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Vo l u m e x x v i i , N o . 11 F e b r u a r y 2 014

The I nde p endent M e dical Business N ewsp ap er

Statins for primary prevention What does the evidence tell us? By Kevin P. Peterson, MD

B

y now nearly everyone has heard about the 2013 American College of Cardiology/American Heart Association Blood Cholesterol Guideline, which was published in mid-November. [Stone N, et al., J Am Coll Cardiol (Nov. 2013)] The new guidelines, which update the 2003 ACC/AHA guidelines, recommend moderate- or high-intensity statin therapy for four groups: • Patients who have cardiovascular disease • Patients with an LDL cholesterol level > 190 mg/dL

Health information privacy breaches There’s a law for that! By Diane Larson, MA, RHIA, CHPS, FAHIMA “Oh no! We inadvertently sent a copy of a patient’s medical record to the wrong patient. What should we do?” I don’t know if there’s an app for that, but there are definitely laws for that. The Health Information Technology for Economic and Clinical Health Act (HITECH Act) requires HIPAA-covered entities to provide notification to affected individuals and to the secretary of the U.S. Department of Health and Human Services following the discovery of a breach of unsecured protected health information (PHI). Specifically, 42 U.S.C. §17932(a) states:

A covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information shall, in the case of a breach of such information that is discovered by the covered entity, notify each individual whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, or disclosed as a result of such breach. In addition, there are relevant Minnesota and Wisconsin notifiPrivacy breaches to page 10

• Patients 40–75 years of age with type 2 diabetes • Patients 40–75 years of age with an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher (the report includes a CV risk calculator) The release of the new guidelines was immediately followed by a flurry of editorials that supported, condemned, or strongly questioned the ACC/AHA expert panel’s findings, in large part because of the guideline’s potential significant impact on many patients. Indeed, under the new guidelines, Statins for primary prevention to page 12


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Februar y 2014 • Volume XXVII, No. 11

Features Health information privacy breaches

There’s a law for that!

1

MINNESOTA HEALTH CARE ROUNDTABLE

By Diane Larson, MA, RHIA, CHPS, FAHIMA Statins for primary prevention

What does the evidence tell us?

1

By Kevin P. Peterson, MD

DEPARTMENTS CAPSULES 4 MEDICUS 7

HOSPITALS 14 Adaptation By Kevin Croston, MD

INTERVIEW 8  aul Kleeberg, MD, P FAAFP, FHIMSS Stratis Health

OPHTHALMOLOGY 28 Does statin use increase the risk of cataracts? By Y. Ralph Chu, MD

Post-acute care Fixing cracks in the system

Thursday, April 17, 2014

PROFESSIONAL UPDATE: ONCOLOGY Changing the face of pancreatic 16 cancer By Vikas Dudeja, MD, and Selwyn M. Vickers, MD

1:00–4:00 PM, Symphony Ballroom Downtown Minneapolis Hilton and Towers

Prostate cancer screening 18 By Stuart H. Bloom, MD, MSc

SPECIAL FOCUS: DATA SECURITY and privacy Mobile devices in health care 20 delivery By Timothy Johnson, JD, and Jesse Berg, JD Staying current to stay compliant By Morgan Vanderburg

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Third-party health care apps 24 By Marc Ohmann Putting the pieces in place By Lisa Moon, RN, BSN, and Bob Johnson, MPP

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Background and focus: Post-acute care is becoming an increasingly important component of health care delivery. It is also becoming increasingly community-based. Medical advances are dramatically expanding the range of access to these services and, at the same time, creating a larger number of problems providing them. Choppy access to electronic medical records and ensuing medication management complications, as well as problems with care team coordination, can impede the goal of improving outcomes while lowering costs.

Objectives: We will discuss the evolution of post-acute care and illustrate the dynamic potential it holds. From the hospital to the physician to skilled nursing, rehab, and home care, we will present perspectives from across the care continuum. We will investigate communication problems between care team members and present potential solutions. We will examine how elements of health care reform like ACOs and insurance exchanges can drive both improvement in and higher utilization of postacute care. We will discuss the tools that are necessary for post-acute care to reach its full potential. Panelists include: • Krista Boston, JD, Director, Minnesota Board on Aging • Rahul Koranne, MD, MBA, Medical Director, Bethesda Hospital • Dawn Simonson, MPH, Director, Metro Area Agency on Aging • Kari Thurlow, JD, Senior Vice President, Aging Services of Minnesota • Carol Zindler, Vice President, Client Experience, Caremerge Sponsors include: • Aging Services of Minnesota • HealthEast Care System • MN Area Agencies on Aging • Senior Linkage Line

www.mppub.com Publisher Mike Starnes mstarnes@mppub.com Senior Editor Donna Ahrens dahrens@mppub.com ASsociate Editor Janet Cass jcass@mppub.com ASsistant Editor Stacey Bush sbush@mppub.com Art Director Alice Savitski asavitski@mppub.com Office Administrator Amanda Marlow amarlow@mppub.com Account Executive Linda C. Johnson ljohnson@mppub.com Account Executive Iain Kane ikane@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not neccessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business or other professional advice and counsel. No part of the publication may be reprinted or reproduced within written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

Please send me ____ tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, 2812 East 26th Street, Minneapolis, MN 55406. Tickets may also be ordered by phone 612.728.8600 or fax 612.728.8601. Name Company Address City, State, ZIP Telephone/FAX Card #  Check enclosed

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Please mail, call in, or fax your registration by 4/7/2014

February 2014 Minnesota Physician

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Capsules

Abbott Labs Settles Kickback Lawsuit Abbott Laboratories, based in North Chicago, Ill., has agreed to pay $5.5 million to settle a lawsuit claiming it illegally paid physicians kickbacks as an incentive to purchase Abbott’s carotid, biliary, and peripheral vascular products between 2005 and 2010. Two former high-ranking sales employees at Abbott, Steven Peters and Douglas Gray, originated the allegations, claiming that Abbott paid doctors for teaching assignments and speaking engagements with the expectation that they would then arrange for their affiliated hospitals to purchase Abbott’s products. The federal government alleged that Abbott violated the anti-kickback law and filed false Medicare claims for their products’ use procedures.

manufacturers competing for their business,” said U.S. Attorney Bill Killian of the Eastern District of Tennessee, where the case was filed. Peters and Gray will each receive more than $1 million from the settlement under the False Claims Act, which stipulates that whistleblowers be rewarded with a percentage of the money that the government recovers as a result of their lawsuits. Abbott has agreed to participate in an investigation of anyone allegedly involved in the illegal activities as part of the settlement terms. “We’re pleased to resolve this matter. Abbott entered into the settlement agreement to avoid the uncertainty and expense of protracted litigation. Abbott believes its actions were appropriate at all times,” said Angela Duff, Abbott spokeswoman.

“Physicians should make decisions regarding medical devices based on what is in the best interest of patients without being induced by payments from

State Begins Destroying Newborn Blood Samples The Minnesota Department of Health (MDH) has begun destroying approximately 1.1 million archived newborn screening blood samples and will pay more than $1 million in court costs as part of a settlement in a lawsuit brought by 21 Minnesota families. The families originally filed the suit in 2009, alleging “the program’s collection, use, storage, and dissemination of residual blood spots and test results without written parental consent violated the Minnesota State Genetic Information Act of 2006,” according to the MDH. The suit was dismissed in district court, and that ruling was appealed, but the dismissal was upheld. In 2011, the Minnesota Supreme Court ruled that the program’s use of blood samples and test results was not authorized for anything other than the

initial newborn screening protocol. Then, in 2012, the Minnesota Legislature changed the statutory language to specifically authorize the short-term storage and use of blood samples and test results for internal operations, but parents must provide written consent for the samples and test results to be stored and used for longer periods. “With the lawsuit behind us, we will now be able to devote our resources to operating and advancing the newborn screening program to ensure a healthy start in life for Minnesota babies,” said Ed Ehlinger, MD, Minnesota commissioner of health.

Scan Protocol Saves Money, Lives Minnesota’s plan to reduce costs and risks associated with unnecessary medical-imaging scans may be implemented at a federal level for Medicare. Minnesota health care leaders met in early January to discuss the project’s

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Minnesota Physician February 2014

URGENT CARE


success and potential future. In 2006, the state enacted a decision support strategy that aimed to identify when medical-imaging scans are necessary by giving physicians a set of standards to follow in their determination process. The standards include a coding system that rates scan recommendations for patients as green, yellow, or red. According to officials, the use of medical-imaging scans had been growing at a rate of 7 percent each year; this was lowered significantly once the protocol was in place, to an annual growth rate of 1 percent from 2007 to 2012. “It happened immediately,” Cally Vinz, vice president of health care improvement at the Institute for Clinical Systems Improvement (ICSI), told the Star Tribune. And now, officials say, more than 80 percent of scans in the state are performed only if a doctor has consulted the decision-support strategies. According to ICSI, the protocol has prevented an estimated $234 million in unnecessary medical-imaging scans and 96 deaths from cancer that likely would have occurred from radiation exposure during scans. Rep. Erik Paulsen (R-Minn.) told the Star Tribune he is hopeful this strategy can be implemented in the Medicare program as part of the ongoing reform efforts for sustainable growth. “If you let this slip away, it’s going to be a lot more difficult to resolve later,” he said at the January meeting.

Sanford Launches Genetic Testing Sioux Falls, S.D.-based Sanford Health has announced the launch of a major genetic testing initiative. The program, called Sanford Imagenetics, will be funded by a $125 million gift from namesake benefactor Denny Sanford. The program will focus on integrating genetic information with primary care, and is the first of its kind to do so, according to Sanford officials. “This is the frontier of medicine,” said Kelby Krabbenhoft, Sanford president and CEO. “This is what’s going to change everything for everybody.”

Sanford will implement certain types of genetic testing at clinics in Bemidji and Fargo, available to patients as early as this spring. Eventually, each of the health care system’s hubs— Sioux Falls, S.D., Fargo and Bismarck, N.D., and Bemidji, Minn.—will hire genetic specialists to work alongside internal medicine doctors in dedicated facilities that will house internal medicine practice, genetic counselors, medical geneticists, research, education, and lab services. Telemedicine technology will allow patients from anywhere in Sanford’s service area to participate in the testing program, if it is recommended by their primary care physicians. “In the long run, I really am a believer that all patients will benefit from a broad survey of genetic markers that will give their physicians a picture of the diseases that they are at risk for,” said Eugene Hoyme, MD, president of Sanford Research. Sanford is also planning a rigorous research program to determine how this genetic information affects patient outcomes, according to Hoyme. The company already has established partnerships with Augustana College and the University of South Dakota to develop new education programs to train medical students in genomic medicine. According to the Star Tribune, the Institute for Clinical Systems Improvement (ICSI) has expressed concerns about the surge of interest in genetic testing, and it hopes to develop a decision support tool for health care professionals similar to the protocol used to determine the necessity of medical image scans in Minnesota.

MinnesotaCare Faces Major Deficit

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When: Tuesday, March 4 - Wednesday, March 5 Where: The Depot Renaissance, 225 3rd Ave S Minneapolis, MN 55401 Cost: $325 MMGMA, HFMA, HRAM & MMA members $550 Nonmembers Please join us at our semiannual conference as we discuss a wide range of healthcare business topics. For registration or more information, please visit: http://www.mmgma.org/events/mmgma-2014-winter-conference

www.mmgma.org or call 651-999-5359

“As physicians, we have so many unknowns coming our way... One thing I am certain about is my malpractice protection.” Medicine is feeling the effects of regulatory and legislative changes, increasing risk, and profitability demands—all contributing to uncertainty and lack of control. What we do control as physicians: our choice of a liability partner. I selected ProAssurance because they stand behind my good medicine. In spite of the maelstrom, I am protected, respected, and heard. I believe in fair treatment—and I get it.

Minnesota Management and Budget (MMB) has released a report that says MinnesotaCare, the state’s publicly subsidized health care program for low-income residents, soon may face major financial concerns. Currently, MinnesotaCare has a $26 million surplus that will carry the program through 2015. But MMB projects a $362 Capsules to page 6

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February 2014 Minnesota Physician

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Capsules from page 5 million deficit by 2016 that would increase to $1.4 billion by 2021. According to the Minnesota House of Representatives website, in 2012 the MinnesotaCare program paid $549 million for medical services provided to enrollees. The state paid 48 percent of this cost, the federal government contributed 44 percent, and enrollee premiums covered 8 percent. Of significant concern is state funding, which comes from a 2 percent tax on medical services provided by hospitals, surgical centers, chiropractors, and other health care providers. The tax was passed in 1992 for the purpose of funding MinnesotaCare. State legislators and Gov. Dayton agreed to phase out and repeal the tax as part of the 2011 budget agreement, and it will be phased out entirely on Dec. 31, 2019. In the meantime, the commissioner of management and budget is required to reduce the tax on health care provider revenues if certain financial criteria are met.

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More than 130,000 individuals are enrolled in MinnesotaCare. As of July 2013, 70 percent of these were parents, children, or pregnant women. MinnesotaCare has never ended a year with a budget deficit in the 22 years it has been in place.

In addition, the health care system plans to expand HealthEast Cancer Care into vacant space within the HealthEast clinic in Woodbury. Radiation oncology services are expected to be available at the new location in January 2015.

HealthEast Reveals Expansion Plans

Construction Begins On U of M Ambulatory Care Center

HealthEast will begin construction on a new clinic site in Woodbury in February, according to HealthEast officials. The new clinic, located at Tamarack Road and Woodbury Drive, will include pediatric and family medicine services. It is expected to open in the fall of 2014.

The University of Minnesota began constructing a $160.5 million ambulatory care center in late December after the Board of Regents approved final agreements between the university, University of Minnesota Physicians (UMP), and Fairview Health Services.

HealthEast plans to continue its growth in the area as the community’s population is expected to increase. It will open another new clinic at the Woodwinds Health Campus that will house internal medicine and specialty providers. That clinic is expected to be open by spring of 2015.

The 330,000-square-foot facility will house several specialty clinics and an outpatient surgery center. It will replace and expand clinics currently located at the Phillips Wangensteen Building that university officials called cramped and outdated, according to the Pioneer Press.

Minnesota Physician February 2014

The Board of Regents approved two 30-year leases with UMP and Fairview Health Services, a parking agreement, guarantees with UMP and Fairview for payment of $150.5 million in special purpose bonds issued by the university, and $12.2 million in capitalized interest. It also approved a master agreement that outlines the framework for clinic management and operation. University officials say the ambulatory care facility is projected to open in January 2016.

New Minnesota ACOs Health and Human Services Secretary Kathleen Sebelius has announced 123 new accountable care organizations (ACOs). The new ACOs include Integrity Health Innovations, LLC, serving Minnesota and Wisconsin, and North Collaborative Care, which will serve Minnesota.


Medicus

Barbara Bowers, MD

Barbara Bowers, MD, board-certified in internal medicine, has joined Minnesota Oncology as a medical oncologist. She earned her medical degree from the University of Minnesota Medical School, Duluth; completed a residency at Abbott Northwestern Hospital, Minneapolis; and completed a medical oncology fellowship at the University of Minnesota Masonic Hospital. Previously, Bowers practiced at Fairview Southdale Hospital.

Jim Davis, CentraCare Health’s vice president for Corporate Services, has retired. The St. Cloud Hospital portion of Davis’ job has been assumed by Kurt Otto, who has served as a vice president for the health system since 2012. Joe Hellie has begun transitioning into the role of CentraCare Health’s vice president of Strategy and Network Development. He will be responsible for strategic planning, communications and marketing, and government and community relations, among other duties. St. Cloud Hospital president Craig Broman assumed the additional responsibility of the regional hospitals Jan. 1. Danielle Dempsey, MD, has joined the OB/GYN Department at Hennepin County Medical Center, Minneapolis. Board-certified in obstetrics and gynecology, she earned a medical degree from the University of Minnesota and completed an OB/ GYN residency at The George Washington University in Washington, D.C. Steven Miles, MD, board-certified in internal medicine, served as lead expert for the prosecution of a South African physician found guilty in December 2013 of violating medical ethics through cooperation with South Africa’s apartheid regime, In addition to seeing patients at Hennepin County Medical Center, Miles is a professor in the University of Minnesota Medical School Department of Steven Miles, MD Medicine and a professor in the university’s Center for Bioethics, where he hold the Maas Family Endowed Chair in Bioethics. Danielle Dempsey, MD

Glen D. Nelson, MD, received the 2013 Shotwell Award in January from the Twin Cities Medical Society. Nelson was recognized for his leadership in developing Park Nicollet Medical Center and Medtronic, Inc.; for assisting health care start-ups; and for supporting medical student training at the University of Minnesota Medical School with scholarships and curriculum input. Glen D. Nelson, MD

Deborah Sah, MD, a board-certified pediatrician and a pediatric hospitalist, has joined Essentia Health–St. Mary’s Children’s Hospital, Duluth. Sah earned her medical degree from Albert Einstein College of Medicine in Bronx, N.Y. She completed a pediatrics residency at Children’s Hospital & Research Center in Oakland, Calif., and a Hair and Nail Clinical Research Fellowship at the University of California, San Francisco. Joining Essentia Health–St. Joseph’s Medical CenDeborah Sah, MD ter in Brainerd as an emergency medicine physician is Desiree Schroeder, MD, board-certified in emergency medicine. Schroeder earned her medical degree at the University of Minnesota Medical School and completed an emergency medicine residency at Strong Memorial Hospital in Rochester, N.Y. Therese Zink, MD, MPH, board-certified in family Desiree Schroeder, MD medicine and formerly on staff at the University of Minnesota Medical School, assumed the position of professor and Chair of the Department of Family Medicine and Community Health at Wright State University College of Medicine, Dayton, Ohio, in January.

R e q u e s t f o R n o m i n at i o n s

2014 HealtH care arcHitecture & Design

Seeking Exceptionally Designed Health Facilities in Minnesota Nomination Closing: Friday, May 9, 2014 Publication Date: June 2014

Minnesota Physician announces our annual health Care architecture & Design honor roll. We are seeking nominations of exceptionally designed health care facilities in Minnesota. the nominees selected for the honor roll will be featured in the June 2014 edition of Minnesota Physician, the region’s most widely read medical publication. eligible facilities include any construction designed for patient care: hospitals, individual physician offices, clinics, outpatient centers, etc. interiors, exteriors, expansions, renovations and new structures are all eligible. in order to qualify for the nomination, the facility must have been designed, built or renovated since January 1, 2013. it also must be located within Minnesota (or near the state border within Wisconsin, north Dakota, south Dakota or iowa). color photographs are required. if you would like to nominate a facility, please fill out the nomination form below and submit the form, three to eight 300 DPi resolution color digital photographs, and a brief project description (150-250 words) by Friday, May 9, 2014. For more information, call (612) 728-8600. 2014 health caRe aRchitectuRe & design honoR Roll nomination foRm FaCility NaMe tyPe oF FaCility loCatioN owNershiP orgaNizatioN owNer CoNtaCt NaMe and PhoNe owNer aDDress City, state, ziP arChiteCt/iNterior DesigN FirM arChiteCt CoNtaCt NaMe and PhoNe arChiteCt aDDress City, state, ziP eNgiNeer CoNtraCtor CoMPletioN Date total Cost square Feet NuMber oF Color PhotograPhs eNCloseD (Note: please include a caption for each photo) NoMiNatioNs ProCeDure: submit the information on this form, along with a project description (150-250 words), and 300 dpi resolution color 8" x 10" digital photographs (no more than eight) to amarlow@mppub.com For further information, please phone (612) 728-8600, fax (612) 728-8601 or e-mail comments@mppub.com

February 2014 Minnesota Physician

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interview

Providing better care for your patients P  hysicians hear a lot about “meaningful use.” Please tell us what that phrase means. Meaningful use is essentially using a certified electronic health record in an effective way to provide quality care for your patients and to allow greater coordination between different providers. Paul Kleeberg, MD, FAAFP, FHIMSS

Stratis Health Paul Kleeberg, MD, is chief medical informatics officer for Stratis Health and clinical director for the Regional Extension Assistance Center for HIT (REACH) for Minnesota and North Dakota. REACH provides health information technology (HIT) services to assist clients with their electronic health records (EHR) planning, implementation, and achieving the effective use of their EHR. Kleeberg is a board-certified family physician and IT professional who has worked in a rural setting and metropolitan health systems. He has played a key role in the implementation of several patient portal, ambulatory, and hospital EHRs. Kleeberg is chair elect of the Healthcare Information and Management Systems Society (HIMSS) Board of Directors. HIMSS leads global efforts to optimize health engagements and care outcomes using information technology.

A qualified electronic health record (EHR) is an electronic record of health-related information on an individual that includes patient demographic and clinical health information. It is “certified” when it is tested by one of the federally approved testing centers and found to meet the meaningful use criteria Meaningful and quality measures we significant discuss later in this interview. W  hat is the role of meaningful use in the work you do with Stratis Health? Stratis Health and its partners, the National Rural Health Resource Center and the College of St. Scholastica, have a contract with the Office of the National Coordinator of Health Information Technology (ONC) to be a Regional Extension Assistance Center for HIT (REACH). We receive funding from the federal government to provide services that enable small primary care practices and hospitals under 50 beds to adopt and become meaningful users of electronic health records. Our goal is to have our clients be self-supporting and not dependent upon outside services to advance in their use of health information technology. W  hat are the requirements for Stage 1 of meaningful use? Stage 1 meaningful use requires that a physician owns an electronic health record, that it has been certified by the ONC, that the physician uses it in an effective way in providing care, and that he or she reports on quality measures regarding that care. Most of the functional measures required to be a meaningful user are the typical things we have always done in providing care. Probably the most challenging of the new processes is providing the patient with a summary of the visit. Many providers felt patients

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Minnesota Physician February 2014

would be reluctant to use the summary or would throw it away altogether. However, once physicians begin to use it, they find they like it, and it improves patient satisfaction. Stage 1 also requires ordering medications through the EHR so allergies can be checked and clinical decision support rules can be used. It requires us to record patients’ problems, medications, allergies and vital signs, and access to their information electronically. Finally, and most importantly, providers must do a security risk analysis and address any risks that are identified. The second requirement is the submission of quality measures. These need to be collected during use offers the period they are demonstrating meaningful use, benefits. and attest to those numbers on a federal or state website. If it is the first year of meaningful use, they need to only attest to a 90-day period. Eventually, these quality measures will be reported publicly and factored into our rate reimbursement. W  hat are the requirements for Stage 2 of meaningful use? Stage 2 essentially expands on some of the requirements for Stage 1. Instead of just ordering meds within the EHR, one must now order meds, labs, and radiology. The most significant changes are the requirements for patient engagement and exchange. For Stage 2 patients need to demonstrate actual use of the portals that providers have created and interact with providers’ offices for clinical purposes. Being able to view, download, and transmit their health data is one requirement, as well as sending their providers electronic messages about their care. Providers are required to electronically send a certain number of transfer of care documents to another location. This will greatly facilitate care coordination and improve care. Stage 1 of meaningful use is basically just recording information within the EHR. Stage 2 really begins to involve patients in exchange of information. Stage 3 will have a lot more to do with quality and demonstrating quality. In fact, there


embrace its usage have found that using it allows them to provide better care for their patients. In my own practice, the EHR made it easy for me to see things that needed to be done that the patient did not necessarily come in for. It reminded me of things I needed to do that I had not thought about; it caught me when I was about to make an error.

is discussion that for Stage 3, providers who demonstrate quality will be assumed to have completed certain functional measures to be seen as meaningful users. F  rom the physician perspective, what are the pros and cons of meaningful use compliance? First the cons: Documenting some of the tasks required to demonstrate meaningful use can be out of the normal workflow and feel contrived. Registering to receive the incentive can be a challenge; we recommend registering early and making sure providers are ready when they go to attest to meaningful use of EHRs.

Finally, as exchange becomes more common and robust, getting documents back electronically from referrals will make it easier to coordinate the care for my patients and thus, as a primary care physician, provide a medical home for my patient.  What feedback have you seen so far in reaction to meaningful use initiatives? Providers like the incentives but some feel they have been inadequate. The incentive was intended to cover only a fraction of the cost of implementing the EHR; it was never meant to cover the entire cost.

The auditing process is another challenge. Providers have to demonstrate either before or after attestation that they did what they claimed they did. This requires the retention of documents and screenshots for six years. Meaningful use offers significant benefits, too. Short term, there are incentives that pay for a small portion of the cost of implementing an EHR. Avoiding the disincentives is another benefit.

W  hat message can you share with physicians about meaningful use? Meaningful use is really about adopting the electronic health record and learning how to use it well in providing care to your patients. Providers who focus just on fulfilling the requirements are often very unhappy. Providers who see the value of the EHR and keep the big picture in mind of why we are doing this are more successful and able to reap the benefits sooner. I can say, from my own experience, that effective use of electronic health records allowed me to provide better care for my patients and communicate better with my colleagues. Sure, the transition was a challenge, but in the end I felt it was well worth it.

The introduction of an EHR creates a significant challenge by completely disrupting the workflow that physicians have refined over the years. Some of us want the

Providers who adopt an EHR and

EHR to enable us to do exactly what we have always done, but faster. Those providers are disappointed and unhappy when the EHR does not do that. Adopting an EHR requires a thorough examination of your workflow and adapting your processes to the new environment.

University of Minnesota Continuing Professional Development 2014 CME Activities

(All courses in the Twin Cities unless noted)

Fundamentals of Critical Care Support March 17-18, 2014

Maintenance of Certification in Anesthesiology (MOCA) Training Course May 3, 2014

Advanced Critical Care for Hospitalists March 17-20, 2014

Live Global Health Training (weekly modules) May 5-30, 2014

Spring Psychiatry Update: Pursuing Wellness Across the Lifespan April 3-4, 2014

Global Health - Honoring Choices Across Cultures May 7, 2014

Cardiac Arrhythmias: Interactive Update for Internal Medicine, Family Practice & Pediatrics April 4, 2014

Midwest Cardiovascular Forum May 17-18, 2014

Integrated Behavioral Healthcare Conference: Building a Framework So You Can Grow April 25, 2014 Pediatric Dermatology Progress & Practices April 25, 2014 Annual Surgery Course: Vascular Surgery May 1-2, 2014

Bariatric Education Days: Decade of Bariatric Education May 21-22, 2014 Topics & Advances in Pediatrics May 29-30, 2014 Workshops in Clinical Hypnosis June 5-7, 2014 NPHTI Pediatric Clinical Hypnosis September 11-13, 2014

ONLINE COURSES (CME credit available) www.cme.umn.edu/online • Global Health - 7 Modules to include Travel Medicine, Refugee & Immigrant Health - NEW! Family Medicine Specialty • Nitrous Oxide for Pediatric Procedural Sedation

For a full activity listing, go to www.cmecourses.umn.edu

Psychiatry Review September 29-30, 2014

Office of Continuing Medical Education 612-626-7600 or 1-800-776-8636 • email: cme@umn.edu

Promoting a lifetime of outstanding professional practice

February 2014 Minnesota Physician

9


Privacy breaches from cover

cation statutes, Minn. Stat. §325E.61 and Wis. Stat. §134.98 (see sidebar on next page). As appealing as the idea of “doing nothing” may seem, it is not an option. If a breach such as the one described above occurs, here are seven steps your organization can take to review and act on the event:

Step 3: Ask the patient who received the information in error to return the information. Step 4: P  repare the breach notification letter. Step 5: Take action to prevent a future occurrence. Step 6: Notify the secretary of the U.S. Department of Health and Human Services (HHS).

Step 1 Confirm that the disclosure is a breach subject to the notification rules.

Step 3 Ask the patient who received the information in error to return it to you.

HIPAA defines a breach as “the acquisition, access, use, or disclosure of protected health information in a manner which compromises the security or privacy of the protected health information.”

Often, individuals receiving PHI in error offer to destroy the information. Instead, encourage the patient to return the information to you. By regaining custody of the protected health information, you will truly know what information was sent in error and you will have the opportunity to retain the information as evidence or to destroy the information according to your facility’s secure destruction policies.

The example above, in which a copy of a medical record was sent to the wrong patient, Step 1: Confirm that the disis a breach and is subject to closure is a breach. the breach notification rules. Step 2: D  ocument everyStep 7: Retain all inforA disclosure is not considered thing you know mation about the a breach or subject to breach about the breach. breach for six years. notification rules when an employee unintentionally accesses the wrong patient’s information or inadvertently shares Often, individuals receiving the wrong information with a fellow PHI in error offer to destroy employee. A patient the information. Instead, overhearing a physician instructing encourage the patient to another patient is return the information to you. considered an incidental disclosure, is not a breach, and is not subject to breach notification rules. Guidance about what constitutes a privacy breach can be found at the U.S. Department of Health and Human Services website, www. hhs.gov/ocr/privacy/hipaa Cutting edge expertise /administrative/breach notificationrule. makes Episcopal Church

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Minnesota Physician February 2014

Step 2 Document everything you know about the information sent in error. You will need to gather specific information about the chronology of events for the patient notification letter and HHS. You will want to know: • What forms were sent in error • What specific clinical information appeared on the forms • Patient demographic information such as birth date and address, as well as how much of the social security number was present (e.g., all nine digits or only the last four digits)

Step 4 Prepare the breach notification letter. HIPAA rule §164.404 (“Notification to individuals”) prescribes how a patient whose unsecured protected health information has been disclosed is to be notified of a breach. According to the rule: • Notification must be provided within 60 calendar days after discovery of a breach. • Notification must be in writing and sent by firstclass mail unless the individual agrees to electronic notice. • Notice must be written in plain language and include the following five elements: 1. A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known. 2. A description of the types of information that were involved in the breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved). 3. Any steps individuals should take to protect themselves from potential harm resulting from the breach.


Minnesota and Wisconsin notification statutes Minn. Stat §325E.61 requires notification following the unauthorized acquisition of unencrypted, computerized data that compromises the security, confidentiality, or integrity of “personal information” of the resident of the state. Note that Minnesota law is limited to computerized data, which differs from the more expansive federal law. Notification must be made “in the most expedient time possible and without unreasonable delay” consistent with “any measures necessary to determine the scope of the breach, identify the individuals affected, and restore the reasonable integrity of the data system.” Wis. Stat. §134.98 requires that any entity that conducts business in the state and maintains personal information of Wisconsin residents in the ordinary course of its business (including those whose principal place of business is not located in the state) notify Wisconsin residents when there has been an unauthorized acquisition of their personal information. Exceptions to this notification requirement include where the “acquisition of personal information does not create a material risk of identity theft or fraud to the subject of the personal information.”

4. A brief description of what you are doing to investigate, mitigate harm to the individual, and prevent a repeat occurrence.

a recurrence. For example, consider additional staff education, use of windowed envelopes, and procedures for addressing envelopes.

5. The name of a contact person, along with an address, telephone number, and email address, should the individual want to ask questions about the breach and actions being taken by the facility.

Step 6 Notify the HHS Secretary.

Notifying patients that their protected health information was breached is always uncomfortable. You will want to be very sensitive to the individual and take additional time to draft the letter carefully. I suggest you start the letter by stating that confidentiality of patient information is a priority of your organization, and end the letter by stating that your organization is committed to maintaining the privacy of patient information and has taken many precautions to safeguard patient information.

The privacy breach must be reported to the HHS Secretary via the HHS website www.hhs. gov/ocr/privacy/hipaa/adminis trative/breachnotificationrule/ brinstruction.html, no later than 60 days after the end of the calendar year. The documentation you retained while investigating the breach will be very helpful during your reporting.

Step 7 Retain all information about the privacy breach for six years. Retain a file of all information gathered, created, and reported during the investigation and reporting of the privacy breach, including a printed copy of the report submitted to the HHS Secretary. This information might be helpful if affected individuals exercise their right to file a privacy breach complaint with HHS. This sometimes does not occur until several years after the breach. Protecting privacy is the goal As health care organizations,

we strive to protect our patients’ privacy. There will be times that errors are made and information is sent to the wrong individual. When that occurs, the seven steps described in this article can help organizations comply with notification requirements. Additional information can be accessed on the HHS website, www.hhs.gov/ocr/ privacy/hipaa/administrative/ breachnotificationrule/. Diane Larson, MA, RHIA, CHPS, FAHIMA, is director of medical records and privacy officer at St. Luke’s, in Duluth, and Lake View, in Two Harbors.

The electronic reporting form asks questions about: • The number of individuals affected by the breach • The type of breach such as unauthorized access, loss or theft • Where the information was located at the time of the breach—e.g., desktop, laptop, email, server

I also suggest that when a social security number is part of the privacy breach, you provide to the patient, at your organization’s expense, access to credit monitoring for a limited amount of time, up to a year. The three credit monitoring sites that I have offered are Experian, TransUnion, and Equifax.

• The type of protected health information involved in the breach—e.g., clinical information, demographic information, financial information

Step 5 Take action to prevent a future occurrence.

• Actions taken in response to the breach, described in detail

You don’t want to have to notify another patient of a privacy breach. Perform a formal or informal root cause analysis to determine how the breach occurred. Review internal procedures to determine what actions can be taken to prevent

When a privacy breach affects more than 500 individuals, an organization must notify the media serving the state or jurisdiction, providing all of the same information required in a letter sent to an individual, described in Step 4.

• How the breach occurred (brief description)

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• Safeguards put in place prior to the breach

Kit Friedemann Mary Foarde 612.436.1020 • ffhealthlaw.com February 2014 Minnesota Physician

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Statins for primary prevention from cover

“Pravastatin did not reduce total myocardial infarction or total stroke in the primary This article discusses five statins would be recommended prevention population, RR 0.94 or considered for millions of ad- trials that have formed the basis (0.78–1.14). … Measures of overfor much of the new guidelines. ditional people in the U.S. John all health impact in the comIt briefly describes each trial Ioannidis, MD, of the Stanford bined populations, total mortaland the study author’s main University School of Medicine, ity and total serious noted: “According to the adverse events, were ACC/AHA guidelines, of unchanged by prava– For primary prevention, there seems to be reasonable the 101 million people statin as compared evidence for high-risk men, 50–70 years of age, to use in the U.S. population to placebo, RR0.98 without cardiovascular statins … For all other patients … there is no compelling (0.84–1.14) and 1.01 disease and aged 40 (0.96–1.06), respecevidence to use statins for primary prevention. to 79 years, 33 million tively.” [“Therapeutics are expected to have a Letter #48 (April–June 10-year predicted risk of 2003)] demonstrated in RCTs. Most conclusion(s), and then looks cardiovascular disease of 7.5% ASCVD events occur after age at “the rest of the story”—the or higher (i.e., high-intensity 70 years, giving individuals >70 Statins for primary numbers behind the numbers— statins are recommended) and years of age the greatest potenprevention in women which needs to be considered in another 13 million are expected tial for absolute risk reduction.” The Anglo-Scandinavian Cardito have a predicted risk between evaluating the use of statins for [Stone et al., op cit., p. 18] ac Outcomes Trial–Lipid Low5% and 7.4% (i.e., statins should primary prevention. Arm (ASCOT-LLA) study ering The Prospective Study of be considered).” [Ioannidis J, was a randomized controlled Pravastatin in the Elderly at Statins for primary JAMA online, Dec. 2, 2013]. trial examining the use of Risk (PROSPER) trial (results prevention in the elderly As a family practitioner who statins for primary prevention published in 2002) examined Regarding global risk assesssees many patients who would in women. The 10,305 women the use of statins for primament for atherosclerotic cardiobe affected by the ACC/AHA in the study population were ry prevention in the elderly. vascular disease in the elderly, guideline, I am concerned about required to have hypertension PROSPER was a randomized the new ACC/AHA guideline both the conclusions and the plus three cardiac risk factors. controlled trial to test the benstates: “Some worry that a implications of the guideline and these trials.

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Minnesota Physician February 2014

person aged 70 years without other risk factors will receive statin treatment on the basis of age alone. The estimated 10-year risk is still >7.5%, a risk threshold for which a reduction in ASCVD risk events has been

efit of pravastatin treatment in an elderly cohort of men and women (aged 70–82) with, or at high risk of developing, cardiovascular disease and stroke. The study included 3,000 women and 2,804 men. It is worth noting that this trial included two populations: 56 percent primary prevention and 44 percent secondary prevention. Findings: Pravastatin decreased the risk of cardiovascular death by 24 percent in the pravastatin cohort.

Author’s conclusion: “Pravastatin given for 3.2 years reduced the risk of coronary disease in elderly individuals. PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle-aged people.” [Shepherd J et al. Lancet 360 (Nov. 23, 2002), 1623–30)] The rest of the story: This appears to be the only study designed to look exclusively at statins in an elderly population. With regard to primary prevention, an article reviewing randomized controlled trials of statin therapy noted of the PROSPER trial results:

As background, the authors stated: “The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (HD) in hypertensive patients who are not conventionally deemed dyslipidaemic.” [Sever PS, et al. Lancet 361 (2003): 1149–1158] Results: The study found that “in hypertensive patients, who on average were at moderate risk of developing cardiovascular events, cholesterol lowering with atorvastatin 10 mg conferred a 36% reduction in fatal CHD and non-fatal myocardial infarction compared with placebo.” The study was stopped after 3.3 years because of the positive outcome in the treatment arm. Author’s conclusion: “The reductions in major cardiovascular events with atorvastatin are large, given the short follow-up time. These findings may have implications for future lipid-lowering guidelines.” The rest of the story: Regard-


ing the effect of atorvastatin on the primary endpoint (non-fatal myocardial infarction plus fatal CHD), the researchers reported: “The proportional effect of atorvastatin on the primary endpoint did not differ significantly in any prespecified subgroup from that noted overall, although the benefit was not significant in six subgroups, including patients with diabetes, and no benefit was apparent among women …” [Lancet 361 (April 5, 2003), 1153]. In addition, a review of statins pointed out that “even with hypertension and 3+ risk factors, these women appear relatively low risk.” [Regier L and Jensen B, RXFiles (Nov. 2004), www. RxFiles.ca] Statins for primary prevention in men and women AFCAPS/TexCAPS (Air Force/ Texas Coronary Atherosclerosis Prevention Study). The objective of the AFCAPS/TexCAPS was to compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without coronary heart disease (CHD). Findings: Lovastatin reduced the incidence of first acute coronary event by 63 percent. Author’s conclusions: “Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.” [Downs JR et al., JAMA 279(20): 1615–1622 (1998)] The rest of the story: This study was terminated early. It is difficult to understand why a study would be stopped early when the overall mortality rate was actually higher in the participants on the statin than in those treated with a placebo (there were 80 deaths in the statin group vs. 77 deaths in the placebo group). Cardiovascular

mortality was 17 in the statin group and 25 in the placebo group, which means non-cardiovascular mortality was 63 in the statin group vs. 42 in the placebo group. Relative risk of harm indicated a 50 percent increase in non-cardiovascular mortality in the statin group.

after the occurrence of very few more relevant events, and analysis of all-cause mortality curves suggests that the curves were tending to converge and would likely have done so with a longer duration of follow-up. These authors question the methodology used to calculate outcomes in JUPITER and note that the results were clinically inconsistent. They cite concerns about industry sponsorship of clinical research, and speculate that the results of JUPITER had potential to entice many healthy people to commit to long-term statin therapy on the basis of flawed data. [de Longeril M et al, Arch Intern Med 170(12):

1032 (June 28, 2010)] The MEGA (Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese) trial. The MEGA trial, conducted by researchers in Japan, investigated the effect of cholesterol reduction with pravastatin on the incidence of cardiovascular disease in subjects with mildly elevated total cholesterol and no evidence of atherosclerotic disease. In the trial, 8,214 men and postmenopausal women in Japan, aged 40 to 70 and with a total cholesterol concentration of 220 to 270 mg/dL, were randomly assigned to a diet with or without pravastatin.

JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin). This randomized controlled trial studied the use of rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. The study subjects—17,802 healthy men and women with LDL <130 and high-sensitivity CRP >2.0)—were randomized to 20 mg rosuvas“2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce tatin or placebo. The Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College combined primary of Cardiology/American Heart Association Task Force on Practice Guidelines” endpoint was myocar[Stone N, et al., J Am Coll Cardiol (Nov. 2013)] may be downloaded at http:// dial infarction, stroke, circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a arterial revascularization, hospitalization for unstable angina, or death Statins for primary prevention to page 38 from cardiovascular causes. Results: The trial was stopped after a median follow-up of 1.9 years. Author’s conclusion: “In this trial of apparently healthy people without hyperlipidemia but with elevated hs-CRP levels, rosuvastatin significantly reduced the incidence of major cardiovascular events.” [Ridker PM et al, NEJM 359 (Nov. 20, 2008): 2195–2207] The rest of the story: This study was terminated early. The Therapeutics Newsletter commented: “A recent research study demonstrated that the magnitude of the bias effect from stopping RCTs early for benefit is surprisingly large and robust, RR 0.71 (0.66–0.77). Testing the effect of this bias estimate on the early-terminated JUPITER trial changes the RR for major CHD from 0.54 to 0.76 and completely negates the mortality benefit.” [Therapeutics Initiative, Therapeutics Newsletter 77, Mar–Apr 2010] An article in the Archives of Internal Medicine (June 28, 2010) points out as well that the trial was discontinued

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Hospitals

A

fter the long lead-up to the passage of the Affordable Care Act (ACA) in March 2010, and another 15 months spent waiting to see whether it would be upheld by the U.S. Supreme Court, the act’s provisions are now well on their way to taking full effect. In October 2012, the government began penalizing hospitals for preventable readmission of Medicare patients. Next year, hospitals with excessively high rates of hospital-acquired infections will see reductions in their reimbursement rates. Medicare’s Hospital Value-based Purchasing Program, now in its second year, provides incentives to hospitals for delivering high-quality care to patients— and withholds quality bonuses for hospitals that fail to do so.

As these health care reforms take effect, hospitals are assessing how they deliver care to patients and adapting to changes in payment systems. Adapting to the requirements of the ACA has led North Memorial Health Care to take a close look

Adaptation A hospital responds to health reform requirements By Kevin Croston, MD

at how we provide patient care. We have moved from inpatient or hospital-centric thinking to what the ACA refers to as population health management. This

Seeing health care through

To help our patients stay healthy and to prevent expensive, avoidable emergency department care, North Memorial developed a community paramedic program. new perspective puts greater emphasis on and resources behind wellness and prevention; highly coordinated, team-based

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primary care; patient education and self-management; and more robust connections between sites of care.

Minnesota Physician February 2014

the eyes of the patient instead of the provider also allows us to build a health system that emphasizes patients’ needs for timely access, lower-cost options, and better access to their own health information and care providers. In addition, creating standard approaches to common problems has helped us reduce variation in how we deliver care. Like many health systems, North Memorial is in the early phases of change, but the improvements in our outcomes have been significant. This article describes some of the key changes we have made to adapt to the evolving health care landscape. Asking tough questions and digging into the numbers Before making major changes, we took a look at our current system. Which patients needed more care and/or a different type of care? How could we work with our own network of doctors and other health care systems to deliver on the promise of affordable, quality care? The basic premise of the ACA is to lower the cost of care while improving the quality of our outcomes. At North Memorial, we started by taking a critical look at our services using data analytics and digging into those numbers.

A case in point is the work of North Memorial’s Women and Newborn Guidance Team, which has nearly eliminated elective inductions of pregnant patients before 39 weeks’ gestation. By sharing a common outcome goal, our obstetricians were able to use evidence-based early induction criteria, standardize their workflows to improve care, and establish measurements to track their progress. Their work has resulted in reducing the rate of elective inductions before 39 weeks from 1.2 percent to 0.3 percent—a 75 percent reduction. This translates into better outcomes for mothers and their babies at a lower cost. Care coordination for patients with chronic conditions Implementing care coordination in our clinics and among different settings of care is another example of how we are working to provide better care to patients with chronic medical conditions. Our care coordination efforts are based on a team approach, with the patient in the center. Applying the right amount of support to our patients keeps them out of the hospital, with fewer complications from their diseases. A collaborative approach is also the cornerstone of our clinic-based diabetes, vascular disease, depression, and asthma programs. Given the multiple factors that influence a patient’s chronic disease, successful management can’t be the responsibility of the medical provider alone. Patients may benefit from support for their social situations, better education, and extended care in their homes to remain healthy. For example, we know that when diabetes patients leave the doctor’s office, it’s essential that they follow their doctor’s instructions on how to manage their diabetes. Those who don’t are more likely to end up in the emergency room instead of having a simple office visit to prevent an avoidable health scare. Our care coordinators, experts who help patients understand their chronic disease and how to become stewards of their own health, connect patients to the resources they need most.


Diabetes patients need to be educated on when and how to test blood sugar, when to take insulin, and how to use exercise and diet to their advantage. Some patients need extra care from their care team and frequent “check-in” meetings to make sure their care remains on track. The care coordinators help make this happen, whether through scheduling appointments, facilitating referrals, answering questions, clarifying instructions, or directing patients to support groups or disease-specific educators. Delivering quality care at affordable prices In addition to hospitals’ own health missions and initiatives, incentives from the Center for Medicare & Medicaid Services (CMS) are now providing additional support to health care systems seeking to improve their quality of care at a lower cost. CMS’s Medicare Shared Savings Program (MSSP) requires participating health care systems to demonstrate improvement in the quality of care that their Medicare patients receive. In other words, participating health systems must learn to manage the health of their population. As a member of the MSSP, North Memorial is guided by the Triple Aim— providing better care for individuals, improving the health of the population, and controlling the cost of care. Our population health management model goes beyond rescuing patients in need of acute medical care and sharpens our focus on wellness, prevention, and chronic disease management. To improve care, health systems rely on timely access to accurate and complete clinical data. North Memorial Health Care was one of the first health systems in the Twin Cities to implement electronic health records, which allow us to capture, analyze, and report on this information. This investment enabled our health system to benefit from incentives CMS created to reward eligible participants that demonstrate meaningful use of EHR technologies. We used our EHR data to determine the best approach to reducing our hospital readmis-

sion rates, to meet the standards set by the CMS Hospital Readmissions Reduction Program. In 2003, North Memorial was one of two hospital systems in the Twin Cities to receive CMS incentive payments for successfully lowering our readmission rates. We are especially proud of this accomplishment because North Memorial, as a Level I trauma center and certified stroke center, cares for some of the sickest patients in the region. Community paramedics Experts examining the trend of skyrocketing health care costs have found that recurrent use of the emergency department by some patients without a primary care physician is an expensive way to provide health care. To help our patients stay healthy and to prevent expensive, avoidable emergency department care, North Memorial developed a community paramedic program. The program, launched in October 2012, puts emergencytrained paramedics in the “slow lane” for one or two days a week. Instead of racing to the scene of accidents or emergencies, the medics make scheduled visits to the homes of our frail and elderly patients or those with chronic medical conditions like diabetes. Paramedics are uniquely skilled for this work, given their medical training and years of experience in assessing and providing care to people in their homes. Patients in the community paramedic program typically are people who may be seen frequently in the ED; may not have a way to receive follow-up care once they’re back home; and/or may not have anyone at home to take care of them until they’re back on their feet. With just a call from a primary care physician or referral from the emergency department, a community paramedic can administer lab tests, take vital signs, give a general assessment, or follow up on hospital discharge orders or clinic instructions. Visits are coordinated through our primary care clinics and supervised by emergency systems medical directors. In 2013, our commu-

nity paramedics made more than 1,500 visits to patients in their homes. Health system collaboration in the insurance exchange A key component of the ACA is the health insurance exchange, the online marketplace where individuals and small employers can shop for insurance coverage. Despite the rocky opening of state and federal exchanges in October 2013, by the end of 2013 more than 2.1 million people in the U.S. had enrolled in the exchanges. One way for health systems to offer access and quality care at lower cost is by collaborating with select physicians, specialists, providers and suppliers, and, in some cases, other health systems. That’s exactly what North Memorial has done. We are participating with other health systems in a few insurance product offerings on the exchange. For example, we are partnering with Fairview and HealthEast to offer a product

that provides metro-wide options for any patient looking for care, at an affordable price. It was the lowest priced product offered on the exchange, and one of the lowest offered on any of the nation’s exchanges. We can expect to see more of these kinds of partnerships offering options on the exchange in the future. Innovating, learning along the way Like other health systems, North Memorial is adapting to changes in the health care landscape—and learning to innovate along the way. In the coming year, we’ll learn more about how our adaptations are affecting the quality of care we deliver to our patients. Kevin Croston, MD, is chief medical officer and president of physician organization and ambulatory care for the North Memorial Health Care system. He is board-certified in general surgery and practices with Specialists in General Surgery, Ltd., in Maple Grove.

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Professional Update: Oncology

P

ancreatic cancer is the fourth most common cause of cancer deaths in United States. Nationwide, more than 43,000 new cases of pancreatic cancer were diagnosed in 2012. To appreciate the lethality of this disease, consider that more than 37,000 patientsâ&#x20AC;&#x201D;including about 600 patients in Minnesotaâ&#x20AC;&#x201D;lost their lives to pancreatic cancer in 2012 alone. Thus, about the same number of patients diagnosed with pancreatic cancer die of this disease every year. Many factors contribute to these abysmal outcomes. Since the pancreas is situated deep in the abdomen, patients with pancreatic cancer do not have many symptoms in the early stage of disease. This leads to patients presenting late in the course of disease. More than 80 percent of patients present at a stage when their disease is not amenable to surgery. Furthermore, pancreatic cancer is one of the most aggressive cancers known.

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Changing the face of pancreatic cancer Recent advances in research By Vikas Dudeja, MD, and Selwyn M. Vickers, MD

Only 10 percent to 15 percent of the patients who have their cancer removed by surgery are alive five years after diagnosis. As a whole, only 1 percent to 5 percent of all patients diagnosed with pancreatic cancer are alive five years after diagnosis. These poor outcomes have remained largely unchanged over many decades due to a dearth of effective therapies. Improving diagnosis Given that over 80 percent of the patients with pancreatic cancer present at stages when their disease is not amenable to surgery,

Minnesota Physician February 2014

an attempt has been made to discover novel biomarkers that could help diagnose pancreatic cancer at early stages. However, due to the low incidence of pancreatic cancer compared, for example, to colon and breast cancer, screening in the general population is unlikely to be cost-effective at this time. Even though groups at higher risk can be targeted for screening, the ideal high-risk group for pancreatic cancer screening has not been identified. Nor is there an ideal screening option. CA 19-9, a protein antigen detected in serum,

has been widely used, but it is neither sensitive (since it is not elevated in all patients with pancreatic cancer) nor specific (its elevation can be observed in many other pancreatic and hepatobiliary diseases). Other proteins, such as mesothelin and MIC-1 (macrophage inhibitory cytokine), are being investigated as novel molecular markers for early diagnosis of pancreatic cancer. If research determines that these proteins can be detected at increased levels in people who have earlystage pancreatic cancer, it might be possible to develop a diagnostic test that uses these proteins to detect the disease earlier than is currently possible. Earlier diagnosis would lead to earlier treatment. But these proteins are not currently available for clinical use, and further research is needed. Improving treatment Currently, the standard of care for patients with resectable disease is surgical resection


followed by chemotherapy with radiation. Data from multiple clinical trials suggest that postoperative chemotherapy improves survival of patients with pancreatic cancer. The precedent for the use of postoperative chemotherapy and radiation was set by the historical adjuvant chemoradiation trial performed by the Gastrointestinal Tumor Study Group (GITSG). This small trial, performed in the U.S., showed that the addition of postoperative chemoradiation with 5-fluorouracil (5-FU) improved the median survival of patients from 11 months to 20 months. The use of postoperative chemotherapy is further supported by the results of the ESPAC-1 trial, which was conducted in Europe. In this trial, addition of postoperative chemotherapy improved the median survival of patients with pancreatic cancer from 15 months to 20 months. In contrast to the U.S. trial, however, this trial showed worse

outcomes with the addition of radiation therapy. Concerns have been raised with respect to the quality and type of radiation used in the ESPAC-1 trial. Addition of radiation is still considered standard care in the U.S.

and treatment strategies. One approach is to target the pathophysiology of cancer. As an example, epidermal growth factor receptor- (EGFR-) dependent signaling cascades are intimately involved in the patho-

Only 10 percent to 15 percent of the patients who have their cancer removed by surgery are alive five years after diagnosis. More recent trials (ESPAC-3 and RTOG 97-04) comparing gemcitabine with 5-FU have shown that gemcitabine is equivalent to 5-FU in terms of effect on survival, and has a better toxicity profile. As a result of these findings, postoperative gemcitabine with radiation has become the standard of care in the treatment of pancreatic cancer. Poor outcomes despite surgery and adjuvant therapy have led researchers and clinicians to evaluate many other drugs

genesis of pancreatic cancer. A recent randomized controlled trial demonstrated that targeting EGFR by erlotinib (Tarceva) in addition to gemcitabine improved the median survival of patients with locally advanced and metastatic pancreatic cancer who could not undergo surgery, when compared to standard therapy with gemcitabine alone. Based on this data, the FDA has approved erlotinib for treatment of pancreatic cancer. However, these improvements were very marginal, extending

life by only two weeks. Clinical trials are currently evaluating whether the addition of erlotinib to gemcitabine and radiation as a postoperative systemic therapy provides any survival advantage. Another clinical trial has demonstrated that FOLFIRINOX (an aggressive chemotherapy regimen that is a combination of 5-FU, Leucovorin, Irinotecan, and Oxaliplatin) is better than gemcitabine alone in improving the median survival of patients with metastatic pancreatic cancer from 6.8 months to 11.1 months. Given the efficacy of this chemotherapy regimen in metastatic disease, researchers are currently evaluating whether the FOLFIRINOX regimen can be more effective than current therapies in patients who have had their pancreatic cancer resected. Similarly, recent studies have suggested that adding album Changing the face of pancreatic cancer to page 34

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February 2014 Minnesota Physician

17


Professional update: Oncology

M

y practice is full of men with metastatic prostate cancer, a disease causing significant symptoms and, inevitably, an early death. Every person with an incurable cancer had, at some point, early stage disease that could have been cured with local treatments. In other words, had their cancer been found and treated before it had metastasized, every one of these patients would have avoided the chemotherapy, radiation, and chemical castration that now make up the bulk of their shortened lives.

And yet, a little over a year ago, the United States Preventive Services Task Force (USPSTF) reviewed the best existing data and concluded that PSA screening for prostate cancer leads to more harm than benefit. The USPSTF recommended against PSA screening for all men. How could this be? What does it mean? Won’t abandon-

Prostate cancer screening

This implies that one-third of men over age 40 may have undiagnosed prostate cancer. And for the vast majority, it will never cause problems their entire lives.

The medical oncologist perspective

The equally true and seemingly contradictory statement is this: Prostate cancer is the second-leading cause of cancer death in men. Each year, more men die from prostate cancer than colon cancer. Clearly, there are some men for whom prostate cancer is an overwhelming and ultimately lethal problem. If their cancers had been found early enough, presumably with an effective screening test, they wouldn’t be in the situation they find themselves in now.

By Stuart H. Bloom, MD, MSc ing PSA screening result in more morbidity and mortality? How can finding prostate cancer early not be a good thing? In order to answer these questions, it is important to first look at two facts about prostate

will develop the disease. And it is not only older men; new data show that a surprising number of younger men have undiagnosed prostate cancer. Two recently reported autopsy studies (men who have died from

“Things should be as simple as possible, but not simpler.”—Albert Einstein cancer. While both are equally true, they appear contradictory. The first is that prostate cancer is remarkably common. It is well known that if men live long enough, the odds are they

something else and have their prostates sectioned at autopsy) have shown that in men aged 50–59, the incidence of prostate cancer is 23 percent to 45 percent. The percentages are similar in men aged 40–49.

Treatment— and overtreatment Most men will get prostate cancer, and the vast majority will not die from it. But some will. For an oncologist, this is not at all surprising. Most cancers have both indolent (low-risk)

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Minnesota Physician February 2014


and aggressive (high-risk) subtypes. In the case of prostate cancer, a positive PSA screen leads to a biopsy. Biopsy yields a diagnosis of cancer. The cancer can be low risk or it can be high risk, the kind that needs intervention to save a man’s life. Since most cancers found at biopsy are low risk, discovering and treating them would not be expected to improve the health of the populace. Yet over the last two decades, more than 90 percent of men diagnosed with prostate cancer received treatment, according to the CaPSURE database (a national registry of more than 14,000 men diagnosed with localized prostate cancer). This is called overtreatment. PSA screening and high-risk cancer The current estimate is that 20 to 40 radical prostatectomies have to be performed to save one life. That is a lot of unnecessary surgery. Moreover, because prostate cancer treatments can

have well-known and life-altering side effects (e.g., impotence and incontinence), this overtreatment has led to significant harm. I am a frequent attendee at prostate cancer support groups, and I can tell you that there are a lot of frustrated and angry prostate cancer survivors who can attest that, as the USPSTF states, “many men are harmed as a result of prostate cancer screening and few, if any, benefit.” But if 90 percent of men with a new diagnosis of prostate cancer receive treatment, then some high-risk patients are getting treatment, too. It follows that in the PSA era fewer men are dying from prostate cancer than before the widespread adoption of PSA screening. Indeed, that is exactly the case. In the early 1990s, 40,000 men died annually from prostate cancer. PSA screening became widespread around this time, and since then, the death rate due to prostate cancer has dropped steadily. For 2013, the

estimate is 29,000 deaths—a 25 percent drop, despite a rise in the population of men over 60. When cancer mortality rates drop despite increasing incidence, it is usually due either to screening or to more effective therapy. While the treatments for prostate cancer are improving, the relapse rates after local treatments have not changed. We have many new therapies for advanced disease that extend survival and improve quality of life, but cure is still not possible for these men. Therefore, the only factor that explains the drop in prostate cancer death is PSA screening. In contrast to low-risk patients who don’t benefit from interventions, treating high-risk patients saves lives. The recently published Prostate Cancer Intervention Versus Observation Trial (PIVOT) randomized men with localized prostate cancer (half of whom were biopsied due to an elevated PSA) to either surgery or observation. Patients

with high-risk disease had 60 percent less chance of prostate cancer death with treatment. There was no benefit seen in those with low-risk disease. The accompanying editorial in the July 19, 2012, issue of the New England Journal of Medicine stated: “High grade, aggressive prostate cancers usually have a lethal course if left untreated … and are most likely to benefit from therapy.” It follows that high-risk patients that are not offered local treatment are at significant risk of mortality. An analysis of the National Cancer Institute’s SEER (Surveillance, Epidemiology, and End Results program) database looked at more than 14,000 men diagnosed with localized prostate cancer, and treated with conservative management (no curative treatment, but intervention if symptoms occurred). The chance of dying from prostate cancer in men aged 66–69 with high-risk cancer was 35 percent Prostate cancer screening to page 32

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SPECIAL FOCUS: DATA security AND privacy

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Mobile devices in health care delivery

he use of mobile devices such as smartphones and tablets by health care providers is here to stay. The compact size, expansive storage capacity, multiple options for rapid communication and increasing availability of powerful clinical tools downloadable as applications make devices a valuable aid for providers in delivering care. However, the use of mobile devices creates unique risks and raises the stakes for HIPAA compliance.

A great tool, but at what price? By Timothy Johnson, JD, and Jesse Berg, JD

(PHI) under HIPAA. For a group that elects to use mobile devices in care delivery, the

The trade-off For each of the benefits mobile devices offer for care delivery, there are corresponding risks that providers must evaluate. For example, while text messaging and quality cameras available on smartphones give physicians a great option for obtaining instant consults with colleagues in other locations, a patient photograph sent to the wrong recipient creates a real risk of a breach of the patient’s protected health information

driven by your

The risks associated with emailing or texting ePHI are obvious. Most of us, at one time or another, have sent an email to the wrong person. most important question to answer is whether providers and other personnel will be required to use employer-provided or

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“enterprise-sponsored” devices or whether the employer will allow a “bring your own device”

Minnesota Physician February 2014

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(BYOD) approach. When employers control the type of mobile device used along with the software and applications loaded on the device, the benefits associated with enterprise-sponsored devices are obvious. The centralization and control afforded by this approach means management can ensure adherence to such requirements as passwords, routine backups, limitations on whether data can be stored on the device and, if so, the duration of storage, data destruction, as well as encryption of data at rest and in transit. For those physician groups that allow a BYOD approach, their inability to achieve this level of centralized control requires the group to take alternative measures to ensure the group’s compliance with the HIPAA security requirements. Mobile devices under the HIPAA Security Rule As part of their obligation to comply with HIPAA, groups—as well as their “business associates”—will need to ensure that the groups’ use of mobile devices complies with the requirements of the HIPAA Security Rule. Although the Security Rule has been on the books since 2005, there recently has been an increased emphasis on enforcement by the HHS Office for Civil Rights (OCR).

Under the Security Rule, covered entities and business associates must meet a number of safeguards that are intended to protect the integrity, confidentiality and availability of electronic PHI (ePHI). For instance, prior to allowing their providers to use medical devices, groups must first conduct a risk analysis that assesses what kinds of risks and vulnerabilities to ePHI are posed by the devices, and then adopt measures to reduce those risks to a reasonable and appropriate level. The Rule is intended to be “scalable,” which means that groups have some flexibility to select safeguards that are appropriate for the group based on factors such as cost, size of the organization, and its technical capabilities. What this means is that the safeguards adopted by a large group with multiple locations and hundreds of employed providers are likely to be more extensive than those implemented by smaller rural groups. The Security Rule has dozens of principles that providers must address. The remainder of this article will discuss how devices fit within several of the Security Rule’s key principles. Electronic communications The risks associated with emailing or texting ePHI are obvious. Most of us, at one time or another, have sent an email to the wrong person, perhaps as a result of the “auto-fill” or “reply all” functions. The safest approach for electronic transmission is via a virtual private network, sponsored and managed by the group, coupled with enterprise-sponsored devices. Locking down both points of access and encrypting channels by which information flows makes it much less likely that ePHI will be accessed improperly. Another advantage of encryption (assuming it is done at levels of security specified by OCR) is that ePHI then becomes “not unsecured,” which means that if an email is sent to the wrong recipient, the provider does not have to treat the error as a “breach” potentially requiring notification to patients, regulators, and the media.


For clinics that permit BYOD use, requiring providers to use a secure channel for transmitting ePHI is the next best option. For organizations that permit providers to use unsecure email services, it is recommended that providers be trained not to transmit ePHI and personnel should be restricted from forwarding emails or documents containing ePHI to their personal accounts. Where patients ask that providers communicate via unsecure email (containing ePHI), it is wise to obtain consent that puts the patient on notice about the risks associated with this communication. Texting ePHI creates even more risk because the network channels over which data are transmitted are not automatically encrypted as they traverse carriers’ wireless channels en route to their destination. This likely means that unless a group buys third-party software that scrambles the text before it is sent (and unscrambles it upon arrival), the data will be in the open during transmission and subject to interception. For groups that do not scramble texts during transmission— but have providers who insist on using texts to consult with colleagues—an alternative approach is to train providers to send a text asking their colleagues to check their secure email, where the ePHI can be transmitted with more confidence. Storing data A big downside of mobile devices is that their compact size makes them easy to lose. Furthermore, cutting-edge devices like iPads and other tablets are attractive targets for thieves. There have been numerous enforcement actions where laptops and other devices containing ePHI have been stolen or lost. There are very simple steps that can be taken to secure ePHI on these devices that are nonetheless overlooked by providers. For example, prohibiting employees from storing ePHI on personal devices, such as mobile devices or USB drives, limits risks that ePHI will fall into the wrong hands. Likewise, establishing minimum requirements

for passwords (that require a combination of characters) and requiring that passwords be changed every 30 days or so will reduce the likelihood of improper access to ePHI. Most mobile devices include functionality that permits locking

satisfied depends on how the software is integrated into the practice and used by personnel at the organization. What happens when it’s time to upgrade? Since mobile devices are

Texting ePHI creates even more risk because the network channels over which data are transmitted are not automatically encrypted. the device—or even wiping its memory entirely—after several unsuccessful attempts to obtain access. In addition, many mobile devices have built-in encryption capabilities for data at rest or allow for downloading applications that encrypt data residing on the phone or tablet. While enterprise-sponsored devices make adherence to these steps easier for management, groups that permit BYOD can still require employees to have these functions operational as a condition of using the device for on-the-job duties. Third-party applications Downloadable applications for mobile devices can help providers in a variety of ways, including facilitating patients’ online access to their health records, monitoring patient adherence to treatment recommendations, creating new ways of managing a group’s calendar and appointment schedules, and even assisting providers in diagnostic decision-making. Groups that desire to use these tools will need to vet their compliance with HIPAA requirements, including whether the application vendor meets the definition of “business associate” and, if so, whether it is willing to sign a business associate agreement (BAA) with the group. For example, providers have been sanctioned in the past for placing ePHI on electronic calendars maintained by third parties that refused to sign BAAs. Further, providers should be wary of vendors who tout their “HIPAA compliant” software. While applications can be designed in ways that aid groups in complying with the law, whether HIPAA guidelines are

relatively inexpensive, and are constantly being improved with new capabilities, it is not uncommon for groups to upgrade their devices every few years, or in groups that permit BYOD, for providers to regularly upgrade their own devices. Upon such upgrades, the Security Rule requires that the replaced device, whether it is recycled, returned, sold, etc., has its memory wiped clean to scrub any ePHI that may remain on the device. Fortunately, many mobile devices can be configured to permit

remote wiping or set to trigger self-wiping after a number of incorrect authentication attempts. Next steps While there is no question that mobile devices offer great potential for improvements in efficiency and quality of care, mobile devices present additional Security Rule compliance risks to groups. One of the most important things a group can do to demonstrate its commitment to HIPAA compliance is having a clear and robust risk analysis and corresponding risk management policy that shows how the organization has taken steps to address the unique risks posed by mobile devices. Timothy Johnson, JD, and Jesse Berg, JD, are attorneys at Gray Plant Mooty in Minneapolis. Timothy specializes in representing health care organizations and has significant experience in HIPAA privacy requirements. Jesse regularly counsels health care organizations on HIPAA and state privacy and confidentiality matters.

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February 2014 Minnesota Physician

21


SPECIAL FOCUS: DATA security AND privacy

H

ealth care providers are constantly trying to stay current with new advancements in clinical care, technology, and research. Consequently, this often leaves little time for staying informed about developments in health information privacy law. Unfamiliarity or disregard for privacy requirements, however, may lead to significant violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), leading to patient lawsuits, corrective action by employers and state licensing boards, and investigations by government regulators. The creation and maintenance of a strong privacy compliance program is the best way to avoid these undesirable outcomes.

Telephone Equipment Distribution (TED) Program

This article discusses two HIPAA issues—the right to request amendment and the right to access— that commonly arise for health providers, and provides tips for complying with applicable privacy requirements.

Staying current to stay compliant Privacy compliance tips for health care providers By Morgan Vanderburg

Right to request amendment With the creation and increased usage of online patient portal accounts, patients are viewing

With the creation and increased usage of online patient portal accounts, patients are viewing their health information more than ever. their health information more than ever. This also means that patients are finding errors or

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22

other points of disagreement in the medical record documentation. Many health care providers who offer patient portal

Minnesota Physician February 2014

accounts are experiencing an influx of amendment requests, so it is vitally important that health care providers maintain effective policies and procedures for these requirements. Health care providers often feel uncomfortable when patients request an amendment to their health information. Under HIPAA, patients have the right to request an amendment of health information in their medical record if they believe that information is inaccurate or incomplete. This may pose a dilemma for the provider, who wants to accommodate the patient’s request but also feels uneasy about changing or removing medically relevant information in the patient’s health record. For example, patients may request that a diagnosis of “obesity” or a description of “emotionally unstable” be removed, even though this terminology is medically accurate and necessary for effective clinical documentation. If the provider feels the use of such terminology is accurate and complete, he or she is permitted to deny the patient’s request. As another example, if the patient would like to include an additional 13 pages of autobiographical information into the “social history” section of a clinical note, a provider may

deny the request if he or she determines that the medical record documentation is already accurate and complete without including that information. The provider is also generally allowed to deny an amendment request if the health information in question was not created by the provider, unless the patient provides a reasonable basis to believe that the original author of the health information is no longer available to act on the requested amendment. Providers should be aware, however, that certain HIPAA obligations apply if an amendment request is denied. The provider must send a written denial to the patient that explains the basis for denial, the patient’s right to submit documentation in response to the denial to the provider for inclusion in the medical record, and a description of how the patient may file a complaint. If the provider agrees to make the requested amendment, the provider must make the appropriate revision to the clinical documentation, inform the individual of the acceptance, and make reasonable efforts to send a revised copy to other parties who may have received the inaccurate or incomplete information. Right to access Health care providers may also encounter issues related to a patient’s right to obtain and inspect a copy of his or her health information. Prior to the enactment of HIPAA, many states failed to pass legislation that provided patients with a right to view copies of their medical records. HIPAA established a federal right to obtain a copy of one’s medical record, which the health care provider must produce within 30 days. Despite this change in law, many health care providers continue to withhold health information from patients for various reasons. For example, some behavioral or mental health providers refuse to provide clinical documentation that includes an analysis of the patient’s mental state at the time of the appointment. Providers also may refuse to provide a copy of the records due to fear that the patient intends to file a malpractice suit,


or in cases when a parent who is facing allegations of child abuse requests a copy of the child’s record. There are limited instances in which a provider may withhold a copy of the patient’s health information. One exception to a patient’s right to access relates to the disclosure of psychotherapy notes, which are specifically and narrowly defined in HIPAA, including a requirement that the notes are kept separate from the patient’s medical record. Another exception allows providers to deny access if they believe the disclosure of the health information could cause harm to the patient or another person. In these situations, the patient has the right of independent review by another licensed health care provider who was not involved in the original decision to deny access. Patients also have a right to file a complaint with the Office for Civil Rights (OCR), which is the office within the federal Department of Health and Human Services that is charged with enforcing HIPAA. OCR reviews each complaint and investigates ones that effectively allege violations of HIPAA. Inappropriate denial of access is one of the

and friends, use of health information for research purposes, and reporting requirements for privacy breach incidents. For health care providers who work in a large medical facility with a robust compliance program, one of the best ways to avoid privacy issues is to review the facility’s policies and procedures related to health information, review the facility’s privacy training materials, and identify the facility’s privacy official who can assist when questions or issues arise. Health care providers who work in small practices often need to work with fellow staff members to ensure applicable privacy requirements are being met. This includes not only developing privacy-related policies but also ensuring that relevant staff members are educated on these policies and follow them consistently. Each practice also needs to designate a privacy official and establish a process for handling privacy complaints. A complete catalog of HIPAA requirements is provided in OCR’s Audit Protocol (see sidebar for link), which is the standardized criteria document that OCR uses when auditing the privacy compliance programs of health care providers.

Health care providers who work in small practices often need to work with fellow staff members to ensure applicable privacy requirements are being met. most commonly received complaint topics that OCR receives, so health care providers should familiarize themselves with the requirements of this HIPAA provision. Avoiding privacy issues Although the right to request amendment and right to access are important and frequently occurring privacy topics encountered by health care providers, the HIPAA regulations include numerous additional requirements that also apply to the medical information held by health care providers. HIPAA also governs, for example, the disclosure of health information to the patient’s family members

Due to the perceived complexity of privacy and security rules, several groups have created education and training materials to help providers navigate the privacy landscape. For example, the American Medical Association recently posted free HIPAA resources on its website (see sidebar for link). These materials include various materials, resources, and privacy toolkits to promote compliance among providers. OCR has also published free educational resources that are specifically tailored for a health-care provider audience (see sidebar for link). These resources provide an explanation in plain language of the privacy

Privacy and security resources OCR audit protocol www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/protocol. html AMA free HIPAA resources www.ama-assn.org/ama/pub/physician-resources/solu tions-managing-your-practice/coding-billing-insurance/hip aahealth-insurance-portability-accountability-act/hipaa-rela ted-web-sites.page OCR HIPAA training materials www.hhs.gov/ocr/privacy/hipaa/understanding/training/ OCR privacy and security email listserv www.hhs.gov/ocr/privacy/hipaa/understanding/coveredent ities/listserv.html

rule and guidance for compliance efforts. OCR also manages a privacy and security email listserv (see sidebar for link) as a means to communicate relevant news, guidance, and updates related to health information privacy and security.

Morgan Vanderburg works as a senior privacy analyst for the Mayo Clinic in Rochester, Minn. The information in this article does not necessarily reflect the views of Mayo Clinic.

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SPECIAL FOCUS: DATA SECURITY and privacy

M

edical professionals work with confidential information on a regular basis. Known as Protected Health Information (PHI), it includes names, diagnoses, and prescriptions, which legally cannot be shared without permission. This information requires information assurance, the act of ensuring that data is protected from unwanted eyes or disaster.

HIPAA and maintaining patient information integrity Physicians understand the importance of guarding PHI and having patients trust them. Patients and physicians also need to be able to have confidence in the communication systems that are in place for them to share information with each other, including third-party apps for mobile devices. Maintaining the integrity of patient information is crucial because physicians will want to make sure patients can request

Third-party health care apps Making sure they are HIPAA-compliant By Marc Ohmann

access to their medical records; carefully handle patients’ health information to protect patients’ privacy; and keep the infor-

must be treated with special care (see next page for list). The consequence for failing to comply with HIPAA can

Keep track of your mobile device at all times. mation in patients’ individual records as accurate as possible. Under the U.S. Health Insurance Portability and Accountability Act (HIPAA), PHI that is linked based on 18 identifiers

result in severe penalties. Even if the mistake is not known, or if the mistake is realized and fixed, there can be negative consequences that can take shape in fines as well as more severe legal ramifications. What to look for in a third-party app When considering a third-party app to facilitate communication between providers and patients, or between providers themselves, do your research to ensure the following 10 key security requirements. The app should:

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Minnesota Physician February 2014

• Have the ability to keep information encrypted both in the sending/receiving process and in storing the information • Have the ability to communicate as quickly as possible, especially when dealing with patients. Look for an app that allows for real-time communication. • Use and enforce strong passwords (include letters and numbers, upper and lower case, and even punctuation) • Have an integrated installation and activation of wiping and/or remote disabling to erase any data on your mobile device in case it is lost or stolen, or if

you choose to replace your old device • Disable the use of file sharing applications, or at least alert you so that you do not run both applications at the same time • Have an installed firewall to block unauthorized access • Have security software to protect against malicious applications, viruses, spyware, and malware-based attacks • Have an updating process with reminders any time there is an update You should: • Keep track of your mobile device at all times. Carry it with you as often as possible and utilize the password protection on your phone • Avoid sending or receiving health information over public Wi-Fi networks Each of these recommendations is in accordance with appropriate requirements by HealthIT.gov and come from our experience developing a third-party app for health care professionals. Business Associate Agreement In addition to ensuring the third-party app complies with the guidelines above, make sure the company offering the product is willing to sign a Business Associate Agreement (BAA). This contract provides written assurances that an organization’s partners will also secure an individual’s PHI. The HIPAA Privacy Rule allows covered entities (health care providers, hospitals, health plans, etc.) to use the services of other persons or businesses to carry out their activities. They are allowed “to disclose protected health information to these ‘business associates’ if the providers or plans obtain satisfactory assurances that the business associate will use the information only for the purposes for which it was engaged


rooms, hospitals, pharmacies, and clinics).

HIPAA PHI identifiers PHI that is linked based on the following 18 identifiers must be treated with special care: 1.

Names

2.

All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census: a. The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people b. The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000

3.

All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older

4.

Telephone numbers

5.

Fax numbers

6.

Email addresses

7.

Social security numbers

8.

Medical record numbers

9.

Health plan beneficiary numbers

10. Account numbers 11. Certificate/license numbers 12. Vehicle identifiers and serial numbers, including license plate numbers 13. Device identifiers and serial numbers

Our experience is that HIPAA-compliant third-party apps for mobile devices are possible as long as all levels and types of security are maintained throughout the development process and with the consumer once the product has gone to market. The future of data security One improvement that may not be far off is object data security, which does not simply lock an account with a password, but instead locks down every single object within an electronic information database. When you are away from home, your primary means of keeping the contents safe is to lock the doors, windows, etc. Now imagine someone were trying to break into your home. Currently, the only security the intruder would have to bypass would be the exterior locks. Once inside, each object

14. Web Universal Resource Locators (URLs)

could be removed. What if your security system were different? What if the intruder found that every object located inside your home was locked down and could not be removed? This is the future of electronic data security. Securing health care electronic data is not only extremely important, it’s the law. As mobile technologies help make health care more responsive, remember to take all necessary steps to ensure that health care communication keeps up with security standards and the law. There is a place for mobile devices in the health care system and with proper security, they can make life better for everyone. Marc Ohmann is the founder and president of Digital Solutions, Inc., a web development and search engine optimization firm based in Bloomington, Minnesota. He is also responsible for the strategic development of the MDWebPro, a platform that enables medical professionals to manage their online reputations.

15. Internet Protocol (IP) addresses 16. Biometric identifiers, including fingerprints and voiceprints 17. Full-face photographs and any comparable images

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18. Any other unique identifying number, characteristic, or code, except the unique code assigned by the investigator to code the data

by the covered entity, will safeguard the information from misuse, and will help the covered entity comply with some of the covered entity’s duties under the privacy Rule.… The satisfactory assurances must be in writing, whether in the form of a contract or other agreement between the covered entity and the business associate.” This is no small thing. According to the Covered Entities and Business Associates section of the HHS.gov website, “Business associates are directly liable under the HIPAA rules and subject to civil and, in some cases, criminal penalties for making uses and disclosures of protected health information that are not authorized by its contract or required by law. A business associate also is directly liable and subject to civil penalties for failing to safeguard electronic protected health information in accordance with

Strengthening the Heart for a Healthier Life

the HIPAA Security Rule.” Example of a third-party app Our company recently worked with a client in creating a third-party app for health care professionals that meets HIPAA requirements. As a third-party business associate we were required to follow the HIPAA rules and regulations as well as formally sign a BAA acknowledging our role and responsibility during the development process with our client. The app we developed combines notes from pagers, text messages, and emails into one app that allows health professionals to communicate with each other securely. Members are allowed two-way and HIPAA-secure messaging between each other as well as with selected staff such as nurses and other health staff assistants in HIPAA-secure locations (nursing stations, emergency

Cardiac Care at Saint Therese offers: • Low rehospitalization rates. Only 11% of cardiac patients under our care readmit to the hospital, compared to the national average of 18% • Integrated programming connecting doctors, nurses, rehab specialists, clinical nutritionists and on-site pharmacists • Specially trained skilled nursing staff • Cardiac trained rehab professionals • On-site EKG equipment • Physician communication training • Four post-discharge phone call check-ins for a smooth transition to home SA I N T TH E R E S E of N E W H O P E

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Special focus: Data security and privacy

M

innesota health care providers, clinics, and hospitals have made great progress in adopting electronic health records (EHRs). As Figure 1 on page 36 shows, nearly all hospitals in the state, as well as 87 percent of clinics, have adopted EHRs. This movement toward the adoption and effective use of EHRs, as well as the secure, standards-based exchange of health information, will continue to accelerate as Minnesota and the nation implement federal meaningful-use standards for the use and exchange of electronic health information. A critical piece of this progress is that patients must have confidence in the integrity of the data being shared and must trust that providers using the data have procedures in place to keep their information safe and secure. Without patients’ trust and confidence, the sharing of health information may be limited or nonexistent, increas-

Putting the pieces in place Minnesota takes steps to protect health information By Lisa Moon, RN, BSN, and Bob Johnson, MPP

ing the opportunity for negative care results, poor quality, gaps or delays in the delivery of care, and increased redundancy—

Patients must have confidence in the integrity of the data being shared and must trust that providers using the data have procedures in place to keep their information safe and secure. and costs—in the health care system.

Read us online Wherever you are!

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The real value in EHR systems comes from using them effectively to support efficient workflows and effective clinical

Minnesota Physician February 2014

decisions that have a positive and lasting effect on the health of individuals and populations. Providers, clinics, and hospitals need to have accurate and complete information at all times in order to deliver high quality patient care that is coordinated across the care continuum. To gain the confidence and trust of patients, all providers of health care services, regardless of size or specialty, must implement standards established by the HIPAA Security Rule to ensure that appropriate safeguards are in place to protect electronic health data from unauthorized access. These administrative, technical, and physical safeguards, together with sound policies, procedures, and practices for use of technology in delivering patient care, will create a framework for meaningful exchange of health information. Minnesota focus on e-health, privacy, and security Minnesota has long been committed to leveraging technology to improve health care. The Minnesota e-Health Initiative, formed 10 years ago, supports the ongoing e-health efforts of health care providers and

organizations in Minnesota. This diverse group includes physicians, nurses, and other representatives of health care associations, clinics, hospitals, consumers, local public health departments, academic health settings, and other health care organizations. The Minnesota e-Health Initiative and its Advisory Committee are charged by the Legislature to advise the commissioner of health on all relevant e-health topics. Their work to advance the Minnesota e-Health Vision “to accelerate the adoption and use of HIT in order to improve health care quality, increase patient safety, reduce health care costs, and improve public health” has provided a model for effective public-private collaboration. Privacy & Security Workgroup. Reporting to the Minnesota e-Health Advisory Committee, the Minnesota e-Health Initiative’s Privacy & Security Workgroup has been in existence since 2005. The workgroup, composed of experts from the legal community, health information management, and stakeholder groups from across Minnesota, provides necessary expertise and feedback to the eHealth Initiative. With input from consumers and other interested parties, the workgroup’s transparent, structured approach drives consensus to motivate collaborative action statewide. LaVonne Wieland, a compliance and privacy officer for a large integrated delivery network in the Twin Cities, has been a part of the Privacy & Security Workgroup since the workgroup began. Wieland, who currently serves as a co-chair, notes: “The collaboration of members has been instrumental in addressing the annual work tasks. The representation of members from throughout the state provides excellent work products for use by all Minnesota health care facilities in their e-health journey.” It is the group’s composition that keeps its members engaged in the workgroup process, Wieland adds.


Privacy & Security Workgroup, 2005–2013 The Privacy and Security Workgroup of the Minnesota e-Health Advisory Committee has been in existence since 2005. Here are some of the group’s accomplishments through 2013: • Developed the Minnesota Standard Consent Form to Release Health Information, which can be used by all patients and consumers to secure the appropriate release of their health information. www.health.state.mn.us/divs/hpsc/dap/consent.pdf • Changed the Health Records Act to include “Representation of Consent,” to assist the movement of electronic health information www.revisor.mn.gov/statutes/?id=144.291 • Focused work on identification of patient consent barriers for health information exchange • Provided essential stakeholder expertise and feedback to address the challenges to health information exchange • Evaluated consent barriers inherent in exchanging information across state borders: www.healthit.nd.gov/files/2010/07/UMHIE_Final_Report_Oct-2011.pdf • Produced 2012 Legislative Study on the current use of Representation of Consent, electronic health information security practices, and patient notification procedures when unauthorized access to an electronic health record occurs (Minnesota Department of Health, “Minnesota Health Records Access Study, Report to the Minnesota Legislature,” February 2013). The 2013 legislative report, findings, and recommendations from this study can be found at www.health.state.mn.us/e-health/hras/hras021913report.pdf. Each year, the workgroup is charged by the Minnesota e-Health Advisory Committee to review and comment on timely privacy- and security-related policies and guidance, and to make recommendations on policies and practices that support compliance with state and federal health IT requirements (including meaningful use). The group recommends, to providers and other health care entities, activities that support the implementation of sound privacy and security practices for health information. The group is also charged with ensuring that the needs of consumers, providers, and health care stakeholders are fully considered in the development of any educational resources and tools related to health information privacy and security. The sidebar lists some of the workgroup’s key accomplishments to date. Workgroup activities, 2013–2014 Informed by the findings of the 2013 Minnesota Health Record Access Study and by stakeholder feedback, the workgroup is currently implementing recommendations from that study’s final report by providing tools that may help establish and improve robust privacy and security programs. Workgroup activities for 2013–2014 include: • Reviewing examples of

“notice of privacy practices” forms provided by national organizations and recommending Minnesota specific considerations, so that all health care providers, whether large or small, can have a consistent understanding of what legal requirements this document must meet

this year, we’re really lucky to have a diverse group of both experienced and specialty practitioners to assist us, along with terrific staff support.” Among the other activities the workgroup supports are the ongoing monitoring of relevant state and national privacy and Putting the pieces in place to page 36

• Identifying leading practices for proactive monitoring and patient notification for unauthorized access of a patient’s EHR and providing related tools, in an effort to increase overall awareness of the importance of these compliance activities

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• Reviewing security risk assessment standards and providing a checklist of basic elements that must be present at the provider level to successfully complete a security risk assessment for stage 2 meaningful use attestations • Participating in the development of consumer-centric materials that inform patients about the purpose of electronic health records and health information exchange and that include information on appropriate security and privacy considerations Laurie Beyer-Kropuenske, an attorney and co-chair of the workgroup, commented: “With all the deliverables on our list

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OPHTHALMOLOGY

A

ccording to the Centers for Disease Control and Prevention (CDC), more than 20.5 million Americans have cataracts. It is the leading cause of vision loss in the U.S., with the federal government spending $3.4 billion yearly to treat the condition.

Does statin use increase the risk of cataracts?

Cataracts are generally an age-related condition in which the lens inside the eye starts to get cloudy, leading to a decrease in vision. In fact, cataracts are the most common cause of blindness. Common symptoms of cataracts include difficulty seeing colors and changes in contrast, driving, reading, and recognizing faces; and coping with glare from bright lights.

New research suggests a link

The condition usually affects one eye first, but gradually affects both. Several factors have been shown to cause cataracts, including long-term exposure to ultraviolet light and exposure to ionizing radiation. Health also plays a role. Conditions such as diabetes, hypertension, advanced age, or trauma can also

By Y. Ralph Chu, MD

result in a breakdown of the lens protein.

According to the results of the study, the risk for cataracts was higher among statin users compared with non-users. Statin use expected to increase Recently, the connection between statins and cataracts has

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been getting a lot of attention. Statins are a class of drugs used to lower cholesterol levels by in-

Minnesota Physician February 2014

hibiting the enzyme HMG-CoA reductase, which plays a key role in producing cholesterol in the liver. It is estimated that one in four Americans over the age of 45 currently take a statin drug. In November 2013, the American College of Cardiology and the American Heart Association announced new treatment guidelines for high cholesterol that likely will double the number of users to an estimated 72 million people (Circulation, 01.cir.0000437738.63853.7a). Such a significant increase in statin use makes it even more important to understand the reports of a link between statin use and cataracts. In previous studies, the results have been controversial as the link between statin use and cataracts is inconsistent or studies of such have produced conflicting, weak or insignificant results. One study even showed that statins lowered the risk of developing cataracts. New research finds higher risk However, in one of the largest studies ever done on the subject, researchers have found a connection between statin use and cataracts. In a study published in the November 2013 issue of JAMA Ophthalmology and published online in JAMA

Ophthalmology, Jessica Leuschen, MD, of the San Antonio Military Medical Center, Tex., and colleagues reported their findings (JAMA Ophthalmology, November 2013, Vol 131, No. 11). The scientists compared the risk of developing cataracts between closely matched statin users and non-users. For the period October 2003 to September 2005, the researchers identified people (ages 30 to 85) who had received at least 90 days’ worth of a statin prescription during this time. People who received a statin prescription, but it lasted for less than 90 days, were excluded from the study. In total, the researchers identified more than 46,000 patients from a military health care database. More than 13,600 of the patients were statin users while 32,600 did not take statins. The researchers combed through the patient data to pair up users and non-users as closely as possible by age, sex, medical conditions and 41 other variables for a total of 7,000 closely matched pairs. According to the results of the study, the risk for cataracts was higher among statin users compared with non-users. Taking into consideration other known risk factors, statin users had a 27 percent higher chance of developing cataracts than non-users. Further analyses found that the cataract risk may be higher when statins are given to people with risk factors for cardiovascular disease but who have not yet had any cardiovascular disease events such as a heart attack or stroke. Dr. Leuschen and her colleagues concluded that there is an increasing need for doctors to carefully weigh the risks and benefits of statin use, especially for primary prevention. The group also called for further studies on the matter. The study does not prove a direct link between cataracts and statins. Essentially, statins are an effective treatment to lower cholesterol and help reduce risk of cardiovascular disease. In some cases, statins Does statin use increase the risk of cataracts? to page 30


EDUCATION TRAINING PROGRAM EDUCATION TRAININGTRAINING PROGRAM EDUCATION PROGRAM

LGBTQ Health Professional Development Training Datesan for this training willHealth be held on 2/15,LGBTQ 3/8, 3/22 andissues. 4/5 The first half of the LGBTQ Health Professional Development Training This 4 hour training offers in-depth understanding of specific health LGBTQ Professional Development Training training This is an4 hour LGBTQ it covers general terms and LGBTQ patient For second training offers an in-depth ofguidelines specific LGBTQ health issues. Thecare. first half ofthe the This101; 4 hour training offers understanding an in-depth understanding offor specific LGBTQ health issues. The first half of the halftraining of theistraining, choose one of theguidelines topics below, or they work theFor RHI. antraining LGBTQclients it may covers general terms and forguidelines LGBTQ patient care. Forwith thecare. second is101; an LGBTQ 101; it covers general terms and for may LGBTQ patient the second half of the training, clients may choose the topics below, or they may work with thework RHI.with the RHI. half of the training, clients one may of choose one of the topics below, or they may

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 Creating a competent clinic: Environment, policy & administration  culturally Creating a culturallyclinic: competent clinic: Environment, & administration Creating a culturally competent Environment, policy & policy administration

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PRA Category 1 Credit s™ 1 Credits™ Earn 4 AMA Earn 4 AMA PRA Category

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This training This is well suitedisfor health and service providers, students pursuing degrees in social training well suited forsocial health and social service providers, students pursuing degrees in social work, is nursing, dentistry, health, and medicine; administrative staff; and health providers. nursing, dentistry, health, and medicine; administrative staff;care anddegrees health care This training wellwork, suited forpublic health andpublic social service providers, students pursuing in providers. social

public health, and medicine; administrative staff; and health care providers. work, nursing, dentistry, The cost of this training is $75 dollars for CEU (to be determined) The cost of this training is $75 dollars for CEU (to be determined)

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ACCME Accreditation ACCMEStatement: Accreditation Statement: This activity hasThis been planned implemented accordance with the Essential Areas and Policies of the activity hasand been planned andinimplemented in accordance with the Essential Areas andAccreditation Policies of the Accreditation Council for Continuing Education through the joint sponsorship of sponsorship the Minnesota Medical Association andAssociation Rainbow and Rainbow Council Medical for Continuing Medical Education through the joint of the Minnesota Medical Health Initiative. The Minnesota Medical Association (MMA) is accredited by the Accreditation Council for Continuing Health Initiative. The Minnesota Medical Association (MMA) is accredited by the Accreditation Council for Continuing ACCME Accreditation Statement: Medical Education to provide continuing medical education for physicians. Medical Education to provide continuing medical education for physicians.

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation AMA PRA Category Credit Statement: AMA 1PRA Category 1 Credit Statement: Council for Continuing Medical Education through the joint sponsorship of the Minnesota Medical Association and Rainbow The Minnesota The Medical Association designates this designates training for this a maximum of 4a AMA PRA Category Credit s™. Physicians Minnesota Medical Association training for of 4 AMA 1PRA Category 1 Credits™. Physicians Health Initiative. The Minnesota Medical Association (MMA) is accredited by maximum the Accreditation Council for Continuing should claim only the credit with the extent with of their in participation the activity. in the activity. should claim commensurate only the credit commensurate the participation extent of their Medical Education to provide continuing medical education for physicians. AMA PRAContact Category 1Brianna.McMichael@rainbowhealth.org Credit Statement:

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February 2014 Minnesota Physician 29 The Minnesota Medical Association designates this training for a maximum of 4 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.


Does statin use increase the risk of cataracts? from page 28

can prevent a heart attack or stroke. Treatment options and prevention Cataracts, on the other hand, are treatable. In fact, The National Institutes of Health says procedures to remove cataracts are some of the most common and safest surgeries performed in the U.S. The best way to treat a cataract is with surgery that removes the old, clouded lens and replaces it with a new, artificial one to restore the patient’s vision and quality of life. Cataract surgery is an outpatient procedure that requires only a few hours and uses a topical anesthetic. During the procedure, the surgeon makes a tiny incision in the eye. Through this incision, the surgeon inserts an instrument about the size of a pen tip. This instrument breaks the cloudy lens into pieces and removes the pieces from the eye. Once the cataract is removed, an artifi-

cial replacement lens is inserted through the same tiny incision and set into position to replace the natural lens.

Dr. Chu using the new FDA-approved Victus Femtosecond Laser for cataract surgery.

A new option for cataract surgery is the VICTUS femtosecond laser, the first FDA-approved laser for cataract surgery. This platform allows surgeons greater precision compared to manual cataract and refractive surgery techniques. The VICTUS received FDA clearance in 2012, and Chu Vision Institute has offered this innovative technique since 2013. When patients who received femto were compared with patients who did not receive femto, there was a substantial decrease in the number of patients with a Crystalens implant who required laser vision correction—like LASIK—to finetune the vision post-operatively.

Photo credit: Chu Vision Institute

With growing options to remove cataracts, the task for doctors is to discuss the issue with their statin patients, helping them weigh the risks and benefits of statin use as it relates to the patient’s specific

case. Doctors can also discuss ways to manage cholesterol levels through lifestyle changes, which could potentially allow a patient to avoid the medication and its potential side effects altogether.

Y. Ralph Chu, MD, is medical director and founder of Chu Vision Institute in Bloomington and is an adjunct associate professor of ophthalmology at the University of Minnesota Medical School, Minneapolis.

DON’T MISS THE SPCO THIS SPRING! BEETHOVEN’S SECOND PIANO CONCERTO Thursday, Mar 13, 7:30pm Friday, Mar 14, 10:30am Friday, Mar 14, 8pm Saturday, Mar 15, 8pm Ordway, Saint Paul

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Minnesota Physician February 2014

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9847-1001_MLHS_MN_Med7_8_13_Layout 1 7/8/13 11:14 AM Page 1

Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We are seeking BC/BE fullrange family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice.

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 consideration, apply online at healthpartners.com/careers and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact diane.m.collins@healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

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MN Physician 4" xSioux 5.25" Falls VA Health Care System 4-color 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) Primary Care (Sioux City CBOC, IA) Psychiatrist Hospitalist Endocrinology

Emergency Medicine Pulmonologist Oncologist Cardiologist (part time) Gastroenterologist (part time) Neurologist

Sioux Falls VA HCS (605) 333-6852 www.siouxfalls.va.gov Applicants can apply online at www.USAJOBS.gov

February 2014 Minnesota Physician

31


Prostate cancer screening from page 19

at 10 years, compared to only 2 percent in the same age group with low-risk prostate cancer. We are in this fix now because over the last two decades, almost every patient with prostate cancer was treated. The low-risk patients did not need it and suffered the significant side effects of treatment needlessly. But some high-risk patients were cured by it. Active surveillance So here’s a crazy thought: What if men continued to be screened for prostate cancer, but treated only if they had high-risk disease? Could such a thing ever actually happen? The answer: It already has, and it is called active surveillance (AS). AS is a protocol that separates men with newly diagnosed prostate cancer into risk groups based on findings at biopsy. Men with low-risk disease

(defined as a Gleason score of 6 or lower, fewer than three cores involved, and less than 50 percent involvement of any one core, in men with a life expectancy less than 10–15 years) are observed without any treatment, though a biopsy is repeated one or two years later to corroborate the low-risk nature of their disease. Men with higher risk disease, either at the initial or subsequent biopsy, are offered definitive local management with either surgery or radiation. Many centers have published their results with AS. All have shown a dramatic reduction in the use of surgery or radiation, with low prostate cancer mortality. Laurence Klotz, MD, of the University of Toronto, has been in the forefront of the AS approach. His research shows that at 10 years of follow-up, men on AS have only a 3 percent risk of dying of prostate cancer. Seven other recently published AS series show similar results. Editorials supporting AS have been published in

JAMA, the Journal of Clinical Oncology, and the Journal of the National Cancer Institute. The National Comprehensive Cancer Network recommends AS for low-risk disease. Even the European Association of Urology (as opposed to the more skeptical American Urological Association) has recently endorsed AS for low-risk patients. A simple (but not too simple) approach PSA screening has led to treating an enormous number of men who did not need to be diagnosed and who did not benefit from (or were actually harmed by) treatment. However, there is a subpopulation of men who benefit greatly from diagnosis and treatment. This group can be identified by typical findings at biopsy. Treating these men will result in fewer of them dying of prostate cancer. Until we have a better screening test, the only way to find them is with PSA screening. From the medical oncology view, it makes

sense to offer men the test, and even refer on for biopsy with a positive screen. However, if diagnosed with prostate cancer, they should be treated only if they have high-risk disease. The rest should be put on an Active Surveillance protocol. While this isn’t rocket science, it does require a thoughtful approach and discussion with patients. It is too simple to state, as the USPSTF does, that PSA screening should not be offered to men of any age. If this is widely adopted, we will eliminate a lot of unnecessary suffering by lowrisk patients. But high-risk patients will lose an opportunity for cure. And then at some point, sadly, they’ll show up in an oncology clinic. As Einstein said, “Things should be as simple as possible, but not simpler.”

Stuart H. Bloom, MD, MSc, practices with Minnesota Oncology and heads its VPCI Multidisciplinary Prostate Cancer Program.

Trinity Health

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

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Minnesota Physician February 2014

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

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


Psychiatrist Cross-Cultural Medicine HealthPartners Medical Group in St. Paul, Minnesota, seeks a BC/BE licensed psychiatrist to practice cross-cultural medicine with our experienced Behavioral Health team at the Center for International Health (CIH), an internationally recognized refugee/immigrant medicine clinic which has helped define best practices in refugee and immigrant healthcare for 30+ years. U.S. and international experience providing psychiatric care to refugees and globally mobile populations is strongly preferred. Qualified bilingual psychiatrists (especially those fluent in Somali, Khmer, Oromo, Karen, Vietnamese, Hmong, Nepali or Russian) are encouraged to apply. This part-time (0.5 FTE) position will provide outpatient psychiatric care closely integrated with primary care in a holistic care model, while partnering with community organizations and the MN Department of Health’s Refugee Health Program. There is also opportunity for an academic faculty appointment at the University of MN and teaching involvement in the Global Health Pathway (www.globalhealth.umn.edu). HealthPartners offers a rewarding practice with a competitive salary and benefits package. Forward your CV and cover letter, specifying your language fluency and global health/refugee medicine experience, to lori.m.fake@healthpartners.com or apply online at healthpartners.com/ careers. For more details, call 800-472-4695 x1. EOE

Opportunities for full-time and part-time staff are available in the following positions: • Dermatologist • Geriatrician/ Hospice/ Palliative Care • Internal Medicine/ Family Practice

• Medical DirectorExtended Care & Rehab (Geriatrics) • Psychiatrist • Urgent Care Physician (IM/ FP/ ER)

Applicants must be BE/BC.

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Minnesota Physician 4" x 5.25" B&W

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north MEMorial

DiffErEncE If you are looking for an alternative to practicing in a big system and want to help lead innovation, change and quality, consider North Memorial Health Care. We are a physician-lead organization with opportunities in primary and specialty care. Practice options include positions with North Memorial, as well as our closely aligned, physician owned practices. We work closely with our physicians to individually tailor practice models that work for our patients and physicians. For more information contact Mark Peterson at (763) 581-2986, mark.peterson@northmemorial.com or visit northmemorial.com.

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

Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible. For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

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February 2014 Minnesota Physician

33


Changing the face of pancreatic cancer from page 17

bound paclitexal to gemcitabine improves progression-free survival and overall survival of patients with metastatic pancreatic cancer. Despite these advances, there is still much room for improvement. A novel therapy Recently, major breakthroughs have occurred in the laboratory of Ashok Saluja, PhD, and Selwyn M. Vickers, MD, in the Department of Surgery at the University of Minnesota. Seminal findings in our laboratory have shown that “heat shock protein-70” (HSP70), a protein that protects the body from stress-induced injury, is upregulated in pancreatic cancer, and that decreasing levels of HSP70 leads to cell death in pancreatic cancer. These results prompted a search for drugs that could decrease levels of HSP70 in pancreatic cancer cells.

Fortunately, such a compound was identified in nature. Triptolide, a natural compound extracted from the Chinese plant Tripterygium wilfordii, was found to inhibit the synthesis of HSP70. Crude extracts of this plant have been used in traditional Chinese medicine for hundreds of years, particularly in treating autoimmune and inflammatory diseases, including rheumatoid arthritis. Studies in our laboratory showed that triptolide decreased levels of HSP70 in pancreatic cancer cells, leading to the death of those cells. Given its potential use as therapy, this compound has been tested aggressively in animal models of pancreatic cancer and has shown encouraging results. Research published in the journal Cancer Research has shown that triptolide, at a very low dose, decreases the growth and metastasis of tumors in a mouse model of pancreatic cancer. Furthermore, the studies suggest that at effective dosage, the therapy is without many of

the adverse side effects associated with chemotherapy and radiation. A limitation in using triptolide in clinics was that it is not soluble in water, making it difficult to administer. At the University of Minnesota, our lab, in collaboration with the Institute for Discovery and Development, worked to make triptolide water soluble. We also tested this novel patented compound comprehensively in our laboratory. The results of our studies were published in Science Translational Medicine in October 2012. We studied multiple clinical scenarios—for example, starting Minnelide when the tumors were very large and metastatic, to recapitulate the presentation of patients who present with metastatic pancreatic cancer. In many models, we stopped Minnelide and then followed the animals to see whether the tumors would return. Results from the studies were very encouraging: Min-

nelide was highly effective in all the animal models in shrinking the tumors and extending the survival time of the mice. In many animals, the tumors disappeared completely and did not return, even after the treatment was stopped. A Phase I clinical trial Minnelide was launched at the University of Minnesota Masonic Cancer Center in September 2013. We are very hopeful that its use as a chemotherapeutic agent will change the face of pancreatic cancer. Vikas Dudeja, MD, was a chief resident in the Department of Surgery at the University of Minnesota from 2008 to 2013, and currently is a surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York. Selwyn M. Vickers, MD, formerly the Jay Phillips Professor and Chairman, Department of Surgery, and associate director of University of Minnesota Masonic Cancer Center, is now senior vice president for Medicine and dean of the University of Alabama at Birmingham School of Medicine.

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

• Obstetrics/Gynecology

• Radiation Oncology

• Family Practice

• Internal Medicine

• Ophthalmology

• Pediatrics 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 34

Minnesota Physician February 2014


THE PATIENT ABOVE ALL ELSE. ®

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Opportunities available in the following specialties: Dermatology

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Olmsted Medical Center, a 160-clincian 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.

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www.olmstedmedicalcenter.org February 2014 Minnesota Physician

35


Putting the pieces in place from page 27

well as the Minnesota e-Health Health Information Clinical labs* (2011) Exchange Workgroup. Hospitals (2012) Together, they Local health depts. (2012) evaluateClinics (2013) cross-cutting issues Nursing homes (2011) and identify commuChiropractic offices (2011) nication, education, and collab02 04 06 08 0 100 oration opPercent of providers with EHRs portunities *Clinical labs use lab information systems rather than EHRs to address Sources: Minnesota Department of Health, Office of Health Information Technology, MN HIT Ambucommon latory Clinic Survey (2013) [response rate: 88% (1286/1623)]; and MDH, OHIT, AHA Annual Survey issues with (2012) [response rate: 92% (136 of 148)]. like-minded committees, worksota e-Health Privacy & Securin summer/fall 2014). groups, and organizations. ity Workgroup works in conParticipation in the workjunction with the Minnesota Coordinated efforts group is voluntary and meetings e-Health Standards and InAs part of the Minnesota are open to the public, with opteroperability Workgroup, as e-Health Initiative, the MinneFigure 1. Minnesota Adoption of EHRs

portunities to attend by teleconference and through webinars. Participants help shape future policy directions and enable their organizations to be more prepared to respond to privacy and security recommendations and requirements and state and federal implementation plans as they are established. For information on how to join or participate, contact Lisa Moon (lisa.moon@state.mn.us) or Bob Johnson (bob.b.johnson@state.mn.us). Bob Johnson, MPP, is project manager and Lisa Moon, RN, BSN, is director of privacy, security and oversight programs for the Office of Health Information Technology, Health Policy Division, Minnesota Department of Health. LaVonne Wieland (HealthEast Care System) and Laurie Beyer-Kropuenske (Minnesota Department of Administration), co-chairs of the Minnesota e-Health Initiative Privacy & Security Workgroup, provided review and input for this article.

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Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an outpatient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal. HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and benefit package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.com/careers or contact diane.m.collins@healthpartners.com. Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE

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Statins for primary prevention from page 13

Findings: Coronary heart disease was significantly lower in the diet with pravastatin group than in the diet-alone group (66 events vs. 101 events; HR 0.67, CI 0.49-0.91; p=0.01). Author’s conclusion: “Treatment with a low dose of pravastatin reduces the risk of coronary heart disease in Japan by much the same amount as higher doses have shown in Europe and the U.S.” [Nakamura H. et al., Lancet 68:1155 (2006)] The rest of the story: All the women involved in this trial were postmenopausal, but because the study included adults 40–70 years of age, it is easy to make the leap that a 40-yearold female may benefit from statins for primary prevention. It’s interesting that the authors concluded that a low-dose statin seemed to have the same benefit (relative risk reduction, RRR) as high-dose statins. The number needed to treat (NNT) was

very high—622 to prevent one primary event. There was no mortality benefit.

Week in 2008, entitled “Do Cholesterol Drugs Do Any Good?”).

In addition, Robert Rosenson, MD, a professor of medicine at the Mount Sinai School of Medicine and director of cardiometabolic disorders at Mount Sinai Heart, commented: “The large number of patients lost to analysis relative to the small number of events in this open label study raises some issues about the results.” (Rosenson RS, UpToDate, Nov. 13, 2012)

Moving forward, cautiously For primary prevention, there seems to be reasonable evidence for high-risk men, 50–70 years of age, to use statins. However, even in this group the NNT is about 250. For all other patients—including all women, men younger than 50, and patients older than 70—there is no compelling evidence to use statins for primary prevention.

I find it very concerning that most of the statin trial results are presented in terms of RRR instead of NNT. There is a big difference in perception between a 33 percent decrease in events vs. NNT = 1,000. Yet, for a study of 2,000 people that demonstrates three events in the placebo group (3/1,000) and two events in the medication group (2/1,000), these are the same (an example used by John Carey in an article in Business

For primary care physicians, it is important to try and grasp the implications of the new guideline for our patients. I wonder if the old saying, “to a hammer everything looks like a nail” applied to the authors of the guidelines, all of whom likely have a focus primarily on cardiovascular health. The new CV risk calculator would have every male >63 years old and every female >71 years old— even with zero additional risk factors—start on a high-intensi-

ty statin (atorvastatin 80 mg or rosuvastatin 20 mg or 40 mg). This applies to about 33 million Americans. In addition, according to the guidelines, all men 59 to 62 years old and all women 67 to 70 years old—even those with zero other risk factors— are now in a group in which “statins should be considered.” As a primary care provider, I believe strongly in shared decision-making with a focus on lifestyle change including healthy eating, and exercise. The evidence for these seem much stronger than widespread use of statins for primary prevention. Wisdom would have us move forward cautiously as we begin the next round of patient-physician conversations about cardiovascular risk and the benefits/risks of taking statins, in light of the new guidelines. Kevin P. Peterson, MD, is a family practice physician and hospitalist at HealthEast Woodwinds Health campus.

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Minnesota Physician February 2014