The key to getting paid
Medical Economics FE B R UARY 25, 2015 ICD-10 DOCU M E NTATION: TH E KEY TO G ETTI NG PAI D FEBRUARY 25, 2015 VOL. 92 NO. 4 ■ G U I DE TO CLAI MS MANAG E M E NT Considerations when treating obesity 33 Taking control of your medical career 35 Prevent denials with efficient claims management The key to getting paid 43 Liability when supervising non-physician providers PLUS 51 How to succeed when working with Medicaid patients ■ 22 PAGE 26 TR EATI NG M E DICAI D PATI E NTS Where to get training Hands-on approaches The truth about EHR support Advertisement not available for this issue Advertisement notdigital available for this issue of the edition of the digital edition www.medicaleconomics.com/resourcecenterindex MedicalEconomics.com Facebook Twitter www.MedicalEconomics.com/HIMSS2012 www.MedicalEconomics.com/ACA MedicalEconomics.com Facebook Twitter See medicaleconomics.modernmedicine.com/himss2012 resource centers related to our Business of Health series You’ve gotYquestions about the Affordable ou've got technology questions. Care Act. as well as topics such as Patient-Centered Medical Homes, accountable We’ve got answers. answers. 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Ext. 121 Sales Support renée schusTer Other people and organizations tweeting about issues that matter to you R ichaR d Vaug h n M d @rvaughnmd Good read. “smallest independent primary care practices, physician owned, provide better care at lower overall cost” http://bit.ly/1qNNnm0 Mou nt S i nai hoS pital @mountSinainYC #Obesity is one of the most important risk factors for #cancer, second to tobacco” - Dr. Paolo Boffetta @ TischCancer http://bit.ly/1uOrM3i Ste ph e n Sch i M pff, M d @drSChimpff Physician frustration is rampant but lets reframe the resolution question http://bit.ly/1s1rcyk #primarycare list account executive 440-891-2613 / [email protected] a. patR ick JonaS, M d @apjonaS Maureen cannon permissions 440-891-2742 / [email protected] Joe loggia Chief Executive Officer ToM ehardT Executive Vice President, Chief Administrative Officer & Chief Financial Officer georgiann decenzo Executive Vice President chris deMoulin Tracy harris Executive Vice President Senior Vice President rebecca evangelou dave esola Executive Vice President, Business Systems Vice President, General Manager Pharm/Science Group Julie MollesTon Michael bernsTein Executive Vice President, Human Resources Vice President, Legal Mike alic Vice President, Media Operations Executive Vice-President, Strategy & Business Development Report: Recruiters have trouble filling primary care openings http://sbne.ws/r/q85a #FMREVOLUTION Francis heid adele harTwick Vice President, Treasurer & Controller Customer service 877-922-2022 advertising 732-596-0276 Back issues 218-740-6477 editorial 800-225-4569 Classifieds 800-225-4569 reprints 877-652-5295, ext. 121 Subscription Correspondence Medical Economics, P.O. 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Library Access Libraries ofer 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 magenta cyan yellow black 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 ofering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community. Medical econoMics ❚ FEBRUARy 25, 2015 ES565803_ME022515_005.pgs 02.03.2015 03:55 5 ADV Referenced in MedLine® Volume 92 Issue 04 FEBRUARY 25, 2015 33 PLANNING FOR YOUR MEDICAL CAREER How to decide between starting, joining, or buying a practice. ICD-10 COLUMNS PA G E 33 DOCUMENTATION STARTS ON PAGE 26 P R A C TI C A L M AT TE R S Keith Borglum, CHBC Making career decisions 35 A PHYSICIAN’S GUIDE TO MANAGING THE CLAIMS PROCESS PA G E 43 Performance improvement must include best practices to reduce and reverse unpaid claims. 43 PHYSICIAN LIABILITY WHEN SUPERVISING MIDLEVEL PROVIDERS Christopher Bernard, JD While supervising non-physician providers can increase liability risk, it can also help prevent medical mistakes. Liability from midlevels 48 MEDICAL MALPRACTICE INSURANCE Considerations for employed physicians when it comes to risk management. C O V E R STO R Y | O P E R ATI O N S 51 WORKING WITH MEDICAID Medicaid is a difcult payer, but growing patient rolls means more physicians must overcome these obstacles. The key to getting paid after the October 1 transition deadline. starts on page 26 Where to get training ❚ Hands-on approaches ❚ The truth about EHR vendor support ❚ 60 MEANINGFUL USE 2 The federal government is lessening the attestation burden for meaningful use 2. 12 13 14 18 22 59 60 ME ONLINE EDITORIAL BOARD FROM THE TRENCHES VITALS CLINICAL ECONOMICS ADVERTISER INDEX THE LAST WORD The federal government is lessening the attestation burden for meaningful use 2. M I S S I O N STATE M E NT Medical Economics is the leading business resource for ofce-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 fnance. Medical Economics provides the nonclinical education doctors didn’t get in medical school. 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Printed in the USA. 6 MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 magenta cyan yellow black Cover: Getty Images/iStock/Getty Images Plus/agsandrew IN DEPTH MedicalEconomics. com ES565820_ME022515_006.pgs 02.03.2015 04:14 ADV Advertisement not available for this issue Advertisement notdigital available for this issue of the edition of the digital edition www.medicaleconomics.com/resourcecenterindex MedicalEconomics.com Facebook Twitter www.MedicalEconomics.com/HIMSS2012 www.MedicalEconomics.com/ACA MedicalEconomics.com Facebook Twitter See medicaleconomics.modernmedicine.com/himss2012 resource centers related to our Business of Health series You’ve gotYquestions about the Affordable ou've got technology questions. Care Act. as well as topics such as Patient-Centered Medical Homes, accountable We’ve got answers. answers. We've got care organizations, and our EHR Best Practices Study at the above link. online MedicaleconoMics.coM Smarter BuSineSS. Better Patient Care. exCluSive online Content and newS. o n li n e exc lu s ive Cms: We’ll ease mU2 reporting reqUirements Responding to pressure from physicians, hospitals and lawmakers, the Centers for Medicare & Medicaid Services (CMS) plans to develop a rule that will give electronic health record users more fexibility in meeting the requirements of its meaningful use 2 (MU2) program. Among other provisions, the rule will shorten the MU2 reporting period from a full year to 90 days. Find more details at: bit.ly/1BUTnRY Twitter Talk Follow us on Twitter to receive the latest news and participate in the discussion. Primary care reimbursement How #MEDPAC proposes paying for continuation of the 10% bonus for primary care providers. http://ow.ly/Ib133 Drug costs People’s perceptions of #drug’s cost may affect how much patients benefit http://ow.ly/Id4on meaningful use Top Headlines Now @MEonline PHysicians may be overtreating seniors for Diabetes Me app. DownloaD free toDay. Get access to all the benefts Medical Economics ofers at your fngertips. The Medical Economics app for iPad and iPhone is now available for free in the iTunes store. MedicalEconomics.com/app immunization resource center Stay up-to-date on the latest developments in immunization and vaccination therapies at MedicalEconomics.com/immunization Older adults may experience more harm than good from their treatments. Read more at bit.ly/1BoqM4G #2 PcmH stuDy rePorts imProveD outcomes A PCMH pilot in a primary care practice brought improved patient outcomes. Read more at bit.ly/15lwgyA #3 onc announces Hire magenta cyan yellow black By using #Apple #mobiledevices, like #iPhone, caregivers will be able to monitor patient’s #glucose levels remotely http://ow.ly/I9uaZ Payment outlook Find out what changes 2015 will bring for physician reimbursement http://ow.ly/HYUQk Practice management Want to run your #medicalpractice more efficiently? Recruit the right people and give them the resources they need. http://ow.ly/HIuOI join us online facebook.com/MedicalEconomics Medical Economics is part of the ModernMedicine Network, a Web-based portal for health professionals ofering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community. Medical econoMics ❚ February 25, 2015 HealtH it Michael James McCoy, MD, will become ONC’s first chief health information officer. bit.ly/1K43CFi Pa r t o f tH e 12 Are you worried about getting audited for #meaningfuluse compliance? Follow these 7 tips, and relax http://ow.ly/IaVh5 twitter.com/MedEconomics MedicalEconomics. com ES564983_ME022515_012.pgs 02.02.2015 23:53 ADV The board members and consultants contribute expertise and analysis that help shape the content of Medical Economics. the Advisers EDITORIAL CONSULTANTS PAGE 33 Choose what will make you personally and professionally happy.” PRACTICE MANAGEMENT Judy Bee www.ppgconsulting.com La Jolla, CA Keith Borglum, CHBC Professional Management and Marketing Santa Rosa, CA —Keith Borglum, CHBC CONSULTANT Kenneth Bowden, CHBC Berkshire Professional Management Pittsfeld, MA Michael D. Brown, CHBC EDITORIAL BOARD Health Care Economics Indianapolis, IN Frank Cohen, MPA www.frankcohengroup.com Clearwater, FL Virginia Martin, CMA, CPC, CHCO, CHBC Mary Ann Bauman, MD Elizabeth A. Pector, MD Healthcare Consulting Associates of N.W. Ohio Inc. Waterville, OH Internal Medicine Oklahoma City, OK Family Medicine Naperville, IL 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 Patricia J. Roy, DO The Rehmann Group Lansing, MI Family Medicine Ft. Collins, CO Family Medicine Muskegon, MI 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 Joseph E. Scherger, MD Business of Medicine, Pediatrics Irvine, CA Family Medicine La Quinta, CA 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 Salvatore S. 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Email your question to [email protected]. MedicalEconomics. com magenta cyan yellow black Foley & Lardner, LLP Boston, MA MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 ES564978_ME022515_013.pgs 02.02.2015 23:52 13 ADV from the Trenches As a young boy I accompanied my father on house calls at night and observed his total involvement in the lives of his patients. I shared his passion for people and their problems. I joined him in practice and was his partner and student for four years and he greatly expanded my knowledge and effectiveness. Bud Gollier, MD, ottawa, kansas family’s commitment to medicine continues I was given a copy of the Medical Economics article, “When practicing medicine Runs in the Family” (November 25, 2014) by my son, a third-generation family physician. Retired nearly 15 years, I mostly follow the changes in medicine with detached concern. As a young boy I accompanied my father on house calls at night and observed his total involvement in the lives of his patients. I shared his passion for people and their problems. I joined him in practice and was his partner and student for four years and he greatly expanded my knowledge and efectiveness. But where did it all start? With my grandfather, a station manager for the Sinclair Prairie Pipeline Company. He was one of the lucky people who had a job in the early thirties and he sent his younger brother and his son to medical school and a sister to Nurses Training, as nursing schools were called in those days. My grandfather’s commitment to service is refected in a letter he sent my father on his 21st birthday while in medical school. I found the letter in an old cigar box with some now-precious trinkets and mementos after my father died. Te letter reads: ‘Dear Son, By the time this letter reaches you will 14 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black have reached the age of manhood. Tis is one of the great events of your life. When we reach this time in life we sometimes shudder to accept the responsibility that goes with it; you have, I believe, been brought up to look these things square in the face which have in a way been taught you, while with some other young men their time being spent playing around with no thought of the future. It may have seemed strange to you many times that your mother and I should keep your eyes pointed to your future expecting of you the many other things that some other parents probably did not think important to expect of their children. All my life I wanted to be of service to my friends and others whom were deserving, longed to be a doctor, wherein I could do for them things they could not do for themselves; For them to have confdence in me would mean everything. Picture a sick bed with relatives and friends around watching the life ebb away from their loved one, awaiting the doctor to bring back to health the one near deaths door. Everything is left to the doctor in whom they have confdence and trust. It means much more than the fee extracted for his service. Dad’ Bud Gollier, MD ottawa, kansas MedicalEconomics. com ES564977_ME022515_014.pgs 02.02.2015 23:52 ADV from the Trenches As a profession, it is time we demand functional tools that allow us to do our jobs effectively. I want an EHR that has had a human factor’s engineer as part of the development team and many docs who actively practice medicine have given their input to make it effective and easy to use. Jay Hammett Jr., MD, knoXVILLE, tEnnEssEE eHR suRVeys measuRe WRonG standaRds I have seen and was trained to have a mission statement for employees. However, the mission statement that is “give our customers tools that are highly efective to complete a task with” is being overlooked by most EHR providers and those who rank the EHR programs. I do not care how much income the EHR has generated for the EHR company as much as how willing they are to work with end users to improve the system. Most providers will say their EHR is a dysfunctional tool. Dysfunctional tools lead to job dissatisfaction, frustration and early burnout. Would a surgeon be happy with sutures that break with every knot tied? Could a nurse give an injection with a rubber needle? As a profession, it is time we demand functional tools that allow us to do our job efectively. I want an EHR that has had a human factor’s engineer as part of the development team and many docs who actively practice medicine have given their input to make it efective and easy to use. It is time to rank EHR’s by lowest (=rubber hammer) to highest (can’t work without it) ranking. An annual competition that puts an EHR system head to head with other systems is needed. Give them four hours to try to see 20 patients—new, existing, walk-in— along with critical test results on patients. Fill MedicalEconomics. com magenta cyan yellow black the challenge with high-risk, difficult diagnoses and documentation challenges. Let the best EHR come to the surface and shine. Tis is a true metric that we as healthcare providers need to demand. Our profession can survive only if we demand efective tools to do our jobs with. It’s time to quit ‘pushing a string’ and start pulling it. Jay Hammett Jr., MD knoXVILLE, tEnnEssEE telemedicine limits tReatment oPtions Telemedicine is a problematic proposition at best and malpractice at worst. Telemedicine is ultimately fawed as it limits the physician’s senses in diagnosing and treating the patient. Insurance companies are already providing these services and hide behind their companies for liability protection. But this too shall fail. Te Federation of State Medical Boards is also trying to pass telemedicine to usurp state licensure board’s authority and exert its own. It is a back door for maintenance of certifcation leading to maintenance of licensure. Tis is just the latest government and special interest scam to extort physicians in the name of phony public safety concerns. 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. Craig M. Wax, DO MULLICa HILL, nEw JERsEY Medical econoMics ❚ February 25, 2015 ES564980_ME022515_015.pgs 02.02.2015 23:52 15 ADV SEE WHAT YOU MAY HAVE BEEN MISSING IN OUR ENEWSLETTER AND ON OUR WEBSITE (Even) more MedEc Industry expects to recoup investment in value models ACA PATIENT DATA GOING TO PRIVATE FIRMS HEALTHCARE leaders expect to recoup investments in technology, staf and facilities that support new models of care,including accountable care organizations, within four years, according to a new survey. U.S. audit, tax and advisory frm KPMG LLP, surveyed 296 healthcare managers and executives in November, fnding that 20% expect to recoup investments in information technology and data and analytics tools in one to two years. Another 36% said they expect such investments to pay for themselves within four years. Twenty-nine percent of respondents put the payback period at under fve years, while 14% Some consumer data gleaned from the federal healthcare.gov website is being shared with private companies, the Associated Press (AP) is reporting. And while no evidence exists that the information is being used illegally or improperly, the disclosure is raising concerns among lawmakers and privacy advocates. “The scope of what is disclosed or how it might be used was not immediately clear, but it can include age, income, ZIP code, whether a person smokes, and if a person is pregnant,” the AP says. “It can include a computer’s Internet address, which can identify a person’s name or address when combined with other information collected by sophisticated online marketing or advertising frms .” The Electronic Frontier Foundation (EFF), a privacy watchdog organization, says it has confrmed the AP’s reporting, and that information from Healthcare.gov is being sent to at least 14 thirdparty domains, including Google.com and Youtube. com. According to the AP, Healthcare.gov’s ties to the outside websites are meant to improve the user’s experience, and the frms can’t use the data for their own interests. said they didn’t expect to recoup costs under any timeframe. Slightly more than a third of the online survey’s respondents said preventive care will be the biggest clinical beneft of population health management, while 23% said the development of evidenced-based clinical protocols to improve the efciency of care would be the biggest beneft. Managing chronic diseases, which are increasingly being carried out by specialty ACOs, was cited by 21% of respondents as the biggest beneft of population management. Te industry is undergoing a shift from feefor-service to value-based models such as bundled payments and ACOs. Te new models place more risk on healthcare providers to encourage preventive care and require substantial investments in information technology and analytics to parse treatment costs and track patient outcomes. Personnel to support the new data infrastructures are now needed, as are specialists in technology, telemedicine, data science and actuarial science. Te industry also needs to redesign care management processes, develop evidence-based medical protocols, and create a strong change management strategy and roadmap. BE SUCCESSFUL IN YOUR PRACTICE, WITH THE HELP OF OUR EXPERTS Receive timely information on the latest developments in primary care practice management, fnances, health law, and other matters vital to your livelihood by signing up for Medical Economics eConsult, delivered to your email box for free. Sign up today! Visit MedicalEconomics.com/enewssignup MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 magenta cyan yellow black MedicalEconomics. com ES564982_ME022515_B16.pgs 02.02.2015 23:52 ADV Want more? We’ve got it. Just go mobile. Our mobile app for iPad® brings you expanded content for a tablet-optimized reading experience. Enhanced video viewing, interactive data, easy navigation—this app is its own thing. And you’re going to love it. get it at medicaleconomics.com/gomobile iPad is a registered trademark of Apple Inc. magenta cyan yellow black ES564637_ME022515_B17_FP.pgs 02.02.2015 22:00 ADV theVitals EmploymEnt rEport: HEaltHcarE job growtH surgEd in latE 2014 Despite conficting reports of healthcare worker surpluses and shortages, a new study says future job security and growth looks bright for healthcare workers. The Altarum Institute Center for Sustainable Health Spending revealed in its annual Health Sector Trend Report that jobs and spending in healthcare was on the rise in 2015, and the future outlook is positive. Healthcare spending grew by 5% throughout the third quarter of 2014, compared to a 3.6% growth rate in 2013. The report attributes the growth to higher prescription drug spending due to fewer drugs hitting the generic market rather than any type of expanded coverage due to healthcare reform. According to the Altarum report, job growth increased by 33% over last year for the third quarter, with an average of 27,000 employees added in the third quarter of 2013 compared to 36,000 added in the third quarter of 2014. 18 Federal government seeks to jumpstart value-based pay seeking to give a boost to the value-based healthcare reimbursements, the Obama administration has announced it wants to tie 50% of feefor-service Medicare reimbursements to alternative, quality-based payment methods by the end of 2018. In a background briefng for reporters Monday, senior ofcials with the U.S. Department of Health and Human Services (HHS) said Medicare will use payment models such as accountable care organizations (ACOs) and bundled payments to reach its goal. HHS has set an interim target of making 30% of reimbursements quality-based by the end of 2016. By the end of 2018 HHS want to have 90% of all Medicare-based payments, including through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reductions programs tied to alternative payment models. Medicare made $362 billion in fee-forservice payments to physicians in 2014. About 20% of those were made through alternative, value-based payment models. Mark Friedberg, MD, MPP, senior natural scientist with the RAND 20% 30% Medical econoMics ❚ February 25, 2015 magenta cyan yellow black Examining the News Affecting the Business of Medicine Corporation, said the long-term impact of the announcement will depend on how the government defnes the concept of value-based payments. “If you’re counting every dollar an ACO [accountable care organization] or a medical home pilot as being value-based, the goal seems achievable but it may not mean that much, because these are programs that are stil running on a fee-for-service chassis. Tat’s where most of the dollars are being generated. But if they’re talking about most of these dollars coming in the form of performance bonuses, that would be a real change for Medicare,” Friedberg said. Medical societies generally endorsed the goals set forth in the HHS announcement. “Today’s announcement by the U.S. Department of Health and Human Services aligns with the American Medical Association’s commitment to work toward innovative care delivery reform that will promote high-quality and efcient care for our nation’s seniors who count on Medicare, while reducing the administrative and regulatory burdens physicians face today,” said Robert M. Wah, MD, president of the American Medical Association. BY THE NUMBERS Amount of qualitybased Medicare payments in 2014. $362 Amount of fee-forservice payments to physicians in 2014. billion Interim target for quality-based Medicare payments by the end of 2016. 90% Goal for percentage of quality-based Medicare payments by end of 2018. MedicalEconomics. com ES565169_ME022515_018.pgs 02.03.2015 01:30 ADV theVitals MEDPAC: Cut specialty pay to support primary care incentive program the medicare Payment Advisory Commission (MedPAC) is looking for short-term solutions to keep primary care physician payment intact amidst possible cuts. In order to continue funding a 10% bonus payment for primary care physicians that expires at the end of 2015, the commission will suggest a 1.4% payment cut to 75% of other services in Medicare’s Physician Fee Schedule (PFS). Te fnal recommendations will be included in a report to be sent to Congress concerning the Medicare PFS in March. Te American Academy of Family Physicians reported that MedPAC Chair Glenn Hackbarth, JD, doesn’t want the recommendations to Congress to remove the urgency of a long-term fx to primary care’s payment problems. "What we’re saying is let’s not go backward and let’s take a step away from fee-for-service,” Hackbarth said. “Tis is a stopgap. It’s small and it’s not going to attract huge numbers of people to primary care.” Te per-benefciary bonus payment goes to physicians who practice internal medicine, family medicine, and general MedicalEconomics. com magenta cyan yellow black “I’ve been involved with the fee schedule from the start, and there’s never been a year when primary care was funded in a way that was appropriate.” —MedPAC Commissioner Kathy Buto, MPA geriatrics and pediatrics as a way to enhance reimbursements and encourage new physicians to study in those felds. Per-benefciary payments are for evaluation and management services provided during ofce visits, patient visits in a long-term care facility and home visits, but not hospital visits. In a presentation to MedPAC members on January 15, the commission said discontinuing the bonus would send a wrong message about the value of primary care in the healthcare system. Other MedPAC recommendations to be made in the March report include repealing the sustainable growth rate formula, rebalancing Medicare payment formulas towards primary care and more options for integrating alternative payment formulas into healthcare. Te AAFP reported that the commission is divided on how to create long-term, fair payment for primary care in the future. “I’ve been involved with the fee schedule from the start, and there’s never been a year when primary care was funded in a way that was appropriate,” said MedPAC Commissioner Kathy Buto, MPA, who suggested valuing primary care separately from specialty care in the Medicare physician fee schedule. Commissioner William Hall, MD, questioned whether the bonus payment is enough of an incentive to fx the problems with primary care. “If we double the salaries of primary care physicians, we would get more people in primary care, but we would have little or no impact on the system of care that people on Medicare need,” Hall said. N.Y. Nurse practitioNers caN practice without phYsiciaN supervisioN Experienced nurse practitioners in New York took a step toward greater independence on New Year’s Day, when new rules under the Nurse Practitioner Modernization Act went into efect. The rules stipulate that nurse practitioners with more than 3,600 hours of clinical practice no longer need to work under a written collaborative agreement with a physician. The required clinical experience equates to about two years in clinical practice. Nurse practitioners with less than the required amount of experience will still be required to work under a physician, according to the legislation. In addition to rescinding the collaboration requirement, the Nurse Practitioner Modernization Act— signed into law along with New York’s state budget in April—will free experienced nurse practitioners from submitting patient charts to a physician for review. The new rules also allow nurse practitioners to diagnose illness, and perform therapeutic and corrective measures. Medical econoMics ❚ February 25, 2015 ES565124_ME022515_019.pgs 02.03.2015 01:09 19 ADV theVitals phYsiciaNs scale back opioiD prescribiNg Clinical use of opioids to treat chronic pain nearly doubled from 2000 to 2010, and primary care physicians are on the front line of the epidemic. While primary care physicians (PCPs) can only rely on patients’ subjective reports when treating pain, 85% of recently-polled PCPs said they somewhat or strongly believed that opioids are overused to treat pain. Another 82% believe to some degree that patients embellish or fabricate symptoms to obtain opioid medications. About 56% of PCPs were moderately confdent and 32% were very confdent of their clinical skills related to prescribing opioids. On the other hand, only 13% of PCPs were comfortable prescribing opioids for chronic, non-cancer pain. Another 36% were moderately comfortable prescribing the medications, but 38% say they are only slightly comfortable and 13% are not at all comfortable. Overall, 53% of PCPs believe prescription drug abuse is a problem. The study appeared in the Journal of the American Medical Association by researchers from Johns Hopkins Bloomberg School of Public Health. 20 skip to icD-11? icD-10 supporters say it’s a bad idea healthcare organizations advocating for ICD-10 continue to defend any argument against the coding system that could again delay its October 2015 implementation. Te latest battle pits Te Coalition for ICD-10 against those that want the United States to skip over ICD-10 and to wait to implement ICD-11. Te Coalition for ICD-10, which includes 22 coding societies, hospitals, health plans and health IT vendors, is on the defense as rumors swirl that another ICD-10 delay could be included in upcoming sustainable growth rate legislation this spring. As the rest of the world readies to implement ICD-11, which will be completed by the World Health Organization (WHO) in 2017, the coalition explains why the coding system is not a good leap for the U.S. Te U.S. version of ICD10 was created after years of modifcations, comment periods, and revisions that added policies and procedures used by the healthcare system in this country. A blog post on the coalition’s website explains how it could take more than four decades to implement ICD-11. “Te modifcation of the WHO version of ICD-10 for Medical econoMics ❚ February 25, 2015 magenta cyan yellow black use in the U.S. took eight years. It was another eleven years before the regulatory process of proposed rules and comment periods was completed and the issuance of a fnal rule establishing ICD-10 as the HIPAA standard code set. Te ICD-10 fnal rule gave the industry three years to get ready for ICD-10 implementation. Two one-year delays have now pushed the time allotted for preparation to fve years. Based on the ICD-10 timeline, ICD-11 would “Learning the medical concepts, training efforts, and overall implementation efforts for ICD-11 will be more challenging if ICD-10 is not implemented first.” not be implemented until 2041,” the blogpost said. Referencing a 2013 report from the American Medical Association (AMA), one of ICD-10’s biggest detractors, the coalition agrees that implementing ICD-10 will help the move to ICD-11 go smoother. “Learning the medical concepts, training eforts, and overall implementation eforts for ICD-11 will be more challenging if ICD-10 is not implemented frst,” the AMA report said. “Focusing solely on moving from ICD9 to ICD-11 risks missing the opportunity to educate physicians and leaving them unprepared for the anticipated transition to ICD-10, which could result in signifcant cash fow disruptions which could result in signifcant cash fow disruptions.” Te AMA has been working with regional societies since November of 2014 on a letter writing campaign to Congress asking members to delay the coding system for a third time. AMA President Robert Wah, MD, spoke to delegates in November of 2014 referencing Star Wars, calling the coding system a droid that would serve Darth Vader. “For more than a decade, the AMA kept ICD10 at bay – and we want to freeze it in carbonite,” Wah said. Not to be outdone, the Coalition for ICD-10 references Samuel Beckett’s play Waiting for Godot saying that the battle to stop another ICD-10 delay hinders all of healthcare: “Nothing happens. Nobody comes, nobody goes. It’s awful.” MedicalEconomics. com ES565126_ME022515_020.pgs 02.03.2015 01:09 ADV Extra Strength Tylenol † Advil † (acetaminophen) 500 mg/tablet (ibuprofen) 200 mg/tablet ® ® ALEVE † (naproxen sodium) 220 mg/tablet Hour 0 1st dose 1st dose 1st dose Hour 6 2nd dose 2nd dose With ALEVE ®, limit the stops in the route to 24-hour OA pain relief ALEVE is indicated for minor arthritis pain. Hour 12 3rd dose 3rd dose 2nd dose Hour 18 X END OF THE LINE 4th dose ‡ Only* ALEVE can provide 24-hour relief with just 2 doses.† ‡ Reflects OTC label dosing for Extra Strength Tylenol for adults and children 12 years and older—maximum daily dose of 6 pills (3 grams) with a dosing interval of 6 hours, unless directed by a doctor. Hour RECOMMEND 24 NOW AVAILABLE *Among OTC brands. † Based on minimum label dosing if pain persists. ALEVE PM is indicated for occasional sleeplessness associated with minor pain. Bayer, the Bayer Cross, ALEVE, and All Day Strong are registered trademarks of Bayer. © 2014 Bayer HealthCare LLC magenta cyan yellow black October 2014 55260-PP-AL-PM-US-0074 Strong on pain. Long on relief. Diphenhydramine HCl plus 12-hour pain relieving strength of ALEVE ES564425_ME022515_021_FP.pgs 02.02.2015 21:01 ADV Clinical Economics Obesity PAGE 24 Key coding considerations PAGE 25 1/3 ore than one-third of American adults are obese, according to the U.S. Centers for Disease Control and Prevention. Tis high prevalence rate has drawn increasing levels of national attention, and the spotlight is often focused on the healthrelated and economic costs of this obesity epidemic. Eforts to manage obesity and related comorbidities are key priorities for primary care physicians. Obesity is linked to a wide range of co-morbidities, contributes to worsening health outcomes, and is associated with reduced physical and psychological quality of life for patients. Te American Medical Association classifes obesity as a chronic disease, indicating the condition requires ongoing management. “While current eforts to reverse the epidemic focus primarily on diet and exercise, losing weight and maintaining weight loss through these lifestyle changes alone can be difcult for some and impossible for others with obesity,” says Nikhil Dhurandhar, PhD, president of the Obesity Society. Te management of obesity can require physicians to allocate signifcant amounts of time and resources in a primary care practice. Physician/patient collaboration is critical to setting realistic goals and expectations, while management strategies must be adjusted based on patient challenges and successes, and regular follow-up visits are necessary to support ongoing weight maintenance. Continued on page 24 MoRe tHan oVerVieW “obesity is taking a toll on our society, both on personal and economic levels. It is an unsustainable, upward trend in need of action.” –NIKHIL DHurANDHAr, PHD, PreSIDeNT oF THe oBeSITY SocIeTY. 42% increase in annual healthcare costs for obese patients over non-obese patients.2 22 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black $891-957 billion3 Estimate of total healthcare costs attributable to the condition, accounting for 16%-18% of U.S. health expenditures. $254 billion3 Patient CommuniCation tiPs See PAGe 24 Evaluate patients effectively Determine patient readiness Provide education Develop a weight management plan Establish realistic goals Use team approach Establish long-term relationships for continuity of care of American adults are obese.1 $46 billion Direct medical costs $208 billion Lost productivity secondary to premature morbidity and mortality 2030 estimate Patient communication tips 2014 Overview Source: 1. Centers for Disease Control, 2. Finklestein, 3. American Heart Association MedicalEconomics. com ES565083_ME022515_022.pgs 02.03.2015 01:08 ADV Advertisement not available for this issue Advertisement notdigital available for this issue of the edition of the digital edition www.medicaleconomics.com/resourcecenterindex MedicalEconomics.com Facebook Twitter www.MedicalEconomics.com/HIMSS2012 www.MedicalEconomics.com/ACA MedicalEconomics.com Facebook Twitter See medicaleconomics.modernmedicine.com/himss2012 resource centers related to our Business of Health series You’ve gotYquestions about the Affordable ou've got technology questions. Care Act. as well as topics such as Patient-Centered Medical Homes, accountable We’ve got answers. answers. We've got care organizations, and our EHR Best Practices Study at the above link. Clinical Economics: Obesity Overview Patient communication tips Key coding considerations Patient CommuniCation tiPs Evaluate patients efectively. At the start of an ofce visit, have staf calculate BMI while evaluating the patient’s vital signs. BMI provides the clinician immediate useful information. Staf should then communicate this information to the clinician before he or she enters the exam room. Tools to facilitate this protocol might include placing BMI charts near each scale in the ofce or including BMI calculators in electronic health record (EHR) systems which display BMI when height and weight are entered. Tracking systems can be established to review patient charts periodically and identify patients who are overweight or obese. Tese systems can then be used to generate reminders for clinicians to discuss weight management with the patient during his or her next ofce visit. Determine patient readiness. Because body weight can be an emotional topic for patients, it is important frst to determine whether the patient is willing to discuss his or her weight, is open to receiving educational materials, and is ready to undertake a management regimen. Practitioners can use a patient readiness scale to determine whether a patient is prepared to move forward with weight management. Te 5 A’s provide a useful framework to evaluate readiness and initiate management: ASK for permission to discuss weight and explore readiness ASSESS obesity-related risks and root causes of obesity ADVISE on health risks and treatment options AGREE on health outcomes and behavioral goals ASSIST in accessing appropriate resources and providers Provide education. Educate patients about their BMI and the associated health risks, and explain the importance of healthy lifestyle changes focused on nutrition and physical activity. Patient education may include the use of tools such as posters and brochures through- 24 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black Patient education ResouRces American Medical Association: Resources on Obesity Management and Prevention bit.ly/keyword Obesity Action Coalition: Educational Resources bit.ly/keyword American Academy of Family Physicians: Obesity Patient Education and Self-Care bit.ly/keyword out the ofce, or recommendation of external sources such as the patient education resources listed below. Develop a weight management plan. Manage obesity with a chronic disease mindset. Individualized patient-centric programs should be developed based on patient motivation, resources, and lifestyle. Management strategies could include nutrition, physical activity, lifestyle changes, self-monitoring, journaling, and commercial weight-loss programs. When indicated, medication or surgery may be considered. Regularly evaluate patient progress and adjust the plan as necessary as patients discover which strategies work best for them. Establish realistic goals. Explain that a 5% to 10% weight loss can reduce health risks in clinically signifcant ways. Assure patients that this can be achieved and maintained with medical management. Because a 5% to 10% weight loss may not result in large cosmetic changes, patients may feel disappointment and frustration after achieving this level of weight loss. Provide positive reinforcement, and remind patients that any amount of weight loss and maintenance is a clinical success. Use a team approach. Obesity is a chronic disease, and weight management can place heavy demands on practice time and resources, making a team approach a necessity. While a primary care physician can recommend diet and exercise for weight management, obesity a complex condition requiring the expertise of a trained interventionist. Te trained interventionist may be a primary care physician with a special interest in treating obesity, a dietician, psychologist or other health counselor with training in weight management. Establishing protocols and consistent monitoring is both fscally responsible as well as paramount to efective surveillance and subsequent determination of successful weight loss and maintenance in the patient. Clinicians, nurses, and ancillary staf members should be educated on obesity management commensurate with their role in patient care. Establish a system for staf training in motivational interviewing, nutrition counseling, physical activity, lifestyle changes, and evaluation of treatment efectiveness. Use EHRs to track response to treatment strategies, record changes in BMI, keep clinicians informed of patient progress, and generate reminders for patient follow-up. Manage barriers to timely referrals by understanding what programs are available to patients and what the requirements are for referral. Establish long-term relationships for consistency in care. Regular follow-up is necessary to maintain physician-patient relationships, reinforce weight management, and prevent weight regain. Followup communication can take the form of in-person ofce visits, scheduled phone consultations, and possible recommendation to commercial weight-loss programs. Because weight management is a lifelong commitment, the healthcare team plays a critical role in facilitating ongoing patient success. —Written by Nicole Klemas, ELS —Reviewed by Bruce M. Wolf, MD, Oregan Health & Science University MedicalEconomics. com ES565079_ME022515_024.pgs 02.03.2015 01:08 ADV Clinical Economics: Obesity Overview Patient communication tips Key coding considerations Key Coding Considerations Insurance carrIers have come a long way when it comes to reimbursing for obesity-related treatment. However, you will need to make sure that your diagnosis coding is specifc and complete in order to support medical necessity. Te frst code set to review when coding for obesity is: (See Diagnosis Codes Table). You need to use V77.8 for obesity screening services. When you look up any of the obesity codes in your ICD-9 code book, you will see the instruction to use an additional code to identify Body Mass Index (BMI), if known. Te ICD-9 codes applicable for obesity complicating pregnancy are 649.10 – 649.14. When utilizing these codes, you should also code to identify the obesity level and the BMI, if known. According to the NCD for Treatment of Obesity, which can be found at Treatment of Obesity NCD, services performed in connection with the treatment of obesity are covered by Medicare when such services are an integral and necessary part of a course of treatment for diseases such as hypothyroidism, Cushing’s disease, hypothalamic lesions, Obesity Diagnosis Codes V85.38 38.0 – 38.9 Code Description V85.39 39.0 – 39.9 278.01 Morbid obesity V85.41 40.0 – 44.9 278.00 Obesity, unspecifed V85.42 45.0 – 49.9 278.03 Obesity hypoventilation syndrome V85.43 50.0 – 59.9 Body Mass Index (BMI) Diagnosis Codes V85.44 60.0 – 69.9 Code Description (BMI - Adult) V85.45 70 and over V85.30 30.0 – 30.9 Code Description (BMI – Pediatric) V85.31 31.0 – 31.9 V85.51 less than 5th percentile for age V85.32 32.0 – 32.9 V85.52 5th percentile to less than 85th percentile for age V85.33 33.0 – 33.9 V85.34 34.0 – 34.9 V85.53 85th percentile to less than 95th percentile for age V85.35 35.0 – 35.9 V85.54 V85.36 36.0 – 36.9 greater than or equal to 95th percentile for age V85.37 37.0 – 37.9 MedicalEconomics. com magenta cyan yellow black cardiovascular diseases, respiratory diseases, diabetes, and hypertension. So you can see that your documentation and claim need to include all diagnoses that the patient presents with that would describe the complexity of his/her conditions. Medicare covers Intensive Behavioral Terapy for obesity and Bariatric Surgery when the guidelines have been met for each. For Intensive behavioral therapy, obesity is defned as a body mass index (BMI) ≥ 30 kg/m2, for the prevention or early detection of illness or disability. Te full NCD can be found at NCD for Intensive Behavioral Terapy for Obesity. For bariatric surgery or other treatment of obesity, Medicare recognizes that obesity may be caused by medical conditions such as hypothyroidism, Cushing’s disease, and hypothalamic lesions, or can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Nonsurgical services in connection with the treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of these medical conditions. In order to be considered for bariatric surgery, Medicare benefciaries need to have a body-mass index ≥ 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. Te full NDC can be found at CMS NCD for Bariatric Surgery for Treatment of Morbid Obesity. —Written by Renee Dowling SourceS American Heart Association. Statistical fact sheet. 2013 update. Overweight and obesity. http://www.heart.org/ idc/groups/heart-public/@wcm/@sop/@smd/documents/ downloadable/ucm_319588.pdf. Accessed January 16, 2015. Canadian Obesity Network. 5As of Obesity Management. http://www.obesitynetwork.ca/5As_adult. Accessed January 18, 2015. Finkelstein EA, Trogden JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer- and service-specifc estimates. Health Afairs. 2009;28(5):w822-w831. Fitch A, Everling L, Fox C, Goldberg J, Heim C, Johnson K, Kaufman T, Kennedy E, Kestenbaun C, Lano M, Leslie D, Newell T, O’Connor P, Slusarek B, Spaniol A, Stovitz S, Webb B. Institute for Clinical Systems Improvement. Prevention and Management of Obesity for Adults. Updated May 2013. https://www.icsi.org/_asset/s935hy/ObesityInteractive0411.pdf. Accessed January 18, 2015. Gudzune KA, Clark JM, Appel LJ, Bennett WL. Primary care providers’ communication with patients during weight counseling: a focus group study. Patient Educ Couns. 2012;89(1):152-157. Michigan Quality Improvement Consortium. Management of overweight and obesity in the adult. Southfeld (MI): Michigan Quality Improvement Consortium; 2013. http:// www.guideline.gov/content.aspx?id=46654. Accessed January 18, 2015. Moyer VA; on behalf of the U.S. Preventive Services Task Force. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(5):373-378. Ogden CL, Carroll MD, Kit BK, Flegal KM. NCHS Data Brief No. 131. October 2013. Prevalence of obesity among adults: United States, 2011-2012. http://www.cdc.gov/nchs/data/ databriefs/db131.pdf. Accessed January 16, 2015. STOP Obesity Alliance. Improving obesity management in adult primary care. 2010. http://www.stopobesityalliance. org/wp-content/assets/2010/03/STOP-Obesity-AlliancePrimary-Care-Paper-FINAL.pdf. Accessed January 16, 2015. Medical econoMics ❚ February 25, 2015 ES565081_ME022515_025.pgs 02.03.2015 01:08 25 ADV CAREER DECISIONS IN DEPTH Making the decision to start, buy or join a medical practice [33] Cover Story The key to getting paid by KE N TE R RY Contributing editor HIGHLIGHTS 01 By coding visits in both ICD-9 and ICD-10, physicians can discover what is missing in their documentation, and improve before the October 2015 transition. 26 REGARDLESS OF how well physicians or their coders understand the new coding system, practices will not fare well on reimbursement unless their providers can document encounters in sufcient detail to support the new codes. Many physicians are putting of the training they will need to do this because they have so many other challenges absorbing their time: Meaningful Use stage 2, the Physician Quality Reporting System, value- Medical econoMics ❚ February 25, 2014 magenta cyan yellow black based reimbursement, patient-centered medical homes…the list goes on. Some doctors are hesitant to put too much efort into ICD-10 because the deadline has been postponed before and they fear it might be delayed again. David Boles, MD, who leads a family practice in Clarksville, Tennessee says, “We don’t have a time set for formal training yet, because we’ve been through this before, where the government delays 28 Getty Images/iStock/Getty Images Plus/agsandrew With the October 1, 2015 deadline for the transition to the International Classifcation of Diseases-10th revision (ICD-10) diagnostic coding set looming, most physicians barely have begun grappling with the central challenge of the shift: documentation. MedicalEconomics. com ES565733_ME022515_026.pgs 02.03.2015 03:37 ADV (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 ICD-10 26 stuf over and over.” Nevertheless, Boles admits, the indications are that the transition will occur this October 1. And he wants to be prepared when that happens. Physicians can derive immediate benefts from learning how to document for ICD10 now, rather than waiting until the last minute, says Jim Lazarus, managing director, strategy and innovation, revenue cycle solutions, for Te Advisory Board Company. “Te improved documentation will beneft physicians now in the ICD-9 environment. It will be refected in their quality and outcome metrics. It will also likely increase their reimbursement.” Here are some tips on how to approach ICD-10 documentation and where to get training for it. In addition, we share the experiences of some physicians as they prepare for the changeover to ICD-10. hoW Big a challenge? Tere are approximately 68,000 ICD-10 codes, compared to 14,000 ICD-9 codes. Tat nearly fve-fold increase in the number of codes requires more specifc documentation than what most doctors provide now in ICD-9 versus ICD-10: Code structure changes ICD-9-CM codes are three to five digits while ICD-10-CM codes can be from three to seven characters, with the seventh character extensions representing visit encounter, subsequent, or sequelae for injuries and external causes, etc. ICD-9-CM Code Format 7 3 3 • 2 coding and coders category ICD-10-CM Code Format 8 s 4 etiology, anatomic site, manifestation 2 • category 1 1 1 etiology, anatomic site, severity Source: Renee Stantz, CPC, billing and coding consultant with VEI Consulting Services. 28 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black their records. But in most cases the change is not as big as it frst appears. To begin with, 78% of ICD-9 codes map “one-to-one” with an ICD-10 code, either exactly or approximately, according to the American Health Information Management Association (AHIMA). Tis means that they require no more documentation than physicians enter now for those codes. Of the ICD-10 codes that do not have ICD-9 counterparts, about half are related to laterality (left, right and bilateral indications), AHIMA says. Another big chunk of ICD-10 codes consists of “external cause reporting” codes, such as what caused a particular injury. While these have been widely mocked by ICD-10 opponents, the Center for Medicare & Medicaid Services does not require providers to use these codes. (Some states mandate certain ones, however.) Among the new codes that physicians must support with documentation are those related to linked conditions such as hypertension and heart disease, new diseases such as Ebola, and musculoskeletal conditions such as bone fractures. Because of the expansion of injury and musculoskeletal codes, “orthopedic doctors are going to have a lot more new codes,” says Angie Comfort, RHIA, CDIP, senior director, HIM practice excellence, coding services, for AHIMA. Tere are signifcant diferences among specialties in terms of numbers of new codes physicians and coders will have to deal with. “If they’re primary care physicians, they’re going to see a lot more than an endocrinologist or a urologist would see,” Comfort says. “Urology has a very small chapter [in the code book], just a few pages.” K extension Physicians employed by hospitals and healthcare systems normally don’t code for themselves, but many independent practitioners do. Tose who code must learn the details of ICD-10 coding that apply to their own specialties, perhaps with the help of certifed coders in their practices. But when it comes to documentation, “doctors don’t want to be trained by coders,” Comfort says, because “most of them are not clinicians.” While the coders can help physicians understand what’s appropriate for billing, they can’t show them how to use ICD-10 when they’re 30 MedicalEconomics. com ES565732_ME022515_028.pgs 02.03.2015 03:38 ADV S. EPATHA MERKERSON Hypertension Sufferer RECOMMEND CORICIDIN® HBP: Cold & Flu Relief Designed for People with Hypertension Like many of your patients, S. Epatha Merkerson has hypertension. Since decongestants may raise blood pressure, these patients need a therapy made for them. Recommend Coricidin® HBP because it’s a smart choice – it’s decongestant-free and specially made to relieve cold and flu symptoms without raising blood pressure. Use as directed. The makers of Coricidin® HBP proudly support the American Heart Association’s efforts to improve heart health. © 2014 MSD Consumer Care, Inc. All rights reserved. magenta cyan yellow black ES564426_ME022515_029_FP.pgs 02.02.2015 21:01 ADV ICD-10 Start preparing now for ICD-10 TransiTion Tips you can use he can click on to build the correct codes. James Morrow, MD, a family practitioner in Cummings, Georgia, says he plans to enter ICD-9 codes into his EHR, using the search function to bring up a list of related ICD-10 codes. Take a financial snapshot TemplaTes and prompTs Begin analyzing the financial health of your practice. Evaluate your payer mix, determine your typical accounts receivable cycle and examine denied claims, both for coding and documentation reasons. Determine what you need to do to survive financially if you encounter a major problem with reimbursements after October 2015. Some physicians hope that their updated EHRs will prompt them through the ICD-10 documentation process. But not all EHRs include the necessary prompts. Te upgrades supplied by some major ambulatory EHR vendors, however, are more related to coding than to documentation. Even where vendors have rewritten templates for ICD-10, Lazarus says, physicians may not be able to use them to guide their documentation because it’s too cumbersome to document everything using pull-down click boxes. “Organizations have found that if you put in too many click boxes, physicians simply become frustrated with the system and are clicking to get out of it or through it,” he says. Consequently, healthcare systems usually customize the templates to make them less burdensome for physicians. In ambulatory care, he adds, the customization needed is not as extensive as in inpatient care. Because there are fewer pathways, “You can use prompts and technology to help a little bit.” Moreover, he points out, “Physicians may do half of their business each day in similar kinds of interactions, so they’ll see patterns. And with a little attention and efort, you can often get sufcient documentation to support coding in a regularly applicable, non-burdensome way.” Physicians in small, independent practices tend not to use pre-canned templates at all. William Harrington, MD, a family physician in Midlothian, Virginia, has always built his own. Morrow prefers to customize his templates on the fy to ft the particular patient he is seeing. And Steven Von Elten, MD, a family practitioner in Warrenton, Virginia, says most of the 12 providers in his practice use free text rather than structured documentation. He’s not sure how he and his colleagues will remember all the details they need to document for ICD-10. Harrington, who doesn’t plan to expand his own EHR templates, is optimistic about his ability to learn ICD-10 documentation. Gather coding data and identify diagnostic patterns Analyze your practice’s coding patterns to determine which codes you use most frequently, which ones make up the largest portion of your revenue, and which ones are denied most frequently, and for what reasons. This should be done for each payer you work with, going back about a year. Contact vendors and health plans Ask your payers and vendors—electronic health records, billing services, clearinghouses—about their ICD-10 readiness. Monitor the preparedness of your vendors and payers and work with them to identify and address gaps. Improve your documentation Providers should begin documenting patient encounters as if ICD-10 is already in place. The goal is to be ready, from a documentation standpoint, for testing and going live with ICD-10. Begin testing Testing ICD-10 claims to ensure that your coding and documentation are working properly is vital, and should begin as soon as possible. The Centers for Medicare and Medicaid Services is holding testing weeks prior to the transition, but waiting for those events is not necessary. Testing is important both within your practice and with the clearinghouses and payers you work with. Make sure you test using records that reflect patient encounters you commonly deal with. 28 trying to care for patients. Lazarus agrees. “Teir perspectives are very diferent. Physicians are attentive to the documentation, whereas coders are focused on what codes and groupings that documentation translates to.” Physicians who code for themselves have fgured out diferent ways to locate the ICD-10 codes they need. Boles, for example, says that his e-MD electronic health record provides body diagrams and code lists that 30 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black MedicalEconomics. com ES565731_ME022515_030.pgs 02.03.2015 03:38 ADV ICD-10 “I don’t want to sound too laissez faire, but I’ve been looking at this for a long time,” he says. “I’ve looked at the ICD-10 codes, and I know the types of things you’d have to put in a chart to justify more detailed codes. So I’m already learning, even though I’m not using it. Every time I code, I see the ICD-10 codes next to the ICD-9 code.” Where To geT Training Lazarus advises all physicians to familiarize themselves with ICD-10 by reading overview materials that CMS and other entities (AHIMA and the American Medical Association among them) ofer on their websites. Other free resources, he adds, are available from some hospitals and physician organizations, as well as trade publications. Beyond that, he suggests, physicians should focus on ICD-10 from the perspective of their specialty and practice setting. “If you’re in a small practice and do [hospital] rounds once a week, you’re going to have different concerns than a doctor employed by a healthcare system as part of a multispecialty group,” he says. Lazarus suggests that physicians seek out physician-specifc training, which can be either peer-to-peer or conducted by other clinicians such as nurse practitioners. Some specialty societies ofer this kind of information on their websites. In addition, the CMS “Road to 10” website features peer-to-peer videos on ICD-10 for small practices in several specialties, and CMS is holding local training sessions for physicians. (For a listing of these events, see www.roadto10.org/events.) AHIMA ofers a few coding briefs for physicians on its website, Comfort says. In addition, it provides free, downloadable tip sheets on documenting 74 diferent conditions for ICD-10. Some consulting frms ofer peer-to-peer educational sessions. While these might be too expensive for small practices, some third party vendors ofer training modules and simulators at an afordable price, Lazarus says. Experts don’t advise physicians to rely on their EHR vendors for training. But many doctors are looking to vendors for help, our interviews suggest, and some companies are providing it. Will ICD-10 be delayed again? Too soon to tell By Donna Marbury, Contributing author s medical practice owners continue to ready their practices for International Classification of Diseases-10th revision (ICD-10) implementation in October 2015, lawmakers are still uncertain whether another delay will be included in sustainable growth rate (SGR) legislation slated for the spring. In December 2014, Republican leaders said that they are working with the Centers for Medicaid and Medicare Services (CMS) to ensure that the October deadline isn’t changed. “Following the most recent delay of ICD-10, we heard from a number of interested parties concerned about falling behind or halting progress…It is our priority to ensure that we continue to move forward in health care technology and do so in a way that addresses the concerns of all those affected and ensure that the system works,” House Energy and Commerce Committee Chairman Fred Upton (R-MI) and House Rules Committee Chairman Pete Sessions (R-TX) said in a written statement. The lawmakers added that hearings on ICD-10 would be scheduled in 2015, although no date has been set. In November 2014, the Medical Society of the State of New York wrote to Speaker of the House John Boehner (R-Ohio) requesting that ICD10 implementation be delayed again until October 2017. The society cited costs and the increased number of codes as reasons that the healthcare community needs more time to implement the system. “The National Physicians’ Council for Healthcare Policy and physicians from innumerable state and national medical organizations and specialty societies have come together to ask for a 2 year delay in the implementation of ICD-10 until October, 2017 in order to allow for physicians to work thru the myriad of new government regulations that face us. The costs of the new ICD-10 coding and billing mandates scheduled for October of 2015 will force financial disruptions and chaos. Patients will lose their doctors!” the New York medical society wrote in the letter. At the end of 2014, the American Medical Association and its regional chapters unsuccessfully lobbied lawmakers to include another ICD-10 delay in an appropriations bill. hands-on approaches MedicalEconomics. com magenta cyan yellow black Medical econoMics ❚ February 25, 2015 ES565730_ME022515_031.pgs 02.03.2015 03:37 31 ADV ICD-10 We’re going to spend more time working on charts than working on patients, just like we are now.” To get practical experience in documentation before the implementation deadline, Comfort says, AHIMA recommends that physicians take advantage of the dual coding that is available in ICD-10-ready EHRs. By coding some visits in both ICD-9 and ICD-10, she points out, physicians can either get feedback from coders in their practices about what is missing in their documentation, or they can fgure it out themselves. AHIMA also advises practices to perform a “document assessment” to determine how their current documentation will support ICD-10 coding. Tis requires coding a current chart in ICD-10, and deciding whether there is enough information in the record to capture the necessary concepts for ICD-10. What if physicians dictate their notes? Although they don’t enter structured data, Comfort says, they must include all of the details required to support ICD-10. “When clinicians dictate, sometimes the documentation gets watered down, and the information needed for coding isn’t there,” she points out. “Laterality is usually included, whether the note is dictated or entered into the EHR,” she adds. “But sometimes the linking of diseases is not there and the severity isn’t there.” real-World challenges Te physicians we interviewed were less concerned with learning how to document for ICD-10 than about two other issues: 1) the degree to which the coding and documentation would slow them down, and 2) the prospect of a cash fow crunch during the ICD-10 transition. Regarding the frst issue, they agreed that the new coding system would reduce their productivity, at least initially. “I’m greatly concerned about how much time I’ll be spending on working through all of these changes as we go from 14,000 codes to 68,000 codes,” Von Elten says. He expects to spend more time on his computer, but doubts that 32 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black it will improve his documentation. Similarly, Boles says, “We’re going to spend more time working on charts than working on patients, just like we are now.” Nevertheless, the physicians we interviewed seem confdent that they can rise to the challenge. Morrow and Harrington both believe they’ll be coding and documenting accurately for ICD-10 within three months of the transition date. Harrington says he views this as a form of on-the-job training. Between self-education and training sessions, he fgures, he’ll be 80% to 85% ready by October 1, and he can pick up the rest as he goes along. In fact, he sees no alternative, considering the number of codes involved. Te question is how a less-than-perfect command of ICD-10 coding and documentation will afect practice revenues during the transition period. Boles says he’s very concerned about that, but he’s still not sure what to do about it. “A three month delay in collections could kill us,” he notes. “So I’ll try to prevent it, but I’m defnitely not in control of that. I don’t have a rock-solid plan.” Overall, physicians expect ICD-10 to be a grind—and an unnecessary one at that--but they’re determined to do whatever it takes. “We have no alternative but to get through it,” Von Elten notes. “It’s going to be a daunting task, no doubt.” More onLine Many physicians still unprepared for ICD-10 http://bit.ly/1BQ3wgc ICD-10 training: How to detail patient encounters http://bit.ly/1uRGu5T MedicalEconomics. com ES565734_ME022515_032.pgs 02.03.2015 03:38 ADV 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 Career deCisions: should you start, buy or Join a praCtiCe? by Ke ith Borg lu m, Ch BC Contributing author There are many ways to have a medical career. Choosing whether to take employment, buy a practice, or start from scratch involves assessing your personal and professional values, and the specifc location you are targeting. The bottom line: Choose what will make you personally and professionally happy. IT’S NOT just new physicians fresh out of residency or fellowship that face career decisions. It can happen to anyone, anytime. Some are fresh out of training. Some are earlycareer physicians who decide they made a mistake in choosing an employer, choosing a location in which to practice, or found that the position they were planning on evaporated. Some always planned to work for someone else until they were more comfortable with their clinical and business skills before setting out on their own. Some are mid-career doctors whose groups break up, or are acquired by bigger group with whom they fnd they disagree. Even senior physicians sometimes fnd themselves in a situation where they MedicalEconomics. com magenta cyan yellow black having to make a choice just a few years before retirement. Joining a practice Decide where you would like to practice, do a little research on community need, then look around for available options and support resources. Taking employment by joining a practice is certainly the simplest solution, if a job is available. There is a food of physicians taking this route now in response to the Afordable Care Act, and with the increasing burdens of administration. On the other hand, I assist a regular stream of physicians that have become unhappy with their employer, and who are eager strike out on their own or be able to control their own work environment. include inheriting antiquated systems in need of replacement, a dysfunctional staf, and perhaps a poor clinical reputation. Sometimes the seller’s spouse was the ofce manager, and management walks out the door with the seller. (Sometimes that’s a good thing.) Buying a practice Location, location Buying a practice is an excellent alternative to starting one, if the purchase is at a fair price. It is less expensive to buy a practice at or below fair market value (FMV) than to start your own; but it is less expensive to start a practice from scratch than to overpay for a purchase. These scenarios compete with each other, and balance each other out fnancially, which is what keeps FMV “fair”. Buying a practice eliminates much of the hassle and expense of a startup, provides a foundation of patients upon which to build, produces quicker cash-fow, and reduces marketing needs. In some competitive markets, the only way in is to buy your way in. Drawbacks can As faculty on the topic for a number of medical associations, I’m commonly asked by attendees, “where in the country should I practice?”—as if there is some magic location that will ensure success. My answer often is not what they expect. The best place to practice is where you want to spend the rest of your life outside of practice. In other words, when you leave the ofce at the end of your day you should be where you want to live. Even those locations that might be considered grossly over-doctored will probably have a niche community opportunity within less than an hour’s drive. All the research says that money only buys happiness up to around $50,000 per year –enough to cover Medical econoMics ❚ February 25, 2015 ES565057_ME022515_033.pgs 02.03.2015 01:07 33 ADV 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 basic necessities–then it has no further impact. So look beyond the potential practice income in selecting a career situation. When to take a risk That’s not to say that I suggest radical untested change in seeking happiness. If you grew up in Florida and have always had an interest in Alaska, take employment for a year before investing in a startup, just in case you didn’t realize what minus 22 degrees and 20 hours of darkness dayafter-day for months really feels like. On the other hand, if you want to specialize in Seasonal Afective Disorder, Alaska in winter might be the perfect location for you. There are many creative ways to have a professional career. I had a client who, for over a decade, alternated practice every two weeks between rural New York State and a Caribbean island, and was quite happy with it until a hurricane eliminated the southern ofce. He sold the northern practice to a buyer wanting to be nearby aging parents. I’ve known several physicians who fy to work, either on commercial airlines or in their own airplanes. If you want more tangible evidence to support your choice of locale, it is easy–and more accurate– to do your own research of community needs rather than buying a demographic survey. Pose as needing a simple evaluation in your specialty for a teenager or parent, and call around to the majority of medical ofces in your specialty to fnd out the wait for a new appointment. Patients like to be seen within a week of calling for an appointment. For every two weeks of wait, there is room for approximately one additional physician. If the only physician in town has a two-week wait, then adding one would theoretically result in two physicians having a one week wait, both still being full. If all three physicians in a community each have a four-week wait, then there is room for six to nine additional physicians. Your wait times will probably equal the others’ within weeks or months. With a little bit of thought and planning you can hardly avoid being successful. Private consultants, most of whom are members of the National Society of Certifed Healthcare Business Consultants (NSCHBC.com), can also ofer personalized guidance and support to your endeavor. Keith Borglum, CHBC, is a practice management consultant, appraiser, and broker in Santa Rosa, California. Send your practice management questions to [email protected]. 34 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black WHAT TO CONSIDER When evaluating an employment offer Compatibility: First and foremost is compatibility between you and the people and environment you will work in—the physicians, the staff, and management. Does it feel like a comfortable environment to you? Visit the workplace for at least a full day. Check references: Interview physicians with your prospective employer. Call another physician who left employment there and ask about his or her experience. Income, fnancial and legal issues: The best approach is to have an independent medical consultant (available at NSCHBC.org or MGMA.org ) review the offer and tell you if it is a good opportunity. A consultant can fnd many hidden problems that an inexperienced person might miss. Security and risk: What’s your “Plan B” if things don’t work out? If you decide after a few months that the job is not for you, can you walk away without major obligations? Always plan your exit strategy going in. Government and management: Who is in charge of the physicians? Is there a senior doctor, or a lay president? If there are disagreements in the way the practice is run, how are they handled? Is there a protocol for arbitration? Staff considerations: Do employees have clear job descriptions? Do the doctors handle the employees professionally, or are they at risk for a lawsuit? Do the physicians treat the staff with respect and professionalism? MedicalEconomics. com ES565054_ME022515_034.pgs 02.03.2015 01:07 ADV Risk ManageMenT In Depth MalpRacTice What liability do physicians accept from providers they supervise? [43] Considerations for employed physicians [48] Preventing payer denials A physician’s roadmap to performance improvement must include best practices to reduce and reverse unpaid claims by D e b ra b eau li e u-VOlk Contributing author HIGHLIGHTS 01 Review all denials within 72 hours and take action on them within seven days. 02 Leverage your team’s insights and expertise, and take advantage of claimsscrubbing systems that help you catch errors. You may be thinking you’re doing everything possible to submit clean, accurate claims to payers—yet denials persist. And if it seems that every day insurers are sending back diferent types of denials, you’re probably right. "ThaT’s The way it is,” says Elizabeth Woodcock, MBA, FACMPE, a healthcare consultant and author with Woodcock & Associates. “No matter how hard you try to make everything perfect, denials still happen. But you have to recognize that the insurance companies have an economic incentive to deny claims, so you’re never going to get it down to zero.” Tat’s the bad news. Te good news, however, is that with a strong parallel strategy of denial prevention and follow-up, you can signifcantly reduce your denial rate and ensure that almost all denied claims get paid. 1/ Follow up promptly To maximize reimbursements, review all denials within 72 hours and act on them within MedicalEconomics. com magenta cyan yellow black seven days, Woodcock says. Gone are the days billing staf can simply reprint a denied claim and send it back to the payer with a rubber stamp that says “appeal,” she adds. “Insurance companies would laugh at you.” But by correcting claims, such as by adding requested information, and sending them back to payers quickly, Woodcock says that at least 80% of them eventually will get paid. 2/ Open your treasure chest Te key to long-term revenue-cycle improvement, however, is learning from and correcting recurrent mistakes. Your most valuable resource in this quest is the denial report, Woodcock says. It can be tempting simply to correct denied claims and send 38 Medical econoMics ❚ February 25, 2015 ES565052_ME022515_035.pgs 02.03.2015 01:07 35 ADV magenta cyan yellow black ES564433_ME022515_036_FP.pgs 02.02.2015 21:01 ADV HEART FAILURE SHATTERS MILLIONS OF LIVES HEART FAILURE PATIENTS: “STABLE” OR SILENTLY PROGRESSING? Heart failure is a progressive disease that is characterized by frequent hospital admissions and high mortality rates: HEART FAILURE HOSPITALIZATIONS OCCUR EVERY YEAR1 OF HEART FAILURE PATIENTS DIE WITHIN 1 YEAR OF DIAGNOSIS3 and rehospitalization continues to be an issue2 this increases to ~50% within 5 years3,4 The neurohormonal imbalance associated with chronic heart failure is a major contributing factor to the progression of the disease. Sustained overactivation of the RAAS and SNS, with dysfunction of the normal counterregulatory effects of the NPS and other compensatory mediators,* lead to impairment in heart function and cardiac remodeling.5-7 *Additional counterregulatory mediators include adrenomedullin, prostaglandin E, bradykinin, etc.8 NPS=natriuretic peptide system; RAAS=renin-angiotensin-aldosterone system; SNS=sympathetic nervous system. References: 1. Go AS, Mozaffarian D, Roger VR, et al. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation. 2014;129(3):e28-e292. 2. Bradley EH, Curry L, Horwitz LI, et al. Hospital strategies associated with 30-day readmission rates for patients with heart failure. Circ Cardiovasc Qual Outcomes. 2013;6(4):444-450. 3. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347(18):1397-1402. 4. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292(3):344-350. 5. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine. 17th ed. New York: McGraw-Hill; 2008. 6. Boerrigter G, Costello- Boerrigter L, Burnett JC Jr. Alterations in renal function in heart failure. In: Mann DL, ed. Heart Failure: A Companion to Braunwald’s Heart Disease. 2nd ed. St Louis: Saunders; 2011. 7. McMurray J, Komajda M, Anker S, et al. Heart failure: epidemiology, pathophysiology and diagnosis. In: Camm AJ, Lüscher TF, Serruys PW, eds. ESC Textbook of Cardiovascular Medicine. New York: Oxford University Press; 2009. 8. Mann DL, Zipes DP, Libby P, Bonow RO, eds. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 10th ed. Philadelphia: Saunders; 2015. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 magenta cyan yellow black © 2014 Novartis 11/14 LZ6-1310824 ES564434_ME022515_037_FP.pgs 02.02.2015 21:02 ADV Claims management 35 them back, but failing to analyze the reasons claims are rejected in the frst place only perpetuates the problem. “Denials are your treasure chest for performance improvement,” Woodcock says. “Tis is your guide to really make a difference.” For example, by reviewing your explanations of benefts you might learn that you’ve been submitting procedure codes that are inconsistent with diagnosis codes, indicating that you need to work on coding. Or you may fnd a pattern of missing or inaccurate demographic information, indicating possible problems with your front-desk registration procedures. 3/ Divide and conquer But to really put this information to work, you need to organize it. For Brett Waress, MHA, FACMPE, chief operating ofcer at Tenet Florida Physician Services, the frst phase of that process is dividing denials into those the practice understands and those it does not. “Tere are denials for reasons that are specifed by insurance companies that we can understand, such as maybe we didn’t get the middle initial or get the patient registration right. Tose are denials we know how to handle,” he says. Denials in this group then go through another (but not the last) round of sorting so they are addressed by the correct department: front ofce; billing ofce; or clinical staf, including physicians, notes Waress. “But there’s a whole other category of denials for reasons that we may not understand or appreciate. It may be a denial for bundling of services in a surgical procedure that is payer-specifc and not supported by Medicare rules,” he says. “Tose types Common reasons for claim denials Duplicate claims insufficient infOrmatiOn OutDateD cODes A duplicate claim was submitted when a practice hasn’t received reimbursement. The claim is defcient in certain information. It may be missing a prior authorization or the efective period of time within which the service must be provided for reimbursement to occur. The claim includes outdated current procedural terminology codes, or it lists deleted or truncated diagnosis codes. typOs Errors or typos were made while collecting pertinent information from the patient or during the data entry process for a claim. serVice nOt cOVereD prOblem witH mODifiers The claim form is missing a modifer or modifers, or the modifer(s) are invalid for the procedure code. DeDuctible The service won’t be reimbursed because the patient hasn’t yet met their insurance plan’s deductible. HealtH plan benefits exceeDeD The patient has exceeded his or her health plan’s beneft for the provided service. 38 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black site Of serVice prOblem An inconsistent site of service is marked on the claim form, such as an inpatient procedure billed in an outpatient setting. cODing mix up There is a coding or data error with mismatched totals or codes that are mutually exclusive. A particular service isn’t cover under the health plan’s benefts. lack Of meDical necessity The health plan could deny a claim if it appears that a service was not medically necessary, or if there is a mismatch between the actual diagnosis and the service performed. Out Of netwOrk When the physician isn’t an in-network provider for the patient, the payer may reimburse a lesser amount if the patient has out-of-network benefts. MedicalEconomics. com ES565058_ME022515_038.pgs 02.03.2015 01:07 ADV Claims management Denials are your treasure chest for performance improvement. This is your guide to really make a difference.” —ELIzabETH WooDcock, Mba, FacMPE, cPc, a HEaLTHcaRE conSuLTanT anD auTHoR WITH WooDcock & aSSocIaTES of denials we like to be able to build them back into our contracting eforts, but it’s exceedingly difcult to call those out and have them addressed specifcally in our contract.” Another complicating factor in this process is lack of consistency in the terminology payers use to describe their reasons for denial. “So getting them translated, crossreferenced, and put into actionable information for those three sections is very diffcult and manual,” he says. Tis process is cumbersome for large systems like Tenet and small practices alike, but is too important to overlook, says Woodcock. “Even though it’s frustrating, we’re in a battle, and this battle is fought every single day. If we give up, we’re going to give up money as well.” 4/ Set priorities Addressing denials is far less daunting, however, if you prioritize well. “Don’t try to fx demographics, coding, and so forth in a month,” says Owen Dahl, MBA, FACHE, principal of Owen Dahl Consulting in Te Woodlands, Texas. “Focus on your biggest impact point frst.” Once the frst item is resolved, move down to the next-biggest problem. “It’s hard to chase more than one rabbit at a time,” agrees Waress. Where to begin, he adds, is a matter of preference. “You either pick the high-dollar, high efort or the lowdollar, low efort.” Either way, he says prioritization is extremely helpful for a practice of any size. 5/ Rally (don’t punish) your team Another common mistake is for a practice MedicalEconomics. com magenta cyan yellow black manager to attempt to come up with the solutions to identifed problems alone, says Dahl. “Talk and brainstorm with your staf and identify what the real source of the problem is,” he says. Tis approach not only eases the burden on managers, it also enhances buy-in among employees to follow through with the solutions they helped create. Keep in mind, too, that fring an employee who may be responsible for a discovered mistake may not be a productive move. “Eighty-fve percent of the time an employee is involved in an error, a system causes the error, not the employee,” Dahl says. And such systems aren’t necessarily ITrelated, but may have to do with inadequate training, poor tools, or too many tasks being assigned to employees, which winds up compromising their performance. “Look at this as a teachable or fxable moment,” Dahl says. “Don’t make the mistake of perpetuating the problem by fring one person and hiring a new one.” 6/ Optimize technology In addition to leveraging your team’s insights and expertise, take advantage of claims-scrubbing systems that help you catch errors before you submit them. “Te clearinghouse world has gotten much better and more sophisticated, so there are tools now available that practices may not be fully aware of or taking advantage of,” Dahl says. Some basic versions of these tools may be bundled into general practice management software that practices already use, he says, adding the caveat that practices might need Medical econoMics ❚ February 25, 2015 ES565053_ME022515_039.pgs 02.03.2015 01:07 39 ADV Claims management Talk and brainstorm with your staff and identify what the real source of the problem is. Eighty-five percent of the time an employee is involved in an error, a system causes the error, not the employee.” — oWEn DaHL, Mba, FacHE, PRIncIPaL oF oWEn DaHL conSuLTInG In THE WooDLanDS, TExaS to spend some time to understand the technology and how it works. “People need to look at both what’s in their practice management system package and what’s in their claims management package from the clearinghouse, and then the compatibility of the two,” he says. “Do I fx a claim in the scrubber or the PMS and how do I make sure that data is being recorded properly?” Furthermore, practices should determine whether their PMS allows them to build in their own edits on top of the basic pre-loaded rules, Woodcock says. “You might say it’s kind of a pain to put in all those edits, all those rules. But remember, if I can prevent fve, six, 15 or 25 errors from happening by building the rule each and every time, it’s defnitely going to be worth the 30 to 45 minutes I spend researching and inputting that rule.” 7/ Find a support system Despite the infux of technology into claims processing in recent years, interpersonal relationships with payers still matter, says Dahl. “Payers are getting more sophisticated and doing more things electronically just like we are, but there’s still no substitute for the fact that I’ve known Mary from insurance company X for all these years and she always tries her best to help me. How you communicate with Mary could change to email, instant messaging, or texting, but I still recommend you contact Mary verbally on occasion just to say hi.” Woodcock agrees, noting that such relationships may help give your practice a voice at the payer if you fnd that a claims- 40 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black scrubbing rule built into the insurer’s system isn’t accurate. “So that relationship may recognize that they’re working for a company just like us, and sometimes humans make mistakes in what they input and we need humans to correct them,” she says. Unfortunately, when Waress experienced just such a problem with a payer incorrectly denying claims, he was unable to reach payer employees empowered to resolve the error. “Even if they agree with and are sympathetic to your problem, people can’t always afect systemic changes in insurance algorithms,” he says. As a result his practice ultimately had to undertake a formal dispute process involving the state medical society and department of insurance, which took 18 months to complete. Because the denials were found to violate the group’s contract as well as department of insurance rules, Waress was successful in obtaining a settlement from the payer that included penalties and interest. “Te department of insurance of the state I was in, particularly their health insurance division, was instrumental in helping us get the attention of payers and getting them to change the way they denied or paid claims,” he says. For situations that require less extreme eforts, professional organizations such as the Medical Group Management Association and state medical societies can often help practices get in touch with other ofces tackling the same challenges, Waress says. “Te important thing to remember is that you’re not alone.” MedicalEconomics. com ES565055_ME022515_040.pgs 02.03.2015 01:07 ADV Rosacea: The physical and emotional toll By Scott Kober, MBA, CCMEP R osacea is a chronic cutaneous disorder that primarily affects the central face, including the cheeks, eyes, nose, chin, and forehead. It is important to note that there is not a specific characteristic or set of characteristics that define rosacea. Rather, there are specific features that vary in presentation and magnitude among patients (Table 1).1 Although the pathophysiology of rosacea is not yet completely understood, it is believed to involve both the innate and adaptive immune systems. Patients with rosacea often have abnormal regulation of the neurovascular system. Vascular abnormalities, microbial activity, and pilosebaceous gland abnormalities may also exacerbate the condition.2 Clinical studies have shown that patients with rosacea have a high concentration of cathelicidin-derived peptide (LL-37), which can contribute to inflammation.3 Recent research has also focused on the possible influence of Demodex mites on the pathophysiology of rosacea, showing that Demodex density is almost 6 times higher in patients with rosacea than it is in the normal population.4 Rosacea affects up to 10% of the general population, with the greatest prevalence in individuals aged 30 to 50 years. Although most common in light-skinned individuals of Northern European descent, rosacea is not exclusive to Caucasians and can be seen, albeit with less frequency, in Asians, Hispanics, African-Americans, and other demographic groups.5 There is certainly a physical burden associated with rosacea, but the emotional impact of the condition is often even more substantial. Whereas acne is often considered almost a rite of passage for teenagers, many adult rosacea patients avoid going out in public due to psychological factors. A recent National Rosacea Society (NRS) survey of more than 400 rosacea suf- Published as a promotional supplement to February 2015 ferers showed that 75% had low self-esteem, 70% were “embarrassed” by their condition, and 56% felt robbed of pleasure/happiness.6 In 2002, the NRS identified 4 distinct subgroups of rosacea. Although there may be some overlapping characteristics of these subtypes, the classifications have helped with diagnosis and initial treatment plans:5 Erythematotelangiectatic rosacea: Mainly characterized by flushing and persistent central facial erythema. Telangiectases are common, but not essential for diagnosis. Most common rosacea subtype. Papulopustular rosacea: Characterized by persistent central facial erythema with transient papules or pustules (or both) in a central facial distribution. Papules and pustules may also occur periodically. Resembles acne, except for the presence of comedones. Phymatous rosacea: Characterized by thickening skin, irregular surface nodularities, and enlargement. Predominantly present in male patients. Ocular rosacea: Characterized by watery or bloodshot eyes, foreign body sensation, burning/stinging, dryness, itching, light sensitivity, blurred vision, telangiectases of the conjunctiva and lid margin, or lid and periocular erythema. In addition to rosacea classifications, the NRS also developed a standard grading system to provide a common reference for diagnosis, treatment, and assessment of results in clinical practice. This grading system is commonly used in clinical trials to allow for comparability of results. A modified version of an available grading scorecard is included in Table 2.7 It gives a general overview of the delineation between severity ratings. The determination of rosacea severity is helpful, but it is important for clinicians to do more than simply perform a visual assessment of a patient’s condition as they consider initial steps of treatment. For example, a patient may present with symptoms consistent with mild rosacea, but if they report significant issues with social and/or professional embarrassment due to their appearance, more-aggressive therapy may be warranted. It is also important to keep in mind that despite the general conditioning of many clinicians to expect more psychological strain in women with rosacea, many men with rosacea also report a significant emotional burden. Determining initial treatment options Many patients with rosacea will try over-thecounter medications indicated for the treatment of acne prior to seeking a clinician’s evaluation. Unfortunately, many of these medications will exacerbate rather than ameliorate a rosacea patient’s inflammation. Patients with rosacea have very sensitive skin that results in a prickly or painful feeling with use of certain agents. It is important for clinicians seeing a patient for the first time to gather a thorough medication history that will help determine initial therapeutic steps. At baseline, a gentle skin care and photoprotective regimen should be recommended for all rosacea patients with centrofacial erythema, regardless of the presence of papulopustular lesions. Generally, a sunscreen with an SPF of at least 30 is recommended for protecting against incidental sun exposure.1 Patients who present with centrofacial erythema but without papules or pustules can often be managed with use of a once-daily alpha agonist, which will demonstrate an initial effect within 30 to 60 minutes of application and peak after 3 to 4 hours. Intense pulsed light or laser therapy may also be incorporated into the treatment plan.8 ROSACEA TYPES AND TREATMENTS SUBTYPES: SYMPTOMS: 1: Erythematotelangiectatic Rosacea (Facial Redness) 2: Papulopustular Rosacea (Bumps and Pimples) 3: Phymatous Rosacea (Skin Thickening) 4: Ocular Rosacea (Eye Irritation) Flushing and persistent redness, may include visible blood vessels, stinging, burning, and swelling Bumps (papules) or pimples (pastules) that come and go, includes red patches Excess tissue often results in enlargement of the nose and irregular surface nodules (bump-like lesions) Watery or bloodshot eyes, tearing and burning, swollen eyelids, recurrent styes EXAMPLES: Courtesy of: National Rosacea Society Published as a promotional supplement to Medical Economics | © 2015 February/2015 magenta cyan yellow black Sponsored by ES559682_ME022515_INSERT1_FP.pgs 01.27.2015 21:23 ADV Rosacea: The physical and emotional toll Table 1 Features of rosacea Primary features Secondary features Flushing (transient erythema) Burning or stinging Nontransient erythema Phymatous changes Papules and pustules Plaque Telangiectasia Dry appearance Edema Ocular manifestations Peripheral location sometimes be managed with a short course of antibiotics but in other instances may require additional topical or systemic therapies. Coming up next In part 2 of this series, we’ll take a closer look at the newest treatment option for the inflammatory component of rosacea—ivermectin— and discuss how it may fit into the overall treatment armamentarium. References Source: Ref 1 Table 2 Severity grading of rosacea papules and pustules Rosacea severity Papules/pustules Plaques Mild Few None Moderate Several None Severe Many Present Source: Ref 7 The majority of research in rosacea has focused on the treatment of inflammatory papules and pustules, which can be more difficult to manage. There are currently 2 topical agents approved by FDA for the treatment of inflammatory lesions of rosacea: metronidazole (MTZ; twice-daily 0.75% gel, cream, or lotion, and once-daily 1% gel or cream) and azelaic acid (AZA; twice-daily 15% gel). Also available is modified-release doxycycline 40 mg once daily, a systemic therapy.9,10 MTZ and AZA are most commonly used initially in patients with mild or moderate disease, whereas doxycycline is often initiated in patients with more severe rosacea. Use of a combination regimen of a topical agent with doxycycline is a popular option for some patients. Recent survey data of 300 dermatologists showed that this combination approach is used as initial therapy in 83.7% of patients with moderate-to-severe papulopustular rosacea.11 The overall safety and tolerability profiles of MTZ and AZA are favorable, with the most common adverse events related to local reactions. AZA may cause neurosensory symptoms after application, but these are usually transient and remit within 1 to 2 weeks after initiating a regimen.9 The submicrobial dose of doxycycline was designed to provide anti-inflammatory effects with no antibiotic activity, even with prolonged duration of use for several months. It has been shown to be equally efficacious regardless of a patient’s rosacea severity at baseline. Common side effects include headache, nausea, and vomiting. These side effects have been shown to appear less frequently in the anti-inflammatory 40-mg dose compared to the antimicrobial 100-mg dose.12 Setting treatment goals Television advertisements often serve as false idols for patients with rosacea, promising “Results within 24 hours!” or “Skin as clear as you could ever imagine!” Unfortunately, this often creates a wildly inflated sense of expectations among patients that can be difficult to temper. It is vital for rosacea patients to understand that, with anything prescribed for them, improvements are not going to occur overnight. In the majority of phase 2 and 3 clinical trials for agents approved by FDA or in latestage clinical trials, patients are treated for 12 to 16 weeks.9,10,13,14 Although patients can expect to see some improvement in their symptoms within a few weeks of therapy (assuming adherence to the prescribed regimen), it may take 6 to 8 weeks for significant improvement to occur. Even then, there may not be complete resolution of background erythema or inflammatory lesions. Some patients will develop an immediate skin reaction to topical medications, but for those who can tolerate them, a 6- to 8-week trial at minimum should be prescribed to gauge efficacy.8 This can be difficult for some patients who want a more-immediate panacea, which is why a frank, upfront discussion is vital to calm overzealous expectations. Because rosacea is a lifelong condition that may wax and wane over the course of a patient’s lifetime, it is also important to discuss long-term maintenance for patients who do get relief from the use of 1 or more medications. Unfortunately, there are few long-term studies in the published literature that address maintenance of disease control beyond 6 months, so it is often up to clinician judgment and patient tolerance to determine the best course of action for lifelong maintenance of rosacea symptoms.8 Many clinicians will see the same patients multiple times during the course of their lifetime to deal with rosacea flares. These flares can Published as a promotional supplement to Medical Economics | © 2015 February/2015 magenta cyan yellow black 1. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 1: a status report on the disease state, general measures, and adjunctive skin care. Cutis. 2013;92(5):234–240. 2. Chang BP-Y, Kurian A, Barankin B. Rosacea: an update on medical therapies. Skin Therapy Lett. 2014;19(3):1–4. 3. Del Rosso JQ, Gallo RL, Kircik L, et al. Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune response in rosacea-prone skin. J Drugs Dermatol. 2012;11(6):694–700. 4. Casas C, Paul C, Lahfa M, et al. Quantification of Demodex folliculorum by PCR in rosacea and its relationship to skin innate immune activation. Exp Dermatol. 2012;21(12):906–910. 5. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46(4):584–587. 6. National Rosacea Society. Coping with rosacea: managing psychosocial aspects of rosacea. www. rosacea.org/patients/materials/coping/managing. php#Managing. Accessed December 24, 2014. 7. Wilkin J, Dahl M, Detmar M, et al. Standing grading system for rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2004;50(6):907–912. 8. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 5: a guide on the management of rosacea. Cutis. 2014;93(3):134–138. 9. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 2: a status report on topical agents. Cutis. 2013;92(6):277–284. 10. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 3: a status report on systemic therapies. Cutis. 2014;93(1):18–28. 11. Del Rosso JQ. Patterns of use of topical and oral therapies in the treatment of different subtypes of rosacea. Presented at the 11th Annual South Beach Symposium; April 11–15, 2013: Miami Beach, FL. 12. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573–576. 13. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating antiinflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791– 802. 14. Stein L, Kircik L, Fowler J, et al. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, doubleblind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316–323. Sponsored by ES559683_ME022515_INSERT2_FP.pgs 01.27.2015 21:23 ADV Physician liability Physician liability for the actions of midlevel providers While the use of physician extenders can bring added legal risks to a practice, they can also help prevent incidents of malpractice by providing more individualized care for patients by Ch r i stoph e r D. B e r nar D, J D Contributing author hysician extender (PE) is a term applied to midlevel professionals who work under the supervision of a physician and carry out functions within the scope of the physician’s practice. Te term refers primarily to physician assistants and nurse practitioners. Teir roles vary from state to state, based on the specifc statutory provisions of the state in which they practice. Tese statutes and associated regulations typically govern training and licensing requirements, PE to doctor ratios, presence and availability of the supervising doctor, and review and cosigning of charts. Some statutes also specifcally establish an agency relationship between the physician and the PE for purposes of imposing liability on the physician for acts of the PE. Te starting point in deciding whether to employ PEs, incorporating them into a medical practice and understanding their liability implications is a full familiarity with the governing statutes and regulations. MedicalEconomics. com magenta cyan yellow black Tere has been an explosion in the number of PEs in the United States over the past decade. According to the American Association of Physician Assistants there are more than 85,000 certifed physician assistants practicing in the United States, more than double the number practicing 10 years earlier. Te American Association of Nurse Practitioners reports that there are 192,000 nurse practitioners employed in the United States, with an additional 14,000 annually completing their training. It is likely that number of PEs will continue to go up as a consequence of the shortage of primary care doctors, the increase in insured patients under the Afordable Care Act, and dwindling reimbursements that require physicians to see an ever-increasing volume of patients. HIGHLIGHTS 01 The growing use of PEs has not lead to an increase in malpractice lawsuits or payouts. 02 The relationship between a physician and a physician extender should not be managed on an ad hoc basis. There must be a written list or description of the activities and procedures permitted to be performed by the PE. Potential Benefits of Using Pes Tis discussion of the fnancial impetus for using PEs is not meant to imply that utilizing PEs does not have the potential for improving the quality of medical care. Tey certainly can and do when employed in the right setting Medical econoMics ❚ February 25, 2015 ES565077_ME022515_043.pgs 02.03.2015 01:07 43 ADV Physician liability a physician can be exposed to liability for malpractice when a patient is harmed by the actions or inactions of a physician extender, even if the physician was not directly involved in treating the patient.” and under appropriate supervision. Te corollary to this is that there are a number of ways that PEs can reduce a physician’s exposure to liability. One of the primary causes of medical malpractice is that physicians cannot or do not spend enough time caring for an individual patient. Tis may include time spent taking a thorough history, doing a proper physical examination, ordering and reviewing tests, speaking with consultants or sometimes just taking a few minutes to think about the patient’s problems before moving on to the next patient. In the complex practice of medicine, not having enough time will inevitably lead to mistakes. Having a PE on staf allows for the thorough and careful treatment of more patients. Having more time facilitates better communication with patients and increases patient satisfaction. Routine tasks such as returning telephone calls, reviewing and acting on test results, communicating with other providers, and ordering prescriptions can be done more quickly and efciently. Perhaps most importantly when it comes to liability risk, good communication and a positive relationship with patients can reduce the likelihood of a malpractice claim in the event of a perceived bad outcome. soUrces of liaBility for acts of Pes Te good news is that the growing use of PEs has not lead to an increase in malpractice lawsuits or payouts. A 2009 study found that between 1991 and 2007, the frst 17 years that the National Practitioner Data Bank was in operation, payments were made on behalf of 37% of physicians, but only 3.1% of physician assistants and 1.5% of nurse practitioners. Te study concluded: “Tere were no observa- 44 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black tions or trends to suggest that PAs and APNs increase liability. If anything, they may decrease the rate of reporting malpractice and adverse events.” Although the overall risk of being sued may not increase with the employment of PEs, a physician can be exposed to liability for malpractice when a patient is harmed by the actions or inactions of a PE, even if the physician was not directly involved in treating the patient. Tere are several legal theories that may be applied to attach liability to a physician, either directly or vicariously, for a PE’s negligence. First, the physician may be directly responsible for negligent hiring of a PE. Te screening process necessary to determine whether a PE is competent and capable of performing the specifc functions that will be required includes a review of educational background, appropriate certifcation, prior work history and recommendations from previous employers or professors. Te other legal ground for fnding a physician directly liable for the actions of a PE is a failure to supervise properly. Te starting place for determining the required level of supervision is the applicable state statute and regulations. Many statutes specify whether the supervising physician must be physically present in the facility where the PE is working, or can have some lesser degree of availability. Te ratio of supervising physicians to PEs also may be spelled out in the statutes. Te responsibility for quality assurance, including review and cosigning of charts is also a common statutory provision. Failure to perform any of these functions may in some instances be deemed negligence per se such that the supervising physician may be held liable even without proof of negligence by the PE. MedicalEconomics. com ES565075_ME022515_044.pgs 02.03.2015 01:08 ADV Physician liability Of course, these statutes set forth just the minimum requirements for supervision. To minimize liability risks and maximize patient safety, the physician must establish a system for meaningful and efective supervision. A physician may also be held vicariously liable for the acts of a PE on the grounds that the PE is acting as an agent of the physician. In some states, statutes create a conclusive presumption of agency so that a physician will always be responsible for the negligence of a PE. In other states, liability will depend on whether the physician has a right to control the work done by the PE. However, given the typical requirements of supervision, it will be a rare circumstance when a PE will not be found to be an agent of the supervising physician. It is also important to be aware, to the extent possible, of the applicable standard of care for PEs. In some states, the PE is held to the standard of care of the supervising physician, on the theory that the PE is carrying out the function of the doctor and the patient is entitled to an equivalent level of treatment regardless of the provider. In other states the PE is held to the lesser standard of a similarly trained and certifed PE, while in still other states the standard of care has not yet been determined by the courts. In this latter circumstance it is best to err on the side of caution and assume that the PE will be held to the higher standard of care. MiniMizing exPosUre to liaBility From my experience representing plaintifs in medical malpractice cases I have seen three main areas where physicians get into trouble in using PEs. First is the failure to have a system in place for working with PEs. Tis relationship should be managed on an ad hoc basis. Practices must have a written list or description of the activities and procedures the PE is allowed to perform. If professional organizations or hospitals have adopted written guidelines or policies for carrying out specifc activities relevant to the PE’s practice, those guidelines or policies should be adopted, taught and enforced by the supervising physician. Review of patient charts for quality assurance purposes, in addition to routine cosign- MedicalEconomics. com magenta cyan yellow black ing of PE’s notes, also should be performed regularly and should include a meaningful, ongoing assessment of competence. A minimum number of annual hours of continuing medical education should also be required for all PEs. Developing and adhering to this type of systematic oversight can help prevent patient safety issues from falling through the cracks. Te second, and undoubtedly the most important element in avoiding problems is efective communication. It is not enough for a PE to have access to the supervising physician. Te PE must feel comfortable initiating communication, and must understand that communication is expected as part of the PE’s responsibilities. Problems may arise when a PE is concerned about bothering the doctor, or is afraid to be seen as incompetent. As professional as PEs may be, they lack the education and training of a doctor, and the relationship only works safely when there is active collaboration between them. Te third suggestion is to recognize and avoid the temptation to give too much autonomy to a PE. Human nature may lead a busy doctor to delegate more and more responsibilities with less and less oversight as long as that trend seems to be working. Likewise, a competent and ambitious PE may be pleased to be given more responsibilities, even if they start going beyond that PE’s level of education and training. Tis arrangement may work wonderfully until disaster strikes. Ten the physician and PE will be asked to explain why the PE was performing functions that should only be undertaken by a doctor. Te way to avoid this insidious process is to adhere strictly to the list of duties and responsibilities assigned the PE, and to regularly reassess the quality of the PE’s work. By following these suggestions, physicians, PEs and, most importantly, patients will reap the many benefts of PEs’ participation in the healthcare team. Christopher D. Bernard, JD, is a medical malpractice attorney with Koskof, Koskof & Bieder, in Bridgeport, Connecticut. Send your legal questions to medec@ advanstar.com Medical econoMics ❚ February 25, 2015 ES565084_ME022515_045.pgs 02.03.2015 01:08 45 ADV F i nan c ial advi c e F r o m th e e x p e rts Financial Strategies Malpractice insurance considerations for eMployed physicians by Jam e s e. s m ith, CPCU, thomas h. stear n s, FaCm Pe, and J U dy m Usg rove Contributing authors Physicians who leave independent private practice to join a large group or a hospital system have different considerations when it comes to medical professional liability (MPL) insurance. MPL insurance is purchased by physicians and healthcare entities to transfer the risk of fnancial loss stemming from an MPL claim to an insurance company. The insurance company in turn agrees to defend and indemnify (pay on behalf of) its insured(s) for such liability exposure. For many years, the purchase of MPL insurance has been a very personal decision made by individual physicians who prioritize defending their professional reputation. Physicians would often select their MPL carrier based on the company’s reputation and ability to defend him or her if faced with an allegation of medical negligence. In small- to mediumsized group practices, the purchase decision often was made by the physicians, rather than by 48 the group’s manager, with emphasis on the insurance company’s willingness to stand by the physician throughout any possible litigation. Now that many more physicians are members of large group practices or are employed by hospital systems, the group practice or hospital’s executive management and board frequently manage the MPL insurance decision, including coverage terms and limits of liability. With this practice mode transition, other considerations understandably take priority. The executive management of larger practices and/or hospital systems must be concerned about the fnancial exposure and potential for adverse publicity for the entity when its employed physicians are involved in a malpractice claim. Medical econoMics ❚ February 25, 2015 magenta cyan yellow black Everyone shares the concern regarding the impact of a large verdict. However, individual physicians and their employers might view these impacts very diferently. Fear of adverse verdicts may increase a larger entity’s interest in settling claims where the potential damages are large, even when the involved physician believes his or her actions were appropriate and in accordance with the standard of care. This often raises questions about “consent to settle” provisions that are frequently part of an individual physician’s MPL insurance policy. The “consent to settle” provision specifes that the physician must authorize any settlement made on his or her behalf–and moves settlement decisions outside the control of the entity’ management. Mangers of group practices or hospital systems may be uncomfortable with this situation, and want to get more involved in the overall claims management process. For those physicians employed by a regional or national healthcare system, it is likely that the system’s management will have a system-wide insurance program in place for all employees. Large healthcare entities often are accustomed to having varying levels of fnancial risk on the revenue side, such as capitation, withholds and various pay-for-performance arrangements with payers. Also, many self-insure their risk of loss to some extent, or may carry large deductibles on some or all of their other coverages such as health insurance, workers compensation and other property and casualty insurance programs. Therefore, it is common for such entities to place some or all of the risk for their medical professional 50 MedicalEconomics. com ES565074_ME022515_048.pgs 02.03.2015 01:07 ADV Bernadette Sheridan, M.D. Grace Family Medical Practice Brooklyn, NY On the network since 2006 BETTER NOW #1 Best in KLAS Services Helping practices thrive through change. Winner of five Best in KLAS awards for 2013, athenahealth helps caregivers thrive through rapid change in the health care industry. Learn more about our cloud-based EHR, practice management and care coordination services. 2013 Best in KLAS #1 Overall Software Vendor #1 Overall Physician Practice Vendor #1 Patient Portal #1 Practice Management System #2 EHR (1-10, 11-75 physicians) (1-10, 11-75 physicians) To learn more about the athenahealth integrated suite of services, visit athenahealth.com/BestInKLAS athenahealth athenahealth provides cloud-based services for EHR, practice management and care coordination, helping caregivers do well doing the right thing. * 2013 Best in KLAS Awards: Software & Services,” January, 2014. © 2014 KLAS Enterprises, LLC. All rights reserved. www.KLASresearch.com magenta cyan yellow black ES564451_ME022515_049_FP.pgs 02.02.2015 21:02 ADV F i nan c ial advi c e F r o m th e e x p e rts Financial Strategies 48 liability into self-insured programs. It is important for the physicians in these arrangements to understand these coverages and the potential fnancial or reputational impact of those coverage arrangements. Most large healthcare entity insurance programs are professionally managed; due consideration usually is given to the implications of their operational decisions on future claims activity as well as physician satisfaction. Physicians covered under selfinsurance programs should understand the program’s operating philosophy and feel comfortable that their needs will be met. Other considerations On another note, as healthcare continues to evolve, new risks are created along the way. Such emerging risks frequently increase the uncertainty of loss and, consequently, the uncertainty of adequate premiums and capital to cover such losses. Some of the evolving areas on the radar today include: TeLeMedicine. New electronic capabilities are enabling healthcare to be delivered efectively in ways not possible before. Telemedicine practice 50 Fear of adverse verdicts may increase a larger entity’s interest in settling claims where the potential damages are large, even when the involved physician believes his or her actions were appropriate may take a physician into less- known regions where the legal climate creates potential liability exposure that is much greater than expected. eLecTronic HeaLTH records (eHrs). While EHRs have great potential for improving care, they also create new opportunities for privacy breaches and other care coordination challenges. No one can deny the potential errors and resulting liability risk that EHR’s bring to the healthcare arena. PHysician exTenders Physician extenders, such as nurse practitioners and physician assistants are playing an ever-greater role in healthcare delivery. State legislatures and healthcare organizations are struggling to fnd the appropriate level of physician supervision. That debate is ongoing. affordabLe care acT (aca) To the extent that the ACA increases the number of patients with healthcare Medical econoMics ❚ February 25, 2015 magenta cyan yellow black insurance there is concern that it may create a misalignment between patients’ expectations of the level and availability of care and the ability of the healthcare system to meet those expectations. The increase in volume may also overwhelm medical practices and thereby increase the risk of loss due to medical malpractice cyber-reLaTed exPosures Patient confdentiality and personal identity are increasingly under attack. Violations of the Health Insurance Portability and Accountability Act and the resulting consequences are a real threat to the entire healthcare arena. With talented criminals exploiting security weaknesses in an attempt to gain access to private information, securing protected health information is a continual challenge. It is a new and everchanging world for physician practices. Professional liability insurance is a vital part of that landscape, but it is certain that physicians will continue to demand excellent MPL coverage that protects their reputation and fnancial well-being in the event of a lawsuit. More online Why business associate agreements are a must for efective risk management http://bit.ly/18ps7RF Talking to patients about adverse outcomes http://bit.ly/1DdlhIr 2014 physician survey: Waiting for the ACA’s malpractice impact http://bit.ly/15PgTFb Smith is a senior vice president, Stearns is a vice president for medical practice services and Musgrove is director of marketing and communications for the State Volunteer Mutual Insurance Company in Brentwood, Tennessee. Send your practice management questions to [email protected]. MedicalEconomics. com ES565080_ME022515_050.pgs 02.03.2015 01:08 ADV In Depth Treating Medicaid patients Medicaid is a difficult payer to work with, but growing patient numbers means physicians must consider how to overcome the obstacles by Tam my WorTh Contributing author HIGHLIGHTS 01 Book Medicaid patients at times it would be less inconvenient to have a noshow, such as immediately before or after lunch or at the end of the day. 02 Physicians will benefit from helping patients overcome some of the care barriers related to poverty because healthcare is moving toward dealing with population health, which includes psychosocial, as well as biological, care. MedicalEconomics. com magenta cyan yellow black Te provider that accepts a large number of Medicaid patients and makes it work for his or her practice is much like the fabled unicorn: there are rumors that they exist, but no one has actually seen them. But with more states expanding Medicaid through the Afordable Care Act (ACA), the number of patients covered by the program is growing, and not all these new patients will fnd it easy to get to a provider. Medicaid is a well-known irritant of physicians, and many providers won’t even accept it as a payer. A 2014 study by Merritt Hawkins looked at Medicaid acceptance by physicians in 15 major metropolitan areas called 1,400 ofces across fve specialties: family medicine, cardiology, dermatology, obstetrics and gynecology and orthopedic surgery. Tey found that the average overall rate of Medicaid acceptance by physicians was 45.7% in 2014, down from 55.4% in 2009. Cardiologists averaged the highest rate of acceptance at 63%; primary care providers averaged 50%. Te lowest acceptance rate was among dermatologists at 27%. Te trend of Medicaid non-acceptance by physicians may only worsen given the expiration of the Medicaid pay boost tied to the ACA at the end of 2014. A study by the Urban Institute estimates that primary care physicians could see their Medicaid reimbursements cut by an average of 43%. At groups such as Salud Family Health Centers, a system of community health clinics in northeastern Colorado, Medicaid expansion was welcome. Te federally qualifed health centers saw a jump from Medical econoMics ❚ February 25, 2015 ES565059_ME022515_051.pgs 02.03.2015 01:07 51 ADV Medicaid The workflow needs to be more patient-centered using the staff to the fullest extent of their licenses. If they aren’t going to have a care model like this, it may be cost-prohibitive or overwhelming to take care of this population.” —CaTHerIne SreCkovICH, ManaGInG dIreCTor, navIGanT’S HeaLTHCare PraCTICe 30% percent of its patient population with Medicaid coverage prior to expansion to 57% post-expansion. Jennifer Morse, development director for Salud, admits there can be challenges to accepting Medicaid, including access issues and greater complexity among patients. But for them, moving 27% of patients from self-pay to insured represented a signifcant improvement. Healthcare is a business. If the money is there to make taking a patient worthwhile, doctors will take them, Morse said. If the reimbursement doesn’t warrant the administrative burdens, they won’t be as motivated. Much of the issue of Medicaid is perspective, she said. “It is a good payer for us, so we don’t experience a lot of challenges,” she said. “We have a really unique perspective–we would rather a patient have Medicaid than no insurance at all.” An increasing number of patients will be enrolling in Medicaid and will be seeking care as states continue to expand the program. Accepting such patients may pose challenges, but making Medicaid a larger part of a practice–or just accepting any Medicaid patients–may be a viable option with some tweaks to a practice. Addressing the issues Te most frequently cited reason for not accepting Medicaid? Low reimbursements. Payments vary from state to state, but, on average, Medicaid pays about 66% of what Medicare reimburses, according to the Kaiser Family Foundation. But that clearly isn’t the only challenge. Medicaid acceptance is down across the country even as provisions in the ACA increased reimbursements (primary care fees 52 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black were increased to Medicare rates in 2013 and 2014). “Reimbursement is the number one factor (physicians provide for not taking Medicaid), but we have seen in states that have increased rates, it doesn’t cause physicians to take more patients,” said Catherine Sreckovich, M.S., managing director in Navigant’s Healthcare practice. “It motivates physicians that are already taking it to take more patients, but not make others add it.” Sreckovich said it can be a challenge for physicians because patients often don’t have child care, so their whole family comes to the waiting room. Physicians tell her that their Medicaid claims are rejected more than other payers. It is more challenging to verify eligibility and deal with prior authorization than with other insurers. Referring to specialists can also be difcult because “there aren’t an overabundance of specialists taking Medicaid, particularly in pediatric subspecialties,” she says. Physicians also cite high turnover rates and long wait times for reimbursements as challenges to accepting Medicaid patients. A study published in Health Afairs found that Medicaid reimbursement times vary considerably from state to state. Te shortest wait time was in Kansas, at 36.9 days (compared with 29 days for commercial insurers) and the longest was 114.6 days in Pennsylvania (compared with 26.8 percent for commercial payers). Not surprisingly, physicians in states with faster reimbursements were more likely to accept Medicaid patients. Minding the gAps From a provider standpoint, there is little that can be done 54 MedicalEconomics. com ES565082_ME022515_052.pgs 02.03.2015 01:08 ADV Make a successful transition to ICD-10 now with Kareo. Change can be hard. In some cases, ridiculously so. Our ICD-10 100% Success Plan helps you transition your private practice as quickly as possible. We’re the ones you can trust for a complete ICD-10 plan, fully integrated medical software and services, and a team dedicated to your success. Don’t wait until October 1. Prepare now, with your partner, Kareo, at 866-231-2871 or kareo.com/icd-10. magenta cyan yellow black ES564436_ME022515_053_FP.pgs 02.02.2015 21:01 ADV Medicaid 52 regarding reimbursements. However, there are options for overcoming problems such as no-shows and patient noncompliance. In recent years, the American Dental Association has been pushing for more dentists to take Medicaid patients. Te association has recommendations on its website for meeting the challenge of no-shows. One option is booking Medicaid patients for times during the day when it would be less inconvenient for the patient not to keep the appointment, such as right before or after lunch or at the end of the day. All a practice’s Medicaid patients should be scheduled on specifc days, if possible. Another option is to overbook, particularly if you have Medicaid patients grouped into one particular day. Morse says that as with all practices, the Salud centers have a problem with noshows. In response, they have instigated a policy whereby such patients have three strikes “then they are out.” Tey have also attempted pilot programs that include calling patients the day before to remind them of their appointments. expAnding resources According to Morse, many no-shows among Medicaid provider figures don’t reflect reality of patient care By Jeffrey Bendix, Senior Editor M ore than half of the physicians across the country who supposedly treat Medicaid patients don’t actually do so, a new government report finds. Approximately 49 million Americans obtain healthcare services under the Medicaid program, and most of those services are provided through Medicaid managed care organizations (MCOs). But according to a report prepared by the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services, 43% of providers listed by MCOs as accepting Medicaid patients either were not practicing at the location where they were listed or were not participating in the MCO, and another 8% were not accepting new patients enrolled in the plan. “When providers listed as participating in a plan cannot offer appointments, it may create a significant obstacle for an enrollee seeking care,” the report notes. “Moreover, it suggests that the actual size of provider networks may 54 Medical econoMics ❚ February 25, 2015 magenta cyan yellow black be considerably smaller than what is presented by Medicaid managed care plans. It also raises questions about whether these plans are complying with their states’ standards for access to care.” Under the Affordable Care Act, states have the option of expanding Medicaid eligibility to include families earning up to 138% of the federal poverty level, with the additional costs covered entirely by the federal government for the first four years and at 90% thereafter. To-date 27 states and the District of Columbia have expanded Medicaid eligibility, and the Congressional Budget Office estimates that the number of people covered by Medicaid will increase to 87 million by 2018. The OIG report thus may raise doubts as to Medicaid’s ability to deliver healthcare services to new enrollees in a meaningful way. Other findings from the report: ❚ among the 49% of providers who did offer appointments, the median wait time was two weeks, but more than 25% had wait times of more than one month, ❚ specialists were more likely to provide appointments than primary care providers (57% versus 44%), ❚ the median wait time for a specialist appointment was 20 days, versus 10 days for a primary care provider The report recommends that the Centers for Medicare and Medicaid Services work with states to: ❚ assess the number of network providers and improve the accuracy of plan information, ❚ ensure that MCO networks meet the needs of their enrollees, and ❚ ensure that plans are complying with existing state standards and assess whether additional standards are needed. ❚ Results of the study were based on telephone calls to a random sample of primary care providers and specialists from July through October, 2013. MedicalEconomics. com ES565076_ME022515_054.pgs 02.03.2015 01:07 ADV Medicaid [Medicaid] is a good payer for us, so we don’t experience a lot of challenges. We have a really unique perspective — we would rather a patient have Medicaid than no insurance at all.” —JennIFer MorSe, deveLoPMenT dIreCTor, SaLUd FaMILY HeaLTH CenTerS, CoLorado the Medicaid patient population are the result of obstacles such as lack of child care, inadequate transportation or jobs that don’t allow for time of. Tis is one reason Medicaid patients are sometimes considered noncompliant. But there are steps providers can take to help remedy these situations. Teresa Koenig, MD, MBA, senior vice president of the Camden Group, says physicians will beneft from helping patients overcome some of these problems because healthcare is moving toward dealing with population health, which includes psychosocial, as well as biological, care. “Tey can always look at elements of the patient-centered medical home and bring the kind of care model into an offce that assists the patients with transitions of care, resources, transportation or clothing or medication needs,” she says. “We want to make sure they remain part of the solution but are being rewarded for those changes to deliver care along a continuum.” One way to do this is to work with outside groups such as churches and community agencies to help patients get needed transportation, medications or other assistance. Tis doesn’t need to be something put upon the shoulders of physicians, either. Sreckovich notes that physician extenders and administrators can connect with resources patients might need. Physician extenders, such as nurse practitioners and physician assistants can also be used to their greatest ability when dealing with Medicaid patients. Tese providers can perform checkups or non-emergent visits in states that allow this with provider oversight. “If they aren’t going to have a care model like this in their ofce, it may be cost- prohibitive or overwhelming to take care of this population,” Sreckovich says. “Te workfow needs to be more patient-cen- MedicalEconomics. com magenta cyan yellow black MedicAid expAnsion stAtus aLL 50 states NH WA MT OR ND ID WY NV CA UT AZ VT MA WI SD IA NE CO IL KS AR IN PA OH KY WV TN MS AL TX NY MI MO OK NM ME MN VA NC SC GA RI CT NJ DE MD DC LA FL AK HI Expanded Medicaid No Medicaid expansion* *As of January 27, 2015 Source: Kaiser Family Foundation tered using the staf to the fullest extent of their licenses.” Sreckovich says she does know physicians near her Chicago ofce making Medicaid work in their practices. It just takes getting used to the payer and patients. “If you are able to deal with the administrative hassles, it becomes a matter of treating a patient just like any other,” she says. Medical econoMics ❚ February 25, 2015 ES565078_ME022515_055.pgs 02.03.2015 01:08 55 ADV P r o d u c t s & S e r v i c e s SHOWCASE FINANCIAL ADVISERS FOR DOCTORS ★ Those companies listed in Medical Economics 2014 Best Financial Advisers for Doctors display this symbol in their ads. 2014 Best Financial Advisers for Doctors FLORIDA FRYE FINANCIAL 1/8 PAGE 4C LAST ISSUE Advertise today: Tod McCloskey • Showcase & Marketplace Advertising [email protected] • 1.800.225.4569, ext.2739 Your connection to the healthcare industry’s best financial resources begins here. Advertise today: Tod McCloskey • Showcase & Marketplace Advertising • [email protected] • 1.800.225.4569, ext.2739 56 MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 magenta cyan yellow black MedicalEconomics. com ES564557_ME022515_056_CL.pgs 02.02.2015 21:49 ADV M A R K ET PL AC E PRODUCTS & SE RVIC ES MEDICAL EQUIPMENT PRACTICE FOR SALE N AT I O N A L SELLING A PRACTICE?? Buying a Practice? Buying Into a Practice? Appraising the Market Value of your Practice? Setting up for a Sale or Purchase? Looking for a Buyer or Seller? I represent physicians selling their practices who are considering retiring or relocating. I also represent physicians who are interested in appraising and evaluating practices they have found themselves. In either case, all the details of your specific practice transfer can be arranged in all specialties of medicine and surgery. During the past 30 years I have appraised and sold hundreds of practices throughout the USA. Should you need to find a prospective purchaser for your practice, I can provide that service. If you would like to be fully prepared for a sale or purchase or buy-in, and require an experienced consultant representing your interests in a tactful and professional manner, I would be pleased to hear from you. See Website Below for Listing of Practices For Sale. For Further Information, Contact: Gary N. Wiessen Phone: 631-281-2810 • Fax: 631-395-1224 Email: [email protected] Website (including credentials): www.buysellpractices.com Repeating an Ad Ensures It will be Seen and SHOWCASE & MARKETPLACE ADVERTISING Remembered! Contact: Tod McCloskey at 800.225.4569 x 2739 • [email protected] MedicalEconomics. com magenta cyan yellow black MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 ES564560_ME022515_057_CL.pgs 02.02.2015 21:49 57 ADV M A R K ET PL AC E CAREERS N AT I O N A L 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 of our program and business by putting me • On-site Call Coverage in contact with Health Care Professionals • All Specialties • Telemedicine around the country • Hospitalist Coverage who are the creators • Telephone Call Coverage and innovators in their • Customized Call Solutions moonlightingsolutions.com [email protected] 58 MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 magenta cyan yellow black feld. It has allowed me to help both my colleagues and their patients. MedicalEconomics. com ES564556_ME022515_058_CL.pgs 02.02.2015 21:49 ADV M A R K ET PL AC E CONNECT with qualified leads and career professionals Post a job today Advertiser Index athenahealth Corporate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Bayer AG Aleve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Coricidin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29* Janssen Pharmaceuticals, Inc. Invokana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 – Back cover Kareo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Novartis Corporate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 – 37* Takeda Pharmaceuticals Colcrys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 www.modernmedicine.com/physician-careers Joanna Shippoli RECRUITMENT MARKETING ADVISOR (800) 225-4569, ext. 2615 [email protected] * Indicates a demographic advertisement. MedicalEconomics. com MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 59 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 Congress seeks to aid physiCians on the burden of Meaningful use 2 by DON NA MAR B U RY, contributing author Legislators are stepping up attempts to help physicians avoid impending meaningful use stage 2 (MU2) penalties that could affect the majority of eligible healthcare providers. If passed, the Flexibility in Health IT Reporting (FLEXIT) Act will allow healthcare providers the option to decrease the MU2 reporting period from a full year to 90 days. The bill was frst introduced by Rep. Renee Ellmers (R-NC) in September 2014, but was untouched during December’s lameduck session. The latest version of the bill, introduced on January 8, includes support from both Republicans and Democrats. Ellmers says that quick changes need to be made to the MU program, considering that nearly half of eligible providers (EPs) are facing stage 1 MU penalties, according to the Centers for Medicare and Medicaid Services (CMS). “The time constraints imposed on doctors and hospitals are infexible and simply unmanageable— and this is evident by the dreadful stage 2 meaningful use attestation numbers released by CMS late last year,” Ellmers said in a press release. Leaders from healthcare 60 advocacy organizations including the American Academy of Family Physicians (AAFP), American Hospital Association, American Medical Association (AMA), College of Healthcare Information Management Executives, Healthcare Information Management Systems Society and Medical Group Management Association urged legislators to pass the bill before the 2015 MU2 deadline in February. In November of 2014, the coalition wrote CMS requesting a more lenient MU2 attestation schedule. “We are pleased with renewed eforts to provide greater fexibility in the Meaningful Use program and hope that this is the frst of several steps to make the program work better for physicians and other providers so that the full potential of these technologies to improve care and value can be realized,” said American Medical Association President-Elect Steven J. Stack, MD in a written Medical econoMics ❚ February 25, 2015 magenta cyan yellow black statement. Robert Wergin, MD, president of the AAFP says that family and primary care physicians are hit hardest by MU requirements and penalties. “As family medicine continues to do its part in building the HER (electronic health records) infrastructure — a massive undertaking — CMS should not set benchmarks so high that it discourages participation in the program…The American Academy of Family Physicians believes this fexibility will help physicians stay on track in building an EHR system that works.” As of December 2014, 4% of EPs and less than 35% of hospitals successfully attested to MU2. EPs have until February 2015 to attest to MU2, or face a 1% reduction in Medicare reimbursements. Meanwhile, nearly 260,000 EPs will face a 1% reduction in Medicare reimbursements for failing to attest to 2014 MU standards. BY THE NUMBERS % 4 Percentage of eligible providers who attested to meaningful use 2, as of December 2014. 260,000 Number of eligible providers who will face a 1% reduction in Medicare reimbursements for failing to attest to meaningful use in 2014. MedicalEconomics. com ES565056_ME022515_060.pgs 02.03.2015 01:07 ADV (Even) more MedEc SEE WHAT YOU MAY HAVE BEEN MISSING IN OUR ENEWSLETTER AND ON OUR WEBSITE New flu test cleared for physician use PHYSICIANS can now use a new, fast molecular fu test in their ofces that previously had only been approved for use in specialized laboratories, the U.S. Food and Drug Administration (FDA) announced. According to the FDA, the nucleic acid-based test uses a nasal swab sample from a patient with symptoms of fu infection. The test provides results in as little as 15 minutes and may be performed in the presence of the patient. Negative results do not rule out infuenza virus infection; the test is intended to aid in diagnosis along with the evaluation of other risk factors. Because the FDA granted a waiver for the test via the Clinical Laboratory Improvement Amendments (CLIA), the Alere test can be distributed to a broad variety of clinical settings, including physicians practices, emergency departments, health departments, and other healthcare facilities. The move comes as the nation’s physicians battle one of the severest fu seasons in years, resulting in dozens of deaths so far and higher levels of cases in the majority of states. One concern among public health experts is that a more severe fu strain, known as H3N2, appears to be circulating this season that fu shots do not fully protect against. BE SUCCESSFUL IN YOUR PRACTICE, WITH THE HELP OF OUR EXPERTS Receive timely information on the latest developments in primary care practice management, fnances, health law, and other matters vital to your livelihood by signing up for Medical Economics eConsult, delivered to your email box for free. Sign up today! Visit MedicalEconomics.com/enewssignup MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015 magenta cyan yellow black 61 INVOKANA™ (canagliflozin) tablets OVERDOSAGE There were no reports of overdose during the clinical development program of INVOKANA (canagliflozin). In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status. Canagliflozin was negligibly removed during a 4-hour hemodialysis session. Canagliflozin is not expected to be dialyzable by peritoneal dialysis. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Instructions: Instruct patients to read the Medication Guide before starting INVOKANA (canagliflozin) therapy and to reread it each time the prescription is renewed. Inform patients of the potential risks and benefits of INVOKANA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change. Instruct patients to take INVOKANA only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time. Inform patients that the most common adverse reactions associated with INVOKANA are genital mycotic infection, urinary tract infection, and increased urination. Inform female patients of child bearing age that the use of INVOKANA during pregnancy has not been studied in humans, and that INVOKANA should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Instruct patients to report pregnancies to their physicians as soon as possible. Inform nursing mothers to discontinue INVOKANA or nursing, taking into account the importance of drug to the mother. Laboratory Tests: Due to its mechanism of action, patients taking INVOKANA will test positive for glucose in their urine. Hypotension: Inform patients that symptomatic hypotension may occur with INVOKANA and advise them to contact their doctor if they experience such symptoms [see Warnings and Precautions]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake. Genital Mycotic Infections in Females (e.g., Vulvovaginitis): Inform female patients that vaginal yeast infection may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions]. Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis): Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions]. Hypersensitivity Reactions: Inform patients that serious hypersensitivity reactions such as urticaria and rash have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction or angioedema, and to take no more drug until they have consulted prescribing physicians. Urinary Tract Infections: Inform patients of the potential for urinary tract infections. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur. Active ingredient made in Belgium Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Finished product manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 Licensed from Mitsubishi Tanabe Pharma Corporation © 2013 Janssen Pharmaceuticals, Inc. 10282403 020588-140827 ES564969_ME022515_061.pgs 02.02.2015 23:52 ADV INVOKANA™ (canagliflozin) tablets Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies (continued) In Combination with Metformin + Pioglitazone (26 weeks) Overall [N (%)] In Combination with Insulin (18 weeks) Overall [N (%)] Severe [N (%)]† Placebo + Metformin + Pioglitazone (N=115) 3 (2.6) INVOKANA 100 mg + Metformin + Pioglitazone (N=113) 3 (2.7) INVOKANA 300 mg + Metformin + Pioglitazone (N=114) 6 (5.3) Placebo (N=565) 208 (36.8) 14 (2.5) INVOKANA 100 mg (N=566) 279 (49.3) 10 (1.8) INVOKANA 300 mg (N=587) 285 (48.6) 16 (2.7) * Number of patients experiencing at least one event of hypoglycemia based on either biochemically documented episodes or severe hypoglycemic events in the intent-to-treat population † Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained) Laboratory Tests: Increases in Serum Potassium: Dose-related, transient mean increases in serum potassium were observed early after initiation of INVOKANA (i.e., within 3 weeks) in a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information]. In this trial, increases in serum potassium of greater than 5.4 mEq/L and 15% above baseline occurred in 16.1%, 12.4%, and 27.0% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. More severe elevations (i.e., equal or greater than 6.5 mEq/L) occurred in 1.1%, 2.2%, and 2.2% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In patients with moderate renal impairment, increases in potassium were more commonly seen in those with elevated potassium at baseline and in those using medications that reduce potassium excretion, such as potassium-sparing diuretics, angiotensinconverting-enzyme inhibitors, and angiotensin-receptor blockers [see Warnings and Precautions]. Increases in Serum Magnesium: Dose-related increases in serum magnesium were observed early after initiation of INVOKANA (within 6 weeks) and remained elevated throughout treatment. In the pool of four placebo-controlled trials, the mean change in serum magnesium levels was 8.1% and 9.3% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to -0.6% with placebo. In a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information], serum magnesium levels increased by 0.2%, 9.2%, and 14.8% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Serum Phosphate: Dose-related increases in serum phosphate levels were observed with INVOKANA. In the pool of four placebo controlled trials, the mean change in serum phosphate levels were 3.6% and 5.1% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to 1.5% with placebo. In a trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information], the mean serum phosphate levels increased by 1.2%, 5.0%, and 9.3% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Low-Density Lipoprotein Cholesterol (LDL-C) and non-HighDensity Lipoprotein Cholesterol (non-HDL-C): In the pool of four placebocontrolled trials, dose-related increases in LDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in LDL-C relative to placebo were 4.4 mg/dL (4.5%) and 8.2 mg/dL (8.0%) with INVOKANA 100 mg and INVOKANA 300 mg, respectively. The mean baseline LDL-C levels were 104 to 110 mg/dL across treatment groups [see Warnings and Precautions]. Dose-related increases in non-HDL-C with INVOKANA were observed. Mean changes (percent changes) from baseline in non-HDL-C relative to placebo were 2.1 mg/dL (1.5%) and 5.1 mg/dL (3.6%) with INVOKANA 100 mg and 300 mg, respectively. The mean baseline non-HDL-C levels were 140 to 147 mg/dL across treatment groups. Increases in Hemoglobin: In the pool of four placebo-controlled trials, mean changes (percent changes) from baseline in hemoglobin were -0.18 g/dL (-1.1%) with placebo, 0.47 g/dL (3.5%) with INVOKANA 100 mg, and 0.51 g/dL (3.8%) with INVOKANA 300 mg. The mean baseline hemoglobin value was approximately 14.1 g/dL across treatment groups. At the end of treatment, 0.8%, 4.0%, and 2.7% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively, had hemoglobin above the upper limit of normal. DRUG INTERACTIONS UGT Enzyme Inducers: Rifampin: Co-administration of canagliflozin with rifampin, a nonselective inducer of several UGT enzymes, including UGT1A9, UGT2B4, decreased canagliflozin area under the curve (AUC) by 51%. This decrease in exposure to canagliflozin may decrease efficacy. If an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) must be co-administered with INVOKANA (canagliflozin), consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA 100 mg once daily, have an eGFR greater than 60 mL/min/1.73 m2, and require additional glycemic control. Consider other black INVOKANA™ (canagliflozin) tablets antihyperglycemic therapy in patients with an eGFR of 45 to less than 60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer and require additional glycemic control [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information]. Digoxin: There was an increase in the AUC and mean peak drug concentration (Cmax) of digoxin (20% and 36%, respectively) when co-administered with INVOKANA 300 mg [see Clinical Pharmacology (12.3) in full Prescribing Information]. Patients taking INVOKANA with concomitant digoxin should be monitored appropriately. Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of INVOKANA in pregnant women. Based on results from rat studies, canagliflozin may affect renal development and maturation. In a juvenile rat study, increased kidney weights and renal pelvic and tubular dilatation were evident at greater than or equal to 0.5 times clinical exposure from a 300 mg dose [see Nonclinical Toxicology (13.2) in full Prescribing Information]. These outcomes occurred with drug exposure during periods of animal development that correspond to the late second and third trimester of human development. During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters. INVOKANA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known if INVOKANA is excreted in human milk. INVOKANA is secreted in the milk of lactating rats reaching levels 1.4 times higher than that in maternal plasma. Data in juvenile rats directly exposed to INVOKANA showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from INVOKANA, a decision should be made whether to discontinue nursing or to discontinue INVOKANA, taking into account the importance of the drug to the mother [see Nonclinical Toxicology (13.2) in full Prescribing Information]. Pediatric Use: Safety and effectiveness of INVOKANA in pediatric patients under 18 years of age have not been established. Geriatric Use: Two thousand thirty-four (2034) patients 65 years and older, and 345 patients 75 years and older were exposed to INVOKANA in nine clinical studies of INVOKANA [see Clinical Studies (14.3) in full Prescribing Information]. Patients 65 years and older had a higher incidence of adverse reactions related to reduced intravascular volume with INVOKANA (such as hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300 mg daily dose, compared to younger patients; more prominent increase in the incidence was seen in patients who were 75 years and older [see Dosage and Administration (2.1) in full Prescribing Information and Adverse Reactions]. Smaller reductions in HbA1C with INVOKANA relative to placebo were seen in older (65 years and older; -0.61% with INVOKANA 100 mg and -0.74% with INVOKANA 300 mg relative to placebo) compared to younger patients (-0.72% with INVOKANA 100 mg and -0.87% with INVOKANA 300 mg relative to placebo). Renal Impairment: The efficacy and safety of INVOKANA were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to less than 50 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information]. These patients had less overall glycemic efficacy and had a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR greater than or equal to 60 mL/min/1.73 m2); patients treated with INVOKANA 300 mg were more likely to experience increases in potassium [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Adverse Reactions]. The efficacy and safety of INVOKANA have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD, or receiving dialysis. INVOKANA is not expected to be effective in these patient populations [see Contraindications and Clinical Pharmacology (12.3) in full Prescribing Information]. Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment. The use of INVOKANA has not been studied in patients with severe hepatic impairment and is therefore not recommended [see Clinical Pharmacology (12.3) in full Prescribing Information]. ES564568_ME022515_062_FP.pgs 02.02.2015 21:50 ADV INVOKANA™ (canagliflozin) tablets In the pool of eight clinical trials, hypersensitivity-related adverse reactions (including erythema, rash, pruritus, urticaria, and angioedema) occurred in 3.0%, 3.8%, and 4.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Five patients experienced serious adverse reactions of hypersensitivity with INVOKANA, which included 4 patients with urticaria and 1 patient with a diffuse rash and urticaria occurring within hours of exposure to INVOKANA. Among these patients, 2 patients discontinued INVOKANA. One patient with urticaria had recurrence when INVOKANA was re-initiated. Photosensitivity-related adverse reactions (including photosensitivity reaction, polymorphic light eruption, and sunburn) occurred in 0.1%, 0.2%, and 0.2% of patients receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Other adverse reactions occurring more frequently on INVOKANA than on comparator were: Volume Depletion-Related Adverse Reactions: INVOKANA results in an osmotic diuresis, which may lead to reductions in intravascular volume. In clinical studies, treatment with INVOKANA was associated with a dose-dependent increase in the incidence of volume depletion-related adverse reactions (e.g., hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration). An increased incidence was observed in patients on the 300 mg dose. The three factors associated with the largest increase in volume depletion-related adverse reactions were the use of loop diuretics, moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2), and age 75 years and older (Table 2) [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Use in Specific Populations]. Table 2: Proportion of Patients With at Least One Volume Depletion-Related Adverse Reaction (Pooled Results from 8 Clinical Trials) Comparator INVOKANA INVOKANA Group* 100 mg 300 mg Baseline Characteristic % % % Overall population 1.5% 2.3% 3.4% 75 years of age and older† 2.6% 4.9% 8.7% eGFR less than 2† 2.5% 4.7% 8.1% 60 mL/min/1.73 m 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 Baseline Pool of Four PlaceboControlled Trials Week 6 Change End of Treatment Change* Baseline Moderate Week 3 Renal Impairment Change Trial End of Treatment Change* Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) eGFR (mL/min/1.73 m2) Creatinine (mg/dL) Placebo N=646 0.84 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) Placebo N=90 1.61 40.1 0.03 -0.7 0.07 eGFR (mL/min/1.73 m2) -1.5 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 100 mg 300 mg N=90 N=89 1.62 1.63 39.7 38.5 0.18 0.28 -4.6 -6.2 0.16 0.18 -3.6 -4.0 * Week 26 in mITT LOCF population In the pool of four placebo-controlled trials where patients had normal or mildly impaired baseline renal function, the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR below 80 mL/min/1.73 m2 and 30% lower than baseline, was 2.1% with placebo, 2.0% with INVOKANA 100 mg, and 4.1% with INVOKANA 300 mg. At the end of treatment, 0.5% with placebo, 0.7% with INVOKANA 100 mg, and 1.4% with INVOKANA 300 mg had a significant renal function decline. In a trial carried out in patients with moderate renal impairment with a baseline eGFR of 30 to less than 50 mL/min/1.73 m2 (mean baseline eGFR 39 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information], the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR 30% lower than baseline, was 6.9% with placebo, 18% with INVOKANA 100 mg, and 22.5% with black INVOKANA™ (canagliflozin) tablets INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with INVOKANA 100 mg, and 3.4% with INVOKANA 300 mg had a significant renal function decline. In a pooled population of patients with moderate renal impairment (N=1085) with baseline eGFR of 30 to less than 60 mL/min/1.73 m2 (mean baseline eGFR 48 mL/min/1.73 m2), the overall incidence of these events was lower than in the dedicated trial but a dose-dependent increase in incident episodes of significant renal function decline compared to placebo was still observed. Use of INVOKANA was associated with an increased incidence of renalrelated adverse reactions (e.g., increased blood creatinine, decreased glomerular filtration rate, renal impairment, and acute renal failure), particularly in patients with moderate renal impairment. In the pooled analysis of patients with moderate renal impairment, the incidence of renal-related adverse reactions was 3.7% with placebo, 8.9% with INVOKANA 100 mg, and 9.3% with INVOKANA 300 mg. Discontinuations due to renal-related adverse events occurred in 1.0% with placebo, 1.2% with INVOKANA 100 mg, and 1.6% with INVOKANA 300 mg [see Warnings and Precautions]. Genital Mycotic Infections: In the pool of four placebo-controlled clinical trials, female genital mycotic infections (e.g., vulvovaginal mycotic infection, vulvovaginal candidiasis, and vulvovaginitis) occurred in 3.2%, 10.4%, and 11.4% of females treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections on INVOKANA. Female patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrence and require treatment with oral or topical antifungal agents and anti-microbial agents [see Warnings and Precautions]. In the pool of four placebo-controlled clinical trials, male genital mycotic infections (e.g., candidal balanitis, balanoposthitis) occurred in 0.6%, 4.2%, and 3.7% of males treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Male genital mycotic infections occurred more commonly in uncircumcised males and in males with a prior history of balanitis or balanoposthitis. Male patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrent infections (22% on INVOKANA versus none on placebo), and require treatment with oral or topical antifungal agents and anti-microbial agents than patients on comparators. In the pooled analysis of 8 controlled trials, phimosis was reported in 0.3% of uncircumcised male patients treated with INVOKANA and 0.2% required circumcision to treat the phimosis [see Warnings and Precautions]. Hypoglycemia: In all clinical trials, hypoglycemia was defined as any event regardless of symptoms, where biochemical hypoglycemia was documented (any glucose value below or equal to 70 mg/dL). Severe hypoglycemia was defined as an event consistent with hypoglycemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained). In individual clinical trials [see Clinical Studies (14) in full Prescribing Information], episodes of hypoglycemia occurred at a higher rate when INVOKANA was co-administered with insulin or sulfonylureas (Table 4) [see Warnings and Precautions]. Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies Monotherapy (26 weeks) Overall [N (%)] In Combination with Metformin (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin (52 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Sulfonylurea (18 weeks) Overall [N (%)] In Combination with Metformin + Sulfonylurea (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin + Sulfonylurea (52 weeks) Overall [N (%)] Severe [N (%)]† Placebo (N=192) 5 (2.6) Placebo + Metformin (N=183) INVOKANA 100 mg (N=195) 7 (3.6) INVOKANA 100 mg + Metformin (N=368) INVOKANA 300 mg (N=197) 6 (3.0) INVOKANA 300 mg + Metformin (N=367) 3 (1.6) 0 (0) Glimepiride + Metformin (N=482) 165 (34.2) 15 (3.1) Placebo + Sulfonylurea (N=69) 4 (5.8) Placebo + Metformin + Sulfonylurea (N=156) 24 (15.4) 1 (0.6) Sitagliptin + Metformin + Sulfonylurea (N=378) 154 (40.7) 13 (3.4) 16 (4.3) 1 (0.3) INVOKANA 100 mg + Metformin (N=483) 27 (5.6) 2 (0.4) INVOKANA 100 mg + Sulfonylurea (N=74) 3 (4.1) INVOKANA 100 mg + Metformin + Sulfonylurea (N=157) 43 (27.4) 1 (0.6) 17 (4.6) 1 (0.3) INVOKANA 300 mg + Metformin (N=485) 24 (4.9) 3 (0.6) INVOKANA 300 mg + Sulfonylurea (N=72) 9 (12.5) INVOKANA 300 mg + Metformin + Sulfonylurea (N=156) 47 (30.1) 0 INVOKANA 300 mg + Metformin + Sulfonylurea (N=377) 163 (43.2) 15 (4.0) ES564587_ME022515_063_FP.pgs 02.02.2015 21:50 ADV 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 or patients on dialysis [see Warnings and Precautions and Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypotension: INVOKANA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA [see Adverse Reactions] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensinaldosterone system (e.g., angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), or patients with low systolic blood pressure. Before initiating INVOKANA in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy. Impairment in Renal Function: INVOKANA increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating INVOKANA [see Adverse Reactions]. More frequent renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2. Hyperkalemia: INVOKANA can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion, such as potassium-sparing diuretics, or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia [see Adverse Reactions]. Monitor serum potassium levels periodically after initiating INVOKANA in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions. Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INVOKANA can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue [see Adverse Reactions]. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA. Genital Mycotic Infections: INVOKANA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections [see Adverse Reactions]. Monitor and treat appropriately. Hypersensitivity Reactions: Hypersensitivity reactions (e.g., generalized urticaria), some serious, were reported with INVOKANA treatment; these reactions generally occurred within hours to days after initiating INVOKANA. If hypersensitivity reactions occur, discontinue use of INVOKANA; treat per standard of care and monitor until signs and symptoms resolve [see Contraindications and Adverse Reactions]. Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C occur with INVOKANA [see Adverse Reactions]. Monitor LDL-C and treat per standard of care after initiating INVOKANA. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA or any other antidiabetic drug. ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Hypotension [see Warnings and Precautions] • Impairment in Renal Function [see Warnings and Precautions] • Hyperkalemia [see Warnings and Precautions] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions] • Genital Mycotic Infections [see Warnings and Precautions] • Hypersensitivity Reactions [see Warnings and Precautions] • Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions] Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Pool of Placebo-Controlled Trials: The data in Table 1 is derived from four 26-week placebo-controlled trials. In one trial INVOKANA was used as monotherapy and in three trials INVOKANA was used as add-on therapy [see Clinical Studies (14) in full Prescribing Information]. These data reflect exposure of 1667 patients to INVOKANA and a mean duration of exposure to INVOKANA of 24 weeks. Patients received INVOKANA 100 mg (N=833), black INVOKANA™ (canagliflozin) tablets INVOKANA 300 mg (N=834) or placebo (N=646) once daily. The mean age of the population was 56 years and 2% were older than 75 years of age. Fifty percent (50%) of the population was male and 72% were Caucasian, 12% were Asian, and 5% were Black or African American. At baseline the population had diabetes for an average of 7.3 years, had a mean HbA1C of 8.0% and 20% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 88 mL/min/1.73 m2). Table 1 shows common adverse reactions associated with the use of INVOKANA. These adverse reactions were not present at baseline, occurred more commonly on INVOKANA than on placebo, and occurred in at least 2% of patients treated with either INVOKANA 100 mg or INVOKANA 300 mg. Table 1: Adverse Reactions From Pool of Four 26−Week Placebo-Controlled Studies Reported in ≥ 2% of INVOKANA-Treated Patients* INVOKANA INVOKANA Placebo 100 mg 300 mg Adverse Reaction N=646 N=833 N=834 Female genital mycotic 3.2% 10.4% 11.4% infections† ‡ Urinary tract infections 4.0% 5.9% 4.3% 0.8% 5.3% 4.6% Increased urination§ 0.6% 4.2% 3.7% Male genital mycotic infections¶ Vulvovaginal pruritus 0.0% 1.6% 3.0% Thirst# 0.2% 2.8% 2.3% Constipation 0.9% 1.8% 2.3% Nausea 1.5% 2.2% 2.3% * The four placebo-controlled trials included one monotherapy trial and three add-on combination trials with metformin, metformin and sulfonylurea, or metformin and pioglitazone. † Female genital mycotic infections include the following adverse reactions: Vulvovaginal candidiasis, Vulvovaginal mycotic infection, Vulvovaginitis, Vaginal infection, Vulvitis, and Genital infection fungal. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=312), INVOKANA 100 mg (N=425), and INVOKANA 300 mg (N=430). ‡ Urinary tract infections include the following adverse reactions: Urinary tract infection, Cystitis, Kidney infection, and Urosepsis. § Increased urination includes the following adverse reactions: Polyuria, Pollakiuria, Urine output increased, Micturition urgency, and Nocturia. ¶ Male genital mycotic infections include the following adverse reactions: Balanitis or Balanoposthitis, Balanitis candida, and Genital infection fungal. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=334), INVOKANA 100 mg (N=408), and INVOKANA 300 mg (N=404). # Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. Abdominal pain was also more commonly reported in patients taking INVOKANA 100 mg (1.8%), 300 mg (1.7%) than in patients taking placebo (0.8%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients participating in placebo- and active-controlled trials. The data combined eight clinical trials [see Clinical Studies (14) in full Prescribing Information] and reflect exposure of 6177 patients to INVOKANA. The mean duration of exposure to INVOKANA was 38 weeks with 1832 individuals exposed to INVOKANA for greater than 50 weeks. Patients received INVOKANA 100 mg (N=3092), INVOKANA 300 mg (N=3085) or comparator (N=3262) once daily. The mean age of the population was 60 years and 5% were older than 75 years of age. Fifty-eight percent (58%) of the population was male and 73% were Caucasian, 16% were Asian, and 4% were Black or African American. At baseline, the population had diabetes for an average of 11 years, had a mean HbA1C of 8.0% and 33% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 81 mL/min/1.73 m2). The types and frequency of common adverse reactions observed in the pool of eight clinical trials were consistent with those listed in Table 1. In this pool, INVOKANA was also associated with the adverse reactions of fatigue (1.7% with comparator, 2.2% with INVOKANA 100 mg, and 2.0% with INVOKANA 300 mg) and loss of strength or energy (i.e., asthenia) (0.6% with comparator, 0.7% with INVOKANA 100 mg, and 1.1% with INVOKANA 300 mg). In the pool of eight clinical trials, the incidence rate of pancreatitis (acute or chronic) was 0.9, 2.7, and 0.9 per 1000 patient-years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. In the pool of eight clinical trials with a longer mean duration of exposure to INVOKANA (68 weeks), the incidence rate of bone fracture was 14.2, 18.7, and 17.6 per 1000 patient years of exposure to comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Upper extremity fractures occurred more commonly on INVOKANA than comparator. ES564592_ME022515_064_FP.pgs 02.02.2015 21:50 ADV 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 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 Please see brief summary of full Prescribing Information at right and on the previous pages. References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014. 3. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial [published correction appears in Diabetes Care. 2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515. >> Pediatric Use: Safety and effectiveness in patients <18 years of age have not been established >> Geriatric Use: 2034 patients ≥65 years and 345 patients ≥75 years were exposed to INVOKANA® in 9 clinical studies. Patients ≥65 years had a higher incidence of adverse reactions related to reduced intravascular volume (eg, hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300-mg dose, compared to younger patients; Janssen Pharmaceuticals, Inc. Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. © Janssen Pharmaceuticals, Inc. 2015 magenta cyan yellow black January 2015 025799-141202 ES564591_ME022515_065_FP.pgs 02.02.2015 21:50 ADV 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 magenta cyan yellow black ES564571_ME022515_066_FP.pgs 02.02.2015 21:50 ADV 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% 8.12% –0.66 –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: Ð2.8%; P<0.001 Difference from Januvia® 100 mg: Ð5.9 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 systolic blood pressure 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. 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 previous pages and the following page. magenta cyan yellow black ES564589_ME022515_CV3_FP.pgs 02.02.2015 21:51 ADV INSPIRE PATIENTS TO 1 GO FURTHER AN N S TH RE IOON MO ILLIPTI E * R T SC DA 2PM RE TO In the treatment of type 2 diabetes, help *Data on file. Based on TRx data sourced from IMS NPA Database, weekly data through 11/21/14. 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 previous pages. magenta cyan yellow black ES564588_ME022515_CV4_FP.pgs 02.02.2015 21:50 ADV
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