Doctor ratings on - Modern medicine

Mar 25, 2017 - paying until they're very old because of the level of debt they've taken on,” says Ellen. Gomes, director of financial aid at Florida. Atlantic University's Schmidt School of. Medicine in Boca Raton, Florida. THE ROLE OF ADMISSIONS. A second challenge schools face in building interest in primary care stems ...
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EXCLUSIVE Physicians voice their biggest insurer hassles

DENIALS NEGOTIATIONS PRIOR AUTHS

Doctor ratings on: Communication Payments Customer service Patient information

FIRST TAKE

BY KEITH L. MARTIN

Physicians want collaboration, not complication, from payers he physician community has a simple message for payers: Let doctors be doctors. Doctors’ sentiment is overwhelmingly negative toward payers, identifying more obstacles than true collaboration in primary care. In this issue, we unveil the results of the Medical Economics Payer Scorecard, an exclusive project gathering input from nearly 1,100 physicians nationwide on their relationship with health insurers. Physicians are fed up with frequent and lengthy prior authorization calls, with begging for a reasonable fee schedule–or simply taking what they can get–and difficulty in getting paid for their work. They want payers out of clinical decisions and more open to working with physicians rather than creating a combative relationship. In a value-based environment, improving this relationship is key for both sides. Payers need up-to-date, quality data about their members to make business decisions. Physicians need metrics that make sense, and to be rewarded for their hard work, not bogged down by red tape and onerous data reporting to prove they are making a difference in patients’ lives. So how do two sides, forced to work together for decades, repair this tenuous relationship? The answer is to let doctors be doctors.

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READ MORE INSIDE

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Physicians who responded to our survey have simple requests. They would like to get back into the exam room, not wait on hold to argue for their latest treatment plan. They want simple online forms and less physical paperwork for themselves and their staff so they can return their focus to

“Physicians need metrics that make sense and to be rewarded for their hard work, not bogged down by red tape and onerous data reporting.”

patient time. They want clear language – and even some guidance – on denied claims (if told what they are doing wrong, doctors are happy to correct the error; it’s the mystery that frustrates them.) If the goal is healthier plan members who utilize fewer services, then that means providing more time for physician-patient interactions. No patient ever got better after a 45-minute phone call with their insurance company about coverage and their bill.

In fact, I’d argue their blood pressure alone suffers. Restore the relationships that matter in healthcare and repair the ones needed to achieve the end goal. Private practice physicians understand the line between medicine and business; they deal with it every single day. They also know when one side of that relationship overwhelms the other. The general feeling–through our survey and various discussions with physicians–is that a payer’s bottom line is becoming more important than the patient’s journey to wellness. But physicians will also have to make some compromises for the relationship to work. Perhaps the role as “payer educator” remains, as patients turn to those they know and trust to help them when they have questions, even about their coverage and their costs. Maybe it is taking a more active role in properly coding claims and working with staff to streamline the process to get paid faster and more accurately. A patient’s road to better health has many twists and turns. It’s time for physicians and payers to work together as steady navigators instead of bickering over the best way to get there. Keith L. Martin is editorial director of Medical Economics. What would you be willing to sacrifice for a better relationship with your payers? Tell us at [email protected]

Exclusive data: Doctors grade payers PAGE 14

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INTERACTIVE

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MedicalEconomics.com Bloggers “Our current healthcare model, based on sevenminute office visits that incentivize procedures and technology, fails to reward physicians for spending the time that patients need.” — Rebekah Bernard, MD, a primary care physician at Gulf Coast Direct Primary Care in Fort Myers, Florida, in a blog regarding doctor burnout

“With the imminent change in national health policy, we simply can’t predict what will happen next when it comes to standardized quality measures. But as physicians, we know we’ll never take our eyes of the quality care of our patients.” — Henry Anhalt, DO, who is in private practice treating pediatric patients with type 1 diabetes, in a blog about defining quality care

Health IT creates lose-lose situation for physicians A recent study by Black Book Research revealed that tech-savvy patients expect their doctors to use health information technology, however, another study by the same research company found that patients don’t trust health IT. This presents a quandary for physicians who want to appease their patients’ desires but don’t want to scare them away. The research also showed that 94% of physicians said they’re deluged with what they think is useless data. Rachel Carlton Abrams, MD, a board-certified primary care physician appreciates when her patients track their health data, as it allows her to be far more accurate in her assessment and recommendations. “It would be naive to imagine that our patients won’t be trying the latest gadgets for personal health monitoring (and wanting to share the data with us), or using the power of the internet to research their own conditions,” she said. Read the rest of the story by visiting MedicalEconomics.com.

Top articles Top 12 secondary incomes for doctors Should medical residents’ work hours be increased? Here’s why membership medicine is gaining physician attention Trump attempts market stabilization of Obamacare

Survey

Will your practice add telemedicine capabilities within the next year? We already utilize this technology

YES

16%

35% NO

49%

Here is the key to a thriving practice Source: Poll on MedicalEconomics.com from February 2 through February 17, 2017

PA R T O F T H E

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Medical Economics is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among members of our community.

MEDICAL ECONOMICS]MARCH 25, 2017

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MARCH 25, 2017

VOLUME 94 ISSUE 6 Referenced in MedLine®

C OV E R STO RY

Physicians weigh in on insurance company hassles PAGE 14

IN EVERY ISSUE 3 Interactive 6 Your voice 7 Vitals 48 Advertiser index

18 Negotiating with payers

30 Defeat claim denials

Strategies to win a better deal

49 Funny bone

11 ways to turn rejection into revenue

26 The problem with prior authorizations

39 Exclusive payer ratings

Why practices are wasting time on the phone

A LS O I N S I D E

Physicians grade payer performance

33 Annual exams and copays

08 When the EHR stops working

When is it appropriate to collect payment?

How to survive a system outage

34 Credit score 101

09 Training new primary care doctors

Why your numbers can impact practice success

The bias against primary care begins in school

24 Stay the course on MACRA Why physicians should participate this year

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MedicalEconomics. com

First line. First thought. Think BAYER® Aspirin first for the secondary prevention of a CV event

t Aspirin reduces the risk of recurrent ischemic stroke by 22% and recurrent MI* by 31%1 t Discontinuation of low-dose aspirin can increase the risk of recurrent ischemic stroke by 40%2 and nonfatal MI by 63%3

Recommend BAYER Aspirin— First for secondary prevention. CV=cardiovascular; MI=myocardial infarction. *Nonfatal MI. References: 1. Antithrombotic Trialists’ (ATT) Collaboration. Lancet. 2009;373:1849-1860. 2. Garcia Rodríguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011;76:740-746. 3. Garcia Rodríguez LA, Cea-Soriano L, Martín-Merino E, Johansson S. Discontinuation of low dose aspirin and risk of myocardial infarction: case-control study in UK primary care. BMJ. 2011;343:d4094. Bayer and the Bayer Cross are registered trademarks of Bayer. © 2017 Bayer December 2016 65986-PP-BAY-PREV-US-0644

To order samples and learn more, visit www.bayeraspirinhcp.com

YOUR VOICE

Have a comment?

SEND YOUR THOUGHTS TO [email protected] FACEBOOK.COM/MEDICALECONOMICS @MEDECONOMICS

Stop hating EHRs and do this I

am writing to say how much I enjoyed Eugene Eisman’s article, “How I learned to love my EHR and spend more time with patients” (January 10, 2017). As someone who just turned 65, and has been in solo internal medicine practice for 37 years, I appreciate Dr. Eisman’s attitude. I started with my own self-programmed EHR, that I carried on a laptop room to room, until better products came on the market in the late 1980s. I now pay a nominal fee per year for my software and don’t have to put up with any advertisements. As with Dr. Eisman, I don’t use the software as designed, but to improve patient care. I can make complete notes for myself and

consultants in seconds. I almost never type in front of the patient, and complete each patient’s note before the next patient arrives. To keep my overhead low and myself on time, I escort the next patient back to my single exam room when I am ready. This approach makes medical practice pleasant, low stress and very satisfying. The only thing my approach won’t do is make you as much money. Keep your overhead low, live within your means and enjoy your patients. George W. Groth, MD

Read the article and let us know what you think: bit.ly/love-my-EHR

SAN DIEGO, CALIFORNIA

Families present lawsuit threat In “Malpractice Pitfalls: 5 Strategies to Reduce Lawsuits Threats” (November 10, 2016), your comment about how a family member might instigate a lawsuit deserves further discussion. Indeed, despite a physician’s sincere contrition for an error, a family member who lives hundreds of miles away, who has never met the doctor and who may not have seen the patient in years, can in just a few impulsive seconds and with just a few inconsiderate words, instigate the threat of a lawsuit against the physician that, more often than not, is unjustified. When a family member, whether unintentionally or otherwise, makes negative comments about a doctor’s

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capabilities or about his or her personality, they plant seeds of suspicion and distrust [in the patient] that may override years of confidence and goodwill. It is impossible to know how frequently this happens, but I suspect it is more than one might expect at first thought. There is no way to protect against this except by ensuring that the sincerity and apology expressed are truly heartfelt. Together with a little luck, this approach may save some physicians from unwarranted lawsuit threats.

In response to “Congress continues down the yellow brick fantasy road with MACRA”

Individuals and health professionals need to speak directly to their representatives now re pending MACRA disaster. Otherwise elites win. Randall Oates, MD @RBOATES

Edward Volpintesta, MD BETHEL, CONNECTICUT

MedicalEconomics. com

VITALS

Steven Gitler, DO

their bills create payment plans and other mechanisms for patients to easily out-of-pocket-costs. The survey found that over the previous decade, HSA participation has grown from 3.2 million in 2006 to 20.2 million in 2016. On average, plans surveyed in 2015 and 2016 enrolled an additional 648,000 consumers—an average net increase of 3.4% in participants. “HSAs give consumers more options and control over their healthcare, and that will help bring down costs,” says Marilyn Tavenner, president and CEO of AHIP. “HSAs give consumers the power to choose and the power to shop.”

More than 20 million American consumers took advantage of the benefits offered by health savings accounts (HSAs) in 2016, according to a recent survey conducted by America’s Health Insurance Plans (AHIP). Since the introduction of HSAs in 2004, enrollment has grown steadily, says AHIP, a national association whose members provide coverage for healthcare and related services. However, along with more HSAs comes more high-deductible plans and more out of pocket expenses for patients—which will require physicians to up their bill-paying systems to ensure patients pay

66% PRODUCT TYPE

ENROLLMENT

Preferred Provider Organizations (PPOs) were the most popular HSA/ HDHP product type, accounting for 66% of enrollment.

GROWTH

HSA participation

2006

20.2 MILLION

I was both pleased and frustrated to see the article “Is electronic prescribing a potential solution to the opioid crisis? ”(January 10, 2017). I’ve wondered for years why this isn’t an option. Surely, sending an electronic prescription through a secure online system is safer than anyone being able to call a pharmacy pretending to be from the doctor’s office and order themselves a supply of Xanax or Tramadol. I’m very glad to see that a few states now allow e-prescribing of controlled substances. The article suggests, however, that this is a widely available option and doctors are just not using it. That is not the case. Here in New Jersey, we cannot e-prescribe these medicines. They must be handwritten or phoned in. This topic actually came up at a recent lecture given by one of the leading pain management physicians in the state. He, too, voiced his frustration that we are not permitted to e-prescribe. It would make our jobs easier and make these prescriptions more secure. Hopefully, now that New York, Maine and Minnesota allow e-prescribing, other states will follow suit and fix this issue finally.

Health savings accounts grow in popularity

3.2 MILLION

Holding out hope for more states to allow e-prescribing

2016

Source: America’s Health Insurance Plans

CAMDEN, NEW JERSEY

MedicalEconomics. com

MEDICAL ECONOMICS]MARCH 25, 2017

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Tech Talk

How to survive an EHR outage

Develop a recovery plan, and revisit it Develop a plan and revisit it on a regular schedule to ensure it adequately addresses the latest additions and updates to your EHR system as well as the ancillary computer systems that connect to it, McCoy says. He adds that it’s worthwhile to work with a consultant who specializes in disaster recovery and business continuity planning.

Practice those plans Diligent practices might think they’re prepared simply because they have a disaster recovery plan and are taking proactive steps, such as backing up EHR files. But medical offices that suffer an extended outage often find they’re not able to cope due to lack of practical experience and/or problems in their plans, McCoy says. Drills will not only give staff that practical experience, they will reveal any unforeseen problems, such as corrupted backup files.

Coordinate with your EHR vendor Restoring patient records is only part of what’s needed following an EHR system failure. The other important piece is restoring the actual application with all the updates and patches that have come through since it was first installed, health IT experts say. “You have to have the ability to restore a valid, non-corrupt back up,” McCoy explains.

Don’t assume the cloud is foolproof Cloud providers generally offer higher levels of redundancy and cybersecurity than any individual practice can muster, but health IT experts note that a cloudbased EHR is still vulnerable to outages. “They still have hardware issues; they have software issues,” McCoy says. Physicians with a cloud-based EHR still need to have disaster recovery and business continuity plans in place, and those plans could include backing up of patient records beyond what the cloud vendor provides.

Know how to transition back to the electronic system Disaster recovery plans should—but often don’t—include strategies for transitioning back to restored computer systems, says Thomas Payne, MD, FACP, medical director of IT services at University of Washington School of Medicine and board chairman for the American Medical Informatics Association. “Oftentimes when systems are down, physicians use paper and then the question is, how much of that record should be entered back in,” he explains. It’s better to map out in advance what data should go back into the electronic records, who will handle that work and at what cost.

Mary K. Pratt is freelance writer who covers healthcare. Send your technology questions to [email protected]

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Rawpixel.com / Shutterstock.com

Most physicians have plans for responding to computer system failures, but many don’t revisit those disaster recovery/business continuity plans with any regularity. The reliability of computer systems is much higher now than it used to be, but failures still occur—whether they stem from short-term power outages, lost internet connections or crippling malware attacks. And with more than 80% of physicians using computers, an electronic health record (EHR) system that goes down could bring a practice to a screeching halt. “It is really incumbent on small physician practices to understand what it takes to keep the business running in case of a disaster,” says Michael McCoy, MD, chief executive officer of the consulting firm Physician Technology Services Inc.

IN DEPTH

Policy

Medical schools struggle to close primary care gap How practicing physicians can help rebuild the next generation of doctors by J E FFR EY B E N D IX Senior Editor

HIGHLIGHTS Probably the most difficult challenge schools face...is overcoming biases against primary care that frequently exist among administrators, faculty and sometimes among students themselves.

MedicalEconomics. com

DIANA HUANG entered medical school ready to work hard to realize her ambition of becoming a primary care doctor. What she wasn’t prepared for was the tepid support she has gotten from some classmates and faculty regarding her chosen specialty. “I definitely got messages along the way where I could tell people had the attitude of, ‘it’s fine if you want to do that, but it’s not anything impressive,” says Huang, a fourthyear student at Temple University’s Lewis Katz School of Medicine in Philadelphia. Huang’s feeling that she receives little encouragement for a career in primary care is common among medical students. Changing the attitude that produces it—that specialization is preferable to more general medicine—is but one of the challenges schools face in trying to graduate enough primary care physicians to meet the expected demand—challenges ranging from their admissions policies to the difficulty of finding acceptable sites for primary care rotations. “I think the AAMC [Association of American Medical Colleges] would acknowledge and endorse the notion that we need a strong primary care workforce,” says Scott Shipman, MD, MPH, director of primary care initiatives and workforce analysis at the AAMC. He adds that the association’s projections “would suggest that we are falling

short on creating enough primary care practitioners to meet the projected demand.” At the same time, Shipman notes, students base career decisions on many factors, and in the absence of a national allocation structure for graduating students, “much of the output of the medical workforce is dictated by student preferences and the availability of GME [graduate medical education] positions,” rather than anything schools themselves can do. While many of these issues lie outside the control of physicians now in practice, those concerned about the future supply of primary care doctors do have opportunities to help, experts say. These can take the forms of mentoring individual students, speaking at medical schools or allowing students into their practices, either to shadow physicians or as part of a clinical rotation program. (See sidebar.)

PRIMARY CARE SHORTAGE EXPECTED TO INCREASE Healthcare policy experts and physicians’ groups have been sounding the alarm about a looming doctor shortage for more than a decade, but the problem shows no signs of abating. A 2016 study of physician supply and demand commissioned by the AAMC forecasts a primary care physician shortfall

MEDICAL ECONOMICS ❚ MARCH 25, 2017

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Policy

Medical school & primary care ranging from about 15,000 to more than 35,000 by 2025—even though the number of graduates matching to residencies in internal and family medicine and pediatrics has been trending up in recent years.

CONFRONTING DEBT LOADS When looking for reasons for students’ ambivalence towards primary care, the logical place to start is with money: primary care pays less than most other specialties, as shown in the Medical Economics Physician Report. In the 2015 report, for example, the median income for cardiologists was $363,000, and $312,000 for surgeons. For internists, family physicians and pediatricians, median income was $188,000. (Results of the latest Physician Report will appear in the April 25 issue of Medical Economics.) In addition, students are leaving medical school with ever-larger debt loads—an average of nearly $182,000 (combined undergraduate and medical school), according to AAMC data. “I think it’s fair to suggest that significant debt burden does serve as a dis-

incentive to choosing any specialty with a comparatively lower salary, given all else being equal in terms of students’ interest,” says Shipman. At Case Western Reserve University (CWRU) School of Medicine in Cleveland, tuition is approaching $60,000 per year, and students graduate owing an average of $180,000 in medical school debt alone. “It’s no secret that there’s a tremendous variance between primary care specialties and surgical specialties, which are the ones students are often comparing,” says Patricia Thomas, MD, PhD, the school’s vice dean for education. “You start off behind and you’ll have trouble catching up. It doesn’t take students long to realize that.” But the links between debt, income and career choice are not always clear-cut, say students and administrators. “I think we know long-term [money] is going to play a role, but I don’t think it’s in the forefront of a lot of people’s minds as they make career decisions,” says Craig Washington, a fourth-year student at Meharry Medical College in Nash-

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PRECEPTING FOR PRIMARY CARE ecoming a preceptor— allowing one’s practice to be used as a site for clinical rotations—is a way to help build enthusiasm for primary care among medical students, but it often requires a substantial time commitment—not to mention proximity to a medical school. At Florida Atlantic University’s Schmidt College of Medicine, for example, preceptors are required to have affiliate faculty status, which includes letters of recommendation and going through the school’s application and vetting process, says Stuart Markowitz, MD, senior associate dean for student affairs and admissions. The next step is for school representatives to visit the applicant’s practice, and to meet with him or her to discuss the school’s curriculum in detail and what it expects from preceptors. “We have de-

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fined clinical goals we would like preceptors to meet when our students are with them,” Markowitz explains. Much of the emphasis is on demonstrating skills that students are learning about simultaneously in the classroom, such as effective history-taking. Among other benefits, the vetting process helps to weed out physicians who may have lost their enthusiasm for practicing medicine. Instances of these have occurred “a couple of times,” Markowitz says, but notes that many of the preceptors the school uses have offered their services without being asked. “The fact that they’re interested tells us they’re highly motivated.” “Many of these physicians really

become ambassadors for primary care and find it very stimulating to work with students,” Markowitz adds. Still, precepting requires a substantial time commitment that not all doctors are prepared to make. ‘When I practiced, I was incredibly busy and it was really challenging sometimes to have students be with me,” he recalls. “There were some periods when I just had to say ‘I can’t do it.’ ” Even physicians not prepared to bring students into their practice can help promote primary care by offering to speak to students about their career and the rewards of practice. “I think interacting with the students actually reinvigorates doctors themselves about primary care, because they see how interested and responsive the students are,” he says.

“Interacting with students atche reinvigoratteually doctors.” s

MedicalEconomics. com

Policy

Medical school & primary care

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ville, Tennessee and chair of the American College of Physicians Council of Student Members. “It’s really more a question of, ‘what do you want to be doing on a day-to-day basis?’” Washington says he will finish medical school owing about $280,000, including loans from undergraduate school, but feels confident he will be able to pay it off. In addition, administrators cite the National Health Service Corps—which offers scholarships and loan repayment in return for two years of work in medically underserved areas—and federally-sponsored programs such as Pay as You Earn (PAYE) and Revised Pay as You Earn (REPAYE) These latter programs ease debt burdens by tying loan repayment amounts to a borrower’s income and forgiving unpaid balances in as little as 20 years. PAYE and REPAYE are “very popular with students because they know there’s an end in sight and they won’t have to keep paying until they’re very old because of the level of debt they’ve taken on,” says Ellen Gomes, director of financial aid at Florida Atlantic University’s Schmidt School of Medicine in Boca Raton, Florida.

I definitely got messages along the way where I could tell people had the attitude of, ‘it’s fine if you want to do [primary care], but it’s not anything impressive.’ ”

THE ROLE OF ADMISSIONS A second challenge schools face in building interest in primary care stems from their admissions policies. Studies show that minority students are more apt to enter primary care (and work in underserved areas) than are students who are white and come from more affluent families and/or families with higher levels of educational attainment. For example, an AAMC analysis of medical school graduation trends between 1982 and 2007 found that, on average, about 42% of AfricanAmerican students and 37% of Hispanic students went into primary care, compared with 32% of white and 30% of Asian students—groups who make up far higher proportions of medical school graduates. Medical schools have long been aware of the problem, of course, and are continually working to diversify their student bodies. In the AAMC’s 2015 Medical School Enrollment Survey, 83% of responding schools said they have, or plan to have, admissions policies and programs to bolster the number of minority groups now underrepresented in medicine. Seventy-five percent

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— DIANA HUANG, STUDENT, LEWIS KATZ SCHOOL OF MEDICINE, TEMPLE UNIVERSITY, PHILADELPHIA, PENNSYLVANIA

said the same regarding students from disadvantaged backgrounds. But medical school administrators acknowledge that diversifying student ranks is a daunting task, especially in light of continually escalating tuitions. “Unless you have a lot of scholarship support for those students, your ability to do that [admit more of them] is somewhat limited,” says CWRU’s Thomas.

ROLE MODELS Still another problem schools confront is finding practicing physicians who can provide positive role models for aspiring primary care practitioners. Exposure to, and experiences working with, a particular physician is often an important driver of a student’s career choice, notes Shipman. The problem where primary care is concerned, he adds, is that “primary care practitioners are, in general, burnt out to a high degree,” thus making them inappropriate role models for students. “Many of us are struggling to find the ideal learning environment for primary care,” says Thomas. “Physicians in the outpatient arena are often stressed out, and that might produce negative learning, with students finishing a rotation and saying, ‘I know I don’t want to be someone who’s at the office until nine every night completing electronic health records.’” First-year students at CWRU spend one afternoon per week in the second half of the year in a preceptorship at a communitybased primary care clinic. Roberts says the school is trying to become “more purposeful” in finding places where students can observe, and participate in, high-quality care. “We look for places where team-based care is happening, with teams that work together and everyone is practicing at the top of their scope,” she says. “We actually get students excited about that mode of practice. They see there are ways of getting physicians back to working with patients and experiencing the joy of practicing primary care medicine.” At Florida Atlantic, medical school administrators interview candidates for primary care preceptorships. The qualification they look for above all is “a really positive attitude about primary care,” says Stuart Markowitz, MD, senior associate dean for student affairs and admissions. “We know there are a lot of docs out

MedicalEconomics. com

Medical school & primary care there who will say to students, ‘I don’t even know why you’d want to get into this business,’” Markowitz says. “We try to find people who are going to be real cheerleaders for primary care.”

FIGHTING THE ‘HIDDEN CURRICULUM’ Probably the most difficult challenge schools face, however, is overcoming biases against primary care that frequently exist among administrators, faculty and sometimes among students themselves—the socalled hidden curriculum of medical school. “The underlying culture of a medical school, in terms of embracing primary care versus considering it sort of an also-ran, is likely to translate into whether it’s an aspirational specialty for students,” says the AAMC’s Shipman. “Too often you hear stories from students about physician faculty telling them they’re too smart to go into primary care, or similar disparaging comments. That sends a message about what is perceived as a valued specialty.” Shipman’s observation is supported by results of a 2013 study published in the journal Academic Medicine, which found an inverse relationship between the prevalence of “badmouthing” primary care at a school and the likelihood of a student from that school choosing a career in primary care. The problem stems in part from the way medical schools usually structure their curricula, Roberts notes. Students begin by learning basic scientific and physiological concepts. “Then we bring in the expert to explore subjects in greater depth, and those folks often can say, even unintentionally, disparaging things about primary care.” Huang recalls a similar experience during her first years as a medical student at Temple, where even basic courses were taught largely by researchers and specialists. She was fortunate to have found faculty with an interest in primary care who encouraged her, she says, but knows others who haven’t been as lucky. “I have friends who would tell faculty they want to do family medicine, and they’d go, ‘why would you want to do that?’” she says. Huang adds that some faculty show more interest in students who aspire to careers in surgical specialties than those like her whose interests lie in primary care. “They’re like, ‘oh, that’s nice,’ but don’t really

MedicalEconomics. com

We know there are a lot of docs out there who will say to students, ‘I don’t even know why you’d want to get into this business.’ We try to find people who are going to be real cheerleaders for primary care.”

— STUART MARKOWITZ, MD, SENIOR ASSOCIATE DEAN FOR STUDENT AFFAIRS AND ADMISSIONS, FLORIDA ATLANTIC UNIVERSITY’S SCHMIDT COLLEGE OF MEDICINE, BOCA RATON, FLORIDA

Policy

consider it something to celebrate. And I think it’s something that should be celebrated,” she says. Just the fact that medical schools tend to attract motivated, high-achieving students can lead to a bias towards specialization, as students themselves concede. “Medicine is full of know-it-alls, and there’s always a little one-upmanship that comes with that,” notes Elianna Peak, a third-year student at the University of Cincinnati College of Medicine. That desire to flaunt one’s knowledge often gets channeled into an interest in narrow medical specialties, and “specialty anything is always more valued in our society,” she says.

THE IMPORTANCE OF FACULTY ENCOURAGEMENT Schools that attempt to counter the hidden curriculum often do so by ensuring that primary care specialists are well-represented among faculty and administrators. At Florida Atlantic, for example, the director of medical education is a pediatrician, while Markowitz and Assistant Dean of Student Affairs Jennifer Caceres, MD, are internists. “Students hear a lot about primary care from us, both in medical education and student affairs,” says Markowitz. The latter department also has responsibility for career planning, “so there’s naturally a bias towards primary care coming from us,” he adds. Students seem to be getting the message: about 28% of its 2016 graduates are pursuing residencies in internal, family or pediatric medicine, and 39% of the class of 2017 are planning to do so. Similarly at Meharry, where more than half the class of 2017 say they plan on careers in primary care, the top two student affairs administrators come from primary care backgrounds. So do a significant number of teaching faculty, says Craig Washington. “I’d say the students here view primary care faculty more favorably than those from other backgrounds,” Washington says. Like many other students intent on primary care careers, Washington is aware of the challenges he faces, including lower earnings and higher stress levels than many of his classmates. But those will be more than balanced, he says, by the benefits of establishing long-term relationships with patients, and contributing to whatever community he settles in.

MEDICAL ECONOMICS ❚ MARCH 25, 2017

13

An inside look at what drives insurers to refuse to negotiate, require more prior auths and deny claims by TOD D S H RYOCK Editor

INSIDE Negotiating with payers PAGE 18 Dealing with prior authorizations PAGE 26 Improving denial rates PAGE 30 Exclusive data: Physicians rate payers PAGE 39

14

MEDICAL ECONOMICS ❚ MARCH 25, 2017

MedicalEconomics. com

2017 PAYER SCORECARD

MedicalEconomics. com

Frequent/unexplained denials

Negotiating

Customer service

Narrowing of networks

No answer

Challenges of interacting with payers

Number of prior authorizations

ASK ANY DOCTOR what they think of payers and they’ll likely say things that can’t be printed. The relationship between physicians and payers has always been turbulent, mainly because they serve two different masters: Doctors are trying to provide the best care possible while maximizing revenue to their practices; most insurance companies are trying to provide the best care while increasing profit for shareholders and minimizing costs to employers. With employers putting increasing pressure on insurers to freeze or lower prices, physicians often get caught in cost-reduction efforts from payers. Throw in a dose of government regulations that make doing business more complicated and you create an environment that can lead to frustration for physicians, as evidenced by the Medical Economics Payer Scorecard, which shows an overall low opinion of payers among physicians. Insurance companies score low (under five on a 10-point scale) in customer service, payment, patient information and communication with practices. Doctors feel increasingly helpless and confused by what payers are doing and question how payers’ policies are saving money or improving care. They see insurers as “playing doctor”— making decisions on what treatments are proper—and ignoring their medical training and familiarity with the patient. “Most of our time is spent doing soulcrushing paperwork for no reason—it doesn’t help with anything,” says David Belk, MD, who runs a solo internal medicine practice in the San Francisco Bay area. “They [commercial payers] are trying to distract everyone with this image they are saving the healthcare system money when in reality, their revenue keeps going up and up.” Bottom line: independent physicians struggle with cash flow, hoping to get paid properly and in a timely manner while health industry juggernauts post multi-billion dollar profits. What physicians consider necessary and practical care is often challenged by insurers who have no relationship with the patient. For example, ordering a CT scan for a possible case of diverticulitis requires a prior authorization, which appears to Belk

79%

70%

64%

64%

58%

8%

On scale of 1-5 (1=not at all challenging; 5=very challenging):

4.3

Number of prior authorizations Frequent/unexplained denials

4.0

Negotiating

4.0

Customer service

3.9

Narrowing of networks

3.7

60%

OF INTERNISTS SAID NEGOTIATING WITH PAYERS IS VERY CHALLENGING

MEDICAL ECONOMICS ❚ MARCH 25, 2017

15

2017 PAYER SCORECARD

Time spent weekly on prior authorizations Practice staff

67%

29%

29%

Less than 11

22%

6

AVERAGE NUMBER OF HOURS PER WEEK FOR PHYSICIANS

11%

13

None

1%

17%

AVERAGE NUMBER OF HOURS PER WEEK FOR STAFF

Biggest frustration with prior authorizations

16

4%

HOURS

3%

11-15

16-20

15%

HOURS

More than 20 hours

Physician

38%

Time spent to get authorizations

34%

Feeling as though a payer is telling me how to do my job/ what’s best for my patients

11%

Reasons for denial

8%

Lack of clarity on what requires a prior authorization

5%

Managing the number of outstanding requests

2%

Other

2%

No frustrations with prior authorizations

MEDICAL ECONOMICS ❚ MARCH 25, 2017

as though the insurance company is trying to be the doctor. “I don’t get paid extra for the scan. Why does a nurse from an insurance company have to sign off on that? How is that about saving money?” says Belk. He points out that the bigger risk to the insurer is waiting too long for the scan, which could lead to severe consequences for the patient. “I’m prescribing what I think is necessary and I have no financial incentive to do so,” says Belk. “And why are they issuing denials on meds that cost less than the copay?” According to our survey, three areas stand out as the biggest frustrations for doctors: an increase in prior authorizations, an unwillingness by payers to negotiate reimbursement rates and an uptick in claim denials. Here’s why payers are taking these actions.

GROWING NUMBERS OF PRIOR AUTHORIZATIONS Physicians are baffled by payers’ requirements of prior authorizations for what they say are often routine, low-cost treatments or for drugs that have already proven effective for a particular patient for years, but suddenly need payer approval. Jeff Kagan, MD, a Newington, Connecticut-based internist, treated a patient with a chronic lung disease who had been hospitalized twice in a seven-month span. After putting her on a particular medication to treat the condition, she went 23 months without a hospital stay. The insurance company decided not to cover the drug any longer, requiring him to go through the appeal process—all for what amounted to a $30-per-month price difference. “Just one hospitalization would have blown all their savings,” says Kagan, who is a member of the Medical Economics editorial advisory board. The appeal was approved eventually, but Kagan couldn’t get his time back. He esti-

Will value-based care help doctors negotiate with payers? Continued on page

36

MedicalEconomics. com

PR11 M ORE T ES I HA TOCRIPLLIO N DA TI N TE 1 ON S M

In the treatment of type 2 diabetes, along with diet and exercise, INVOKANA® can

AWAKEN A TRANSFORMATION

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®, such as anaphylaxis or angioedema >> Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

In the treatment of type 2 diabetes, along with diet and exercise, INVOKANA® can

AWAKEN A TRANSFORMATION INVOKANA® 300 mg demonstrated superior reductions in A1C, body weight,* and systolic blood pressure (BP)* vs Januvia® 100 mg2-4 >> In a prespecified analysis, superiority was determined once noninferiority was confirmed3†

Adjusted Mean Change in A1C From Baseline at 52 Weeks (%)2 Mean baseline:

8.13%

8.12%

–0.66 –1.03 Januvia® (sitagliptin) 100 mg + metformin and a sulfonylurea (n=378)

INVOKANA® 300 mg + metformin and a sulfonylurea (n=377)

>> INVOKANA® 300 mg difference from Januvia® 100 mg: –0.37% (95% CI: –0.50, –0.25; P<0.05)

Prespecified secondary endpoints:

Adjusted mean change in body weight from baseline at 52 weeks2: >> Difference from Januvia®: –2.8% (–5.3 lb) (95% CI: –3.3, –2.2; P<0.001)

Adjusted mean change in systolic BP from baseline at 52 weeks3: >> Difference from Januvia®: –5.9 mm Hg (95% CI: –7.6, –4.2; P<0.001)

INVOKANA® 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 Indicated trademarks are registered trademarks of their respective owners.

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.

Similar overall incidence of AEs vs Januvia®3 Incidence of any AE, Januvia® 100 mg: 77.5%; INVOKANA® 300 mg: 76.7% Incidences of specific AEs were similar between groups, except for: Male/female genital mycotic infection, Januvia® 100 mg: 0.5%/4.3%; INVOKANA® 300 mg: 9.2%/15.3%

Superior Reductions vs Januvia®2,3‡ >> A1C† >> Body weight* >> Systolic BP*

Similar Rate of Hypoglycemia and Overall Tolerability Profile to Januvia®2-4§

Learn more and register for updates at ll

Preferred coverage for most commercial and Medicare Part D patients5

INVOKANAhcp.com

*Prespecified secondary endpoint. INVOKANA® is not indicated for weight loss or as an antihypertensive treatment. † Noninferiority of INVOKANA® + metformin and a sulfonylurea to Januvia® + metformin and a sulfonylurea was assessed based on a prespecified margin of 0.3% for the upper limit of the 2-sided 95% CI for the comparison in the primary last observation carried forward analysis. If noninferiority was demonstrated, then superiority was assessed, as determined by an upper bound of the 95% CI around the between-group difference (INVOKANA® minus Januvia®) of <0.0%.3 ‡ INVOKANA® 300 mg vs Januvia® 100 mg. § Similar overall incidence of adverse events vs Januvia® 100 mg across multiple studies. 3,4 ll For the plans listed, brand-name drugs that are generally covered at lower co-payments than higher tier brand-name drugs. (The lowest tiers are generally reserved for generic drugs.)

A randomized, double-blind, active-controlled, 52-week study of 755 patients with type 2 diabetes inadequately controlled on maximally or nearmaximally effective doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated) and a sulfonylurea. The primary endpoint was the change in A1C from baseline to 52 weeks. 2,3 >> Ketoacidosis: Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been identified in patients with type 1 and 2 diabetes mellitus receiving SGLT2 inhibitors, including INVOKANA®. Fatal cases of ketoacidosis have been reported in patients taking INVOKANA®. Before initiating INVOKANA®, consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency, caloric restriction disorders, and alcohol abuse. In patients treated with INVOKANA®, consider monitoring for ketoacidosis and temporarily discontinuing in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). >> Acute Kidney Injury and Impairment in Renal Function: INVOKANA® causes intravascular volume contraction and can cause renal impairment. Postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, were reported; some reports involved patients younger than 65 years of age. Before initiation, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications. Consider temporarily discontinuing INVOKANA® in any setting of reduced oral intake or fluid losses; monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue promptly and institute treatment. INVOKANA® increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiation. Renal function should be evaluated prior to initiation and periodically thereafter. Dose adjustment and more frequent renal function monitoring are recommended in patients with an eGFR <60 mL/min/1.73 m2.

Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

IMPORTANT SAFETY INFORMATION (cont’d)

DRUG INTERACTIONS >> UGT Enzyme Inducers: Rifampin: Co-administration 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 co-administered 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 co-administered 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.

>> Nursing Mothers: There is no information regarding the presence of INVOKANA® in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, advise women that use of INVOKANA® is not recommended while breastfeeding. >> 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; more prominent increase in the incidence was seen in patients who were ≥75 years. Smaller reductions in HbA1c relative to placebo were seen in patients ≥65 years (‒0.61% with INVOKANA® 100 mg and ‒0.74% with INVOKANA® 300 mg) compared to younger patients (‒0.72% with INVOKANA® 100 mg and ‒0.87% with INVOKANA® 300 mg). >> Renal Impairment: Efficacy and safety were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2). These patients had less overall glycemic efficacy and a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR ≥60 mL/min/1.73 m2); patients treated with 300 mg were more likely to experience increases in potassium. INVOKANA® is not recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), with end-stage renal disease, or receiving dialysis. >> Hepatic Impairment: INVOKANA® has not been studied in patients with severe hepatic impairment and is not recommended in this population.

OVERDOSAGE >> In the event of an overdose, contact the Poison Control Center and employ the usual supportive measures, eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as needed.

ADVERSE REACTIONS >> The most common adverse reactions associated with INVOKANA® (5% or greater incidence) were female genital mycotic infections, urinary tract infections, and increased urination.

Please see Brief Summary of full Prescribing Information at right and on the following pages. References: 1. Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, Total Prescriptions, April 2013-December 23, 2016. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 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. 4. Lavalle-González FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56:2582-2592. Supplemental tables available at: http://link.springer.com/article/ 10.1007%2Fs00125-013-3039-1. Accessed December 5, 2016. 5. MMRx data on file. Janssen Pharmaceuticals, Inc. Data as of 1/10/2017.

USE IN SPECIFIC POPULATIONS >> Pregnancy: Based on animal data showing adverse renal effects, INVOKANA® is not recommended during the second and third trimesters of pregnancy. Limited data with INVOKANA® in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to mother and fetus associated with poorly controlled diabetes in pregnancy.

Janssen Pharmaceuticals, Inc. Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. © Janssen Pharmaceuticals, Inc. 2017

January 2017

048359-170104

057917-160810

>> 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. >> Urosepsis and Pyelonephritis: There have been reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors, including INVOKANA®. Treatment with SGLT2 inhibitors increases this risk. Evaluate patients for signs and symptoms and treat promptly. >> 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, including angioedema and anaphylaxis, 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. >> Bone Fracture: Increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using INVOKANA®. Consider factors that contribute to fracture risk prior to initiating INVOKANA®. >> Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C can occur with INVOKANA®. Monitor LDL-C and treat per standard of care after initiating. >> Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA® or any other antidiabetic drug.

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, such as anaphylaxis or angioedema [see Warnings and Precautions and Adverse Reactions]. • Severe renal impairment (eGFR less than 30  mL/min/1.73  m2), end stage renal disease (ESRD), or patients on dialysis [see Warnings and Precautions and Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypotension: INVOKANA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA [see Adverse Reactions] particularly in patients with impaired renal function (eGFR less than 60  mL/min/1.73  m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensinaldosterone system (e.g.,  angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), or patients with low systolic blood pressure. Before initiating INVOKANA in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy. Ketoacidosis: Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including INVOKANA. Fatal cases of ketoacidosis have been reported in patients taking INVOKANA. INVOKANA is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and Usage]. Patients treated with INVOKANA who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels, as ketoacidosis associated with INVOKANA may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, INVOKANA should be discontinued, patient should be evaluated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement. In many of the postmarketing reports, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized and institution of treatment was delayed because presenting blood glucose levels were below those typically expected for diabetic ketoacidosis (often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as insulin dose reduction, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse were identified. Before initiating INVOKANA, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. In patients treated with INVOKANA consider monitoring for ketoacidosis and temporarily discontinuing INVOKANA in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery). Acute Kidney Injury and Impairment in Renal Function: INVOKANA causes intravascular volume contraction [see Warnings and Precautions] and can cause renal impairment [see Adverse Reactions]. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving INVOKANA; some reports involved patients younger than 65 years of age. Before initiating INVOKANA, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing INVOKANA in any setting of reduced oral intake (such as acute illness or fasting) or fluid losses (such as gastrointestinal illness or excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue INVOKANA promptly and institute treatment. 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].

INVOKANA® (canagliflozin) tablets Renal function should be evaluated prior to initiation of INVOKANA and monitored periodically thereafter. Dosage adjustment and more frequent renal function monitoring are recommended in patients with an eGFR below 60 mL/min/1.73 m2. Use of INVOKANA is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Dosage and Administration (2.2) in full Prescribing Information, Contraindications, Use in Specific Populations]. 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 at an increased risk of developing hyperkalemia [see Dosage and Administration (2.2) in full Prescribing Information and 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. Urosepsis and Pyelonephritis: There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including INVOKANA. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated [see Adverse Reactions]. 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, including angioedema and anaphylaxis, have been reported with INVOKANA. These reactions generally occurred within hours to days after initiating INVOKANA. If hypersensitivity reactions occur, discontinue use of INVOKANA; treat and monitor until signs and symptoms resolve [see Contraindications and Adverse Reactions]. Bone Fracture: An increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using INVOKANA. Consider factors that contribute to fracture risk prior to initiating INVOKANA [see 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 if appropriate 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] • Ketoacidosis [see Warnings and Precautions] • Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions] • Hyperkalemia [see Warnings and Precautions] • Urosepsis and Pyelonephritis [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] • Bone Fracture [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® (canagliflozin) tablets

INVOKANA® (canagliflozin) tablets

INVOKANA of 24  weeks. Patients received INVOKANA 100  mg (N=833), INVOKANA 300 mg (N=834) or placebo (N=646) once daily. The mean age of the population was 56  years and 2%  were older than 75  years of age. Fifty percent (50%) of the population was male and 72%  were Caucasian, 12%  were Asian, and 5%  were Black or African American. At baseline the population had diabetes for an average of 7.3  years, had a mean HbA1C of 8.0%  and 20%  had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 88 mL/min/1.73 m2). Table  1 shows common adverse reactions associated with the use of INVOKANA. These adverse reactions were not present at baseline, occurred more commonly on INVOKANA than on placebo, and occurred in at least 2% of patients treated with either INVOKANA 100  mg or INVOKANA 300 mg. Table 1: Adverse Reactions From Pool of Four 26−Week Placebo-Controlled Studies Reported in ≥ 2% of INVOKANA-Treated Patients* INVOKANA INVOKANA Placebo 100 mg 300 mg Adverse Reaction N=646 N=833 N=834 ‡ 3.8% 5.9% 4.4% Urinary tract infections Increased urination§ 0.7% 5.1% 4.6% 0.1% 2.8% 2.4% Thirst# Constipation 0.9% 1.8% 2.4% Nausea 1.6% 2.1% 2.3% N=312 N=425 N=430 2.8% 10.6% 11.6% Female genital mycotic infections† Vulvovaginal pruritus 0.0% 1.6% 3.2% N=334 N=408 N=404 Male genital mycotic 0.7% 4.2% 3.8% infections¶

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% 2.6% 4.9% 8.7% 75 years of age and older† eGFR less than 60 mL/min/1.73 m2† 2.5% 4.7% 8.1% Use of loop diuretic† 4.7% 3.2% 8.8% * Includes placebo and active-comparator groups † Patients could have more than 1 of the listed risk factors

* 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. ‡ 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. # Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. Note: Percentages were weighted by studies. Study weights were proportional to the harmonic mean of the three treatment sample sizes. Abdominal pain was also more commonly reported in patients taking INVOKANA 100 mg (1.8%), 300 mg (1.7%) than in patients taking placebo (0.8%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions for canagliflozin was evaluated in a larger pool of patients participating in placebo- and active-controlled trials. The data combined eight clinical trials [see Clinical Studies  (14) in full Prescribing Information] and reflect exposure of 6177  patients to INVOKANA. The mean duration of exposure to INVOKANA was 38  weeks with 1832  individuals exposed to INVOKANA for greater than 50  weeks. Patients received INVOKANA 100 mg (N=3092), INVOKANA 300 mg (N=3085) or comparator (N=3262) once daily. The mean age of the population was 60 years and 5% were older than 75 years of age. Fifty-eight percent (58%) of the population was male and 73%  were Caucasian, 16%  were Asian, and 4%  were Black or African American. At baseline, the population had diabetes for an average of 11  years, had a mean HbA1C of 8.0% and 33% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired (mean eGFR 81 mL/min/1.73 m2). The types and frequency of common adverse reactions observed in the pool of eight clinical trials were consistent with those listed in Table 1. Percentages were weighted by studies. Study weights were proportional to the harmonic mean of the three treatment sample sizes. In this pool, INVOKANA was also associated with the adverse reactions of fatigue (1.8% 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 0.1, 0.2, and 0.1 receiving comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively.

Falls: In a pool of nine clinical trials with mean duration of exposure to INVOKANA of 85 weeks, the proportion of patients who experienced falls was 1.3%, 1.5%, and 2.1% with comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. The higher risk of falls for patients treated with INVOKANA was observed within the first few weeks of treatment. 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 Placebo N=646 Creatinine (mg/dL) 0.84 87.0 eGFR (mL/min/1.73 m2) Creatinine (mg/dL) 0.01 -1.6 eGFR (mL/min/1.73 m2)

Baseline Pool of Four Week 6 Placebo- Change Controlled End of Trials Creatinine (mg/dL) Treatment Change* eGFR (mL/min/1.73 m2)

0.01

0.02

0.03

-2.3 -3.4 INVOKANA INVOKANA Placebo 100 mg 300 mg N=90 N=90 N=89 Creatinine (mg/dL) 1.61 1.62 1.63 Baseline  40.1 39.7 38.5 eGFR (mL/min/1.73 m2) Moderate Creatinine (mg/dL) 0.03 0.18 0.28 Week 3 Renal -0.7 -4.6 -6.2 eGFR (mL/min/1.73 m2) Impairment Change Trial End of Creatinine (mg/dL) 0.07 0.16 0.18 Treatment -1.5 -3.6 -4.0 Change* eGFR (mL/min/1.73 m2)

* Week 26 in mITT LOCF population

-1.6

INVOKANA INVOKANA 100 mg 300 mg N=833 N=834 0.82 0.82 88.3 88.8 0.03 0.05 -3.8 -5.0

INVOKANA® (canagliflozin) tablets

INVOKANA® (canagliflozin) tablets

In the pool of four placebo-controlled trials where patients had normal or mildly impaired baseline renal function, the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR below 80 mL/min/1.73 m2 and 30% lower than baseline, was 2.1% with placebo, 2.0% with INVOKANA 100 mg, and 4.1% with INVOKANA 300 mg. At the end of treatment, 0.5% with placebo, 0.7% with INVOKANA 100 mg, and 1.4% with INVOKANA 300 mg had a significant renal function decline. In a trial carried out in patients with moderate renal impairment with a baseline eGFR of 30 to less than 50 mL/min/1.73 m2 (mean baseline eGFR 39 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information], the proportion of patients who experienced at least one event of significant renal function decline, defined as an eGFR 30% lower than baseline, was 6.9% with placebo, 18% with INVOKANA 100  mg, and 22.5% with INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with INVOKANA 100 mg, and 2.2% with INVOKANA 300 mg had a significant renal function decline. In a pooled population of patients with moderate renal impairment (N=1085) with baseline eGFR of 30 to less than 60 mL/min/1.73 m2 (mean baseline eGFR 48 mL/min/1.73 m2), the overall incidence of these events was lower than in the dedicated trial but a dose-dependent increase in incident episodes of significant renal function decline compared to placebo was still observed. Use of INVOKANA has been associated with an increased incidence of renal-related adverse reactions (e.g., increased blood creatinine, decreased glomerular filtration rate, renal impairment, and acute renal failure), particularly in patients with moderate renal impairment. In the pooled analysis of patients with moderate renal impairment, the incidence of renal-related adverse reactions was 3.7% with placebo, 8.9% with INVOKANA 100 mg, and 9.3% with INVOKANA 300 mg. Discontinuations due to renal-related adverse events occurred in 1.0% with placebo, 1.2% with INVOKANA 100  mg, and 1.6% with INVOKANA 300  mg [see Warnings and Precautions]. Genital Mycotic Infections: In the pool of four placebo-controlled clinical trials, female genital mycotic infections (e.g., vulvovaginal mycotic infection, vulvovaginal candidiasis, and vulvovaginitis) occurred in 2.8%, 10.6%, and 11.6% of females treated with placebo, INVOKANA 100 mg, and INVOKANA 300  mg, respectively. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections on INVOKANA. Female patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrence and require treatment with oral or topical antifungal agents and anti-microbial agents. In females, discontinuation due to genital mycotic infections occurred in 0% and 0.7% of patients treated with placebo and INVOKANA, respectively [see Warnings and Precautions]. In the pool of four placebo-controlled clinical trials, male genital mycotic infections (e.g., candidal balanitis, balanoposthitis) occurred in 0.7%, 4.2%, and 3.8% of males treated with placebo, INVOKANA 100 mg, and INVOKANA 300  mg, respectively. Male genital mycotic infections occurred more commonly in uncircumcised males and in males with a prior history of balanitis or balanoposthitis. Male patients who developed genital mycotic infections on INVOKANA were more likely to experience recurrent infections (22% on INVOKANA versus none on placebo), and require treatment with oral or topical antifungal agents and anti-microbial agents than patients on comparators. In males, discontinuations due to genital mycotic infections occurred in 0% and 0.5% of patients treated with placebo and INVOKANA, respectively. In the pooled analysis of 8 controlled trials, phimosis was reported in 0.3% of uncircumcised male patients treated with INVOKANA and 0.2% required circumcision to treat the phimosis [see Warnings and Precautions]. Hypoglycemia: In all clinical trials, hypoglycemia was defined as any event regardless of symptoms, where biochemical hypoglycemia was documented (any glucose value below or equal to 70 mg/dL). Severe hypoglycemia was defined as an event consistent with hypoglycemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained). In individual clinical trials [see Clinical Studies  (14) in full Prescribing Information], episodes of hypoglycemia occurred at a higher rate when INVOKANA was co-administered with insulin or sulfonylureas (Table 4) [see Warnings and Precautions].

Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies Monotherapy (26 weeks) Overall [N (%)] In Combination with Metformin (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin (52 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Sulfonylurea (18 weeks) Overall [N (%)] In Combination with Metformin + Sulfonylurea (26 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin + Sulfonylurea (52 weeks) Overall [N (%)] Severe [N (%)]† In Combination with Metformin + Pioglitazone (26 weeks) Overall [N (%)] In Combination with Insulin (18 weeks) Overall [N (%)] Severe [N (%)]†

Placebo (N=192) 5 (2.6) Placebo + Metformin (N=183)

INVOKANA 100 mg (N=195) 7 (3.6) INVOKANA 100 mg + Metformin (N=368)

INVOKANA 300 mg (N=197) 6 (3.0) INVOKANA 300 mg + Metformin (N=367)

3 (1.6) 0 (0) Glimepiride + Metformin (N=482) 165 (34.2) 15 (3.1) Placebo + Sulfonylurea (N=69) 4 (5.8) Placebo + Metformin + Sulfonylurea (N=156) 24 (15.4) 1 (0.6) Sitagliptin + Metformin + Sulfonylurea (N=378) 154 (40.7) 13 (3.4) Placebo + Metformin + Pioglitazone (N=115) 3 (2.6)

16 (4.3) 1 (0.3) INVOKANA 100 mg + Metformin (N=483) 27 (5.6) 2 (0.4) INVOKANA 100 mg + Sulfonylurea (N=74) 3 (4.1) INVOKANA 100 mg + Metformin + Sulfonylurea (N=157) 43 (27.4) 1 (0.6)

INVOKANA 100 mg + Metformin + Pioglitazone (N=113) 3 (2.7)

17 (4.6) 1 (0.3) INVOKANA 300 mg + Metformin (N=485) 24 (4.9) 3 (0.6) INVOKANA 300 mg + Sulfonylurea (N=72) 9 (12.5) INVOKANA 300 mg + Metformin + Sulfonylurea (N=156) 47 (30.1) 0 INVOKANA 300 mg + Metformin + Sulfonylurea (N=377) 163 (43.2) 15 (4.0) INVOKANA 300 mg + Metformin + Pioglitazone (N=114) 6 (5.3)

Placebo (N=565) 208 (36.8) 14 (2.5)

INVOKANA 100 mg (N=566) 279 (49.3) 10 (1.8)

INVOKANA 300 mg (N=587) 285 (48.6) 16 (2.7)

* Number of patients experiencing at least one event of hypoglycemia based on either biochemically documented episodes or severe hypoglycemic events in the intent-to-treat population † Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained) Bone Fracture: The occurrence of bone fractures was evaluated in a pool of nine clinical trials with a mean duration of exposure to INVOKANA of 85 weeks. The incidence rates of adjudicated bone fractures were 1.1, 1.4, and 1.5 per 100 patient-years of exposure in the comparator, INVOKANA 100 mg, and INVOKANA 300 mg groups, respectively. Fractures were observed as early as 12 weeks after treatment initiation and were more likely to be low trauma (e.g., fall from no more than standing height), and affect the upper extremities [see Warnings and Precautions]. Laboratory and Imaging Tests: Increases in Serum Potassium In a pooled population of patients (N=723) with moderate renal impairment (eGFR 45 to less than 60 mL/min/1.73 m2), increases in serum potassium to greater than 5.4 mEq/L and 15% above baseline occurred in 5.3%, 5.0%, and 8.8% of patients treated with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Severe elevations (greater than or equal to 6.5 mEq/L) occurred in 0.4% of patients treated with placebo, no patients treated with INVOKANA 100 mg, and 1.3% of patients treated with INVOKANA 300 mg. In these patients, increases in potassium were more commonly seen in those with elevated potassium at baseline. Among patients with moderate renal impairment, approximately 84% were taking medications that interfere with potassium excretion, such as potassium-sparing diuretics, angiotensin-converting-enzyme inhibitors, and angiotensin-receptor blockers [see Warnings and Precautions and Use in Specific Populations].

INVOKANA® (canagliflozin) tablets

INVOKANA® (canagliflozin) tablets

Increases in Serum Magnesium: Dose-related increases in serum magnesium were observed early after initiation of INVOKANA (within 6 weeks) and remained elevated throughout treatment. In the pool of four placebo-controlled trials, the mean percent change in serum magnesium levels was 8.1% and 9.3% with INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to -0.6% with placebo. In  a  trial of patients with moderate renal impairment [see Clinical Studies (14.3) in full Prescribing Information], serum magnesium levels increased by 0.2%, 9.2%, and 14.8% with placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. Increases in Serum Phosphate: Dose-related increases in serum phosphate levels were observed with INVOKANA. In the pool of four placebo controlled trials, the mean percent change in serum phosphate levels were 3.6% and 5.1%  with INVOKANA 100  mg and INVOKANA 300  mg, respectively, compared to 1.5%  with placebo. In a trial of patients with moderate renal 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. Decreases in Bone Mineral Density: Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry in a clinical trial of 714 older adults (mean age 64 years) [see Clinical Studies (14.3) in full Prescribing Information]. At 2 years, patients randomized to INVOKANA 100 mg and INVOKANA 300 mg had placebo-corrected declines in BMD at the total hip of 0.9% and 1.2%, respectively, and at the lumbar spine of 0.3% and 0.7%, respectively. Additionally, placebo-adjusted BMD declines were 0.1% at the femoral neck for both INVOKANA doses and 0.4% at the distal forearm for patients randomized to INVOKANA 300 mg. The placebo-adjusted change at the distal forearm for patients randomized to INVOKANA 100 mg was 0%.

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: Risk Summary: Based on animal data showing adverse renal effects, INVOKANA is not recommended during the second and third trimesters of pregnancy. Limited data with INVOKANA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. In animal studies, adverse renal pelvic and tubule dilatations that were not reversible were observed in rats when canagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at an exposure 0.5-times the 300 mg clinical dose, based on AUC. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Postmarketing Experience: Additional adverse reactions have been identified during postapproval use of INVOKANA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ketoacidosis [see Warnings and Precautions] Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions] Anaphylaxis, Angioedema [see Warnings and Precautions] Urosepsis and Pyelonephritis [see Warnings and Precautions] DRUG INTERACTIONS UGT Enzyme Inducers: Rifampin: Co-administration of canagliflozin with rifampin, a nonselective inducer of several UGT enzymes, including UGT1A9, UGT2B4, decreased canagliflozin area under the curve (AUC) by 51%. This decrease in exposure to canagliflozin may decrease efficacy. If an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) must be co-administered with INVOKANA (canagliflozin), consider increasing the dose to 300  mg once daily if patients are currently tolerating INVOKANA 100  mg once daily, have an eGFR greater than 60 mL/min/1.73  m2, and require additional glycemic control. Consider other antihyperglycemic therapy in patients with an eGFR of 45 to less than 60  mL/min/1.73  m2 receiving concurrent therapy with a UGT inducer and require additional glycemic control [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information].

Clinical Considerations: Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Animal Data: Canagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 4, 20, 65, or 100 mg/kg increased kidney weights and dose dependently increased the incidence and severity of renal pelvic and tubular dilatation at all doses tested. Exposure at the lowest dose was greater than or equal to 0.5-times the 300 mg clinical dose, based on AUC. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development. The renal pelvic dilatations observed in juvenile animals did not fully reverse within a 1 month recovery period. In embryo-fetal development studies in rats and rabbits, canagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. No developmental toxicities independent of maternal toxicity were observed when canagliflozin was administered at doses up to 100 mg/kg in pregnant rats and 160 mg/kg in pregnant rabbits during embryonic organogenesis or during a study in which maternal rats were dosed from gestation day (GD) 6 through PND 21, yielding exposures up to approximately 19-times the 300 mg clinical dose, based on AUC. Lactation: Risk Summary: There is no information regarding the presence of INVOKANA in human milk, the effects on the breastfed infant, or the effects on milk production. Canagliflozin is present in the milk of lactating rats [see Data]. 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 of the potential for serious adverse reactions in a breastfed infant, advise women that use of INVOKANA is not recommended while breastfeeding. Data: Animal Data: Radiolabeled canagliflozin administered to lactating rats on day 13 post-partum was present at a milk/plasma ratio of 1.40, indicating that canagliflozin and its metabolites are transferred into milk at a concentration comparable to that in plasma. Juvenile rats directly exposed to canagliflozin showed a risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. Pediatric Use: Safety and effectiveness of INVOKANA in pediatric patients under 18 years of age have not been established.

INVOKANA® (canagliflozin) tablets

INVOKANA® (canagliflozin) tablets

Geriatric Use: Two thousand thirty-four (2034)  patients 65  years and older, and 345  patients 75  years and older were exposed to INVOKANA in nine clinical studies of INVOKANA [see Clinical Studies (14.3) in full Prescribing Information]. Patients 65  years and older had a higher incidence of adverse reactions related to reduced intravascular volume with INVOKANA (such as hypotension, postural dizziness, orthostatic hypotension, syncope, and dehydration), particularly with the 300 mg daily dose, compared to younger patients; a more prominent increase in the incidence was seen in patients who were 75  years and older [see Dosage and Administration (2.1) in full Prescribing Information and Adverse Reactions]. Smaller reductions in HbA1C with INVOKANA relative to placebo were seen in older (65 years and older; -0.61% with INVOKANA 100  mg and -0.74% with INVOKANA 300  mg relative to placebo) compared to younger patients (-0.72% with INVOKANA 100 mg and -0.87% with INVOKANA 300 mg relative to placebo). Renal Impairment: The efficacy and safety of INVOKANA were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to less than 50 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information]. These patients had less overall glycemic efficacy and had a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR greater than or equal to 60 mL/min/1.73 m2). Dose-related, transient mean increases in serum potassium were observed early after initiation of INVOKANA (i.e., within 3 weeks) 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. Severe elevations (greater than or equal to 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 [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Adverse Reactions]. The efficacy and safety of INVOKANA have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD, or receiving dialysis. INVOKANA is not expected to be effective in these patient populations [see Contraindications and Clinical Pharmacology (12.3) in full Prescribing Information]. Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment. The use of INVOKANA has not been studied in patients with severe hepatic impairment and is therefore not recommended [see Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There were no reports of overdose during the clinical development program of INVOKANA (canagliflozin). In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status. Canagliflozin was negligibly removed during a 4-hour hemodialysis session. Canagliflozin is not expected to be dialyzable by peritoneal dialysis. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Instructions: Instruct patients to read the Medication Guide before starting INVOKANA (canagliflozin) therapy and to reread it each time the prescription is renewed. Inform patients of the potential risks and benefits of INVOKANA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change. Instruct patients to take INVOKANA only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time. Inform patients that the most common adverse reactions associated with INVOKANA are genital mycotic infection, urinary tract infection, and increased urination.

Inform female patients of child bearing age that the use of INVOKANA during pregnancy has not been studied in humans, and that INVOKANA should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Instruct patients to report pregnancies to their physicians as soon as possible. Inform nursing mothers to discontinue INVOKANA or nursing, taking into account the importance of drug to the mother. 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. Ketoacidosis: Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of INVOKANA. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue INVOKANA and seek medical advice immediately [see Warnings and Precautions]. Acute Kidney Injury: Inform patients that acute kidney injury has been reported during use of INVOKANA. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue INVOKANA use in those settings [see Warnings and Precautions]. Serious Urinary Tract Infections: Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur [see Warnings and Precautions]. 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, rash, anaphylaxis, and angioedema, have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction, and to discontinue drug until they have consulted prescribing physicians. Bone Fracture: Inform patients that bone fractures have been reported in patients taking INVOKANA. Provide them with information on factors that may contribute to fracture risk. Pregnancy: Advise pregnant women, and females of reproductive potential of the potential risk to a fetus with treatment with INVOKANA [see Use in Specific Populations]. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible. Lactation: Advise women that breastfeeding is not recommended during treatment with INVOKANA [see Use in Specific Populations]. 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. Revised: 07/2016 058055-160811

2017 PAYER SCORECARD

Let’s make a deal Successful payer negotiations require preparation, persistence and a bit of salesmanship by TOD D S H RYOCK Editor

HIGHLIGHTS Practices should avoid presenting any customer-based marketing spin to payers. Focus on how the practice can help the payer. The negotiation process should be a data-driven exercise for the practice. Demonstrate quality care and solid cost containment.

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hysicians looking to negotiate reimbursement rates with payers often find themselves dealing with take-it-or-leave-it offers, leaving them feeling frustrated and powerless. When asked how challenging payer negotiations are as part of the Medical Economics Payer Scorecard, 64% of respondents rated it a four or five on a five-point scale, where five is “very challenging.” But an attitude of indifference from payers should not be taken as a final answer to negotiation attempts, experts say. Instead, think of it as the opening round in what can often be a long process to get the attention of the right person in the insurance company. “It’s an endurance test,” says Marcia Brauchler, MPH, FACMPE, president of Physician’s Ally, a Littleton, Colorado-based consulting firm. “I think payers put up hurdles to intentionally wear down a busy practice administrator or physician who still sees patients. Probably 95% of practices go away when they are told ‘no.’” Payers looking to standardize operations may not be interested in negotiating fee-forservice contracts, but there is interest in value-based care deals and in protecting their position in the marketplace. “The payers don’t want the small or inde-

MEDICAL ECONOMICS ❚ MARCH 25, 2017

pendent practice to join larger groups with more leverage,” says Nathaniel Arana, owner of healthcare consulting firm NGA Healthcare in Tucson, Arizona. “For the first time, they are saying, ‘Maybe we need to look to work with smaller groups more to limit the amount of consolidation.’” In some markets, large physician groups are starting to wield as much negotiating power as the payers because of their market dominance, hurting payer profits, he adds. Every market is different, and the extent of competition on both the payer and the provider side will affect payers’ interest in negotiating, particularly with smaller practices. Experts say successfully negotiating in any market requires a thorough understanding of what value the practice offers the payer, a dogged determination to find the right decision-maker at the payer and the ability to sell the practice’s attributes to that person.

START WITH PREPARATION The first step to a successful negotiation is for practices to figure out what value they bring to the payer. “It’s not about size, it’s all about the value proposition,” says Anthony D’Eredita, executive vice president of consulting for Advisory Board, a healthcare research firm. “If you deliver value, then size enhances that. But if

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Payer negotiations

a practice can create [something the payer values that is] unique to the market, they can negotiate well.” D’Eredita says it’s all about the data. Focus on showing what impact the practice has on the patient population and how they are saving on costs. “The more data-based, the better,” he adds. Things like current procedural terminology codes and frequency counts of Healthcare Common Procedure Coding System codes are important in creating a value proposition for the practice. These will help illustrate what services physicians provide and how often, says Brauchler. Also know how much business goes to each payer and how much time the staff is spending on claims for each. “That’s so you know how important each payer is before you approach them—and if you can afford to walk away,” she says. And practices should avoid presenting any customer-based marketing spin to payers, because they aren’t interested in a “spa-like waiting room” or “service that comes with a smile,” notes Brauchler. “Focus on how you are helping the payer: Are you serving major employers in the area? How long have you been in network? Have you expanded hours to help keep patients out of the [ED]?” This is also the time for a practice to collect any relevant testimonials from employers, if the practice is caring for a large number of their employees or has a good relationship with their leadership teams. D’Eredita says these business relationships are effective for convincing payers to negotiate, because healthcare costs ultimately go back to the employers. “If you can help the business control costs, they will want to work with you more and can communicate that to the payer,” he says.

FIND A DECISION-MAKER Negotiation experts agree: To be successful, practices have to find someone at the payer who has the authority to be a decision-maker, and that person is hardly ever a customer service representative. “I sense that payers are becoming more centralized and that autonomy at a local level has declined,” says Lucien Roberts III, MHA, FACMPE, practice administrator for GI Specialists Inc. in Richmond, Virginia.

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2017 PAYER SCORECARD

“You have to push until you find the weak spot. It’s not as easy as it used to be, and you have to be persistent telling your story until they listen and you can make your case.” Provider representatives, if known, can reveal who handles contracts and quality incentive programs. “If you don’t know your provider rep, find out who handles contracts by talking to colleagues at larger practices that might know who handles contracts,” says Roberts. “Try asking medical societies if they know, and get a phone number.” Another starting point is to find out who at the payer company signed the previous

I think payers put up hurdles to intentionally wear down a busy practice administrator or physician who still sees patients. Probably 95% of practices go away when they are told ‘no.’” — MARCIA BRAUCHLER, MPH, FACMPE, PRESIDENT, PHYSICIAN’S ALLY, LITTLETON, COLORADO

contract. If that person no longer works there, Brauchler suggests calling the headquarters to find out who replaced him or her. Once the person is identified, reach out and start the dialogue. But don’t get discouraged if at first the payer still isn’t interested in negotiations, as it may not be the right person. “You have to be able to work through and up the chain of command,” says D’Eredita. Brauchler often starts with a pitch letter of up to nine pages that outlines all the value the practice brings to the network along with a one-page executive summary. She sends this via certified mail and uses it as a starting point for a discussion that may eventually get to the level of a vice president or director in the insurance company. “If you take a ‘no’ before 20 attempts to negotiate, you have settled prematurely,” she says. “You have to hang in there despite the obstacles, because it will pay off for you.”

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2017 PAYER SCORECARD

Continued from page 19

NEGOTIATE THE BEST TERMS With thorough preparation, the negotiation process should be a data-driven exercise for the practice. If the data show quality care and solid cost containment, payers should listen and talks can progress from there. By this point the practice should also have a clear picture on how much revenue comes from the payer. This will provide a better idea of the competitiveness of an offer.

You have to push until you find the weak spot. It’s not as easy as it used to be, and you have to be persistent telling your story until they listen and you can make your case.” — LUCIEN ROBERTS III, MHA, FACMPE, PRACTICE ADMINISTRATOR, GI SPECIALISTS INC., RICHMOND, VIRGINIA

“All payers have their homegrown fee schedules, and they are almost always awful,” says Brauchler. But financials aren’t the only thing on the table. “If prior auths are a problem, ask for exceptions,” she says. “If late payments from the payer are a problem, that can be resolved in the contract and is good leverage.” Some other specifics to look at include: What are the initial terms of the deal—is the practice locked into the same rate for a certain time period? What are the termination details? What happens if the payer merges with another? Each practice must prioritize what is most important and negotiate hardest on the terms that matter most, using the data gathered during the preparation phase to make its case. But experts caution that negotiations should be kept cordial and professional. “Relationship- building is important,” says Arana. “You don’t want to bite the hand that feeds. You want to go in with an attitude of, ‘I’m willing to do whatever it takes to create some cost savings and add value, but I want a quid pro quo where we help each other out.’”

MEDICAL ECONOMICS ❚ MARCH 25, 2017

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Practical Matters

MACRA compliance: Staying the course is the best option Last year, the U.S. Centers for Medicare & Medicaid Services (CMS) indicated that it would offer several “pick-yourpace” options to help physicians ease into compliance in 2017. These options give provider organizations some leeway as to when they can start meeting MACRA requirements in 2017, allowing providers that were not ready to participate in the program to do so without penalty. How should physicians approach this choice? Should they select a partial or full participation option?

Strive for full participation Although pick-your-pace offers physicians the flexibility to report their 2017 MACRA measures for either a partial year or with partial data without penalty, practices should not view these options as a way to delay compliance. In fact, practices would be well advised to proceed full steam ahead, aiming to document and report all full set of Merit-based

MIPS “PICK YOUR PACE” OPTIONS FOR 2017 Test pace

1

Partial year

2

Full year

Submit something

Submit a partial year

Submit a full year

Submit some data after January 1, 2017 Neutral or small payment adjustment

3

Report for 90-day period after January 1, 2017

Fully participate starting January 1, 2017

Small positive payment adjustment

Modest positive payment adjustment

Source: CMS

Incentive Payment System (MIPS) data measures for a full reporting period in 2017. There are several reasons why this is a good approach. First and foremost, there are no risks to full participation. CMS has made 2017 a transition year, so organizations can take part in MACRA without penalty. This provides the opportunity to test their reporting capabilities, identify potential compliance weaknesses and implement solutions in preparation for 2018 without risk. In addition, there are potential in-

centives for organizations that participate for the full year. Another reason to fully embrace compliance in 2017 is that most practices are familiar with what they need to do. Those that participated in the Meaningful Use and Physician Quality Reporting System programs are well-positioned to transition easily to MACRA, because it is comprised of many of the elements of those programs. With a few tweaks, providers can ready themselves for full MIPS reporting in 2017, which will leave them well po-

sitioned to earn incentives and avoid penalties in the future.

Making the commitment With policy changes possible under the new administration, many aspects of healthcare reform face an uncertain future in 2017. But value-based reimbursement initiatives such as MACRA, should remain in place in 2017 and beyond. Those practices that commit to following the requirements for 2017 can seize opportunities without penalty and reap positive benefits.

Chris Emper is the government affairs advisor at NextGen Healthcare. Send your practice management questions to [email protected]

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MEDICAL ECONOMICS ❚ MARCH 25, 2017

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2017 PAYER SCORECARD

The payer time drain: dealing with prior authorizations by JAN ET KI D D STEWART Contributing author

HIGHLIGHTS Drugs are such a routine part of primary care medicine that they are involved in a high percentage of patient visits, so the sheer volume of authorizations is daunting. Though payers’ prior authorization rules generally don’t allow for flexibility, some doctors are attempting to use their quality scores to make a case for reducing prior auths.

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espite recent moves to streamline the prior authorization process, physicians still struggle mightily as they jump through payers’ hoops. Eight in 10 respondents to the Medical Economics Payer Scorecard of nearly 1,100 physicians reported that prior authorizations represent a significant challenge. A separate American Medical Association survey in December found practices are handling an average of nearly 37 requests per week, per physician. It’s not just the number of authorizations, but the implications for patient care that are concerning, physicians say. “Sometimes it’s just a real hassle, and sometimes it’s also a financial hit,” says Kenneth Kubitschek, MD, FACP, an internist with an Asheville, North Carolina-based practice and a member of the Medical Economics editorial advisory board. Kubitschek says he has received preapprovals for stress echocardiograms that were later denied when a patient couldn’t complete the stress portion. But he continues with the test because, he says, it’s the right thing to do for the patient rather than rescheduling the procedure once he’s obtained a new approval. Delegating prior authorization calls to staff members doesn’t always work either, because some payers insist on speaking with the ordering physician, he says. And at

MEDICAL ECONOMICS ❚ MARCH 25, 2017

the beginning of each year, payers typically make changes to their contracts with pharmaceutical manufacturers, so there are new medications that sail through the process, while some existing ones no longer do. Like Kubitschek, other physicians are battling obstacles in trying to do what’s best for their patients, while finding solutions to combat a cumbersome prior authorization process.

PICK THE RIGHT PLAYERS In the Medical Economics survey, practices reported spending an average of 19 hours of physician and staff time per week on prior auths. Dedicating a staff person to obtaining authorizations, as well as developing a care coordination protocol, has helped reduce time spent on the process, says Jennifer Aloff, MD, a primary care physician practicing in Midland, Michigan. Mary Ann Bauman, MD, an Edmond, Oklahoma-based internist and member of the Medical Economics editorial advisory board, says fax and email authorizations, while not fully electronically integrated with electronic health records, have also reduced staff time spent waiting on the phone for approvals.

DRUG DILEMMAS Pharmacy orders tend to generate the worst teeth-gnashing, says Marc O’Connor, MBA, chief operating officer for Curant Health, a

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Prior authorizations

STRATEGIES

2017 PAYER SCORECARD

FOR EASING THE PRIOR AUTH BURDEN

Parse payers

Convenient call times

Focus attention on payers that insure the majority of the practice’s patient base and keep summaries of what information they typically require at the ready.

Target slower times and days for the practice to handle prior authorization calls.

Monitor the measures Track wins and losses Track what types of care are frequently denied … and those that are consistently paid on time, and learn from both.

Keep a list of payer criteria for prior authorizations handy so physicians know what kind of information to include in the request to better the chances of success.

Mind medications Keep a list of common medications that trigger prior authorizations so staff and physicians can be prepared when one is needed.

Smyrna, Georgia-based medication management firm that assists providers with prior auths. Payers increasingly deny highercost drugs unless patients have first tried less-costly ones, a process known as step therapy. In addition, prescription drugs are such a routine part of primary care medicine that they are involved in a high percentage of patient visits, so the sheer volume of authorizations is daunting. “The growth of specialty medications has thrown a wrench in everything,” O’Connor says. The prior auth process isn’t limited to pricey brand-name drugs, however, says John Meigs Jr., MD, a primary care physician in Centreville, Alabama. “Patients are different and their responses to medications are different so not every drug works for every patient with the same problem,” says Meigs. “We have newer meds that work better with fewer side effects but they are expensive and some companies don’t want to pay for them,” he adds. Meigs says some payers have become

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Payer point of contact If possible, assign a staffer to one or two payers each so they are familiar with the requests and the rules for prior authorizations and make connections with their insurer.

It makes sense that if you’ve proven yourself over time, you shouldn’t have to go through the silliness. It just drives another wedge in the doctor-patient relationship.” —KENNETH KUBITSCHEK, MD, FACP, INTERNIST, ASHEVILLE, NORTH CAROLINA

better at telling practices which alternatives they cover, but there is still no universal set of guidelines among payers, and requirements such as step therapy remain common. Lynne Lillie, MD, recalls experiencing some shock last year when a colleague mentioned being asked by a national retail pharmacy chain to fax a year’s worth of a patient’s medical records regarding a pre-

MEDICAL ECONOMICS ❚ MARCH 25, 2017

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2017 PAYER SCORECARD

Prior authorizations

We’re getting some relief [from online prior auths], but not nearly enough. It’s almost impossible to stay ahead of the game.” — LYNNE LILLIE, MD, PRIMARY CARE PHYSICIAN, ROCHESTER, MINNESOTA

scription for routine diabetic supplies. Then, a few months later, Lillie herself got a similar request. Payers are also moving much of the process online, Lillie says, which can help reduce time spent on hold, but requests often call for more work than what can be accomplished by checking a few electronic boxes. “We’re getting some relief, but not nearly enough,” says Lillie, a primary care physician in Rochester, Minnesota. “It’s almost impossible to stay ahead of the game.”

TO CHARGE OR NOT Some practices charge patients for time spent obtaining prior auths, while others say the potential backlash from both payers and patients doesn’t justify the practice. Practices considering this step need to review their payer contracts carefully, as some prohibit such charges. Keith Dinklage, MD, a primary care physician in New Castle, Indiana, doesn’t accept insurance, but will help patients submit insurance claim forms and occasionally charges $5 for prior authorization work, depending on the situation. “Patients are understanding of the time involved,” he says. He thinks if a payer is requiring the prior auth, it should at least share in the cost on behalf of the patient, an idea echoed by Meigs. When insurers change the formularies on what drugs require prior authorization, Dinklage says, they should be held responsible for at least some of the administrative time needed to adjust. Keeping up with formulary changes isn’t always straightforward, adds Jeffrey M. Kagan, MD, an internist in Newington, Connecticut and a Medical Economics editorial advisory board member.

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MEDICAL ECONOMICS ❚ MARCH 25, 2017

Often, he says, payers will simply start denying requests instead of pre-publishing a list of which preferred drugs are on their formularies. And they will frequently issue an authorization that expires in 12 months, and so will resume denying coverage after that time period, even if the drug remains on the preferred list and the prescription is still active.

ADVOCATE FOR YOURSELF Though payers’ prior authorization rules generally don’t allow for flexibility, some doctors are attempting to use their quality scores to make a case for reducing prior auths. As part of a patient-centered medical home, Aloff ’s practice has been highlighting its low rate of emergency department visits and radiological equipment use, for example, when it negotiates with payers. A North Carolina insurance company waived prior authorizations for Kubitschek’s practice a few years ago after the practice had gone a lengthy period with no denials, he says. But the reprieve only was good for about a year and then it was back to square one, despite the practice winning awards for cost-effective care. “It makes sense that if you’ve proven yourself over time, you shouldn’t have to go through the silliness,” he says. “It just drives another wedge in the doctor-patient relationship.” Be aware, however, that there are times when speaking up for a specific patient may put a practice at risk for losing contracts, warns Kagan, who has written letters to payers requesting they cover pricier drugs for certain patients. “I understand that when I write these letters I’m at risk of de-selection” as a provider under a payer’s contract, he says.

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2017 PAYER SCORECARD

Fighting back against denials 11 strategies for turning rejection into revenue by LI SA A. E RAMO, MA Contributing author

HIGHLIGHTS When practices receive a denial, they should contact the insurer to determine exactly what information it needs to process the claim. Focus on payer documentation requirements, especially when billing a sick visit on the same day as a preventive visit.

S

eventy-five percent of physicians say frequent payer denials are an ongoing problem at their practices, according to the Medical Economics Payer Scorecard. Rejected claims are clearly a source of frustration, but is there anything physicians can do about them? Yes, experts say. Consider these strategies to better handle denials.

1 DON’T “DENY” THE DENIALS

Many physicians incorrectly assume that they’re not experiencing denials simply because cash is flowing into the practice, says consultant Elizabeth W. Woodcock, MBA, CPC. This is rarely the case, Woodcock says, adding that a 5% denial rate is average, and anything above that should be cause for concern.

2 DIG INTO THE DATA

Identify the root causes of the denials, and take steps to address those causes, says Maureen Clancy, MBA, FACHE, CPC, senior vice president of revenue cycle management and credentialing at Privia Health, a physician practice management and population health technology company. This is especially important in the case of denials stemming from incorrect patient information. “Otherwise, what hap-

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MEDICAL ECONOMICS ❚ MARCH 25, 2017

pens is that the billers keep fixing the [registration-related] errors, the front-end keeps making the errors and the loop continues,” Clancy says. Pre-registration is one solution. Another is to make time for validating patient information, she says. Pay attention to the patient’s specific health plan, says Raemarie Jimenez, CPC, vice president of membership and certification at the AAPC, an organization representing medical coders. A physician might have a contract with a particular insurer, for example, but it might not be the specific plan covering the patient. “Verification of insurance is so important—not just the first time the patient comes in, but each and every time,” she says. Consider using the patient portal for part of the registration process, Clancy says. For example, Privia Health directs patients to the portal prior to their appointments so they can fill out most of their own demographic information. That gives front-office staff members more time to focus on entering patient insurance information correctly and confirming it when the patient arrives for his or her appointment, she explains.

HAVE SOMEONE MONITOR 3 DENIALS AS THEY OCCUR

If the practice receives paper payments, this may require asking the coder or biller to manually post denials in the practice management system using the claim adjustment

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Claim denials

explanation code associated with the denial, says Jimenez. If the practice uses electronic payment posting, ensure that the practice management system posts denials and their associated reason codes automatically, she says. Once denials are entered into the system, it’s much easier identify trends, such as denials from expired contracts. These are easy to spot and fix when running reports based on the denial code.

INVEST IN ADMINISTRATIVE 4 STAFF

This includes hiring a certified medical coder and a skilled registration clerk. Many practices also outsource their billing, but should be sure the coder at the outside firm is certified. Also invest in updated coding manuals annually, and ensure that EHR vendors update any problem lists annually by October 1 ( for ICD-10 diagnosis codes) and January 1 for CPT codes, says Jimenez. Don’t rely on outdated manuals.

5 WORK THE SCRUBBER EDITS

These are the billing system warnings that occur before claims are sent to the payer, says Clancy. For example, a scrubber edit may indicate that a certain coding modifier is necessary prior to submitting the claim. Ideally, a practice should have twice as many scrubber edits as back-end denials. This ratio means the practice is addressing coding or billing errors immediately without having to wait 20 to 30 days for the payer to adjudicate and deny the claim, she adds.

USE DENIALS AS TEACHING 6 TOOLS FOR PHYSICIANS

Ask coders, billers or other members of the administrative staff to identify and present the top five to 10 denials for the practice on a weekly basis, says Woodcock. Treat these sessions as a benefit for physicians, Clancy says. “If it’s done in the spirit of training and improvement—and not seen

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2017 PAYER SCORECARD

as punitive—it’s usually very well-received,” she says.

7 KNOW EACH PAYER

When practices receive a denial, they should contact the insurer to determine exactly what information it needs to process the claim—and provide this information consistently in the future, says Patricia Cortez, practice administrator at Plano Internal Medicine Associates, PA in Plano, Texas. Pay attention to contracts, says Clancy. For example, does a payer reimburse for labs done in-house, or does it require the practice to send labs out? In addition, payers may have unique requirements related to reporting routine blood capture, says Jimenez. Most payers bundle this into an E/M service performed on the same day; however, if the blood draw occurs on a different day than the E/M service, physicians may be able to unbundle the draw and receive separate payment, she adds. Focus on payer documentation requirements, especially when billing a sick visit on the same day as a preventive visit. This happens often as patients with high-deductible health plans try to maximize their annual wellness visit by asking the physician to address their acute problems as well, Jimenez says. Payers want to see that physicians spent a significant amount of time separately addressing a patient’s acute medical issues beyond what would normally be required for the preventive exam. The sick visit usually requires an extended history and more complex medical decision-making. Only then may they report a separate E/M code with a modifier -25 in addition to the preventive service.

Verification of insurance is so important— not just the first time the patient comes in, but each and every time.”

— RAEMARIE JIMENEZ, CPC, VICE PRESIDENT OF MEMBERSHIP AND CERTIFICATION, AAPC

REVIEW MEDICATION 8 FORMULARIES BEFORE PRESCRIBING Prescribe generic medications whenever possible, and check the formulary before prescribing, says Yul Ejnes, MD, MACP, an internist with Coastal Medical in Cranston, Rhode Island.

MEDICAL ECONOMICS ❚ MARCH 25, 2017

31

2017 PAYER SCORECARD

Claim denials

If [discussing denials is] done in the spirit of training and improvement—and not seen as punitive—it’s usually very well-received.” — MAUREEN CLANCY, MBA, SENIOR VICE PRESIDENT OF REVENUE CYCLE MANAGEMENT AND CREDENTIALING, PRIVIA HEALTH

Physicians may be able to convince a payer to cover a drug that isn’t included on the formulary, but only if they can provide detailed documentation regarding why the patient needs that specific drug, Ejnes says. J. Fred Ralston, Jr., MD, MACP, an internist in Fayetteville, Tennessee, says he frequently sees denials for albuterol inhalers. “My [EHR] won’t let me write this as a generic, so I add a note in the comment section of each standard script stating, ‘May change to different branded HFA albuterol if preferred on insurance, but please let us know so we can adjust the records.’” Joseph W. Stubbs, MD, MACP, an internist at Albany Internal Medicine in Albany, Georgia, and a physician leader in Privia Medical Group, uses the web-based service Covermymeds.com, which electronically automates prior authorizations, thereby reducing medication-related denials. Stubbs also works to develop relationships with local pharmacists who help him identify which drugs are and aren’t covered under certain plans, including Medicare Part D.

UNDERSTAND MEDICAL 9 NECESSITY REQUIREMENTS

Order only clinically appropriate tests, and be familiar with local coverage determinations as well as prior authorization criteria, says Ejnes. For example, if a patient presents with lower back pain and an exam reveals only a slight tenderness in the patient’s back, an MRI is likely not warranted, he says.

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MEDICAL ECONOMICS ❚ MARCH 25, 2017

APPOINT SOMEONE IN 10 THE PRACTICE TO MONITOR PAYER POLICIES Woodcock recommends having a biller spend one hour per month visiting the websites of the practice’s major payers to identify any policy changes.

REPORT SPECIFIC 11 DIAGNOSIS CODES, WHEN POSSIBLE Identify all comorbid conditions that are treated or managed during the encounter— and be as specific as possible with the diagnosis, says Jimenez. Doing so helps support the E/M levels assigned, and prevents denials due to a mismatch between the diagnostic severity and E/M level. The ICD-10 grace period for physicians ended last October, and Stubbs says he has already seen denials due to a lack of specificity—even when that specificity is lacking on the secondary (not primary) code for the encounter. Physicians should make a list of the most common chronic diagnoses they treat, and identify what specificity is required for each code, says Stubbs. “People need to go ahead and get used to this and change their problem lists to reflect ICD-10 codes that are more specified,” he says.

MORE AHEAD Physicians rate payers: Exclusive survey results Page 39

MedicalEconomics. com

Coding Insights

Annual exams and more: Clearing up when to collect copays

Q:

Sometimes my practice collects copays from patients who come in for annual exams. Many times, the patient then presents with a problem at the same time so then it is not an annual. The practice believes it could collect a copay. Is this the right thing to do?

A:

It sounds like the physicians know in advance whether or not the patient has problems that require assessment or treatment beyond the health maintenance portion of the visit. If so, that’s actually a good thing, and it is appropriate that they collect the copay. However, if doctors are collecting from patients whom they don’t know will have a medical problem addressed, this is a problem. Do they collect a copay in all annual visits? That would certainly shade this towards an inappropriate scenario. Recognize that the copay is applicable only to the additional evaluation and managements codes for problems addressed. Without that, do not charge a copay.

MedicalEconomics. com

Q:

Our practice gives providers 30 days to complete their notes. The charges go out the day after the patient is seen. Should we be completing these charts more quickly?

A: The current guidance from the government states: “To maintain an accurate medical record, document services during the encounter or as soon as practicable after the encounter.” This does not mean weeks. Local guidance from the Medicare Administrative Contractor (MAC) in my state says: “Medicare expects the documentation

to be generated at the time of service or shortly thereafter. Delayed entries within a reasonable time frame (2448 hours) are acceptable for purposes of clarification, error correction, the addition of information not initially available, and if certain unusual circumstances prevented the generation of the note at the time of service.” This one is quite clear: 24 to 48 hours or a reasonable time frame. I don’t think you’d get much sympathy from Medicare if you asked them for even a one-week delay.

Q:

Some of our providers document “greater than 30 minutes spent with the patient and over half of that spent counseling” and then bill 99214. But when we look at the content, it is one stable chronic condition and mostly tobacco cessation counseling. Can we do this?

A: This one may not break in favor of your provider. If the bulk of the counseling time was spent in tobacco cessation counseling, then there is a more specific code for that, 99406 or 99407. Rather than coding for time, if there is a more specific code that describes the service, CPT would suggest that you use that.

Bill Dacey is a billing and coding consulting and principal in the Dacey Group. This article was first published in our partner publication, Physicians Practice. Send your coding and billing questions to [email protected]

MEDICAL ECONOMICS ❚ MARCH 25, 2017

33

Financial Strategies

What is and what isn’t in a credit score Physicians in independent practice looking to build their business will undoubtedly need capital and credit. Whether it’s to expand the office, upgrade technology or buy new equipment, a physician’s credit score will determine how much funding for which you’re approved—and having necessary capital can help you get through the lean times caused by delayed reimbursements.

Here are the five components that make up the Fair Isaac Corporation (FICO) score:

10%

Credit Mix This is your overall credit mix—a good mix includes mortgage loans, installment loans, credit cards and retail accounts. The number of accounts in each type isn’t as important as simply having experience with more than one type of account.

WHEN IT COMES TO YOUR CREDIT SCORE, THE HIGHER, THE BETTER.

35%

Payment History This is whether you pay your bills when they’re due. Even the occasional missed payment can cause problems. If a creditor reports payment lapses to a credit reporting agency, negative credit accounts can stay on your credit report for seven years. TIP: Make your payments on time by enrolling in automatic payments.

30%

TIP: A mix is OK, if managed properly and paid on time.

Credit Utilization This is your loan balances and debt level compared to your overall credit limit. If your balance gets above 50%, it will affect your credit score. If you use personal credit cards for your business, this might keep your revolving credit too high.

10%

New Credit Inquiries This is how often a potential creditor pulls your credit and/or you open new accounts. TIP: A new account or inquiry could drop your score, especially when multiple actions take place in a short period of time. Get credit checks only when you need them. There are some exceptions that won’t have a negative impact on your score, such as exploring different mortgage offers.

34

MEDICAL ECONOMICS ❚ MARCH 25, 2017

15%

Credit History Length This is how long you’ve had credit, from your first account to the most recent. This factor also looks at how long it’s been since you’ve used certain accounts. TIP: When you close a card, your credit availability is reduced and it affects the age of your account. Instead, designate an old card to use once a year and pay it off when it’s due. This keeps it open and benefits your score.

TIP: Make small payments throughout the month to maximize cash flow and prevent the balance from reaching more than 50% of your credit limit.

April Brissette is chief lending officer at Bankers Healthcare Group, the leading provider of financial solutions to healthcare professionals. Send your finance questions to [email protected]

MedicalEconomics. com

www.medent.com ALL-IN-ONE ALL-IN-ONE MACRA/MIPS/ACI/HCC Disease Management Chronic Care Management

EMR/EHR Prescriptions, ePA & EPCS DIRECT Messaging, FHIR eVisit & Medent Mobile

Flexible Documentation Lab Clearing House DASHBOARDS & Reports

Practice Management

Patient Portal

2017 PAYER SCORECARD

Continued from page 16

Why payer negotiations are so difficult 16

mates his staff spends 20 hours a week on prior authorizations, which doesn’t include his additional time to get approvals. “There are more and more things that need prior auths, which just puts me further behind schedule everyday.” Aparna Higgins, senior vice president, private market innovations, for America’s Health Insurance Plans (AHIP), the industry trade group for healthcare payers, says that the goal of payer prior authorizations are to make sure patients are getting the proper care and most efficient care. “Sometimes the clinical evidence changes or there are changes to the formulary,” she says. “There is a process that every com-

I think it is becoming clearer to physicians that healthcare is a big business and a big machine and that all the personalization is being wrung out of it.” — NARESH RAO, DO, PRIMARY CARE PHYSICIAN, NEW YORK CITY

PAYER NET PROFITS FOR FISCAL 2015 $11Billion

United Healthcare Anthem Aetna Cigna Humana

$2.6 Billion $2.4 Billion $2.1 Billion $1.3 Billion

Source: SEC filings

36

MEDICAL ECONOMICS ❚ MARCH 25, 2017

Average CEO comp annual for these fi ensation ve compan ies:

$14.6 MILLION

pany has in place that is based on evidence. They do an evidence-based review to decide which treatments and interventions are going to require prior authorizations. This is not something that is just decided by a group of health plan executives.” She adds the reviews are based on a variety of sources, including information from the FDA and peer-reviewed journals. Experts say prior authorizations exist because physicians don’t always agree on the best treatment for a patient. A payer’s physician panel may recommend a course of treatment for an ailment that is based on the latest studies, but that won’t always meet a patient’s needs as determined by their doctor. Prior auths are also a way to reel in physicians who are overtesting or not following accepted guidelines, which can hurt profits or possibly the patient. “Every provider out there believes they are the best practice with the best doctors, and while they would never do anything to cause harm, there is a tremendous variation in care that is given and what treatments look like,” says Zach Hafner, a partner at Advisory Board, a healthcare consulting firm, who works with payers on contract negotiations. “Plans have an increasing focus on doing the homework and research to really determine whether certain types of treatment or care deliver the benefit the consumer is hoping for. The only leverage the payers have to create a gate there is a prior auth.” And with the number of individuals payers cover, a $10 monthly increase by the manufacturer to a generic drug price multiplied across tens of thousands of plan participants can quickly add up, which may cause a payer to remove it from the formulary if an equally effective—but cheaper— option is available. In some instances, however, there may be only one accepted treatment or one test every patient should receive, but it still requires a prior auth. In those cases, it may just be a matter of the insurance company going too far, says Joel Shalowitz, MD, MBA, FACP, a professor at Northwest-

MedicalEconomics. com

2017 PAYER SCORECARD

TAKE IT OR LEAVE IT NEGOTIATIONS Payers are increasingly moving toward value-based reimbursement models and are less interested in negotiating individual feefor-service schedules, says AHIP’s Higgins. Similar to the way Medicare is shifting some risk to providers, insurance companies are looking for partnerships to provide quality care while sharing in any savings the partnership generates. “A lot of plans are partnering with physician groups and helping them move toward value-based care, because that’s where healthcare is moving,” says Higgins. “The big difference we see is that it is more challenging for the plans to tailor each contract to an independent practice.” The trend toward value-based care has also created a greater administrative burden on plans, because the contracts are more complicated than traditional fee-for-service agreements, says Hafner. “The administrative costs of custom fee schedules are real, and the plans have a huge focus on efficiency, standardization and streamlining,” he says. “It’s just not possible to be dealing with individual line items for each participant, and with value-based payment models, it becomes unadministrable.” Payers have to negotiate with employers

MedicalEconomics. com

Contract negotiations Who at your practice negotiates payer contracts? Solo practice

Hospital-owned practice

45%

37% 34% 31%

6%

along with health networks, preferred providers, physician groups, ACOs and other entities, each with its own wants and needs. The more value a provider group brings to the payer, the more open the insurance company will be to negotiating better terms. The more standardization the payers can implement across all these contracts, the more they will save in administrative costs. Hafner says future negotiations with small practices may occur, but the context will change. “The negotiations are going to be on upside risk and performance-based payments, if anything,” he says. “The focus will be on shared savings and will not be on unit pricing of fee-for-service that sits beneath it. That’s not where the upside opportunity for payers is.” The good news for physicians is that the U.S. Justice Department’s prevention of the two recent attempted mega-mergers in the payer industry—Aetna and Humana; Anthem and Cigna—should help maintain competition and not make negotiations even harder for physicians.

8% 1%

Other

12%

Attorney

Other staff

6%

Practice manager

24%

Physician

ern University who teaches MBA and MPH students about the U.S. health insurance system. “They probably shouldn’t care about lowcost tests,” says Shalowitz. “It’s a drain of the doctors’ time, a drain on the insurers’ money and adds a hassle factor. But it may also be something [employers] are asking for, even if it doesn’t necessarily make sense.” Hafner agrees, noting that, “docs are blaming prior auths on insurance companies, but in fact, it is consumers and employers who are designing the benefit that sits behind it. The insurance company is just administering it.” Payers and employers both benefit financially when patients don’t receive unnecessary care, incenting both to avoid it when possible. As consumers absorb more of their medical expenses, Hafner expects physicians to face similar prior auth questions from them: Is this test absolutely necessary? Are there other drugs that are cheaper that still work? Is there a different treatment plan that costs less?

There are more and more things that need prior auths, which just puts me further behind schedule everyday.” —JEFF KAGAN, MD, INTERNIST, NEWINGTON, CONNECTICUT

INCREASING CLAIM DENIALS The growing number of claim denials is a third source of frustration for physicians, according to the Payer Perspectives Study, delaying payments that are often vital to cash flow. This increase may be due in part to a greater use of automated sys-

MEDICAL ECONOMICS ❚ MARCH 25, 2017

37

2017 PAYER SCORECARD

tems and analytics within the industry. “Payers have to build systems so they are not manually reviewing every case,” says Shalowitz. A mismatched diagnosis and CPT code might flag a claim for rejection. An annual exam that happens a few days earlier than

Most of our time is spent doing soul-crushing paperwork for no reason —it doesn’t help with anything.” —DAVID BELK, MD, SOLO INTERNIST, ALAMEDA, CALIFORNIA

Can EHRs solve the prior auth problem? Joel Shalowitz, MD, a professor at Northwestern University’s Feinberg School of Medicine, says that oft-maligned electronic health records (EHRs) may offer some benefits in the form of helping with prior authorizations and building trust with payers. If EHRs were better integrated with payers, then as physicians entered information the EHR could flag treatments that require prior authorizations and ask all questions needed to get the authorization as part of the process. It would also serve as a virtual assistant, making suggestions based on symptoms to help physicians cover all possibilities, thereby reducing risk to the doctor and the insurer. “There is an opportunity with the technology available to provide knowledge that goes beyond what physicians have the ability to keep in their heads,” says Shalowitz. “It isn’t reasonable to ask physicians to know everything in their specialty anymore.” With payer system integration, prior auths and claim denials could become things of the past, Shalowitz believes. Integration would save time and money for physicians, who could obtain instant answers on treatment and drug options. Moreover, he says, payers would be able to automate the administrative burden of checking to see that all steps were followed before approving coverage of a particular procedure or prescription. Currently, proprietary systems and the lack of interoperability among EHRs make any large-scale rollout of such features difficult.

38

MEDICAL ECONOMICS ❚ MARCH 25, 2017

the previous year might also cause a denial, notes Shalowitz. “It’s not just the complexity of coding, but the sophistication of the insurance company to detect and deny inaccurate claims,” says Hafner, adding that payers aren’t necessarily improperly denying more claims, they are just getting better at flagging those that should have been denied in the past. Higgins points out that all payers have educational programs for how claims should be submitted and how to code, and that if providers have questions about why claims are continually being denied, they should contact the payer to get more information regarding claim submission requirements. Naresh Rao, DO, a primary care physician in New York City, sees claim denials as not just a frustration but a negative influence on how his patients view his practice. So he has taken a proactive approach to minimizing them. “Trying to check on what’s covered and what’s not with the patient in the office detracts from building positive patient relations,” says Rao. He outsources insurance verification so he knows before a patient arrives exactly what is and isn’t covered. That saves time and allows him to focus more on patient care and less on insurance issues. Rao, whose father was also a physician, has heard the same complaints about payers for most of his life and thinks that the changes rippling through healthcare present opportunities for himself and his practice partners. “We are willing to work harder to work with the insurance companies to compromise and find that win-win,” he says. He adds that payers could do a better job of understanding the challenges doctors face. While doctors are frustrated with payers, the converse is not true, says Hafner, because payers are focused on different priorities. “Payers are struggling with macro issues,” he says. “Employers are not willing or able to absorb significant increases in costs, so they are clamping down on prior auth issues and managing denials. I think it is becoming clearer to physicians that healthcare is a big business and a big machine and that all the personalization is being wrung out of it.”

MedicalEconomics. com

PHYSICIANS RATE THE PAYERS For the first time, Medical Economics has polled doctors to get to the heart of the payer-physician disconnect. Nearly 1,110 doctors nationwide shared their day-to-day experiences with insurers, highlighting major pain points and areas for improvement in our inaugural Payer Scorecard.

93%

90%

MedicalEconomics. com

Medicaid

Medicare

Commercial (private)

68%

Either Medicare or Medicaid

76%

None, practice does not accept insurance

Payers accepted

5%

MEDICAL ECONOMICS ❚ MARCH 25, 2017

39

2017 PAYER SCORECARD

NUMBER OF PAYERS

Physicians rate the payers

28%

26%

23%

16%

7%

1-4

5-7

13

8-10

11-20

More than 20

1% NO ANSWER

AVERAGE NUMBER OF PAYERS

18% NO

Biggest challenges with Obamacare plans 67%

Addressing high copay/deductible issues with patients

55%

Low reimbursement from the payer

40%

Getting paid

11%

Do you accept Obamacare plans?

81% YES

Other

11% None, no challenges with these plans

75%

OF INTERNISTS ACCEPT OBAMACARE PLANS

40

MEDICAL ECONOMICS ❚ MARCH 25, 2017

MedicalEconomics. com

Average rating of largest payer Overall

Independent practices

Patient information

3.8 3.5

Clarity of info on patient’s insurance card

4.1 3.8

Responsiveness to changes in patient data provided by practice

3.9 3.6

Pre-authorization process

3.6 3.5

Communication with patient on copays/deductibles

3.6 3.2

Q:

How can payers improve their relationship with physicians?

“When a denial decision is triggered by their computer or low-level screener, then that should be elevated immediately to someone with specialty experience, and direct communication between that individual and the physician should then occur. In most cases, the denial would be overturned because we have good clinical reasons for the medications we are prescribing.” “Pay more, argue less.”

“See us as partners, rather than peons.”

Communication with practice

3.8 3.6

“Listen to us and make us partners in the process.”

Clear identification of who practice should contact with inquiries

4.0 3.8

“Allow physicians to practice medicine and determine what is in our patient’s best interest according to sound evidence based practices.”

Ease of reporting health plan employer data and information set (HEDIS) info Easy to navigate website/ practice portal

Easy to navigate phone system

3.9 3.6 3.8 3.7 3.4 3.3

“Transparency.”

“Pay us and staff for time required to deal with them.” “Access to physicians who make final decisions need to be easier. Nurses with algorithms cannot help patient care with no access to medical directors.”

Continued on page 42 Continued on page 42

MedicalEconomics. com

MEDICAL ECONOMICS ❚ MARCH 25, 2017

41

Continued from page 41

Physicians rate the payers

Overall

Independent practices

Customer service Continued on from 41

“Actually listen to physicians. Not try to pigeon-hole a patient into their algorithm-driven denial system. Have a system where you can actually talk to a real person.” “Dealing with insurance companies has made me regret being a doctor. I give my patients 100% and feel like in this environment it has been too difficult to continue. I actually received a check from an insurance company for 5 cents. I never cashed it. I framed it and put it on my wall.”

“Agree upon a standardized set of rules amongst all payers.” “Allow doctors to make decisions, stop lowering reimbursements, clear red tape.”

4.2 3.9

Response time to inquiries

3.4 3.1

Time on hold/talking to rep

3.3 3.0

Willingness to negotiate on reimbursement rates

Payment

2.5 2.0

4.9 4.8 6.2 6.3

Ability to make e-payments

Payment turnaround time/time in accounts receivable

5.1 5.0

Rates as specified in contract

4.9 4.7

“Get rid of prior authorizations.”

Claims successfully resolved in one submission

4.2 3.9

“Unify the prior authorization process and criteria.”

Fair/reasonable rate as compared to other payers

4.3 4.0

Explanation of denied claims

4.0 3.9

“Give good physicians a voice in negotiation of contracts and payment and networks. Show physicians some genuine respect. Many of us work hard and put our patients needs ahead of our own and are getting burned out.”

42

Responses to inquiries on claims denied or requiring more information

3.6 3.0

MEDICAL ECONOMICS ❚ MARCH 25, 2017

OVERALL PAYER RATING

4.0 3.7

MedicalEconomics. com

Physicians rate the payers

2017 PAYER SCORECARD

Family medicine

Pediatrics

Internal medicine

OB/GYN

Surgical specialty

Other IM specialty

Cardiology

Other

SPECIALTY

ABOUT THE SURVEY RESPONDENTS

21%

18%

16%

13%

8%

3%

3%

18%

Type of practice 38% 37% 20% 2% 3%

Number of physicians at practice

Solo practice Independent group practice Owned by hospital/health system VA or other government system Other

Practice location West

21%

35% 33% 12% 9% 11%

1 2-5 6-10 11-25 26 or more

Midwest

19%

ABOUT THIS SURVEY

Northeast

22% South

34% No answer: 4%

MedicalEconomics. com

The findings cited in this report are based on a survey conducted by ReadEx Research on behalf of Medical Economics. Data was collected via online survey between November 18 and December 5, 2016. The survey received 1,176 responses from physicians. The results are based on the 1,098 respondents who indicated that they are actively practicing medicine (full or part time). As with any research, the results should be interpreted with the potential of non-response bias in mind. It is unknown how those who responded to the survey may be different from those who did not respond. The margin of error for percentages based on the responses is + / - 2.9 percentage points at the 95% confidence level.

MEDICAL ECONOMICS ❚ MARCH 25, 2017

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IN CASE YOU MISSED IT “We try to find people who are going to be real cheerleaders for primary care.”

“Most of our time is spent doing soulcrushing paperwork for no reason.”

“I think payers put up hurdles to intentionally wear down a busy practice.”

DAVID BELK, MD, SOLO INTERNIST, ALAMEDA, CALIFORNIA

MARCIA BRAUCHLER, MPH, PRESIDENT, PHYSICIAN’S ALLY, LITTLETON, COLORADO

PAGE 14

PAGE 18

STUART MARKOWITZ, MD, SENIOR ASSOCIATE DEAN, FLORIDA ATLANTIC UNIVERSITY’S SCHMIDT SCHOOL OF MEDICINE, BOCA RATON, FLORIDA PAGE 9

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MONIQUE MICHOWSKI National Account Manager

DESIGN

732-346-3098 / [email protected]

NANCY BITTEKER Director, Design and Digital Production

ROBERT McGARR Art Director

JOHN CURRID

MEG BENSON Special Projects Director

AMY ERDMAN VP, Marketing

GAIL KAYE Director of Marketing & Research Services

National Sales Manager

REPRINTS

212-600-3134 / [email protected]

877-652-5295 ext. 121 / [email protected] Outside US, UK, direct dial: 281-419-5725. Ext. 121

TOD McCLOSKEY Sales Manager

440-891-2739 / [email protected]

Customer service 877-922-2022 Editorial 800-225-4569

MedicalEconomics. com

Advertising 732-596-0276 Classifieds 800-225-4569

Back Issues 218-740-6477 Reprints 877-652-5295, ext. 121

Subscription Correspondence Medical Economics, P.O. Box 6085, Duluth, MN 55806-6085

MEDICAL ECONOMICS ❚ MARCH 25, 2017

45

M A R K ET PL AC E PRODUCTS & SE RVIC ES MEDICAL EQUIPMENT

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 in contact with Health Care Professionals around the country who are the creators and innovators in their field. It has allowed

Reach your target audience. Our audience.

me to help both my colleagues and their patients.

Contact me today to place your ad. Tod McCloskey, Sales Manager 440-891-2739 [email protected]

46

MEDICAL ECONOMICS ❚ MARCH 25, 2017

MedicalEconomics. com

M A R K ET PL AC E PRODUCTS & SE RVIC ES ON CALL SU PPORT

T R A N S C R I P T I O N S E RV I C E S

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MedicalEconomics. com

Sales Manager 440-891-2739

[email protected]

MEDICAL ECONOMICS ❚ MARCH 25, 2017

47

M A R K ET PL AC E

Advertiser Index

CAREERS Bayer AG Aspirin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Janssen Pharmaceuticals, Inc. Invokana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16a – 16h*, 17*, Back cover MEDENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Pfizer Inc. Nexium OTC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

* Indicates a demographic advertisement.

It’s as if job candidates are delivered to your door. Place a recruitment ad in Medical Economics.

Joanna Shippoli National Account Manager Healthcare Careers (440) 891-4569 [email protected]

48

MEDICAL ECONOMICS ❚ MARCH 25, 2017

MedicalEconomics. com

FUNNY BONE

BY JON CARTER, CARTERTOONS.COM

“Come at me as if I’m an insurance provider who’s denied your reimbursement, Dr. Cantrell.”

COMING NEXT ISSUE

Telemedicine: Today and Tomorrow A look at what’s happening with virtual visits, where they are headed and what independent physicians need to know about it. Also, some lessons learned from small practices on utilizing this emerging technology.

PLUS

❚ Beware partner breaches: Practices are increasingly aware of the cyberattack threat. But don’t forget about your business partners.

MedicalEconomics. com

❚ Virtual groups 101: The government says “virtual groups” can help smaller practices with Medicare payment reform. What you need to know and when it could be available.

MEDICAL ECONOMICS]MARCH 25, 2017

49

11 MMOR ET HA I TIO LL N N S IO TO N DA

PR ES CR IP

TE 1

PREFERRED* COVERAGE FOR MOST COMMERCIAL AND MEDICARE PART D PATIENTS2 Learn more and register for updates at INVOKANAhcp.com *For the plans listed, brand-name drugs that are generally covered at lower co-payments than higher tier brand-name drugs. (The lowest tiers are generally reserved for generic drugs.) References: 1. Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, Total Prescriptions, April 2013-December 23, 2016. 2. MMRx data on file. Janssen Pharmaceuticals, Inc. Data as of 1/10/2017.

Janssen Pharmaceuticals, Inc. Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. © Janssen Pharmaceuticals, Inc. 2017

January 2017

049570-170104