Volume XXVl, No. 6
September 2012
The Independent Medical Business Newspaper
Twin Cities Resident Council Joining forces on hospital handoffs and pagers By Lindsay Byrnes, MD, Sarah Lee, MD, Josh Becker, MD, Nate Scott, MD, and Ruth Thomson, MD
W
O
hen the newly formed Twin Cities Resident Council started meeting in the fall of 2011, the members wasted no time: By the close of the second meeting, they had agreed on two topics to target for improvement in metro-area teaching hospitals. By the spring of 2012, efforts were underway to disseminate their findings to the staff at those six hospitals. And now, the council is setting its sights on new ways to improve hospital care and patient safety. The council members, all experienced resident physicians from Twin Cities residency programs, are pioneers in this effort to improve patient care and safety in the metropolitan teaching hospitals. The council’s pur-
Breaking barriers
the Supreme Court largely n June 28, 2012, the What the upheld the law, with few U.S. Supreme Court issued its long-awaitSupreme Court’s changes. In the closely decided 5–4 opinion, the Supreme Court ed decision on the Patient decision means ruled that the ACA’s individual Protection and Affordable mandate provision was constifor doctors Care Act (often referred to tutional. The court viewed that as the Affordable Care Act and patients requirement as a or the ACA). The decision valid exercise of By Paul Thissen, JD, removes substantial uncerCongress’s constiand Amber Thomas, JD tainty about the future directutional power tion of health care reform in to levy taxes. this country. The court did, however, Prior to the decision, some commentainvalidate a provision requirtors speculated that the so-called individual ing states to expand their mandate, which requires most legal resiMedicaid coverage or risk the dents of the United States to obtain health loss of federal funding. In insurance by Jan. 1, 2014, or pay a penalty effect, the Supreme Court’s tax, would be struck down and, with that, the whole ACA would fall. As it turns out, BARRIERS to page 10
COUNCIL to page 30
MINNESOTA HEALTH CARE ROUNDTABLE Page 18
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CONTENTS
SEPTEMBER 2012 Volume XXVI, No. 6
FEATURES Breaking barriers What the Supreme Court’s decision means for doctors and patients
1
MINNESOTA HEALTH CARE ROUNDTABLE
By Paul Thissen, JD, and Amber Thomas, JD
Twin Cities Resident Council Joining forces on hospital handoffs and pagers
1
By Lindsay Byrnes, MD, Sarah Lee, MD, Josh Becker, MD, Nate Scott, MD, and Ruth Thomson, MD
Minnesota Health Care Roundtable Specialty pharmacy
18
T H I R T Y- E I G H T H
SESSION
Background and Focus: The recent Supreme Court ruling on the Affordable Care Act clears the way for implementation of health insurance exchanges. States have the option of creating their own exchange by January 2014 or joining one created by the federal government. A health insurance exchange would provide consumers a place to compare and shop for health insurance coverage. In Minnesota this idea was first proposed as part of the Pawlenty administration’s healthAssuring they are meaningful care reform task force, and Gov. Dayton is a strong supporter of Thursday, November 1, 2012 creating a state-run program. 1:00 – 4:00 PM • Duluth Room Though simple and compelling at Downtown Mpls. Hilton and Towers first brush, creating a consumeraccessible, “apples-to-apples” website for comparing health insurance costs is challenging and very complex.
Health Insurance Exchanges:
DEPARTMENTS 4
GASTROENTEROLOGY IBD treatment
MEDICUS
7
By James Abraham, MD, and Robert D. Madoff, MD
INTERVIEW
8
CAPSULES
Joseph Gryskiewicz, MD
26
By Andrew Tubesing, MSEE
Minnesota Society of Plastic Surgeons
POINT OF VIEW Supreme Court ruling on the ACA
PATIENT PERSPECTIVE Living with IBD
16
PROFESSIONAL UPDATE: PEDIATRICS Back pain in children 36 By Tenner Guillaume, MD
12
Minnesotans react
Objectives: We will define what a health care insurance exchange is and, considering the detailed and proprietary design of health insurance coverage, how it can be meaningful. Health insurance policies contain terms like “medically necessary,” “investigative,” “cosmetic,” “not medically necessary,” and “contract/benefit exclusion”—all terms that are defined differently by different insurers. This alone makes it virtually impossible for anyone to compare plans effectively. Further, networks of providers vary, depending on whether you choose the “bronze,” “silver,” “gold,” or “platinum” option within a given insurer, as will access to hospital-based facilities, DME providers, and ancillary services. Throw in features like “deductibles,” “co-insurance,” “maximum out-of-pocket expenses,” “formulary design,” and “covered preventive services,” and you have a bewildering mathematical matrix. We will offer suggestions as to how an insurance exchange can address these issues and provide a meaningful, consumer-friendly comparison service. Panelists: Peter Dehnel, MD, President, Twin Cities Medical Society; Medical Director for Utilization Management, BC/BS MN Beth McMullen, Health Policy Director, Minnesota Business Partnership
The Independent Medical Business Newspaper
Manny Munson-Regala, JD, Deputy Director of the Health Insurance Exchange, Department of Commerce Charles Sawyer, DC, Senior Vice President, Northwestern Health Sciences University Sponsors: Northwestern Health Sciences University • Novartis
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SEPTEMBER 2012 MINNESOTA PHYSICIAN
3
CAPSULES
Mayo Clinic Pays $1.26 Million on Billing Charges
Residency Center To Be Run by Essentia Health
Mayo Clinic has announced it will pay $1.26 million to settle a Department of Justice (DOJ) lawsuit concerning false claims to Medicare and Medicaid for pathology services that were not provided. Mayo Clinic officials call the claims a billing error and note that they repaid the original amount of false billing in 2007. “While Mayo Clinic corrected the error prior to knowledge of the Department of Justice’s suit and voluntarily refunded $262,975 to the government, Mayo agreed to settle with the DOJ for an additional $1 million because we believe the prolonged legal process would have been more costly than the settlement itself, and allows us to best direct our resources to patient care, education, and research,” the Rochester-based system said in an Aug. 2 statement.
The Duluth Family Practice Center (DFPC) has agreed to hand off its day-to-day management to Essentia Health in an effort to firm up the residency training center’s finances. For many years, the DFPC has worked in partnership with Essentia, St. Luke’s Hospital, and the University of Minnesota Duluth to train family practice physicians for Duluth and rural Minnesota. Officials say increasing regulatory and financial pressures, including cuts to state medical education funds, have endangered the center’s mission. Under the new arrangement, Essentia will provide management of the DFPC and the center’s employees will officially become Essentia employees. The center’s founding organization, the Duluth Graduate Medical Education Council, still will own the residency program, but the management and administration of the center will be handled by Duluth-based Essentia.
4
MINNESOTA PHYSICIAN SEPTEMBER 2012
Ann Bussey, vice president for the Essentia Institute for Rural Health, says that standalone residency centers are facing increasing financial pressures due to reimbursement cuts. “The whole idea was to associate the residency with a health system as a way to address the financial sustainability of the program,” she says. “It’s a way to increase volume of patients as well as reduce the costs of operating the clinic.” According to Daniel Nikcevich, MD, president of Essentia Health’s East Region, the change in management at the center will expand the number of locations where residents can train. He says the changes will help educate physicians on innovations such as team-based care, population care management, telemedicine, and electronic medical records. Nikcevich notes that Essentia’s support is matched by St. Luke’s hospital, and that the U of M also provides funding, and adds the three organizations have created a healthy partnership. “We’ve been able to make
this work because of the common vision about how it’s necessary to train family medicine residents to practice in rural communities,” Nikcevich says. “Obviously, Essentia and St. Luke’s are competitors. But for this purpose we’re able to transcend all that and become collaborators in the training of our residents.” John Strange, president and CEO of St. Luke’s, agrees that the partnership has been important for maintaining primary care residency training in the region. “I give Essentia a lot of credit for stepping up,” he says. “It’s a program that the health systems and the U of M should be proud of. It really speaks to the dedication of the Duluthbased systems to education.”
Accretive, Swanson Settle Lawsuit Accretive Health and Minnesota Attorney General Lori Swanson reached a settlement in July in the federal lawsuit that Swanson had filed over collection tactics and data privacy.
Under the terms of the settlement, Accretive will pay approximately $2.5 million to the state, and will cease operations in the state for the next six years. Money from the settlement will go to a restitution fund used to compensate patients, and any funds remaining will go to the state treasury. Swanson had sued Chicagobased Accretive over its management of revenue operations for several hospitals in the state, including hospitals with Fairview Health System, North Memorial Hospital, and Maple Grove Hospital. Swanson charged that Accretive used coercive tactics, such as demanding payment when patients were suffering in the emergency room, and violated patient privacy laws. “A hospital emergency room is a place of medical trauma and emotional suffering for patients and their families. It should be a solemn place, not a place for a financial shakedown of patients. It is good to close the door on this disturbing chapter in Minnesota health care,� says Swanson. For its part, Accretive did not admit to any wrongdoing, and in a statement criticized Swanson’s lawsuit as “unnecessarily aggressive.� “Even though we believe the claims against us were either baseless or exaggerated, we have used this opportunity to carefully examine our own practices in order to ensure we are setting the very highest standards for our own performance and achieving the best possible outcomes for hospitals, patients, and communities,� says Mary Tolan, Accretive’s CEO.
DHS Gets OK to Contract with State Providers The Minnesota Department of Human Services (DHS) has received approval from the Centers for Medicare & Medicaid Services (CMS) for changes to the way it makes Medicaid payments to providers. Officials say the changes allow the state to contract
directly with providers, rather than using traditional fee-forservice or managed care approaches. Health Care Delivery System (HCDS) demonstration projects will allow the state to contract with providers, allowing them to share in cost savings through quality improvements and better coordination of care, officials say. “Minnesota is moving full steam ahead when it comes to reforming our health system so that we pay for quality of care and outcomes for our clients, not just the quantity of procedures,� said Human Services Commissioner Lucinda Jesson. “I’d like to thank our federal partners for their cooperation and support in this effort to provide better care for Minnesotans and greater savings to taxpayers.� State officials say they will begin implementation of the HCDS pilot this year. The pilot projects will include up to 150,000 enrollees in Minnesota Health Care Programs who receive Medicaid funding. DHS is currently negotiating with nine providers on an initial project.
CMS Levies Penalties for Hospital Readmissions The Centers for Medicare & Medicaid Services (CMS) will cut reimbursements for hospitals that have higher-than-average rates of readmission under a new provision of the Affordable Care Act (ACA). The reimbursement cuts will affect more than 2,000 hospitals nationwide and result in $280 million in lost payments overall, based on an analysis by Kaiser Health News. In Minnesota, 29 hospitals will see cuts totaling $1.7 million, according to officials with the Minnesota Hospital Association (MHA). Under the new program, hospitals that have above-average readmission rates in three areas—heart attacks, heart failure, and pneumonia—will see a percentage of their reimburseCAPSULES to page 6
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SEPTEMBER 2012
MINNESOTA PHYSICIAN
5
CAPSULES Capsules from page 5 ments cut for all Medicare billing they submit to CMS, no matter what services the billing is for. The highest penalty for a Minnesota hospital is Mayo Clinic Health System-Fairmont, at 0.81 percent. According to Mark Sonneborn, vice president of information services for MHA, hospitals never want to take a cut to payments, but they also understand the need to reduce readmissions. “It’s a burden,” he says. “The fix to that is reducing readmissions.” Sonneborn notes that Minnesota hospitals have been busy doing just that. The Reducing Avoidable Readmissions Effectively (RARE) campaign, sponsored by Stratis Health and the Institute for Clinical Systems Improvement (ICSI), has been adopted by 80 of the state’s 135 hospitals and all the large-volume hospitals in the state. The program has a goal of reducing hospital readmissions by 20 percent from a 2009 baseline.
“RARE has tools and resources for hospitals and other community partners to help [reduce readmissions],” says Sonneborn. “We really are quite proud of the collaboration we have with both Stratis Health and ICSI. This is a great model and we’re very hopeful that it’s going to be successful.” Sonneborn says that overall, Minnesota hospitals have an average reimbursement cut of 0.1 percent, under the numbers released by CMS. “Among the states, we were 14th lowest,” he says. “That’s good; but we’re used to actually being closer to number one. So we think we still have some work to do.”
New Strain of Swine Flu Raises Concerns A new strain of swine flu was raising concerns among public health officials at the end of August. The Minnesota Department of Health (MDH) confirmed the state’s first two cases of H3N2v on Aug. 20, with two children from the same family develop-
2012-13 CME Activities
ing flu-like symptoms after visiting a live animal market. Neither child required hospitalization but the sudden rise in cases—more than 200 have been reported in the U.S. since the beginning of the year—have health officials across the country keeping a close eye on the spread of the disease. The emergence of the new strain of swine flu in this state came just days before the Minnesota State Fair was scheduled to open, and prompted discussion of whether pigs should be banned from the fair. State officials did not recommend any drastic actions, but they did encourage safety precautions for fair visitors, such as hand washing and avoiding eating or drinking while near animal exhibits.
Minnesota: No. 1 For e-Prescribing
Arlington, Va.-based Surescripts says Minnesota achieved the highest rate of e-prescribing use in the nation during 2011 to capture the No. 1 ranking in its seventh annual Safe-Rx Awards. The rankings are determined by measuring e-prescribing use by physicians, pharmacies, and payers in each state. State officials say Minnesota’s success comes from the collaboration between different elements of the health care system in this state. “E-prescribing has been a collaborative effort in Minnesota, and we want to congratulate the providers, pharmacists, health plans, patient groups, and public health professionals who have all joined together to improve the safety and efficiency of prescribing medicine in Minnesota,” says Ed Ehlinger, MD, Minnesota commissioner of health.
One of the nation’s largest networks for electronic prescriptions has ranked Minnesota No. 1 in the United States for e-prescribing.
www.cmecourses.umn.edu
(All courses in the Twin Cities unless noted)
FALL 2012
Emerging Infections in Clinical Practice & Public Health November 16, 2012 Geriatric Orthopaedic Fracture November 29-30, 2012 Maintenance of Certification in Anesthesiology (MOCA) Training December 8, 2012
Pediatric Clinical Hypnosis (NPHTI) September 20-22, 2012 Psychiatry Review & Update October 1-2, 2012 North Central College Health Association Conference - Duluth, MN October 2-4, 2012 Twin Cities Sports Medicine October 5-6, 2012 Internal Medicine Review & Update October 24-26, 2012 Practical Dermatology for Primary Care - Duluth, MN October 26-27, 2012
SPRING 2013 Maintenance of Certification in Anesthesiology (MOCA) Training January 19, 2013 WORLD Symposium - Orlando, FL February 12-15, 2013 Maintenance of Certification in Anesthesiology (MOCA) Training February 23, 2013 Lillehei Symposium April 4-5, 2013 Integrated Care Conference April 12, 2013
Chronic Pain: Challenges & Solutions for Primary Care April 19, 2013 Cardiac Arrhythmias April 26, 2013 Global Health Training (weekly modules) May 6-31, 2013 Controversies in Cardiovascular Disease June 1-2, 2013
ONLINE COURSES (CME credit available) www.cme.umn.edu/online Fetal Alcohol Spectrum Disorders (FASD) Global Health (7 Modules)
U U
Office of Continuing Medical Education 612-626-7600 or 1-800-776-8636 email: cme@umn.edu
Promoting a lifetime of outstanding professional practice
6
MINNESOTA PHYSICIAN
SEPTEMBER 2012
MEDICUS Jewelia Wagner, MD, has joined the staff of Clinic Sofia, a women’s health care provider in the Twin Cities. She will be based at the clinic’s Edina location. Wagner received her medical degree from the University of Nebraska and completed her obstetrics and gynecology residency at the University of Kansas. Peter Gloviczki, MD, has been elected 2012–2013 president of the Society for Vascular Jewelia Wagner, MD Surgery. Gloviczki is the Joe M. and Ruth Roberts Professor of Surgery at the Mayo Clinic College of Medicine, Rochester, and chairs the Division of Vascular Surgery. He has also served as director of the Gonda Vascular Center at Mayo Clinic. Gloviczki has a medical degree, internship, residency, and fellowship from Semmelweis University in Budapest, Hungary. He completed Peter Gloviczki, MD residencies at the Hospital St. Michel and Hospital St. Joseph in Paris, as well as at Mayo Clinic, where he completed his training in vascular surgery. Nancy Raymond, MD, has been named associate dean of faculty affairs for the University of Minnesota Medical School. In this role, a 50 percent appointment, Raymond will oversee and direct the Medical School Office of Faculty Affairs. Previously, Raymond has served as director of the Deborah E. Powell Center for Women’s Health since its inception in 2003. She is currently a professor in the Department of Psychiatry and in the Department of Family Medicine and Community Health. David Tilstra, MD, has been named president of St. Cloud-based CentraCare Health System, following the retireDavid Tilstra, MD ment of Allen Horn, MD. Tilstra joined CentraCare in 1995, and was named medical director of CentraCare Clinic George Morris, MD in 2003. He is board-certified in pediatrics and medical genetics. George Morris, MD, will succeed Tilstra as CentraCare Clinic’s medical director. He has practiced at CentraCare Clinic–St. Joseph since 2008 and is board-certified in family medicine and sports medicine. Minnesota Commissioner of Health Ed Ehlinger, MD, was recently given the 2012 Child Advocacy Award by the Minnesota Chapter of the American Academy of Pediatrics (MN-AAP). The St. Paul-based group praised Ehlinger for his work on issues such as newborn screening, immunizations, lead poisoning, teen pregnancy prevention, and health care homes during a time of state budget deficits and a divided Legislature. “We are fortunate to have a commissioner who demonstrates his commitment to keeping children and their families healthy on a daily basis, despite countless challenges,” said Robert Jacobson, MD, incoming president of the MN-AAP. Ed Ehlinger, MD Judith Kashtan, MD, has been elected to serve on the American Psychiatric Association’s (APA) board of trustees. Kashtan has a private practice in Minneapolis and is board-certified in adult psychiatry and forensic psychiatry. She has served as president of the Minnesota Psychiatric Society and was recognized as the MPS Psychiatrist of the Year in 2003. At the national level, Kashtan has been an APA Assembly Representative since 2001 and has served on the APA’s membership committee and finance/budget committee. She is a Distinguished Fellow of the APA.
The Minnesota Organization on Fetal Alcohol Syndrome (MOFAS) is pleased to announce the first annual statewide FASD conference
“Building brighter futures: Working together to create change in Minnesota” November 1-2, 2012 DoubleTree by Hilton, 7800 Normandale Blvd, Bloomington, MN
You wouldn’t give a 2-year old a drink, so why would you give one to an unborn child?
Each year, over 8,500 babies are born in Minnesota with prenatal alcohol exposure which can cause permanent brain damage. This conference for both parents and professionals from all around Minnesota will present information on best practices, exchange insights and experiences and learn about the latest research in the field of FASD. Breakout topics will include prevention, intervention, diagnosis, national research and family support. Keynote Speaker: Dr. Sterling Clarren Dr. Clarren is a Clinical Professor of Pediatrics at the University of British Columbia Child and Family Research Institute and an internationally renowned FASD expert with over 35 years experience in the field. He will speak on how we collectively envision and encourage a comprehensive and coordinated approach to FASD prevention and intervention. Registration is $100 per person, groups of five or more are $90 each and includes admission to all sessions, program materials, and continental breakfast and lunches.
To register or for more information please contact Angie Dyer at angie@mofas.org or call 651-917-2370 or go online to www.mofas.org/events.
SEPTEMBER 2012
MINNESOTA PHYSICIAN
7
INTERVIEW
The reality of plastic surgery ■ What are some common misconceptions about
reconstructive surgery? I think the most common misconception about reconstructive surgery is that people expect perfection. For example, if a woman has a breast cancer and goes on to have a mastectomy—either immediately at the time of her mastectomy, or in the future when she undergoes breast reconstruction— it just doesn’t look like the normal side. You can get close, but most of the time it just doesn’t do it, and sometimes people expect more than we can deliver. Joseph Gryskiewicz, MD Minnesota Society of Plastic Surgeons Joseph Gryskiewicz, MD, is immediate past president of the Minnesota Society of Plastic Surgeons and owner of Gryskiewicz Twin Cities Cosmetic Surgery. He has practiced medicine in the Twin Cities for more than 25 years and is an adjunct professor at the University of Minnesota School of Dentistry Cleft Palate and Craniofacial Clinics. Gryskiewicz has also served as president of the Rhinoplasty Society and is the current president of the Aesthetic Society Education and Research Foundation. He has traveled internationally, both as a speaker on plastic and reconstructive surgery and for medical mission trips, including many trips to Guatemala. His volunteer work in Guatemala and South America led to recognition from the University of St. Thomas, which gave him its Humanitarian of the Year award in 1992.
8
■ How do you respond to TV shows and movies
that portray plastic surgery?
The most controversial area in plastic surgery right now, whether it’s reconstruction or cosmetic, is injecting fat into the breasts. Then the question is whether that causes changes on mammogram years later. Some fat can calcify a little bit and then it might be mistaken for a cancer because a lot of breast cancers form some calcium, so it’s really controversial. But for people that want breast enlargement, it’s nice if you can use your own tissue. Who would argue with that? But that’s really when you get the room going and get some arguments going—in terms of what we talk about at our society meetings. ■ How do you work with other physicians in doing
reconstructive surgery? The fictional ones, I think, are very misleading and I think that probably the biggest example of worka joke. The reality shows tend to sometimes give ing together with surgical colleagues is when you unrealistic expectations, but, by and large, I think have a breast reconstruction. The general surgeon, they give you an idea of what it’s all about. A lot the breast surgeon, does the mastectomy and then of people come in and they know all about the you would do reconstruction. operation they came in to see Another one would be where me for. Great! Because then you have a case of an accident Sometimes people we don’t have to educate so victim with multiple trauma, much. Overall, I’d say they’re expect more than we and so you’ve got a whole a net plus. team working on the patient. can deliver. The biggest example that I ■ What are some recent can give you personally is that advances in the field? I’ve been working at the Cleft Lip and Palate Clinic Dealing with fat is the hottest topic there is in at the University of Minnesota in the School of plastic surgery. You can suction fat, you can inject Dentistry for 27 years, and we have a team of fat, you can melt fat, you can laser fat, you can about 11 people that sees each child that comes in. freeze fat. We evaluate the child for hearing, speech, teeth, Probably the biggest one that’s come around bite, dental hygiene, social situation, and any assothe corner right now is freezing fat. Let’s say you ciated diseases. That’s the most significant case have love handles or you have tummy fat. You can where I interact with probably 10 other people to put a device on there for an hour and 12 weeks see one patient. later, anywhere from 20 percent to 40 percent of those fat cells have died and have been absorbed by the body. The device is a big suction cup-like thing, so it would be about the size of your love handle or the size of the stomach—there’s a big and small size. You put it on for an hour and it suctions the tissue in there; it makes it really, really cold; and then the cells die. Then they gradually break up and the body absorbs them. There’s no downtime. There’s no anesthesia. There’s virtually no discomfort. What they discovered many years ago in England was there were a lot of children who would run around in the summertime with a popsicle in their mouths. They noticed a number of these kids had a dent in their cheeks. A couple of investigators decided to investigate whether cold would kill fat. It turned out that fat is the most sensitive cell to cold. The skin is resistant, and the deeper skin is resistant, and the muscle is resistant, and the lining around the muscle, called fascia, is resistant, but the fat itself is exquisitely sensitive to cold. So they put it together that these kids had dents in their cheeks; they tried it out on clinical studies and found out, by golly, it killed the fat.
MINNESOTA PHYSICIAN SEPTEMBER 2012
■ With elective procedures, how much of an issue
is insurance reimbursement? It’s very difficult to get insurance reimbursement by and large. They put a lot of roadblocks in your way. It’s a challenge for us as doctors to give people the care they deserve from their insurance policy when there are all kinds of appeals and roadblocks. Even for my kids with cleft lips, I’ve had to ask the family to get an attorney to write a letter to their insurance company just to pay for the kid’s touch-up surgeries of their cleft lips, because in the teen years, they said, “They’re cosmetic,” and it’s like, “Well, they might be cosmetic, but they’re from a birth defect.” So it’s a perpetual tug-of-war between the insurers and us as caregivers. ■ Can you compare the work you do that is
referred by other doctors versus patient selfreferral? What’s the ratio? Depends a little bit on your practice. I do mostly cosmetic surgery, so my patients are all self-referral from the Internet or from previous patients of mine.
I would say maybe 50 percent come from the Web, and probably 45 percent are self-referral, and then 5 percent are from dermatologists or something like that. â– You mentioned for some patients the
results don’t live up to their expectations. What about the possibility of lawsuits? How much does that affect your practice? I think about malpractice every single day, and I’ve been in practice 27 years and I’ve never been sued; I’ve never even been served a summons. And I still think about it every single day. A lot of my buddies who are plastic surgeons tell me the same thing. It’s just too bad because unless you're an impaired physician, I’m assuming you’re doing the very best you can. I’m on the judicial council and ethics committee for our society, and I see a lot of cases that end up going to court. I read the transcripts, and the way some of my friends are beat up by the plaintiffs’ attorneys is unbelievable. Now, all I know is these guys are just doing the best they can, and something went wrong. Sorry, but that’s not a reason to treat you as a criminal. So I think this is a big topic, very oppressive. It would be wonderful if we could get tort reform in Minnesota. I think expectations have been raised in all of these areas, including general surgery,
all kinds of surgery. People want perfection and they don’t want to suffer and they have that drive-through mentality where it should be quick and easy. We all want that, I guess. If I can just say, I find my relationships with my patients overall to be very warm and very satisfying for me. I like working— I like working a lot. I enjoy getting up in the morning and helping people feel better about themselves.
the highest body dysmorphic disorder. If people come in and they have some little teeny thing on their eyelid or little teeny thing on their nose and it’s driving them crazy and they say, “I can’t sleep at night,� or “I obsess about this,� or “Everybody’s looking at me,� that’s a red flag. ■What do you suggest for them?
Oh yeah, and sometimes we decide not to operate on them. I’ve often told someone I don’t think I can help them. I tell them I can’t do what they’re asking.
I talk to them honestly and say this is a really minor issue and I don’t think it’s worth the risk of having anesthesia and surgery. I just tell them, “Honestly, it’s a very small problem. If you’ve got a lot of anxiety about it, I don’t think surgery is the right answer for you and I don’t have the ability to help you.�
â– Can you give me a better sense of what
â– What message do you have for the
â– Are there some patients who come in
and then decide against surgery?
physicians that read our magazine?
that’s like?
Just make sure you’re sending patients to board-certified colleagues. That would be my main advice. I would do the same. I send a lot of my patients out to other doctors, and I just make sure they’re qualified practitioners, do good work, and they’re friendly. You know, the three A’s— affable, available, and has ability.
Well, there’s a disorder called body dysmorphic disorder. Just think of a graph: One part of the graph has anxiety level and the other part of the graph has the magnitude of the defect. If you have a very minor defect and you have a really high anxiety level about it, that is not an indication to do surgery. Chances are they have body dysmorphic disorder, and those people are never happy. I see them frequently because I do a lot of nose surgery, and that’s the group that has
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Barriers from cover decision allows states to choose whether or not to expand eligibility for Medicaid coverage to adults without children whose income is below 138 percent of the federal poverty level, or about $15,414 per year. Currently, federal Medicaid does not cover adults without children.
nurse when they need to. The state Department of Human Services estimates that thousands of additional Minnesotans will qualify for Medicaid under the revised eligibility requirements. Implications for Minnesota
Expanding access to health care is something we can all cele-
match may reduce the need for continued reliance on the socalled Minnesota provider tax (the 2 percent tax levied on health care goods and services to pay for state-subsidized health care coverage for lowincome individuals) and allow for its elimination or reduction over time. In the 2011 legislative session, Minnesota lawmakers
Physicians are presented with a unique chance to finally influence the system for the better. This part of the ruling is likely to have little impact in Minnesota, as the state has provided coverage for poor, childless adults using state-only funds for decades. In January 2011, Minnesota became one of a handful of states to opt in early to the Medicaid expansion program, reducing the cost to the state of making sure that poor adults can see a doctor or
brate. Further, every newly insured Minnesotan presents a new opportunity for Minnesota physicians to broaden their patient base and serve their community. These opportunities are the reasons why large physician organizations like the American Medical Association and the American College of Physicians support the ACA, despite areas of concern. Moreover, the new federal
agreed to phase out the 2 percent provider tax and repeal it altogether in 2019. On the other hand, continued close attention must be paid to the low reimbursement rates paid for public patients and the challenges that presents for practices. The Supreme Court’s decision should remove much of the uncertainty about the future of health care reform in this state. As an example, in contrast to other state governments that claim they will refuse to implement the ACA reforms, Minnesota appears committed to forging ahead with plans to develop a health insurance exchange— an electronic marketplace where Minnesotans can get information about, and purchase, the most affordable health insurance options available. The State of Minnesota Health Exchange Advisory Task Force estimates that more than 1.2 million Minnesotans will use its proposed health insurance exchange to purchase coverage, and that by 2016, 300,000 uninsured, middle-class Minnesotans will gain health insurance through the exchange. (Updates on the task force’s activities are available at http://mn.gov /commerce/insurance/topics /medical/exchange/ExchangeAdvisory-Task-Force/index.jsp) Physicians’ concerns
The larger reality, however, is that many of the changes in health care delivery envisioned in the ACA are likely to proceed regardless of the law’s fate. In Minnesota, long a pioneer of
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MINNESOTA PHYSICIAN SEPTEMBER 2012
reform and a beacon of public health, that is doubly true. Indeed, the state of Minnesota, in partnership with health providers, health plans, businesses, and consumers, has already moved forward with significant health care reform initiatives. Yet, despite the knowledge that health care reform will move ahead, there is still understandable anxiety and apprehension in the physician community about the reform’s effects. As the Minnesota House minority leader and former Health Committee chair in the Minnesota House of Representatives, as well as in my law practice, I have heard physicians’ views on various parts of the ACA. Common concerns that physicians express are how the law will affect patient care, reimbursement, ability to innovate, and physician autonomy. My colleagues and I know these worries are real and serious, but we also believe physicians are presented with a unique chance to finally influence the system for the better. Perhaps the biggest evolution that Minnesota physicians will see in their payer and government program agreements is the focus on and emergence of integrated care. The ACA reflected a paradigm shift in health-care delivery reform in the U.S.—a shift already reflected in Minnesota reforms and on the ground in health systems across the state. The system will continue to move away from a fee-for-service model to a new approach that requires physicians and other health care providers across many practice areas and levels to work together to coordinate patient care. Some of these reforms include the accountable care organizations (ACOs), bundled payment programs, and hospital-physician partnership models that hope to improve outcomes for patients transitioning from hospitals to other settings. Minnesota physicians will inevitably see the old fee-forservice model of care decline, and integrated and coordinated care become the new standard of health care delivery.
One consequence of healthcare reform initiatives like these is increasing pressure on and, perhaps, declining numbers of small physician practices. More physician clinics are opting to affiliate with larger health systems, especially under the ACA initiatives. Many physicians have felt financial pressure to partner with larger institutions to offset declining reimbursement rates or take advantage of special payment programs where physicians receive a portion of a global or bundled payment. This type of “vertical integration” can take the form of contracts, direct ownership, or other types of relationships. Understandably, many physicians are anxious and hesitant to partner with larger systems over concerns that they may lose autonomy in how they practice medicine. There are also serious regulatory concerns, including under the Stark laws, about such arrangements. However, in our experience, carefully negotiated and structured agreements with health systems can empower physi-
cians to continue practicing medicine autonomously but with greater resources and less risk, all with an eye toward improved patient outcomes. When physicians demand active roles in the administration and oversight of patient care, they’re able reap the rewards of vertical integration but maintain a high level of practice autonomy and professional satisfaction. And while government and health systems can enact and implement ACA
These reforms will mean a change in health care delivery models that will affect everyone.
reform, it’s ultimately the physicians who are on the front lines of these initiatives. Therefore, physician wisdom and expertise are of significant value to any health system, and that value should be reflected in an integration agreement. With the Supreme Court now having laid to rest uncertainty about the ACA, what will these reforms mean for Minnesota physicians? In the future, it will mean more insured patients with access to care other than via the emergency room. It will lower barriers to entry into
the health insurance market for working, middle-class Minnesotans. But these reforms will also mean a change in health care delivery models that will affect everyone. Physicians should assert themselves to make sure their voices continue to be a central part of the dialogue as these reforms take shape. Paul Thissen, JD, has been a member of the Minnesota House of Representatives since 2003. He is currently house minority leader and was the former chair of the House Health and Human Services Policy Committee. He is a partner with the law firm of Lindquist and Vennum in Minneapolis, specializing in health law. Amber Thomas, JD, has served in the U.S. Department of Health and Human Services and in the Centers for Medicare & Medicaid Services, and is an attorney in Lindquist and Vennum’s health law practice group.
In person
Inbox
When changes in the local health care landscape promised a major influx of new UCare members coming through metro-area clinics and hospitals, we made sure those providers were prepared. In a span of just two weeks, May Ly was among the UCare staff that personally visited 449 unique health care locations to offer a heads-up and explain the impacts. Because being responsive to our partners’ needs isn’t just talk—it’s what we mean by health care that starts with you.
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POINT
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merican Cancer Society: Critical patient protections
OF
VIEW
The Supreme Court’s ruling on the Patient Protection and Affordable Care Act (ACA) on June 28 will have major repercussions for patients and providers. Minnesota Physician asked representatives from Minnesota health care organizations to respond to this question: How will the Supreme Court’s ruling on the ACA affect your organization and its patients/constituents? Their differing viewpoints on the ruling underscore the complexity and challenge of health reform efforts aimed at balancing the needs for access, quality, and cost efficiency in health care.
• Prohibiting insurance companies from denying children insurance due to their health history • Prohibiting insurance companies from unfairly revoking coverage when a person gets sick • Establishing an online exchange where individuals and small businesses can compare affordable, quality health plans and choose the one that’s best for them and their families Access to such care saves lives. Research from the American Cancer Society has shown that people without health coverage are more likely than those with private insurance to be diagnosed with cancer at more advanced stages and are less likely to survive the disease.
The Supreme Court’s decision ensures that critical patient protections benefitting cancer patients and survivors will be implemented, such as: • Prohibiting insurance companies from denying coverage to kids with a preexisting condition • Requiring insurers to provide consumers with easy-to-understand summaries about their coverage • Requiring health plans in the individual market to offer essential benefits needed to prevent and treat serious conditions such as cancer • Prohibiting arbitrary lifetime limits on health insurance plans (limMinnesotans react —Matt Schafer, state government its often reached by patients with relations director–Minnesota, expensive diseases like cancer) American Cancer Society • Providing states with the option to expand Medicaid to some of its most vulnerable citizens—in Minnesota, 250,000 people could be American Diabetes Society: newly eligible for Medicaid enrollment Quality, cost-effective diabetes care Moreover, the ruling preserves vital provisions that are already The ability for Minnesota’s health care systems to provide quality improving the ability of people with cancer and their families to and cost-effective diabetes care will be a harbinger for the overall access needed care, including: success of the ACA. • Ensuring proven preventive services such as mammograms and Many ACA components critical to millions of individuals with colonoscopies are covered at no cost to patients diabetes are already in place: continued coverage under one’s par• Eliminating annual dollar limits on coverage that can suddenly ents’ insurance until age 26 (very helpful for young adults with type terminate care 1 diabetes); no insurance exclusion for a preexisting condition; no lifetime cap on insurance coverage; and health insurance made available to many disadvantaged individuals with diabetes who currently rely on the emergency department for their care. Costeffective strategies to help prevent diabetes, included in the ACA thanks to the leadership of Sen. Al Franken, are now being implemented in Minnesota and nationwide. The International Diabetes Center at Park Nicollet and others have shown that the most effective way to manage diabetes is a patient-centered team approach that focuses on shared decisionmaking and innovative use of technology. Accountable care organizations in Minnesota will be closely scrutinized to see how effectively they can organize teams to learn from the promising medicalhome model in Minnesota to create actual or virtual “diabetes homes” that facilitate the triple aim for their patients with diabetes.
Supreme Court ruling on the ACA
—Richard M. Bergenstal, MD, executive director, Park Nicollet International Diabetes Center, Minneapolis
Fairview Health Services: Building a sustainable system
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Despite the controversy regarding the Affordable Care Act, everyone appears to agree that we have an affordability crisis in health care. The rate of growth in health care costs is the No. 1 driver of longterm structural deficits at both the state and federal levels over the coming decades. To address this concern, Fairview has transformed its primary care delivery system over the past three years to deliver team-based care focused on the needs of the populations it serves. This work has led to better quality outcomes and a slower rate of growth in health care costs. We have also worked to change the way we are paid so that we are rewarded for delivering quality and lowering the cost of care, rather than simply being paid for the volume of services provided. We recently began participating in Medicare’s Pioneer Accountable Care Organization program, which will extend our care model MINNESOTA PHYSICIAN SEPTEMBER 2012
changes to the Medicare patients we serve. We began this work because the health care status quo was unsustainable, not because of the ACA. The Supreme Court ruling has resolved the legal uncertainty surrounding the ACA; however, our work would have continued regardless of what the Supreme Court had decided. We will continue to work with policymakers across the political spectrum to build a sustainable system that rewards quality care and controls the growth of health care costs. —Brent Asplin, MD, MPH, president, Fairview Medical Group
Metro Area Agency on Aging: A collaborative community strategy Assuming that Minnesota will stay the course on expansion of Medicaid, the Supreme Court’s ruling on the Affordable Care Act did not change the services of the Area Agency on Aging. However, the court’s decision validated our priority outreach messages to Medicare beneficiaries about new benefits under the ACA, including the annual wellness visit, personalized prevention plan, and reduction in drug copayments for individuals in the Part D donut hole. Medicare’s emerging focus on prevention and expanding access to prescription drug coverage is key to the health of our growing older population. The court’s decision left intact the ACA’s beginning policy framework to better integrate our nation’s health and long-term care systems. The decision supports the Area Agency’s new partnerships with hospitals and nursing homes to reduce readmissions of Medicare beneficiaries via a collaborative community strategy funded under the Community Based Care Transitions program. We’re excited, too, about new resources for State Aging and Disability Resource Centers (ADRC) to expand capacity for “options counseling” to help seniors and people with disabilities navigate our complex health and long-term care systems. In Minnesota, ADRC services are provided by the Area Agencies on Aging and Centers for Independent Living in partnership with the MN Board on Aging.
Of great concern to me is the impact of this law on ophthalmology, and for that matter all non-hospital-based specialties. As I understand it, the payment reform with accountable care organizations will concentrate all the money in the hands of hospitals, to be then distributed to providers. That seems like a recipe for being voted off the island if you are not a hospital insider. Ophthalmology is increasingly an outpatient entity, and ambulatory surgery centers are an efficient way to deliver care. The evolution of more efficient delivery systems could be thwarted. The Independent Payment Advisory Board puts an incredible amount of power into the hands of a small number of unelected individuals. This board will control prices for medical care as a whole and seems to have tremendous potential for being affected by political maneuverings and other influence peddling. The ACA is a vast, complex bill that will take many years to understand and implement, and many of the ideas it puts forth are basically untested. It seems likely that a massive bureaucracy will be generated to manage the provisions of this bill, and the regulations it generates will make it more difficult to provide care as is currently done. This, combined with the huge influx of patients, will make for an unmanageable workflow for physicians. —Edwin Ryan, Jr., MD, president, Minnesota Academy of Ophthalmology
Minnesota Association of Community Health Centers: A need for infrastructure and resources As providers of care to almost 200,000 patients, of whom 70,000 are uninsured, Minnesota’s Community Health Centers (CHCs) are gratified by the court’s decision to uphold the Affordable Care Act. CHCs are on the front lines, providing medical, dental, and behavioral health services to those who would be turned away at many other SUPREME COURT RULING to page 14
—Dawn Simonson, executive director, Metro Area Agency on Aging
Minnesota Academy of Family Physicians:
“As physicians, we have so many unknowns coming our way...
More autonomy in health care decision-making As family physicians, we regularly face the challenges of caring for patients in an environment controlled by insurance companies. I see the ACA as a steppingstone to giving patients and their physicians more autonomy in health care decision-making. From better insurance coverage for children and young adults to closing the donut hole in Medicare Part D, these types of changes are good things. Best are the law’s provisions that will build the primary care workforce to meet patients’ needs, support wider implementation of the patient-centered medical home, and value primary medical care through payment incentives for primary care physicians: All are important in reducing health care costs on a large scale. Time will tell if the claims of less bureaucracy come to fruition. As many patients remain on the same plans they were enrolled in prior to the ACA taking effect in 2010, coverage of preventive services in “grandfathered” insurance plans remains to be seen. Much work lies ahead, including a permanent fix for the sustainable growth rate and liability reform, but overall, many parts of the ACA are viewed as positive change for Minnesota family physicians and their patients.
One thing I am certain about is my malpractice protection.” Medicine is feeling the effects of regulatory and legislative changes, increasing risk, and profitability demands—all contributing to uncertainty and lack of control. What we do control as physicians: our choice of a liability partner. I selected ProAssurance because they stand behind my good medicine. In spite of the maelstrom, I am protected, respected, and heard. I believe in fair treatment—and I get it.
—Julie Anderson, MD, president, Minnesota Academy of Family Physicians
Minnesota Academy of Ophthalmology: Added bureaucracy and regulations I was personally disappointed in the Supreme Court’s ruling on the Affordable Care Act. My preference would be to have a bottom-up evolution of health care reform rather than a top-down imposition of reform. Top-down never works for complex entities.
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Supreme Court ruling from page 13 clinics. They see firsthand the struggle and hardship of patients without health insurance. Assuming Minnesota implements the Medicaid expansion, we expect a large number of our uninsured patients will get the coverage they need. However, “coverage” is not the same as “access.” Even though many will have insurance coverage for the first time, a vast majority of the newly insured will continue to live in poverty. CHCs must have the infrastructure and resources to provide services that enable people to access care, such as patient outreach, language translation, transportation assistance, and nutrition assistance. As more patients secure medical assistance coverage, we expect the demand for CHC services to sharply increase, as it did in Massachusetts under its universal coverage reforms. In spite of the new opportunities to gain coverage, we also know that the uninsured rate in Minnesota will be reduced by only 50 percent. The remaining uninsured will likely seek care from CHCs and will likely increase the uninsured “market share” at CHCs. The overall impact of pent-up demand and an actual increase in the uninsured served by CHCs will present significant challenges in terms of physical plant space, workforce, and funding to support enabling services. Nonetheless, we are very pleased by the progress represented by coverage expansion under the ACA and the opportunities for all to access the care they need. Minnesota’s CHCs stand ready to deliver, but will need the support of federal and state policymakers to assure that CHCs remain a strong, viable component of the safety net as reforms are implemented. —Rhonda Degelau, executive director, Minnesota Association of Community Health Centers
Minnesota/American College of Emergency Physicians: Integration with outpatient care resources From an emergency medicine perspective, the American College of Emergency Physicians (ACEP) has worked extensively to demonstrate the value of emergency care in our system. Everyone recognizes the indispensable role the emergency department (ED) plays in caring for life-threatening emergencies on a 24/7 basis. An often overlooked role of the ED is the value of providing rapid and thorough evaluations in an effort to avoid unnecessary hospital admissions and readmissions. In a fragmented system, the ED plays an important role at the interface of outpatient and inpatient care. Given the Supreme Court ruling and the coming expansion of Medicaid coverage, it is likely that ED visits will continue to increase. ACEP believes it is important that the ED become better integrated with other sources of outpatient care in the system so there are options for patients who do not require admission to the hospital. A critical component of this integration is the ability of patients with new Medicaid coverage to access care. Insurance coverage does not always guarantee access to care. ACEP looks forward to working with policymakers to ensure that patients have access not only to insurance coverage, but also to care outside of the ED. —William Heegaard, MD, MPH, president, Minnesota/American College of Emergency Physicians; associate chief, Department of Emergency Medicine, Hennepin County Medical Center
Minnesota Gastroenterology: Enormous changes in care processes The ruling by the Supreme Court concerning the ACA will have profound effects on specialty medical care, including that of my practice, Minnesota Gastroenterology. ACA has helped more people access medical care and we are noting an increased demand for clinic visits and procedures. This situation has forced us to change how we schedule new patients, and we must now shift follow-up patients to midlevel providers. Since preventive tests, including colonoscopy, are provided without copays or deductibles under ACA, our procedure capacity has been stressed as well. Some providers have shifted to fecal occult blood testing as their primary colon cancer screening test so it should be noted that colonoscopy done for a positive stool test is a diagnostic, not a preventive, test. As such, it is not fully covered, and this comes as a shock to many patients with a high-deductible plan. The ACA has increased barriers to adoption of new medical technology and will certainly lead to reduced choices for high-priced therapies such as biological infusion drugs for inflammatory bowel disease. Minnesota Gastroenterology adopted an electronic medical record in 2003 and has been producing performance metrics since 2005. Even so, programs like PQRS, Physician Compare, and ValueBased Modifiers for Medicare payment all are difficult (and expensive) for us to manage. While we applaud the concept of universal access for health care, we understand that the current cost of medical care will force enormous change in our processes and will lead to some type of rationed care. We are doing our best to anticipate trends in gastroenterology needs and are committed to maintaining our high standards of patient care. —John Allen, president, Minnesota Gastroenterology
Minnesota Health Care Safety Net Coalition: Pent-up demand from the newly insured
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The Supreme Court’s decision to uphold the ACA creates unique opportunities and challenges for Minnesota’s “safety net” (those providers who, by legal mandate or specific mission, deliver care regardless of ability to pay). Experience from Massachusetts, where similar coverage expansion has already occurred, indicates that safety-net providers in particular will face pent-up demand from MINNESOTA PHYSICIAN SEPTEMBER 2012
newly insured patients seeking culturally specific and customized health-care services. In addition, safety net providers expect to continue to be an essential access point for many of Minnesota’s 230,000 remaining uninsured. The state’s work on other pieces of health care reform, including risk adjustment, payment reform, and the health exchange, will also have a profound impact on the safety net’s ability to provide access in a post-2014 environment. Without adequate payment and quality measurement reforms, a disproportionate burden of serving the highest cost and most complex patients will undoubtedly fall to the safety net. Safety net providers will need support to undergo care model transformations and to invest in new technologies that are necessary to provide care in a reformed system. A robust safety net is the key to maintaining access for Minnesota’s low-income, disadvantaged, and vulnerable populations. —Emily Zylla, staff director, Minnesota Health Care Safety Net Coalition
NAMI (National Alliance on Mental Illness) Minnesota: Hope for improved access, coverage The Supreme Court’s ruling allows the mental health community to hold onto hope for improved access and coverage because several key provisions will remain intact. The health care exchanges under the ACA require plans to cover mental health and substance abuse treatment and to follow the mental health parity law. This means that insurance for people with single or small group plans will cover their needed mental health treatment. People will no longer be unable to obtain health insurance simply because they live with a mental illness—a preexisting condition. Young adults can remain on their parents’ health insurance plans until age 26. Young adults are often without insurance and yet are at an age when first psychotic episodes occur. Our one concern is that Medicaid expansion is not guaranteed. Eligibility based on income alone, and not also on having a certified disability, is important because of the difficulty in proving—and saying—that you have a disability that results in never being able to work again. Medicaid expansion would have resulted in many people with mental illnesses being able to access care and treatment. We hope Minnesota continues to expand Medicaid. —Sue Abderholden, executive director, NAMI-MN
Physicians for a National Health Plan:
University of Minnesota/State Health Access Data Assistance Center: A coverage ”floor” for the very poor Under the Affordable Care Act, states were required to set a universal Medicaid eligibility standard of 138 percent of the federal poverty level ($32,000 for a family of four). HHS was authorized to withhold federal Medicaid matching payments for those states that did not comply. The Supreme Court took these penalty provisions away, effectively making Medicaid expansion optional. The Medicaid expansion represented over half (17 million) of the estimated 30 million newly insured under the ACA. But if the 26 states that signed on to the ACA Supreme Court challenge choose not to expand Medicaid, the Medicaid expansion will cover fewer than 9 million people. Minnesota has a long tradition of funding health care for is citizens, first through General Assistance Medical Care and, later, through MinnesotaCare. These formerly state-financed programs will now be almost fully funded by the federal government—100 percent for the first two years, then phased down to 90 percent. Full implementation of the ACA will extend coverage to an estimated 290,000 citizens, dropping Minnesota’s uninsurance rate to a very low 4 percent. The ACA provides a floor for coverage for the very poor and helps Minnesota continue its historical health coverage of those in need. —Lynn A. Blewett, PhD, professor, University of Minnesota School of Public Health; director, State Health Access Data Assistance Center
Quality Transcription, Inc.
ACA will not fix the health care crisis The work of the Minnesota chapter of Physicians for a National Health Program (PNHP) will continue in earnest. While the ACA will be helpful for some patients who gain access to insurance coverage, the legislation will not fix the health care crisis facing our state and nation. Even with the ACA fully enacted, more than 200,000 Minnesotans will be left out of the system completely (uninsured) and thousands more will remain woefully underinsured. PNHP’s goal remains comprehensive health care for ALL Minnesotans, and the ACA will not get us there. In Minnesota, we can and should hold ourselves to a higher standard. By enacting a single-payer, Medicare-for-all system, we can show the nation what happens when individuals flourish and fulfill their productive potential without the fear of financial ruin should they become ill. By severing our unhealthy relationship with a private insurance industry that amasses great wealth at the expense of sick patients, we can save a tremendous amount of money and actually spend it on health care. The Lewin study (March 2012) showed us that the administrative simplicity of a single payer system in Minnesota would lower health care spending while covering everyone with comprehensive care. —Ann Settgast, MD, and Elizabeth Frost, MD, co-chairs, Minnesota Chapter, Physicians for a National Health Program
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GASTROENTEROLOGY
I
nflammatory bowel disease (IBD) is a group of autoimmune disorders that affect different parts of the gastrointestinal (GI) tract. Crohn’s disease and ulcerative colitis represent the two major classifications of IBD. Although they are related, treatment considerations may differ. Both diseases are characterized by acute and chronic inflammation of the GI tract. Ulcerative colitis is primarily limited to colonic mucosal disease; Crohn’s disease typically may involve the GI tract transmurally, anywhere from the mouth to the anus. According to the Centers for Disease Control and Prevention, more than 1 million people in the United States are afflicted with IBD. (See article on p. 26 for a patient’s perspective on living with IBD).
Determining treatment is often the biggest challenge
Initial treatment of IBD focuses on medical therapy to reduce the inherent inflammation and limit the consequences of chronic persistent inflammation.
IBD treatment Modern management changes By James Abraham, MD and Robert D. Madoff, MD Consequences may include specific nutritional deficiencies, bleeding, and fistulas (abnormal bowel connections to other surrounding structures) in Crohn’s disease; and extraintestinal manifestations of IBD, such as chronic joint pain and skin rashes. Because no single medical treatment is universally effective, therapy considerations must be individualized based on objective medical factors as well as patient-specific lifestyle factors. Discussions about treatment begin by evaluating the extent and severity of the disease through a combination of endoscopic, imaging, and biochemical studies. Next we offer a thorough explanation of the desired goals of therapy, along with the risks, benefits, and alternatives of the various therapies that are
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MINNESOTA PHYSICIAN SEPTEMBER 2012
available. Treatment extends beyond merely imparting information about blood tests, medication, and surgery, however. It is also important for the treating IBD physician to have a clear understanding of the patient’s short- and long-term life goals, which can sometimes affect ongoing management of the condition. Discussions about the disease may encompass school or work plans, marriage and fertility, genetic risks, and dietary and lifestyle modifications, as well as availability of new research. The significant time spent to address these issues is necessary to ensure that we treat the whole person, not just the disease. Crohn’s disease
Crohn’s disease, much like any other autoimmune disease, can present across the spectrum from mild to severe. In addition, inflammation can occur in any part of the GI tract and can often be associated with fistula formation, perianal disease, and other extraintestinal manifestations. The biggest change in treating Crohn’s disease in the past 10 years has been the availability of new drugs and a tendency to take a more aggressive approach to medical therapy. The main goal in treating the disease is to modulate the way the autoimmune system propagates inflammation. For many years, standard therapy involved the use of 5-ASA compounds and long-term steroids. Both of these are used to reduce inflammation, and milder cases may still respond favorably to these drugs. When the condition is more aggressive, however, we use more specifically targeted therapies that get to the core of treating these autoimmune diseases. When patients don’t respond, and their symptoms begin to worsen, the next step is
immunomodulators and biologic agents. Once used strictly to treat cancers, immunomodulators have expanded into the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and other autoimmune diseases. These medications— 6-mercaptopurine and azathioprine—antagonize the immune cascade that causes inflammation. When traditional medication therapy fails, biologic treatment with monoclonal antibodies such as infliximab, adalimumab, or certolizumab may be used. They bind to the proinflammatory cytokine tumor necrosis factor-alpha, or TNF-alpha, to mute the autoimmune response. As a treatment method, these monoclonal antibodies have allowed more patients to achieve clinical remission and avoid complications of chronic inflammation, dramatically reducing the need for surgery. In addition, use of these monoclonal antibodies has tended to reduce the recurrence of Crohn’s disease after patients have undergone surgery for complications of the disease. Surgical necessity. Surgery is indicated for complications, such as obstruction or perforation, and for medically refractory disease. In general, because of the risk of postoperative recurrence (particularly as it relates to Crohn’s disease), a conservative approach is taken. A central goal of surgery for Crohn’s disease is bowel preservation. When surgery is required, it often can be performed using laparoscopy. In addition, strictureplasty is frequently used to alleviate areas of focal obstruction without the need for bowel resection. Ulcerative colitis
Ulcerative colitis is by definition isolated to the colon and rectum. Typical symptoms include diarrhea, mucus discharge, rectal bleeding, and abdominal pain. Longstanding colitis may be associated with an increased risk of colorectal cancer. Patients with colitis of eight to 10 years’ duration require annual colonoscopies with surveillance biopsies to detect early dysplasia.
Considerations for medical therapy are similar to those for the Crohn’s disease patient. The goal of therapy is to reduce the active inflammation and improve symptom control. For milder cases of ulcerative colitis, agents such as mesalamine (given in pill, enema, or suppository form, based on the extent of disease) are used. Corticosteroids are often prescribed for patients with more severe symptoms. Long-term use is not recommended, however, due to serious side effects, including hyperglycemia, weight gain, hypertension, sleep disturbances, and anxiety). In the short term, steroids in enema, foam, or pill form can be used while other therapies take hold to obtain a remission. Steroid dependence for symptom control is a marker of more aggressive disease, and as such, it becomes necessary to discuss with patients the risks and benefits of immunomodulator or biologic agents. Surgical necessity. Indications for surgery in ulcerative colitis include management of
complications (for example, perforation or severe hemorrhage), medically refractory disease and the development of colonic dysplasia or neoplasia. As with Crohn’s disease, laparoscopic surgery is the most common approach. Because ulcerative colitis is necessarily limited to the large bowel, surgery is curative and obviates the risk of development of colorectal cancer. Proctocolectomy (removal of the entire large bowel and rectum) is required for ulcerative colitis. Although this operation once required placement of a permanent ileostomy, most patients now undergo reconstruction with a neorectum created from the small bowel— commonly known as a J-pouch or ileoanal reservoir. Pouch surgery is almost always done in stages, with a temporary ileostomy being placed to optimize healing before intestinal continuity is restored. Proctocolectomy with permanent ileostomy is still the procedure of choice for elderly patients with severe associated medical conditions
and those whose continence is impaired. Fortunately, quality of life in these individuals is high, despite the presence of a stoma. Conservative treatment; better quality of life
Even though no clear cause has been established for either Crohn’s disease or ulcerative colitis, we know that some people are predisposed to these diseases, especially those whose family history includes autoimmune disease. Early recognition can allow us to move quickly to change or slow the course of the disease. More emphasis on medical management, including the use of immunomodulators and biologic agents, has significantly altered the outlook for patients with IBD. Although none of the drugs is without side effects, they are generally effective in achieving remission and improving a patient’s quality of life. In addition, modern medical therapy significantly reduces the need for surgical intervention both in primary disease and in patients who have already
undergone resection for Crohn’s disease. Potential future therapies with alteration of the intestinal microbiome and probiotic agents (formulations of commensal bacteria that may affect the inflammatory cascade) are still undergoing significant research and may hold the promise of more treatment options for IBD patients down the line. Surgery for both Crohn’s and ulcerative colitis is predominantly performed using laparoscopy, a minimally invasive surgery. The laparoscopic approach allows patients to recover faster, spend less time in the hospital, and return to their normal activities earlier than conventional open surgery. James Abraham, MD, is a gastroenterologist at University of Minnesota Medical Center, Fairview, and an assistant professor in the University of Minnesota Medical School. Robert D. Madoff, MD, is the Stanley M. Goldberg, MD, Professor of Surgery and chief of the Division of Colon and Rectal Surgery at University of Minnesota Medical Center, Fairview.
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About the Roundtable MR. CHRISTENSON: How do we define specialty pharmacy?
Minnesota Physician Publishing’s 37th Minnesota Health Care Roundtable examined the topic of specialty pharmacy. Five panelists and our moderator met on June 7, 2012, to discuss this issue. The next roundtable, on Nov. 1, will explore the subject of health insurance exchanges.
MS. DRAKE: Specialty pharmacy encompasses specialty pharmacy drugs and the infrastructure that delivers those products to the patient. Minnesota statute 256B states that specialty pharmacy products are those used by a small number of patients or patients with complex and chronic diseases that require expensive and challenging drug regimens. Specialty pharmacy products include injectables and infusion therapies, biotechnology drugs, antihemophilic factor products, high-cost therapies, and therapies that require complex care. DR. HEATON: CMS has a definition in terms of high cost. That is $600 a month. DR. BEECHER: Specialty pharmacy is part of the whole management program. It has a lot to do with cost and with the special nature of these products. But, in fact, the questions that we’re going to be talking about today will also have to do with how resources will be allocated.
Specialty pharmacy
MR. CHRISTENSON: What problems do patients face in accessing specialty pharmacy medicines? MR. JOHNSON: The number one barrier is out-of-pocket cost for the consumer. Close to 20 percent of Minnesotans who are prescribed a specialty MS drug are either reducing or not taking it at all because of the cost. DR. STRATTON: There could be concern about how effective many of these medications are. They have been tested in relatively small numbers of patients because of the special nature of many of these conditions, and we need clinical evidence before we do well-designed cost-effectiveness studies. Many times we don’t have adequate clinical evidence of effectiveness—comparing one product to another for a given disease— to talk about which approach is the costeffective way to treat a particular disease. DR. BEECHER: The way access to these expensive drugs is structured, the patient has an awful lot of hoops to jump through and so does the doctor. It depends on how the doctor is reimbursed, whether he or she is an independent practitioner, etc.
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Controlling the cost of care MS. DRAKE: Sometimes distribution channels for specialty drugs present a challenge for the patient. Many of these products are only available through specialty pharmacies or mail order pharmacies, which is a switch for patients who are used to having their prescription filled by their local pharmacist. Making sure that the product gets from the specialty pharmacy either to the patient or to the clinic and then delivered to the patient presents a challenge. Another barrier is some of the administrative requirements. Most payers have prior authorization requirements. We’ve run into situations where patients are not able to get their drug because they haven’t received a response from their insurance company yet. MR. JOHNSON: For a condition like MS, that can present significant negative repercussions for a patient. We’ve heard stories that those appeals processes or step programs lead to marked differences in physiological measures of someone with multiple sclerosis. The appeal process needs to be prompt.
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MR. CHRISTENSON: How does utilization of specialty pharmacy create conflict among health care stakeholders? MS. DRAKE: What we’ve seen in Medicaid is around some of the drugs that span between what has traditionally been the medical benefit, which is buy-and-bill in the physician office, versus what is now specialty pharmacy benefit. There is the question of who buys the product, who stores the product, and who bills for the product. Different payers have different requirements. There is not a standard, and there are questions about what is Medicare Part D versus Medicare Part B. That back-and-forth between the medical benefit and the pharmacy causes confusion. MR. CHRISTENSON: There are multiple stakeholders in specialty pharmacy, including pharmaceutical manufacturers, pharmacy benefit managers, physicians, and DHS. What are their priorities? DR. STRATTON: Pharmaceutical manufacturers have an obligation to their shareholders to bring in as much profit as they can on these products. When you’re talking about a smaller market to recoup the costs involved, you have to charge more. DR. HEATON: From a pharmaceutical manufacturer perspective, you always want to find the unmet need. Now we have drugs for Pompe disease that we never had before. If you’re first in the market for the Pompe drug, you set the price. The PBM, depending on how they’re reimbursed by the plan, could have a similar aligned interest. If rebate contracts are available, the PBM will take advantage of that if they are reimbursed by the plan on a PMPM [per member per month] target. On the other hand, they may have a direct conflict in that type of scenario and will put barriers, prior authorization, step edits, you name it, in front of that. It all depends, unfortunately, on the money flow. DR. BEECHER: I want to stay in business as a physician, otherwise I’m not going to be of any help to anyone. As a psychiatrist, I want patients to take responsibility for their own health and be able to enjoy the benefits of their insurance as much as possible. All of these specialty drugs require insurance to some degree.
MS. DRAKE: Our priority in managing the drug benefit is to give the best possible health care and drug benefit to individuals who need our program and, at the same time, provide the best value to the Minnesota taxpayer. MR. CHRISTENSON: With all of these priorities, can we get them in sync? MR. JOHNSON: We’re hopeful. How do we help people become more intelligent about making informed decisions about their health? That challenge is compounded by the nature of MS. People with MS who have visual impairments, mobility issues, cognitive issues, come to the process in a state that adds to the potential confusion, from the perspective of the client. We need to strive toward making it simpler for consumers. DR. HEATON: The system to treat a population works reasonably well; we have to be exquisitely sensitive to the exceptions to the population, the individual patient. Right now, it drives a disproportionate amount of cost. MR. CHRISTENSON: What makes a physician hesitant to prescribe specialty pharmacy? DR. BEECHER: In most cases, we don’t know about rare diseases. The difficulties of producing, storing, and distributing the drugs: We aren’t aware of them. That’s why the pharmaceutical industry is going to the airwaves, to prompt patients to spur the doctor to prescribe this or that. MR. JOHNSON: In the case of multiple sclerosis drugs, for the most part, these disease-modifying drugs didn’t exist 15, 20 years ago. Neurologists who have an MS specialty practice understand the benefits of prescribing. Up to 20 percent of people with MS in Minnesota don’t have access to an MS specialist who’s a neurologist. Some people in rural parts of North and South Dakota travel as far as 600 miles to see an MS specialist. The issue is education, working with clinicians. MS. DRAKE: Some of the concentration into certain provider groups as far as prescribing might not be bad. Some of the new regimens, such as the new hepatitis C regimens that are making a great difference in cure rates for this disease—these regimens are not easy. For a prescriber who only has to prescribe it once a year, I think it would be a
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huge challenge. Whereas specialists in hepatitis C who write these prescriptions over and over become better over time. Maybe at some point there can be better communication between specialists and practitioners in rural areas to share information so that rural practitioners can get specialist knowledge without having to know everything about everything. MR. CHRISTENSON: Many physicians believe that specialty meds don’t work; some are not aware of what a drug can do. Is this general within the physician world? DR. BEECHER: Yes. You have to know what you don’t know if you’re a physician. MR. CHRISTENSON: One of the biggest issues is spending money on high-priced drugs, hoping in the future to reduce hospitalizations and other costs. DR. HEATON: That’s a very good point, one that all payers are struggling with. I may make a decision to cover an MS drug or an oral oncology agent, and I may not reap the benefit of that decision. I have all the up-front costs, but to see that the patient continues to work, continues to pay taxes, or is cured of their disease may occur someplace down the road. Ultimately, we have to take a much broader societal picture of that. Covering a drug today for the promise of tomorrow is fraught with problems because nobody knows how far off is “tomorrow.” The rest of the world does very good pharmacoeconomics studies—I can think of the National Institute of Clinical Excellence in England— trying to answer questions such as, is it cost effective and looking at a life saved. We don’t do that in the United States. MR. JOHNSON: There’s evidence that there are enough dollars currently in this country devoted to care and treatment that, if managed correctly, we’d have much better outcomes. We still haven’t figured out how to manage those dollars. In the case of people with multiple sclerosis who are being prescribed an MS disease–modifying drug—no generic equivalent, unlike some specialty drugs—there’s a high likelihood that they will be on that drug for the rest of their lives, and they will likely not die of MS, they’ll die from another condition. If the cost
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A B O U T T H E PA N E L I S T S Lee Beecher, MD, maintains a solo practice in adult and addictions psychiatry in St. Louis Park. He is an adjunct professor of psychiatry at the University of Minnesota Medical School, a Distinguished Life Fellow of the American Psychiatric Association, a fellow of the American Society of Addiction Medicine, a past trustee for the Minnesota Medical Association, and was medical director for psychiatric services at PreferredOne from 1991 to 1995. He also serves as president of the Minnesota PhysicianPatient Alliance (MPPA), a nonprofit organization committed to improving health care. MPPA believes that efficient, quality health care depends on strong doctor-patient relationships and that interference in the doctor-patient relationship by third parties can alter market-based reimbursement and undermine the traditional ethics of the medical professions. Sarah Drake, RPh, MPH, MBA, is the pharmacy program manager for the Minnesota Department of Human Services (DHS), where she oversees all pharmacy-related activities for the Medical Assistance program. This includes drug utilization review, formulary and preferred drug management, two drug rebate programs, establishment of state maximum allowable costs, prior authorization, utilization management, policy development, and legislative activities. Before working at DHS, she was a senior consultant for Deloitte Consulting in its strategy and operations practice, served in product management at Blue Shield of California, and worked as a pharmacist in both inpatient acute care and in retail pharmacies. Alan Heaton, PharmD, RPh, director of pharmacy management for UCare, is responsible for all facets of the pharmacy benefit program for more than 300,000 Medicaid and Medicare Part D members. He is an adjunct clinical instructor in the University of Minnesota School of Public Health and a clinical assistant professor in the College of Pharmacy, University of Minnesota, Minneapolis, where he lectures on diseases and their relationship to drug therapy. Previously, he was pharmacy director for Blue Cross Blue Shield of Minnesota and vice president for health outcomes integration at Prime Therapeutics. In the latter role, he directed medical and pharmacy data integration applications and outcomes research, including retrospective database studies and clinical trials of a wide variety of therapeutic agents. Daniel Johnson, MEd, is vice president of public policy and mission advancement for the National Multiple Sclerosis Society Upper Midwest Chapter, leading its consumer advocacy, political engagement, client programs, and professional outreach and education. Reducing the financial burden of MS specialty drugs is a chapter priority; more than 17,000 people live with MS in Iowa, Minnesota, North Dakota, South Dakota, and several counties in western Wisconsin and Nebraska. Previously, as vice president of UnitedHealth Group, he led its social responsibility culture to focus on chronic disease. He has also served as executive director of Blue Cross and Blue Shield of Minnesota Foundation. Early in his career, he provided direct care to people living with chronic illnesses, including MS. Timothy Stratton, PhD, BCPS, FAPhA, is a board-certified pharmacotherapy specialist and a professor of pharmacy practice in the University of Minnesota College of Pharmacy, Duluth, where he teaches ethics and supervises medicine and pharmacy students at the HOPE free clinic. He also practices occasionally at the Min No Aya Win Clinic in Cloquet. Stratton earned his MS in hospital pharmacy and PhD in pharmacy administration from the University of Arizona and completed a pharmacy residency at Arizona Health Sciences Center. He previously taught at the University of British Columbia and the University of Montana and has practiced pharmacy in Alaska and with the Indian Health Service in Montana. Bruce Silcox Photography
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Robert Christenson, with 40 years’ experience in health care policy and consulting, helps solo and smallgroup practitioners build a full practice of ideal clients and improve their net revenue.
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M I N N E S O T A is such that they’re not able to afford it and therefore compliance with treatment is not followed, there’s some argument to be made that they’re being discriminated against. They’re paying a premium, they’re eligible for a government program, they can’t gain access to the drug, and so their health is harmed as a result. Again, it goes back to the question: How do we manage the overall resource in ways that are smarter than we’re currently doing? DR. STRATTON: Part of it’s a cultural bias, comparing a city of cure versus a city of care. City of cure: We go in, we replace the organ, we cure the patient. Then we have the city of care, patients who have chronic illnesses. We’re never going to cure them. We can only provide care for them. The U.S. does not like things to draw out that long. We like to get in there and fix it and move on and stop paying for it. MR. JOHNSON: We haven’t talked enough about investment in prevention and the cost benefit of that. Evidence shows that if you stop smoking, if you deal with issues around obesity, nutrition, and stress, that chronic disease will most likely diminish. What does that mean long term in terms of health care dollars? There’s the argument that you’re prolonging people’s lives and what’s the cost there; but I think that in terms of quality of life factors, that is indisputable. MS. DRAKE: Over 10 percent of the population is on some kind of specialty drug in this country. If most specialty drugs run between $20,000 and $30,000 a year, spread that across the whole U.S. population and that’s $2,500 a year for every man, woman, and child in this country. Is that an acceptable amount that we’re willing to pay for these advances in therapy? Those are questions we need to ask. MR. CHRISTENSON: If it’s $25,000 a year for an AIDS drug and there are a million people who are HIV-positive, that amounts to $2.5 billion a year in costs. DR. STRATTON: Let’s talk about spending $25,000 a year for one patient’s medication. How many patients could we vaccinate against influenza that year at $20 apiece? 1,250. We know there’s a certain percentage of patients with flu every year who die from that after an expensive hospital stay, versus one patient whose quality of life will improve dramatically with that $25,000. This
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is where, from an ethics standpoint, it becomes a justice issue. Justice is the fair distribution of scarce resources. That’s one of the big issues we’re struggling with as a society. DR. HEATON: It also points out why many health care plans have medical ethicists and medical policy committees. We, also, are struggling with what is fair. Is it fair for an MS patient to have 20 percent coinsurance on a drug that’s $3,000 a month? MR. JOHNSON: There was a story last night on NPR that spoke to increasing concern about cancer rates among people who have been exposed to radiation through CT scans, and some suggestion that we could probably cut the number of CT scans in the country and
MS. DRAKE: One of the biggest challenges is waste. There’s a push toward white bagging, where the specialty pharmacy bills the pharmacy benefit directly and then ships it to the doctor’s office for administration. We run into the situation where a specialty pharmacy will ship the drug to the clinic, we’re billed for it, and the patient doesn’t show up. Patients have things going on in their lives, there’s disruption, and that drug sits at the clinic and ultimately gets thrown away. When it’s a 10-cent pill, we don’t care, but when we’re talking a $5,000-a-month infusion that we’re billed for and it gets
Over 10 percent of the population is on some kind of specialty drug in this country. Sarah Drake, RPh, MPH, MBA
there wouldn’t be any adverse effect. At the same time, a CT scan is the No. 1 way that MS is diagnosed and the progression of the disease is modified. So how do we apply resources that are already on the table in much more informed and educated ways so that we make sure that there’s not waste— that we can still provide flu immunization for all those folks that should be getting a flu vaccination, and at the same time be able to provide the AIDS drug? MR. CHRISTENSON: The issue of medical benefits and pharmacy benefits: What challenges does this present for the state Medicaid program?
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thrown away, that’s a problem. We have gone to our policy of, “It’s administered in the clinic, it needs to be billed on medical,” because then we’re not billed for it until it’s actually used. Some commercial plans have specialty pharmacies they contract with, and the specialty pharmacies have an incentive to dispense the drug because they make a margin on that. It’s a difficult tug in each direction. MR. CHRISTENSON: One of the components of finding solutions to this is good data. DR. HEATON: We have a wealth of data, but it’s the wrong data. I can tell you to the penny how much we spent on PMPM basis on both the pharmacy and the medical side
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M I N N E S O T A for the drug for hepatitis C, for example. Plans have a wealth of data. It’s retrospective, not forward-looking, and that’s what we need. I’ll give you a practical example: the new oral therapies for hepatitis C on top of the IV therapies. You can literally eradicate the virus now. The trouble is, you’ve got be on these oral drugs for three to six months. This is a particularly acute problem in Medicaid, where you have month-to-month enrollment changes, so when suddenly someone leaves a plan, we’ve lost continuity of care. Huge societal cost problem looming. Huge problem in the short term because it breeds resistance to the drugs. Data almost has to always follow the patient.
Many consumers continue to be insulated from cost.
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patients. They could go to clinics and get stuff as needed for their kids and for themselves, and their costs would be accounted. They would have some kind of fallback for hospitalization. There would be no doughnut hole or anything like that. I don’t see why their meds couldn’t be done the same way. We need to look at different methods of payment based on individual experience and then get data. MS. DRAKE: Laws state that any willing provider, as long as there is not some reason as far as a license issue, can enroll as a Medicaid provider and provide specialty drugs. I think one of the challenges might be access to products at prices that are similar to what the big providers get. Some of the bigger providers negotiate better pricing on the products. Independent
MR. JOHNSON: Many consumers continue to be insulated from cost. That’s changing with the advent of copay and coinsurance. I hope that people would be making decisions about their specialty drugs or other kinds of treatment based on how they perceive the outcome and the desired benefit. If they see that they improve their health, however they define it, that should be the driving force. How do they become more educated and informed of options in that regard? MS. DRAKE: We need to think about multidisciplinary efforts to ensure that patients are using their medications and using their medications correctly. It probably needs to go beyond the physician and the pharmacist to maybe social workers in Medicaid cases, or other kinds of care coordinators or providers. If we’re going to, as payers, invest in high-cost products at $25,000 a year, it makes sense that we make another nominal investment to make sure they’re using these medications appropriately. Studies show that by getting the pharmacist involved in spending time understanding what’s going on with the patient, you achieve better adherence.
Daniel Johnson, MEd
physicians might need to join a buying group in order to get better negotiated rates on those drugs.
MS. DRAKE: If we invest in this drug today, where is the advantage in the future? We don’t have a good way to track a patient’s health care outcomes across time. MR. CHRISTENSON: Can physician-owned, independent medical practices provide specialty pharmacy unless they join provider networks? DR. BEECHER: We’ve got to learn how to costaccount the individual case. I want to know how much a patient is costing. Then, I want to design my system around the best venue to provide the care that patient needs without wasting anything. My colleague, Dr. Geist, has come up with a solution. Medical Assistance could have a card that would be given to AFDC-type medical assistance
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macists, nursing staff. We identified 16 different things that touch compliance, not including cost. From a plan perspective, there have been plans that have said, these lifesaving drugs are free or low cost or the $4 generic. Other attempts have been, if you’re compliant for three months, the fourth month is free. Then there are patient assistance programs. Cost is what scares everybody off right off the bat, but once you tackle the cost issue you still have all these other factors to contend with.
MR. CHRISTENSON: How do we make patients more compliant with instructions? DR. BEECHER: There is a direct relationship between decreased adherence to medications and copayments. Expensive drugs with a high copayment, that’s going to further complicate our problem. DR. HEATON: We have instances of Medicaid where there is no cost and yet there still is noncompliance, and it gets to a wide variety of social issues: denial that they’re sick; educational effort among physicians, phar-
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DR. STRATTON: Whether it’s a pharmacist or physician sitting down with a patient, identifying what’s important to the patient, involving the patient in that discussion. Patients who have rheumatoid arthritis may know fairly soon if they’ve missed a dose. Patients who have high blood pressure may skip doses. With a recent patient, we had at the HOPE Clinic—it had been two years since they’d been on their blood pressure medicine. Their numbers concerned us, but the patient felt fine. So, taking the time to figure out what’s important to that patient is important. MR. CHRISTENSON: Once you find out what’s important to the patient, which works more
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M I N N E S O T A effectively—penalty or positive incentive? DR. BEECHER: Positive incentive. Motivating the patient though different ways, including the family and social work, to do the right thing is a process involving the pharmacist, involving the physician. How do you get them to do the right thing? You do what you do with your children: You keep working on it. Punishment, penalties, copayments—all that does is to make things worse. DR. HEATON: If I put a $125 copay on something, I’m intending to decrease utilization and that’s exactly what I get. We’ve got to get more creative than upping coinsurance and copays. One individual did a very good cost-utility analysis. He was asking about the treatment of rheumatoid arthritis and the doughnut hole. He came up with the observation he’d be spending roughly the equivalent of two big-screen TVs annually. He said, “I think I’ll get more satisfaction out of watching the Vikings than I will taking the drug.” That is what a lot of the rest of the world does. They’ll do that cost-utility analysis and say, it’s more important to our population to treat potholes than it is to treat rheumatoid arthritis. When patients are less insulated against the true cost of these drugs and their outcomes or nonoutcomes, they start making those judgments to say what’s more important to them. DR. STRATTON: Involving the patient in that discussion, we may learn that the patient may be willing to use a less effective medication, live with some level of discomfort, versus a very expensive medication that would provide complete relief. We need to ask the patient those questions. MR. JOHNSON: All eight of the current MS-modifying drugs have patient assistance programs. There is a copayment assistance program. There are nonprofit organizations that provide support when patients run into financial binds within the doughnut hole. Nonfinancial assistance programs, educational programs: There are a lot of those, by and large, available from pharmaceutical companies. Not to say those aren’t valid, but they would have some bias toward the medication that the company represents. MR. CHRISTENSON: What is the role of the PBM in expanding use of specialty pharmacy?
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MS. DRAKE: It depends on the PBM. As far as expanding the role: Should we be expanding the role of specialty pharmacy? From our perspective at the state, we’re not really a PBM; we’re managing a public program. We’re trying to make sure that patients get the best care for the best dollar. As far as commercial PBMs, they have a split role where they’re accountable to the ultimate payer—whoever’s hired them as a PBM—to try to get them the best value in their drug benefit. They also have an incentive to make a profit and many are doing that through their contracted or in-house specialty pharmacies. So they’re expanding the role of specialty by being a distributor as well as a payer.
I would like to have a relationship with the pharmacy team where I, as a physician, know that pharmacist is looking over what I’m doing. That’s the role of the retail pharmacist, and I think they are getting cut out of the deal here. MS. DRAKE: In some instances that does happen, and it’s a challenge for the patients as well as for the pharmacist. Maybe your patient goes to their corner drugstore for all their medications, but [this time] they need a specialty drug, and either their insurance requires it or, sometimes, the drug manufacturers have exclusive arrangements with a particular specialty pharmacy—so the only way the patient can get that product is through mail order. There are a lot of questions about how information is shared be-
You have to know what you don’t know when you’re a physician. Lee Beecher, MD
MR. CHRISTENSON: Are there concerns with PBMs having their own pharmacies? DR. HEATON: I’d say there are some inherent conflicts. Along those lines, if you look where PBMs are going, they’re not necessarily buying a lot of pharmacies. They’re going to mail order and specialty. The recent merger/acquisition of Medco by Express Scripts underlines that because that was predicated on increasing mail order business and increasing specialty pharmacy business. Those are the two high-profitability items they have. DR. BEECHER: Pharmacists have special expertise to do counseling, to look at utilization patterns, to look at multiple drug prescriptions, to do all kinds of things for which we in our offices don’t have the data.
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tween those two pharmacy providers. Who’s really looking over that patient’s whole regimen? Is the doctor being informed that the patient is using multiple pharmacies? The physician could end up getting refill requests from multiple places. It does add complexity to the regimens of folks who have complicated medical conditions. MR. CHRISTENSON: What do employers need to know about specialty pharmacy? DR. STRATTON: Many times, employers look at their drug spend for the health benefit they’re offering their employees separately from the medical spend. When you consider cost as separate silos, you don’t get the big picture. Spending on specialty pharmaceuticals that keep patients out of the hospital often gets lost when you look at increase in drug spend for a given year. Employers generally will not use the entire spectrum of information available to them in making determinations in benefit design. DR. HEATON: I agree. The usual knee-jerk response to something like this is to create a carve-out scenario. Pharmacy has been a
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M I N N E S O T A victim of being carved out for years. We’re even seeing that nationwide, when mandatory specialty pharmacy gets carved out of pharmacy benefit. You get into this scenario where if I’m a member and see my rheumatologist or neurologist or oncologist, and they write me a prescription, and I go to the drugstore or the specialty pharmacy, I’m typically looking at 20 percent coinsurance. However, if I stay in the office and they infuse the drug into me, I’m looking at maybe just my office copay. I may not be paying anything at all for the drug. Perversely, the usual employer group reaction to this type
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hire a PBM and they’ll take care of it. The employers need to be ready to ask those kinds of questions and really get into the weeds of what is the PBM doing for me and how are they helping to make sure that there’s not waste and I’m getting the best deal. Another thing that employers should consider is some of the changes in the Affordable Care Act and what that might mean in terms of specialty pharmaceuticals. Part of that was elimination of lifetime limits on employer and insurance policies. In a world with no lifetime limits, someone who’s a million-dollar-a-year patient could have big implications for an employer. MR. JOHNSON: The other thing I want the employer to be aware of, beyond medical or pharmacy costs, is the broader cost to the employer—the return from specialty drugs that allows the person to con-
Ultimately, we have to take a much broader societal picture. Alan Heaton, PharmD, RPh
Minnesota Department of Health has, that all payers are required to accept. We’re not seeing a lot of use of that right now because most payers use existing forms. The hope is, and I think legislation specifies, that in 2015, there will be national standards for electronic PA. I know the National Council on Prescription Drug Plans, the standards organization for pharmacy, is working on how to do PA in a standard way electronically. I know the AMA has been involved, as have other stakeholder groups, looking at what needs to be standardized. Is it just the form, is it the question, can it be integrated with e-prescribing, can there be a real-time check to see if a drug needs a PA before the prescriber puts in for the PA? There’s a lot of work in this area because I think all stakeholders agree that it is out of control as far as the administrative burden. Most people understand the need for PA to make sure the drug is being used at safe and effective doses for the right populations. How can we make that process easier? DR. HEATON: On the Pharmacy and Therapeutics committees that I am on, safety is the first criterion. We’ll go safety, efficacy, uniqueness, first drug to market for a condition. Cost is the last factor we consider. MR. CHRISTENSON: What role does the FDA play in measuring efficacy?
of thing sets up the fact that their pharmacy cost drops, and it becomes a self-fulfilling prophecy. Unfortunately, their medical costs on the delivery of this drug go through the ceiling. Then they’re trying to figure out what happened because they come back and say, “Well, you said if I do all this my medical costs will drop.” No. It sets up a perverse incentive. Unless you’re a fully integrated system, you’re going to be fighting that all the time. MS. DRAKE: What an employer needs to know as well is to think about, who is my PBM and what are my PBM’s incentives? How are they looking out for me and how are they looking out for my bottom line versus how is the PBM making their money? Sometimes, employers will say, I’m going to
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DR. STRATTON: None, in this country. In Canada, they pay some attention to that. Australia has been leading that charge over the years. The Brits have done a better job through their National Institute of Clinical Excellence. The U.S., we’re way behind the curve.
tinue to work and be productive. MR. CHRISTENSON: What criteria should be used when evaluating new specialty products for inclusion in a standard insurance benefit set? Will authorization approaches be a criterion? MR. JOHNSON: Does the medical, physiological, or emotional benefit outweigh the risks? DR. HEATON: About three years ago, legislation was passed for uniform prior authorization that was then delayed until 2015. The health plans are in favor of that because it is an administrative burden on us. For those who have Medicare, any administrative burden now goes to MLR [medical loss ratio]. This is a big issue with Medicare. MS. DRAKE: There is a standard prior authorization, or PA, form that the
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MR. CHRISTENSON: How is efficacy measured? DR. STRATTON: A randomized clinical trial. Those types of well-designed trials provide groundwork information for cost-effectiveness studies between different products or cost-benefit analyses, of which there are even fewer well-done studies because of challenges in conducting a proper costbenefit analysis. Testing should be transparent so that that another research team could go back and replicate the study to see if they get similar results. That includes reporting studies that fail. DR. BEECHER: There seems to be little incentive from the pharmaceutical industry to do comparative analyses. They even have some reluctance to compare their own products.
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M I N N E S O T A You can’t do head-to-heads very often. If you do, at least in our field, there’s not enough time to tell. Usually there’s only a month or two to get the outcome. It’s very difficult to get meaningful data. DR. HEATON: About 30 years ago, I was a study coordinator on antidepressant studies. We compared drug versus placebo, which is the randomized trial that gets it FDA-approved, and we had a 54 percent response rate on drug. We had a 46 percent response rate on placebo. That means for every 10 people the doctor would see in his office, 5.4 responded to the drug, and 4.6 responded to placebo. It’s roughly five out of 10 both ways. That’s statistically significant. That was the second confirmatory trial. The drug got approved. There were 27 other trials in which there was no difference, and in fact there were a few trials in which the placebo performed better than the drug. Conventional wisdom at the time said, that can’t happen. We know now, it could happen. Even with randomized controlled clinical trials, we are lacking in good information. MS. DRAKE: A lot of times what’s presented to us is that a drug is more efficacious than placebo statistically, but what does that mean clinically? What does that mean for the patient, that their score on this metric is 10 percent better? What does that mean in terms of their quality of life? Sometimes it’s really difficult to pull those answers out of the data. MR. CHRISTENSON: Lee, how can consumers make their perspectives known when these criteria are being set? DR. BEECHER: First of all, I think they have to have a choice of providers. Secondly, they have to have some control of dollars on the front end. I alluded earlier to how public assistance patients could do that. We are in a reality of high-deductible plans in Minnesota now, somewhere around 14 percent. There are issues around how much discretion the patients have on the front end, before they get to their deductible, and the rates. But patients need to understand the economics of their own care. I think we’re just emerging into an era where, although some of us have a public health view of a right to health care, we haven’t thought, as patients, about how much things cost. We don’t know how much our pharmaceuticals really cost.
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MR. CHRISTENSON: What is the Minnesota Physician-Patient Alliance doing in this regard? DR. BEECHER: I mentioned a program to empower Medical Assistance patients with a debit card and let them do some front-end shopping and select their own providers. We’re working with legislators on those issues. We have to become more costconscious. MR. CHRISTENSON: What causes the time lapse between when a new pharmaceutical product is proven to achieve superior results and when it becomes widely used? DR. HEATON: One of the big causes is lack of clear evidence. We have seen over the last 10, 15 years—independent of specialty pharmacy but now it’s linked because of cost issues—a surge of noninferiority trials or nonsuperiority trials: “It’s just as good as something else,” or it’s randomized
against placebo. Placebo is not one of my treatment options in the real world. So there’s a lack of high-quality information that says, “This works.” With a drug that’s $3.28 a day, like Lipitor was, versus something that’s $34,000 a month, like Revlimid, scrutiny is exponentially higher. We don’t have good comparative trials like there are in the rest of the world, so we’re left with a lot of uncertainty. DR. STRATTON: A well-designed cost-effectiveness study first and foremost would be based upon a well-designed clinical trial with an adequate number of patients in both the innovative drug arm and the comparator arm, whether that was placebo or another comparative drug in the same therapeutic category. Collecting that data, you would need to conduct a cost-effectiveness compo-
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nent of the trial from the get-go. Many times, cost-effectiveness studies are conceived after the fact, after the clinical trial has been completed. You’ll see researchers saying, I wish we had collected that data during the clinical trial. It takes a lot of planning up front. Again, it’s a very complex process to adequately design those kinds of trials, and we don’t have a lot of expertise in North America to conduct those kinds of trials. Expertise aside, they are very expensive to undertake, so who’s going to pay for that? Pharmaceutical company? National Institutes of Health [NIH]? NIH is underfunded and that’s not going to improve any time soon. Those are some of the barriers. It’s
Taking the time to figure out what’s important to the patient is important. Timothy Stratton, PhD, BCPS, FAPhA
complex to do these studies properly. MR. CHRISTENSON Could the FDA’s approval process be more efficient without compromising quality? DR. HEATON: It’s a two-edged sword question. FDA approved Avastin on a fast-track scenario. Lo and behold, at least in breast cancer, it did not seem to be effective and, arguably, may have caused excess mortality. Yes, we do have a need to speed to get these drugs to a susceptible population, but we can’t overlook the safety issue. Unfortunately, those trials take a long time. The drug I saw yesterday had two studies, and I think there was a grand total of 31 patients, worldwide, that were studied. So the odds of seeing efficacy diminish but, more importantly, the odds of seeing something that
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M I N N E S O T A will kill you or cause an adverse reaction, are very difficult to find in these studies. The FDA is caught by the need to speed, but on the other hand, it has to be conducted with a large enough number of patients and a sufficient period of time to see safety signals that often come out after the fact. MR. JOHNSON: There is a great need for additional resources for medical research. With NIH funding, unfortunately, politics are getting in the way of making informed decisions and supporting things that are important for the health and well-being of the population. MR. CHRISTENSON: What are the biggest developments coming in specialty pharmacy? DR. BEECHER: The biggest opportunity will be learning about genetics. Pharmaceutical companies are keying on tailoring drugs. Specialty pharmacy is based on genetics. DR. HEATON: Two words come to mind: “prevalence” and “oral.” Look out on the pipelines of many drug manufacturers and where the research is in specialty pharmaceuticals. Increasingly, these are oral drugs. I’ve had the conversation with quite a few members who have multiple myeloma, went to the drugstore, and found their 20 percent specialty charge was $3,000 if they wanted to get their drug. That’s for basically a threeweek supply. Increasingly, these are oral. They’re not injectable any more. They’re not infusion. The other aspect of this that’s scary is prevalence. If you recall, I said, 99 percent of claims are not specialty pharmaceutical. It is relatively isolated, small numbers of unique conditions. That’s changing. Dr. Beecher pointed out the issue of genomics. Suddenly, we will have specialty drugs for hypertension, hyperlipidemia, diabetes. We can see that coming: prevalent conditions that account for 30 percent to 40 percent of claims
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volume and huge amounts of cost. The future looks, depending on one’s perspective, very scary. MR. JOHNSON: The National MS Society has looked at this issue, and leaped to seeking relief via insurance regulation. Just in the last month or so, there have been stories about specialty drugs and the costs in the New York Times, the Washington Post, the LA Times. It’s important that we inform all the various stakeholders about what’s playing out because in many ways, this has been somewhat of an invisible movement despite the decades that specialty drugs have been around. It’s fair to say that increased attention will fuel a lot of hand-wringing that often leads to “let’s create a bill, let’s regulate this issue.” On one hand, that’s something we need to take a close look at. We know that mandating some kind of benefit is not going to be a solution, and it’s not necessarily the approach that I want to take as the Midwest Chapter of the National MS Society. We’re contemplating convening a small group of stakeholders to sort out from a public perspective, whether it’s a policy solution or an education solution, what’s the best way for us to move forward—not in an adversarial relationship with health plans, but [rather], how do we come up with a common solution? MS. DRAKE: There’s going to be more attention to this topic, partly because of the prevalence of the conditions that they’re treating. Also, during the last several years, most plans have been able to stabi-
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lize a lot of it on the drug side with the introduction of generics for what have typically become blockbluster drugs like Lipitor, Seroquel, Zyprexa. All of those have gone generic in the last year, and that has decreased cost for pharmacy benefit managers. The generic tide is ending soon, probably within the next few years, and at that point we’re left with a trend that is going to be driven by these specialty pharmaceutical products. Pharmacy benefit managers, employers, public payers that traditionally haven’t looked closely at specialty pharmacy because it has been a small portion of their cost, are going to have to start looking because that’s what going to be driving the trend in the future. The other development I would mention is health reform and the Affordable Care Act. There is a lot of talk about ACOs— accountable care organizations—and different payment reform methodologies. How does specialty pharmacy fit into that? If you’re talking about a total-cost-of-care arrangement with a provider group, what does it mean if that provider group treats a lot of patients who need specialty drugs, and how is that adjusted for? I think that’s going to be an important development, too. DR. STRATTON: With the advent of accountable care organizations, having a pharmacist on that patient care team on the patient level, as well as on a health system level—it’s going to be very important to have a pharmacist’s input on a lot of the decisions that are going to be coming down the pipeline in terms of including particular specialty pharmaceuticals on a formulary.
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PAT I E N T
W
hen we ask ourselves what a Crohn’s or colitis patient ultimately wishes for, we think, “That’s easy—a cure.” Everybody wants a cure, certainly, and we all want to feel better. That’s the obvious answer, but those are not the only objectives in the improvement of patients’ lives. We also need to look at the other factors that make being sick a burden— not just health-wise, but also logistically—and focus on what we can do to improve those components as well. For the past 10 years I’ve made a living standing in front of college students, sharing with them the wonders of electrical engineering—while hoping desperately to avoid sharing with them the visceral (and what would undoubtedly be a painfully memorable) experience of living with a disease that involves sudden, urgent, bloody diarrhea. Hopefully I don’t have to elaborate on what a horrifying prospect that is to confront on a daily basis, or how that might take its toll eventually on
Living with IBD Holding onto hope By Andrew Tubesing, MSEE
one’s stress level. (Ever wonder how patients can become so consumed by nervous energy? This particular fear is part 1 in every IBD patient’s personal Book of Anxiety.) The other half of my job involves overseeing laboratory operations for the department. I
rest of my IBD adventure story, is chronicled in my book, “Colitiscope: Living with Crohn’s Disease and Ulcerative Colitis.” A moment, frozen in time
One afternoon I had called my gastroenterologist’s office because I was flaring up, again,
What most of us crave is simply hope for a tomorrow, or even for today. spend much of that time with students who stop by looking for help on homework, project designs, and choosing parts. The flow in and out of my office can be pretty steady, so time to myself is hard to come by. The following tale, along with the
American Diabetes Association EXPO Healthcare Professional Breakfast Saturday, October 13, 2012 7:00 am Minneapolis Convention Center *Exhibitors feature the latest products, services and medications FREE Educational Credits!
*Ask the Expert: Questions answered by medical professionals Innovations in Diabetes Care and e-Healthcare by Brandon Nathan, MD
*Exciting speakers on diabetes topics Brandon Nathan, MD, is a Pediatric Endocrinologist at University *Healthy Eating cooking and Active Living fitness demo’sof Minnesota Amplatz Children's Hospital, Fairview in Minneapolis, Minnesota. *FREE health screenings Dr. Brandon Nathan has spent the last four years supporting an online *FREE Admission pediatric diabetes learning community at the U of M. He has demonstrated *For more information call1-888-DIABETES success with using the Pediatric Diabetes Learning Community and is or visitworking www.diabetes.org/minneapolisEXPO currently on a project targeting high risk adolescents with type 1 diabetes and the use of on-line education/video tools to educate patients and families and improve care through utilizing e-Healthcare communication. Objectives: Describe two challenges of implementing the Pediatric Diabetes Learning Community and how these challenges were overcome. Describe two benefits associated with the online educational tools and e-Healthcare communication for the healthcare provider and the patient. 7:00 am - 8:15am Breakfast, Presentation and Discussion Event is free of charge and open to all healthcare professionals. RSVP on-line at https://diabetesmn.wufoo.com/forms/hcp-breakfast/ Space is limited. Please RSVP by Friday, September 28, 2012 1.0 Credits Hours Available through Minneapolis St. Paul Diabetes Educators (MSDE) for RN, RD, CDE, PharmD
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after unsuccessfully trying to wean off prednisone, again (Anxiety, part 2). I was waiting for the proverbial callback from the nurse, or scheduler—I didn’t care which; I’d been getting desperate for some help. This process is one I’ve always found painful. Nothing could be handled with a simple phone call; it always requires some complex orchestration of communication channels, always seemingly mismatched, talking in secret code to one another, which might result in a callback today, or tomorrow, or perhaps never. (Anxiety, part 3) I was in my office. My hands were full, working on something delicate at my desk that I couldn’t really let go of without losing significant progress. The phone started ringing and posed an interesting predicament. I looked at the phone and back at my work. If this was the GI office calling, I definitely wanted to take it (lest I have to wait through the callback routine yet again), but I couldn’t really let go and pick up the receiver or I’d have to redo my work for the fourth time (the previous three interruptions were warp-speed trips to the restroom). So, stretching a bit, I used my elbow to hit the speakerphone button. Just as I answered, “Hello, this is Andy,” a couple of stu-
dents walked into my office. I shook my head and gave them a look like they were interrupting something, but the message didn’t get through. Before I had a chance to stop what was already in motion, the voice on the speaker filled the room: “Hello, Andrew? This is Melanie from Dr. So-and-so’s office; we got a message that you have rectal bleeding.” The moment stood, frozen, dangling in time, during which nobody in the room could recall a more awkward situation in their life. I was paralyzed, mouth agape. The looks on my students’ faces were priceless, as was mine I am sure. The pair took one look at each other and, without saying a word, decided they didn’t need help as badly as they had thought and quickly left the room. I agonized for a moment, with no alternative but to put faith in their maturity and discretion (Anxiety, part 4). I dropped my work and picked up the phone receiver to chat with Melanie. I explained that I was flaring up; that the doctor I’d been seeing wasn’t a good match for me, which was another developing complication I haven’t mentioned; and that I wanted to see someone ASAP— I couldn’t afford to wait three to four months as was commonly required (Anxiety, part 5). I had to work hard to get a reassignment and a timely appointment, and ultimately I found a better match that worked well for the long term. What do patients want?
While I have since moved to a different part of the country and come to appreciate that doctor office logistics are not so difficult everywhere, this incident is worth relating as an example of the many factors that contribute to a patient’s overall struggle— including some that aren’t disease-related medical issues, but rather purely logistical. The difficulty in scheduling office visits, speaking to someone when there’s a question or concern, coordinating among multiple caregivers, and many other challenges contribute signifiIBD to page 42
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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and insulin has not been studied. CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dosedependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have subsequently been reported. This comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~ 1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with ontreatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebotreated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: In clinical trials of Victoza®, there were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,
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MINNESOTA PHYSICIAN SEPTEMBER 2012
pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® and other potentially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparatortreated patients in the five controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. The most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer. Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Event Term Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Upper Respiratory Tract Infection 9.5 5.6 Headache 9.1 9.3 Influenza 7.4 3.6 Urinary Tract Infection 6.0 4.0 Dizziness 5.8 5.2 Sinusitis 5.6 6.0 Nasopharyngitis 5.2 5.2 Back Pain 5.0 4.4 Hypertension 3.0 6.0 Table 2: Adverse events reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Placebo + Glimepiride + Metformin N = 724 Metformin N = 121 Metformin N = 242 (%) (%) (%) Adverse Event Term Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial All Victoza® + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Event Term Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and insulin has not been studied. CONTRAINDICATIONS: Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dosedependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). One additional case of thyroid C-cell hyperplasia in a Victoza®-treated patient and 1 case of MTC in a comparator-treated patient have subsequently been reported. This comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Four of the five liraglutide-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One liraglutide and one non-liraglutide-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~ 1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with ontreatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebotreated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: In clinical trials of Victoza®, there were 7 cases of pancreatitis among Victoza®-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). Five cases with Victoza® were reported as acute pancreatitis and two cases with Victoza® were reported as chronic pancreatitis. In one case in a Victoza®-treated patient,
pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. One additional case of pancreatitis has subsequently been reported in a Victoza®-treated patient. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® and other potentially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) may have an increased risk of hypoglycemia. In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 7 Victoza®-treated patients and in two comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea or other insulin secretagogues [see Adverse Reactions]. Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions]. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® was evaluated in a 52-week monotherapy trial and in five 26-week, add-on combination therapy trials. In the monotherapy trial, patients were treated with Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, or glimepiride 8 mg daily. In the add-on to metformin trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or glimepiride 4 mg. In the add-on to glimepiride trial, patients were treated with Victoza® 0.6 mg, Victoza® 1.2 mg, Victoza® 1.8 mg, placebo, or rosiglitazone 4 mg. In the add-on to metformin + glimepiride trial, patients were treated with Victoza® 1.8 mg, placebo, or insulin glargine. In the add-on to metformin + rosiglitazone trial, patients were treated with Victoza® 1.2 mg, Victoza® 1.8 mg or placebo. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparatortreated patients in the five controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. The most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Tables 1, 2 and 3 summarize the adverse events reported in ≥5% of Victoza®-treated patients in the six controlled trials of 26 weeks duration or longer. Table 1: Adverse events reported in ≥5% of Victoza®-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Event Term Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Upper Respiratory Tract Infection 9.5 5.6 Headache 9.1 9.3 Influenza 7.4 3.6 Urinary Tract Infection 6.0 4.0 Dizziness 5.8 5.2 Sinusitis 5.6 6.0 Nasopharyngitis 5.2 5.2 Back Pain 5.0 4.4 Hypertension 3.0 6.0 Table 2: Adverse events reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Placebo + Glimepiride + Metformin N = 724 Metformin N = 121 Metformin N = 242 (%) (%) (%) Adverse Event Term Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial All Victoza® + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Event Term Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2
SEPTEMBER 2012
MINNESOTA PHYSICIAN
29
Council from cover pose is to identify best practices and implement them in all of the teaching hospitals in the Twin Cities: the University of Minnesota Medical Center, Fairview; Regions Hospital; Hennepin County Medical Center; Children’s Hospitals and Clinics of Minnesota; Minneapolis VA Health Care System; and Abbott Northwestern Hospital. Council benefits patients, residents
The idea of a resident council arose in the summer of 2011 at a meeting of the Metro Minnesota Council on Graduate Medical Education (MMCGME). Carl Patow, MD, an MMCGME board member and executive director of HealthPartners Institute for Medical Education, proposed the formation of a resident council representing all of the teaching hospitals in the Twin Cities. The organizational structure was a departure from resident councils elsewhere in the nation, which have been confined to a single hospital or
The council’s purpose is to identify best practices and implement them in all of the teaching hospitals in the Twin Cities. residency sponsoring institution. The Twin Cities Resident Council differs in that its membership includes resident representatives from all sponsors of residency programs, not just a single institution. Experienced residents were encouraged to join the council because of their participation in patient care at many of the cities’ hospitals. The Twin Cities Resident Council meets monthly, as an active group of about 15 residents. All the residents are volunteers who attend the council meetings on their own time. The council is led by the residents, who pick the topics for review and organize the topics for discussion and study. Faculty assistance is provided by Drs. Carl Patow, Louis Ling (until January 2012, associate dean of graduate medical education at the University of
Minnesota School of Medicine; now relocated to Chicago), Melissa King-Biggs (HealthPartners and University of Minnesota Medical School), and Meghan Walsh (Hennepin County Medical Center). The role of the faculty is to disseminate the best practices identified by the council and to work with administration at each of the teaching hospitals to implement ideas generated by the resident council. Identifying, standardizing best practices
The inclusion of all the hospitals that sponsor residency programs and residents in their final years of training provides a broad view of the care offered to patients in the Twin Cities. It also offers the opportunity to improve care by identifying best practices for care and by stan-
dardizing practices across all the teaching sites. Why is this approach important to resident physicians? As residents progress through their education, they participate in the care of patients in many hospitals. They see where processes of care work especially well and where the processes can use improvement. They often must learn local variations in care processes, sometimes without really appreciating why the processes of care should be different from hospital to hospital. Some may raise the question: If there is a best practice for a certain procedure, why is it necessary to learn a different technique at every hospital? The resident council structure and purpose allow residents from different facilities to ask these kinds of questions, compare processes, discuss reasons for the differences, and, with input from the council faculty, identify potential opportunities for standardization among facilities. For residents, standardizing best practices across hospitals reduces COUNCIL to page 32
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MINNESOTA PHYSICIAN SEPTEMBER 2012
Mon. – Fri., 9am – 6pm
2012 physician opinion survey 3of 4 7. I am concerned that the cost of providing care to patients using a health insurance exchange will be higher than the compensation for providing that care. 50 43.8% Percentage of total responses
We are pleased to present the results from the third of four physician opinion surveys we will publish in 2012.Through a number of sampling methods, we received 146 responses to Phase 3. If you would like to be included in future surveys, please contact us via e-mail at comments@mppub.com or call 612-728-8600.The surveys are online, are quick to complete, and are completely anonymous and confidential. We welcome your suggestions for this and future surveys. Our thanks to those who participated.
40 32.2% 30 20 13.7% 10 0
1. I understand what a health insurance exchange is.
8.8%
10
30 24.0% 20.5%
Strongly agree
Agree
Disagree
2. I feel health insurance exchanges should be available to anyone, regardless of employer size. 38.4%
40
0
Strongly disagree
4.1%
Percentage of total responses
19.9%
15 10 4.8%
5 Agree
No opinion Disagree
17.8% 13.0%
10 4.1%
5 Strongly agree
Agree
No opinion Disagree
Strongly disagree
30 17.8%
20
20.5%
25 19.2%
20 15
11.6%
10 0.7% Strongly agree
10 Strongly agree
Agree
No opinion Disagree
Strongly disagree
No opinion Disagree
31.5% 30 20
10. It wonâ&#x20AC;&#x2122;t matter if patients know what insurance costs if they do not know what care costs.
11.6%
11.0%
40 30 20
21.2%
19.9% 13.0%
10
4.1% 0
Strongly disagree
43.8%
5.5%
1.4%
Agree
50
40
10
0.0% Strongly disagree
29.5%
41.8%
40
No opinion Disagree
39.5%
30
0
50
54.8%
50
Agree
35
20 15
0.0% Strongly agree
40
6. I think the standard benefit set used by federal employees should be used by health insurance exchanges.
Percentage of total responses
Percentage of total responses
60
11.6% 10
9. I am concerned that pharmaceutical coverage offered by plans in a health insurance exchange will make it more difficult for my patients to receive the right meds.
30.1%
25
0
Strongly disagree
3. When appropriate, I will ask patients if they are using a health insurance exchange.
20
5
0.7% Strongly agree
36.3%
30
Strongly disagree
Percentage of total responses
Percentage of total responses
25
0
No opinion Disagree
30
30
0
Agree
34.9%
35
36.3%
40
0
5. I think a health insurance exchange should be run on a state, not federal, level.
35
20
Strongly agree
Strongly disagree
50
10 3.4%
0
Percentage of total responses
13.7%
40
20
No opinion Disagree
52.1%
Percentage of total responses
20
Percentage of total responses
Percentage of total responses
29.5%
30
Agree
60
47.9%
40
0.7% Strongly agree
8. I think physicians should be on the governing boards of health insurance exchanges.
4. I think a health insurance exchange will lower patient health care costs.
48.6%
9.6%
Strongly agree
Agree
No opinion Disagree
To participate in future surveys or offer suggestions, please contact us at comments@mppub.com.
Strongly disagree
2.1% 0
SEPTEMBER 2012
Strongly agree
Agree
No opinion Disagree
Strongly disagree
MINNESOTA PHYSICIAN
31
FIGURE 1. Guidelines for patient handoffs. Council from page 30
• Focus on resident handoffs within the same specialty services.
the variations in practice, improves efficiency, and reduces the stress of learning local variations in processes every time they change locations. Why is this approach important to patients? Reducing variation in clinical practice improves residents’ competence and confidence in providing care. Standardizing best practices improves care, reduces mistakes, and potentially increases patient safety. In September 2011, as we considered which topics to tackle first, two immediately rose to the surface: (1) patient handoffs and (2) the use of pagers. Over the course of the next six months, the residents on the council conducted research on the processes of handoffs and pager communication. A set of best practices guidelines has been identified for each of these issues.
• Provide protected time and location for handoffs.
Patient handoffs
Patient handoffs have become an issue nationally as the number of hours that residents can
• Require face-to-face communication. • During handoffs, clearly delineate responsibility for patients. • Require supervision for sign outs by first-year residents. • Provide faculty development on best practices for handoffs. • Emphasize needs of sick patients and expected admissions during handoffs. • Teach residents the best information to include in a handoff.
FIGURE 2. Best practices for pager communication. • Establish pager etiquette, e.g., responding to urgent vs. non-urgent pages. • Emphasize accurate use of 10-digit numbers. • Emphasize proper use of technology. • Prohibit the use of pagers for social networking. • Do not send patient identifiers in pages, and adhere to HIPAA requirements. • Think about effectiveness and efficiency in every page. • Beware of technology failures. • Use team pagers for special purposes. • Create a pager directory where appropriate. work has been reduced by the residency accreditation organization. With residents having fewer hours to participate in care, the number of handoffs between care teams has
increased. While handoffs have always been a part of medicine, the number of handoffs and focus on patient safety have increased attention on complete and effi-
cient handoffs. For nurses, the handoff between nursing team shifts has generally had more structure and dedicated time. In contrast, resident handoffs historically have not incorporated as much attention to detail and have been more hurried. The resident council identified improving the system of handoffs as a priority in the effective transmission of care decisions from one team to another and in preventing patient errors. In studying this issue, we examined ways to better organize the handoffs between one team and the next and identified key information to be included in each handoff (see Fig. 1). The information contained in patient handoffs cannot be uniform across all medical specialties, as physicians’ cues to their patient’s health vary. For example, the handoff of a surgery patient might include information on the patient’s surgical site and expected postoperative course, while the handoff for a psychiatric patient might focus on the next visit to an outpatient menCOUNCIL to page 32
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Park Nicollet is expanding! We’re looking for dedicated, passionate Family Medicine, Internal Medicine, Med-Peds, Pediatricians and Urgent Care physicians to join the team at our newest community clinic, opening January 2013 in Champlin. We’re also seeking Primary Care physicians to join our growing family of clinics in the northwest suburbs. To learn more about available opportunities, contact Missy Fisher at 952-993-6025 or melissa.fisher@parknicollet.com.
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Council from page 32 tal health provider. Certain principles were found to be constant, such as an accurate identification of the patient, a current list of key medications, laboratory and imaging studies that require review, and identification of the person responsible for future care. In studying this issue, we also found that while the information contained in a handoff is important, the setting, space, and time for completing a handoff are also very important. The culture of handoffs deserves to be improved, so that there is ample time and quiet to adequately communicate the care needs for every patient. Pager communication
The second issue identified by the resident council was communication—specifically, the use of pagers. In our initial discussions of this subject, we were amazed to discover that every hospital in the Twin Cities has a different system for contacting physicians. In many cases, the system of communication even
differs among services within the same hospital. Sometimes residents have one or two pagers, or use cell phones, or have other communication devices like Vocera (a handsfree, voice-controlled device). Some pagers are digital and allow for text paging; others are numerical only. In many cases, it is not possible to tell who paged, or how to return the call. For residents, the system of communication creates considerable confusion, especially when coming to a hospital for the first time. As with paging, we found extensive variation in the systems of communication among hospitals, care units, attending physicians, and residents. A survey that we conducted of pages received by residents, and the ability of the receiving resident to return the call, identified many points of failure in the pager systems. We identified some best practices we would like to see disseminated across other teaching hospitals (see Fig. 2). While it may not be possible to completely standardize com-
munication systems, improving the quality of the communication is a start. For example, all pages should include a phone number where the calling party can be reached. It sounds simple—but in practice, identifying the caller can be difficult. An opportunity to make lasting improvements
As a council of residents, we have an exciting opportunity to identify issues that are important to patient safety, to research the best means to improve care, and to recommend improvements to care practices across all the teaching hospitals in the Twin Cities. The way the council is structured, it has the potential to make lasting improvements to patient safety that will affect patients, physicians, and hospitals for years to come. And for us as residents, improving care now means we will have better environments of care and happier patients as we graduate and become attending physicians. It feels great to make a system better at the same time we become full participants
in it! The authors served as members of the Twin Cities Resident Council in its initial year of existence (2011–2012). Currently, Lindsay Byrnes, MD, is a primary care physician in Garden City, Kan.; Sarah Lee, MD, is a critical care medicine fellow at the Mayo Clinic, Rochester; Josh Becker, MD, is a physician with Abbott Northwestern Medicine Associates; Nate Scott, MD, is a resident physician in emergency medicine and internal medicine at Hennepin County Medical Center; and Ruth Thomson, MD, is a medical fellow in neurology at the University of Minnesota Medical School, Minneapolis. The authors gratefully acknowledge the assistance of the following individuals in preparing this article: Carl A. Patow, MD, MPH, executive director, Health Professional Education, HealthPartners Institute for Education and Research; and Louis Ling, MD, senior vice president, hospital-based accreditation, at the Accreditation Council for Graduate Medical Education, Chicago (formerly associate dean of graduate medical education at the University of Minnesota Medical School, Minneapolis); and Troy Taubenheim, director, Metro Minnesota Council on Graduate Medical Education.
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MINNESOTA PHYSICIAN SEPTEMBER 2012
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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: â&#x20AC;˘ ENT â&#x20AC;˘ Internal Medicine â&#x20AC;˘ Psychology â&#x20AC;˘ Family Medicine â&#x20AC;˘ Med/Peds Hospitalist â&#x20AC;˘ Pediatrics â&#x20AC;˘ General Surgery â&#x20AC;˘ OB/GYN â&#x20AC;˘ Pulmonary/ Critical Care â&#x20AC;˘ Geriatrician/Outpatient â&#x20AC;˘ Oncology Internal Medicine â&#x20AC;˘ Radiation Oncology â&#x20AC;˘ Orthopedic Surgery â&#x20AC;˘ Hospitalist â&#x20AC;˘ Rheumatology â&#x20AC;˘ Psychiatry â&#x20AC;˘ Infectious Disease For additional information, please contact:
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PROFESSIONAL
B
ack pain is uncommon among children who are under 10 years old, but the incidence increases for adolescents. A 2005 study of 7,542 European teenagers states, “A total of 1,180 (20.5 percent) teenagers reported one or more episodes of low back pain (LBP), of whom 900 (76.3 percent) had consulted a health provider” [Masiero S. et al., Acta Paediatr, 2008, 97(2)]. Not surprisingly, athletes have a higher incidence of back pain than nonathletes. For primary care providers, the key questions are these: • When is back pain the result of overuse or muscle strain? • When is the pain symptomatic of more serious pathology, such as a herniated disc, spondylolysis, Scheuermann’s disease, osteomyelitis, discitis, leukemia, tumors, or ankylosing spondylitis? What follows is a practical guide to evaluating pediatric back pain with recommendations about which cases should be referred to an orthopedic specialist and which can be managed in the primary care setting.
When to sit up and take note By Tenner Guillaume, MD Start with a thorough history
The answers to the following questions will provide nearly all of the information needed to differentiate a benign issue from a more serious condition. The answers will also help you determine whether to simply treat the symptoms with conservative or nonoperative management or whether a complete radiographic work-up is warranted. 1. Characterize the back pain. Is the pain acute? The result of trauma? Unremitting or more subtle? Has it grown progressively worse? Is the pain recurrent, related to activity or worse at night? Is the pain associated with constitutional symptoms, such as unintentional weight loss, fevers, chills, or malaise? 2. Determine the location of the pain. Establish whether the
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P E D I AT R I C S
Back pain in children
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pain is lumbar, thoracic, or cervical and whether it is focal, diffuse, radiating, or radicular. The more focal the pain, the easier it will be to potentially identify an underlying cause. Nonfocal, diffuse pain (“My whole back hurts” or “I can’t put my finger on it because it hurts everywhere”) is less likely to result in the discovery of a focal underlying pathology with radiographic work-up. Radiating, radicular pain in a clear dermatomal distribution is also highly likely to result in a positive radiographic work-up. 3. Consider the patient’s age and check neurological signs. Is the patient 10 or younger? The younger the patient, the more worrisome the back pain, because a pathologic abnormality is more likely to be the cause.
Also, ask about transient paraparesis, paralysis, numbness, or paresthesias, and determine if bowel or bladder function is affected. Neurological impairment signals a more complex condition. 4. Listen for these reassuring signs. Ask if the patient has missed school or sports because of the pain, whether the pain has improved over time, and if the pain responds to nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen. Additionally, discuss whether the pain is intermittent or activityrelated, generalized or focal. If the pain is decreasing, responds well to NSAIDs, is generalized, or is activity-related, it is more likely to be the result of muscle strain or injury. Similarly, if the patient participates in normal activities (i.e., pain does not prevent him or her from participating), the back pain is less likely to be serious. The exception would be a highly competitive athlete or dancer who might be motivated to comBACK PAIN to page 38
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Internal and Family Medicine Opportunities Stillwater Medical Group is an 90+ provider multi-specialty group practice affiliated with Lakeview Hospital. For more than 50 years we have been providing comprehensive healthcare services in the St. Croix Valley, just east of the Twin Cities metro area. Internal and Family Medicine Physician Opportunities: Stillwater Medical Group has exciting new Internal and Family Medicine Physician opportunities at our NEW Mahtomedi, MN clinic opening Fall 2012! Additional opportunities also available in Stillwater, MN. Mahtomedi, MN? (Ma-toe-me-dye) So what if you can’t pronounce it? We can help with that. Mahtomedi is located in Washington County, on the east shore of White Bear Lake. Residents appreciate the community’s small town charm, lakeside flavor, and close proximity to the Twin Cities Metropolitan Area. In addition, the Mahtomedi School District and other area colleges offer excellence in education. For further information please contact: Lori Martin, Executive Assistant 1500 Curve Crest Blvd, Stillwater MN (651) 275-3305, lmartin@lakeview.org stillwatermedicalgroup.com
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Our award winning patient care and uncommon medical specialties set us apart from other regional health care groups. Lake Region’s physicians and their families also enjoy an unmatched quality of professional and personal life.
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We make a difference in the lives of our patients, our staff, and our communities. Physicians can focus on patient care and can professionally thrive in Allina, and the result is the quality of care for which we are known. We are based in Minneapolis, and have comprehensive services throughout Minnesota and in western Wisconsin. Become a part of the Allina team, joined together with a common purpose and uncommon caring. For more information, please contact: Kate Steiner, Allina Physician Recruitment Toll-free: 1-800-248-4921 | Fax: 612-262-4163 Email: kate.steiner@allina.com Website: allina.com/jobs EOE
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Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community
An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community. Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000. Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org AA/EOE - Not subject to H1B Caps
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Guide to imaging studies for pediatric back pain Back pain from page 36 pete despite significant pain. An absence of all of the “red flags” listed below is also reassuring. 5. Beware of these red flags. Associated findings such as those noted below are definitely cause for concern. Pursue additional testing if the pain is: • Associated with constitutional symptoms like fever, malaise, night sweats, unintentional weight loss, easy bleeding or bruising • Worse at night or wakes the patient from sleep • Associated with neurologic symptoms • Acute, unremitting, or focal pain that is not responsive to NSAIDs or acetaminophen • Constant (not activity-related) Complete a comprehensive exam for back pain
Evaluate patients while they are standing, walking, bending at the waist, and lying on the exam table. Include these exams: Standing and walking. Are BACK PAIN to page 40
Overview—what to request and when Radiographs • For trauma or a history that suggests the pain is not muscular, start with AP and lateral radiographs, rather than an MRI. • Request a standing view (or seated view, if the patient cannot stand). • For lumbosacral involvement, avoid pelvic shielding. • Request an oblique view radiograph for suspected spondylolysis. • Request flexion/extension view radiographs for suspected spondylolisthesis.
MRI • Reserve MRIs for cases in which the back pain has lasted more than six weeks and is not responding to NSAIDs or therapy. Consider an MRI if the patient’s history and physical reveal focal back pain or radicular pain. • Consider an MRI if there are obvious red flags during history-taking that suggest possible underlying infection or neoplasm. • Request an MRI if the preliminary radiographs point to a serious condition (acute stress reactions or fractures, spondylolysis, spinal neoplasms, discitis, and so forth). • If you are likely to refer the patient to a specialist, the specialist can order an appropriate MRI. CT Scan Reserve for cases that fail nonoperative management or for visualization of bony changes that have resulted from fracture, tumor or infection. This can largely be left to the specialist to order, if it is indicated. Bone Scan/Scintigraphy/SPECT Scan Because these tests are highly sensitive and nonspecific, they are used much less commonly today. They will iden-
tify areas of high metabolic activity or bone turnover. MRIs are currently the preferred test of choice among orthopedic surgeons and radiologists. Interpreting Imaging Results—What to Look For Anterior/Posterior Radiographs • Check overall alignment—Any scoliosis? • Pedicles—Normal cascade? Widening at any level? Clearly identifiable at all levels? Any effacement or cortical destruction? • Spinous processes—Widening between spinous processes? Well-aligned? No offset in coronal plane?
Lateral Radiographs • Overall alignment—Lumbar lordosis, thoracic kyphosis, cervicothoracic lordosis? • Posterior vertebral body cortical line—Is it aligned? Is there anterior or posterior offset of a vertebra (possible spondylolisthesis)? • Interspinous widening? Cervical spine posterior laminar line? Lumbar Oblique Radiographs Look for spondylolysis (the infamous “Scotty dog” sign). Flexion/Extension Radiographs Check for atlantoaxial instability (cervical) or spondylolisthesis (lumbar). MRI Examine images for acute stress reactions or fractures, apophyseal ring fractures, cord abnormalities, discitis, herniated nucleus pulposus (HNP), juvenile degenerative disc disease, spinal neoplasms, spondylolysis. CT Scan Examine bony anatomy for suspected cases of vertebral, burst, or pedicle fractures or of osteoid osteoma.
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MINNESOTA PHYSICIAN SEPTEMBER 2012
FAMILY PRACTICE w/OB Warroad, MN Roseau, MN Crookston, MN • Dedicated Team Approach • Competitive Salary & Benefits • EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesota’s most beautiful lakes. Contact: Kerri Hjelmstad, Physician Recruiter Altru Health System PO Box 6003 Grand Forks, ND 58201-6003 1-800-437-5373 Fax: 701-780-6641 khjelmstad@altru.org
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Opportunities available in the following specialties:
Olmsted Medical Center, a 150-clinician multi-specialty clinic with 9 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.
Family Medicine Rochester Northwest Clinic Wanamingo Clinic Chatfield Clinic Dermatology Southeast Clinic Child Psychiatry Southeast Clinic Hospitalist OMC Rochester Hospital Emergency Medicine OMC Rochester Hospital Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 1650 4th Street SE
Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. Evening and weekend shifts are currently available. We are seeking BC/ BE full-range family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice. For consideration, apply online at healthpartners.jobs and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact diane.m.collins@ healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE
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Back pain from page 38 the shoulders level? Does the patient have any obvious abnormalities of the spine, hips or stance? Does the patient limp? Appearance. Look for rash, bruising, or ecchymoses, which are potential symptoms of leukemia. Check for cutaneous manifestations of dysraphism: hairy patches, dimples, and deep sinuses at the base of the spine (possible neural tube defect); café au lait spots (possible neurofibromatosis); heart-shaped buttocks (possible high-grade spondylolisthesis); and kyphosis. Palpation and inspection. Palpate to determine the location and nature of the pain: focal, diffuse, in the spinous process, or paraspinal. Have the patient do an Adams forward bend test, and inspect the spine for any deformity, such as scoliosis or kyphosis. Range of motion. Is the pain worse with spine flexion (anterior column: vertebral body or intervertebral disc) or with extension (posterior column: pars interarticularis or facet joints)?
Neurologic exam. Test light touch and motor strength in all dermatomes and myotomes, respectively. Check these reflexes: biceps (C5); triceps (C6); brachioradialis (C7); patellar (L3, L4); Achilles (S1); Babinski; Hoffman’s test; and clonus. Also look for unilateral or bilateral weakness, asymmetric abdominal reflexes, foot drop, or loss of fine motor skills in the hands. Special tests
Include these additional exams, if you suspect: Spondylolysis—check extension in single leg stance and popliteal angles. If the patient has pain while standing on the right leg and extending the spine but does not have pain when standing on the left leg and extending the spine, presume a unilateral pars stress fracture/spondylolysis on the right. If the pain occurs bilaterally, presume that the pars stress fracture/spondylolysis is bilateral. Hamstring tightness is often seen with spondylolysis. Herniated nucleus pulposus or apophyseal ring avul-
CHART TALK
sion—straight leg raise. Consider the test positive if any degree of passive elevation reproduces pain radiating down the affected leg. The straight leg raise specifically tests nerve roots that contribute to the sciatic nerve (L4, L5, S1). For suspected femoral nerve root involvement (L1, L2, L3), perform a femoral stretch test, because those nerve roots contribute to the femoral nerve. Cervical radiculopathy— Spurling’s test. Turning the patient’s head in the direction of the suspected cervical radiculopathy while tipping and extending the neck in the same direction will cause foraminal compression. That compression should reproduce the patient’s experience of radiculopathy and pain radiating down the affected upper extremity. Refer red flags immediately
The history and physical exam will help determine the severity and acuity of the patient’s back pain. Refer patients suspected of having leukemia to a pediatric oncologist. Refer patients with
the following conditions to a pediatric spine specialist: • Vertebral fractures • Apophyseal ring fracture • Discitis • Vertebral osteomyelitis • Osteoid osteoma • Disc herniation • Spondylolysis • Spondylolisthesis • Scheuermann’s disease • Idiopathic scoliosis • Ankylosing spondylitis If there are no red flag issues, send the patient to a physical therapist who provides care for children for evaluation and follow up with the patient in clinic. If the history and physical uncover red flag issues, request appropriate radiographs (see sidebar) and lab tests. If screening radiographs point to a serious orthopedic condition, request an MRI or refer the patient to an orthopedic specialist who will get the necessary MRI. Tenner Guillaume, MD, is a pediatric spine surgeon at Gillette Children’s Specialty Healthcare in St. Paul.
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Practice Well. Live Well.
St. Cloud VA Health Care System
Lake Region Medical Group is seeking a full-time Certified Physician Assistant to join our Lake Region Healthcare team of 2 orthopedic surgeons; providing care in a multi-specialty clinic with 50+ providers. We are looking for a hardworking, conscientious individual committed to providing quality care to our patients as we develop our Orthopedic Center of Excellence. Duties will include new and follow-up patient visits, assisting with surgery, post-op visits and hospital rounds in our 108 –bed community based hospital. The ideal candidate will have 2-5 years experience in orthopedics. We offer a competitive salary with a healthy benefit package. For more information contact Barb Miller, Physician Recruiter bjmiller@lrhc.org • (218) 736-8227
is accepting applications for the following full or part-time positions: • Associate Chief, Primary & Specialty Medicine (Internist-St. Cloud) • Dermatologist (St. Cloud) • Director, Primary and Specialty Medicine (Internal Medicine) (St. Cloud) • ENT (St. Cloud)
712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424
• Internal Medicine/ Family Practice (Alexandria, Brainerd, St. Cloud, Montevideo) • Medical DirectorExtended Care & Rehab (IM or Geriatrics) (St. Cloud) • Psychiatrist (Brainerd, St. Cloud) • Radiologist (St. Cloud)
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SEPTEMBER 2012
MINNESOTA PHYSICIAN
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IBD from Page 26 cantly to the overall stress level (Anxiety, part 6). Even something as simple as waiting for test results can be excruciating when we are desperate for resolution (Anxiety, part 7). Or sorting through the bills, submitting them to insurance, reconciling the claim reports, and then, of course, paying for it all (Anxiety, parts 8, 9, 10, and 11). I understand we are making progress with medical research. I realize new treatments are in development and on their way. I celebrate that our knowledge of these diseases is progressing every day. I realize that these are all of critical importance. But in the midst of all that, what I wish for—sometimes even more than for a cure—is that we could do a better job with the administrative details, so patients and their families could focus their energy on the true priorities: healing, caring for one another, and, ultimately, living good lives despite illness. So, what do patients really want?
How can you, both today and in the future, make the burden of orchestrating health care the smallest possible component of the healing process? We want appointments in a timely manner. We want to know that there’s somebody to take care of us, even if we don’t have an appointment. We want to feel like the various entities looking after various components of our lives are working together to solve the problem. A question you as a health care professional might consider asking yourself is, How can you, both today and in the future, make the burden of orchestrating health care the smallest possible component of the healing process? Putting adequate focus on that pursuit might strip away some of the hassle, enabling us to focus on the disease. And when we look there, what do patients wish for?
Most of all, we want to feel like there’s hope. For a cure? Yes, absolutely, someday. That lofty goal is always there. But, at ground level, what most of us crave is simply hope for a tomorrow, or even for today. For a future without surgery. For a year without a flare. For a semester without infusions. For a month without prednisone jitters. For a week without an accident at work. For a single bloody day without a bleeding backside (Anxiety, part ∞). In some cases, it’s hope for the slightest glimpse of peace, in which, for just one precious fleeting moment, the machine seems to function … the world works … the outlook is clear … the crushing pressure lifts … the anxiety eases … and life feels good. Some of us would go to
the end of the earth for this rare luxury. Many of us can only dream of it. All of us want to feel like we’re making progress toward it. That is the simple hope to be held dear. On your patients’ behalf. On your own behalf. On behalf of everyone who needs you. The question to be asked here, for each patient, wherever the patient is on the spectrum, is, How can you, today, bring that hope just one step closer? Big step? Small step? It doesn’t matter, as long as it’s real. And hopefully doesn’t feel like too much of a step backward, or too far into the dark. Andrew Tubesing, MSEE, teaches electrical engineering at University of St. Thomas in St Paul. He is a chapter board member for the Crohn’s and Colitis Foundation of America (www.CCFA.org), and author of “Colitiscope: Living with Crohn’s Disease and Ulcerative Colitis” (www.ColitisBook.com).
continuing medical education 30th Annual Strategies in Primary Care Medicine
September 20-21, 2012
• New this year: “Customized Learning” featuring over 35 breakout sessions • Post-Conference Activities – Basic Life Support for Health Care Providers – Recertification – ABIM Maintenance of Certification Learning Session
Midwestern Region Burn Conference
October 11-12, 2012
• Pre-Conference Workshops – Burn Rehabilitation: The Bridge to Recovery – The Pathway to Improving Outcomes for Pediatric Burn Injuries (includes simulation-based learning) • Post-Conference ABLS Provider Course
Optimizing Mechanical Ventilation 13th Annual Women’s Health Conference Pediatric Fundamental Critical Care Support Emergency Medicine and Trauma Update: Beyond the Golden Hour Geriatric Orthopaedic Fracture Conference 34th Annual Cardiovascular Conference
education that measurably improves patient care 42
MINNESOTA PHYSICIAN SEPTEMBER 2012
October 10, 2012
October 13, 2012
October 26-28, 2012 November 2, 2012 November 8-9, 2012 November 15, 2012 November 29-30, 2012 December 13-14, 2012
HealthPartnersInstitute.org
You wouldnâ&#x20AC;&#x2122;t give a 1-year-old a beer, so why would you give one to an unborn child? As a physician, itâ&#x20AC;&#x2122;s your responsibility to let her know: the U.S. Surgeon General Advisory says no amount of alcohol is safe during pregnancy. Share 049: Zero Alcohol For Nine Months.
www.mofas.org
We protect your peace of mind. And we do it in lots of ways for physicians, facilities and hospitals. Whatever your situation, we’ve been there, and will be there. We’ve gotten good at it. Excellent, actually, with a proven success rate. It’s a peace of mind movement. And we’d love to have you along. Join the Peace of Mind Movement at PeaceofMindMovement.com,or contact your independent agent or broker.