-SHOP • Self-Insured • Small Business Health Options (SHOP)
• Direct Purchase • High-Risk Pools (MCHA and PCIP) • MNsure
• Medical Assistance • MinnesotaCare • Medicare
Implications In a series of seminal reports, the Institute of Medicine (IOM) documented the consequences of uninsurance. The main findings of the IOM’s work included the facts that people who are uninsured have worse health and die younger than people with health insurance, are more likely to delay or forgo needed medical care, and experience significant financial strains and mental stress. In addition, the studies found that the problem of uninsurance has negative financial consequences for health care providers and the communities they serve. In communities with high levels of uninsurance, even people with insurance coverage are more likely to have difficulty obtaining needed care.
Recent research evidence from Massachusetts and Oregon illustrates the impacts on health care access and use of reducing the number of uninsured. In Massachusetts, a study by Sharon Long showed large reductions in the number of uninsured in the first year after implementation of a comprehensive reform law similar to the ACA. These reductions in uninsurance were accompanied by an increase in the share of individuals who got a doctor’s visit for preventive care, a reduction in the share of people who did not get needed care, and a reduction in the share of adults with high out-of-pocket costs and problems paying medical bills. The proportion of adults who had a usual source of care also increased. However, this same study reported an increase in the percentage of people who had unmet health care
needs because they couldn’t get an appointment or find a provider who would see them; this suggests that increases in the demand for care may strain system capacity, at least in the short run. A more recent study by Benjamin Sommers, Sharon Long, and Katherine Baicker examined the impacts of health care reform on mortality rates in Massachusetts’ counties, and found reductions in all-cause
and “health care amenable” mortality compared to similar counties in other states. In Oregon, results from a study of uninsured individuals who were randomly selected to receive Medicaid coverage showed that compared to the uninsured, individuals with Medicaid coverage increased Coverage impacts of the ACA to page 34
Family or Internal Medicine Physician An ideal balance between your professional and personal life. Provide comprehensive care in a clinical and hospital practice. ER coverage available, but not required. GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cites. For more information Call Kirk Stensrud, CEO 320.634.4521 Mail CV to: Kirk Stensrud, CEO 10 Fourth Ave SE Glenwood, MN 56334 Email CV to: firstname.lastname@example.org
October 2014 Minnesota Physician
Coverage impacts of the ACA from page 33
Figure 2. Shifts in Minnesota health insurance coverage (Sept. 30, 2013 – May 1, 2014)
Number of people Type of insurance
Sept. 30, 2013
May 1, 2014
Percent of population Difference
Sept. 30, 2013
May 1, 2014
Private insurance Group insurance Fully-insured (non-SHOP) Self-insured SHOP Total, group insurance Nongroup insurance Direct purchase MCHA Federal high-risk pool (PCIP) MNsure Total, nongroup insurance Total, private insurance
948,925 2,113,828 — 3,062,753
908,984 2,146,982 761 3,056,726
(39,941) 33,154 761 (6,027)
17.5% 38.9% 0.0% 56.4%
16.7% 39.4% 0.0% 56.1%
-0.8% 0.5% 0.0% -0.3%
262,301 25,506 733 — 288,540 3,351,293
273,555 8,690 — 42,265 324,510 3,381,236
11,254 (16,816) (733) 42,265 35,970 29,943
4.8% 0.5% 0.0% 0.0% 5.3% 61.7%
5.0% 0.2% 0.0% 0.8% 6.0% 62.0%
0.2% -0.3% 0.0% 0.8% 0.6% 0.3%
Public insurance Medical Assistance MinnesotaCare Medicare Total, state programs Total, public insurance
622,044 131,926 879,389 753,970 1,633,359
834,140 75,345 896,150 909,485 1,805,634
212,096 (56,581) 16,760 155,515 172,275
11.5% 2.4% 16.2% 13.9% 30.1%
15.3% 1.4% 16.4% 16.7% 33.1%
3.8% -1.0% 0.2% 2.8% 3.0%
Uninsured Uninsured Total population
Coverage impacts of the ACA to page 36
Are you satisfied with your claims processing? You will be with ClaimLynx! Every medical practice depends on cash flow. Very few people understand the required processes between when a doctor sees a patient and how/when insurance reimbursement is disbursed. We make these steps simple for you. Among the services we offer: • Direct, real time verification of eligibility • Secure online access to claims tracking • Secure online access to claims correction • Never miss a payment due to late filing • We handle every kind of insurance and every medical specialty • Less time on paperwork, more time with patients
ClaimLynx is used by many national clearinghouses. You may already be using our services and not know it. Shorten your submission route and remittance time—go straight to the payer using ClaimLynx. Every practice is unique and whether a solo practitioner or large multi-specialty group (and everything in between) we can tailor a solution to your claims processing needs that will maximize your benefits.
Claims processing is an art. Let us show you the difference we can make
For more information please contact: Russel Campbell email@example.com 10700 Old County Road 15 Suite 200, Plymouth, MN 55441
Minnesota Physician October 2014
Sioux Falls VA Health Care System
Join the top ranked clinic in the Twin Cities
Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package.
A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:
The VAHCS is currently recruiting for the following healthcare positions in the following location.
Sioux Falls VA HCS, SD Primary Care (Family Practice or Internal Medicine)
• Family Practice • Urgent Care
Pulmonologist Oncologist Cardiologist (part time)
We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years. We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.
Please contact or fax CV to:
Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429
763-504-6600 Fax 763-504-6622
Physician Assistant (Mental Health)
Sioux Falls VA HCS (605) 333-6852 www.siouxfalls.va.gov
Applicants can apply online at www.USAJOBS.gov
Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an outpatient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal. HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and beneﬁt package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.com/careers or contact firstname.lastname@example.org. Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE
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MN Physician 4" x 5.25" 4-color
Take your leadership career in a new direction At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our 90+ clinics, 12 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel.
Make a difference. Join our award-winning team. 1-800-248-4921 (toll-free) Crystal.Lester@allina.com
18821 0714 ©2014 ALLINA HEALTH SYSTEM. TM - A TRADEMARK OF ALLINA HEALTH SYSTEM. EOE/AA/Vet/Disabled Employer
Apply today at allinahealth.org/careers October 2014 Minnesota Physician
the health care system.
Coverage impacts of the ACA from page 34
Reducing the number of uninsured also has financial implications for health care providers. A June 2014 report by the Colorado Hospital Association analyzed data from 30 states (not including Minnesota)
Figure 3. P ercent change by type of insurance (Sept. 30, 2013 – May 1, 2014)
-10% -20% -30% -40% -50% their use of health care, were less likely to have unpaid medical bills or experience other financial hardships, and had fewer positive screenings for depression. However, the researchers also found higher
use of the emergency department for nonemergent, primary care treatable, and emergent preventable visits. This finding suggests that people who are newly insured may need education and assistance to navigate
The problem of uninsurance has negative financial consequences for health care providers and the communities they serve. and found a 30 percent drop in average charity care per hospital in states that implemented the ACA’s Medicaid expansion, while states that did not expand Medicaid experienced no changes. The study compared the first quarter of 2014 to the same period in 2013. Although payment rates for patients with Medicaid coverage are usually
substantially lower than rates for people with private insurance, reductions in uncompensated care should provide financial relief to health care providers and reduce shifting of these costs to private-pay patients. In summary, the early impacts of the ACA in Minnesota include a large and rapid decline in the number of people who lack health insurance. More analysis needs to be done to determine how these coverage gains will affect population health, demand for health care services, and health care providers. Results from studies in other states suggest that improvements in access to health care are likely, but will come with new challenges. Julie Sonier, MPA, is a senior research fellow and deputy director at the State Health Access Data Assistance Center (SHADAC), located in the University of Minnesota School of Public Health. Elizabeth Lukanen, MPH, is a senior research fellow at SHADAC.
Physician Practice Opportunities Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership.
Avera Marshall Regional Medical Center 300 S. Bruce St. Marshall, MN 56258
Currently we are seeking to add the following specialists:
• General Surgery
• Internal Medicine
• Radiation Oncology
• Family Practice
For details on these practice opportunities go to http://www.avera.org/marshall/physicians/ For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691 • Dave.Dertien@avera.org
Minnesota Physician October 2014
Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We are seeking BC/BE fullrange family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice. For consideration, apply online at healthpartners.com/careers and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact email@example.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE
WE CHOSE MERCY FOR THE PRACTICE; WE’RE STAYING FOR THE COMMUNITY! Mercy and North Iowa offer: • Premier rural health care network in northern Iowa and southern Minnesota; • Centers of Excellence: Bariatric, Breast Imaging; • Family-friendly communities with plenty of parks, great schools and activities; • Culture: museums, nature centers, The Legendary Surf Ballroom; • Half-way between Des Moines and Mpls/St. Paul
Family Medicine (with and without OB) Opportunities in the following North Iowa communities: • Ackley/Iowa • Emmetsburg Falls • Hampton • Algona • Lake Mills • Britt • Mason City • Clear Lake • Osage • Cresco
For more information:
Cindy Scott: 641-428-5551, firstname.lastname@example.org www.mercynorthiowa.com
Jonna Quinn, D.O., OB/GYN, joined Mercy 2013 Mark Lloyd, D.O., Family Medicine, joined Mercy 2014
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MN Physician 4" x 5.25" 4-color
HEALTH Fairview-Southdale Hospital ICU Medical Director
The perfect match of career and lifestyle.
University of Minnesota Physicians is seeking a Medical Director for the Fairview-Southdale ICU (FS-ICU). This position will provide and direct outstanding care of critically ill patients in a multidisciplinary ICU at Fairview-Southdale Hospital. This position will also serve as Chair of the multidisciplinary critical care committee. The majority of efforts will be onsite at Fairview-Southdale Hospital.
Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties:
Requirements for this position include:
• ENT • Family Medicine • General Surgery • Geriatrician • Outpatient Internal Medicine
• Hospitalist • Infectious Disease • Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery
• Pediatrics • Psychiatry • Psychology • Pulmonary/ Critical Care • Rheumatology • Urgent Care
F O R M O R E I N F O R M AT I O N :
Kari Lenz, Physician Recruitment | email@example.com | (320) 231-6366 www.acmc.com |
• Have or be eligible for MN State Medical License • Board certified in Critical Care (Anesthesia, Medicine, Surgery or Pulmonary; Pulmonary physicians will have opportunity to develop additional practice if desired) • Four years of experience post fellowship is preferred • Experience in a community setting strongly desired
FOR MORE INFORMATION AND A COMPLETE JOB DESCRIPTION, CONTACT: Greg J. Beilman, M.D. Medical Director, Fairview System Critical Care Program Deputy Chair, Department of Surgery University of Minnesota 420 Delaware Street S.E., Mayo Mail Code 195 Minneapolis, MN 55455 EMAIL: firstname.lastname@example.org October 2014 Minnesota Physician
Diabetes education from page 29
abetes report never having had formal diabetes education. Both the patient and your practice will benefit from getting even those who have had diabetes for a while into a DSME program. Refer patients with diabetes to a CDE or to a DSME center annually. Just as diabetes self-care is an ongoing process, self-care education and training should be ongoing as well. A lot can change in a year, requiring different self-care practices. Patients also can get discouraged if they are not meeting care goals or seeing the results they want. A diabetes educator can get them back on track, coach and inspire them to make changes, and serve as a liaison to the primary care team who may be unaware of the patient’s struggles. You can find a listing of ADA-recognized diabetes education centers at: www.professional.diabetes.org/ erp_zip_search.aspx. AADE-accredited education centers are
listed at: www.diabeteseduca tor.org/ProfessionalResources/ accred/Programs.html. AADE also has a searchable diabetes educator directory on its website. How can diabetes educators further benefit your practice? Consider making CDEs active members of your care team. A CDE is a credentialed nurse, dietitian, pharmacist, or other health professional having a minimum of two years of clinical experience and at least 1,000 hours of DSME practice. A CDE also must pass a rigorous certification exam and obtain at least 15 CEUs (continuing education units) related to diabetes each year. CDEs can titrate meds and adjust the treatment, help the patient set goals and achieve them, provide medical nutrition therapy, remind patients of routine preventive visits, and stimulate lasting healthy behavior changes. They can help manage comorbidities of diabetes such
as hyperlipidemia and hypertension. They also can link patients to community resources such as social services and smoking cessation, fitness, and weight loss programs. A number of innovative practices are seeing real advantages to expanding the role of their CDEs to include case management, care coordination, chronic disease program management, patient navigation, health and wellness promotion, and research. CDEs can provide solutions that manage the needs of patients with complex health issues. They also can play an integral role in care transitions. The chair of the AADE Minnesota Network, Jodi Lavin-Tompkins, says it best, “Since the majority of [diabetes] patients are managed by primary care providers, diabetes educators are becoming embedded within primary care sites. As more people are diagnosed with prediabetes and diabetes, this team approach is what is
going to make the difference. “Diabetes education is really a misnomer because we do much more than just educate. We focus not only on glucose, but also on the other comorbidities that often present in our patients with diabetes. Our patients deserve to have access to the knowledge and skills that will help them live better with this lifelong disease. If your patient was a family member, wouldn’t you want that to happen? Thank you so much for partnering with us!” Laurel Reger, MBA, is a program planner with the Minnesota Department of Health Diabetes Program and co-chairs the Improving Patient Access to Diabetes Education group working to improve the use of DSME programs. Mary Beth Dahl, RN, is a program manager at Stratis Health. She leads the Reducing Disparities in Diabetes Care: Everyone with Diabetes Counts (EDC) initiative by addressing barriers and improving access to education programs on diabetes self-management across Minnesota.
Behavioral Health Assistant Medical Director – Outpatient Care Minneapolis/St. Paul, Minnesota HealthPartners Medical Group is a large, successful, award-winning multispecialty physician practice in Minneapolis/St. Paul, Minnesota. Our Behavioral Health Division seeks a high-energy, visionary psychiatric leader for all HealthPartners Behavioral Health outpatient sites and services throughout the Twin Cities metropolitan area. Our ideal candidate is an engaging, adaptable, forward-thinking leader who focuses on collaboration and creativity while effectively analyzing our internal data in order to achieve national benchmarks for quality of care, patient satisfaction and affordability. In partnership with the Director of Outpatient Professional Services, you will ensure excellence in the care, patient satisfaction and stewardship of mentally ill and substance abuse patients while continuously improving our systems, encouraging the professional growth, satisfaction and interdisciplinary teamwork of our providers and staff, and promoting integration and collaboration efforts with HealthPartners’ primary and specialty care divisions and the community. You will be responsible for the clinical quality, productivity and efﬁcient use of outpatient clinical care resources, performance improvement processes and outcomes, and documentation/billing/compliance for our clinicians. As liaison with our outpatient primary and specialty care physicians, we will rely on you for communication and networking, as well as mentoring and professional consultation to our clinical directors. Board certiﬁcation in psychiatry with at least two (2) years of administrative and ﬁve (5) years of clinical experience is strongly preferred; Minnesota medical licensure and unrestricted credentialing eligibility are required. Forward your CV and cover letter to email@example.com, or apply online at www.healthpartners.com/careers. Call (800) 472-4695 x1 for more information. EOE
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38 Minnesota Physician Minnesota Physician 8.5" x 5.25" B&W
BC/BE Family Practice Mercy Family Clinic – Lake Mills, Iowa (Outpatient only) Manage your own outpatient practice This outstanding practice opportunity provides approximately 75-100 outpatient visits per week. Become part of a 9-hospital and 43-clinic Mercy Health Network–North Iowa. Services include: Primary Care–for men, women and children of all ages, Laboratory, X-ray, EKG, Podiatry Clinic, Behavioral Services-Individual and Family Counseling Lake Mills is a family oriented community of approximately 2,000 people.
Opportunities for full-time and part-time staff are available in the following positions:
Located just 35 miles from Mason City, Iowa and 117 miles from Minneapolis, MN, it is home to many high quality businesses, an industrious labor force, excellent municipal facilities and an equitable tax structure. An abundance of amenities include a new aquatic center, a beautiful golf and country club, and four city parks. Outdoor activities abound and the excellent school system was one of 64 nationwide to be named a “Service Learning Leader.”
Practice where your skills are appreciated, where physicians are highly respected members of the community, where you and yours will flourish as you become rooted in a lifestyle second to none.
• Medical DirectorExtended Care & Rehab • Geriatrician/ Hospice/ (Geriatrics) Palliative Care • Ophthalmologist • Internal Medicine/ Family Practice
Jonna Quinn, D.O., OB/GYN, joined Mercy 2013 Mark Lloyd, D.O., Family Medicine, joined Mercy 2014
Applicants must be BE/BC.
Send CV to: firstname.lastname@example.org (888) 877-5551 or (641) 428-5551 www.mercynorthiowa.com Mercy Medical Center–North Iowa
1000 4th Street SW, Mason City, IA 50401
Olmsted Medical Center, a 160-clincian multispecialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.
Opportunities available in the following specialties: Cardiologist Rochester Southeast Clinic Child Psychiatrist Rochester Southeast Clinic Family Medicine Byron Clinic Pine Island Clinic General Surgery Call Only – Rochester Hospital Hospitalist Hospital Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: email@example.com Phone: 507.529.6748 Fax: 507.529.6622
US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible recruitment bonus. EEO Employer. Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.
For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303
www.olmstedmedicalcenter.org October 2014 Minnesota Physician
Systematic case review from page 27
depressive symptoms improve (PHQ-9 improved by at least five points or now are under 10), compared to the initiative’s goal of 40 percent. • Only 28 percent of diabetes patients had their HbA1c in control (<8.0) at baseline. That percentage improved to 42 percent (an absolute improvement of 14 percent, compared to the initiative’s goal of 20 percent). • Of the 450 patients identified with uncontrolled blood pressure at baseline, 237 have achieved control, an improvement of 53 percent compared to the initiative’s goal of 20 percent. While improving, their complex conditions make it difficult to graduate patients out of COMPASS, resulting in care manager capacity issues. Clinics now are moving toward
less frequency and length of contact for improving patients, implementing relapse programs, and determining patient follow-up postgraduation.
disease, he or she enters the clinic’s DIAMOND program. According to Hedlund at North Memorial, “As health care moves to Total Cost of Care and accountable care organizations, we need a way to holistically care for these complex patients without compromising the entire workflow in a clinic. We’re looking at what
Integration and sustainability Medical groups currently are exploring how to integrate the model into their workflows, and how to sustain it once Survival will be based on payment through the getting better outcomes. CMS grant ends. Medical groups report that the model is most beneficial and definitely needed for the very complex patient at the top strata of their health care homes, but possibly unnecessary for other patients. So, they are exploring stratification. At Stillwater, if a patient is severely depressed but doesn’t quite meet COMPASS eligibility criteria for diabetes or cardiovascular
elements of COMPASS can be applied on a broad scale to serve this population.” Participating medical groups continue to see the COMPASS vision and its implementation as essential for building better health care systems going forward.
“The model requires more FTE [full-time employee] hours, maybe a social worker, and more robust patient registries to monitor and treat this population,” notes Dr. Sanford. “But as payment shifts to outcomes, COMPASS is showing its potential to improve the health of our sickest patients who do not reach care goals in the current visit-based model.” “Our survival will be based on getting better outcomes, lower costs, building for the future. If this type of care can’t achieve those goals, I don’t know what will,” says Dr. Keeling. This article was made possible by grant number 1C1CMS331048-01-00 from the Department of Health and Human Services, Centers for Medicare & Medicaid Services. Jim Trevis is director of marketing and communications at the Institute for Clinical Systems Improvement.
Family Medicine & Physician Assistant
Great Opportunity In a St. Cloud area URGENCY CENTER
• Immediate Openings • Casual weekend or evening shift coverage • Set your own hours • Competitive rates • Paid Malpractice
763-682-5906 | 763-684-0243 firstname.lastname@example.org www.whitesellmedstaff.com 40
Minnesota Physician October 2014
Psychiatrist Unique Practice – Unique Psychiatrist Needed! HealthPartners Medical Group is a top Upper Midwest multispecialty group practice based in Minneapolis/St. Paul, Minnesota. We have a unique metropolitan-based outpatient position available for a talented, bilingual BC/BE psychiatrist interested in a non-conventional practice. This full-time position combines cross-cultural psychiatric medicine with community mental health. Receiving practice support from both HealthPartners Center for International Health and from the Ramsey County Mental Health Center, 0.5 FTE of the position will provide psychiatric care to an international refugee patient population utilizing an integrated holistic/ primary care model. The other 0.5 FTE of the position will work as part of a multidisciplinary team to provide care to individuals with serious mental illness, chemical health difﬁculties and/or co-occurring medical problems. This exciting practice is full-time, but qualiﬁed candidates interested in part-time outpatient opportunities in Cross-Cultural Psychiatric Medicine or Community Mental Health are encouraged to apply. In addition to a competitive salary and beneﬁts package, there are opportunities for an academic faculty appointment at the University of Minnesota, teaching involvement in the Global Health Pathway (globalhealth.umn.edu) and further development of best practice programming at Ramsey County Mental Health Center. For consideration, please forward your CV and cover letter to email@example.com, apply online at healthpartners.com/careers, or call Lori at (800) 472-4695 x1. EOE
General Adult Psychiatry
Be part of a broad-based mental health practice that is uniquely team-oriented! Hutchinson Health is seeking a sixth psychiatrist with a focus on general adult inpatient and outpatient care. Call responsibilities are 1 in 6. Compensation (salary plus productivity) and benefits are highly competitive. Our Mental Health services include a 12-bed inpatient unit and an outpatient clinic. The psychiatric staff includes two Fellowship-trained in child and adolescent, one Fellowshiptrained in geriatrics, 10 other mental health professionals, and two chemical dependency professionals. Hutchinson Health, 50 miles west of the Twin Cities, includes a 66-bed acute care hospital, a 30-physician multi-specialty clinic, and several outpatient and specialty clinics. It serves 35,000 as the primary health care provider.
Hutchinson Health is an approved National Health Services site. Patient safety and evidence-based care are at the core of all clinical processes.
For further information, contact Hutchinson Health Human Resources: (320) 484-4685 or firstname.lastname@example.org healthpartners.com © 2014 NAS (Media: delete copyright notice)
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Psychiatric consultations for children from page 19
immediately available bridgeresource to primary care. With a successful 12-month grant-supported period, it is hoped that PAL can continue through an extended grant or third-party funding. PAL provides mental health clinical triage and voluntary psychiatric consultations to primary care clinicians in a way that is convenient, effective, and free. By providing these services, PAL supports and empowers primary care clinicians treating patients with mental illnesses; it strengthens the existing capabilities of primary care providers; and reinforces best practices. Reimbursement methodologies currently exist for primary care providers to be compensated for their time and efforts in accessing PAL.
Feedback The administrators of PAL and PrairieCare Medical Group continually gather and assess feedback from primary care regarding service needs and effectiveness. This is done through the dissemination of a “pre-survey,” which was conducted in July 2014 to help establish the service. The feedback from the pre-surveys showed that 88 percent of primary care providers reported being more comfortable managing psychiatric conditions if a CAP was available through a service such as PAL. According to the survey respondents, nearly 48 percent reported that they have little or no access to CAPs. The respondents also reported that they are seeking a service that offers easy access and immediate availability. More than 88 percent report having a need to consult with a CAP regarding medication advice and dosing.
PAL also collects follow-up surveys after each consultation to continually assess performance and improve the service. Feedback from follow-up surveys throughout July shows that 100 percent of the respondents “strongly agree” that the service was easy to access and that the CAP was helpful. All of the respondents also noted that their comfort level in treating mental illness in their clinic setting has increased as a result of contacting the service. Here is some of the feedback from PAL so far: • “What an amazing service. In just 15 minutes, I got at least three new ideas to help me manage my patient.” • “Very helpful, and so easy to access!! I will definitely spread the word.”
• “With the dearth of mental health services, a consult line like this is a lifeline for primary care providers.” For more information about PAL, please call (855) 431-6468 or visit www.mnpsychconsult.com.
Todd Archbold, LSW, MBA, is a licensed social worker, the chief development officer at PrairieCare, and the practice manager of PrairieCare Medical Group. He served on the Executive Committee of the Minnesota Collaborative Psychiatric Consultation Service. Linda Vukelich is the owner of Vukelich and Associates, Inc., an association management firm. She is the executive director of the Minnesota Psychiatric Society and the Minnesota Mental Health Community Foundation, and served on the Executive Committee of the Minnesota Collaborative Psychiatric Consultation Service.
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Minnesota Physician October 2014
GET READY FOR
STAY ON THE ROAD TO 10 STEPS TO HELP YOU TRANSITION The ICD-10 transition will affect every part of your practice, from software upgrades, to patient registration and referrals, to clinical documentation and billing. CMS can help you prepare. Visit the CMS website at www.cms.gov/ICD10 and find out how to: •
Make a Plan—Look at the codes you use, develop a budget, and prepare your staff
Train Your Staff—Find options and resources to help your staff get ready for the transition
Update Your Processes—Review your policies, procedures, forms, and templates
Talk to Your Vendors and Payers—Talk to your software vendors, clearinghouses, and billing services
Test Your Systems and Processes—Test within your practice and with your vendors and payers
Now is the time to get ready. www.cms.gov/ICD10
Official CMS Industry Resources for the ICD-10 Transition
5/28/14 1:52 PM
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Published on Oct 16, 2014
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