here`s how - Modern medicine
Transcription
here`s how - Modern medicine
Medical Economics J U LY 25, 2015 H I PAA B R EACH: SECU R E DATA AN D PR EVE NT FI N ES JULY 25, 2015 VOL. 92 NO. 14 Preventing hospital readmissions: What you can do Protect your practice from HIPAA audits ■ HOSPITAL R EADM ISSIONS Six proven ways to strengthen your staff ■ STR E NGTH E N YOU R STAFF Financing practice improvements the right way Simplify your estate planning HIPAA B REACH Secure data & prevent fines —here’s how JOIN THE FORCE FOR LUNG HEALTH We are a force to be reckoned with. We share our voices, and we stand together, for our breath—for our lives. We are facing a crisis in women’s health. Every five minutes, a woman in the U.S. is diagnosed with lung cancer, and every eight minutes, a woman dies from lung cancer. In the last 37 years, the lung cancer death rate has risen 98 percent among women, while falling 28 percent among men. The American Lung Association asked women across the country about their perceptions around lung cancer and the results were published in our Women’s Lung Health Barometer. Only one percent of women knew that lung cancer was the #1 cancer killer of both women and men. We launched LUNG FORCE to make lung cancer a national priority and to defeat lung cancer. Please visit LUNGFORCE.ORG to Join the Force. Referenced in MedLine® Volume 92 Issue 14 JULY 25, 2015 IN DEPTH SPECIAL REPORT 18 CONNECTING CARE: 2015 PHYSICIAN WRITING CONTEST ENTRY Donna M. Parker, MD, writes about the importance of caring. 20 PREVENTING HOSPITAL READMISSIONS HIPAA BREACH STARTS ON PAGE 26 COLUMNS PA G E 33 L E G A L LY S P E A KI N G Rachel V. Rose HIPAA audits: What you need to know PA G E How to be part of the solution. 48 FINANCIAL STR ATE G I E S 33 HIPAA AUDITS David J. Schiller How to survive a HIPAA audit if the government comes calling. Simplify your estate planning Proven methods to get the most out of your staff members. C O V E R STO R Y | TE C H 42 PREVENTING DISPUTES Resolve employee dispues before they begin with these tips. Secure data and prevent fines now—here’s how 43 FINANCING PRACTICE IMPROVEMENTS Physicians should follow these tips before seeking out financing. 47 CODING INSIGHTS Questions answered about incidentto billing. 48 FINANCIAL STRATEGIES Now is the time to simplify your estate planning. starts on page 26 4 bad practices to avoid ] Large vs. small practices ] Data breaches: By the numbers ] 50 HIRING NPS AND PAS How to make the most of an expanded healthcare team. 56 THE SUPREME COURT’S ACA DECISION 4 ways King vs Burwell will impact healthcare. 6 8 10 11 14 52 55 56 ME ONLINE EDITORIAL BOARD FROM THE TRENCHES VITALS CLINICAL ECONOMICS ADVERTISER INDEX THE LAST WORD 4 ways the King vs. Burwell Supreme Court decision will impact healthcare. M I S S I O N STATE M E NT Medical Economics is the leading business resource for office-based physicians, providing the expert advice and shared experiences doctors need to successfully meet today’s challenges in practice management, patient relations, malpractice, electronic health records, career, and personal finance. Medical Economics provides the nonclinical education doctors didn’t get in medical school. MEDICAL ECONOMICS (USPS 337-480) (Print ISSN: 0025-7206, Digital ISSN: 2150-7155) is published semimonthly (24 times a year) by UBM Medica, 131 W. First St., Duluth, MN 55802-2065. Subscription rates: one year $95, two years $180 in the United States & Possessions, $150 for one year in Canada and Mexico, all other countries $150 for one year. Singles copies (prepaid only): $18 in US, $22 in Canada & Mexico, and $24 in all other countries. Include $6.50 for U.S. shipping and handling. Periodicals postage paid at Duluth, MN 55806 and at additional mailing offices. 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Ext. 121 Permissions 440-891-2742 / [email protected] Physician frustration is rampant but lets reframe the resolution question http://bit.ly/1s1rcyk #primarycare A. 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Library Access Libraries offer online access to current and back issues of Medical Economics through the EBSCO host databases. To subscribe, call toll-free 888-527-7008. Outside the U.S., call 218-740-6477. MedicalEconomics. com join us online facebook.com/MedicalEconomics twitter.com/MedEconomics PA RT O F TH E Medical Economics is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community. MEDICAL ECONOMICS ❚ JULY 25, 2015 7 MEDICALECONOMICS.COM SMARTER BUSINESS. BETTER PATIENT CARE. EXCLUSIVE ONLINE CONTENT AND NEWS. online I N-D E P TH C O V E R A G E MEDICARE AT 50: IS IT WORKING? Medicare has evolved into a colossus covering more than 52 million Americans and accounting for 3% of the federal budget, and touching virtually every aspect of healthcare financing and delivery. And while beneficiaries are shouldering more of the cost of their care now compared with the program’s early days, the fact remains that Medicare has significantly reduced the financial burden that healthcare used to impose on the elderly. Read more at: http://bit.ly/1GVfuun Twitter Talk Follow us on Twitter to receive the latest news and participate in the discussion. FACILITY FEES The increasing use of facility fees force physicians to talk money with patients http://ow.ly/G8oTO ELECTRONIC HEALTH RECORDS Is your EHR use as efficient as it could be? Learn 5 key factors in our eBook. http://bit.ly/1y9iS0M HEPATITIS C TREATMENTS Top Headlines Now @MEonline HIGH-VALUE CARE STRATEGIES FOR DOCTORS The push is on for physicians to embrace the concept. Read more: http://bit.ly/1aUy3Df ME App. MedicalEconomics.com/app #2 JOINING FORCES TO RETAIN INDEPENDENCE IPAs can help doctors meet the business challenges of independent practice, but do your homework first. http://bit.ly/1EFC62u Cholesterol lowering resource center Find the latest research and information on medication and treatment strategies. #3 CHRONIC CARE MANAGEMENT SUCCESS How to bill the new Medicare code succesfully. Read more: http://bit.ly/1BJ8JqB MedicalEconomics.com/cholesterol PA RT O F TH E Medical Economics is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community. 8 MEDICAL ECONOMICS ❚ JULY 25, 2015 DIABETES #Diabetes is the leading cause of #visionloss in working-aged Americans http://ow.ly/GcAUT CORONARY DISEASE DOWNLOAD FREE TODAY. Get access to all the benefits Medical Economics offers at your fingertips. The Medical Economics app for iPad and iPhone is now available for free in the iTunes store. Health plans have been excitedly awaiting an alternative to the extremely costly #Sovaldi for treating #hepC http://ow.ly/Ghi7Z #Coronaryheartdisease is estimated to kill more than 385,000 persons a year. http://ow.ly/G97Dz REIMBURSEMENTS Getting paid for chronic care under Medicare’s new program http://ow.ly/G8oHa MEDICAL MALPRACTICE The future of malpractice reform http://ow.ly/G8oNd join us online facebook.com/MedicalEconomics twitter.com/MedEconomics MedicalEconomics. com With ALEVE ®, your patients can have Fewer Doses. Fewer Interruptions. Your patients on Extra Strength Tylenol® and Advil® may require more frequent dosing if their pain persists, so they may have more interruptions throughout their 24-hour day. Recommend ALEVE, with the strength of naproxen sodium. Give your patients all-day relief from minor OA pain with just 2 doses. 1st dose 2nd dose (naproxen sodium) 220 mg/tablet Extra Strength Tylenol 1st dose 2nd dose 1st dose 2nd dose 3rd dose (acetaminophen) 500 mg/tablet Advil (ibuprofen) 200 mg/tablet HOUR 0 HOUR 6 HOUR 12 3rd dose HOUR 18 OTC label dosing for Extra Strength Tylenol for adults and children 12 years and older— *Reflects maximum daily dose of 6 pills (3 grams) with a dosing interval of 6 hours, unless directed by a doctor. Strong on pain. Long on relief. Use as directed for minor arthritis pain. OA=osteoarthritis. Tylenol is a registered trademark of Johnson & Johnson. Advil is a registered trademark of Wyeth LLC. The Bayer Cross, ALEVE, and All Day Strong are registered trademarks of Bayer. © 2015 Bayer HealthCare LLC June 2015 59050-PP-AL-BASE-US-0558 X* 4th dose HOUR 24 the Advisers The board members and consultants contribute expertise and analysis that help shape the content of Medical Economics. PAGE 33 Make sure that all HIPAA policies and procedures are up to date and comprehensive.” —Rachel V. Rose, JD ATTORNEY EDITORIAL CONSULTANTS PRACTICE MANAGEMENT Judy Bee www.ppgconsulting.com La Jolla, CA Keith Borglum, CHBC Professional Management and Marketing Santa Rosa, CA Kenneth Bowden, CHBC Berkshire Professional Management Pittsfield, MA Michael D. Brown, CHBC Health Care Economics Indianapolis, IN EDITORIAL BOARD Frank Cohen, MPA www.frankcohengroup.com Clearwater, FL Virginia Martin, CMA, CPC, CHCO, CHBC Mary Ann Bauman, MD Kenneth R. Kubitschek, MD Healthcare Consulting Associates of N.W. Ohio Inc. Waterville, OH Internal Medicine Oklahoma City, OK Internal Medicine Asheville, NC Rosemarie Nelson MGMA Healthcare Consultant Syracuse, NY Mark D. Scroggins, CPA, CHBC Clayton L. Scroggins Associates Inc. Cincinnati, OH Gray Tuttle Jr., CHBC John L. Bender, MD, MBA Melissa Lucarelli, MD The Rehmann Group Lansing, MI Family Medicine Ft. Collins, CO Family Medicine Randolph, WI Healthcare Management and Consulting Services Bay Shore, NY Michael J. Wiley, CHBC H. Christopher Zaenger, CHBC Z Management Group Barrington, IL Karen Zupko Karen Zupko & Associates Chicago, IL Maria Y. Chandler, MD, MBA Elizabeth A. Pector, MD Business of Medicine, Pediatrics Irvine, CA Family Medicine Naperville, IL TAXES & PERSONAL FINANCE Lewis J. Altfest, CFP, CPA Altfest Personal Wealth Management New York City Robert G. Baldassari, CPA Matthews, Carter and Boyce Fairfax, VA Todd D. Bramson, CFP George G. Ellis Jr., MD Joseph E. Scherger, MD North Star Resource Group Madison, WI Internal Medicine Youngstown, OH Family Medicine La Quinta, CA Insurance consultant New York City Glenn S. Daily, CFP Barry Oliver, CPA, PFS Thomas, Wirig, Doll & Co. Capital Performance Advisors Walnut Creek, CA Gary H. Schatsky, JD David C. Judge, MD Salvatore S. Volpe, MD IFC Personal Money Managers New York City Internal Medicine Cambridge, MA Internal Medicine-Pediatrics Staten Island, NY Schiller Law Associates Norristown, PA David J. Schiller, JD Edward A. Slott, CPA E. Slott & Co. Rockville Centre, NY HEALTH LAW & MALPRACTICE Barry B. Cepelewicz, MD, JD Jeffrey M. Kagan, MD Garfunkel Wild, PC Stamford, CT Internal Medicine Newington, CT Wheeler Trigg Kennedy, LLP Denver, CO John M. Fitzpatrick, JD Alice G. Gosfield, JD Alice G. Gosfield and Associates Philadelphia, PA James Lewis Griffith Sr., JD Fox Rothschild Philadelphia, PA Have a question for our advisers? E-mail your question to [email protected]. 10 MEDICAL ECONOMICS ❚ JULY 25, 2015 Lee J. Johnson, JD Mount Kisco, NY Lawrence W. Vernaglia, JD, MPH Foley & Lardner, LLP Boston, MA MedicalEconomics. com from the Trenches APRNs may not be the bargain that they appear when only the cost per provider is considered. APRNs order more patient imaging and make more referrals to specialists than physicians. Both of these practice patterns...potentially eliminate savings associated with APRN substitution for physicians. Ryan Gamlin, medical student, CINCINNATI, OHIO USING APRNS WON’T SOLVE PHYSICIAN SHORTAGE The United States has a doctor shortage, and it promises to get worse before it gets better. Our population is aging, chronic disease is on the rise, and the physician workforce—with mean age of 50—is nearing a demographic tipping point. Some policy analysts have suggested that a less restrictive scope of practice for Advance Practice Registered Nurses (APRNs) would solve the physician shortage, asserting that APRN’s would promote healthcare workforce expansion, maintain quality of patient care, and lower costs. These proposals coincide with the recent introduction of HR 1247, a bill calling for APRN independent practice within the Veterans Affairs health system. Healthcare costs and cost growth are indeed unsustainable. There is a looming physician shortage. And yes, APRNs are valuable members of the healthcare team, part of a solution that best addresses both problems. But proponents of APRN autonomy–currently the model in 20 states and the District of Columbia–often fail to account for the entirety of both benefits and costs associated with using nurses alone to do jobs historically done by physicians. The assertion that expanded APRN autonomy will lower costs suffers from a myopic focus on one element of healthcare MedicalEconomics. com spending: the explicit cost paid to providers. Measures of efficiency such as speed of throughput, quality of product produced, and other factors beyond the cost of wages are routinely part of labor analysis in other industries, and those same tools must be applied in healthcare workforce policy debates as well. On important measures of efficiency–and thus total cost–APRNs may not be the bargain that they appear when only the cost per provider is considered. APRNs order more patient imaging and make more referrals to specialists than physicians. Both of these practice patterns increase healthcare resource use and narrow or potentially eliminate savings associated with APRN substitution for physicians. In a U.K. study, nurse practitioners’ consultations with patients were longer than those conducted by physicians. Longer visits are desirable, certainly, from the perspective of some patients, but longer appointments mean lower throughput, another drag to the savings asserted by advocates of expanded APRN practice. And there is little cause to believe that allowing a full scope of practice to APRNs would solve our persistent shortage of primary care practitioners, or to provide primary care at a lower cost; in 2012, 58.4% of medical procedures billed independently by nurse practitioners and MEDICAL ECONOMICS ❚ JULY 25, 2015 11 from the Trenches Nothing with regard to a medical office visit can be done in 10 minutes, let alone 20 minutes. Between making sure all the boxes are checked, all the ancillary meaningless questions are answered—oh, and by the way, let’s talk about your blood pressure and diabetes—there is no way in hell the quality of care is improving. Elmer F. Toro, M.D., LEHIGH ACRES, FLORIDA TELL US [email protected] Or mail to: Letters Editor, Medical Economics, 24950 Country Club Boulevard, Suite 200, North Olmsted, Ohio 44070. Include your address and daytime phone number. Letters may be edited for length and style. Unless you specify otherwise, we’ll assume your letter is for publication. Submission of a letter or e-mail constitutes permission for Medical Economics, its licensees, and its assignees to use it in the journal’s various print and electronic publications and in collections, revisions, and any other form of media. 12 physician assistants were dermatological. Allowing APRN’s independent practice may simply buy us more of the same costly specialty care already used in abundance. Ryan Gamlin, student, University of Cincinnati College of Medicine CINCINNATI, OHIO MEANINGFUL USE DOESN’T IMPROVE QUALITY OF CARE Kudos to Dr. Graeser from Fremont Michigan. (“Physicians can’t be expected to do other tasks,” May 10, 2015.) We are not data entry experts. If we are, then we must be among the highest-paid technicians on the face of the earth. To expand and take this issue a step further is the idea that this meaningful use baloney will provide high-value care. I take offense to such comments and assumptions. The reason being the assumption that the care provided before this mumbo-jumbo was of lesser value and of lesser quality. The powers that be conveniently seem to forget what it was that led to the disaster that we now call meaningful use. There was a time not that long ago when we were asked to see patients in about 10 minutes, giving us six patients per hour. Then along came electronic medical records and they truly were excellent for the purposes they were originally designed. Unfortunately, the government and a host MEDICAL ECONOMICS ❚ JULY 25, 2015 of other regulatory agencies have bastardized the entire electronic medical record system into something that is literally a disaster and a waste of time. Nothing with regard to a medical office visit can be done in 10 minutes, let alone 20 minutes. Between making sure all the boxes are checked, all the ancillary meaningless questions are answered—oh, and by the way in the last three minutes let’s talk about your blood pressure and diabetes—there is no way in hell the quality of care is improving. If anything, it is deteriorating as we speak. The idea that we as doctors have allowed this meaningless use to get this far is embarrassing. Before this is all said and done it is going to be my goal to become a thorn in the side of all of the proponents for meaningful use. The only thing meaningful use has done in my estimation is to create yet another entire industry that relies and survives on the coattails of the blood, sweat and tears that we have all put in during our medical school training, residency and thereafter. I don’t know if I am the only one who feels this way, but if by any chance I am not I will be more than happy to start a movement. A movement that will serve as a notice to all of the regulatory agencies to get off our back. Allow us to practice REAL medicine. Get out of our way! Elmer F. Toro, M.D. LEHIGH ACRES, FLORIDA MedicalEconomics. com theVitals HUMANA, ADA PARTNER FOR PATIENTCENTERED DIABETES PROGRAM Humana and the American Diabetes Association (ADA) have partnered to develop a consumer-centric diabetes curriculum and delivery model with the goal of helping slow the progression of diabetes. Type 2 diabetes can be effectively managed with appropriate education and self-management behaviors. However, research shows that almost two-thirds of adults with type 2 diabetes do not receive any diabetes education. Lack of standardization in diabetes education also often creates conflicting information for those who have the disease. The new delivery model between Humana and ADA will offer curriculum that is evidence-based, culturally relevant, engaging, and available in multichannel formats, according to Chris Kay, JD, Humana chief innovation officer. Each year, the ADA publishes its Standards of Medical Care which provide clinicians with the evidence and established targets to attain the goals of diabetes care. 14 MEDICAL ECONOMICS ❚ JULY 25, 2015 Examining the News Affecting the Business of Medicine Affordable Care Act survives Supreme Court Challenge The Affordable Care Act (ACA) has survived its latest legal challenge. In a much-anticipated decision, the U.S. Supreme Court ruled in June the case of King v. Burwell that tax subsidies for buying healthcare insurance made available through the law apply in all 50 states. Most economists and analysts believed that eliminating the subsidies would have made healthcare insurance unaffordable for most of the seven million people buying insurance through the federal exchange. King v. Burwell: By the numbers 7 MILLION 287% Number of people who have bought insurance through the federal exchanges Estimated percentage increase in premium if the Supreme Court would have banned federal subsidies. 87% of people buying insurance through the healthcare.gov exchange receive subsidies. 25 MILLION Number of people who remain uninsured. $272 28 Average monthly amount of subsidies Number of states that have expanded Medicaid coverage Sources: U.S. Department of Health and Human Services; MedicalEconomics. com theVitals ARE PHYSICIANS IN MEANINGFUL USE LIMBO? Asthma: women hospitalized more than men, study shows WOMEN ARE more likely than men to need hospitalization after seeking emergency department (ED) treatment for an asthma attack, according to a study published recently in the Annals of Allergy, Asthma and Immunology. According to the National Institute of Allergy and Infectious Diseases, the number of people with asthma continues to grow. One in 12 Americans (about 25 million, or 8% of the population) had asthma in 2009, compared with 1 in 14 (about 20 million, or 7%) in 2001. Women were more likely than men to have asthma. Rose Chasm, MD, a clinical assistant professor of emergency medicine at the University of Maryland’s School of Medicine in Baltimore, and colleagues analyzed the likelihood that 2,000 patients treated in the ED for asthma would need to be admitted to the hospital. Although the men and women had similar risk factors for a flare-up of their condition, women still were 60% more likely to be hospitalized. Just 10% of the women in this study had been seen by an allergist in the last year. Chasm and researchers found that many of the ED patients had poorly controlled chronic asthma. Of the women, 13% had been intubated at some point, 36% had been hospitalized before for asthma and 16% had been admitted within the past year. In comparison, 12% of men had been intubated in the past, 32% had been hospitalized for asthma and 13% had been admitted in the past year. “These findings demonstrate the inadequacy of current clinical and public health measures to manage female patients with asthma.” “The gender difference is probably related to the effects of female sex hormones, to genderspecific health behaviors, to perceived differences in the severity of troubled breathing, and to differences in bronchial hyperactivity and resulting airway obstruction,” Chasm says. More evidence-based studies are needed to pinpoint the causes of the sex-based differences that the study showed, she adds. The study also emphasized the importance of an aggressive treatment plan that provides optimal pharmacotherapy along with close, frequent follow-up for all asthma patients, but especially for female patients who are at a higher risk for severe exacerbations and for hospitalization. “We tend to focus on the treatment of acute exacerbations, but long-term management is just as, if not more, important,” Chasm says. “Our report should encourage primary-care providers to be more assertive in advocating lifestyle changes that reduce or eliminate risk factors for asthma and its exacerbations, such as smoking cessation and weight loss while avoiding known triggers such as environmental and chemical allergens. “Depending on the primary-care provider’s comfort level and competency in managing asthma, the treatment plan should include referral to a specialist such as a pulmonologist or allergist, particularly for those with severe disease, to ensure that their management is maximized.” The Medical Group Management Association (MGMA) recently joined organizations such as the American Medical Association and American Hospital Association in urging CMS to delay finalization of Stage 3 of its EHR incentive program. In a letter to CMS acting administrator Andrew Slavitt, MGMA President and CEO Halee Fischer-Wright notes the group’s strong support for the adoption of health information technology, but, “in order to maximize the success of the [meaningful use] program,” it feels a delay is in order. Among the issues the MGMA notes in its letter is the conflict between the stronger requirements in the Stage 3 proposed rule and the recently proposed relaxation of similar requirements under the Stage 2 rules. The group also recommends delaying Stage 3 until the impact of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is fully known. In addition to repealing the Medicare Sustainable Growth Rate (SGR) formula, MACRA streamlines existing quality reporting programs. The Vitals is continued on page 17 MedicalEconomics. com MEDICAL ECONOMICS ❚ JULY 25, 2015 15 SIGN UP FOR OUR FREE WEEKLY EMAIL NEWSLETTER! Discover effective strategies for a successful practice Receive timely and vital practice management information on these topics: MONDAY Practical Matters Strategies to improve your workflow, efficiency and finances. WEDNESDAY Coding Insights Expert coding and billing advice for clinical conditions. Plus, how to prepare for ICD-10 and solutions for your common billing issues. SATURDAY Technology The latest on technology, including EHRs and mobile health. SIGN UP TODAY! Visit MedicalEconomics.com/enewssignup theVitals The Vitals is continued from page 15 LARGE-SCALE COPD PATIENT NETWORK IN THE WORKS New study to evaluate lipid management in clinical practice AS LIPID management in the United States undergoes transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) announced a new study to better understand contemporary lipid management and the beliefs and attitudes of patients and providers regarding cholesterol, cardiovascular (CV) risk assessment, and options for lipid treatments. The DCRI’s Patient and Provider Assessment of Lipid Management (PALM) study will enroll about 7,500 patients in the community practice setting from 175 sites across the United States with cardiovascular risk factors warranting consideration of lipidlowering therapies, as well as patients already on statin therapy. In 2013, the American Heart Association and American College of Cardiology guidelines for lipid management changed drastically from prior guidelines, broadening candidacy for statin medications, recommending statin treatment based on patients’ predicted 10-year atherosclerotic cardiovascular disease risk and de-emphasizing LDL-C MedicalEconomics. com targets, according to Tracy Wang, MD, MHS, MSc, principal investigator of the PALM study and director of the Duke Center for Educational Excellence. “However, the degree to which these new guidelines have been adopted by clinicians in community practice is unknown,” Wang said. “We expect that patients will report barriers to optimal lipid management largely related to a different understanding of CV risk reduction goals compared with providers.” “The PALM registry was designed to assess patterns of lipid-lowering therapy use among a nationally representative cohort of community clinics, determine consistency of treatment with current lipid guidelines, and assess provider and patient perspectives on lipid management and CV risk reduction.” The ultimate goal is to optimize CV risk prevention among contemporary adults. “These are patients who receive care across primary care, family medicine, cardiology, and lipid clinics, as well as other specialty clinics,” Wang said. “The goal of this registry is to reflect treatment patterns in these clinics, identify potential gaps, and understand patient and provider barriers to optimal medication use.” Wang expects current practice to differ significantly from guidelinesrecommended care. “We expect that provider report of their practices may differ from actual patterns of care observed,” she said. “We expect that patients will report barriers to optimal lipid management largely related to a different understanding of CV risk reduction goals compared with providers. “Cardiovascular risk prevention can be challenging because of the broad population of patients we need to reach, who have not just differing clinical needs but also different perception and understanding of CV risk prevention goals,” Wang added. “Their care is made more complex by changing guideline recommendation with varying provider buyin. PALM Registry will be critical to sorting out these issues.” The COPD Foundation’s COPD360 program is being assembled to accelerate research and foster innovation for chronic obstructive pulimary disease (COPD). “The data will allow physicians to gain greater insight into the disease as well as patient priorities,” Elisha Malanga, senior director of research, tells Medical Economics. “The information provided will allow physicians to develop best practices based on patient feedback.” The program will enroll 125,000 patients to databases on an integrated research registry consisting of the COPD Patient-Powered Research Network and physician registries. When fully realized in the next three to five years, COPD360 will combine patientreported outcomes, clinical data, electronic health records, and observational research into what the Foundation says will be one of the largest COPD research networks ever assembled. According to Malanga, of the top 10 deadliest diseases in the United States, COPD is the only one with mortality rates on the rise. MEDICAL ECONOMICS ❚ JULY 25, 2015 17 SPECIAL R EPORT Medical Economics is proud to unveil the honorable mention entries in our 2015 Physician Writing Contest. We believe the essays exemplify what connecting with your patients is truly about, and demonstrate the levels of heart, determination, and empathy you strive to bring into every exam room, every day. Thanks for reading. Connecting care HONORABLE MENTION Donna M. Parker, MD is a pediatrician in Gainesville, Florida I t was only my second time seeing her. She was beautiful, peaceful, resting in her mom’s arms; inactive. Her inactivity was the result of the trauma from a motor vehicle accident which occurred a few weeks before, when she was only two weeks old. She was not expected to survive after ventilator support was withdrawn, but she did and had been discharged home. Then, there she was with her young parents; she, their first-born baby. Their concern that morning: she was having trouble breathing. As I spoke with her parents, I observed her in her mother’s arms. She had agonal respirations. She was actively dying. I sat facing her parents; I empathized and with utmost compassion, informed them that their baby was dying. They had been aware that she was not expected to survive for a long time but did not realize that the time had come. We talked about how beautiful she was; not a scratch on her beautiful skin. Dad expressed his anger at the driver of the car in which the family was travelling; the driver who had pulled out into oncom- ing traffic. At that moment, everything else was put on hold. I was in an outpatient clinic. There was no social worker or chaplain nearby. I asked the parents if they wanted me to pray with them. They said they were unsure. I reassured them that whatever they chose to do was the right decision. I inquired if I should call hospice, to which they had already been introduced prior to discharge from the hospital. They agreed. Within forty five minutes to an hour, a hospice team of two arrived. We all sat together in the exam room, sometimes in silence, sometimes in conversation. The parents directed the pace. They decided that they wanted prayer and we did pray, led by the hospice chaplain. After the hospice team left, I again sat with the parents and their beautiful, peaceful baby. I hugged them, cried with them, grieving the impending death of their baby girl, whom I held for a while. (I am the mother of two young adult daughters, who were much younger at the time). When the parents were ready, I let them go. They had a long drive home, about one and one half hours. I explained to them that their baby may not make it home alive; they As busy physicians, we do not usually have time but I do believe that we have to make time for humanistic endeavors, for healing.” S U P P O R T E D BY 18 MEDICAL ECONOMICS ❚ JULY 25, 2015 MedicalEconomics. com 2015 Physician writing contest were at peace with that. Later that evening as I arrived at the venue for the work Christmas party, where ornaments were being exchanged, I received a page. It was the sheriff ’s office notifying me that the beautiful daughter of the young couple had died in the car on the way home. The sheriff needed to confirm that she had died from natural causes. Several months later, my mother who had lived a full life and had passed her 89th birthday, was diagnosed with a brain tumor. As she was dying, hospice was invited to assist in my home as my mother had resided with me for almost fourteen years, offering support as I raised my own two children. I had memories of the beautiful infant who did not live to see her first birthday. Her and her parents’ experience helped to give me a sense of peace with the dying of my mother. Through them I came to realize that dying was a process, not an event. Over the past several years, I have remembered the beautiful baby girl and her parents and wondered if they have had other children and how they are doing. The experience is etched in my memory. On that day when that family came to see me, there was no medical intervention to perform. Only listening and talking, and caring and empathizing and helping to fulfill a spiritual need. All that was required was my compassion and time, and the understanding of those who had to wait longer than usual. As busy physicians, we do not usually have time but I do believe that we have to make time for humanistic endeavors, for healing. To comfort parents while their baby is dying is the duty of physicians along with other healthcare team members. For this baby and her family, this was a once-in-a-lifetime event. This experience required communication in various forms and between different team members. There were verbal and nonverbal exchanges; attentive listening and observation were called into play; information had to be conveyed to the hospice team; the sheriff had to communicate with the parents and with me. The nursing and clerical staff had to explain confidentially to other patients why they had to wait longer than usual to be seen. The parents had to communicate with each other and they did so in a loving way with few words. Comforting words and touch were also communicated to the baby. MedicalEconomics. com SPECIAL REPORT As the infant daughter of the young couple was actively dying that day, my roles as healer and professional were intertwined.” To heal means to become sound or healthy again or to alleviate a person’s distress or anguish. A physician has two roles, that of healer and of a professional. These roles are served simultaneously. Attributes of a healer include caring and compassion, openness, respect for the healing function, respect for patient dignity and autonomy and presence. According to Hippocrates, “healing is a matter of time but it is sometimes also a matter of opportunity.” As the infant daughter of the young couple was actively dying that day, my roles as healer and professional were intertwined. Medically, there was nothing to offer. There was no physical pain. Life support had been tried and withdrawn. The baby had been diagnosed as brain dead and the parents had previously made their decision that when this time for physical death came, they would allow their daughter to die peacefully. They could have changed their minds that day but they did not. There was no needed intervention. However, I was needed as a healer. There was an opportunity for healing by alleviating distress and anguish. There was no second thought. It occurred quite naturally; being present with the family and offering compassionate care in an environment of openness. The parents maintained autonomy over who, what, where and when. All of the healing factors were facilitated by positive communication between family, physician, hospice team and nursing staff. This beautiful baby and her family’s care were connected via communication. MORE ONLINE Read the winners of the 2015 Physician Writing Contest at: www.modernmedicine.com/tag/2015-physicians-writing-contest MEDICAL ECONOMICS ❚ JULY 25, 2015 19 IN DEPTH Preventing hospital readmissions How to be part of the solution As payment models shift toward value, physicians will increasingly be measured on their ability to keep patients out of the hospital. Here’s how to get ahead of the curve. by CHAR LOTTE H U FF Contributing author HIGHLIGHTS 01 While some say primary care doctors will need to join forces into larger collaborative networks, at minimum, to succeed with care transitions, others doctors maintain that smaller practices can redesign their discharge approach, taking advantage of relatively new revenue streams. 02 Researchers and doctors are still sorting out the best strategies to prevent turnstile readmissions. 20 Federal 30-day readmission penalties, which have already caught the attention of hospitals, now are beginning to affect the way primary care doctors interact with their patients after discharge. TRADITIONALLY, PHYSICIANS have had a professional desire to keep their patients out of the hospital, but “no economic skin in the game,” says Lance Lang, MD, medical director of the California Quality Collaborative, a healthcare improvement organization. The growing number of accountable care organizations (ACOs) and other bundled reimbursement models is changing that equation, he says. “It’s only now that there is an actual schedule under which CMS is moving away from fee-for-service, and it’s becoming believable that there’s really going to be a MEDICAL ECONOMICS ❚ JULY 25, 2015 change, that the business case is growing to work on this,” Lang says. The question still being hashed out in studies and by those on the front lines of care is two-pronged. First, what specific interventions work best to keep patients from bouncing back? Meanwhile, how can doctors—particularly those in smaller practices—afford to provide that additional discharge support in a world that remains largely fee-for-service? Lang argues that size matters, and to be successful primary care doctors will need to join forces into 22 MedicalEconomics. com Hospital readmissions Requirements for billing Transitional Care Management services CPT code 99495 CPT code 99496 Face-to-face visit within 14 days of discharge from inpatient setting Face-to-face visit within 7 days of discharge from inpatient setting Medical decision-making of at least moderate complexity Communication (defined as phone call, e-mail exchange, or face-toface) with patient or caregiver within two business days of discharge Medical decision-making of high complexity Communication with patient or caregiver within two business days of discharge The 30-day TCM period begins on the date the beneficiary is discharged from the inpatient setting and continues for the next 29 days. The reported date of service should be on the 30th day. Source: Centers for Medicare and Medicaid Services, Medicare Learning Network 20 larger collaborative networks, at a minimum. Other doctors maintain that smaller practices can redesign their discharge approach, taking advantage of relatively new revenue streams, such as the Transitional Care Management (TCM) billing codes that are designed to reimburse for the additional time required for post-discharge care coordination. Still, even a small shop can step up efforts to maximize the time and skills of each person on staff, says Carol Henwood, DO, a family medicine physician in Royersford, Pennsylvania. With only a physician assistant and nurse practitioner, Henwood’s practice still can tap into the resources of the larger physician network that she’s part of through Philadelphia’s Main Line Health, with roughly two dozen practices totaling more than 80 physicians. Together, the practices share the discharge backup services of five nurse care managers. Henwood relies on a nurse care manager to call patients within 48 hours of discharge and to gauge, with her guidance, how quickly each one should be brought in for an office appointment. The first visit occurs within five to 14 days depending upon the patient’s 22 MEDICAL ECONOMICS ❚ JULY 25, 2015 post-discharge vulnerability, Henwood says. “Say they have chronic obstructive pulmonary disease and they were in [the hospital] with pneumonia,” she says. “Well that patient is going to be seen quickly because they could get worse.” A small practice could revamp its own processes to provide similar support, such as by requiring the office’s licensed vocational nurse to call any newly-discharged patients each morning. “Then for the first half hour, that’s her job,” Henwood says. “It might be one patient a day—it might be five a day. Handle that very first thing, do the [medication] reconciliation and then see when they need to be seen, and see what else they need.” BRIDGING DISCHARGE For their part, hospitals already have increasing incentives to forge closer relations with their local doctors. Last year, officials at the Centers for Medicare & Medicaid Services levied readmission penalties against a record 2,610 hospitals, threefourths of those eligible, according to a Kaiser Health News analysis. Moreover, numerous studies reveal significant room for improvement—for both doctors and hospitals. Consider that one out of every three patients discharged don’t see a doctor within 30 days, according to a 2011 study conducted by the Center for Studying Health System Change. A 2007 review article in the Journal of the American Medical Association highlights other communication gaps: among them, a median of only 53% of discharge letters and 14.5% of discharge summaries reach the primary care doctor within the first week following a patient’s discharge. Researchers and doctors are still sorting out the best strategies to prevent turnstile readmissions. A review article published in 2011 in the Annals of Internal Medicine found a dozen potential interventions that have been studied, including medication reconciliation and home visits. But the researchers couldn’t isolate any one, or specific bundle of steps, that has consistently reduced readmissions, in part because of limitations in the quality of the studies. One common measure, implemented in studies and quality improvement efforts, has been to add a post-discharge care coordinator. In one initiative involving Oregon MedicalEconomics. com Hospital readmissions CMS is moving away from fee-for-service, and it’s becoming believable that there’s really going to be a change, that the business case is growing to work on [hospital readmissions].” —LANCE LANG, MD, MEDICAL DIRECTOR, THE CALIFORNIA QUALITY COLLABORATIVE Health & Science University (OHSU) a care manager was added in each of four primary care clinics. The manager was a registered nurse able to triage medical issues, says Brett White, MD, the study’s lead author. The nurse was able to address gaps in care, starting with ensuring that the hospital discharge paperwork reached the clinic, White says. Previously, the hospital physician typically would fax that paperwork to the primary care physician, he says. “With really no way of knowing whether that ever arrived, whether it was attended to, whether that primary care physician then followed up on it, reviewed it, or any of that,” says White, who previously practiced at OHSU and now is health plan medical director at ZoomCare in Portland. Under the new approach, the nurse care manager also would call the patient shortly after discharge, reaching roughly 90% compared with fewer than 10% previously, according to White’s recollection. That early call was particularly key to catching medication problems, from potential interactions to difficulties in obtaining or affording prescriptions, he says. White recalls a patient of his who had been hospitalized for an exacerbation of his chronic obstructive pulmonary disease. Follow up after discharge determined that the patient wasn’t faring well. “It was in large part because of the inhalers that he was prescribed upon discharge—he couldn’t afford them,” White says. “And so he just didn’t pick them up. So he was using his albuterol inhaler over and over and over to no avail.” The patient was brought in for an office appointment and switched to a more affordable inhaler, says White, who believes that a readmission was thus prevented. MedicalEconomics. com During the 12-month period studied, readmission rates at those four OHSU primary care clinics declined from 27% to 7.1%, according to findings from 685 post-discharge patients published in February 2014 in The Journal of Family Practice. (The intervention group also incorporated eight of the dozen potential interventions described in the Annals study.) In the usual care group of 276 patients, the readmission rates were variable with no discernible pattern. READ MORE Seven key interventions for managing care transitions Go to page 25 PRACTICE CHANGES White notes that the four primary care clinics did benefit from additional funding enabling them to add the nurse care managers. Oregon is one of seven states or regions selected to participate in the Comprehensive Primary Care initiative, a CMS program, which provides participants a monthly nonvisit case management fee for fee-for-service Medicare patients. Even without a similar funding stream, White says, a smaller practice can alter its process to better help patients after discharge. One crucial step is setting up a mechanism with hospitals so the practice is routinely notified of any discharged patients, ideally electronically and not via fax, he says. “Things can get lost. It’s not incorporated into the records. Someone then has to abstract that paperwork into the chart.” Electronic notification allows Henwood to check from her computer on a weekend to see which patients have been discharged. “I might even call them on a Saturday and say, ‘are you OK?’” Primary care doctors also need to be prepared on their end, building some wiggle room in their schedule for that recently discharged and struggling patient, Henwood says. She keeps at least one transition of care MEDICAL ECONOMICS ❚ JULY 25, 2015 23 Hospital readmissions For Henwood, electronic notification allows her to check from her computer on a weekend to see which patients have been discharged. “I might even call them on a Saturday and say, ‘Are you OK?’ ” slot open daily, one that she can typically fill with a back pain or sore throat patient if it’s not needed. If the requirements are met, the Transitional Care Management (TCM) billing codes—CPT codes 99495 and 99496— can help cover time devoted to patient care for the remainder of that first month, including phone calls, even if they don’t return to the office, she says. (More details at: http://www.nacns.org/docs/TransCareMgmtFAQ.pdf) But billing services under the TCM codes is easier described than accomplished, says Bruce Williams, DO, part of a two-doctor practice in Blue Springs, Missouri. A visit that’s booked as hospital follow-up can quickly morph into other medical issues, such as when a patient hospitalized for heart failure develops diabetic complications that need to be addressed. Williams strives to get a patient in within two weeks after discharge. For elderly patients with complex medical issues, that appointment can stretch as long as 45 minutes, he says. To assist with reconciliation, patients are encouraged to bring their medications to their appointment. “It is challenging for smaller practices, particularly if they have an elderly population,” White says. “I am a family physician, but most days I feel like I’m a geriatric internist. There are days where I don’t see anybody under the age of 50.” IS BIGGER BETTER? Despite a doctor’s best efforts, a patient may show up with no records, requiring a further sorting out of the diagnosis and the care plan, before even getting to how the patient is feeling and whether they’ve had any medication issues, says Lang, with the California Quality Collaborative. “Can you imagine 24 MEDICAL ECONOMICS ❚ JULY 25, 2015 doing that in 15 minutes by yourself with a medical assistant? So it simply doesn’t usually work.” The collaborative serves as a partner for an ongoing initiative—Avoid Readmissions through Collaboration (ARC)—that has significantly reduced readmissions since it began collecting data in January, 2010. By October of 2014 the roughly two dozen participating California hospitals reported a 30-day readmission rate of 10.8% compared with 12.5% at the start. The Cynosure Health project encourages hospitals to work more closely with outpatient doctors and other entities such as skilled nursing facilities to tackle readmissions. While the participating hospitals have been educated about various prevention strategies, they’re encouraged to tailor their approach based on their own facility’s readmission patterns and challenges, says Pat Teske, RN, implementation officer for Cynosure Health. Doctors who are not part of a large system can build their own discharge support network, Lang says. For example, four to eight doctors could team up to hire a clinician to visit patients in their homes and contract with a pharmacist to assist with medication reconciliation, among other investments, he says. Lang points to a recent such effort, albeit on a much larger scale, in California’s Riverside County, where doctors created an accountable care organization (ACO). The ACO, formed by the Inland Empire Foundation for Medical Care and Accountable Care Associates, includes about 350 doctors, according to Dolores Green, executive director of the Riverside County Medical Association. The participants range from a large multi-specialty practice to 25 MedicalEconomics. com 1 GO FURTHER AN INSPIRE PATIENTS TO TH ONS I N RE MO ILLPTIO* I E 4PRMESTCOR DAT In the treatment of type 2 diabetes, help *Data on file. Based on TRx data sourced from IMS NPA Database, weekly data through 6/1/15. The recommended starting dose of INVOKANA® (canagliflozin) is 100 mg once daily. 2 INVOKANA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. INVOKANA® is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS >> History of a serious hypersensitivity reaction to INVOKANA® >> Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis Please see additional Important Safety Information and brief summary of full Prescribing Information on the following pages. In the treatment of type 2 diabetes, help INSPIRE PATIENTS TO GO FURTHER INVOKANA® (canagliflozin) starting dose: 100 mg once daily. In patients tolerating the starting dose who have an eGFR ≥60 mL/min/1.73 m2 and require additional glycemic control, the dose can be increased to 300 mg once daily.2 IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS and PRECAUTIONS >> Hypotension: INVOKANA® causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA®, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system, or patients with low systolic blood pressure. Before initiating in patients with ≥1 of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating >> Impairment in Renal Function: INVOKANA® increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiation. More frequent renal function monitoring is recommended in patients with an eGFR <60 mL/min/1.73 m2 GREATER REDUCTIONS in A1C2 INVOKANA® 300 mg demonstrated greater reductions in A1C vs Januvia® 100 mg at 52 weeks in patients inadequately controlled on metformin + a sulfonylurea2 Adjusted Mean Change in A1C From Baseline (%) Mean baseline: 8.13% –0.66 8.12% –0.37% difference* –1.03 Januvia® (sitagliptin) 100 mg + metformin and a sulfonylurea (n=378) INVOKANA® 300 mg + metformin and a sulfonylurea (n=377) *95% CI: –0.50, –0.25; P<0.05. Secondary endpoint: Secondary endpoint: GREATER REDUCTIONS 2 GREATER REDUCTIONS 3 Difference from Januvia® 100 mg: –2.8%; P<0.001 Difference from Januvia® 100 mg: –5.9 mm Hg; P<0.001 Incidence of hypoglycemia2 Adverse events (AEs)3 INVOKANA® 300 mg: 43.2%; Januvia® 100 mg: 40.7% The incidence of hypoglycemia increases when used in combination with insulin or an insulin secretagogue. Incidences of AEs were similar between groups except for: Male/female genital mycotic infection, INVOKANA® 300 mg: 9.2%/15.3%; Januvia® 100 mg: 0.5%/4.3% Increased urine frequency/volume, INVOKANA® 300 mg: 1.6%/0.8%; Januvia® 100 mg: 1.3%/0% in body weight † INVOKANA® is not indicated for weight loss or as an antihypertensive treatment. †Adjusted mean change from baseline. Indicated trademarks are registered trademarks of their respective owners. in systolic blood pressure † Learn more and register for updates at INVOKANAhcp.com A randomized, double-blind, active-controlled, 52-week study of patients with type 2 diabetes inadequately controlled on maximally or near-maximally effective doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated) and a sulfonylurea.3 >> Hyperkalemia: INVOKANA® can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia. Monitor serum potassium levels periodically in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions >> Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: INVOKANA® can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA® >> Genital Mycotic Infections: INVOKANA® increases risk of genital mycotic infections. Patients with history of these infections and uncircumcised males were more likely to develop these infections. Monitor and treat appropriately >> Hypersensitivity Reactions: Hypersensitivity reactions (eg, generalized urticaria), some serious, were reported with INVOKANA®; these reactions generally occurred within hours to days after initiation. If reactions occur, discontinue INVOKANA®, treat per standard of care, and monitor until signs and symptoms resolve Please see additional Important Safety Information and brief summary of full Prescribing Information on the following pages. IMPORTANT SAFETY INFORMATION (cont’d) >> Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA® or any other antidiabetic drug DRUG INTERACTIONS >> UGT Enzyme Inducers: Rifampin: Coadministration of INVOKANA® with rifampin decreased INVOKANA® area under the curve (AUC) by 51% and therefore may decrease efficacy. If an inducer of UGT enzymes must be coadministered with INVOKANA®, consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA® 100 mg once daily, have an eGFR ≥60 mL/min/1.73 m2, and require additional glycemic control. Consider other antihyperglycemic therapy in patients with an eGFR <60 mL/min/1.73 m2 who require additional glycemic control >> Digoxin: There was an increase in the AUC and mean peak drug concentration of digoxin (20% and 36%, respectively) when coadministered with INVOKANA® 300 mg. Monitor appropriately >> Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose test results. Use alternative methods to monitor glycemic control >> Interference With 1,5-Anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control USE IN SPECIFIC POPULATIONS >> Pregnancy Category C: There are no adequate and well-controlled studies of INVOKANA® in pregnant women. During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters >> Nursing Mothers: It is not known if INVOKANA® is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, discontinue INVOKANA® more prominent increase in the incidence was seen in patients who were ≥75 years. Smaller reductions in HbA1c relative to placebo were seen in patients ≥65 years (‒0.61% with INVOKANA® 100 mg and ‒0.74% with INVOKANA® 300 mg) compared to younger patients (‒0.72% with INVOKANA® 100 mg and ‒0.87% with INVOKANA® 300 mg) >> Renal Impairment: Efficacy and safety were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2). These patients had less overall glycemic efficacy and a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR ≥60 mL/min/1.73 m2); patients treated with 300 mg were more likely to experience increases in potassium. INVOKANA® is not recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), with end-stage renal disease, or receiving dialysis >> Hepatic Impairment: INVOKANA® has not been studied in patients with severe hepatic impairment and is not recommended in this population OVERDOSAGE >> In the event of an overdose, contact the Poison Control Center and employ the usual supportive measures, eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as needed ADVERSE REACTIONS >> The most common adverse reactions associated with INVOKANA® (5% or greater incidence) were female genital mycotic infections, urinary tract infections, and increased urination Please see brief summary of full Prescribing Information on the following pages. References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2015. 3. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial [published correction appears in Diabetes Care. 2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515. >> Pediatric Use: Safety and effectiveness in patients <18 years of age have not been established >> Geriatric Use: 2034 patients ≥65 years and 345 patients ≥75 years were exposed to INVOKANA® in 9 clinical studies. Patients ≥65 years had a higher incidence of adverse reactions related to reduced intravascular volume (eg, hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300-mg dose, compared to younger patients; Janssen Pharmaceuticals, Inc. Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. © Janssen Pharmaceuticals, Inc. 2015 June 2015 033360-150417 017715-140630 >> Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C can occur with INVOKANA® (canagliflozin). Monitor LDL-C and treat per standard of care after initiating INVOKANA® (canagliflozin) tablets, for oral use Brief Summary of Prescribing Information. INDICATIONS AND USAGE INVOKANA® (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) in full Prescribing Information]. Limitation of Use: INVOKANA is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. CONTRAINDICATIONS • History of a serious hypersensitivity reaction to INVOKANA [see Warnings and Precautions]. • Severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage renal disease (ESRD), or patients on dialysis [see Warnings and Precautions and Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypotension: INVOKANA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA [see Adverse Reactions] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensinaldosterone system (e.g., angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), or patients with low systolic blood pressure. Before initiating INVOKANA in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy. Impairment in Renal Function: INVOKANA increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating INVOKANA [see Adverse Reactions]. More frequent renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2. Hyperkalemia: INVOKANA can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion, such as potassium-sparing diuretics, or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia [see Adverse Reactions]. Monitor serum potassium levels periodically after initiating INVOKANA in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions. Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INVOKANA can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue [see Adverse Reactions]. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA. Genital Mycotic Infections: INVOKANA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections [see Adverse Reactions]. Monitor and treat appropriately. Hypersensitivity Reactions: Hypersensitivity reactions (e.g., generalized urticaria), some serious, were reported with INVOKANA treatment; these reactions generally occurred within hours to days after initiating INVOKANA. If hypersensitivity reactions occur, discontinue use of INVOKANA; treat per standard of care and monitor until signs and symptoms resolve [see Contraindications and Adverse Reactions]. Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C occur with INVOKANA [see Adverse Reactions]. Monitor LDL-C and treat per standard of care after initiating INVOKANA. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA or any other antidiabetic drug. ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Hypotension [see Warnings and Precautions] • Impairment in Renal Function [see Warnings and Precautions] • Hyperkalemia [see Warnings and Precautions] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions] • Genital Mycotic Infections [see Warnings and Precautions] • Hypersensitivity Reactions [see Warnings and Precautions] • Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions] Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. INVOKANA® (canagliflozin) tablets Pool of Placebo-Controlled Trials: The data in Table 1 is derived from four 26-week placebo-controlled trials. In one trial INVOKANA was used as monotherapy and in three trials INVOKANA was used as add-on therapy [see Clinical Studies (14) in full Prescribing Information]. These data reflect exposure of 1667 patients to INVOKANA and a mean duration of exposure to INVOKANA of 24 weeks. Patients received INVOKANA 100 mg (N=833), INVOKANA 300 mg (N=834) or placebo (N=646) once daily. The mean age of the population was 56 years and 2% were older than 75 years of age. Fifty percent (50%) of the population was male and 72% were Caucasian, 12% were Asian, and 5% were Black or African American. At baseline the population had diabetes for an average of 7.3 years, had a mean HbA1C of 8.0% and 20% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 88 mL/min/1.73 m2). Table 1 shows common adverse reactions associated with the use of INVOKANA. These adverse reactions were not present at baseline, occurred more commonly on INVOKANA than on placebo, and occurred in at least 2% of patients treated with either INVOKANA 100 mg or INVOKANA 300 mg. Table 1: Adverse Reactions From Pool of Four 26−Week Placebo-Controlled Studies Reported in ≥ 2% of INVOKANA-Treated Patients* INVOKANA INVOKANA Placebo 100 mg 300 mg Adverse Reaction N=646 N=833 N=834 Female genital mycotic 3.2% 10.4% 11.4% infections† Urinary tract infections‡ 4.0% 5.9% 4.3% Increased urination§ 0.8% 5.3% 4.6% Male genital mycotic 0.6% 4.2% 3.7% infections¶ Vulvovaginal pruritus 0.0% 1.6% 3.0% Thirst# 0.2% 2.8% 2.3% Constipation 0.9% 1.8% 2.3% Nausea 1.5% 2.2% 2.3% * The four placebo-controlled trials included one monotherapy trial and three add-on combination trials with metformin, metformin and sulfonylurea, or metformin and pioglitazone. † Female genital mycotic infections include the following adverse reactions: Vulvovaginal candidiasis, Vulvovaginal mycotic infection, Vulvovaginitis, Vaginal infection, Vulvitis, and Genital infection fungal. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=312), INVOKANA 100 mg (N=425), and INVOKANA 300 mg (N=430). ‡ Urinary tract infections include the following adverse reactions: Urinary tract infection, Cystitis, Kidney infection, and Urosepsis. § Increased urination includes the following adverse reactions: Polyuria, Pollakiuria, Urine output increased, Micturition urgency, and Nocturia. ¶ Male genital mycotic infections include the following adverse reactions: Balanitis or Balanoposthitis, Balanitis candida, and Genital infection fungal. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=334), INVOKANA 100 mg (N=408), and INVOKANA 300 mg (N=404). # Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. Abdominal pain was also more commonly reported in patients taking INVOKANA 100 mg (1.8%), 300 mg (1.7%) than in patients taking placebo (0.8%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions for canagliflozin was evaluated in a larger pool of patients participating in placebo- and active-controlled trials. The data combined eight clinical trials [see Clinical Studies (14) in full Prescribing Information] and reflect exposure of 6177 patients to INVOKANA. The mean duration of exposure to INVOKANA was 38 weeks with 1832 individuals exposed to INVOKANA for greater than 50 weeks. Patients received INVOKANA 100 mg (N=3092), INVOKANA 300 mg (N=3085) or comparator (N=3262) once daily. The mean age of the population was 60 years and 5% were older than 75 years of age. Fifty-eight percent (58%) of the population was male and 73% were Caucasian, 16% were Asian, and 4% were Black or African American. At baseline, the population had diabetes for an average of 11 years, had a mean HbA1C of 8.0% and 33% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 81 mL/min/1.73 m2). The types and frequency of common adverse reactions observed in the pool of eight clinical trials were consistent with those listed in Table 1. In this pool, INVOKANA was also associated with the adverse reactions of fatigue (1.7% with comparator, 2.2% with INVOKANA 100 mg, and 2.0% with INVOKANA 300 mg) and loss of strength or energy (i.e., asthenia) INVOKANA® (canagliflozin) tablets (0.6% with comparator, 0.7% with INVOKANA 100 mg, and 1.1% with INVOKANA 300 mg). In the pool of eight clinical trials, the incidence rate of pancreatitis (acute or chronic) was 0.9, 2.7, and 0.9 per 1000 patient-years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In the pool of eight clinical trials with a longer mean duration of exposure to INVOKANA (68 weeks), the incidence rate of bone fracture was 14.2, 18.7, and 17.6 per 1000 patient years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Upper extremity fractures occurred more commonly on INVOKANA than comparator. In the pool of eight clinical trials, hypersensitivity-related adverse reactions (including erythema, rash, pruritus, urticaria, and angioedema) occurred in 3.0%, 3.8%, and 4.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Five patients experienced serious adverse reactions of hypersensitivity with INVOKANA, which included 4 patients with urticaria and 1 patient with a diffuse rash and urticaria occurring within hours of exposure to INVOKANA. Among these patients, 2 patients discontinued INVOKANA. One patient with urticaria had recurrence when INVOKANA was re-initiated. Photosensitivity-related adverse reactions (including photosensitivity reaction, polymorphic light eruption, and sunburn) occurred in 0.1%, 0.2%, and 0.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Other adverse reactions occurring more frequently on INVOKANA than on comparator were: Volume Depletion-Related Adverse Reactions: INVOKANA results in an osmotic diuresis, which may lead to reductions in intravascular volume. In clinical studies, treatment with INVOKANA was associated with a dose-dependent increase in the incidence of volume depletion-related adverse reactions (e.g., hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration). An increased incidence was observed in patients on the 300 mg dose. The three factors associated with the largest increase in volume depletion-related adverse reactions were the use of loop diuretics, moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2), and age 75 years and older (Table 2) [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Use in Specific Populations]. Table 2: Proportion of Patients With at Least One Volume Depletion-Related Adverse Reaction (Pooled Results from 8 Clinical Trials) Comparator INVOKANA INVOKANA Group* 100 mg 300 mg Baseline Characteristic % % % Overall population 1.5% 2.3% 3.4% 75 years of age and older† 2.6% 4.9% 8.7% eGFR less than 60 mL/min/1.73 m2† 2.5% 4.7% 8.1% Use of loop diuretic† 4.7% 3.2% 8.8% * Includes placebo and active-comparator groups † Patients could have more than 1 of the listed risk factors Impairment in Renal Function: INVOKANA is associated with a dosedependent increase in serum creatinine and a concomitant fall in estimated GFR (Table 3). Patients with moderate renal impairment at baseline had larger mean changes. Table 3: Changes in Serum Creatinine and eGFR Associated with INVOKANA in the Pool of Four Placebo-Controlled Trials and Moderate Renal Impairment Trial Pool of Four PlaceboControlled Trials Baseline Week 6 Change End of Treatment Change* Baseline Moderate Week 3 Renal Impairment Change Trial End of Treatment Change* Creatinine (mg/dL) Placebo N=646 0.84 eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) 87.0 0.01 -1.6 0.01 eGFR (mL/min/1.73 m2) -1.6 Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) * Week 26 in mITT LOCF population INVOKANA INVOKANA 100 mg 300 mg N=833 N=834 0.82 0.82 88.3 0.03 -3.8 0.02 88.8 0.05 -5.0 0.03 -2.3 -3.4 INVOKANA INVOKANA Placebo 100 mg 300 mg N=90 N=90 N=89 1.61 1.62 1.63 40.1 39.7 38.5 0.03 0.18 0.28 -0.7 -4.6 -6.2 0.07 0.16 0.18 -1.5 -3.6 -4.0 INVOKANA® (canagliflozin) tablets In the pool of four placebo-controlled trials where patients had normal or mildly impaired baseline renal function, the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR below 80 mL/min/1.73 m2 and 30% lower than baseline, was 2.1% with placebo, 2.0% with INVOKANA 100 mg, and 4.1% with INVOKANA 300 mg. At the end of treatment, 0.5% with placebo, 0.7% with INVOKANA 100 mg, and 1.4% with INVOKANA 300 mg had a significant renal function decline. In a trial carried out in patients with moderate renal impairment with a baseline eGFR of 30 to less than 50 mL/min/1.73 m2 (mean baseline eGFR 39 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information], the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR 30% lower than baseline, was 6.9% with placebo, 18% with INVOKANA 100 mg, and 22.5% with INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with INVOKANA 100 mg, and 2.2% with INVOKANA 300 mg had a significant renal function decline. In a pooled population of patients with moderate renal impairment (N=1085) with baseline eGFR of 30 to less than 60 mL/min/1.73 m2 (mean baseline eGFR 48 mL/min/1.73 m2), the overall incidence of these events was lower than in the dedicated trial but a dose-dependent increase in incident episodes of significant renal function decline compared to placebo was still observed. Use of INVOKANA has been associated with an increased incidence of renal-related adverse reactions (e.g., increased blood creatinine, decreased glomerular filtration rate, renal impairment, and acute renal failure), particularly in patients with moderate renal impairment. In the pooled analysis of patients with moderate renal impairment, the incidence of renal-related adverse reactions was 3.7% with placebo, 8.9% with INVOKANA 100 mg, and 9.3% with INVOKANA 300 mg. Discontinuations due to renal-related adverse events occurred in 1.0% with placebo, 1.2% with INVOKANA 100 mg, and 1.6% with INVOKANA 300 mg [see Warnings and Precautions]. Genital Mycotic Infections: In the pool of four placebo-controlled clinical trials, female genital mycotic infections (e.g., vulvovaginal mycotic infection, vulvovaginal candidiasis, and vulvovaginitis) occurred in 3.2%, 10.4%, and 11.4% of females treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections on INVOKANA. Female patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrence and require treatment with oral or topical antifungal agents and anti-microbial agents. In females, discontinuation due to genital mycotic infections occurred in 0% and 0.7% of patients treated with placebo and INVOKANA, respectively [see Warnings and Precautions]. In the pool of four placebo-controlled clinical trials, male genital mycotic infections (e.g., candidal balanitis, balanoposthitis) occurred in 0.6%, 4.2%, and 3.7% of males treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Male genital mycotic infections occurred more commonly in uncircumcised males and in males with a prior history of balanitis or balanoposthitis. Male patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrent infections (22% on INVOKANA versus none on placebo), and require treatment with oral or topical antifungal agents and anti-microbial agents than patients on comparators. In males, discontinuations due to genital mycotic infections occurred in 0% and 0.5% of patients treated with placebo and INVOKANA, respectively. In the pooled analysis of 8 controlled trials, phimosis was reported in 0.3% of uncircumcised male patients treated with INVOKANA and 0.2% required circumcision to treat the phimosis [see Warnings and Precautions]. Hypoglycemia: In all clinical trials, hypoglycemia was defined as any event regardless of symptoms, where biochemical hypoglycemia was documented (any glucose value below or equal to 70 mg/dL). Severe hypoglycemia was defined as an event consistent with hypoglycemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained). In individual clinical trials [see Clinical Studies (14) in full Prescribing Information], episodes of hypoglycemia occurred at a higher rate when INVOKANA was co-administered with insulin or sulfonylureas (Table 4) [see Warnings and Precautions]. INVOKANA® (canagliflozin) tablets Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies Monotherapy (26 weeks) Overall [N (%)] In Combination with Metformin (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin (52 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Sulfonylurea (18 weeks) Overall [N (%)] In Combination with Metformin + Sulfonylurea (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin + Sulfonylurea (52 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin + Pioglitazone (26 weeks) Overall [N (%)] In Combination with Insulin (18 weeks) Overall [N (%)] Severe [N (%)]† Placebo (N=192) 5 (2.6) Placebo + Metformin (N=183) INVOKANA 100 mg (N=195) 7 (3.6) INVOKANA 100 mg + Metformin (N=368) INVOKANA 300 mg (N=197) 6 (3.0) INVOKANA 300 mg + Metformin (N=367) 3 (1.6) 0 (0) Glimepiride + Metformin (N=482) 165 (34.2) 15 (3.1) Placebo + Sulfonylurea (N=69) 4 (5.8) Placebo + Metformin + Sulfonylurea (N=156) 24 (15.4) 1 (0.6) Sitagliptin + Metformin + Sulfonylurea (N=378) 154 (40.7) 13 (3.4) Placebo + Metformin + Pioglitazone (N=115) 3 (2.6) 16 (4.3) 1 (0.3) INVOKANA 100 mg + Metformin (N=483) 27 (5.6) 2 (0.4) INVOKANA 100 mg + Sulfonylurea (N=74) 3 (4.1) INVOKANA 100 mg + Metformin + Sulfonylurea (N=157) 43 (27.4) 1 (0.6) INVOKANA 100 mg + Metformin + Pioglitazone (N=113) 3 (2.7) 17 (4.6) 1 (0.3) INVOKANA 300 mg + Metformin (N=485) 24 (4.9) 3 (0.6) INVOKANA 300 mg + Sulfonylurea (N=72) 9 (12.5) INVOKANA 300 mg + Metformin + Sulfonylurea (N=156) 47 (30.1) 0 INVOKANA 300 mg + Metformin + Sulfonylurea (N=377) 163 (43.2) 15 (4.0) INVOKANA 300 mg + Metformin + Pioglitazone (N=114) 6 (5.3) Placebo (N=565) 208 (36.8) 14 (2.5) INVOKANA 100 mg (N=566) 279 (49.3) 10 (1.8) INVOKANA 300 mg (N=587) 285 (48.6) 16 (2.7) * Number of patients experiencing at least one event of hypoglycemia based on either biochemically documented episodes or severe hypoglycemic events in the intent-to-treat population † Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained) Laboratoryy Tests: Increases in Serum Potassium:: Dose-related, transient mean increases in serum potassium were observed early after initiation of INVOKANA (i.e., within 3 weeks) in a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information].] In this trial, increases in serum potassium of greater than 5.4 mEq/L and 15% above baseline occurred in 16.1%, 12.4%, and 27.0% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. More severe elevations (i.e., equal or greater than 6.5 mEq/L) occurred in 1.1%, 2.2%, and 2.2% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In patients with moderate renal impairment, increases in potassium were more commonly seen in those with elevated potassium at baseline and in those using medications that reduce potassium excretion, such as potassium-sparing diuretics, angiotensinconverting-enzyme inhibitors, and angiotensin-receptor blockers [see Warnings and Precautions].] Increases in Serum Magnesium:: Dose-related increases in serum magnesium were observed early after initiation of INVOKANA (within 6 weeks) and remained elevated throughout treatment. In the pool of four placebo-controlled trials, the mean percent change in serum magnesium levels was 8.1% and 9.3% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to -0.6% with placebo. In a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information],] serum magnesium levels increased by 0.2%, 9.2%, and 14.8% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Serum Phosphate:: Dose-related increases in serum phosphate levels were observed with INVOKANA. In the pool of four placebo controlled trials, the mean percent change in serum phosphate levels were 3.6% and 5.1% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to 1.5% with placebo. In a trial of patients with moderate renal INVOKANA® (canagliflozin) tablets impairment [see Clinical Studies (14.3) in full Prescribing Information],] the mean serum phosphate levels increased by 1.2%, 5.0%, and 9.3% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Low-Density Lipoprotein Cholesterol (LDL-C) and non-HighDensity Lipoprotein Cholesterol (non-HDL-C): In the pool of four placebocontrolled trials, dose-related increases in LDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in LDL-C relative to placebo were 4.4 mg/dL (4.5%) and 8.2 mg/dL (8.0%) with INVOKANA 100 mg and INVOKANA 300 mg, respectively. The mean baseline LDL-C levels were 104 to 110 mg/dL across treatment groups [see Warnings and Precautions].] Dose-related increases in non-HDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in non-HDL-C relative to placebo were 2.1 mg/dL (1.5%) and 5.1 mg/dL (3.6%) with INVOKANA 100 mg and 300 mg, respectively. The mean baseline non-HDL-C levels were 140 to 147 mg/dL across treatment groups. Increases in Hemoglobin: In the pool of four placebo-controlled trials, mean changes (percent changes) from baseline in hemoglobin were -0.18 g/dL (-1.1%) with placebo, 0.47 g/dL (3.5%) with INVOKANA 100 mg, and 0.51 g/dL (3.8%) with INVOKANA 300 mg. The mean baseline hemoglobin value was approximately 14.1 g/dL across treatment groups. At the end of treatment, 0.8%, 4.0%, and 2.7% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively, had hemoglobin above the upper limit of normal. DRUG INTERACTIONS UGT Enzyme Inducers: Rifampin: Co-administration of canagliflozin with rifampin, a nonselective inducer of several UGT enzymes, including UGT1A9, UGT2B4, decreased canagliflozin area under the curve (AUC) by 51%. This decrease in exposure to canagliflozin may decrease efficacy. If an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) must be co-administered with INVOKANA (canagliflozin), consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA 100 mg once daily, have an eGFR greater than 60 mL/min/1.73 m2, and require additional glycemic control. Consider other antihyperglycemic therapy in patients with an eGFR of 45 to less than 60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer and require additional glycemic control [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information].] Digoxin: There was an increase in the AUC and mean peak drug concentration (Cmax) of digoxin (20% and 36%, respectively) when co-administered with INVOKANA 300 mg [see Clinical Pharmacology (12.3) in full Prescribing Information].] Patients taking INVOKANA with concomitant digoxin should be monitored appropriately. Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of INVOKANA in pregnant women. Based on results from rat studies, canagliflozin may affect renal development and maturation. In a juvenile rat study, increased kidney weights and renal pelvic and tubular dilatation were evident at greater than or equal to 0.5 times clinical exposure from a 300 mg dose [see Nonclinical Toxicology (13.2) in full Prescribing Information].] These outcomes occurred with drug exposure during periods of animal development that correspond to the late second and third trimester of human development. During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters. INVOKANA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known if INVOKANA is excreted in human milk. INVOKANA is secreted in the milk of lactating rats reaching levels 1.4 times higher than that in maternal plasma. Data in juvenile rats directly exposed to INVOKANA showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from INVOKANA, a decision should be made whether to discontinue nursing or to discontinue INVOKANA, taking into account the importance of the drug to the mother [see Nonclinical Toxicology (13.2) in full Prescribing Information].] INVOKANA® (canagliflozin) tablets Pediatric Use: Safety and effectiveness of INVOKANA in pediatric patients under 18 years of age have not been established. Geriatric Use: Two thousand thirty-four (2034) patients 65 years and older, and 345 patients 75 years and older were exposed to INVOKANA in nine clinical studies of INVOKANA [see Clinical Studies (14.3) in full Prescribing Information].] Patients 65 years and older had a higher incidence of adverse reactions related to reduced intravascular volume with INVOKANA (such as hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300 mg daily dose, compared to younger patients; a more prominent increase in the incidence was seen in patients who were 75 years and older [see Dosage and Administration (2.1) in full Prescribing Information and Adverse Reactions].] Smaller reductions in HbA1C with INVOKANA relative to placebo were seen in older (65 years and older; -0.61% with INVOKANA 100 mg and -0.74% with INVOKANA 300 mg relative to placebo) compared to younger patients (-0.72% with INVOKANA 100 mg and -0.87% with INVOKANA 300 mg relative to placebo). Renal Impairment: The efficacy and safety of INVOKANA were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to less than 50 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information].] These patients had less overall glycemic efficacy and had a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR greater than or equal to 60 mL/min/1.73 m2); patients treated with INVOKANA 300 mg were more likely to experience increases in potassium [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Adverse Reactions].] The efficacy and safety of INVOKANA have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD, or receiving dialysis. INVOKANA is not expected to be effective in these patient populations [see Contraindications and Clinical Pharmacology (12.3) in full Prescribing Information].] Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment. The use of INVOKANA has not been studied in patients with severe hepatic impairment and is therefore not recommended [see Clinical Pharmacology (12.3) in full Prescribing Information].] OVERDOSAGE There were no reports of overdose during the clinical development program of INVOKANA (canagliflozin). In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status. Canagliflozin was negligibly removed during a 4-hour hemodialysis session. Canagliflozin is not expected to be dialyzable by peritoneal dialysis. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Instructions: Instruct patients to read the Medication Guide before starting INVOKANA (canagliflozin) therapy and to reread it each time the prescription is renewed. Inform patients of the potential risks and benefits of INVOKANA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change. Instruct patients to take INVOKANA only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time. Inform patients that the most common adverse reactions associated with INVOKANA are genital mycotic infection, urinary tract infection, and increased urination. Inform female patients of child bearing age that the use of INVOKANA during pregnancy has not been studied in humans, and that INVOKANA should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Instruct patients to report pregnancies to their physicians as soon as possible. Inform nursing mothers to discontinue INVOKANA or nursing, taking into account the importance of drug to the mother. INVOKANA® (canagliflozin) tablets Laboratoryy Tests: Due to its mechanism of action, patients taking INVOKANA will test positive for glucose in their urine. Hypotension: yp Inform patients that symptomatic hypotension may occur with INVOKANA and advise them to contact their doctor if they experience such symptoms [see Warnings and Precautions].] Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake. Genital Mycotic y Infections in Females (e.g., ( g , Vulvovaginitis): g ) Inform female patients that vaginal yeast infection may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions].] Genital Mycotic y Infections in Males (e.g., ( g , Balanitis or Balanoposthitis): p ) Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions].] Hypersensitivity yp y Reactions: Inform patients that serious hypersensitivity reactions such as urticaria and rash have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction or angioedema, and to take no more drug until they have consulted prescribing physicians. Urinaryy Tract Infections: Inform patients of the potential for urinary tract infections. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur. Active ingredient made in Belgium Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Finished product manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 Licensed from Mitsubishi Tanabe Pharma Corporation © 2013 Janssen Pharmaceuticals, Inc. 030609-150304 Hospital readmissions 24 very small primary care offices, Green says. As part of the ACO, the practices can access the help of a care coordination team, which includes a medical assistant backed up by a registered nurse and a part-time medical director. That team, working with the doctor’s office, strives to call patients within 48 hours of discharge to schedule a follow up appointment, answer medication questions or even arrange for the pharmacy to deliver the prescriptions if the patient can’t get there, Green says. “By grouping together these doctors, using the care coordination of the ACO,” she says, “we can help them provide those services when they couldn’t afford to have that staff person just in their office.” Small practices, though, might possess undersold strengths, according to an analysis of preventable admission rates published 2014 in the journal Health Affairs. The analysis found that practices with one or two doctors had 33% fewer such avoidable hospital admissions and practices of three to nine doctors had 27% fewer compared with their larger practice counterparts (10-19 physicians). While the study focused on preventable hospital admissions, not readmissions, both scenarios require similar care management approaches, says Lawrence Casalino, MD, PhD, a study author and chief of the division of health policy and economics at the Weill Cornell Medical College in New York City. In that regard, larger practices have a clear leg up, because they can afford to hire additional staff, he says. “What our article raises is the question of whether there is something that goes on in small practices that doesn’t depend upon being big, and that in fact being big might make worse,” Casalino says. One possibility is that doctors in smaller practices might know patients better, and have forged closer staff bonds through years of working together, says Casalino, reflecting on his own experience in a family practice. “It would happen frequently that I’d be running between exam rooms, and my medical assistant would stop me and say, ‘Larry, Mrs. Smith just called.’ And I might roll my eyes. And she’d stop me and say, `I know she calls almost every day. But today I think there’s really something wrong with her. I just don’t like the way she sounds. I think we ought to get her right into the office.’ ” MedicalEconomics. com Managing transitions of care Seven key interventions After evaluating transition of care models for years across different populations, from rural to big cities, the National Transition of Care Coalition has identified seven key interventions that all models have in common: 1. Medications management Ensuring the safe use of medications by patients and their families and based on patients’ plans of care. 2. Transition planning A formal process that facilitates the safe transition of patients from one level of care to another including home or from one practitioner to another. 3. Patient and family engagement/education Education and counseling of patients and families to enhance their active participation in their own care including informed decision making. 4. Information transfer Sharing of important care information among patient, family, caregiver and healthcare providers in a timely and effective manner. 5. Follow-up care Facilitating the safe transition of patients from one level of care or provider to another through effective follow-up care activities. 6. Healthcare provider engagement Demonstrating ownership, responsibility and accountability for the care of the patient and family/caregiver at all times. 7. Shared accountability across providers and organizations Enhancing the transition of care process through accountability for care of the patient by both the healthcare provider (or organization) transitioning and the one receiving the patient. Source: National Transition of Care Coalition MEDICAL ECONOMICS ❚ JULY 25, 2015 25 IN DEPTH Cover Story HIPAA B REACH Secure data & prevent fines —here’s how MANY PRIVATE practices lack written policies and procedures for data security and haven’t done a security risk assessment, health IT consultants say. These omissions are a mistake for several reasons, the observers note. First, both the Health Insurance Portability and Accountability Act (HIPAA) security rule and the meaningful use criteria require periodic security risk assessments, and HIPAA mandates written policies and procedures. If you’re subjected to a HIPAA audit and found to be in violation of the rules, you could be facing a stiff fine. If your meaningful use attestations are audited, you might have to INSIDE 26 30 HIPAA rule violations MEDICAL ECONOMICS ❚ JULY 25, 2015 return your electronic health record (EHR) incentive payments to the government. Security breaches can also open you up to lawsuits from patients and damage your reputation in the community. Moreover, if the breach is large enough to require you to report it immediately to the Office of Civil Rights (OCR) in the U.S. Department of Health and Human Services (HHS), OCR may investigate your security procedures. Most physicians are at least vaguely aware of these perils. So why don’t they pay more attention to data security? Some doctors are unaware of the need for security risk assessments because they’re too busy to 31 4 Things to avoid 33 What you need to know about HIPAA audits MedicalEconomics. com Gety Images/iStock/Getty Images Plus/maxkabakov by KE N TE R RY Contributing editor HIPAA security keep abreast of compliance requirements, says David Zetter, a consultant in Mechanicsburg, Pennsylvania. Others know the rules but figure there’s only a slim chance they’ll be caught if they ignore them, he adds. While it is difficult to keep track of all the government requirements, this is an area that you don’t want to ignore or be ignorant of. In either case, you’re putting your practice, your patients, and your own financial security at risk. Here are some basics to consider as you evaluate your current security posture. PRACTICE SETTING Security approaches differ by practice setting. Large medical groups and healthcare systems have their own IT staffs and can afford to hire security consultants. Small and medium-sized practices, in contrast, usually depend on their EHR vendors and local computer service companies to implement the security options they have chosen. You need your IT vendors to establish data security, but you can’t rely on them to protect you. While they must all sign business associate agreements under the latest iteration of the HIPAA rules, their liability is limited to the security breaches they cause directly, Zetter notes. For example, if the EHR or network vendor made a mistake in configuring the system, and protected health information (PHI) was exposed as a result, that vendor would be responsible. But if a practice chose not to encrypt its data or didn’t secure its mobile devices, the practice would be liable. Theoretically, an EHR developer would be liable if a software design flaw led to the unauthorized release of PHI; but none of the experts we consulted had heard of that happening. Employed physicians must follow the security policies and procedures of their healthcare system or group. If an employed doctor violates HIPAA rules, the healthcare organization is responsible. But those physicians may face a range of sanctions from their employer. In fact, HHS requires that organizations have a sanctions policy for employees who violate HIPAA, notes Ron Sterling, CPA, a health IT consultant in Silver Spring, Maryland. The type of liability a physician has may depend on the nature of his or her relationship with a hospital, says Mac McMillan, chief executive officer of the security firm CynergisTek and chair of the privacy and MedicalEconomics. com BY THE NUMBERS $21,906,500 15 Monetary settlements, as of June 19, 2015, involving HIPAA Privacy, Security and Breach Notification Rules $4.3 MILLION The lone civil money penalty issued by OCR for violations of HIPAA Privacy Rule (http://www.hhs.gov/ocr/privacy/hipaa/news/ cignetnews.html) 115,929 Number of complaints received by OCR since compliance date of HIPAA Privacy Rule in April 2003, as of May 31, 2015 1,216 Compliance reviews initiated over that same time period Resolutions of cases involving the HIPAA Breach Notification Rule, as of May 31, 2015 $15,581,000 Monetary settlements tied to those resolution agreements 549 Number of referrals made by OCR to the U.S. Department of Justice for criminal investigation tied to knowing disclosure of obtaining protected health information in violation of HIPAA 23,580 Number of cases investigated and resolved by OCR requiring technical changes in privacy practices and corrective actions, or technical assistance to, HIPAA covered entities and their business associates, as of May 31, 2015. Source: HHS’ Office for Civil Rights security policy task force of the Healthcare Information and Management Systems Society (HIMSS). “In some cases, they’re autonomous; in other cases, they’re almost like an employee; in other cases, they manage their staff in their own practice locations, but they get other services from the hospital, and those are governed by the hospital policies,” McMillan says. But regardless of their hospital relationship, he adds, non-employed physicians are responsible for complying with HIPAA rules. MEDICAL ECONOMICS ❚ JULY 25, 2015 27 HIPAA security SECURITY IMPLICATIONS OF HOSTING Most practices have an on-site client-server system or use a cloud-based EHR. If you have the latter, the EHR vendor is responsible for the security of the server that stores your application and data, as well as for data backup. If you have an on-premises server, that’s your responsibility. The physical security mandated by HIPAA includes having a locked room or closet where your server resides. In addition, off-site data backup is required. You must have policies governing the receipt and removal of hardware and electronic media containing PHI to and from a facility, and you must implement policies to protect PHI from improper alteration or destruction. McMillan strongly advises that small and medium-sized practices consider outsourcing their health IT to remote hosting companies. “For the physician, it’s like buying a If data is properly encrypted, it’s not considered PHI. If I lost a thumb drive with encrypted information on it, that wouldn’t be considered a breach.” RON STERLING, HEALTH IT CONSULTANT, SILVER SPRING, MARYLAND service: he’s buying an EHR, email, network support, workstations, file servers and data storage, and it’s all hosted in a virtual environment. So he doesn’t have the headaches of having to understand how to secure the system. He’s buying it as a service.” From a security standpoint, McMillan adds, “the only thing practices are responsible for are their own employees and their physicians, and how they interface with that system and what they do with the information once they have access to it. That’s much easier for them to manage.” Some of the larger EHR vendors, including Epic, Cerner, McKesson, Allscripts, and eClinicalWorks, offer this kind of soup-tonuts hosted solution, McMillan notes. Alternatively, he says, a practice could use a third party hosting firm that understands HIPAA requirements. The total cost of ownership for running your own client-server network, 28 MEDICAL ECONOMICS ❚ JULY 25, 2015 he says, is probably greater than the fees you’d pay to a remote hosting service. David Boles, D.O., who leads a 12-provider practice in Clarksville, Tennessee, says his practice recently decided to switch to remote hosting “because keeping up with the security requirements got to be more than I wanted to deal with.” While it’s too soon to evaluate the results, he notes that he made the switch after a cloud-based EHR offered by his group’s longtime vendor failed to work as promised. The group went back to the EHR’s client-server version; but rather than invest in new servers, Boles decided to hire the remote hosting company. THE IMPORTANCE OF ENCRYPTION Regardless of how your system is set up, there are certain security basics that you need to be familiar with. To start with, the experts say, you should encrypt all of your data. Encryption is a strong defense against thieves and is considered nearly unbreakable, note McMillan and Sterling. It is possible that a “brute force attack” could be used to obtain a user password, which would sidestep the encryption, Zetter says. Questioned on that point, McMillan replies, “It’s certainly possible, but encryption is still a sound risk mitigation and liability manager response.” Encryption is especially important on laptops, smartphones and computer tablets, because these devices can easily be lost or stolen. In fact, lost or stolen mobile devices account for 39% of the security incidents in healthcare, and for 78% of the records compromised in security breaches, according to one study. One way to prevent theft of mobile devices is to prohibit providers and staff from taking them out of the office or facility, Zetter notes. If a physician goes to the hospital, he points out, that doctor can use a hospital laptop and connect to the office network from that device. If a laptop or other mobile device is lost, and PHI is on it, the incident should be reported, Zetter says, even if the data is encrypted. “Because if you fail to and the government finds out, you’re going to be in bigger trouble,” Zetter says. Sterling takes a different view. “If data is properly encrypted, it’s not considered PHI,” he says. “If I lost a 30 MedicalEconomics. com ELIGIBLE PATIENTS MAY PAY ONLY $15* FOR ULORIC Give your patients the ULORIC Savings Card. Patients can visit ULORIC.com for eligibility and enrollment information. Once enrolled, patients will save on each prescription. Patients may download the savings card at ULORIC.com *Maximum benefit of $75 per prescription. This offer cannot be used if a patient is a beneficiary of, or any part of his or her prescription is covered by: (1) any federal or state healthcare program (Medicare, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program, (2) the Medicare Prescription Drug Program (Part D), or if a patient is currently in the coverage gap, or (3) insurance that is paying the entire cost of the prescription. ULORIC is a trademark of Teijin Limited registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. ©2015 Takeda Pharmaceuticals U.S.A., Inc. USD/FEB/15/0017e Printed in U.S.A. 02/15 HIPAA security HIPAA RULE VIOLATIONS Categories & penalty amounts The Health Insurance Portability and Accountability Act Omnibus Rule establishes four “tiers” of violations, based on what it terms “increasing levels of culpability,” with a range of fines for each tier. Violations of the same requirement or prohibition Did not know of breach $100 to $50,000 for any of the categories are Had reasonable cause $1,000 to $50,000 limited to $1.5 to know million per calendar year. Willful neglect, corrected $10,000 to $50,000 The language of the rule states Willful neglect, $50,000 that actual dollar not corrected amounts will be based on “the nature and extent of the violation, the nature and extent of the resulting harm, and other factors…includ[ing] both the financial condition and size of the covered entity or business associate.” Category Fine range 28 thumb drive with all kinds of encrypted information on it, that wouldn’t be considered a breach.” What constitutes a security breach under HIPAA is discussed later in this article. At this point, it’s just important to understand that encryption greatly reduces the possibility of such a breach. END-USER DEVICES AND PHI Another strategy that many practices have adopted is to set up their computer systems in such a way that PHI is stored only on their servers or in their cloud-based EHRs. Desktops, laptops and other mobile devices that doctors and staff members use are not allowed to store PHI. Some practices have “thin-client” networks, where the desktops in the office are dumb terminals that cannot store programs or data. Other practices can’t use that approach because the physicians have to carry 30 MEDICAL ECONOMICS ❚ JULY 25, 2015 their laptops with them when they travel to other practice settings. They keep the EHR applications on their laptops but don’t store any data on them. For example, Jeffrey Kagan, MD, an internist in Newington, Connecticut and a Medical Economics editorial consultant, and his partner use laptops when they visit patients in nursing homes and when they travel. Several years ago, they stored all of their patient records on their laptops, synching with the office server every day. Then, because their laptops didn’t have enough disk space, they stopped storing PHI on them and began using remote access to the network when they needed to see their records. Boles’ practice discourages providers from taking laptops out of the office, but allows remote access to the system from home computers. “We’d never get through with the paperwork if we didn’t let people work at home, too,” he says. Security experts advise caution when using personal computers, because they can be infected with malware or used as conduits to break into a network. If you do use a personal computer, McMillan says, remote access should include a proxy server or a virtual private network to ensure you don’t store any PHI on the personal computer and to shield the network from unauthorized intrusions. TWO-FACTOR AUTHENTICATION Good access controls are critical, McMillan notes, because thieves impersonating users can gain access to EHRs. Besides having strong passwords, practices should deploy “two-factor authentication,” he says. Under this approach, which he says is very affordable, the practice can use a biometric tool, such as thumbprint authentication, or a proximity badge to confirm the user’s identity. Alternatively, users might be asked a personal question when they log on. To make two-factor authentication less onerous, he adds, you can set up the system so that the password has to be entered only once a day. “You use some second factor associated with the person so they only have to put their username and password in once. Then the system might time out, but I can touch it with my badge or my fingerprint and it comes right back up,” McMillan says. Two-factor authentication also can be MedicalEconomics. com HIPAA security used for remote access, he says. iPhone users, for example, can download a free app that enables this kind of identity access, while Google Mail provides options for encryption and two-factor authentication. PHI is presumed to be a breach unless the HIPAA-covered entity or business associate shows there is a low probability that the PHI has been compromised, based on a risk assessment of these factors: REPORTING BREACHES What should you do if you have a security incident? That depends on whether it’s regarded as a security breach and how many patients are involved. As noted earlier, experts disagree over whether the loss of encrypted data constitutes a breach. The HIPAA security rule says that an impermissible use or disclosure of ❚ The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification; ❚ The unauthorized person who used the PHI or to whom the disclosure was made; ❚ Whether the PHI was actually acquired or viewed; and ❚ The extent to which the risk to the PHI has been mitigated. HIPAA: 4 THINGS TO AVOID By Aubrey Westgate of steps to assess potential risks and vulnerabilities to the confidentiality, integrity, and availability of their electronic protected health information (ePHI). Though the security risk analysis requirement has been in place since the security rule was formally adopted in 2003, it’s been pretty widely ignored by practices. Since conducting a security risk analysis is now an attestation requirement in the EHR incentive program, auditors are increasingly noting whether practices are in compliance. You may think you know HIPAA inside and out, but experts say many practices and physicians are making mistakes regarding protected health information (PHI) that could get them into big trouble with the law. Here are four of the most common compliance missteps they say practices and physicians are making. 3 1 Texting or E-mailing Unencrypted PHI For most physicians, texting is an easy, convenient, and efficient way to communicate with patients and colleagues. But if a text contains unencrypted PHI, it could raise serious HIPAA problems. That’s not to say that texting PHI is never appropriate, it just means that physicians must find a way to do so securely. Most likely, the answer will be a secure messaging service with encryption. Similar to text messaging, many physicians are e-mailing unencrypted PHI to patients and colleagues. If your providers are e-mailing PHI, consider implementing a secure e-mail application. If your practice would rather prohibit the use of e-mail altogether, an alternative might be a patient portal that enables secure messaging. 2 Failing To Conduct A Risk Analysis If your practice has not conducted a security risk analysis, it is violating HIPAA. The security rule requires any covered entity creating or storing PHI electronically to perform one. Essentially, this means practices must go through a series MedicalEconomics. com Failing To Update The NPP If your practice has not updated its Notice of Privacy Practices (NPP) recently, it could be in violation of HIPAA. The HIPAA Omnibus Rule requires practices to update these policies and take additional steps to ensure patients are aware of them. In addition to updating the NPP, a practice must post it prominently in its facility and on the website, and have new patients sign it and offer a copy to them. Some of the required updates to the NPP include information regarding: uses and disclosures that require authorization; an individual’s right to restrict certain disclosures of PHI to a health plan; and an affected individual’s right to be notified following a privacy or security breach. 4 Not Providing Sufficient Training The privacy and security rules require formal HIPAA education and training of staff. Though the rules don’t provide detailed guidance regarding what training is required, experts recommends training all the members of your workforce on policies and procedures that address privacy and security at the time of hire, and at least annually thereafter. Be sure to document any HIPAA training provided to staff. MEDICAL ECONOMICS ❚ JULY 25, 2015 31 HIPAA security There’s a whole group of security vendors now that cater to the small practice. And there are some good ones.” MAC MCMILLAN, CEO, CYNERGISTEK “If there’s a low probability that the PHI was compromised, you don’t have to report it,” Sterling maintains. “But you have to maintain the documentation.” If the records of 500 or more patients are breached, you are required to notify the patients and HHS within 60 days. If fewer than 500 patients are involved, you don’t have to tell the government right away, but you must notify the patients. If 10 or more patients can’t be reached, you have to make a public announcement that a breach has occurred, Sterling says. You must document all security breaches, regardless of size, and report them to HHS annually. If a laptop is stolen in a practice where PHI can be accessed only through the network, Zetter advises consulting an attorney. The practice should tell him or her what they think is on the laptop and when it was taken. Then they should ask the lawyer whether they need to notify HHS or the patients immediately. Kagan says his practice has had a couple of minor HIPAA security issues over the years, but they affected only a few patients. “We jumped up proactively and paid for identity protection for those people for a couple of years,” he says. “If somebody broke into our server, with 22,000 patients’ records in it, we’d have to send them all a letter.” cated.” But subsequent annual updates are much easier. A group that’s never done it before might want to get some advice from a security consultant, he says. McMillan, whose company doesn’t work with small practices, echoes Sterling’s point. A few thousand dollars for a security risk assessment, he says, is “small potatoes” compared to the amount that a practice might have to refund to the government if its meaningful use attestation is ever audited. If a practice can’t afford to hire a consultant, there are vendors who can walk you through the process using online software. “There’s a whole group of security vendors now that cater to the small practice. And there are some good ones.” McMillan says. Zetter agrees, noting that one vendor he knows will help practices perform a security risk assessment for $350. CONCLUSION Your practice can do an adequate job of safeguarding your PHI. But it takes some dedicated effort to find out what you need to do and to make sure that it gets done. That could prove challenging. Boles and some of his colleagues, for example, did their own security risk assessment this year, having laid off the in-house IT technician who used to do it. “We go through it the best we can,” he says, “but it’s like the IRS code.” Hiring a consultant, however, would be too expensive, he adds. Kagan says he’s concerned about security risks, “but I’ve got so many concerns going on simultaneously. I’m more worried about the quality of patient care, malpractice suits, and my reputation in the community. Cybersecurity and HIPAA issues just get a lower priority for most doctors.” That’s all true, until the HIPAA police come knocking at the door. Then you’ll be glad you did your due diligence on data security. ESTABLISHING POLICIES AND PROCEDURES Templates for security policies and security risk assessments are available for free from a variety of sources, but must be adapted to the specifics of the practice situation, consultants say. HIMSS and the Office of the National Coordinator for Health IT (ONC) have security risk assessment tools online, McMillan notes. Sterling specifically cites ONC’s Security Risk Assessment Tool. Sterling admits that the first time a practice does such an assessment, “it’s compli- 32 MEDICAL ECONOMICS ❚ JULY 25, 2015 MORE ONLINE Defend your practice against HIPAA violations http://bit.ly/1GbbVSS 7 ways to prepare for a meaningful use audit http://bit.ly/169AUFW Why business associate agreements are important for risk management http://bit.ly/1thukb9 MedicalEconomics. com LEGAL ADVI C E F R O M TH E E X P E RTS Legally Speaking WHAT YOU YOU NEED TO KNOW OFFICE OF CIVIL RIGHTS HIPAA AUDITS By RACH E L V. ROS E, J D, M BA Contributing author PHASE II U.S. Health Information Portability and Accountability Act (HIPAA) Audits by the Office for Civil Rights (OCR) —which were supposed to begin in the summer of 2014—appear finally to have begun. HIPAA and the Health Information Technology for Economic and Clinical Health Act (HITECH) are very nuanced laws and the fines for not complying can be significant. Take the Phase II Audits as a signal that OCR is becoming more serious about enforcement of HIPAA rules and policies. According to OCR’s website, the “HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. The audit protocol covers Privacy Rule requirements for (1) notice of privacy practices for [protected health information] (PHI), (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures. The protocol covers Security Rule requirements for administrative, physical, and technical safeguards. The protocol covers requirements for the Breach Notification Rule.” There are several notable differences between the Phase I and Phase II Audits. Phase I reviewed all of the HIPAA standards, while Phase II will focus on the key noncompliance areas identified in Phase I, as well as those areas associated with the security of PHI. Another purpose is to discern best practices. On the flip side, an entity, whether a covered entity or business associate, may be subject to civil monetary penalties in the event that a significant compliance concern is revealed. If a physician’s office or one of its business associates is contacted, it has two weeks to respond to the audit request. The requests can be very specific; however, if the entity is compliant, then everything should be organized and easily accessible. Preparing for an OCR audit should be approached like a Joint Commission accreditation. O N LY 18% O F PHYSICIANS are ‘very confident ’ th mobile devices are eir H IPAA compliant Source: NueM D Rachel V. Rose, JD, MBA, is a Houston-based attorney advising on federal and state compliance and areas of liability associated with a variety of healthcare legal and regulatory issues. Send your legal questions to medec@ advanstar.com. Getty Images/iStock/Getty Images Plus/rob eyers In order to be reasonably assured that no major violations exist, physicians should: 1 2 3 4 5 6 Have a thirdparty HIPAA risk assessment performed by a qualified individual. Make sure that all policies and procedures are up to date and comprehensive. Look closely at electronic files to find out which ones have been encrypted and which have not. Create a complete file of all business associates and subcontractors, including their contact information. Ensure that the Breach Notification Policy contains relevant state laws. Verify that a Notice of Privacy Practices is displayed publicly, not just a website privacy notice. MedicalEconomics. com MEDICAL ECONOMICS ❚ JULY 25, 2015 33 STAFF DISPUTES IN DEPTH How to be proactive and avoid disgruntled staff [42] Strengthen your staff Six strategies to inspire accountability and effort by AU B R EY WE STGATE Contributing author HIGHLIGHTS 01 When determining if your staff is the right size, in addition to benchmarks and your practice’s unique characteristics, consider your goals and priorities. 02 If a staffer expresses an interest in something new and your practice can cultivate that skill, the staffer will become more engaged and productive 03 Frame goals around positive changes you would like to see occur in your practice. Goals can be practice-wide and/or specific to individuals. Physicians and administrators across the country are working hard to boost staff performance and productivity. But it’s not easy. Employees are already stretched thin as practices operate with smaller staffs due to declining reimbursement and increasing overhead. LUCKILY, EXPERTS say there are many ways practices can retain staff members while boosting their performance and productivity. We asked administrators and consultants to weigh in on this subject. Here’s what they say your practice should do to make the most of its staff. 1/ Finding the magic number Right-sizing your staff is critical as reimbursement declines and overhead increases. One staff member too many could push your practice into the red, one too few could lead to backlogs and high turnover. Industry benchmarks, such as those included in the 38 MEDICAL ECONOMICS ❚ JULY 25, 2015 Medical Group Management Association’s cost survey reports, provide average physician-to-staff ratios by specialty. Consulting such benchmarks can help you determine if your practice’s staffing numbers align with other similar practices. Still, don’t adhere to benchmarks too strictly. The ideal staffing number for a practice depends on several factors, including reimbursement model, technology, and even the physicians in the practice. Some physicians, for instance, are more productive if they are working with two or three medical assistants (MAs), while others are “gangbusters” with just one, says medical practice MedicalEconomics. com Staff performance consultant Charlene Mooney of the Halley Consulting Group in Columbus, Ohio. Similarly, a practice that has acquired the newest technologies may have different staffing needs than one that has not, says Karen Zupko, president of Chicago-based practice management consulting and training firm Karen Zupko & Associates. When determining if your staff is the proper size, also consider your goals and priorities, says practice management consultant Owen Dahl. For example, if increasing the number of visits is an important objective, an additional receptionist may be appropriate. Similarly, if you are adding ancillary services, you may want to add staff as well. “It really depends upon the driver of the type of practice you have, and then the type of services and volume of patients that you would have in the practice,” says Dahl. 2/ Identifying responsibilities Ensuring your staff members have the right roles and responsibilities is just as important as finding the right staffing numbers. Problems that arise when responsibilities are not clearly defined can include doing a task that someone has already completed, failing to complete a task because you believe it is delegated to someone else, and assigning a task for which the staff member is over- or under-qualified. While it sounds simple, good job descriptions can help counteract or prevent these problems from arising, says Dahl, noting that even if you already have job descriptions in place, it may be time to reevaluate. “I would interview and talk with the staff and find out: ‘Is the job description that I have appropriate? Is it too broad?’ And then if that’s OK, ‘Have we done the right training? Do we have the right tools?’” says Dahl. The latter question is especially crucial as new technologies emerge. For instance, automated insurance verification or online appointment booking might help front-desk staff spend more time interacting with patients when they come for appointments. “You’ve got to really drill down to figure out what they are doing and if there are any tools and techniques that may be available to help with that process,” he says. 3/Allocating responsibilities While job descriptions ensure that staff MedicalEconomics. com IMPROVING YOUR STAFF 7 things to know right now During tough times, it’s critical to ensure your practice is making the most of its staff. Here’s how: ❚ Make sure your staffing numbers align with practices of similar specialties. ❚ Craft strong job descriptions outlining staff roles and responsibilities. ❚ Create an operations manual that addresses responsibilities within the practice. ❚ Equip staff with the necessary tools and training. ❚ Evaluate staff performance and hold staff accountable. ❚ Encourage goal setting, mentoring, and delegating to broaden staff members’ skills. ❚ Foster teamwork by cross training, discouraging gossip, and treating staff fairly. members know their responsibilities, an operations manual helps them understand how to fulfill those responsibilities. The manual should list each task that occurs in your practice, identify who is primarily responsible for it, and state very specifically how it should be completed, says Carol Stryker, founder of Houston-based medical practice consulting firm Symbiotic Solutions. If practices lack such a manual, productivity and performance suffers, she says, “because it’s not real clear who’s responsible for something, or maybe people are responsible but they don’t do it and there’s no consequences for it, there ends up being a relatively high level of mistrust in the office,” says Stryker. “The effect … is that sometimes the work gets done two or three times. Maybe Sally is supposed to be calling patients with lab results — but I know Sally’s not real faithful about that — so Sally calls with lab results, and then I go back later in the day and look to make sure she’s [done that].” An operations manual helps eliminate those issues because it’s easier to hold staff members accountable when they don’t perform properly, says Stryker. “You have an objective definition of what’s expected and MEDICAL ECONOMICS ❚ JULY 25, 2015 39 Staff performance that helps train the staff, it helps keep the staff on track, and it allows the physician to fairly hold them accountable.” 4/ Accountability READ MORE Preventing staff disputes “Many staff disputes can be prevented long before they become dangerous.” Find out how on pg 42 40 One of the best ways to hold staff accountable is by addressing issues as soon as they occur, says Stryker. For example: If a physician enters an exam room and finds that the MA has not taken all the patient’s necessary vitals, he or she should immediately leave the room and ask the MA to complete the task properly. If the physician completes the task for the MA, the MA’s behavior will not change and this will become a recurring issue, says Stryker. “Sometimes it’s worth going a little slower and maybe even falling behind to make the point about what it is you expect and get the behavior you want,” Stryker says. On a more long-term basis, hold regular performance reviews to ensure staff members are held accountable and know what they need to improve. Practice manager Sharon Grosscup with Coshocton Hospital Orthopaedic Clinic, a two-physician practice in Coshocton, Ohio, holds monthly performance reviews with staff. After Grosscup and the staff are more accustomed to working together, she plans to hold performance reviews less frequently. The evaluations serve to hold both her and staff members accountable, Grosscup says. “I’ll ask them, ‘Is there anything that you need from me to help you do your job better?’” she says. If staffers fail to perform properly despite repeated attempts to evaluate their behavior fairly and correct their mistakes, “Get rid of them sooner rather than later,” says Stryker. Poor performers are a drag on overall morale and productivity, and retaining them could make it difficult to keep your highest performers. “If I’m doing a good job, and my reward for doing a good job is I have to do my job and somebody else’s too, that doesn’t make me want to stay there,” says Stryker. 5/ Improving performance In addition to holding performance evaluations, set goals with your staff. That way, staff members will work not just to maintain their performance, but to improve it. Frame goals around positive changes you would like to see occur in your practice, says MEDICAL ECONOMICS ❚ JULY 25, 2015 Mooney, adding that goals can be practicewide and/or specific to individuals. For example, if a staffer needs to be more punctual, her goal could be: “I’m going to make an effort to be on time every single day.” If instituting a practice-wide goal, break it into specific, measurable goals that can be tied to action items, says Zupko. Thus, if the overall goal is to improve collections, ask front-desk staff to increase time-of-service collections by 20%. Always provide incentives for meeting goals, says Mooney, adding that even small treats, such as a pizza party, a thank-you card from the physicians, or a certificate of achievement, are great motivators. If money is tight, consider offering time off or flex time, says Dahl. 6/ Broadening skills Perhaps one of your staff members would like to help manage an EHR implementation, or a receptionist has marketing experience and would like to craft an e-newsletter. You never know until you ask. If a staffer expresses an interest in something new and your practice can cultivate that skill, the staffer will become more engaged and productive, says Mooney, who recently worked in a practice where an MA wanted to get involved with referrals and prior authorizations. Providing the MA with the training to take on the new role boosted her commitment and engagement, and benefited the practice because her clinical knowledge helped streamline the referral and preauthorization process, says Mooney. When attempting to broaden staff members’ skills, consider sending them to conferences, seminars, and courses. But your practice itself is a great education-development hub. Mooney suggests instituting a mentoring program to encourage staff to help each other develop new skills. A nurse mentoring an MA, for instance, can help the MA hone her skills and explore new ones, while a receptionist mentoring an MA can share her customer service and communication skills. Also, identify areas where staffers shine, and foster those skills, says Mooney. For instance, if an employee is financially savvy, ask her to find a better and cheaper medical supply vendor. Editor’s note: This story was first published in our partner publication Physician’s Practice. MedicalEconomics. com (tablet not actual size) AUTHORIZED GENERIC OF COLCRYS AVAILABLE Visit COLCRYS.com to learn more COLCRYS is a trademark of Takeda Pharmaceuticals U.S.A., Inc., registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. ©2014 Takeda Pharmaceuticals U.S.A., Inc. USD/COL/14/0046c Printed in U.S.A. 11/14 P R ACTI C E MANAG E M E NT ADVI C E F R O M TH E E X P E RTS Practical Matters Three ways to avoid employee disputes by PAU L E DWAR D S Contributing author “I’m not worried about employee lawsuits, because I don’t mistreat my employees.” Who hasn’t thought this after hearing about an employer who ended up in court over an employee dispute? You’re a good boss, after all, so there’s no need to worry. Unfortunately, it’s possible to sow medical practice dissent without realizing it. Luckily, many disputes can be prevented long before they become dangerous. Here’s how. 1 Treat employees consistently Stellar employees should be rewarded, and employees who need to improve their performance shouldn’t feel coddled. However, owners and managers still need to treat employees equally. When “good” employees receive preferential treatment and “bad” employees are marginalized, you are helping to brew dissent and distrust in your practice. To reward high-performing employees, come up with fun, non-monetary perks they can earn, like an extra-long paid lunch. Don’t focus all energy on your best performers, because this will alienate those who don’t receive the same attention. Likewise, remain fair in your treatment of any employees you are less fond of. If performance is not satisfactory, coach the employee and set goals so they can see a path toward success. 2 Explain decisions when appropriate When meeting with the team or individual employees, doctors and owners often explain their decision-making process in an attempt to be approachable and fair. And in moderation, that’s a good thing. When your team buys into your vision, things run more smoothly. But collaboration can be taken too far. Bending over backwards to justify changes or new initiatives sets an expectation with your employees that they aren’t expected to comply with unpopular decisions. Don’t hamstring yourself by seeking input when you don’t really want it. Some decisions are yours to make. Get a handbook— and follow it 3 Assuming it’s complete and up-to-date, your employee handbook is your best protection against employee disputes. It provides guidelines to help both you and your employees navigate day-today responsibilities and addresses how grievances should be handled. As a doctor, owner, or manager, don’t let “Do as I say, not as I do” become your management style. This prompts disrespect from bad employees and good ones, and will eventually cost you. Each policy is there for a reason, and to avoid the most common yet serious issues, you need to follow them consistently. Getty Images/E+/t_kimura Paul Edwards is chief executive office of CEDR HR Solutions. This article was first published in Physicians Practice. Send your practice management questions to [email protected]. 42 MEDICAL ECONOMICS ❚ JULY 25, 2015 MedicalEconomics. com IN DEPTH CODING AND BILLING HIRING NPS AND PAS Examining an incident-to billing scenario [47] When to bring advanced practitioners on board at your practice [50] Financing practice improvements the right way Experts say it is essential to have a solid business plan in place before approaching lenders about any capital improvements by B ETH THOMAS H E RTZ Contributing author Patients appreciate physician offices that look fresh and employ the latest technology, but these features can be expensive. For a physician in a solo or small-group practice, keeping up can mean taking on debt, and all the planning and tough decisions that entails. "WHERE IS THIS practice growing? How are they improving? What’s the overall plan? Because simply doing a remodel doesn’t mean that you will suddenly attract new patients or gain greater acceptance for your ancillary services. You have to have the bigger picture that goes with it,” says Gavin Shea, senior director of sales and marketing at Wells Fargo Practice Finance. 1/ Where to look for financing Choosing the right source for financing de- MedicalEconomics. com pends on the complexity of what the practice is trying to accomplish, Shea says. “If it’s just simply adding a single piece of equipment and they already know how it will be integrated into their practice, there’s a myriad of options available to them, from manufacturer financing to existing bank relationships and other lines that that doctor may have in place,” he says. For bigger projects, such as a complete office refresh or a relocation, working with a specialized lender can help you make a HIGHLIGHTS 01 For bigger projects, such as a complete office refresh or a relocation, working with a specialized lender can help you create a more comprehensive financial plan that will include the many factors that can come into play. 02 When considering a loan request, lenders will look at a practice’s debt load factor, whether it has consistent and/or growing revenue over time, and what is its compliment of services. MEDICAL ECONOMICS ❚ JULY 25, 2015 43 Financing improvements WHAT YO U YOU NNEOEWD Securing a line of credit TO K If applying for a credit line, Marc Lion CPA, CFP, founding member of Lion and Co. CPAs LLP in Syosset, New York, recommends bringing these items with you: 2 years of personal tax returns; 2 years of business tax returns; financial statements for the current year; 3 months of current personal and business bank statements; 3 months of current brokerage statements (regular and retirement), if applicable; copies of 2 years of any K-1s that may appearing on the return on schedule E; regarding number 6, if any of the K-1s are related to businesses that a significant ownership position may exist, be prepared to provide 2 years of copies of those tax returns as well; and if a business owner, a letter from your certified public accountant indicating that if any funds from the business are to be used toward the purchase or the refinancing, it will not hurt business operations. larger financial plan that will include the many factors that can come into play, such as downtime in the office during renovations or staff training needed to adapt to the changes. “In those instances, working with somebody who has experience lending into the private practice arena and can understand that practice’s cash flow is going to be critical because the lender needs to be able to assess intangible assets, such as goodwill, properly when considering a practice’s ability to repay debt,” he says. Mike La Penna, principal of The La Penna Group, a consulting firm in Grand Rapids, Michigan, suggests that practices break their financing needs into categories, then create a budget that reflects their historical 44 MEDICAL ECONOMICS ❚ JULY 25, 2015 performance and projects their capital costs as part of their expense structure. Physicians can hire consultants to help them do this if they are considering spending several millions of dollars for a new building, because they might need to move beyond the standard banking realm and look to insurance companies or a real estate investment trust, he says. But for smaller transactions, the office’s accountants or bookkeepers can often do it. Many private practices have a line of credit to cover expenses such as payroll when reimbursements are delayed, he says, and they should make sure they are using that properly. “They should take a look at what loans they already have because this is an opportunity to assess all of their debt,” La Penna says. 2/ Owning vs. leasing La Penna says that if physicians are thinking about making improvements to their property, a major consideration is whether they own the property or lease it. “If they own the property, then refinancing a real estate loan is generally the most efficient way to go,” he says. “”If they are leasing, they want to see if the landlord will finance that or perhaps adjust the rent if the renters pays for the improvements.” Similarly, equipment can be bought or leased. “A capitalizing lease allows the piece of equipment to be purchased at the end of the term for $1. It is essentially lease-financing. A non-capitalizing lease never pays for the piece of equipment fully. The person who is leasing to you retains the ownership,” he explains. One consideration when deciding what type of lease you want is how long you plan to use the equipment. Some devices will be obsolete in three years, so you do not want to pay more to own it at the end of the lease. Leases that are non-capitalizing should specify how a renewal would be handled at the end of the term. The fees in a renewal period are typically less because the device is usually worth less than it was at the beginning, La Penna says. In addition, there are tax implications to consider in the leasing versus buying decision. If you own the device, you can take the depreciation on it. For nonprofit organizations, this might not be an issue, but it can MedicalEconomics. com Financing improvements Working with somebody who has experience lending into the private practice arena and can understand that practice’s cash flow is going to be critical because the lender needs to be able to assess intangible assets.” —GAVIN SHEA, SENIOR DIRECTOR OF SALES AND MARKETING, WELLS FARGO PRACTICE FINANCE be for many others, he says. La Penna also advocates keeping your overall budget in mind when looking at leasing versus buying. While buying might save you money on interest over the long term, your cash flow might dictate going with a lease with lower monthly costs. Comparing lease rates is easier today than in the past, La Penna adds, because you can often get multiple bids on the Internet, instead of having to seek each one out individually. When looking to purchase equipment, he suggests asking vendors if they offer financing. They may offer premium rates if you buy additional options, such as supplies or a service agreement. Another place he suggests looking for financing is a local hospital or organization such as an independent physician association or physician hospital organization with which a practice may be affiliated, especially if the practice is looking to add electronic medical records or other technology that could tie into the larger organization. “They often have money available to get everyone on the same system and they can offer very favorable terms,” La Penna says. 3/ Your practice’s financial status When considering a loan request, La Penna says, lenders will look at a practice’s debt loading factor, whether it has consistent and/or growing revenue over time, and its range of services. “If there are 10 doctors, that is more stable than if it is a 68-year-old doctor and a 30-year-old doctor, which might make you wonder if the practice can sustain a debt package,” he says. MedicalEconomics. com La Penna notes that physician accounts receivable generally cannot be used as collateral. “Other businesses can let their receivables act as security for a loan but physicians cannot because there are preclusions against people collecting Medicare receivables unless they are the physician who actually performed the service,” he says. Similarly, you generally cannot use your 401k account as debt security. “The government gave you a tax advantage to develop that 401k and it doesn’t want you signing that off against a new car loan,” La Penna says. Shea says that when Wells Fargo considers financing for a practice, its top metric is cash flow. “They need consistent and sufficient income to pay back the debt. ‘Consistent’ meaning they have had a steady or increasing level of revenue over the past two or three years. ‘Sufficient’ means looking at how much income is being generated from the practice today, how much debt are we asking this practice to pay back, and is there enough left over for a personal salary, personal debt, and a little bit of cushion to make that work,” he says. If more than one physician is asking for the loan, their cash flow ratios are assessed as a group. “That’s where picking a good partner comes into play,” Shea says. Having personal or medical school debt does not mean someone cannot qualify for a loan, but the person needs to show he or she has good cash flow, he adds. For that reason, Shea suggests practitioners aim to keep their monthly student loan payments as low as possible, rather than trying to pay that debt down quickly. MEDICAL ECONOMICS ❚ JULY 25, 2015 45 Financing improvements We don’t know how things are going to turn out in life. You could end up having to collect the debt from my spouse, or my estate, and having it in writing will help make the process smoother.” — MIKE LA PENNA, PRINCIPAL, THE LAPENNA GROUP, GRAND RAPIDS, MICHIGAN MORE ONLINE Time is money: 4 ways to manage practice productivity http://bit.ly/1aWORtS Lines of credit: A tool to boost cash reserves http://bit.ly/1KaMwsD The ICD-10 transition: Avoiding revenue disruptions http://bit.ly/1CtECnN He also counsels physicians to think twice before taking on a $500 monthly car payment, for example, that could hinder their ability to finance a piece of equipment that costs $500 a month but could generate several hundred thousand dollars of revenue. “People often look at those as separate decisions, but they really are connected and (the personal debt) could inhibit your ability to qualify for a business loan,” he says. Another issue that physicians need to “connect” is internal practice debt, says La Penna. “Debt between partners should be treated in the same businesslike fashion that debt is treated by external parties,” he says. The terms of the loan should be spelled out in writing, with a bank or a lawyer acting as an intermediary. “I tell my clients that we don’t know how things are going to turn out in life. You could end up having to collect the debt from my spouse, or my estate, and having it in writing will help make the process smoother,” La Penna says. One type of debt that should definitely be spelled out clearly in partnership agreements is how a partner buyout would be handled, LaPenna says. It should cover how long the remaining partner(s) have to pay the departing person, as well as what the interest rates will be and a specific due date for monthly payments, if applicable. practice because they are afraid no one will want to buy it when they retire. However, she adds, she also hears from physicians who want to work for themselves instead of being an employee. “There are people who would greatly benefit from buying a practice that has that goodwill and patient flow,” she says. “As human beings, we’re very driven by habits, and many patients who are used to going to a specific place for medical care will continue, so there is something to sell. That goodwill is something that we see that maintains itself. It is valuable.” She recommends that doctors who are planning to retire in three to five years should consider upgrades such as new equipment, better technology, fresh paint, new flooring and new chairs in the reception area to keep their practice up to date. “This type of investment will do two things. It allows them to make the practice more attractive to potential buyers when they are ready to sell, and, in the short term, it will help them attract new patients and maintain or grow the practices revenue,” she says. “It can be tough to find a buyer or for that buyer to find financing if the practice is experiencing declining revenues, year over year.” 4/ What about the future? Personal finance: An opportunity to simplify your estate planning Tammara Plankers, assistant vice president and manager of client practice services at Wells Fargo, sometimes hears physicians express reluctance to invest too much in their 46 MEDICAL ECONOMICS ❚ JULY 25, 2015 READ MORE Go to page 48 MedicalEconomics. com C O D I N G AN D B I LLI N G ADVI C E F R O M TH E E X P E RTS Coding Insights CAN THIS ENCOUNTER BE BILLED INCIDENT-TO? Q If an nurse practitioner or physician assistant gathers the history and other information and the physician then examines the patient and establishes assessment and plan, does this qualify for incident-to billing even if a new problem comes up? A: IN THE SITUATION that you described, incident-to guidelines would not necessarily apply, depending on which part(s) of the history the nurse practitioner (NP) or physician assistant (PA) documents. Per Evaluation and Management Guidelines, “The review of systems (ROS) and/or past, family and social history (PFSH) may be recorded by ancillary staf or on a form completed by the patient. To document that the physician reviewed the information, there must be a notation supplementing or confrming the information recorded by others.” Therefore, as long as the NP or PA does not document the history of present illness (HPI), the visit should be billed under the physician’s National Provider MedicalEconomics. com magenta cyan yellow black Identifer (NPI). However, if an NP or PA documents more than the ROS and/or PFSH, the documentation would not support incident-to requirements. According to the Centers for Medicare & Medicaid Services (CMS), to be covered incident-to the services of a physician or other practitioner, services and supplies must be: ❚ an integral, although incidental, part of the physician’s professional service, ❚ commonly rendered without charge or included in the physician’s bill, ❚ of a type that are commonly furnished in physician’s ofces or clinic, ❚ furnished by the physician or by auxiliary personnel and under the physician’s direct supervision According to CMS, “there must have been a direct, personal, professional service furnished by the physician to initiate the course of treatment of which the service being performed by the nonphysician practitioner is an incidental part, and there must be subsequent services by the physician of a frequency that refects the physician’s continuing active participation in and management of the course of treatment. In addition, the physician must be physically present in the same ofce suite and be immediately available to render assistance if that becomes necessary.” This means that a physician individually must have diagnosed a medical problem and established a course of treatment, which the NP or PA would follow during subsequent visits. If the patient presents for a subsequent visit for treatment of the diagnosis for which the physician established the course of treatment and a new problem, incident-to guidelines would not apply because the physician has not diagnosed the new problem and established a course of treatment. In this situation, the NP or PA would be required to bill the visit under his/ her own NPI, for which he/ she would be reimbursed at 85% of the Medicare Physician Fee Schedule. The answer to the reader’s question was provided by Renee Dowling, a billing and coding consultant with VEI Consulting in Indianapolis, Indiana. Send your billing and coding questions to [email protected]. MEDICAL ECONOMICS ❚ JULY 25, 2015 ES637645_ME072515_047.pgs 07.01.2015 03:00 47 ADV F I NAN C IAL ADVI C E F R O M TH E E X P E RTS Financial Strategies AN OPPORTUNITY TO SIMPLIFY YOUR ESTATE PLANNING by DAVI D J. SCH I LLE R, J D Contributing author Because of the high exemption amounts in place today, you have a great opportunity not only to update your estate planning documents, but simplify them as well. UNTIL RECENTLY, many physicians structured their estate planning documents to avoid federal estate taxes on wealth passed to their spouse and children. Over the past four years, estate tax rates have been 40% to 50% and the exemption amount has varied between $600,000 and an unlimited exemption. Currently it stands at $5.43 million per person. This means that in the case of a married couple, if your plan is set up correctly, you can exempt over $10,000,000. Although 99% of the households are below this high threshold, there are still many opportunities, as well as pitfalls. Thus, planning remains as important as ever. Over the past 30 years of my practice and until recently, it was common to recommend and structure “by-pass trusts” which are a complex way of placing assets into trust upon the death of the first spouse 48 so as to take advantage of each person’s death tax exemption amount. These trusts were required to limit access to the assets by the surviving spouse. If you have not changed your will recently, these trusts probably are still in place and will become effective upon your demise. Not only are these trusts not useful for most people, they include several substantial drawbacks besides limiting access by the surviving spouse. These trusts carry higher administrative fees and capital gains within the by-pass trusts since you won’t enjoy a basis step up. Because of the high exemption amounts in place today, you have a great opportunity not only to update your estate planning documents, but simplify them as well. Spouse considerations Although not universal, it is common for individuals to MEDICAL ECONOMICS ❚ JULY 25, 2015 want their spouse to have access to assets upon his or her demise. If your spouse is honest, has good judgment, financial maturity and will look out for your children, why would you want to limit your spouse’s access? The rules recently changed and now allow the surviving spouse to use the $5.43 million exemption of both spouses upon the death of the survivor, a feature known as “portability.” When you leave assets to your surviving spouse, it does not count as using any of your exemption since there is an unlimited marital deduction for estate tax purposes. So upon the death of the surviving spouse, conditioned on following the rules, both exemptions would be available. In order to take advantage of this opportunity, however, two important details cannot be overlooked. Upon the first death, even if no federal estate tax is otherwise due, Form 706 still must be filed within nine months of death to preserve the exemption of the first spouse. Second, if the surviving spouse remarries and the new spouse has used up his or her exemption through lifetime giving or at death, and if the new spouse predeceases them, the surviving spouse would lose the second exemption because you are only entitled to the second exemption through portability of your most recently deceased spouse, not the original spouse. Selling or gifting assets In anticipation of death, people sometimes give away real estate, stocks or other assets that have appreciated in value with the thought that they are saving estate taxes. Contrary to popular belief, because of the so-called “step up” in basis, they are actually increasing their tax bill because the exemption amounts mentioned above shelter most estates from federal estate taxes. If you purchase a vacation home for $500,000, and its fair market value is $1.5 million upon your demise, your heirs receive a new basis of $1.5 million. But if you gift it during your life, the recipient would assume your basis MedicalEconomics. com F I NAN C IAL ADVI C E F R O M TH E E X P E RTS THE HIGH EXEMPTION AMOUNTS IN PLACE TODAY PRESENT A GREAT OPPORTUNITY NOT ONLY TO UPDATE YOUR ESTATE PLANNING DOCUMENTS, BUT SIMPLIFY THEM AS WELL. of $500,000. If the property were then later sold for $1.5 million, the recipient would pay a capital gains tax based on the $1 million gain. Because gifts do not receive a stepped-up basis, it makes great sense to hold on to assets such as real estate, stocks and anything else with unrealized capital gains until your demise so that your heirs receive a stepped-up basis and avoid federal and state capital gains taxes. In community property states, surviving spouses receive a stepped-up basis on the entire property. In common law states, surviving spouses receive MedicalEconomics. com a 50% stepped-up basis on the first death. For example, if you purchase stock for $200,000 and it is worth $600,000 on the death of the first spouse, the surviving spouse would receive a basis of $400,000 in a common law state, but $600,000 in a community property state. The bottom line is that as death approaches, often it does not make sense to sell or gift assets with unrealized gains. Living expenses What happens if you need some of your assets for living expenses and you do not want to sell them because of the capital gains tax? One option is to borrow against the assets, because doing so will not trigger a capital gains tax. Brokerage accounts allow you to borrow against your securities. Another option is to withdraw funds from a qualified plan, IRA or annuity. Because these assets generally result in ordinary income to you or your heirs, it makes little difference whether you withdraw such funds now or leave them to your heirs since there will be no stepped-up basis. If it is anticipated that one spouse will die sooner, more assets can be moved into that spouse’s name so as to enjoy a larger step-up in basis upon the first death. RETIREMENT: HOW MUCH IS ENOUGH? Deciding how much you need in retirement starts with questions and making decisions based on your priorities. What inputs from your life matter? Here are questions to consider: Q: How much do you want to spend annually to live the life you’ve dreamed of? Q: How long will you be retired? Q: What should we assume for a portfolio rate of return and for inflation? Q: How much of your portfolio is pre-tax money in 401(k) plans and IRAs, which will be taxed when withdrawn? Q: Will you receive full Social Security due to them under current projections or will there be changes that result in their payout being reduced or taxed at a higher rate over the next 30 years? Source: Joel Greenwald, MD, CFP Such gifts or transfers must occur at least one year prior to death to use this benefit. Only Connecticut has a state gift tax and the federal gift tax can usually be avoided. Some states still have a state inheritance or estate tax of up to 20% that applies if you are a resident of the state upon your demise. If your wealth is considerable, you might review the option of changing your residence to avoid your current state’s death taxes. However, it is important to consider income, real estate and sales taxes, automobile insurance rates and the other benefits and costs of living in a different state. David J. Schiller, JD, is a tax and estate-planning specialist and Medical Economics editorial consultant based in Norristown, Pennsylvania. Send your financial questions to [email protected]. MEDICAL ECONOMICS ❚ JULY 25, 2015 49 Advanced practitioners Hiring an NP or PA for your medical practice Advanced practitioners can deliver significant value, but recruiting must be driven by practice needs and a commitment to team-based care. BY S H E LLY K. SCHWARTZ Contributing author HIGHLIGHTS 01 Include all key staff members, especially those who will work directly with the new hire, in the interview process and solicit their feedback during the initial trial period. 02 Physicians can introduce a new PA or NP to patients by highlighting the person’s experience, training, and areas of expertise. A dvanced practitioners bring many benefits to a medical practice. They can enhance the quality of care, improve patient access, and help boost revenue. But they are not a magic bullet. Nurse practitioners (NPs) and physician assistants (PAs) only deliver value if you can justify their salary and, perhaps more importantly, if your physicians are committed to making them part of the team. “[Advanced practitioners] make a lot of sense,” says Max Reiboldt, CPA, chief executive officer of the healthcare advisory firm Coker Group. “They are less costly than hiring another physician, and yet able to generate more revenue for the practice, and provide a better patient experience. But it must be based on need.” THE BUSINESS CASE Before hiring an NP or PA, he says, consider the business case for doing so. Factors include how busy you are, your goals for future growth, and patient wait times. “If your ability to grow your patient base is limited because you don’t have 50 MEDICAL ECONOMICS ❚ JULY 25, 2015 enough providers, or your patients cannot get in to see you for several weeks for non-urgent appointments, that’s a real problem and the solution may be to hire [an advanced practitioner],” says Reiboldt, noting that patients these days often aren’t willing to wait. “You have to look at supply and demand.” If patient access is the issue, look at whether your practice may be able to improve patient flow through creative scheduling alone, says Charlene Mooney, a consulting executive with Halley Consulting Group “It used to be that every patient was given a 15-minute time slot, but [these days] you have to cater the schedule to the patients you have,” she says, noting that a new patient may require 30 minutes, while a simple check-up may need only 10. “By tailoring your scheduling to the patients and their needs, you can help take the most advantage of the time you have.” Your practice also may be able to increase patient volume by using staff members more efficiently, says Mooney. “Take a look at the reception process or the process used to take patients to the back and make sure everyone is working efficiently and to the highest level of their ability,” she says. MedicalEconomics. com Advanced practitioners “A lot of times you can take some of the administrative tasks off the clinical people to free them up.” Square footage is yet another consideration. You can’t very well add providers if you don’t have space for them to work, says Mooney, noting that many practices are converting closets that once held paper records into mini-exam rooms with great success. “I’ve seen practices hire [an advanced practitioner] and they don’t have anywhere to put them so everyone is falling all over each other,” she says. Apart from solving patient access problems, says Reiboldt, PAs and NPs might be a fit if you feel you aren’t spending enough time on patient education, wish to expand your hours, are losing new business to walkin urgent care clinics, or simply can’t afford to recruit a full-time physician. Given a physician’s higher salary, says Reiboldt, the average primary care physician would need to collect $400,000 to $500,000 annually to pay for salary, benefits, and overhead, while an advanced practitioner need only generate $250,000 to $300,000 in revenue to positively impact net income. “It doesn’t take much of a financial analysis to see that [an NP or PA] starts to make sense,” he says. ONBOARDING If you do decide to recruit an NP or PA, you must onboard effectively. “You should treat bringing [one of these professionals] into your practice the same way you would bring in another partner,” says Lloyd Van Winkle, MD, FAAFP, a family physician in Castroville, Texas, and board member of the American Academy of Family Physicians. “You need to spend a lot of time in preparation — hiring someone who is a fit for your staff and your patient population, which improves your chance of success down the road.” To that end, he says, include all key staff members, especially those who will work directly with the new hire, in the interview process and solicit their feedback during the initial trial period. The employment contract should include an opt-out clause with a 30-day and 90-day review, allowing both sides to bail if it’s not working out. A designated mentor who can show your new hire the ropes, answer any questions, and make him or her feel welcome can also help smooth the transition, says Van Winkle. Likewise, all new recruits should be given a MedicalEconomics. com copy of your practice mission and standards so that everyone knows what to expect from each other. It goes without saying that advanced practitioners should be included in medical staff meetings, but Mooney suggests taking it one step further. “If you can get them involved in a committee at the hospital where your doctors are affiliated, it helps make them feel even more a part of the medical community, which is another important way to introduce [them] to [their] peers,” she says. “You want them to feel at home and welcomed with open arms.” As for patients, the process of introducing an advanced practitioner is more delicate. Integration works best when the doctor to whom the NP or PA reports introduces him or her personally, highlighting the person’s experience, training, and areas of expertise. “Especially with [advanced practitioners], some patients may feel they aren’t as knowledgeable as the doctor, so you need to explain to them why you brought them on and that they are part of your team,” says Mooney. “It is important to present this person as a partner in delivering their care, rather than making the patient feel that you are dumping them onto someone new and abandoning them.” Exceptions should be made, however, for patients who feel strongly that they’d prefer to see only the doctor. To demonstrate that your practice takes the teamwork approach seriously, it’s also useful to have providers reference a note or comment that another provider made in a prior encounter. While in the exam room, for example, the NP or PA might note that the doctor was pleased with the patient’s latest test results or blood work. Such comments help reassure your patients that the providers in your office regularly consult each other. Advanced practitioners can deliver significant value, but the decision to recruit must be driven by practice requirements and a commitment to team-based care. Before deciding to hire, practices should take the pulse of patient access, consider growth objectives, and perform a cost-benefit analysis to ensure their investment will produce a return. You should treat bringing [an NP or PA] into your practice the same way you would bring in another partner.” —LLOYD VAN WINKLE, MD, FAAFP, FAMILY PHYSICIAN, CASTROVILLE, TEXAS Editor’s note: This story was first published in Physicians Practice. MEDICAL ECONOMICS ❚ JULY 25, 2015 51 Clinical Economics Rheumatoid Arthritis PATIENT MANAGEMENT TIPS Estimated lifetime risk of the condition 1.7% 3.6% AMONG WOMEN AMONG MEN ECONOMIC IMPACT $ 61k-122k Total median lifetime costs of living with rheumatoid arthritis $2,700 The likelihood that patients with rheumatoid arthritis will incur medical charges compared with those without the condition $ 5,700 6X Estimate indirect and nonmedical expenditures MORE ONLINE Clinical Economics For more information on rheumatoid arthritis, including expanded patient management tips and key coding considerations, go to: http://www.modernmedicine.com/tag/clinical-economics 1.5 The number of American adults affected by rheumatoid arthritis Estimated direct medical expenditures Refer when possible, but be prepared to oversee care Coordinate communication among care-team members Identify patient goals, and evaluate progress Recommend supportive lifestyle changes AT A GLANCE MILLION R heumatoid arthritis is a systemic inflammatory disease. It is responsible for premature morbidity and disability. Its causes are unknown and there is no cure. In addition to the financial burden associated with rheumatoid arthritis, patients suffer from reduced quality of life and increased disability. A self-reported survey found that patients with rheumatoid arthritis were 40% more likely to categorize their general health as “fair” or “poor” compared to patients without arthritis. These patients were also 30% more likely to require assistance with personal care and twice as likely to have limitations on their activities due to their health. Patients with rheumatoid arthritis experience more losses in work, leisure, and social function. “Arthritis is a leading cause of disability,” says Stephen I. Katz, MD, PhD, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “With the aging of the population, it will increasingly burden individuals as well as the economy.” Because of the chronic nature of rheumatoid arthritis management, and because patients may not have access to specialty rheumatology care, primary care physicians are challenged with the task of providing education, encouragement, and ongoing support to patients and their caregivers. Source: U.S. Centers for Disease Control and Prevention 52 MEDICAL ECONOMICS ❚ JULY 25, 2015 MedicalEconomics. com M A R K ET PL AC E PRODUCTS & SE RVIC ES MEDICAL EQUIPMENT Content Licensing for Every Marketing Strategy MARKETING SOLUTIONS FIT FOR: Outdoor Direct Mail Print Advertising Tradeshow/ POP Displays Social Media Radio & TV Leverage branded content from Medical Economics to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright’s Media to find out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. SHOWCASE & MARKETPLACE ADVERTISING For information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com Contact: Tod McCloskey at [WPFFORVNH\#DGYDQVWDUFRP MedicalEconomics. com MEDICAL ECONOMICS ❚ JULY 25, 2015 53 M A R K ET PL AC E PRODUCTS & SE RVIC ES ON CALL SU PPORT REST ASSURED — WE WORK NIGHTS AND WEEKENDS SO YOU DON’T HAVE TO. Mark J. Nelson MD FACC, MPH E-mail: [email protected] Advertising in Medical Economics has accelerated the growth moonlightingsolutions.com [email protected] 54 of our program and business by putting me in contact with Health Care Professionals around the country who are the creators and innovators in their field. It has allowed me to help both my colleagues and their patients. 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CONNECT * Indicates a demographic advertisement. with qualified leads and career professionals Post a job today Joanna Shippoli RECRUITMENT MARKETING ADVISOR (800) 225-4569, ext. 2615 [email protected] MedicalEconomics. com MEDICAL ECONOMICS ❚ JULY 25, 2015 55 TH E B R I D G E B ETWE E N PO LI CY AN D H EALTH CAR E D E LIVE RY The Last Word FOUR HEALTHCARE CONSEQUENCES OF KING V. BURWELL DECISION by STUART M. G E R SON, J D Contributing author The much-anticipated Supreme Court 6-3 ruling in King v. Burwell, upholding the key provision of the Affordable Care Act (ACA) regarding tax credit subsidies payable to economically eligible persons, while wildly anticipated, is unsurprising. YET WHILE unsurprising, there are several healthcare consequences that likely will follow from the Court’s decision. No. 1: Regulatory freedom The first is the political momentum from which the Obama Administration continues to benefit. The ACA is the centerpiece of whatever legacy President Barack Obama will have and he will leave office with the program essentially intact. Administration bureaucrats can now proceed with their regulatory activities free from the specter of the ACA’s collapse. No. 2: Death spiral avoided Perhaps most importantly, health insurers now gain the 56 Had the subsidies at issue in King not been available to economically eligible persons, would insurance risk pools have been thrown into disarray? certainty that is required for proper rate setting. Had the subsidies at issue in King not been available to economically eligible persons, would insurance risk pools have been thrown into disarray? These persons generally are young and relatively healthy. If they could not get the credits, which would have put them in an income situation that required them to purchase health insurance and hence could opt out of the system, insurers would have been faced with statistically MEDICAL ECONOMICS ❚ JULY 25, 2015 unhealthier populations and rates would have had to increase substantially, threatening the entire balance that the ACA was intended to provide. Relatedly, health insurance subscribers generally will be able to make more affordable and predictable choices in upcoming open seasons. likely will be spurred more quickly to comply with their ACA mandate and will encourage their employees to purchase health insurance (if they are not providing it). No. 4: Are state exchanges history? Fourth, a bit more speculatively, will be the effect on the states and their exchanges. The literal language of section 18031 made it more advantageous to citizens of states that had their own exchanges. However, now that any useful distinction between state and federal exchanges has been removed by the Supreme Court, there is little incentive for new state exchanges. One thus foresees an increasing federal presence at the grass roots of health insurance as the result of a case that marks the triumph of “contextualism” over strict “textualism.” MORE ONLINE No. 3: Small businesses impacted Eligible employers, particularly smaller businesses, Read more analysis on how the Supreme Court’s decision will impact physicians at: http://MedicalEconomics.com MedicalEconomics. com
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