Minnesota Physician July 2013

Volume XXVll, No. 4

July 2013

The Independent Medical Business Newspaper

Word for word Building a workforce of medical interpreters

By Scott Homler, PhD

O

ver the past two decades, Minnesota’s immigrant population has surged. Between 2000 and 2010, the immigrant population in the state grew 45 percent— about 118,000 people. This increasing language diversity has created a growing demand for language interpreters at health care clinics and hospitals throughout the state. As a dramatic example, in 2011, 30 percent of patients at Hennepin County Medical Center (HCMC) in Minneapolis required language services, and HCMC/HHS utilized interpreters 130,572 times that year (Hennepin Healthcare System, Inc. Health Services Plan 2012–2013).

The need for medical interpreter services extends well beyond the Twin Cities, however, as individuals with limited English proficiency (LEP) live in almost every county of Minnesota.

There are, of course, many perils associated with the use of untrained interpreters. Physicians and other

Regulating bad actors

Page 20

SAFETY to page 10

PAID

M

ost medicine and pharmacy practitioners will recognize the name New England Compounding Center (NECC). Last fall, the Massachusetts company was linked to NECC’s distribution of a contaminated sterile product in 20 states that led to 55 deaths and infected more than 740 people nationwide, according to the Centers for Disease Prevention and Control (CDC). In addition to raising anxiety and fear in patients, medical practi-

SPECIAL FOCUS: HEALTH CARE ROUNDTABLE

PRSRT STD U.S. POSTAGE

By Ronald S. Hadsall, PhD, MS

tioners, and pharmacists across the U.S., this single event has initiated a national discussion bringing into question the integrity of our pharmaceutical manufacturing, distribution, regulatory, and quality control systems.

Now, at both the state and national level, regulators, professional associations, and other engaged parties are crafting regulatory and quality control measures to weed out unscrupulous suppliers/manufacturers. In the meantime, the needs of patients remain at stake. This article discusses the issues behind the

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Compounding pharmacies and patient safety

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CONTENTS

JULY 2013 Volume XXVII, No. 4

FEATURES Regulating bad actors Compounding pharmacies and patient safety

1

MINNESOTA HEALTH CARE ROUNDTABLE

By Ronald S. Hadsall, PhD, MS

Word for word Building a workforce of medical interpreters

1

By Scott Homler, PhD

Minnesota Health Care Roundtable Patient engagement

20

FORTIETH

DEPARTMENTS CAPSULES

4

MEDICINE AND THE LAW 2013 legislative wrap-up 18

MEDICUS

7

By H. Theodore Grindal, JD, and Nate Mussell, JD

INTERVIEW

8

DFL-Rochester

By Frank S. Rhame, MD

Thursday, October 24, 2013

By James M. Welters, MD, FAAFP

INFECTIOUS DISEASES Hepatitis C

16

DERMATOLOGY Scalp disorders

Advance care planning Addressing end-of-life issues

PROFESSIONAL UPDATE: PRIMARY CARE Modern family medicine 28

Rep. Tina Liebling

SESSION

30

By Kristina Shaffer, MD, MPH

1:00 – 4:00 PM • Symphony Ballroom Downtown Mpls. Hilton and Towers

Background and focus: For the majority, end-of-life is the most medically managed part of life. With it come complex issues that involve economics, ethics, politics, medical science, and more. Advances in technology are extending life expectancies and require a redefinition of the term “end-of-life.” It now entails a longer time frame than one’s final weeks or hours, and provokes debate as to when life is really over. Mechanisms exist to facilitate personal direction around this topic, but there is a need for improved coordination among the entities that provide end-of-life support.

Objectives: We will discuss the significant infrastructure that supports end-of-life care. We will examine the roles of long-term care/assisted living, palliative care, gerontology, and hospice. We will review the elements that go into creating advanced directives, including societal issues that make having them necessary, and the difficulties encountered in bringing them to their current state. We will present a potential road map to optimal utilization of end-of-life support today and how it may best be improved in the future.

Panelists include: Ed Ratner, MD, University of Minnesota Center for Bioethics Suzanne M. Scheller, JD, Elder Law and Advocacy Cheryl Stephens, PhD, MBA, President, CEO, Community Health Information Collaborative

The Independent Medical Business Newspaper

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3

CAPSULES

U of M Opens Medical Devices Center The University of Minnesota recently opened a new medical devices laboratory at its Minneapolis campus.

Officials say the new stateof-the-art, 8,000-square-foot Medical Devices Center (MDC) facility was built specifically for designing, prototyping, and testing new medical devices.

Medical devices research has seen significant growth in recent years. Officials say U of M researchers had outgrown their previous location in the university’s Shepherd Labs, which opened in 2008 with 2,500 square feet and was later expanded to 5,000 square feet.

Art Erdman, director of the MDC, says U of M leaders have been forward-thinking by providing space over the years for medical devices research, but that the new center is a huge step forward from the “A room here, a room there,� approach of the past. “This is night and day,� he says. “Our facilities are going to

be an order of magnitude better than the old space, where we were limited by the small amount of square footage.�

Health Groups Pleased With Legislative Session The 2013 legislative session was a momentous one for the health care community in Minnesota.

Public programs were expanded, a major new health insurance model was established, and funding was increased for providers. Health care organizations expressed satisfaction that policymakers had worked to address the concerns of providers during the session.

The early part of the session saw lawmakers working to implement provisions of the Affordable Care Act (ACA) that had been stymied last year. With the Legislature controlled by the DFL in 2013, the ACA’s Medicaid expansion was signed into law on Feb. 19, ensuring that 35,000 additional Minnesotans would have access to Medicaid.

The Legislature then tackled health insurance exchanges, another key provision for expanding health insurance coverage to uninsured Americans. In Minnesota, the Dayton administration had moved forward with planning for the exchange, but legislation was needed to set up the new insurance model. Officials estimate that with the passage of the exchange in early March, 300,000 currently uninsured Minnesotans will find coverage.

The end of the session was dominated by budget issues.

Taxes were raised on cigarettes, drawing praise from health groups, and Mayo Clinic in Rochester will benefit from new funding for a Destination Medical Center project, which will help create infrastructure improvements in Rochester.

Although the health and human services budget was cut by about $60 million, lawmakers were able to make small increases in reimbursement to some providers. For physicians, legislators approved a 5 percent increase in reimbursements for

treating Medical Assistance patients; outpatient hospital services will receive a 3 percent increase when caring for Medical Assistance patients in the fee-for-service program.

According to Dave Renner, director of Minnesota Medical Association’s (MMA) department of state and federal legislation, his group saw progress on nearly all its priorities. “This was a very successful session,� Renner says. In addition to Medicaid expansion and the insurance exchanges, Renner points to funding increases for medical education and the passage of preventive health-care measures.

New VBP Program Costs Minnesota Hospitals $1.4 Million According to new data from Stratis Health, Minnesota hospitals are beginning to feel the financial impact of health care reforms that are moving Medicaid reimbursement from a system that pays for volume of care to one that pays for the

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value of care.

Stratis’ Quality Update newsletter for spring 2013 reports that Minnesota hospitals are projected to lose $1.4 million in reimbursements due to diagnosis-related payment group (DRG) payment adjustments for fiscal year 2013.

The change in reimbursement was due to the new Centers for Medicare & Medicaid Services’ (CMS) Hospital ValueBased Purchasing (VBP) program, officials say. The VBP program was put into place as part of the Affordable Care Act (ACA), which uses a range of strategies to try to “bend the curve” of rising health care costs. The program adjusts reimbursement payments to reward quality, rather than quantity, in hospital services.

For fiscal year 2013, 1 percent of DRG payments from CMS were withheld to fund $800 million in payments based on overall hospital performance.

Performance scores were based on clinical care measures and patient experience. CMS will add new measurement compo-

nents, including mortality and other outcome measurements, over the next two years.

The VBP system ranked Minnesota 30th in the nation for 2013, and more than half the Minnesota hospitals participating in the program received lower reimbursements as a result. “Minnesota hospitals are performing slightly lower than average for their total performance scores,” the report says. “Of the 50 Minnesota hospitals eligible for 2013 VBP, 52 percent (26 hospitals) lost money, compared to the national average of 48 percent.”

Stratis officials say the relatively poor scores for hospitals in this state suggest other states are improving quality at a quicker rate. “I anticipate Minnesota will perform better compared to the rest of the nation once efficiency is included as part of the total performance score, starting in fiscal year 2015,” says Vicki Olson, Stratis Health program manager. “To receive incentive payments, hospital leaders need to be working to improve their clinical process, patient experi-

ence, and mortality measures— with the ultimate aim of improving care.”

RARE Campaign Meets Initial Goals, Is Extended A campaign to reduce hospital readmissions has continued to see success, and the effort has been extended through the rest of this year, officials say.

When it was launched in January 2011, the Reducing Avoidable Readmissions Effectively (RARE) campaign set a goal of preventing 4,000 readmissions over a one-year period. Officials with the campaign recently announced that it prevented 4,570 avoidable hospital readmissions between Jan. 1, 2011 and Jan. 1, 2012. The program saved an estimated $40 million in inpatient costs from 2011 to 2012.

More than 80 hospitals and 93 community partners in this state are members of the coalition that runs the RARE campaign.

Officials say RARE was initiated to address data showing that in Minnesota, nearly one in five Medicare patients has been readmitted to a hospital within 30 days. To address the issue of readmissions, the campaign looked at a number of areas, including comprehensive discharge planning; medication management; patient and family engagement; and transition care support and communications.

“Improving care transitions is part of the Minnesota healthcare community’s effort to mend the fragmented delivery of care and achieve the Triple Aim of improving population health, the experience of care, and the affordability of care,” says Jennifer Lundblad, president and CEO of Stratis Health, a member of the coalition.

Officials have been pleased with the results. Data from the fourth quarter of 2012 show a 17 percent reduction in avoidable readmissions, they say. To expand on the program’s success, the campaign will seek to improve patient care coordinaCAPSULES to page 6

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CAPSULES Capsules from page 5 tion between hospitals and community partners such as longterm care facilities, home care organizations, and primary care clinics.

Study Finds Minnesota Healthiest State for Seniors Minnesota is the healthiest state in the nation for seniors, a new report from United Health Foundation says.

The foundation, a division of Minnetonka-based UnitedHealth Group, released its study on May 29. It found that Minnesota, Vermont, New Hampshire, Massachusetts, and Iowa are the top five states for seniors’ health. The state with the lowest ranking for senior health is Mississippi.

Foundation officials say the report builds on the annual America’s Health Rankings report, which is in its 23rd year.

Minnesota often has been ranked among the top five states

for health in that study as well.

“The America’s Health Rankings Senior Report is a comprehensive portrait of senior health designed to inspire new, effective solutions that meet the health care needs of this rapidly expanding demographic,” says Reed Tuckson, MD, senior advisor to United Health Foundation. “We are measuring senior health in order to help improve it. States with healthy seniors have a combination of positive personal behaviors and community support, which demonstrate that improving senior health will only come about by acting on individual, family, community, and state levels.”

The report finds that Minnesota’s strengths include high rates of annual dental visits, prescription drug coverage that the report finds reasonably comprehensive, relatively high availability of home health care workers, and a low rate of seniors at risk of hunger.

Minnesota’s ranking also reflects a large number of seniors who report being in very good or excellent health. The study says

among the challenges in Minnesota are a low percentage of seniors with a personal doctor or health care provider. The report notes that Minnesota’s senior population is expected to grow nearly 55 percent between 2015 and 2030.

MCHA Program Being Phased Out State officials have announced a timeline for phasing out the Minnesota Comprehensive Health Association (MCHA).

MCHA is the state’s groundbreaking health insurance plan for people who cannot get coverage due to preexisting conditions.

Created in 1976, MCHA has been recognized as a model for high-risk health insurance pools in other states. Due to provisions in the Affordable Care Act (ACA) that bar insurance plans from denying coverage due to preexisting conditions, such plans are being phased out.

The Minnesota Department of Commerce, which oversees

MCHA, has published a timeline for phasing out the plan over the next six months. The ACA’s provision requiring private insurance plans to cover consumers with preexisting conditions takes effect on Jan. 1, 2014. Officials say individuals who are members of high-risk plans will be able to switch to private insurance either on the open market or through MNsure, the state’s health insurance exchange.

“In compliance with the federal and state health insurance laws, the Commerce Department will work with MCHA and its enrollees to develop a prudent and orderly plan to make a transition as seamless as possible,” says Commerce Commissioner Mike Rothman. “The Commerce Department will seek to develop a plan with opportunity for public input that best addresses the challenges of transitioning to new health coverage for people who have been enrolled in MCHA.”

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MINNESOTA PHYSICIAN

JULY 2013

MEDICUS

Kristine Matson, MD, a board-certified pediatrician, has joined the staff at PACE Pediatrics Clinic’s West St. Paul site; PACE is part of Children’s Hospitals and Clinics of Minnesota.

Matson earned her medical degree from Sanford School of Medicine of the University of South Dakota and completed a residency in pediatrics at Fairview University Medical Center.

Kristine Matson, MD Ronald C. Peterson, MD, PhD, a professor in the Department of Neurology at the Mayo Clinic and the director of the Mayo Clinic Alzheimer’s Disease Research Center, testified before the Senate Special Committee on Aging regarding the status of the National Alzheimer’s Project Act, legRonald C. Peterson, islation that aims to effectively treat Alzheimer’s MD, PhD disease by 2025. The Mayo Clinic center is part of a network of 28 centers nationwide that is sponsored by the National Institute on Aging. In his testimony, Peterson addressed such points as the potential burden and cost of Alzheimer’s disease on the health care system and current research that shows the benefits of early care and treatment.

Lipi Ramchandani, MD, MS, has joined Hennepin County Medical Center’s (HCMC) St. Anthony Village Clinic. She graduated from Grant Medical College, Mumbai, India; completed family medicine residency training at the University of Minnesota, North Memorial Program; and earned a master’s degree in clinical research from the university’s School of Public Lipi Ramchandani, Health in 2008. Andrew MD, MS H. Schmidt, MD, an orthopedic surgeon at HCMC, has begun his term as president of the Orthopaedic Trauma Association, elected by his peers who are voting members of that international organization.

William O. Roberts, MD, director of the University of Minnesota St. John’s Hospital Family Andrew H. Schmidt, MD Medicine Residency Program, has received the 2013 Merit Award from the Minnesota Academy of Family Physicians.

This award recognizes a family physician that has worked diligently through the Academy to further the ideals of family medicine.

Richard Sveum, MD, an allergy specialist William O. Roberts, MD with Park Nicollet Clinic, has received the Lifetime Achievement Award from the American Lung Association in Minnesota. Sveum is a member of the health charity’s Leadership Board, the medical board for the Lung Association’s Camp Superkids program, and the board of the American Lung Association of the Upper Midwest. Sveum is also a clinical professor in pediatrics and medicine at the University of Minnesota Medical School.

Michael Harold Wall, MD, FCCM, will assume the role of head of the Department of Anesthesiology at the University of Minnesota in late summer 2013. Wall is currently chief of clinical anesthesiology at Barnes-Jewish Hospital and a professor of anesthesiology and carMichael Harold Wall, diothoracic surgery at Washington University, MD, FCCM in St. Louis. He earned his medical degree from Dartmouth Medical School; completed a residency in anesthesiology and a fellowship in cardiothoracic anesthesia at the University of Washington in Seattle; and completed a fellowship in critical care medicine at Stanford University.

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7

INTERVIEW

Moving forward with health care reform ■ At the beginning of this session, what were your

main legislative priorities?

Rep. Tina Liebling DFL-Rochester Rep. Tina Liebling (DFL) is the chair of the Minnesota House Health and Human Services Policy Committee.

She has represented Rochester and district 26A since 2004.

Liebling played a key role in shaping health-care reform legislation this spring. The session saw the formation of the state’s health insurance exchange as part of the Affordable Care Act (ACA), an expansion of Medicaid, new funding to create a Destination Medical Center (DMC) in Rochester with Mayo Clinic, and other measures.

Liebling is a graduate of the University of Minnesota and has a master’s degree in public health from the University of Massachusetts and a law degree from Boston University.

8

Going into the session, we knew that the state needed to set up the insurance exchange and that we had a pretty short deadline for doing that in order to meet federal requirements. So that was one of the first things we knew we were going to be grappling with. In addition, we wanted to get the Medicaid expansion done right away.

It was a great relief that Democrats were in the majority coming into the session, because if we had been in the minority, these things probably wouldn’t have happened. The Administration was already moving ahead as much as it could to get ready to implement the exchange, but they needed legislative authorization to do it. [Without legislative support] Medicaid expansion could not have happened. After the Supreme Court made it optional for states, it was imperative that the Legislature authorize the expansion.

■ As this year’s HHS omnibus bill progressed in

the Legislature, it became clear that there would be an overall cut in health care spending. Why was that reduction necessary, and how will it affect providers and patients in the state?

That’s a difficult question for me to answer because it was a leadership decision, and it always is, what the targets will be for the various bills. In the House we started out with $150 million cut in a year when [the state is] raising $2 billion in taxes.

I know that leadership wanted to tell the public that we were trying to bend the cost curve in health care. I don’t think the public saw it that way, because we have been trying to bend the cost curve. We did that when we were in the majority before. The Republicans attempted to continue to do that—everybody wants to save costs.

We know that in this country, generally we don’t get the best bang for our buck in health care, but Minnesota does better than many or most other states in ■ The Legislature faced some The ACA tries to that regard. A $60 million cut pressing deadlines for these from the base was agreed on make a real measures. What were the ultimately with the governor challenges there? marketplace out and with the Senate. I think The exchange was a complicaof private insurance. this was more a messaging thing than anything else. ted bill. There were many comWe were able to make mittees it had to go through. It some pretty substantial increases within the was hard to explain, and also the minority party budget. We actually raised provider rates, including really slowed it down. This is always a dynamic, dental rates, and we increased rates for long-term I think. Probably in most legislatures, certainly in care and nursing homes. We did some wonderful Congress, you see this, where the minority party things in autism and in mental health for children. sees itself as an element of obstruction at a certain It was a budget where we were able to make stratepoint. These hearings were very long, lots and lots of questions, lots and lots of amendments. It took a gic investments in some important areas. lot of legislative time and effort to get that through, ■ The Destination Medical Center initiative, but we did meet the deadline. which approved state funding for infrastructure ■ There remain questions about how the insurimprovements in Rochester, drew a lot of ance exchange will be implemented. How will debate by lawmakers. What can you tell us this law overcome the uncertainties? about this initiative?

With any new, big policy change, there is always going to be confusion, but a lot of the point of doing the exchange is to simplify this for consumers. When this is up and running, it should be a fairly simple process. Compared to what it’s like now to go out on the private market and buy insurance—where you can’t compare policies, where you’re not sure what you’re paying for—this should be a much simpler process for the public.

I feel pretty confident that once it rolls out, people will start to understand it much better than they do now. I don’t have rose-colored glasses. I understand that when you roll out any big policy change you’re going to have some complications, but part of MNsure’s job is to get the word out to the public about what’s available and how to make use of it.

MINNESOTA PHYSICIAN JULY 2013

To judge by the reaction in the community, people are pretty happy about what happened. It’s an amazing thing to see a proposal this big go through the legislature in one session. I haven’t seen that happen before. It really lays the groundwork for some pretty serious developments in Rochester.

This is going to roll out over about 20 years. How it’s going to look is yet to be determined. It’s going to be quite an exciting thing to watch.

The bill started out as being much more controlled by Mayo Clinic, and that gave a lot of us heartburn—legislators, the city itself, and some of the citizens—as they started to see what the proposal was. It came out pretty quickly; the actual bill wasn’t released until about three weeks into January, when we were well into the session. It really did cause concern, because it looked like Mayo was doing something without fully involving the community.

■ Do you feel that Mayo handled this in the

right way?

I had concerns about that because I think that reputation is everything. I was concerned that Mayo would damage its reputation at the Capitol. I feel like all’s well that ends well; but there was a sense that a lot of political capital was burned in that effort.

I hope that will not come back to haunt us later, because those of us who represent Rochester always have had a difficult time at the Capitol, explaining that even though we have this wonderful entity, the Mayo Clinic, that creates a lot of jobs and we have a really robust economy in Rochester, we also have a lot of the urban problems here in my district.

On one end, there are large homes and physicians and scientists who live there and people who work at IBM. On the other end of the district, I have trailer parks and people who have a lot of needs. Rochester is really a very diverse city. It has a lot of needs that go along with the great things that happen here. That’s part of the story we always need to tell, and I’m hoping that this DMC won’t make that harder. Because now we are afraid that what will happen is people will say, “You don’t need this project, you’ve got the DMC.” Then we’ll be dealing with that for years to come.

■ Can you talk about a few things in the

HHS omnibus bill that might have flown under the radar?

An omnibus bill always covers lots and lots of ground. I had a couple of small bills that mostly affect Olmsted County. One of them has to do with fetal alcohol syndrome. It’s a small grant to a program, which had been defunded, that intervenes with pregnant women who are at risk for drug and alcohol use during pregnancy. It’s a wonderful public health program because there are so few programs where you can show an immediate result, where you can really prove that your program has changed the course of health. It’s a tremendously successful program, so that got funded in our bill.

We had hoped to have it statewide, which we were not able to do, but I’m hoping that we’ll be able to expand it.

Newborn screening hasn’t really been talked about. The health department worked closely with a lot of legislators over the session to try to make sure that the newborn screening program can continue, and they did some work to repair what the Court broke in the 2011 Bearder decision. We were able to straighten out some of the issues about saving the specimens that the Health Department collects both for newborn screening and in other areas.

SHIP funding was increased. It has been cut back very severely in the last two years,

and they were not able to implement it statewide. I think this will really expand the reach of the program.

■ What are some issues you see down the

road for health care reform in Minnesota?

The ACA is a huge step forward. I’m really thrilled to be part of a state government that is taking it seriously and really working to implement it, because you can’t say that for every state. Minnesotans are in a much better position than residents of many other states. But the ACA is not going to cover everybody, and everybody’s coverage is not going to be affordable. There are still going to be challenges as we move forward.

The ACA tries to make a real marketplace out of private insurance. It remains to be seen how successful that is going to be and how much it will control costs. I think we’re seeing some pretty hopeful data out of other states that have got it running now.

We’re seeing that insurance exchanges really are driving down cost. I’m hopeful that’s going to happen, but we’re going to have plenty of challenges with the ACA with making sure people get the care they need, and the right care at the right time at the right price. It’s still going to be a challenge. I’m not worried about going out of business as a policymaker.

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If those at the manufacturing, regulatory, and procurement levels, using the existing regulatory systems, had done their jobs, the NECC event might not have occurred.

Safety from cover tragic event of last fall and offers guidance to physicians and physician practices about ways to ensure purchased product integrity for their patients.

Background

In mid-September 2012, an alert physician reported a patient’s suspicious fungal infection to the Tennessee Department of Health. The CDC, working across states and internally, identified the primary causal pathogen, Exserohilum rostratum; the vehicle, preservativefree methylprednisolone acetate injection; and the source, NECC. Within days, the FDA recalled the contaminated products, ordered the closure of NECC, and began an extensive and ongoing investigation. At the point of recall, more than 13,000 patients had been exposed to potentially contaminated products in 23 states.

Failures at the manufacturing, regulatory, and procurement levels allowed this tragedy to unfold. New regulation undoubt-

10

edly will evolve from this seminal event (see sidebar on page 11); but the fact remains that if those at the manufacturing, regulatory, and procurement levels, using the existing regulatory systems, had done their jobs, it might not have occurred.

The extemporaneous compounding of patient-specific products by pharmacists at the request of the patient’s physician

MINNESOTA PHYSICIAN JULY 2013

is as old as the two professions.

The need and demand for individually prepared dosage forms has declined steadily over many years; today much of the nonsterile compounding is limited to dermatological preparations, specialized products for pediatric delivery systems (e.g., lozenges, lollipops, solutions) and veterinary products. At the same time, the needs for sterile compounding (e.g., of ophthalmic and injectable products) have grown.

As the demand for these specialty products has increased, so, too, have the regulatory standards and the equipment available to safely and consistently meet the growing need. The United States Pharmacopeial Convention (USP) has developed standards for sterile (USP-797) and nonsterile (USP-795) compounding (www.usp.org /usp-healthcare-professionals /compounding). The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires all JCAHOaccredited institutions whose pharmacies engage in the preparation of sterile products to comply with USP-797 standards.

The Massachusetts Board of Registration in Pharmacy issued a report of its preliminary findings on Oct. 23, 2012, stating that NECC was not in compliance with USP-797 sterile compounding standards. Although only six facilities in Minnesota had purchased the potentially contaminated methylpredni-

solone from NECC, a total of 110 Minnesota facilities had purchased other sterile and nonsterile products from NECC between May 21, 2012, and the FDA’s recall in mid-October.

Apparently NECC was well known to the medical and pharmacy purchasing communities in Minnesota.

Clearly, this tragedy could have been much worse, as many more products from NECC could have been contaminated (the FDA list of products includes more than 2,300 line items recalled; see www.fda.gov /safety/recalls/ucm322979.htm).

It is appropriate to explore how such a broad distribution of questionable products could happen, given the apparent obscure position of the firm.

Practice and regulatory failures

The New England Compounding Center has a long record, dating back to 1999, of failure to meet regulatory/practice standards at both the federal level (FDA) and the state level. Yet, no formal sanctions were imposed on the firm—in part, because NECC was classified as a pharmacy, not a manufacturer.

Compounding pharmacies are required by state statute to prepare a specific formulation for a specific patient upon receipt of a prescription from a licensed practitioner. This expectation certainly does not preclude advance preparation of the specific formulation by the pharmacy, but it does imply some level of communication among the pharmacy, the prescriber, and the patient.

Pharmaceutical manufacturers, in contrast, are not expected to meet the individual patient/ practitioner standard of a pharmacy, but they are regulated by the FDA and are subject to FDA inspection and oversight.

It appears that NECC was acting like a manufacturer but was licensed as a pharmacy, manipulating the individual prescription requirement through some sort of internal listing of patients receiving specific medications. It does not appear that this process was reviewed or approved by any board of pharmacy, and certainly not by the

Massachusetts Board of Pharmacy. Given the wide distribution and breadth of NECC’s product line, it is hard to understand why NECC’s operations were not challenged prior to the events in the fall of 2012.

Indeed, it is known that in 2004, pharmacists in Iowa, Wisconsin, and Texas notified the Massachusetts Board of Pharmacy of irregularities regarding NECC marketing/sales practices.

The licensing and regulation of pharmacies is a state matter.

The Minnesota Board of Pharmacy (MNBoP), like equivalent bodies in all other states, issues an annually renewable license to pharmacies serving the citizens of Minnesota. Given the increase in the variety of pharmacy outlets (mail order, Internet, specialty, etc.), the number of pharmacy licenses issued by Minnesota and all other states has risen dramatically in recent decades. Yet, little increase in staff support at the board level has accompanied this growth.

Currently there are 1,877 pharmacies licensed in Minnesota, just over 30 percent of which (573) are nonresident pharmacies. Surveyors inspect all in-state facilities licensed by the MNBoP prior to initial licensure and periodically thereafter.

The purpose of the inspections is to evaluate a facility’s compliance with Minnesota statutes and rules and with generally accepted practice standards. Nonresident pharmacies are not inspected by Minnesota surveyors; the MNBoP has relied on information provided by the facility during the licensing process and the facility’s home state regulatory agency when deciding whether or not to issue a license. In the case of NECC, these sources apparently failed to provide the Minnesota Board of Pharmacy with any information that would indicate procedure problems requiring MNBoP action.

Pharmaceutical price increases, though common and expected, have a negative financial impact on health care practices. Additionally, unexpected shortages of commonly used pharmaceuticals are now not

Proposed legislation addresses pharmaceutical compounding • In Minnesota: During the 2013 legislative session, the Minnesota Legislature adopted, in the Health and Human Services omnibus budget bill (HF1233), a Minnesota Board of Pharmacy proposal to more tightly regulate pharmacies and drug distributors. The bill requires all out-of-state pharmacies and wholesale drug distributors to be inspected by Minnesota inspectors or by the regulatory agency of the state in which the wholesaler is located. • In Washington, D.C.: In May, legislation aimed at improving the safety of compounded human and animal drugs was introduced in the U.S. Senate. S. 959, the Pharmaceutical Compounding Quality and Accountability Act, clarifies the compounding oversight responsibility of state and federal authorities. Traditional compounding pharmacies would continue to be regulated primarily by state pharmacy boards, while compounding manufacturers would be regulated by the U.S. Food and Drug Administration. In addition to defining the FDA’s role in oversight of compounding manufacturers, the legislation also sets forth requirements on compounding manufacturers.

The legislation is sponsored by a bipartisan group of senators, led by Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.), and Al Franken (D-Minn.). The bill passed the Senate Health Education Labor and Pensions Committee on May 22 with no substantive changes. The full bill text and its current status are available at www.govtrack.us/congress/bills/113/s959. unusual in the U.S. health care environment. Thus, it should be no surprise that there is a market niche for responsive alternative suppliers of specialty pharmaceuticals. It is clear from the NECC distribution list obtained by the FDA that NECC sold products to more than 3,000 customers throughout the U.S.; they sold products in every state, including to more than 100 customers in Minnesota (see www.fda.gov/downloads/Drugs /DrugSafety/FungalMeningitis /UCM325467.pdf). This implies that NECC was a registered pharmacy in virtually every state and had a broad customer base, ranging from major health care institutions to small specialty clinics.

In hindsight, it is easy to question the due diligence of purchasers. But the realities of financial issues and drug shortages also may have played a substantial role in the wide distribution of NECC’s customer network and subsequent product sales.

What now?

Over the next weeks and months, the FDA can be expected to step up inspections and oversight of pharmacy-based compounding operations, based

upon its current guidance.

Recent FDA actions in New Jersey and Georgia seem to support this expectation. Basically, the FDA’s current position fol-

lows the “If it looks like a duck� rule: If a pharmacy operation looks like manufacturing and not extemporaneous compounding, the FDA reserves the right to inspect.

According to a recent report by the U.S. Public Interest Research Group that analyzed FDA warning letters to compounding pharmacies from 2002 to 2012, the most frequent violations cited included: • Misbranding drugs • Producing unapproved new drugs • Producing drugs under unsanitary conditions • Repackaging sterile drugs • Using unapproved, potentially unsafe ingredients (Source: U.S. PIRG, “Prescription for Danger: How Unsafe Drugs Produced by Compounding Pharmacies are Putting American Lives at Risk,â€? May 2013) Individual states working in conjunction with the National Association of Boards of Pharmacy (NABP) have begun an initiative to share inspection SAFETY to page 38

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Resources Interpreting from cover health care providers employ their communication skills to make very deliberate inquiries of their patients so they can acquire information that will be crucial in making a correct diagnosis. Any lack of clear information presented in an understandable way to clinicians can lead to real danger, such as untreated conditions, higher rates of complication, incorrect patient histories, lack of awareness of potential allergic reactions, etc.

Moreover, a client who is unable to understand a clinician’s speech is likely to fail to comply with after-care instructions and medication regimens. It makes good health sense to employ trained, professional interpreters to avoid complications, higher rates of repeat visits, and unintended consequences of inadequate or inappropriate treatment for LEP clients.

Minnesota is among a growing number of states deeply concerned about a lack of standards for the employment of spoken language interpreters in health care. Stakeholders, including

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Contacts for the entities mentioned in this article: • State of Minnesota Department of Health, www.health.state.mn.us • National Board for Certification in Healthcare, www.certifiedmedicalinterpreters.org • Certification Commission for Healthcare Interpreters, www.healthcareinterpretercertification.org • National Council on Interpreting in Health Care, www.ncihc.org • University of Minnesota, www.umn.edu • Century College, www.century.edu • U.S. Department of Health and Human Services, www.hhs.gov/ocr/ civilrights/resources/factsheets/yourrightsundertitleviofthecivilrightsact.pdf • Interpreting Stakeholder Group, www.isgmidwest.org • Upper Midwest Translators and Interpreters Association, www.umtia.org

hospitals, clinics, patient advocacy groups, interpreters, insurers, and language agencies, are working together to develop tools to help guarantee that qualified and capable interpreters work with patients not only during routine check-ups but also as they face life and death decisions that require the best possible communications with all parties.

This article describes current state and national efforts to build a competent workforce of health care interpreters.

Background

America’s linguistic composition has always been complicated.

MINNESOTA PHYSICIAN JULY 2013

Today, Spanish is a well-established second language across the United States. Nevertheless, most interpreters of Spanish have not had a degree in translation or interpreting, and many have had little or no formal training or testing. The level of training and professionalism among interpreters of other languages of importance locally (like Somali, Hmong, Russian, Bosnian, Karen, Bhutanese, Oromo, Vietnamese, Lao, and French) is often even harder to predict.

Through implementation of the Americans With Disabilities Act, America’s deaf and hard of hearing have won access to the best-trained interpreters in the U.S. Some members of the Registry of Interpreters for the Deaf (R.I.D.) credit R.I.D. clients with pushing for better standards for interpreter training. To fully comply with the mandate represented by Title VI of the Civil Rights Act of 1964, most in the interpreting field anticipate that a similar push for professional training will soon apply to all interpreting, perhaps starting with the largest language groups and eventually trickling down to even rare languages. The HHS document “Know the Rights that Protect us from Discrimination Based on Race, Color, or National Origin” (www.pdfone. com/view/22_discrimination/kno w-the-rights-that-protect-us-forcivil-from-discrimination.html) provides a useful and succinct explanation of the federal policy and how it applies to LEP clients.

Implementing Title VI creates unique challenges in the medical field. New refugees to the U.S. are frequently cited as the most challenging language group to work with because of

the unavailability of fully trained bilingual speakers of languages that may be brand-new in the U.S. In addition, refugee mobility creates challenges in preparing to provide interpreting services. It is clear that medical providers need to work closely with nonprofit refugee assistance organizations such as Catholic Charities and Lutheran Social Services to anticipate future needs and put in place the resources needed to serve LEP clients, regardless of their native language.

From roster to registry

In the state of Minnesota, the Department of Health maintains a roster of interpreters for various languages. Information on this roster is unverified, and the onus is on users to carefully examine the credentials and experience of interpreters hired to work in clinical settings with patients and providers. This imperfect tool is due to be supplemented by a more reliable and dynamic registry with verified and detailed information including training in interpreting, language proficiency, interpreting skills testing, national certification by an accredited certifying body, criminal background check, post-secondary training, and completion of university-level degrees in the fields of interpreting and translation as well as other potentially related fields.

This registry is not intended to be mandatory; however, like the roster that is currently in place, reimbursements from federal sources may be sought in the state of Minnesota only for services provided by interpreters listed on the registry. It is clear that the registry will be widely used and continually relied upon by many stakeholders as the field of spoken language interpreting evolves. The Minnesota legislature will be asked to fully implement the registry in the next legislative session.

A national code of ethics

The National Council on Interpreting in Health Care has convened for several years to elicit information from a wide INTERPRETING to page 32

PROVEN. LOW RATE OF HYPOGLYCEMIA

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For adult patients with type 2 diabetes, Victoza® offers these benefits and more.

Visit VictozaPro.com/Care to learn how the support program helps patients get started.

*Victoza® 1.2 mg and 1.8 mg when used alone or in combination with OADs. † Victoza® is not indicated for the management of obesity, and weight change was a secondary end point in clinical trials.

Indications and Usage Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered 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.

Victoza® has not been studied in combination with prandial insulin.

Important Safety Information Liraglutide causes dose-dependent and treatment-durationdependent 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 Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Do not use in patients with a prior serious hypersensitivity reaction to Victoza® (liraglutide [rDNA origin] injection) or to any of the product components.

Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected.

Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.

Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and antiliraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

There is limited data in patients with renal or hepatic impairment.

Please see brief summary of Prescribing Information on adjacent page.

0513-00015590-1

JULY 2013

June 2013

MINNESOTA PHYSICIAN

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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 treatmentduration-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. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered 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 prandial insulin has not been studied.

CONTRAINDICATIONS: Do not use 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). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent 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. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One 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. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-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 on-treatment 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 placebo-treated 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: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, 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® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-

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MINNESOTA PHYSICIAN JULY 2013

ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin 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. 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. 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. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. 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® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind 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. In these five trials, 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. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions 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® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction 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 Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2

Constipation Dyspepsia

5.3 0.9 1.7 5.2 0.9 2.6 Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Victoza® 1.8 mg once daily + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials.

Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia: In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin,

the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Glimepiride + Placebo + Metformin Add-on to Metformin Victoza® + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + Metformin Victoza® + Metformin + Metformin alone (N = 163) (N = 158*) Patient not able to 0 0 — self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat Patient able to self−treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin Victoza® + Metformin + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) Patient not able to 0 — 0 self−treat Patient able to self−treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + + Glimepiride + Glimepiride (N = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat Patient able to self−treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator.

After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo.

The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.

OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request.

For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending.

Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015681-1 5/2013

JULY 2013

MINNESOTA PHYSICIAN

15

INFECTIOUS

Hepatitis C

S

ometimes in medicine, a momentous advance can be associated with a single milestone. For hepatitis C treatment, that moment was the Late Breaker Session at the 63rd Liver Meeting of the American Association for the Study of Liver Diseases, held in Boston on Nov. 12, 2012.

The convention center room was packed and anticipation was high: A hint of what was to come had been provided at the European Association for the Study of the Liver meeting in Barcelona five months earlier; the abstracts had been online for a week; and many in the room were investigators in the studies about to be presented.

All were stunned nonetheless.

Five of the Late Breaker presentations (and 34 other hepatitis C treatment presentations) established with certainty that we are on the brink of a revolution in hepatitis C management.

This article summarizes information about these new treatments and wrestles with their implications.

16

DISEASES

The forthcoming revolution in treatment and management

By Frank S. Rhame, MD

Natural history of untreated hepatitis C infection

The natural history of untreated hepatitis C infection remains surprisingly controversial, partly because the disease proceeds so slowly in most infected individuals, taking decades to produce illness. Few cohorts have been followed for >30 years, and the subjects in the most studied cohorts of hepatitis C-infected persons tend to be more ill and further advanced than the universe of hepatitis C-infected individuals.

A reasonable estimate is that after 25 years of infection, 25 percent of hepatitis C patients will develop end-stage liver disease or hepatocellular carcinoma. Better understood, and probably more relevant to

MINNESOTA PHYSICIAN JULY 2013

clinical practice, is the prognosis of cirrhosis: In the U.S., about 50 percent of patients who reach the stage of cirrhosis survive for five years.

Current state of hepatitis C treatment

For more than 20 years, the only agents used for hepatitis C treatment were interferon and ribavirin. Interferons must be given parenterally and have substantial toxicity. The side-effect profile was modestly improved when PEG interferon was licensed in 2001, permitting weekly self-injection. But interferon still causes substantial malaise, mental health problems, cytopenias, and aggravation of autoimmune illness.

Ribavirin aggravates anemia by producing hemolysis, aggravates bone marrow suppression, and is teratogenic.

These drugs are used for six to 12 months. While severity of adverse effects varies greatly among patients, treatment with interferon and ribavirin generally represents a substantial commitment by both patient and clinician. Close monitoring of the complete blood count is mandatory and dose modification is common.

The goal of hepatitis C therapy is sustained virologic response (SVR), the lack of detectable HCV RNA more than a specific period after the end of treatment. For example, SVR12 is undetectable HCV RNA 12 weeks after the last treatment.

SVR12 is tantamount to cure.

The most important predictor of SVR is the HCV genotype.

To oversimplify, genotypes 1 and 4 have about a 30–40 percent chance of SVR after 12 months of treatment; genotypes 2 and 3 have about a 60–70 percent chance of SVR after six months of treatment.

In May 2012, the FDA approved two serine protease inhibitors for treatment of hepatitis C genotype 1: boceprevir and telaprevir. These drugs raised the chance of cure from 30–40 percent to 60–70 percent and enabled about half of patients—those with a rapid HCV RNA response—to shorten treatment from 12 months to six months. These drugs are the first marketed direct-acting antiviral agents, which directly inhibit viral enzymes, and are a clear advancement. But because PEG-interferon and ribavirin are still needed, the new drugs add toxicity to the drug regimen.

Both new drugs aggravate the anemia and neutropenia of ribavirin and PEG-interferon; telaprevir can cause severe rash and produce an unusual anal pain.

Furthermore, these drugs are complicated to use. Because of the rapid development of resistance when viral suppression is inadequate, stopping criteria (“futility rules”) are needed to be sure that failing drugs are promptly stopped. In addition, they are expensive: The announced prices were $49,200 for a course of telaprevir and $26,400–$48,400 for boceprevir.

Investigational compounds for hepatitis C treatment

The website www.hcvdrugs.com listed 96 inhibitors and 37 immune modulators on July 1.

These drugs are under development at a wide array of pharmaceutical companies. Most observers believe that successful regimens will be interferon-free; be given for three or fewer months; and consist of two or three of the new drugs, with or without ribavirin. Avoiding ribavirin is desirable because it causes anemia by shortening RBC survival and can’t be used in patients with hemolytic conditions. Furthermore, now that ribavirin is being studied without interferon co-administration, it has been seen to cause malaise on its own.

Comprehensive discussion of all the drugs in development is beyond the scope of this article, but discussion of two of the most promising regimens illus-

FIGURE 1. SVR 12 Rates in M11 -652 by HCV Subtype (N = 448) trates how the new drugs will substantially alter treatment of hepatitis C. Gilead Sciences is studying a two-drug, once-a-day, singletablet regimen with sofosbuvir, a nucleoside polymerase inhibitor, and ledipasvir (formerly GS5995), an NS5A inhibitor. Little information on the performance of this combination has been made public. But data on sofosbuvir and declatasvir, an NS5A inhibitor being developed by Bristol-Myers Squibb, were presented at the Liver Meeting. In the arms treated with these two drugs (half also with ribavirin) for 24 months, 85/88 patients (97 percent) achieved SVR (see Table 1). [Editor’s note: The FDA has set a target review date of early December, under the Prescription Drug User Fee Act, for use of sofosbuvir with ribavirin or ribavirin and interferon, depending on the HCV genotype.]

AbbVie (the pharmaceutical portion of what used to be Abbott Laboratories) is studying combinations of ABT-450, a protease inhibitor boosted by ritonavir; ABT-267, an NS5A inhibitor; and ABT-333, a nonnucleoside polymerase inhibitor.

In the complex 14-arm AVIATOR study, also presented at the Liver Meeting, focusing on the 12-week regimens with all three investigational drugs, SVR 24 rates for genotype 1b were 100 percent; and for genotype 1a, when ribavirin was also used, 98 percent (see Fig. 1).

These new treatments are likely to be quite expensive.

Gilead Sciences acquired sofosbuvir by buying Pharmasset, a company producing no other drug with nearly as much potential. Gilead paid $11 billion; it undoubtedly intends to recoup that price. This revolution in hepatitis C management is a high-stakes arena.

Implications of the new drugs for hepatitis C treatment

The developments discussed above raise a number of questions about future management of hepatitis C. What will happen to liver biopsy? Given the very slow pace of liver damage due to hepatitis C infection and the arduous course of current treatments, it

ABT-450 ABT-267 ABT-333 RVB

ABT-450 ABT-333 RVB

ABT-450 ABT-267 RVB

ABT-450 ABT-267 ABT-333

ABT-450 ABT-267 ABT-333 RVB

ABT-450 ABT-267 RVB

ABT-450 ABT-267 ABT-333 RVB

Source: KV Kowdley, E Lawitz, F Poordad, et al., Abstract LB-01, 63rd Annual Meeting of the American Assoc. for the Study of Liver Diseases (AALSLD) Boston, Mass., Nov. 9-13, 2012. Reprinted with permission of the author and the AASLD.

is natural to want to stave off treatment until it is necessary.

Fibrosis is the hallmark of cirrhosis. In the most widely used histological scheme, fibrosis is classified in stages from 0 to 4; F0 indicates no fibrosis and F4, cirrhosis. In making a “treat now” vs. “treat later” decision, most patients and clinicians prefer biopsy: Even given some possible sampling error, it is the most definitive measure and the most accurate way of staging fibrosis. But in a world where the new drugs provide little disincentive to treat, I expect we’ll treat all active hepatitis C patients—and biopsy for staging fibrosis will disappear.

What about antiviral treatment for decompensated cirrhosis? Current treatments are too difficult for decompensated cirrhotics to tolerate. We can do little more than provide supportive care and put them on the transplant list. But studies of treating decompensated cirrhotics are underway, and it is likely that the new, less arduous treatments will afford a net benefit to such individuals.

What will be the future role of IL-28B genetic testing for inherent treatment responsiveness and hepatitis C virus genotyping? People with the CC (as opposed to the CT or TT) genetic polymorphism at a site

near the IL28B gene, which encodes interferon-λ-3, have a twofold increase in cure after ribavirin and PEG-interferon treatment and a greater likelihood of spontaneous cure.

Many clinicians obtain an

MORE THAN

assessment of this genotype as part of deciding when to treat.

But with cure rates >90 percent, the rationale for this assessment would disappear.

HEPATITIS C to page 34

75%

OF ADULTS

INFECTED WITH HEPATITIS C ARE BABY BOOMERS

CDC AND THE U.S. PREVENTIVE SERVICES TASK FORCE RECOMMEND ANYONE BORN FROM 1945-1965 GET TESTED FOR HEPATITIS C

Liver disease, liver cancer, and deaths from Hepatitis C are on the rise. Testing can lead to lifesaving care and treatment for your patients.

For more information, go to: www.health.state.mn.us/hepatitis JULY 2013

MINNESOTA PHYSICIAN

17

MEDICINE

LAW

A whirlwind session with few surprises

By H. Theodore Grindal, JD, and Nate Mussell, JD

revenue would come from and how it would be spent, and what the insurance exchange would look like in the end.

Putting together a budget

Even in the busiest of legislative sessions, legislators (and the public) never lose sight of the biggest task of the year: putting together a budget. Despite the budget deficit of $627 million for 2014 and 2015, this session felt different; this year, the focus was more on how much revenue would be raised and how it would be spent, rather than what areas of the budget would get cut.

Omnibus tax bill (HF 677).

In the last week of session, the governor and legislative leaders

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18

THE

2013 legislative wrap-up

A

combination of factors— from a historic shift following the November elections, to an all-DFL Legislature and DFL governor, to full legislative agendas in health care and beyond—made for a whirlwind session in 2013, from start to finish. Most legislative sessions have followed the adage that “It’s a marathon, not a sprint,” but this year’s legislators hit the ground running in early January and never stopped sprinting. Legislators raced from one deadline to the next, leaving only minutes to spare before adjourning May 20.

Looking at the 2013 session as a whole, there were few surprises; much of what was expected going into the session in January occurred in one form or another. On the health care side, there was little suspense about whether the new Legislature was likely to pass bills expanding the state’s Medical Assistance program and creating a state-based health insurance exchange. The surprises—or more properly, the questions— were related to where the tax

AND

MINNESOTA PHYSICIAN JULY 2013

Jennifer Resner VICE PRESIDENT, COMMERCIAL BANKING

952-841-9313

reached an agreement on a $2 billion omnibus tax bill that set the framework for the rest of the budget. One item in the tax bill of particular interest to the health care community was the increase in the price of tobacco.

While the governor’s push to increase taxes on the state’s toptier earners was expected, given his campaign position in 2012, the governor’s inclusion of a tobacco tax increase was a drastic change from two years ago.

The final budget agreement raised the cigarette tax by $1.60 per pack, which is expected to generate almost $430 million.

HHS omnibus budget bill (HF 1233). As other budget committees were quibbling over how much to spend, the Health and Human Services (HHS) Budget Committee had the opposite problem, as it faced a $150 million negative budget target. Legislative leaders gave the HHS budget committee chairs a bit of a reprieve in the last weeks of the session when they settled on a $50 million budget reduction. This year’s budget included a long-awaited 5 percent across-the-board increase for physicians in the fee-for-service portion of the state’s Medical Assistance program. Other highlights included more than $12 million reinvested in the state’s Medical Education and Research Costs program, bringing the total state and federal funding for the program back up to almost $58 million; and a $17.5 million investment in the Statewide Health Improvement Program for each of the next two years.

The HHS budget bill also includes significant long-term changes to the MinnesotaCare program. Although many individuals previously covered under MinnesotaCare were transferred to the Medical Assistance program, the state

plans to use the remaining MinnesotaCare program as the basic health plan, under the Affordable Care Act requirements, to continue serving the state’s working poor population.

The bill also requires that health licensing boards in the state, including the Board of Medical Practice, begin requiring criminal background checks for all applicants for initial licenses and those applying for reinstatement of a suspended license, beginning Jan. 1, 2018.

In addition, by Jan. 1, 2017, all of the licensing boards must establish a plan for completing criminal background checks of all licensees in the future.

The licensing boards had been working on some amicable language over the last year and were finally able to reach some consensus this session around this issue.

One thing the HHS budget did not include was a provision that would have removed the repeal of the provider tax in 2019 that was part of the 2011 budget agreement. There was concern initially when Sen. Tony Lourey (DFL-Kerrick), chair of the Senate HHS Finance Committee, released his original budget proposal, which included a provision removing the repeal.

The Senate Tax Committee moved swiftly in taking this provision out of the Senate bill.

Despite removal of the repeal, the final HHS budget included a study of the provider tax and other Medicaid surcharges as the state looks at the long-term future of the Health Care Access Fund in light of implementation of the Affordable Care Act. The provider tax currently raises more than $500 million each year and has been used to fund affordable health care for Minnesota’s low- and moderateincome working families through MinnesotaCare.

Health insurance exchange

On just the second day of session, the Legislature sprinted into action on the state-based health insurance exchange. The exchange was an early priority for the 2013 session, largely due to the federally imposed deadline of March 31 for states to pass and sign into law stand-

For more information alone exchange legislation.

Sen. Lourey and Rep. Atkins (DFL-Inver Grove Heights) got the ball rolling with a rollout of the proposed health-care exchange legislation. Although three Republican legislators stood beside the DFL leaders during that early January press conference, after the dust settled in March there were no Republican votes favoring passage of the bill creating the exchange.

Following the November elections, there was little question that Minnesota would opt for a state-based insurance exchange rather than opting to participate in the federal exchange. The questions the Legislature had to grapple with mainly concerned exchange financing, the governance model, and whether to adopt an “active purchaser” or a “clearinghouse” model. The exchange bill journeyed through almost 15 committee hearings in both the House and Senate, where the focus remained almost solely on the exchange board and conflictof-interest provisions.

The final legislation that was passed and signed into law in late March created an insurance exchange marketplace with a seven-member governing board. There was considerable debate throughout the process about how many people should be on the board, who could be a representative serving on the board, and what the board’s powers would be over the products offered on the exchange.

Following the bill’s passage in March, Gov. Dayton announced that the newly created exchange would be given the title MNsure; by the end of April, he had announced the board’s composition, naming six individuals (along with Dept. of Human Services Commissioner Lucinda Jesson) to serve on the MNsure board over the first few years.

The $50 million per year cost of operating the exchange will be paid for by a scaled portion of premium financing that is scheduled to be adjusted from 1.5 percent up to 2.5 percent of exchange premiums.

On the question of an “active purchaser” versus a

• Up-to-date information on the status of legislation, as well as descriptions of all bills introduced during the legislative session: www.leg.state.mn.us/ or call Senate Information at 651-296-0504 or House Information at 651-296-2146 • Contact information for all members of the Minnesota House and Senate: www.leg.state.mn.us/ • Contact information for the governor’s office: http://mn.gov/governor “clearinghouse” model, the Legislature opted for a hybrid approach. The exchange will operate as an open clearinghouse model for the first year, allowing any plans that are certified by the Department of Commerce as a Qualified Health Plan to be offered during that first 12-month time window.

Beginning in 2015, the exchange will shift to an “active purchaser” model, and the board will have more oversight over the exchange insurance products.

Passage of the implementing legislation may turn out to be the easiest part of the exchange rollout. The potentially bumpier road lies ahead, when enrollment in the exchange begins in October and the exchange goes live on Jan. 1, 2014.

While the success or failure of the exchange is a matter of speculation, one of the key questions that physicians continue to raise is what type of networks will be offered on the exchange.

There is growing concern among independent physicians that they might be left out of the narrow network–type plans that are commonly deemed to be more cost effective. At the same time, physicians are wondering what the population of exchange recipients will look like; if more individuals get covered outside of the exchange, will this leave a more vulnerable population of patients inside the exchange? All of these questions, and more, will remain unanswered until at least midway through the 2014 session, as MNsure works through its early twists and turns.

meningitis in patients injected with an infected compounded steroid product from the New England Compounding Center (NECC).

A bill was brought forward midway through the session.

The stripped-down version that eventually passed creates new regulations around compounding pharmacies and the physicians and pharmacists who are receiving products from out-ofstate compounding pharmacies (as was with case with the NECC). This is an issue to watch very closely over the next year, particularly at the federal level, as the U.S. Congress and the FDA look to crack down on some of these large-scale compounders (see the cover story of this month’s Minnesota Physician).

Looking ahead

One major health policy issue the Legislature was unable to get to in the 2013 session was scope of practice. There is a nationwide effort to push for independent practice of advanced practice registered nurses in light of the impending physician shortage, perceived access issues of an aging population, and an onslaught of new enrollees on public programs.

Physicians got a preview of things to come when legislation was introduced in the 2013 session that would have eliminated the statutory requirement for collaborative management with physicians and for written prescribing authority. Though neither the Senate nor the House bill received a hearing in committee this session, the 2014 session likely will see the most significant scope-of-practice fight the Legislature has faced in years.

H. Theodore Grindal, JD, and Nate Mussell, JD, are with the Minneapolis law firm of Lockridge Grindal Nauen PLLP. They provide government relations and legal services for health care providers.

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Under the radar

One issue that could have significant impact on physicians and health care practice largely flew under the radar this session: pharmaceutical compounding.

The issue first came to light in the summer and fall of 2012, following an outbreak of bacterial

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Editor’s note: A medical emergency prohibited Peter Mills, MD, PhD, from participating on this panel. His comments were added after the initial edit of the conference transcript. Panelists participate in a three-phase curriculum development survey for every session of the Roundtable, and Dr. Mills’ active involvement in that process was an important part of this conference.

MR. STARNES: The contentious battles surrounding health care reform have somewhat subsided and yielded a new operating system to which we all must adapt. ACOs will reward improved population health; health insurance exchanges will allow consumers more affordable access; and ICD-10 codes will provide better compensation to physicians for spending more time with their patients. Central to the success of these new models is engaging patients and creating tools to let each of their individual stories count toward improved aggregate wholes. Today we will discuss the topic of patient engagement and determine ways it can be developed to its full potential.

Let’s begin with a definition of patient engagement.

DR. KLODAS: It’s the constructive and helpful participation of a patient in their own care.

DR. NERSESIAN: A motivated patient has a desire to do what’s necessary to change their lifestyle in order to achieve certain goals.

We can usually determine that subjectively or objectively. Subjectively, there’s body language: the patient looking at you and their posture; and there are objective measures like the patient activation measure.

DR. GANDRUD: It’s family engagement: Does that family work together as a unit? Are there different levels of motivation and engagement between the child and the parents?

How can I help them connect and be on the same page? We work a lot with family dynamics to improve patient engagement.

DR. VAN ZYL YORK: Patient engagement is where the patient is in terms of their interest in their own health. It’s broader than any one provider, broader than any single health issue. A patient’s relationship with one provider may be very different than with another provider. There’s not a single patient engagement status; it’s what the patient brings to the relationship. You can have an engaged patient and not have an engaged health care provider or health care system,

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About the Roundtable Minnesota Physician Publishing’s 39th Minnesota Health Care Roundtable examined the topic of patient engagement. Six panelists and our moderator met on April 25, 2013, to discuss this issue. The next roundtable, on Oct. 24, will address end-of-life topics.

DR. MILLS: It’s a patient’s willingness to actively participate in decisions about their health and care needs.

DR. FISCHER: I define patient engagement broadly. It is the sharing of responsibility for care between patients and their families and guardians; health care providers—the entire health care team; and, when applicable, the health-care insurance payer. “Insurance payer” includes the insurance company, employer, TPA, and federal and state governments. The engagement must occur at every step of the health care process, including but not limited to education, evaluation of options, care delivery, and financial support.

MR. STARNES: Patient engagement is receiving more attention than before. Why?

Patient engagement Creating measures that work and that patient can still thrive, or they can be defeated because of not having a good relationship. Many times, parts of the health care system see patient engagement as patients engaged to do what the health care system thinks they ought to be doing rather than what the patient may see as the best course of action. A health care provider may prescribe treatment as the best action for the patient. The employer may want the patient to reach particular goals because they see it as fulfilling their goals for health cost containment and population health status. The patient, on the other hand, may be looking at what is best suited to choices they have to make day to day, and see it differently. Medication is a good example. Patients may be prescribed a particular medication but because of the side effects, cost, management routine, how it reacts with other things, they may not be as sold on that as the path to health as their provider may be.

DR. VALDIVIA: Patient engagement is the degree to which an individual acts in an informed manner to achieve and maintain optimal health.

DR. FISCHER: There are a couple of reasons.

The health of all Americans has become a core national strategy. We know that if we’re going to change the health of America today, it’s going to require patient engagement.

Secondly, data show that an engaged patient has better outcomes and at a lower cost.

DR. MILLS: The main reason is the inexorable rise in health care costs over the last two decades and the fact that America has gotten to the point where, as a nation, it just cannot afford the proportion of GDP—18 percent— that is spent delivering care. This, coupled with the fact that there is increasing evidence to support lower costs and better outcomes for individuals and populations that are active participants in when, where, and how their care is delivered.

DR. VALDIVIA: It’s ineffective for health plans or other third parties not directly involved in patient care to intervene and make changes.

Another reason is change in reimbursement models. Fee-for-service encouraged us to engage patients around the level of visit but not necessarily in terms of their behavior. Now that we’re moving to population-based payment models, we have a different incentive.

We need to think not only about the most complex cases where we can intervene but also about those who are well and how to keep them well.

DR. KLODAS: Patient engagement is a hot topic because there’s a perfect storm. We’re facing unsustainable costs that we can’t afford. Insurance companies are realizing that they can’t ignore prevention anymore.

Smoke? You have a higher payment. Quit

smoking, and your payment goes down. That’s going to engage patients.

For a long time, individuals were passive recipients of care and it didn’t matter how many MRIs you had, how many procedures you had, or how many drugs you were on, because somebody else paid for it. Insurance companies are realizing that they can’t ignore prevention any more. They didn’t used to pay for that; they didn’t used to be interested in that. All insurance companies cared about was minimizing the number of people with disease.

Now they’ve got to make sure that people without disease are truly healthy because eventually, those people may come back to the same insurance company, even if they switch insurance carriers for a while.

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correlation between those two things.

DR. VAN ZYL YORK: Patient engagement and outcomes aren’t just related to physicians. Patients get to where they are by a variety of means.

Assuming that the health care system has a high level of control over patient engagement is going to lead us down the wrong road.

DR. MILLS: One thing we may not be very good at is recognizing when we don’t have good rapport with a patient and giving them the opportunity to see a colleague. Having a measure of patient engagement recorded may help make this more tangible and could help improve engagement across the whole provider community.

DR. GANDRUD: Success isn’t focused solely on the provider but also on how well providers utilize resources outside MR. STARNES: the clinic to What makes help certain paWe shouldn’t need patient engagetients. In our ment worth financial incentives to do clinic, a lot of it pursuing? the right thing. has to do with DR. KLODAS: selection bias.

Peter Mills, MD An engaged One provider patient has a might be hard to better quality of life. I don’t know get in to see, so patients who go to how to measure that, but patients that provider are those that are orinvolved in their own care are ganized enough to schedule the aphappier, on fewer medications, see pointment in time. Those doctors’ the doctor less, have better metrics, dashboards look better because their and feel better. patients are more engaged to begin with. Many variables play into this; DR. NERSESIAN: Outcomes. If my pait’s hard to use just one number to tient population looks better overall, describe the success of one provider. that’s a good way to assess engageWe have a provider in our clinic that ment. The PAM (patient activation sees all the adolescents. In that measure) is in all Fairview records. provider’s measured success, they The problem is that it’s not used very may be just as good at engaging the often. It needs more physician patient, but the outcomes may not be awareness; three-quarters of physias clear as for a provider caring for a cians don’t understand the term. If 3-year-old whose parents oversee that that’s true community-wide, we need child. not only more patient engagement; we need more provider education.

MR. STARNES: Laura, you see diabetic DR. MILLS: We know outcomes are better for engaged patients.

MR. STARNES: Can we discern why a given doctor has better results with certain patients? How do we translate that across the provider community?

DR. VALDIVIA: It’s difficult to measure.

Short term, you might see a change in specific behaviors. Long term, you might see changes in cultural norms.

The journal Health Affairs showed a

children. Is part of success in patient engagement attributable to a psychosocial match between patient and provider?

DR. GANDRUD: Definitely. Certain providers work better with certain age groups. Certain providers are better at motivating and asking engaging questions.

MR. STARNES: What are the best ways to create a more engaged patient?

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A B O U T T H E PA N E L I S T S Vivi-Ann Fischer, DC, is chief clinical officer at ChiroCare (Chiropractic Care of Minnesota, Inc.), a nonprofit independent chiropractic provider network based in Shoreview, Minn. ChiroCare serves more than 1 million managed care members throughout Minnesota, North Dakota, South Dakota, Iowa, and Wisconsin. A practicing chiropractor, she owns Plymouth Grove Chiropractic and serves on the Northwestern Health Sciences University board of trustees. With more than 25 years’ experience in providing clinical care and 20 years of managed health care experience, she is a strong advocate of collaboration with medical doctors, focused on improving patient experience, community health, and reducing health care costs.

Laura Gandrud, MD, is a clinician in pediatric endocrinology and diabetes at Children’s Hospitals and Clinics of Minnesota. In addition, she serves as primary or co-investigator on multiple research projects that investigate type 1 and type 2 diabetes in children and adolescents. Previously, she was a staff physician in the Division of Pediatric Endocrinology and Diabetes in the Department of Pediatrics at Stanford University School of Medicine and an instructor in the Stanford University School of Medicine. While at Stanford, she pursued research focused on the use of glucose sensors in children with diabetes.

Elizabeth Klodas, MD, FACC, is a board-certified cardiologist with more than 15 years of experience treating patients with heart disease.

Klodas completed fellowships at both the Mayo Clinic and Johns Hopkins University. She specializes in noninvasive cardiac imaging, including stress testing, echocardiography, nuclear, CT, and MRI imaging. Klodas founded Preventive Cardiology Consultants and sees patients at her independent practice in Edina. She has led several patient education initiatives at the American College of Cardiology (ACC) and spearheaded the formation of ACC’s patient education website (www.cardiosmart.org). Klodas is a medical editor for webMD, and also serves as director of the Heart Disease Prevention Program at General Mills.

Peter Mills, MD, PhD, is a specialist in respiratory medicine who practices part time at the Whittington Hospital in London. He also co-founded and actively participates in nGageHealth as its CEO. nGageHealth creates patient engagement and health management solutions for health care providers to help them address the new challenges brought about by health care reform. Mills was part of the founding team at global health management consultancy vielife, acquired by CIGNA in 2006. He has also worked extensively with Minneapolis-based RedBrick Health, helping create some of RedBrick’s market-leading health management solutions.

William Nersesian, MD, MHA, is chief medical officer at Fairview Physician Associates, where he leads clinical quality efforts for a health care network of 2,000 providers. A board-certified pediatrician, he has served as the chairman of pediatrics at Fairview Southdale Hospital and as a member of Minnesota Community Measurement committees on patient satisfaction surveys and asthma. He is a member of a workgroup that, under the auspices of the Institute for Clinical Systems Improvement, studies ways to reduce avoidable hospital readmissions. His published works include those that address the impact of diabetes outpatient education and changing lifestyle behaviors.

Tomás D. Valdivia, MD, MS, an internist and medical informaticist with 20-plus years’ executive experience in health care, is co-founder and CEO of Minnesota-based Luminat and Valquist, LLC. Previously, Valdivia founded Advanced Informatics, a company providing evaluation technology used by health care organizations. As chief medical officer for Definity Health, he led development of consumer activation strategies and services. As president of Carol, he helped develop the first direct-to-consumer health services exchange, used by many large providers nationwide.

Pamela Van Zyl York, MPH, PhD, RD, LN, has been involved in health promotion programs for more than 20 years. She has worked in local public health agencies, including the Minnesota Department of Health (MDH), and has held faculty positions at the University of Minnesota and St. Catherine University. York has worked in the areas of nutrition and physical activity across the age span and currently works on prevention and management of chronic disease, health promotion for adults, healthy aging, and adult falls prevention at MDH. She also directs MDH’s implementation of the Stanford Chronic Disease Self-Management Program.

Mike Starnes has been the publisher at Minnesota Physician Publishing since 1986. His duties include the production of Medfax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.

Bruce Silcox Photography

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DR. FISCHER: I would like to see it go JULY 2013

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It’s going to require good communication that’s consumer friendly, timely, persistent, and specific to the patient’s needs.

DR. MILLS: When I ask a patient to do something, such as monitor their blood pressure or report back to me about side effects from a new medication, this is the first step along the road to being an engaged patient, being involved in care and decisions that are made about that care. Have a greater number of “touch points” between physician and patient over the course of a year. These interactions don’t have to be face-to-face.

MR. STARNES: What problems do physicians have in getting patients engaged?

DR. KLODAS: I think it’s doctors’ own education and it’s about time and money. No. 1 is education. I didn’t have training in engaging a patient. Plus, it always comes down to time and money. We don’t have enough time to sit and ask people how they live, where they are, what their personal goals are around their health.

It’s very hard to know how patients live, how their lives really are. One of the greatest losses in care has been the decline or disappearance of the house call. In two seconds after you walk into someone’s home, you know so much about where they’re coming from. You can’t possibly ascertain the same information when they’re sitting in a clinical setting in a chair outside of their environment, trying to describe their life to you. We don’t sometimes have a really good sense of where patients are, so we have a tough time meeting them where they live.

The other problem is money. Lifestyle-based disease is going to bankrupt our country.

Also, here’s almost a disincentive to engage a patient: I spend a lot of time talking to my patients about what they eat and counseling them on a personal plan. But when I submit for payment, the insurance company says the only way it could make my payment reflect the time I put into an appointment would be if I had prescribed medication. It enforces a paternalistic attitude on the part of the doctor: “Do this and I'll see you back in three weeks.”

DR. NERSESIAN: I don’t think society has the money resources, and doctors don’t have the

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time, to coach all the people who need coaching in better eating and getting rid of drugs and alcohol and more exercise and so forth. At FPA we have several health coaches.

One’s a nurse, one’s a kinesiologist, and one’s a registered dietitian. For over seven years we’ve coached people on healthy eating, and about 40 percent of our people lose weight.

That’s pretty good when you look at the literature. Even the ones who don’t lose weight often maintain their weight, or at least they feel better about themselves or are exercising more. We physicians have to educate ourselves on what’s necessary to assess patient motivation and to improve it. Then we have to hand off those patients to people who are, quite honestly, better than I am, and maybe better than you are, at motivating patients.

That’s their job. They’ve studied it, they’ve done it, and they have a lot of experience in it.

Quite honestly, from what I’ve learned in the last few years, although I considered myself a pretty good

talking about what we can do as physicians, it helps to ask families what their obstacles are: Financial? Psychological? We have a lot of children with mental health issues. We may identify them, but unfortunately, they may not be seen for six months. We don’t have availability in our hospital for mental health evaluations. Do families have transportation to the clinic? My role is to make insulin dose adjustments and educate the family about how to manage diabetes but also to identify obstacles so I can appropriately triage them to the right community services.

DR. VAN ZYL YORK: It is hard to have an engaged relationship with a health care provider when other stuff is in the way. They may be seeing a physician but insurance isn’t going to pay for it, or they couldn’t get the referral, or the last bill they got has never gotten paid.

MR. STARNES: How should health care literacy improve to create a more engaged patient?

DR. VAN ZYL YORK: There’s health literacy, and there’s health care literacy. Health care literacy is how to negotiate the system and make sure you get to where you need to

We have difficulty measuring patient engagement.

Pamela Van Zyl York, PhD

motivator as a physician I’m outclassed by some of the people who do this for a living.

MR. STARNES: What should we avoid in creating an engaged patient?

DR. NERSESIAN: In the past we told patients what to do; that’s not the key to patient engagement. They may have different motivations than we have. The key is to find out what motivates patients and to work with them to find common goals and common ground, so we can achieve their goals and our goals. Five of the top 10 causes of death—heart disease, cancer, strokes, accidents, diabetes—can be changed by altering lifestyle.

MR. STARNES: Are there reasons that people with every reason to be engaged aren’t?

DR. GANDRUD: There are a lot of obstacles. In

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go. You learn by the seat of your pants.

Increasingly, patient navigators help you figure out who to call and how to make this happen. We’ll probably see more of that because the health care system isn’t getting less complicated any time soon. Health literacy is a responsibility on both sides. We don’t communicate well in patient-friendly, consumer-friendly language, and that is something we need to pay better attention to.

DR. NERSESIAN: So far, we haven’t made the distinction between primary prevention, secondary prevention, and tertiary prevention. If I wait till I have heart failure and my cardiologist tells me to stop smoking or lose weight, that’s good, but that’s tertiary prevention. I might see a kid with a BMI of 33, and I try to tell him or an adult who needs a little more exercise to get on the ball; that’s sec-

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M I N N E S O T A ondary prevention.

MR. STARNES: What is the benefit of having a patient engagement measurement in the medical record?

DR. FISCHER: Defining patient engagement lets the patient identify what’s of value to them and lets them monitor and measure their progress. It also gives the practitioner an idea if the patient is making progress, and if not, it gives you an opportunity to change the plan.

DR. MILLS: A measure of patient engagement would help providers tailor the way they interact with their patients and the type of information they provide them. Rather than the trial-and-error approach we often use in engaging our patients in monitoring and managing their conditions, a finite measure could potentially streamline this process and lead to patients better managing their lifestyle and medical issues earlier.

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DR. GANDRUD: Disconnect between child and parent is hard to sum up with one number; disconnect can lead to issues in care.

MR. STARNES: How would we address patients who don’t want to be engaged, particularly if providers are going to penalized for this?

DR. NERSESIAN: If a patient is unmotivated, there is usually some reason. If they’ve failed in the past, the coach’s or provider’s job is to make sure they understand that they can be successful now. If the patient has other issues to deal with—divorce or their kid’s on drugs or failing school—those concerns need to be addressed before the patient wants to exercise more or lose weight.

MR. STARNES: One of the biggest hurdles that increased emphasis on patient engagement faces is convincing physicians that it’s worthwhile. Why are doctors hesitant to embrace this?

DR. GANDRUD: As a clinician, it’s tough to measure something when we feel we don’t have the resources to address deficiencies. We need

MR. STARNES: Could it be problematic to have a measure of patient engagement in the medical record?

DR. VAN ZYL YORK: We have difficulty measuring patient engagement. There’s the

Find out what motivates patients and work with them to find common goals.

William Nersesian, MD

Patient Activation Measure, but that’s a single number that is on a multidimensional scale. I can look at that number but not know what contributes to it. Also, the assumption we may make about where the patient is and what they’re willing to do based on that score may not be valid. It depends on when the score was done, and in what context. If I’m seeing that patient as a cardiologist, for example, and that patient is in a very different place than they were when that score was developed before a diagnosis, it may have no validity.

DR. VALDIVIA: The downside to the patient engagement score is its pigeonholing effect, which can backfire. If it labels somebody as not engaged, does that prevent us from engaging them? If they have a wonderful score, I may feel like I don’t need to do anything.

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resources to be able to address those things, both with our medical training and with health coaches and educators, social workers, mental health providers. The patient activation measure is just the starting point.

DR. VALDIVIA: Until we move down the path of beginning to pay ourselves for something other than piecework, there is going to be a continuous disincentive, especially when you think about the temporal disconnect between what we do today and the value that we’re going to reap from our actions as a system.

It’s not like tomorrow things get better and costs drop and roses bloom. One of the big issues is how do we further payment model shifts to allow us the time and the tools to do patient engagement.

DR. FISCHER: Providers are concerned about training. Who’s going to provide the training;

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are we all going to get the same training? Are we going to be out of our office, and does that mean decreased revenue? Will our staff need training? Tools are nice for implementing change, but who’s going to produce the tools? Who’s going to pay for them? Do we have enough time to spend with the patient?

And if measurements become a requirement, are we going to be spending too much time in front of the computer measuring patient measurements and doing electronic health records? Are we going to have quality time left with the patient?

DR. MILLS: With new regulations and reporting requirements being mandated for physicians, a potential challenge is keeping on top of all of the new things we have to do while remaining focused on the patient. Remunerating physicians based on outcomes is one key that will focus physicians on this area.

MR. STARNES: Patients still trust their doctor.

How can we leverage this to create a more engaged patient?

DR. NERSESIAN: Remove financial and transportation barriers.

DR. KLODAS: Patients need to feel that something comes of their being engaged. I try to get my patients with high blood pressure to buy their own blood pressure monitor and start checking their readings. It’s amazing how often that can change their medication regimen to something simpler.

It’s not just engagement for the sake of engagement, but having a goal around that engagement, that helps.

DR. FISCHER: We have to be able to reward the patient and the provider for accomplishments. If we make everything a penalty, patients are more likely to not be honest with their provider.

MR. STARNES: In order for patient engagement measures to work, what needs to be measured?

DR. NERSESIAN: What I’m looking for is something like an Apgar score of motivation.

An Apgar score is simple; all nurses and physicians learn it. A baby could have been delivered in Australia, and if I hear that he had Apgars of 7 and 8, it gives me a rough idea of how that delivery went. PAM or other measures just haven’t taken off yet. It took us a while to come up with the PHQ 9 as our general measure for depression in patients.

It’s kind of accepted in Minnesota now and Minnesota Community Measurement uses it.

Maybe PAM has the potential to do that, or maybe there’s another measure. There has to be something that’s simple to establish in

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patients that’s pretty universal and gets taught to those of us in the clinical field.

to motivate patients. So what is our reward system?

behavior inside a system, rather than from within, is probably not the best way to do it.

DR. VAN ZYL YORK: We have a problem reliably measuring motivation. A key difference between it and an Apgar score is that the Apgar measures health status. When you’re measuring motivation, you’re measuring potential. You’re also trying to determine what someone would be willing to do in the future. Anytime you ask people the hypothetical question, “Would you be willing to do this?” the correlation with what they actually do is generally pretty low, and it’s situational.

Motivation is only part of successful behavior change or maintenance. Also, when you’re looking at people who may be motivated, they are at different points in their life, different points in the social structure. All that is hard to reflect in a number.

DR. VAN ZYL YORK: One of the key questions is, how does that affect that trust relationship that patients have with providers or that people have with their employer? If you feel that your employer is just out to have you pay more of the money and them pay less and not keep the bargain that was made when you were employed, that may be motivating in some respects. But is it, over the long haul, going to decrease motivation when we look at incentives for performance or for maintenance of health?

DR. NERSESIAN: I agree. We make a distinction between intrinsic and extrinsic motivators. An extrinsic motivator might be that my 30th reunion is coming up and I want to fit in a dress I wore in high school. Or my employer is giving $20 a month so that I can join the health plan subsidizing my gym, so I will do that. I don’t think those things are bad because sometimes, that’s the hook that you get into a patient. But we’re looking for longterm, lifelong change, and I don’t think you get that with fitting in your dress for the reunion, because when the reunion’s over you’re back to square one. This is what we, as physicians, were not trained in during medical school. I’d say, “Why don’t you stop smoking? You don’t want to get lung cancer, do you?” But how many 20year-olds are thinking about lung cancer? They’re thinking, “When I’m 70, I’m going to die from something.” I wouldn’t think to ask them, “When you play softball, wouldn’t you like to have a little more speed running around the bases or a little better agility?”

And they think, “Gee, I never thought

DR. KLODAS: Motivation varies second to second. So I don’t know how you could possibly quantify it and enter it in a chart as a number.

MR. STARNES: Who should be involved in determining what factors go into a measure of patient engagement?

MR. STARNES: Should employers be involved in this type of work at all?

DR. FISCHER: It would be really helpful for employers to have the same message that physicians and insurance companies give to patients. Having health as a company value is important too. I’ve had patients that are losing weight because the company has decided that it, as a whole, is going to lose 1,000 pounds

DR. VALDIVIA: Developing a score will require a tremendous amount of input from the academic community. Think about what we’ve learned about things that are simpler to measure, like blood pressure; we just recently changed the limits on blood pressure for diabetes. We are learning more and more about how to use even those measures that have been around for many years, like blood pressure. We are a long way from being able to understand patient engagement.

DR. VAN ZYL YORK: I wonder whether that is necessarily putting money in the right place.

I think we need to do a lot more research about what sort of factors, programs, services, what sort of environment, help people move in directions that are in their best interest. We need to understand some of those things before we can measure them. Using something like the patient activation measure in looking at the outcome of some of those programs may be helpful, but it’s multidimensional. We’re going to have to look at this in a more complex way because humans are complex organisms. What characteristics make something work for one person and not for another?

DR. FISCHER: What is the reward system for the patient? That’s what we have to look at.

Financial reward might be part of it, but I don’t think that’s the thing that’s really going

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We work a lot with family dynamics to improve patient engagement.

Laura Gandrud, MD

and now employees are walking at lunch and exchanging healthy recipes. I don’t know that they would have done that on their own, but as a group, they’re willing to participate.

DR. KLODAS: The big advantage of an employer is the ability to create a village. It’s your family for eight hours of every day, five days a week. That’s your support system, and the company can choose what foods are in the cafeteria and what activities are promoted at break time. It’s a huge opportunity.

MR. STARNES: Remembering the work that went into developing utilization review and how that went into best practice guidelines, could we apply any of that to patient engagement?

DR. VALDIVIA: Absolutely. There were important lessons learned. One of them is that trying to apply rules from the outside to control

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about that.” That’s intrinsic motivation.

MR. STARNES: How can technology be used to facilitate patient engagement?

DR. NERSESIAN: The top-selling apps in this country have to do with calorie counts, exercise, weight loss, and fitness kinds of things.

There are apps used to manage arthritis with a picture of a guy on the screen. You touch those places that hurt this morning, what hurt tonight, and at the end of the month, you show it to your rheumatologist and your rheumatologist has a good idea where most of your aches and pains were. There are fairly simple apps that could be used to help people keep track of their exercise and eating.

DR. GANDRUD: There have been different meter designs for patients with diabetes,

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M I N N E S O T A particularly children, which give the patient the ability to use a video game if they test their blood sugar at the appropriate time.

This links rewards or the removal of rewards to behaviors that you want to encourage.

Technology could be used in that way.

DR. MILLS: Email is a very effective way of maintaining a connection with patients, especially when following up after an office visit. There are some concerns around the security of email, so the next natural step is to use secure messaging via a designated HIPAA-compliant communications portal.

Encouraging patients to track specific health metrics via phone or online is a great way of making them active participants in ongoing management of conditions. It also allows us as physicians to get a greater and more tangible insight into how well their condition is being managed and what impact it is having on their day-to-day life.

MR. STARNES: Do we run into issues when people don’t have access to technology?

DR. VAN ZYL YORK: We run into that a lot, particularly when you’re trying to lead people to reliable health information as opposed to less reliable health informa-

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MR. STARNES: How can clinic patient portals help?

MR. STARNES: What is the best role that a health plan can play in patient engagement?

DR. MILLS: They certainly have a role, but we should not see them as a panacea for patient engagement. A well-designed portal can help individuals track certain elements of their health and can be an excellent conduit to establish an ongoing dialog between physician and patient outside the office environment. In addition, the data an individual patient can provide can also help a physician better manage their health issues to drive better outcomes.

DR. FISCHER: It would be really nice to see all the stakeholders get together on a task force and collaboratively work together on how to share this information. It seems like different pods are trying to come up with information and they’re not sharing it, or it’s not the same information, and that leads to more patient confusion and more cost.

DR. NERSESIAN: My patients have MyChart on Epic so they can see the results of their tests. A lot of these technologies will work if they get down to the personal level. If you’re a heart failure patient, your scale can notify your doctor if you gain more than two pounds in a day. In this country within a couple years, everyone’s going to have a smartphone. Blood pressure cuffs were developed that plug into an Apple iPhone. The FDA went to Apple and said, we’re going to regulate

An engaged patient has a better quality of life.

Elizabeth Klodas, MD

tion. We’ve done some partnership work with public libraries by telling people that they can access information there. But we need to not overestimate the availability of technological means although I think that’s going to change. We’ll be seeing more and more availability of those sorts of things. When we talk in some of our workshops about medication management and ask, how do you remember to take your medication on time, the one that always comes up—and is when you see a lot of light bulbs go on—is using your cell phone to set an alarm to remind you when it’s time to take medication or do something else.

DR. MILLS: The telephone is a great tool for checking in with patients, making sure they understand instructions or that they’re not experiencing any undue side effects from medications.

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this as a medical device, and the last thing Apple wants is regulation from the Food and Drug Administration, so they backed off from it.

DR. VAN ZYL YORK: Evaluation is key. Some weight loss apps do work for some people or may work for a period of time. But we need to seriously consider what is cost-effective and who it’s effective for. There is some great informational work being done by the CDC, the Text4baby Project for expectant mothers.

The CDC sends moms texts on a regular basis with health information and reminders.

That has been shown to be fairly effective in having people follow through on needed health behaviors. We need to not assume that all of these will work, and to determine the best way to design them.

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DR. NERSESIAN: It may sound inflammatory, but I think health plans can do a lot more. I think they support wellness in theory more than they do in practice. There are some good things that have been done, like promotion to get to the gym. Some plans have health coaches over the phone, but to me they’re so far removed from the patient and the patient’s doctor and providers that it’s not optimal. Some of it comes across as window dressing. Whether it’s the employer or the health plan, there is some conflict of interest or at least dual interest. They want to keep more of their money and the employer wants you to be healthy so you don’t miss work, and that’s okay. I would just like to see a win/win situation or maybe a win/win/win situation. There are certain interventions that benefit the health plan, that benefit your employer, and also benefit you, and a case must be made for that. If it looks like it’s purely in the interest of the employer or the health plan or just the patient, the other parties won’t buy into it.

DR. KLODAS: Health plans are critical. They have all the data. They know where you live, they know what drugs you take, they know where you got them filled, they know how often you got them filled, they know how much you weigh, they know where you work.

I mean, they know everything about you.

That’s a little scary, but it’s also a tremendous opportunity to influence behavior, and health plans can be very creative. Humana has this program called Humana Vitality that’s a partnership between Humana and Wal-Mart. If a person goes with their Humana Vitality card and they buy apples, they get points on their Vitality card and those points can be used for stuff. If they buy Cheetos, nothing happens.

DR. VALDIVIA: That’s a great example of incentivising behavior without interfering in on-the-ground activities. How are they going to reward us for focusing on population health and managing and engaging patients?

The other is changing benefit models; in one of the European countries, you can sign up

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M I N N E S O T A for a health plan for 10 years. Suddenly, the dynamic changes. There’s a different incentive, both for the provider and for the insurance company, to put resources into different segments of the population that today they have no interest in doing from a business standpoint.

DR. VAN ZYL YORK: One of the key points in terms of that short-term vs. long-term view is a message from health plans that they’re trying to help you do things that are going to be in your long-term best interest in terms of your health. That’s what shapes cultural norms; it is no longer a cultural norm that everybody smokes. It will soon cease to be a cultural norm that we eat some of those things that we shouldn’t be eating, or that we don’t walk every day or that our employer doesn’t provide the opportunity to walk on company grounds. That shapes outcomes for everybody, regardless of which health plan you’re with and whether you switch plans every three years. As those norms impinge on people, it has a positive outcome.

MR. STARNES: How could these initiatives be coordinated?

DR. KLODAS: There are so many things we could try to improve about people’s lives, but maybe the thing to coordinate around is prediabetes. Pick something that everybody agrees is what we’re going to engage around at the payer level, at the employer level, at the care level. Pick one problem and address it in a coordinated fashion. Otherwise you get stuck with multiple inputs about all these different diseases.

It’s overwhelming, and when you’re overwhelmed, you give up.

DR. MILLS: The ideal scenario would be a completely coordinated approach. A first step along this road would be sharing of data from employer and health plan initiatives so that it is accessible to providers to help them proactively manage their populations. To do this we are going to have to move from “closed” systems to ones with APIs (Application Programming Interfaces) that will allow patients to easily share and connect appropriate data.

MR. STARNES: How are we going to finance increased patient engagement?

DR. FISCHER: That’s the toughest question we have here today. Currently, I think everybody in the health care chain is going to have to bear some of the cost. I like Liz’s idea of being creative with it, because that’s what can actually move progress.

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DR. VALDIVIA: This is a great question because the system is going to respond to this as a key input and change on that basis. I think you break the question down into, is this new money or is this existing money?

We’re learning we’re not tolerating the nearly $3 trillion spent on health care in this country, so it’s probably not new money going to the system. So if it’s not new money, then it’s existing money. The next question is, is it short-term repayment, or are we going to say, well gosh, we’re going to have a windfall in 50 years so let’s invest the money now and we’ll repay ourselves in the future. I don’t think that’s going to work. I think somewhere we’re going to have shift money to support this, and it’s going to have to pay off in the short term. Our only way to get there is to change the payment model away from feefor-service to something that we can use to invest in these short-term activities and be repaid for them.

financial incentives to do the right thing, the truth is that if a patient-centric approach to care is to be universally adopted, there needs to be a reason for physicians to get involved.

DR. NERSESIAN: Can state and federal reform issues help? I don’t think we wait for government or wait for a lot of dollars. Honestly, as a pediatrician, how hard can I promote breast-feeding if a nursing mother doesn’t have a place to go and pump? Most of my moms were back to work in a month. How many women stayed out more than a month when they had their babies? Six weeks at most. Otherwise, you’re probably out of a job. And yet, how many places have a good place to pump at work and a refrigerator to store the pumped milk? Low-key stuff. I think we’re the solution.

MR. STARNES: How could existing stakeholders work together to create this funding?

DR. VALDIVIA: Big challenges exist today because of the way we finance health

We are a long way from being able to understand patient engagement.

Tomás Valdivia, MD

DR. MILLS: There are two elements to financing improved patient engagement. The first is the purchase of systems that facilitate the process. A technological solution that sits alongside the electronic health record and facilitates patient data capture and out-ofoffice communication, although not absolutely necessary, is desirable if one is serious about making a step change in patient engagement and participation in decisionmaking. If CMS and other payers are serious about improving outcomes through better engagement, then it would seem appropriate to subsidize or have some financing options available for the purchase of such systems.

The second is providing financial incentives, or a mechanism by which engagement activities can be billed for, so that physicians can be remunerated for the extra time they may need to spend in new activities. Although in the ideal world we shouldn’t need

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care. One of the challenges from a financial standpoint is the plan sponsor, whether it’s the employer or whether that’s the health plan that doesn’t have an incentive to invest in people that are well today. That’s one of the big disconnects in the system that doesn’t allow us to fund these kinds of activities.

Sometimes there are windfalls like the tobacco suit. We’re able to invest those kinds of dollars, but those don’t come along very often. Another disconnect is the payment model that rewards us for doing things today.

It’s not a health system, it’s a disease cottage industry, and we’re paid that way and it’s creating that problem. Until we address the fundamental issue of what’s shaping us, and that is how we get paid, that’s a disconnect as well. I’m sorry to bring more problems than solutions to the table, but I think fundamentally, until we address our financing model of paying a year at a time as opposed to over a

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M I N N E S O T A longer time frame, and, ultimately, the way we fund our delivery system in global payment versions versus fee-for-service, we’ll have a difficult time paying for these things.

DR.GANDRUD: I’m in agreement.

DR. VAN ZYL YORK: One of the key pieces in looking at that payment system is that our payment system now is organized primarily around doctors and hospitals, and we need a payment system that looks at the broader health care services that are provided. Those broader services currently do not have adequate financial support, so we don’t use those services, and they could make a difference. We have the illusion that doing this is somehow going to save us money. I’m not sure it will.

DR. KLODAS: What are we paying for? I don’t know that we know exactly what it is that we’re going to buy with any money that we throw at this. What’s the outcome? If the outcome is people buying oranges, well, people are going to bear that cost. There

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a Cheetos-like snack that happens to be made out of pinto beans. It’s just as portable and it’s flavored with less salt. Have you made a seismic change in care? No. But you’ve stopped maybe 100,000 people from eating Cheetos that day. Wow. That’s a huge thing if you look at it from a population perspective. If you make a sandwich with 100 fewer milligrams of sodium? This is where Subway and companies can be part of the solution. One hundred milligrams of sodium is nothing from an individual perspective, but Subway has 30 million individual unique customers a week. How many truckloads of salt is that across a population? It’s huge. So there are things that can be done for which there’s just a tremendous amount of opportunity.

DR. VALDIVIA: Private enterprise has to play a role. We don’t have as much capital as we used to. We used to have the luxury of fat, juicy margins, and what we did with those margins was to fund more daVinci machines and

Data show that an engaged patient has better outcomes and at a lower cost.

Vivi-Ann Fischer, DC

might be some points or something, but I guess I’m not sure.

MR. STARNES: Is there is a role that private enterprise can play in funding patient engagement?

DR. KLODAS: Private enterprise can make advice more actionable. We spend a lot of time educating people, we spend a lot of time making them feel really bad about their blood tests—and then they go home and try to do something and it fails, because ultimately they go home and back to the environment where they were failing before, and they don’t know what to do. There’s a huge gap between knowing and doing. There’s tremendous opportunity for that gap to be filled by individuals or companies that see something that could actually help, is not tremendously expensive, and is maybe a shift in spend. Instead of buying Cheetos, you buy

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maybe some Gamma Knives and other things with that capital. I don’t know that we’re going to have the same luxury of excess capital. I don’t think we have any choice but to partner with private enterprise to get some of this stuff done. Technology is one of the easiest and simplest examples, like apps to diagnose skin diseases. Technology is here and it’s going to happen, so I would suggest you get engaged and partner with organizations and private enterprise because they’re going to do this whether we want it or not.

So let’s guide it and get involved in it.

MR. STARNES: How will we know that patient engagement is working?

DR. GANDRUD: Quality of life measures, quality of care, efficiency of care, cost of care— all those measures would be helpful in defining our success.

DR. MILLS: We will know because our patients will be more satisfied, the health-related out-

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comes of our patients will improve, and the cost of delivering care will not be rising at the rate it has over the last decade.

DR. VALDIVIA: We must understand what’s effective and what isn’t. It’s going to take an extraordinary amount of research to understand how this all works and what role it plays.

DR. VAN ZYL YORK: Knowing whether patient engagement is working or not requires asking the patient. There were comments made earlier about the information that advertisers and companies have about us as consumers.

We can have some of that sort of information about people as health care consumers and across the whole spectrum of health care activities. We have to be willing to ask the questions to figure out what are the right questions. Just because you have data doesn’t necessarily mean that you have information.

How do they relate? A lot of those are research questions about what it is that makes a difference. Ultimately, there is a sense of “you either know it’s there or you don’t” when you ask a patient how their health care system is working for them, if they are getting what they need, and how they are feeling about it. If you’re asking them in a safe environment where there is nothing at risk for them, I think we can learn a lot of information. But we have to be willing to explore, to ask questions, and to do the necessary research.

DR. FISCHER: We’re going to know that patient engagement is working when we see an increase in healthy behavior as reported at the annual physicals, a reduction in diabetes, and a reduction in diabetes relapse rates. I’m hoping that we will be able to stop some of these disease processes earlier, when people are 10 to 20 years old, and not wait until they’re 60 and then try to change their cardiac problems.

DR. NERSESIAN: When the average person thinks, “What I can do for my own lifestyle to enhance my health, and how can I work with others, make use of community resources, make use of people with expertise and form those partnerships?”; when employers and government and health payers are all together—we may not agree on everything but when we agree on a lot of very basic facts—then we will have reached the point where this will be successful.

DR. KLODAS: My measure is pretty simple, but aspirational: that the colors on the CDC map of obesity start to reverse.

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PROFESSIONAL

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Modern family medicine

T

he past decade has witnessed an evolution in family medicine. The model of care, reimbursement, records, even the relationship between a doctor and patient— all have undergone a transformation. Yet, despite the numerous changes, both good and not so good, the family practice or primary care model continues to prove its worth and value.

After all, your primary care doctor is typically the only doctor who has the whole picture of your health. He knows that pain in your chest is likely not a heart attack, but rather another bout of acid indigestion.

She’s monitored your weight and your diabetes risk. He’s measured your progress trying to “exercise more.” And she’s seen all of your children.

This article looks at the field of family medicine through the lens of the changing medical landscape, focusing on team care, electronic health records, the patient-doctor relationship, models of reimbursement, and family care vs. specialty care.

U P D AT E :

An ongoing evolution in care

By James M. Welters MD, FAAFP

A team dedicated to the patient

As primary care doctors, we recognize that it is just not possible anymore for one physician to provide all the care necessary to a patient in a 15-minute office visit. Today’s patients need more care, have more questions, and, essentially, want more than a quick check-up.

This means that, more than ever, the entire care team, from the front desk to the back, must be focused on the patient and all aspects of his or her health.

For example, if a patient comes into our clinic complaining of cold symptoms, the physician will address that need while also checking a program

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in our electronic health record called the Patient Manager.

This program alerts us to any standing orders like a needed mammogram or colonoscopy.

A nurse may perform these tests or discuss scheduling them.

The idea is to make the most use of the limited time we have with our patients.

Similarly, if a patient goes to the lab for a simple blood draw, we will look in Patient Manager to see if there are any other tests we can do at that time. Maybe the patient needs his cholesterol, PSA, or blood sugar checked, too. The resulting efficiency is helpful both to the clinic and to the patient, who doesn’t have to make another appointment and another trip to the doctor just for labs.

This process has helped increase our quality of care and patient satisfaction quite a bit.

In fact just this fall, Consumer Reports Magazine rated Northwest Family Physicians “The Best in Minnesota” in terms of cost and quality.

Northwest beat out more than 500 other clinics in the state. I believe efficiencies like these play a big role in our success.

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At Northwest Family Physicians we went electronic in 2004.

Today I can’t imagine going back to paper records. We used to have a full-time employee whose job it was to wander around the clinic to find records. We had another person who spent the day copying records. I can remember being on call and not having access to charts. Today I can access a patient’s records from anywhere at any time. It’s really quite an advancement for health care.

Computers and technology have also added to the “con-

sumerization” of health care, or this patient-driven desire to have access to health care wherever and whenever the patient wants. We’re seeing more urgent care clinics, virtual visit options, and weekend hours.

Patients can email us questions and get an answer without even having to come to the clinic.

This type of consumer-focused care has come a long way. A decade ago a colleague was booking her patients six to eight weeks out. These days, patients have many other options—and if you aren’t willing to fit into their schedule, they will go somewhere else.

Patient-doctor relationship

Computer technology and the easy availability of information and resources online have also altered the patient-doctor relationship, as patients increasingly come to appointments with a wealth of knowledge.

This development has both good and bad implications for communication with our patients.

Sometimes patients are convinced of one diagnosis, but it’s not the right one. For example, recently celiac disease has received a fair amount of attention. While increasing in frequency, it is still not common.

Often the symptoms are vague and could easily be caused by any number of diseases.

Patients frequently come into the office convinced that they need to be evaluated for celiac disease.

On the flip side, there are times when patients’ self-diagnoses are accurate. In my practice I have also dealt with many “second-party” diagnoses.

The stereotype is the out-oftown child who is convinced his parent has Alzheimer’s or other condition, when the patient is dealing strictly with normal memory loss associated with aging. As physicians, we need to listen to the person’s input and research, but use our expertise to make the final decision.

I have found the Internet to be useful in cases where a patient does the basic research on a condition and comes pre-

Changes in reimbursement

The dominant reimbursement model remains fee-for-service.

Criticism of this model is largely that it encourages needless tests and treatments.

Increasingly, however, medical groups are adopting new models that focus more on the quality of care and results— for example, paying more to a provider who improves the condition of a patient than to a provider whose treatment is ineffective or even makes the condition worse.

At Northwest Family Physicians, we have our own quality control program. It is an all-staff bonus program with a simple method: If we all hit our targets, everyone gets a bonus; if we don’t hit our goals, no one is rewarded. The program helps to foster a team environment that is effective in health care.

Primary care doctor or specialist?

Over the past few decades, patients have sought the care of specialists rather than depending on their primary care doctor first. The United States is really an anomaly compared with other countries.

Two-thirds of our health care providers are specialists while one-third are primary care doctors. That ratio is flipped in most other countries.

Consider again the patient with chest pain. Let’s say he went to his cardiologist to get checked out, thinking that he was having a heart attack. Even in patients with cardiac risk factors, most of the time chest pain is not caused by heart disease in the outpatient setting.

That patient would be right just

More than ever, the entire care team, from the front desk to the back, must be focused on the patient and all aspects of his or her health. one out of eight times, meaning that his pain is likely something else—something his primary care doctor would have been able to diagnose, saving the patient much anxiety, and at a much lower cost.

There is an increasing demand for primary care physicians, but not enough of us around. According to the Association of American Medical Colleges, the U.S. currently is short about 16,000 primary care doctors. That leaves about 55 million people without a doctor or struggling to find one.

One of the main reasons for the shortage is that we’re getting older. I’ve been in practice for 22 years and many of my colleagues are in the same boat.

According to a 2012 Physicians Foundation survey, nearly half of the approximately 830,000 doctors in the U.S. are over 50 and approaching retirement.

They are also seeing fewer patients than they did in 2008.

Another element of the equation is pay. A specialist may make two to three times as much as a primary care physician. Many medical school students graduate $250,000 in debt. No wonder young doctors are choosing procedural specialties like cardiology or orthopedic surgery, where they can earn much more, or other fields like dermatology or radiology that purportedly offer a better lifestyle. In a recent study published in the Journal of the American Medical Association, researchers asked more than 50,000 doctors training in internal medicine about their career plans. The majority of the respondents planned on becoming subspecialists.

In recognition of the value of primary care, efforts are under way to reverse this trend.

For example: • Medical students are being exposed to primary care earlier and encouraged to pursue

residencies, especially at schools like the University of Minnesota, which traditionally have graduated more doctors in these fields.

• Loan repayment programs exist for students willing to serve in underserved areas.

• Reimbursement is being increased for primary care doctors. As we move to new payment schemes focused on quality and cost effectiveness, like accountable care organizations, compensation for primary care doctors likely will increase further.

provides quality care at an affordable price. The primary care physician has a perspective on the overall health and wellbeing of a patient and tracks that person’s care from diagnosis and treatment to recovery and beyond.

I have enjoyed being a primary care physician for more than 20 years now. I may work more hours and get paid less than some specialties, but I am rewarded in the faces of families I’ve come to know and those who have come to call me their doctor.

James M. Welters, MD, FAAFP, has been practicing medicine for 22 years and has been with Northwest Family Physicians since 1991. Northwest Family Physicians is a group with 15 doctors, three clinics, and two urgent care centers in the northwest suburbs of the Twin Cities.

The future of family medicine

I believe health care reform has brought the issue of primary care to the forefront of the discussion. I think it needs to be the foundation of all care, as it

Telephone Equipment Distribution (TED) Program

pared to ask advanced questions. For example, a patient diagnosed with a low thyroid condition may have learned the symptoms of this condition and is ready to ask more detailed, specific questions about treatment and limitations. Or a patient with this condition may realize she needs her prescription altered. She may not need to be seen, and the entire request can be handled by email or over the phone.

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability?

If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify.

Please contact us, or have your patients call directly, for more information.

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services JULY 2013

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D E R M AT O L O G Y

A

n itchy scalp can be a persistent condition and one that is often difficult to treat. Some of the more common causes of scalp pruritus, depending on the age of the patient, are seborrheic dermatitis, psoriasis, tinea capitis, and allergic contact dermatitis.

Seborrheic dermatitis

Seborrheic dermatitis is the most common scalp disorder, affecting 2 percent to 5 percent of the population. There are two incident peaks with seborrheic dermatitis: The first occurs as cradle cap in infants 0–3 months of age, and a second peak occurs in people 40–70 years of age.

The lipophilic yeast Pityrosporum ovale may play a role in the etiology of adult seborrheic dermatitis.

Dandruff is the most common form of seborrheic dermatitis, with dry, flaky, noninflammatory desquamation. It is easily treated by frequent shampooing, and over-the-counter medicated shampoos are helpful.

Classic seborrheic dermatitis is defined as an erythematous,

Scalp disorders Treatment and management update

By Kristina Shaffer, MD, MPH

raised scaling disorder on the sebum-rich areas of the scalp, face, and trunk. The scalp appearance can vary from mild, patchy scaling to widespread thick, greasy, yellow adherent crusts with an erythematous scalp. Plaques often have a reddish-yellow to yellowish hue.

Other affected body areas may help with the diagnosis of seborrheic dermatitis, including dermatitis in the external ear canals, eyebrows, eyelids, and beard and around the nose and smile lines. The condition tends to wax and wane in its severity, and borders of lesions are often ill defined. Because seborrheic dermatitis is not common in preadolescent children, one should have a high index of suspicion for a fungal infection in this age group.

Common treatments for seborrheic dermatitis include medicated shampoos and topical corticosteroids. Medicated shampoos should contain ingredients targeting superficial yeast, including ketoconazole, selenium sulfide, zinc pyrithione, and tar or keratolytics to break down scale, including salicylic acid. Ideally, these shampoos should be used daily initially and left lathered onto the scalp for at least five minutes. Once control is obtained, they can be used once or twice weekly as maintenance.

Some patients will have better results if they alternate shampoos containing different active ingredients. Anti-inflammatory, low- to mid-potency topical corticosteroids can also be extremely helpful and come in foam, solutions, oils, and

Lake Region Healthcare is located in a magnificent, rural, and family-friendly setting in Minnesota lakes country where we aim to be the state’s preeminent regional health care partner.

Current opportunities including competitive salary and benefit packages available for BE/BC physicians are: • Dermatologist • Family Medicine • Emergency Medicine • Internal Medicine

• Orthopedic Surgeon • Pediatrics • Psychiatrist • Psychiatric NP or PA

For more information contact John D. Peterson, Physician Recruiter jdpeterson@lrhc.org (218) 736-8090

Psoriasis

Psoriasis affects 2.1 percent of the U.S. population, of all ages, genders, and ethnicities. It is an immunologic, genetic disease

St.Health Cloud VA Care System

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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.

shampoo delivery systems, suited to the patient’s preference and frequency of shampooing.

Initially these products should be used daily, but for the majority of seborrheic dermatitis cases, they can be tapered to maintenance regimens or as-needed use after two weeks.

Seborrheic dermatitis can be more severe and difficult to treat in patients with Parkinson’s disease and other neurologic conditions, HIV, and/or poorly controlled diabetes mellitus. It is very important to determine your patient’s hair care practices because compliance is the key to successful treatment. It is also important to refer to a dermatologist when the dermatitis is recalcitrant to medicated shampoos and topical corticosteroids, if focal hemorrhage is present (especially in newborns), or if widespread erosions or weeping lesions occur.

Brainerd | Montevideo | Alexandria

Opportunities for full-time and part-time staff are available in the following positions: • Associate Director, Primary & Specialty Medicine (IM)

• Medical Director, Extended Care & Rehab (Geriatrics)

• Dermatologist

• Pain Specialist

• Geriatrician/Hospice/ Palliative Care

• Psychiatrist

• Internal Medicine/ Family Practice

• Urgent Care Physician (IM/FP/ER) Applicants must be BE/BC.

US Citizenship required or candidates must have proper authorization to work in the US. Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible recruitment bonus. EEO Employer.

Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.

712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424 Lake Region Healthcare is an Equal Opportunity Employer. EOE

For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

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MINNESOTA PHYSICIAN JULY 2013

mediated by T-cells. The scalp is the most common site affected by psoriasis in both children and adults, with over 80 percent of psoriatic patients experiencing scalp involvement at some point in their disease.

Scalp psoriasis can be very pruritic, and the visibility of scalp scaling can be very distressing to patients. With severe scalp psoriasis, there can be increased hair shedding and even some alopecia. In contrast to seborrheic dermatitis, psoriatic scalp plaques are usually well demarcated and discrete.

Favorite scalp locations of psoriasis include behind the ears, the occipital scalp, and the frontal scalp, where the psoriasis may extend beyond the hairline onto the forehead. Plaques are salmon pink and covered with silvery white scale that may be thick and adherent. With removal of the scale, one can see pinpoint bleeding (Auspitz sign).

Clues aiding the diagnosis of psoriasis include involvement of skin on the body, especially the elbows, knees, top of the gluteal crease, and nails. Furthermore,

Seborrheic dermatitis can be more severe and difficult to treat in patients with Parkinson’s disease and other neurologic conditions, HIV, and/or poorly controlled diabetes mellitus. scalp psoriasis often will not respond to monotherapy or typical seborrheic dermatitis treatments. Because psoriasis is a chronic disease, long-term therapies are required, and the extent and severity of the disease will determine the appropriate treatments. We now also know that even with limited skin involvement, psoriasis increases the risk of cardiovascular disease, even in younger patients.

Therefore, screening for other risk factors and counseling your patients about cardiovascular disease are important in treating this patient population.

Specifically for scalp treatment of psoriasis, keratolytic agents and oil-based products are often needed to break down the thick scale. Once the scale is addressed, high-potency topical

corticosteroids in conjunction with vitamin D3 analogs can help many patients. One approach to minimize the risk of scalp skin atrophy and lessen tachyphylaxis to the corticosteroids is the use of sequential therapy. First described by John Koo, MD, of the University of California San Francisco, sequential therapy involves initial twice-daily use of both highpotency topical steroids and the topical vitamin D3 analog until control is obtained. Then the therapy indicates using the topical vitamin D3 analog alone twice daily Monday through Friday, and adding the highpotency topical steroid back into the regimen on Saturdays and Sundays.

Another addition to or replacement for topical thera-

pies for psoriasis is Excimer laser treatments on hair-bearing areas. Laser treatments typically are done twice a week for six to eight weeks, with a resultant remission lasting up to six months.

Because scalp psoriasis can be recalcitrant to topical therapies, a referral to a dermatologist for systemic treatment is warranted if a patient fails to respond to topical treatments or there is doubt about the diagnosis. Finally, the National Psoriasis Foundation (www.psoriasis .org) is a great resource for both patients and physicians.

Tinea capitis

Tinea capitis, or ringworm, is a fungal infection of the scalp and the hair follicles, and may or may not be itchy. Prevalence in the U.S. is generally estimated to be between 3 percent and 8 percent of the pediatric population, with carriers occurring in as many as 34 percent of household contacts of infected persons. Most cases occur in children between the ages of 3 and SCALP DISORDERS to page 36

Physician Practice Opportunities Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership.

Currently we are seeking to add the following specialists: General Surgery

Pediatrics

Orthopedic Surgery

Obstetrics/Gynecology

Radiology/Oncology

Family Practice

Internal Medicine

Emergency Medicine

Psychiatry

Ophthalmology Optometry

Live in the relaxed lake country of Mille Lacs and practice medicine where you will make a difference.

We’re looking for a Family Physician to join us at Mille Lacs Health System in Onamia, Minnesota.

Loan forgiveness options – J-1Visas considered.

Contact: Fern Gershone: fgershone@mlhealth.org or Dr. Tom Bracken: tbracken@mlhealth.org

For details on these practice opportunities go to http://www.avera.org/marshall/physicians/ For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691.

Dave.Dertien@avera.org Avera Marshall Regional Medical Center 300 S. Bruce St. Marshall, MN 56258

www.averamarshall.org

Caring for body, mind and spirit.

Onamia, MN • mlhealth.org • 877 -535-3154 7 FAMILY PHYSICIANS • 9 PAs • CRITICAL ACCESS HOSPITAL ER STAFFED 24/7 • ATTACHED GERIATRIC UNIT & LTC FACILITY • 4 CLINICS

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Interpreting from page 12 variety of sources to determine which ethical principles apply in health care interpreting. The result is the widely available and virtually universally accepted Code of Ethics, Standards of Practice, and Standards for Training documents that have provided tremendous guidance in the field of interpreting.

The Code of Ethics instructs interpreters to faithfully and wisely implement principles of accuracy, confidentiality, impartiality, protocol, professionalism, respect, cultural competency, and patient advocacy. Without this fundamental guide, interpreters have tended to define their function according to their own particular understanding of their purpose in the health care encounter, leaving providers and patients often frustrated, confused, and dangerously misled. Standards of Practice further refines expectations for successful interpreting to ensure best outcomes for clients. The Standards of Training are intended to provide similar guidance with respect to the key

Minnesota is among a growing number of states deeply concerned about a lack of standards for the employment of spoken language interpreters in health care. components of a legitimate program that trains bilinguals to work effectively and competently in the field of health care interpreting. Such documents are perhaps the best evidence yet that spoken language interpreting is evolving as a profession.

National certification efforts move ahead

Meanwhile, two organizations have begun offering certification testing for spoken language interpreters in the field of health care. Similar exams have existed for quite some time in the legal interpreting field, and there is growing acceptance that certification exams are a natural step toward improvements in interpreter professionalism in health care as well.

As of May 2013, the Certification Commission for

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MINNESOTA PHYSICIAN JULY 2013

Healthcare Interpreters (CCHI) offers a bilingual certification exam in Spanish, Arabic, and Mandarin, and the National Board of Certification for Medical Interpreters (NBCMI) certifies interpreters in Spanish, Russian, Mandarin, and Cantonese.

Exams for other languages are currently in development at both organizations. These certification exams evaluate not just knowledge of medical terminology, but also interpreting skills and accuracy. They also require continuing education to maintain certification status, so interpreters who have earned this credential will continue to improve their skills and general knowledge.

Interpreting instruction programs in Minnesota

Minnesota is a leader in postsecondary health-care interpreter training. The University of Minnesota’s Twin Cities campus offers an academic certificate in interpreting with specializations in medical interpreting, legal interpreting, and educational interpreting. Century College, in White Bear Lake, offers training at the associate’s degree level. Both programs train speakers of any language pair, so interpreters who speak English and any other language can distinguish themselves from their peers in what is often a highly competitive employment field.

The experience of interpreters for the deaf and hard of hearing has shown that a college degree should be the near-term goal to ensure that spoken language interpreters possess the cognitive skills, social and emotional maturity, and critical awareness of cultural norms and differences required to serve LEP clients and health care practitioners competently.

Working interpreters who seek to add a credential to their

resume, as well as undergraduate and graduate students with bilingual skills, take courses to train to work as interpreters.

The result is that Minnesota’s pool of highly skilled bilinguals with specialized knowledge in a variety of subject areas will continue to grow. A number of so-called “heritage learners” (i.e., children of immigrants who grew up often interpreting informally for family members in the absence of a professional, trained interpreter) have developed a genuine interest in properly providing this valuable service to the LEP community they know so intimately.

Better outcomes for Minnesota

Organizations in Minnesota that advocate for improved training and better working conditions for interpreters include the Interpreting Stakeholder Group (ISG) and the Upper Midwest Translators and Interpreters Association (UMTIA). ISG is a coalition of hospitals, clinics, insurers, educational institutions, interpreting agencies, and working interpreters. UMTIA is a regional branch of the American Translators Association, a national organization of professionals in the language services industries.

While these two organizations represent very different parts of the language services delivery apparatus in the state, they have reached the common recognition that reform is necessary to improve compliance with Title VI in Minnesota, and they are committed to making these reforms together. These two bodies have united to craft registry language so that in the near term, interpreter qualifications and credentials will at last be reliable and verifiable in the state of Minnesota. Interpreters and any employer or user of interpreter services are encouraged to join these entities and help shape these reforms.

Scott Homler, PhD, is the director of the Program in Translation and Interpreting in the College of Continuing Education at the University of Minnesota, Minneapolis. He is a certified legal interpreter for the states of Minnesota, Wisconsin, and Iowa.

Sioux Falls VA Health Care System Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package.

The VAHCS is currently recruiting for the following healthcare positions in the following location.

Sioux Falls VA HCS, SD Primary Care (Family Practice or Internal Medicine) Psychiatrist Hospitalist

Endocrinology Emergency Medicine Neurologist

Here to care At Allina Health, we’re here to care, guide, inspire and comfort the millions of patients we see each year at our 90+ clinics, 11 hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel.

Pulmonologist Make a difference.

Join our award-winning team.

Madalyn Dosch, Physician Recruitment Services Toll-free: 1-800-248-4921 Fax: 612-262-4163 Madalyn.Dosch@allina.com

Sioux Falls VA HCS (605) 333-6858 www.siouxfalls.va.gov Applicants can apply online at www.USAJOBS.gov

allinahealth.org/careers EOE/AA 10127 0213 ©2013 ALLINA HEALTH SYSTEM ® A TRADEMARK OF ALLINA HEALTH SYSTEM

Trinity Health One of the region’s premier healthcare providers.

Currently Seeking BC/BE s Ambulatory Internal Medicine s General Surgery

s Psychiatry s Urology

Contact us for a complete list of openings.

Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life.

Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes, Trinity Health hosts a Level II Trauma Center, Critical Care Helicopter Ambulance, Rehab Center, Open Heart and Lung Program, Joint Replacement Center and Cancer Care Center.

For immediate confidential consideration, or to learn more, please contact

Physicians are offered a generous guaranteed base salary. Benefits also include a health and dental plan, life and disability insurance, 401(k), 401(a), paid vacation, continuing medical education allowance and relocation assistance.

www.trinityhealth.org

Shar Grigsby Health Center - East 20 Burdick Expressway Minot ND 58702 Ph: (800) 598-1205, Ext 7860 Pager #0318 Email: shar.grigsby@trinityhealth.org

JULY 2013

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Hepatitis C from page 17 The future role of hepatitis C virus genotyping is more complex. If a regimen produces cure rates approaching 100 percent for all genotypes, this test, too, would fade into history. But there seems to be a subset of hepatitis C-infected people with poor responses to all therapies.

This “null responder” status appears to be associated with specific genotypes, notably 1a.

Of all the changes discussed in this section, forgoing ascertainment of HCV genotype will be the last change to occur.

Should we treat people with acute hepatitis C today?

Over the past decade, it has become increasingly accepted that treating hepatitis C within the first six months of infection increases the chance of cure to at least 80 percent, even with only six months of treatment.

It has seemed warranted to subject people with acute disease— especially those with genotypes 1a, 1b, or 4—to six months of difficult treatment in order to increase the cure probability by

TABLE 1. SVR 24 rates in daclatasvir plus sofosbuvir-treated HCV patients.

Sustained virologic response rates in treatment-naïve patients chronically infected with HCV genotypes 1, 2, or 3 after 24 weeks of treatment with daclatasvir (NS5A inhibitor) plus sofosbuvir (nucleotide NS5B inhibitor), with or without ribavirin.

Treatment HCV genotype N treated SVR 12 N, % Declatasvir Sofosbuvir

1a, 1b

29*

28 (96%)

Declatasvir Sofosbuvir

2, 3

30**

28 (93%)

Declatasvir Sofosbuvir Ribavirin

1a, 1b

15

15 (100%)

Declatasvir Sofosbuvir Ribivirin

2,3

14

13 (93%)

* 15 patients had a one-week lead-in of only sofosbuvir ** 16 patients had a one-week lead-in of only sofosbuvir (Table adapted from Sulkowski MS, et al., The Liver Meeting of the American Assoc. for the Study of Liver Diseases, Boston, Mass., Nov. 12, 2012, abstract LB-2)

20 percent with a shortened regimen. The timing of starting treatment of acute disease has been a question when it’s possible that the patient will be in the lucky 10–20 percent who will self-cure. Most clinicians postpone treatment until the HCV RNA is still present at week 12 of infection, after which spontaneous cure is rare.

But what is the best course of treatment now, with markedly improved treatment two or three years away? I stopped recommending treatment for acute hepatitis C after the Barcelona meeting a year ago, acknowledging that no consensus body has yet taken this stance. The counter argument is the rare patient who proceeds to serious disease in the first several years of infection. But with such good drugs on the near horizon, at this point it’s hard to justify giving a newly infected patient six months of ribavirin and PEGinterferon, with or without telaprevir/boceprevir.

Who will provide hepatitis C treatment in the future?

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MINNESOTA PHYSICIAN JULY 2013

The CDC estimates that 3,200,000 Americans (about 1 percent) have active hepatitis C infection. Most should be treated in the next decade, if the new drugs come anywhere near the expectation. But who is going to do it?

Heretofore, most hepatitis C treatment has been provided by gastroenterologists with an interest in liver disease. Liver biopsy, an important management tool, most often has been done by hepatologists (now it’s more often done by invasive radiologists). Care of patients with decompensated cirrhosis was often needed. These features made the expertise of hepatologists highly desirable in the care of patients with hepatitis C. However, current compen-

sation rates for endoscopies constitute a disincentive for gastroenterologists to embrace hepatitis C care. In addition, liver biopsy and management of cirrhosis will occupy a shrinking portion of hepatitis C care in the future. Further disincentives for current treatment with protease inhibitors are the somewhat tedious stopping rules and toxicity management algorithms, as well as issues of viral resistance (although it’s uncertain whether those issues will persist with newer regimens).

In addition, hepatitis C patient populations are enriched for active drug abuse and social disorganization.

Infectious diseases physicians could help close the treatment gap, but no surge of interest by this group is evident so far. Most infectious diseases physicians primarily do inpatient consultation, but hepatitis C care is a pure outpatient care activity. HIV physicians are accustomed to treating the socially disorganized, but HIV care is supported by Ryan White funds and other exceptional governmental services. This support structure is not available for hepatitis C care.

It is tempting to think that in the future, hepatitis C care will be uncomplicated enough that any clinician can provide it.

However, there are likely to be several companies manufacturing a larger number of drugs that will compete in the marketplace. Different genotypes might be best treated by different regimens. Null responders will have special considerations. Some patients will have cirrhosis. And most of us are uncomfortable providing care in an arena where we see fewer than five patients a year.

So most clinicians will probably refer hepatitis C patients— but to whom? It will be interesting to see whether a cadre of interested specialty clinicians will develop.

Frank S. Rhame, MD, is an adjunct professor in the Division of Infectious Diseases, Department of Medicine, University of Minnesota; carries out HIV and HCV research at Abbott Northwestern Hospital, Minneapolis; and is a physician at Allina Medical Clinic–The Doctors, in Minneapolis.

Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an out-patient clinical position. Previous electronic medical record experience is helpful, but not required.

We use the Epic medical record system in all of our clinics and admitting hospitals.

Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal.

HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefit package, paid malpractice and a commitment to providing exceptional patient-centered care.

Apply online at healthpartners.jobs or contact diane.m.collins@healthpartners.com.

Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE

healthpartners.com

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

Emergency Medicine Emergency Practice Associates has immediate full-time, part-time and locums opportunities at our sites in:

Hibbing Little Falls Park Rapids Alexandria Austin For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:

recruiting@epamidwest.com or visit our website at

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Your Emergency Practice Partner

Join the top ranked clinic in the Twin Cities A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:

• Family Practice • Urgent Care We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years.

We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.

Please contact or fax CV to:

Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

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Scalp disorders from page 31 7, and African-Americans are more commonly affected.

Trichophyton tonsurans is the most common cause of tinea capitis in the U.S. T. tonsurans is anthropophilic and spread by human-to-human contact and through fomites, including hats, combs, pillowcases, and other inanimate objects. Microsporum canis is a zoophilic dermatophyte, with dogs and cats being the most common reservoirs and vectors for infection. Humans may become infected by direct contact with family pets (which may be asymptomatic).

Zoophilic tinea capitis is often very inflammatory. Typical signs and symptoms of tinea capitis include scalp scaling, pruritus, alopecia (patchy or diffuse) and cervical (especially posterior) adenopathy. Scale plus posterior cervical adenopathy equals tinea capitis in a prepubescent child until proven otherwise. Less common presentations of tinea capitis include Kerion formation (boggy, tender, inflamed nodules with alopecia), pustules. Tinea capitis may also

be asymptomatic, with minimal scaling. Though there have been cases of tinea capitis in mostly elderly adults, it is extremely rare.

Hair and scalp cultures are the most sensitive and specific way to diagnose tinea capitis.

One can pull a few hairs and take a glass slide to scrape some scale for culture. Both adults and children living with an index case of tinea capitis have been shown to carry dermatophytes without symptoms, so it is important to culture the scalps of all prepubescent children in the family, control fomites, and have adults and children shampoo with ketoconazole shampoo.

Oral antifungals are the only way to treat tinea capitis effectively in affected patients; the single FDA-approved treatment is griseofulvin, given for six to eight weeks. Terbinafine or fluconazole, both dosed by weight, are other non-FDAapproved options that typically work well at four weeks and are well tolerated.

According to the American

Academy of Pediatrics, children receiving treatment for tinea capitis may attend school.

Haircuts, shaving of the head, or wearing a cap during treatment are not necessary.

Allergic contact dermatitis

A final note on itchy scalps is the increasing number of patients I am seeing with allergic contact dermatitis due to a component in one of their hair care products. Even if patients swear that they haven’t changed anything in their hair care routine, repeated low-level exposures to the preservatives and fragrances found in many hair care products can lead to an itchy scalp.

When patients tell you that they have already changed their products and “it didn’t make a difference,” don’t be deterred from recommending a change in the product(s) they use. Many different product lines contain similar preservatives, surfactants (bubbling agents), and fragrances. Ask your patients to switch for a one-month trial to a fragrance-free regimen. (Free

and Clear, made by the local company Pharmaceutical Specialties, is a good product to start with.) Also, do not be misled by the words “organic,” “baby formula,” or “sensitive” in the labeling for these products; they all need to contain preservatives to have a shelf life, and are often loaded with fragrances, both natural and synthetic.

When to refer or seek a different diagnosis

Scalp conditions can be difficult to treat and can be persistent and painful for many patients.

It is a good idea to refer these patients to a dermatologist when topical or more standard treatments and home regimens are not effective. Scaling, erythema, and pruritus of the scalp can also be seen with skin cancers and other neoplastic disorders, connective tissue disorders, and infections. Failure to respond to treatment should prompt a search for a different diagnosis or a referral.

Kristina Shaffer, MD, MPH, practices in the Eagan and Woodbury offices of Dermatology Consultants.

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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MINNESOTA PHYSICIAN JULY 2013

Spine Surgeons, join our team and set the standards for patient care.

Orthopaedic Associates of Duluth is seeking a highly motivated passionate and experienced SPINE SURGEON to provide outstanding orthopaedic care to its patients. The successful candidate will be part of our expanding and growing, well-respected team that serves patients from Duluth to northern Minnesota.

Orthopaedic Associates of Duluth is a group of nine orthopaedic surgeons that provide comprehensive orthopaedic services ranging from specialty specific exams and diagnosis to state-of-the-art inoffice MRI and imaging and surgery at their physician-owned surgery center.

Email CV to jwaller@slhduluth.com or call 800-461-8843 (Sue) or 218-625-2731 (June)

Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We will be opening a new Urgent Care clinic in Hugo, MN in the spring of 2013!

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.

The perfect match of career and lifestyle.

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

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: • ENT • Family Medicine • Geriatrician/Outpatient Internal Medicine • Hospitalist • Infectious Disease

• Internal Medicine • Med/Peds Hospitalist • OB/GYN • Oncology • Orthopedic Surgery • Psychiatry

• Psychology • Pediatrics • Pulmonary/ Critical Care • Radiation Oncology • Rheumatology

For additional information, please contact:

Kari Bredberg, Physician Recruitment karib@acmc.com, (320) 231-6366

Julayne Mayer, Physician Recruitment mayerj@acmc.com, (320) 231-5052

www.acmc.com

healthpartners.com

Emergency Medicine Physician

Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth.

Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere.

The Rochester community provides numerous cultural, educational, and recreational opportunities.

Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Opportunities available in the following specialties: Dermatology Southeast Clinic

Family Medicine Cannon Falls Clinic and Pine Island Clinic

Hospitalist Rochester Hospital

BC/BE Family Medicine or BC/BE Emergency Medicine Physician to work exclusively in our ED. 10 patients average per 24 hrs.

24 hr. shifts-Full Time or Part Time.

GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cities.

For more information Call Kirk Stensrud, CEO 320.634.4521

Internal Medicine Southeast Clinic

Mail CV to: Kirk Stensrud, CEO 10 Fourth Ave SE Glenwood, MN 56334

Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: dcardille@olmmed.org

Submit CV Online kirk.stensrud@glacialridge.org

Phone: 507.529.6748 Fax: 507.529.6622

www.olmstedmedicalcenter.org

EOE

www.glacialridge.org

JULY 2013

MINNESOTA PHYSICIAN

37

Safety from page 11 information regarding nonresident pharmacies across participating states and establish standards specific to sterile and nonsterile compounding (www.nabp.net/news/states -take-action-to-ensure-safety-of -compounded-drugs). These standards would, in all likelihood, be closely aligned with USP standards 795 and 797.

These are good and necessary initiatives, but they are unlikely to address concerns in the short term. Today, due diligence by purchasers/prescribers of pharmaceutical products, particularly sterile products, is essential. They should be asking questions like the following: • Does the facility follow appropriate USP 795/797 standards?

• Is there evidence of an independent assessment/inspection of the facility?

• What type of accreditation, if any, does the producer hold?

This information is not easily obtained, and suppliers may balk at a request for it, but the answers can alert suppliers

This tragedy could have been much worse, as many more products from NECC could have been contaminated. to prescribers’ attentiveness (or inattentiveness) to these issues.

One readily accessible source of information in Minnesota, and other states as well, is the Board of Pharmacy (www.phcybrd.state.mn.us/). The board reports the type of license held, whether the license is

active or not, and any disciplinary action taken against a licensed entity. Discussion with a MNBoP representative can inform the questioner of the limits of the license held and alert the inquirer to any potential concerns. An inquiry to the MNBoP would have immediately

disclosed that New England Compounding Center was a nonresident community/outpatient pharmacy that provided nonsterile and sterile product compounding and did not hold a manufacturing license in the state of Minnesota.

There are no entirely safe systems, and mistakes will happen. However, the actions taken

by NECC were not mistakes; the company demonstrated a knowledgeable and purposeful disregard for patient safety.

Many patients were harmed and the public’s confidence in physicians and pharmacists was damaged as a result. The lessons learned from these events will improve the pharmaceutical distribution system in the U.S. The tragedy is that individuals were harmed and lives were lost.

Ronald S. Hadsall, PhD, MS, is a Distinguished Teaching Professor and the assistant dean for professional education in the College of Pharmacy at the University of Minnesota, Minneapolis.

continuing education Fundamental Critical Care Support Simulation Facilitator Course Trauma Education: The Next Generation* * Formerly Emergency Medicine and Trauma Update: Beyond the Golden Hour Managing Life Limiting Illness and End of Life Care (two-day event) Primary Care Update: Pathways to Knowledge

August 20-22, 2013 September 5, 2013 October 1 and October 3, 2013 October 10-11, 2013

Fundamental Critical Care Support

October 24-25, 2013

Simulation Facilitator Course

November 6-8, 2013

Pediatric Fundamental Critical Care Support

November 14-15, 2013

35th Annual Cardiovascular Conference: Current Concepts and Advancements in Cardiovascular Disease

December 12-13, 2013

Education and research to improve the health of our community

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July 18-19, 2013

MINNESOTA PHYSICIAN JULY 2013

HealthPartnersInstitute.org

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