CAPG Health Fall 2016 Colloquium Issue

HEALTH Volume 10 • No. 3

Colloquium Issue CAPG Proliferates in DC and Across the Nation, p.12 Creating Five-Star Care Coordination, p.36 Home Healthcare’s Critical Role in New Practice and Payment Methods, p.46

Fall 2016

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TABLE OF CONTENTS

ON THE COVER

12

Proliferating in DC and Across the Nation New Federal Affairs staff and expanding national membership amplify CAPG’s advocacy on value-based care

HEALTH

DEPARTMENTS

FEATURES

Editor-in-Chief

Don Crane

7

36

Editorial Advisory Board

From the President

Creating Five-Star Care Coordination

8

38

Names in the News

Evolution of the Capitated/Delegated

Publisher

Valerie Okunami

Lura Hawkins, MBA Amy Nguyen Howell, MD, MBA Mary Kay Payne, Arch Health Partners Managing Editor

Daryn Kobata

Editorial Assistant

Nelson Maldonado Contributing Writers

Jim Agronick Bill Barcellona Megan Calhoun Don Crane Rob Francis Rajesh Gade, MD Valerie Green-Amos, MD Janelle Howe Laura Jacobs Pamela Laesch, MD Stephanie Mamane Amber Manko Tracey Moorhead Jeremy Rich, MD CAPG Health Magazine is published by

Valerie Okunami Media PO Box 674, Sloughhouse, CA 95683 Phone 916.761.1853

capghealth.com Please send press releases and editorial inquiries to capghealth@capg.org or c/o CAPG Health, 915 Wilshire Blvd., Suite 1620, Los Angeles, CA 90017 For advertising, please send email to vokunami@netscape.com Subscription rates: $32 per year; $58 two years; $3 single copy.

Advertising rates on request. Bulk third class mail paid in Jefferson City, MO Every precaution is taken to ensure the accuracy of the articles published in CAPG Health Magazine.

Opinions expressed or facts supplied by its authors are not the responsibility of CAPG Health Magazine. Š 2016, CAPG Health Magazine.

All rights reserved.

Reproduction in whole or in part without written permission is strictly prohibited.

10 Upcoming Events

Model in California and Beyond

40 Creating Practical Solutions to Enhance

18 Policy Briefing: Accurate Provider Directories Will Change the World

22 Federal Policy Update: Transitions to a New Administration and U.S. Congress

31 Member Spotlight: MHMD Clinical Programs Committee Serves as System-Wide Quality Engine

34 CAPG Member List

Patient Outcomes Within Coordinated Care Organizations

42 Integrating Behavioral and Primary Healthcare: An Intricate Partnership with Provider and Patient Payoffs

44 The Domino Effect of the Affordable Care Act

46 Home Healthcare: Playing a Critical Role in New Physician Practice and Payment Methods

48 Brown & Toland Physicians and Aetna Continue Successful Accountable Care Collaboration

6 l CAPG HEALTH

Fall 2016

From the President A M ES S AG E F R O M D O N A L D C R A N E , P R ES I D E N T A N D C EO , C A P G

CAPG Members and Friends: I’m pleased to present the Fall 2016 CAPG Health issue. Highlights in this edition include several articles contributed by speakers at the upcoming CAPG Colloquium, September 28-30 in Washington, DC, along with an update on CAPG’s expanding national presence and new DC staff. I trust you’ll find it informative and enjoyable.

I also hope to see you at the Colloquium—one of our premier educational events on valueDonald Crane, based care delivery. A recurring theme for me this year is that we’re entering a new era of CAPG President and CEO learning and teaching. As ongoing policy, regulatory, and technological changes spur rapid transformation of our healthcare system, education and information sharing are becoming more and more critical to success.

A prime example of the need for education is the pending start of MACRA, the Medicare Access and CHIP Reauthorization Act, which will effectively make value-based healthcare payment mandatory in Medicare. In response to requests that CMS delay the law’s January 1, 2017 launch, the agency recently added some starting date flexibility, allowing physician groups to “pick their pace” in participating.

CAPG had advocated for timely implementation, and we’re pleased that organizations who are prepared to start in January can still do so. Regardless of when physician groups begin participating, however, the law will require major changes in how they practice—creating both a need and a huge opportunity for education and resources on what organizations need to successfully comply.

We’re continuing to help fill this need for information with programs like our CAPG Educational Series. The second Symposium in the series, October 27 in Chicago, will cover the how-to’s of risk contracting, performance measurement, and other coordinated care areas. The final series webinar, Health Plan Delegation Oversight, Compliance, and Regulations, takes place December 2. Learn more and register for these events at capg.org/riskessentials.

Our website, capg.org, is another source for learning. There you’ll find resources including CAPG’s Guide to Alternative Payment Models and our Risk Readiness Tool, information on MACRA, a calendar of upcoming events, and much more. o

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CAPG HEALTH l 7

Names in the News WELCOME TO OUR NEWEST MEMBERS CAPG warmly welcomes these members who have recently joined: Organizational Members Angel Medical Group, Los Angeles, CA Equality Health – Q Point, Scottsdale, AZ Group Health Physicians, Seattle, WA Hawaii Pacific Health, Honolulu, HI Iora Health, Boston, MA Monterey Bay IPA, Monterey, CA Mount Sinai Health System, New York, NY One Medical Group, San Francisco, CA The Portland Clinic, Portland, OR Corporate Members Nestle Health Science, Portland, OR Shionogi, Inc., Florham Park, NJ Associate Member Bristol-Myers-Squibb, Plainsboro, NJ Affiliate Member Acurus Solutions, Inc., Anaheim, CA

SYNERMED RECEIVES MOLINA HEALTHCARE’S 2016 INNOVATIVE AWARD FOR DOWNTOWN COORDINATED CARE CENTER SynerMed has received Molina Healthcare’s 2016 Innovative Award for excellence in clinical management and effective partnership for its Downtown Coordinated Care Center (DC3). The clinic provides access to quality healthcare for high-risk, high-cost patients. Many low-income patients with chronically complex conditions have greater healthcare needs that often go undiagnosed due to lack of service and a fragmented healthcare system.

“The fact that services are provided in an effort to treat the ‘whole’ person, even when services are not covered

by Medi-Cal or Medicare, is exemplary,” said Milaine Isaac, Associate Vice President of Molina Healthcare of California.

“SynerMed serves as a true shining example of the principles for which we stand to improve the health and well-being of the community at large.”

The whole-person care approach has enabled SynerMed to lower costs for the top one percent of high-risk patients from $30,000 per member per month to about $5,000, and to provide them the resources needed to better manage their conditions, said Peter Winston, the organization’s Executive Vice President. SynerMed plans to develop more complex care models and expand its services to include behavioral health, substance abuse and long-term care. For more information about the DC3, visit www.dc3medical.com.

DR. CASSIDY TSAY JOINS CAPG AS VP OF BUSINESS DEVELOPMENT

SEVENTY-ONE PHYSICIAN GROUPS EARN 2016 STANDARDS OF EXCELLENCETM ELITE HONORS The 2016 Standards of ExcellenceTM (SOE®) Elite winners were announced at the CAPG Annual Conference in June.

CAPG member physician organizations earn the SOE® survey rankings based on their performance in improving patient experience, clinical care, and affordability of care.

This year, 114 of CAPG’s approximately 250 members took part in the voluntary self assessment, covering 11.6 million people in the commercial line of business, including Medicare Advantage, along with an additional estimated 3.1 million individuals in government programs. Seventy-one physician organizations achieved the Elite honor, an increase of six groups over 2015, despite increased requirements this year for demonstrating improved performance. To learn more, visit capg.org/soe.

8 l CAPG HEALTH

Fall 2016

CAPG recently appointed Cassidy Tsay, MD, as vice president of business development. “We’re delighted to welcome Dr. Tsay,” said CAPG President and CEO Don Crane. “She comes to us with a very strong background. Dr. Tsay is a great asset for CAPG, and we look forward to a stronger team with her on board.”

Most recently the Regional Medical Director at Blue Shield of California, Dr. Tsay previously spent four years with Nautilus Healthcare Management Group, working as medical director for Greater Newport Physicians and managing more than 170 primary care providers and 400 specialists. Her clinical experience includes seven years with Kaiser Permanente and three years with Bristol Park Medical Group, Inc. Dr. Tsay earned her medical degree from Albert Einstein Medical College and her MBA from the University of California, Irvine. o

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E V E N T S

CONTRACTS COMMITTEE

CAPG COLLOQUIUM 2016 Wednesday to Friday, September 28-30 Hyatt Regency on Capitol Hill, Washington, DC capgcolloquium.com

APM COMMITTEE Tuesday, October 25 WebEx

SYMPOSIUM: HOW TO THRIVE IN RISKBASED COORDINATED CARE WEBINAR: HOW TO IMPROVE PATIENT SATISFACTION

Thursday, October 27 Chicago, Hyatt Regency O’Hare

Tuesday, September 20 WebEx

PHARMACEUTICAL CARE COMMITTEE

GENERAL MEMBERSHIP - SOUTHERN CALIFORNIA Wednesday, September 21 CAPG

HUMAN RESOURCES COMMITTEE Wednesday, September 21 CAPG

U P C O M I N G

Thursday, October 20 CAPG

GENERAL MEMBERSHIP - NORTHERN CALIFORNIA Thursday, September 22 Oakland, Hilton Oakland Airport Hotel

I-AM CAPG ADVOCACY LUNCHEON Friday, September 30 CAPG Colloquium, Washington, DC

CLINICAL QUALITY LEADERSHIP COMMITTEE Tuesday, October 11 CAPG

NORTHWEST REGIONAL MEETINGS

Wednesday, November 2 CAPG

TEXAS REGIONAL MEETINGS Tuesday, November 8 Houston, JW Marriott

SOUTHWEST REGIONAL MEETING Thursday, November 10 Phoenix, TBD

PUBLIC POLICY COMMITTEE CONFERENCE CALLS Thursday, November 10

STATE GOVERNMENT PROGRAMS COMMITTEE Tuesday, November 15 CAPG

PRIMARY CARE PRACTICE TRANSFORMATION COLLABORATIVE Wednesday, November 30 CAPG

Thursday, October 13 Seattle, Hilton Seattle Airport & Conference Center

WEBINAR: HEALTH PLAN DELEGATION OVERSIGHT, COMPLIANCE, AND REGULATIONS

PUBLIC POLICY COMMITTEE CONFERENCE CALLS

Friday, December 2 WebEx

Thursday, October 13

NORTHEAST REGIONAL MEETINGS Tuesday, October 18 Philadelphia, TBD

SOUTHEAST REGIONAL MEETING Thursday, October 20 Tampa Bay, TBD

10 l CAPG HEALTH

Fall 2016

PUBLIC POLICY COMMITTEE CONFERENCE CALLS Thursday, December 8 Unless otherwise noted, contact CAPG for more information on these events: 213.624.2274.

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Fall 2016

CAPG HEALTH l 11

ON THE COVER

CAPG Proliferates in DC and Across the Nation

BY DON CRANE, PRESIDENT AND CEO, CAPG

Until late 2013, the association you now know as CAPG was called the California Association of Physician Groups. We originated in a state where physician organizations strongly believe in value-based healthcare and have successfully practiced it for years. However, following the 2010 passage of the Affordable Care Act and as capitation and other valuebased arrangements were spreading across the country, we saw a rising need for a national organization supporting groups in alternative payment models.

Earlier in 2013, Mara McDermott had been hired as Director of Federal Affairs to launch an office in Washington, DC. Advocacy has always been central to our association, and this move provided a much-needed ongoing presence among federal policymakers and legislators. By the second half of the year we also were gaining increasing numbers of outof-state members. Clearly, we were growing beyond our California roots.

The time was ripe for official change. Our Board of Directors voted to rebrand to better reflect our now national identity, and we began 2014 as CAPG, the Voice of Accountable Physician Groups.

Fast forward to fall 2015. CAPG’s non-California membership was multiplying and gaining momentum. Commensurate with our growing nationwide presence was the need to further amplify our voice in Washington, DC—the heart of lawmaking and regulation for Medicare, Medicaid, and other programs central to our members’ work. Once again, the Board voted, approving the hire of new staff and the move to a larger office.

Today, Mara, now Vice President, oversees a Federal Affairs team that includes Amber Manko, Director, and Shelley Robinette, Manager. Their extended outreach on the Beltway will be indispensable to our credibility on policy issues. Together with establishing the DC-based CAPG Colloquium—an annual healthcare conference that’s gaining in influence—it’s raising CAPG’s profile and setting the stage for us to engage federal legislators and other leaders with authority. They now know who we are, and we’re already seeing our advocacy become more effective.

In lockstep with our growing visibility in Washington, CAPG’s national membership is increasing apace. Our nonCalifornia members now compose close to 20 percent of our approximately 250 member groups. The growth in each 12 l CAPG HEALTH

Fall 2016

area helps drive the other, positioning us to pursue our vision of proliferating value-based care across the country through education and leadership.

CAPG’s Washington, DC, staff. From left: Shelley Robinette, Manager; Amber Manko, Director; and Mara McDermott, Vice President.

The task is huge.

Healthcare costs consume more than 17 percent of the U.S. gross domestic product (GDP)—almost double the 8.8 percent average for other countries in the Organization for Economic Co-operation and Development (OECD).1 Yet for all that spend, the U.S. is 57th in the world in infant mortality, with a rate almost triple that of countries such as Iceland and Japan.2 And we’re the only developed country whose maternal mortality rate has actually risen in recent years, from 18.8 to 23.8 per 100,000 live births3—a change that some attribute to factors including a lack of access to affordable care.

Clearly, our historically volume-based, fee-for-service system is failing. We have no choice but to move to value—and our country’s leaders agree. The Medicare Access and CHIP Reauthorization Act (MACRA), approved by landslide bipartisan majorities in the House and Senate, effectively mandates practitioners to move to value-based payment in Medicare.

In passing MACRA, Congress is asking physician groups to quickly adopt a very different business model—kicking into overdrive what had been a slow acceleration toward value. The law was originally scheduled to launch January 1, 2017, and a number of voices called on the Centers for Medicare & Medicaid Services (CMS) to delay the start and allow more time to prepare. CAPG successfully urged Congress and the Administration to continue offering a January start date for those ready to go on day one, and CMS recently announced a compromise: a range of starting dates to accommodate various stages of readiness among physicians and groups.

Still, the transition is a tall order and will require new and different knowledge, skills, and management, both administrative and clinical. With CAPG’s longtime experience in what’s been known variously as managed care, value-based care, risk-based care, and now alternative payment models, we’re exhilarated to find ourselves in a prime place for sharing our knowledge and helping others succeed.

On the one hand, MACRA adds to Medicare a pay for performance component—very familiar to CAPG members with California roots. On the other hand, it also makes available a new 5 percent incentive for risk-based coordinated care, well known to our members nationwide.

The law’s requirements tap into all areas of CAPG’s expertise—making us an ideal resource for the future.

We’re in a new era of learning and teaching, and the timing couldn’t be better. In the emerging healthcare landscape of integration, coordination, and public-private partnerships, collaboration and information sharing will be key. Until a few years ago, CAPG’s own information sharing was largely “intramural,” staying with our members already in risk. Now it’s becoming “extramural,” extending beyond the fold to others who may just be getting ready to dive in. We want to become the go-to group for learning in value-based care.

TH E

date

for

Our members are thrilled at this prospect. After all, it validates their success and holds them up as models and leaders in replicating risk-based care across the country. Besides, who else could do it better? While Washington, DC may be the authority on the what and why of the need to move into value, it’s physician organizations who have on-the-ground experience with implementation.

Regardless of whether physician groups start in January or later, MACRA will soon be the law, and motivation should be high and rising to become immersed in its requirements.

CAPG members have the know-how and experience, and our Board of Directors is charging us with sharing that knowledge. We look forward to continuing to partner with the healthcare community and nation in accelerating the move to better, lower-cost care for all. o David U. Himmelstein and Steffie Woolhandler. The Current and Projected Taxpayer Shares of US Health Costs. American Journal of Public Health: March 2016, Vol. 106, No. 3, pp. 449-452.

1

Central Intelligence Agency. Country Comparison: Infant Mortality Rate.

The World Factbook, https://www.cia.gov/library/publications/the-worldfactbook/rankorder/2091rank.html 2

Marian F. MacDorman, PhD, et al. Recent Increases in the U.S. Maternal Mortality Rate. Obstetrics & Gynecology: September 2016, Vol. 128, No. 3, p. 447.

3

<http://d279m997dpfwgl.cloudfront.net/wp/2016/08/MacDormanM. USMatMort.OBGYN_.2016.online.pdf> Accessed September 10, 2016.

2017 CONFERENCES

CAPG ANNUAL CONFERENCE 2017

June 22-25 | Manchester Grand Hyatt, San Diego, CA

C A P G C OL L O Q U I U M 2 0 1 7

November 8-10 | Hyatt Regency on Capitol Hill, Washington, DC

See you there!

Fall 2016

CAPG HEALTH l 13

Value Based Reimbursement is Here.

Are You Ready?

BY MANFRED STEINER, MANAGING DIRECTOR, BROWN GIBBONS LANG & COMPANY

Rising levels of waste, skyrocketing medical costs, and increased public scrutiny within the U.S. healthcare system have driven both public and private payors to work with providers to find alternative methods of healthcare delivery and reimbursement. Following the sudden, sweeping changes in the market structure of U.S. healthcare under the Patient Protection and Affordable Care Act (“PPACA”), coupled with pressure from payors, providers have implemented an array of arrangements to cope with the new environment. PPACA emphasizes value (as opposed to volume) as a primary objective of care. The legislation seeks to motivate providers with incentives for successful patient outcomes, reduced healthcare spending, shorter throughput, and other goals supporting “value” in healthcare. Alternative models, which differ from traditional Fee-for-Service (“FFS”) models, incentivize providers for risksharing.

Although new reimbursement models offer a departure from traditional methods, they can also provide competitive advantage for those savvy providers with the wherewithal to adapt, the capacity to collect and digest data, and the willingness to invest in the resources necessary for success.

Only the truly adaptive and innovative will thrive. Providers must not only re-evaluate the care they provide, but the way it is delivered and the foundation it is built upon. Providers transitioning to these models must not only understand and anticipate how best to provide value but also need the necessary infrastructure and scale. As PPACA and subsequent legislation snowball, providers have a simple choice: weather the changes (including increased risk of penalties) and remain independent, or partner with another provider. Nevertheless, the traditional business model faces imminent extinction, and providers cannot afford to remain idle.

Traditionally, FFS payment models have been the standard.

However, these models contribute to a variety of major issues.

Namely, FFS drives overutilization which consistently results in healthcare that is substantially more expensive in the United States than in other developed nations with no distinguishable difference in quality. The “volume” mentality leads to immense systemic inefficiencies and medical waste - a Dartmouth Institute of Health Policy brief estimates 30 percent of Medicare clinical care spending is unnecessary. Thus, valuebased reimbursement (“VBR”) is quickly emerging as the new standard in healthcare reimbursement. Further, mandates from the Center for Medical Services (“CMS”), in particular, have driven the shift from FFS towards VBR. In 2015, the Department of Health and Human Services (“DHHS”) announced a goal to tie 50 percent of all reimbursement and 90 percent of Medicare reimbursements to alternative models by 2018. As of March 2016, DHHS achieved a previous goal of tying 30 percent of all payments to alternative models.

CMS rolled out a suite of programs to help transition providers to VBR. While programs such as the Pioneer Accountable Care Organization (“ACO”) model incentivized the early adoption of alternative value-based payments, CMS also imposed penalties on providers who fail to implement certain measures. One such example is the requirement to utilize Electronic Medical Record (“EMR”) systems in provider networks, as the agency believes EMR technology is an important part of fostering value. Under previous rules, providers would have been penalized up to five percent of all Medicare reimbursements for failing to adopt EMR, though new legislation has increased penalties. In short, providers cannot afford to ignore evermore frequent calls for value. CMS is incentivizing high-quality, low-cost care through several PPACA provisions, such as the Value Based Modifier, and continues to implement new legislation such as the Medicare Access & CHIP Reauthorization Act of 2015 (“MACRA”).

MACRA shifts Medicare’s entire reimbursement structure away from the Sustainable Growth Rate which sought to increase reimbursement annually by a flat rate. Currently, MACRA is moving reimbursement to value-based measures.

By 2019, when CMS converts to the new reimbursement calculations outlined under MACRA, providers will have to create value or risk facing substantial (upwards of 9 percent) reductions to their Medicare reimbursements from FFS levels. As CMS moves to tie the financial success of providers to value through implementation and utilization of EMR,

paid sponsorship 14 l CAPG HEALTH

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focus on preventative care (versus reactive treatment), and promotion of population health, providers have responded by implementing new contracting arrangements and payment models that will change the nature of the healthcare industry.

MACRA offers two different reimbursement paths, each of which offers substantial incentives for providers willing to innovate. Understanding the inner-workings of each path will help providers make the right choices. As the U.S. population ages, payor attention to Medicare and MACRA is becoming increasingly important. After all, CMS expects federal and state governments to make nearly half of all healthcare payments by 2024. Providers cannot view the changes under MACRA as merely a Medicare-based shift; the entire industry, public and private, is following suit and providers need to take MACRA and its implications seriously.

The two tracks of MACRA are strikingly different: The Merit-Based Incentive Payment System, (“MIPS”) rewards improvement in care, while Alternative Payment Models (“APMs”) fundamentally transform the delivery of care. Both tracks have their own incentives and requirements and hold substantial rewards for high-performing providers. While it is too early for providers to decide whether MIPS or APMs will suit their business model better, APMs hold great promise for providers that manage to surmount the associated risks and create a strong, forward-looking care network.

The less disruptive MACRA model, MIPS, functions identically to Pay for Performance (“P4P”) models that have become a key part of VBR. Providers can implement MIPS with relative ease. The path allows CMS to adjust Medicare payments for a provider based upon performance in four key areas: quality of care, EMR implementation and use, resource use, and participation in CMS Clinical Practice Improvement Activities (“CPIA”). CMS hopes MIPS will incentivize providers to provide care that is outcome-focused, integrated, and ultimately more affordable. Estimates by CMS project that in 2019, (the first year of MACRA reimbursement) approximately 50 percent of providers will fall below the performance benchmark and see their reimbursements negatively adjusted, with the lowest quartile penalized at the maximum rate. Conversely, the upper quartile will receive an annual bonus of up to 10 percent of their total reimbursements for the first five years of the program. The bonus is drawn from a $2.5 billion pool specifically designated for providers with “exceptional performance.”

Exceptional performance payments aside, MIPS is meant to be a “budget neutral” program - if the number of providers meeting the performance benchmark is fewer than the number falling below it, they will have their reimbursements adjusted upwards further by a multiplier. The inverse will occur if there are more providers above rather than below the benchmark. The amount of reimbursements providers receive

will be heavily dependent on the performance of their peers.

Since there is a hard floor on the maximum amount a provider can be penalized, the budget-neutral provisions ensure that when providers exceed CMS expectations, their bonuses will actually be penalized collectively, to ensure budget neutrality.

During the first year of MACRA alone, 55 percent of all providers are expected to receive bonuses from CMS. Due to the fact that a majority of providers are earning a bonus, this will mean that providers who are penalized will be penalized more than those getting awarded, with bonuses being scaled down to maintain budget neutrality. Budget neutrality will cause bonus payments rewarding providers for their efforts to be significantly scaled back as more bonuses are awarded.

In addition, while the initial incentive payments for exceptional performance may be tempting for highly functioning providers, there will be far less of a monetary incentive to participate in MIPS when these payments stop after 2024. While MIPS appears rewarding, many of the bonuses contain caveats that will greatly challenge providers seeking incentive payments from CMS. Given that participation in either MIPS or APMs will be mandatory for providers, physicians must understand the difficulties of transitioning and adapting to this new system.

Industry experts critique MIPS as a continuation of the Physician Quality Reporting System (“PQRS”), another CMS quality initiative maligned for the excessive bookkeeping burden placed upon physicians. However, unlike PQRS, MIPS quality reporting is mandatory (Berenson). Providers implementing MIPS must face difficult reporting quality metrics and meet the seemingly arbitrary standards of “quality.” In fact, 25 percent of a providers’ MIPS reimbursement comes from “advancing care information,” or how effectively the provider uses EMRs. MIPS’ call to invest in expensive EMR technology, devote more time to bookkeeping, and provide high quality care coincides with the CMS estimate that nearly 80 percent of physician groups with less than 10 physicians will be penalized under MIPS. MIPS’ flaws notwithstanding, other trends in reimbursement are showing meaningful results. P4P is quickly becoming the most popular form of VBR for its proven track record.

Even within MIPS, the top providers could even see their reimbursements adjusted upwards by a staggering 27 percent (CMS). P4P shows promise as a means of reimbursement, so long as providers make the necessary investments.

Providers offering care that not only meets, but exceeds, MIPS standards, will be rewarded while those who struggle to reconfigure their practices will face reduced or delayed benefit. However, to earn reimbursements that keep pace with costs, successful reconfiguration will be a necessity.

P4P is a viable model; however, other alternatives can place many providers in a better strategic and financial position. continued on next page paid sponsorship Fall 2016

CAPG HEALTH l 15

continued from page 15

Instead of using the MIPS approach of influencing outcomes through incentives, APMs fundamentally change the way care is provided. Although CMS favors APMs such as bundled payments, ACOs, and Patient Centered Medical Homes (PCMH), CMS has created stringent guidelines for what may qualify for APM reimbursement. Due to these stringent standards, only a mere 5 percent of all providers expect to qualify for APMs in 2019 (AHIMA). These requirements necessitate that 75 percent of a provider’s physicians utilize EMR technology; that the provider bear a minimum amount of financial risk; and that payments are primarily based upon quality measures comparable with MIPS criterion. If a provider meets these requirements, they are able to exempt themselves from MIPS submissions and adjustments.

APM bonus payments currently can be obtained one of two ways. While both subsets are not subject to MIPS, providers will receive an annual bonus equal to 5 percent of their Medicare Part B revenues until 2024 if they either serve more than 20 percent of their patients through or receive 25 percent of their reimbursements from APMs meeting the above qualifications. Though this threshold for the bonus payment will eventually increase to 50 percent of patients and 75 percent of reimbursements, a 5 percent unconditional performance bonus will strongly incentivize providers and place those who adopt APMs in a stronger financial position than those who continue to rely on MIPS- adjusted FFS models. Further, research supports that providers switching to capitated and bundled payments could see revenue increase as much as 36 percent (MGMA).

For providers considering the switch to APMs, there are still several reasons to convert, even if they are not expected to meet the CMS bonus payment threshold qualification. For one, providers will still be exempt from downward reimbursement adjustment by MIPS and can even opt into MIPS if they would receive a favorable adjustment. Furthermore, all providers using APMs, even those below the threshold, will qualify for monetary rewards from CMS and after 2026 will be subject to a different fee schedule that grows at an annual rate of 0.5 percent above the MIPS fee schedule. CMS is clearly pushing providers to adopt APMs as soon as possible, but APMs are not without their pitfalls. Providers taking advantage of these favorable conditions to remain competitive must address a myriad of challenges as they transition.

Like MIPS, providers face hurdles when implementing APMs. EMR is a concern for providers, not only to ensure eligibility for MACRA payments, but also to coordinate care between increasingly complicated medical organizations. Likewise, since the key objective of APMs is to reduce the cost of care, providers making the switch must bear a large amount of risk, placing many in a potentially precarious financial position.

The uncertain regulatory environment presents an additional concern for providers, since certain APM arrangements such as PCMHs and ACOs are at increased risk of compliance

violations related to legislation such as Stark Law; however, CMS can waive certain ACOs to protect their exposure.

CMS acknowledges the financial, legal, and operational risks that MACRA will present to providers, particularly for small practices with ten or fewer physicians. This April, CMS released a statement highlighting steps to be taken to aid small practices—a direct response to critiques of the potential unduly negative effects of MACRA on many physician practices. The most important provisions were special allowances permitting more flexibility in submitting MIPS data to CMS for practices with fewer than ten providers. In addition, practices earning less than $10,000 from Medicare or those that treat fewer than 100 Medicare patients annually will be entirely exempt from MACRA. Additionally, over the next five years, CMS has pledged to distribute up to $100,000 for training and assistance to practices struggling with EMR implementation. While CMS promised assistance to providers, the impact of these programs remains uncertain.

In general, the MIPS allowances do not relax thresholds for smaller practices; they merely reduce reporting requirements.

Further, the technical assistance fund is inconsequential when compared to the pool CMS has earmarked for incentive payments. Though these provisions will certainly help providers, for many they may not be enough.

The arrival of MACRA is approaching, and providers cannot afford to remain idle. They must leverage industry resources to continue to educate and prepare themselves for a dramatically different healthcare landscape. A study by GE Healthcare found that providers aspiring to enter population health would need at least one million patient lives to be effective. Even CMS concedes that small providers may be disproportionately affected by MACRA’s new changes in their latest estimates.

New approaches and provider reorganization may be necessary to achieve the patient-focused population-healthbased approach MACRA engenders.

Providers must be self-sufficient and search for solutions while charting a course to navigate the complex and everevolving healthcare marketplace. They must not only consider quality of care, but how it plays into changing government reimbursement models and subsequently, commercial payor models. Providers must emphasize value and desired outcomes, while weighing the financial implications and capital requirements to implement the infrastructure (EMR, staff, physicians). These dynamics raise questions of partnerships, joint ventures, and even mergers or acquisitions.

Will providers evolve to remain competitive under the new guidelines? They must decide whether to weather MACRA’s storm of increased compliance and reimbursement penalties on their own, or pursue an alternative strategy to expand their scale. o For more information, questions, or comments, please contact Manfred Steiner, Managing Director | Brown Gibbons Lang & Company | 312.658.1600 | msteiner@bglco.com

paid sponsorship 16 l CAPG HEALTH

Fall 2016

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CAPG HEALTH l 17

Policy Briefing Accurate Provider Directories Will Change the World

BY BILL BARCELLONA, SENIOR VP FOR GOVERNMENT AFFAIRS, CAPG

Health plan provider directories are inaccurate, out-of-date, and incomplete, failing to indicate which providers are accepting new patients. Consumers find them next to useless. The industry has failed over the last three open enrollment periods to fix the problem. Government will now step in to impose a solution. This development is important to providers because they will increasingly be required to participate in the business process of creating and maintaining accurate, timely directories.

on we “Early recognized that the crisis and opportunity of the provider directory issue were going to be significant to our members.”

Once accurate and timely provider directories are achieved, their impact will be felt in network adequacy oversight, plan contracting, pay-for-performance, and value-based payment, as well as other areas of the healthcare market. Up to the present, the healthcare marketplace has developed a good understanding of the demand side for healthcare services. The supply factors have remained murky. No one knows how many active-practice providers exist. Full-time equivalent provider workforce estimates are sketchy. Network adequacy standards and timely access to care oversight are effectively unenforceable beyond isolated incidents. Any healthcare process that relies on the correct denominator of supply will be greatly affected by the increased accuracy of provider directories.

Why are we now facing so much government intervention in the provider directory process? The problem arose in early 2014 when Covered California and the Federal exchanges attempted and failed to publish multiplan provider directories. A “multiplan” directory incorporates the individual plan networks, but also enables users to compare individual providers, groups, and facilities across plans. In that way, consumers can compare whether two or three plans include the same physician in their respective networks and whether their preferred hospital is available.

Why can’t the exchanges publish multiplan directories? The reasons are complex and solutions not readily available. Individual providers’ names vary from one directory to the other. Physicians may practice at multiple office locations. A doctor may own three office locations, practice one day a week at a local federally qualified health center, and have varying privileges at local hospitals. No information about when that individual maintains office hours at each location is captured in the directory. Provider groups and facilities are not uniformly named and may appear under 20 different names in directories.

Since the industry does not subscribe to a uniform naming convention for providers and provider entities or use technology that reconciles naming discrepancies, each individual listing is merely piled on top of the other as plans create their own directories and exchanges attempt to create multiplan directories. Consumers see two or three entries regarding a single physician and wonder which one is correct. They call a phone number and don’t get an answer. Or they call and find out that the physician is not accepting new patients in the plan that they are enrolled under.

18 l CAPG HEALTH

Fall 2016

CAPG found that the process essentially relies on information maintained in Excel spreadsheets that is transferred between providers and plans and plans and regulators. It’s one-dimensional, static, and snapshot-based.

When a provider or provider group is listed under different names and locations, duplicative entries pile up on top of each other as multiple spreadsheets are combined.

In one instance we found a single plan listed 10,300 distinct provider groups in its directory. The problem was that only 230 such entitles existed within the state. In another instance, the contractual relationships were not connected to the directory—so a plan’s preferred provider organization (PPO) directory incorporated any provider group with which a single physician was identified. The result was a listing of over 130 independent practice associations (IPAs) in a PPO plan directory when only one group had a consent decree from the Federal Trade Commission (FTC) to accept PPO contracts on behalf of its physicians. One listed group had 1,200 physicians, yet only seven were ultimately incorporated into the PPO plan network.

Figure 1

CA SB 137 CA SB 137 Exchanges Exchanges Medicare Medicare Medicaid Medicaid NAIC NAIC

Name Name

X X X X X X X X X X

Address Address

X X

X X

Contact Specialty Contact Specialty Information Information X X X X X X X X X X

License/ License/ Board Cert.

Board Cert.

X X X X X X X X X X

In short, the inaccuracy problem results from several factors that create a fragmented process: • Lack of uniform identifying factors for individual providers, provider entities and facilities; • Inability to capture multiple practice locations, including office hours at each location; • Inability to tie the contracting relationships between individual providers, providers in provider groups, and provider-to-plan relationships to the directory listings; • Use of differing formats, procedures, and processes that are ill-defined and vary from plan to plan; • Lack of real-time data capture and electronic exchange of information between providers, payers, and purchasers;

X X X X

X X X X

• Lack of automated validation processes to continuously scrub provider directory data; and • Increasing emergence of multiple governmental standards that require differing data fields and compliance timing.

Many providers feel that this issue is a plan problem.

It’s everyone’s problem. A recent experience in the 2015 California legislative session drove home this point. California’s new provider directory law (SB 137) requires statutory compliance by all contracted providers within a plan’s network. A contracted provider, provider group, or facility must respond to health plan inquiries for validation of provider directory listings. They must do so as frequently as the plan requires, and they face penalties for noncompliance.

De-listing is one such outcome. Withholding of up to one-half of a month’s payment is another. Provider compliance is serious business. We fully expect other state jurisdictions to adopt similar provisions requiring provider compliance.

Open/ Open/ Closed Closed X X X X X X X X X X

Group Group Affiliation Affiliation X X X X X X X X X X

Office Office Hours Hours

X X

Facility Facility Admitting Admitting

Languages Languages Spoken Spoken

X X X X

X X

X X X X

X X X X

Network Network Tier Tier X X X X

X X

In Figure 1, we have compiled the emerging differences in the state and federal standards for directory compliance. Meeting these varying standards is challenging and increasingly, providers will be required by law to comply and provide information to their contracted payers, regardless of how time-consuming, duplicative, and costly that may be.

What has CAPG done about this problem? Early on we recognized that the crisis and opportunity of the provider directory issue were going to be significant to our members. Curiously, health plans were not very interested in partnering to create solutions, so we began a dialogue with a data management firm, Gaine Solutions, to develop an approach to solve our members’ pending compliance issues. continued on next page Fall 2016

CAPG HEALTH l 19

Accurate Provider Directories...continued from page 19

For capitated, delegated physician groups, compliance with the emerging provider directory requirements in commercial, Medicaid, and Medicare Advantage is daunting. Health plans will require provider groups to frequently validate rosters of their individual physicians, nurse practitioners, physician assistants, and other affiliated providers for accuracy. Each plan has a different format for such “roster review” and a different process. It is common for our physician group members to hold between 12 and 25 health plan contracts across different lines of business. We anticipated that our membership could be inundated if a number of plans dumped their rosters on a physician group all at the same time.

Gaine Solutions studied the process at the physician group level and recommended an automated registry model to solve the problem. In a registry, multiple sources contribute information to inform the development of a single physician directory profile.

Information can come from established sources, like the NPSS for provider identification number, the national change of address database, credentialing databases, and state-level licensing agencies. All plan, provider group, and provider-supplied demographic information can be incorporated. Algorithms can be developed to reconcile discrepancies in information between rosters and directory listings. Office locations can be linked to claims data.

Gaine created a provider directory registry called “Sanator” (Latin for “caregiver”) to facilitate automation of a physician group’s compliance with the varying roster reconciliation formats and processes used by health plans. The system was tested in a San Diego County pilot between January and March 2016 and implemented effective July 1, 2016. Gaine has contracted with a number of CAPG members (over 40 at last count) to undertake the roster review compliance process

20 l CAPG HEALTH

Fall 2016

on their behalf. The Sanator system is being linked directly to health plans—slowly at first, and we hope more rapidly in the future, as the regulatory compliance standards are finalized by government agencies. What results is an automated, real-time, multidimensional database of active providers in a community, across a state, and eventually across the nation.

CAPG also advocated before California regulators to require health plan funding and development of an online multiplan provider directory. The pending “mega-mergers” of large health plans are subject to state-level review by the California Department of Managed Healthcare (DMHC). Beginning in October 2015, the DMHC issued undertakings that required the funding and development of common electronic infrastructure to develop an online multiplan directory.

The effort is part of a $50 million pool for this and other infrastructure projects. On August 3, 2016, the State and other stakeholders held the kick-off summit in Sacramento to develop the online multiplan directory.

Numerous standardization issues remain to be solved.

We are confident that solutions can be achieved rapidly in this area, now that Sanator is up and running and our members are increasingly linked to an automated system. o For more information on SB 137 compliance, please visit www.capg.org/sb137. CAPG and Gaine Solutions will present a demonstration of the Sanator automated registry at the CAPG Colloquium on Wednesday, September 28, at 2:00 pm, Room Columbia C.

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CAPG HEALTH l 21

Federal Policy Update What to Expect When You’re Expecting: Transitions to a New Administration and U.S. Congress

BY A M B E R M A N KO , D I R ECTO R O F F E D E R A L A F FA I R S , C A P G

As we near the end of President Obama’s eight-year term in the White House, despite the ultimate outcome of the Presidential election having yet to be decided, the expectation that a new president-elect and vice president-elect will be inaugurated this January is ever present. In the new year, a new administration will take the reins and begin to make its mark by advancing its own policy initiatives through a new team of appointed leaders.

Also in January, hundreds of federal congressional elections across the nation will deliver a slew of new representatives to the U.S. Congress. Members of the U.S. House of Representatives and U.S. Senate are elected on a biennial basis. Every four or eight years, that turnover in Congress is destined to coincide with the installation of a new administration. Next year, following this November’s general election, we will experience exactly that.

In 2017 many threads of newly elected representatives and appointed officials will report for duty in Washington, DC. Through their work over the next two years, their paths will weave together to change the tapestry of our political future. In this cycle with the Executive Office and control of the U.S. Senate in play, that tapestry may present in bluer or redder hues—but ultimately its pattern of influence will be grounded in the communities who took action on November 8 to choose their elected representatives.

To maintain the momentum of delivery system reform it is especially important for CAPG physician organizations to continue to lead in their communities and educate their constituencies about how and why the risk-based models we administer improve the quality of care and offer a superior patient experience. Without a line of communitybased communication reaching all the way to Washington, DC, compelling the federal government to stay on track with its implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), or to incentivize avenues to expand risk-based contracting in Medicare Advantage, may prove challenging in a post-election environment characterized by change.

EXPECTING: ROBUST MACRA EDUCATIONAL EFFORTS When it comes to MACRA—the landmark law that repealed and replaced the sustainable growth rate (SGR) with new policies intended to promote quality-driven and valuebased payment in Medicare—CAPG supports implementation of the law beginning with reporting on Jan. 1, 2017. MACRA creates new incentives for the movement to risk-based coordinated care and a nationwide pay-for-performance program. MACRA pushes America’s physicians into the very models that many CAPG members have been practicing for decades.

So, what are our MACRA expectations for the new Congress and administration? We recognize that this law represents new terrain. While both parties have shown a strong commitment to the path it sets forth, the law and its implementing regulations are complex, with multiple moving parts. We expect that it will take time for new members of Congress and a new administration to get up to speed. To ensure the timely and successful implementation of the law amidst this time of transition, it will be critically 22 l CAPG HEALTH

Fall 2016

important for CAPG and its members to make our voices heard. We must commit to educating new lawmakers and regulators about the vast opportunity MACRA presents for creating a delivery system prepared to meet the challenges of an aging population for decades to come.

elections will be held within each chamber to fill Democrat and Republican congressional leadership offices, such as the Speaker of the House, Majority Leader, Minority Leader, and the Whip’s office. Barring extreme circumstance, the candidates elected to hold those positions will determine the legislative agenda for the next two years.

EXPECTING: A NEED FOR ROBUST ADVOCACY ON MEDICARE ADVANTAGE

A certain degree of turnover on House and Senate committees is customary in a new Congress. However, in 2017 several retirements and term limits will have an added impact on committee leadership. Rising chairs and ranking members on both sides of the aisle will bring with them new interests and priorities related to healthcare and could go on to hold their posts well into the foreseeable future.

CAPG maintains its strong commitment to the Medicare Advantage (MA) program. MA offers physician groups unique opportunities, facilitating payment in ways that promote coordinated and high-quality care for the populations they serve through risk-based contracting.

MA payment rates are set through an annual process.

Payments made to Medicare Advantage plans by the Centers for Medicare & Medicaid Services (CMS) have a direct impact on the physician payments established through downstream contracts. In the past several years, the CMS has proposed to cut payments to the MA program, limiting investment in the types of arrangements described above that support coordinated care. CAPG has successfully pushed back against these proposals to protect payments that support innovative care models. In 2017, the draft rate notice that determines MA payment is expected to be released in February and finalized in April— at the very start of the new administration and Congress.

What can we expect for Medicare Advantage rates? The answer largely depends on the political party in charge.

Historically, MA had been considered a partisan issue, a symptom of the program’s origin during the Bush Administration. Over time this has changed and support for MA has steadily increased on both sides of the aisle.

Notably, last year a veto-proof majority of more than 400 members of Congress registered their support of the program; approximately two-thirds were Republicans and one-third Democrats. Looking forward to 2017, one thing remains clear: to build on this progress, there will be a persistent need to continue explaining the connection between payments to MA plans and the direct impact of payment changes on downstream physician organizations.

For this reason, it is important, too, for physicians who rely on MA to establish their support for the program within their communities and with their elected representatives both early and often in the beginning of the new year.

EXPECTING: AN OPPORTUNITY TO LEAD Several other elements at play have the potential to impact how Congress in particular may prioritize healthcare related issues, including implementation of MACRA and treatment of MA. Both the House and Senate are statutorily required to gavel in on January 3. Members of the 115th Congress will be sworn into office at that time and, shortly thereafter,

As one example, the GOP imposes term limits on its party’s chair and ranking members in the U.S. House of Representatives. The rule requires that members relinquish the gavel after three consecutive Congresses or six consecutive years. Because of this rule, Fred Upton (RMI), current chair of the House Energy and Commerce Committee with jurisdiction over healthcare, will step down from his seat at the end of the 114th Congress. Chairman Upton’s personal interest in healthcare, particularly related to his 21st Century Cures initiative, has driven much of the committee’s agenda over his tenure. His successor will likewise seek to advance his or her own priorities through the committee, and influence the policies taken up by Congress as a result.

These additional transitions are significant environmental factors to be aware of. They will play out at a critical juncture for our industry—while MACRA is implemented and Medicare Advantage rates are negotiated. As new congressional leaders emerge, our industry must become attuned to their new perspectives, which will drive the national agenda, and continue to communicate the value of our vision for a transformed delivery system.

We expect that these changes will present a unique opportunity for CAPG to lead the healthcare industry into new models of care, a new delivery system, and new riskbased coordinated care opportunities.

OUR COMMITMENT TO YOU CAPG’s mission is to expand access to high quality, riskbased, and coordinated care throughout the nation. While significant progress has been made on this front, much more remains to be done. In any time of transition it is natural for long-term institutional goals to recalibrate. As we approach the beginning of 2017, your federal affairs team will continue to identify new opportunities to engage in education, advocacy, and leadership with lawmakers and regulators new and old. It’s an exciting time to be a CAPG member as the nation finds its way toward a new model of healthcare. We look forward to the work ahead. o Fall 2016

CAPG HEALTH l 23

NEW DATA: IMBRUVICA® EXTENDED OVERALL SURVIVAL VS CHLORAMBUCIL IN FRONTLINE CLL/SLL

MAKE IMBRUVICA® YOUR FIRST STEP No chemotherapy required

CLL SLL

IMBRUVICA® is a once-daily oral therapy indicated for • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)1 • CLL/SLL with 17p deletion1

IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.

The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.

Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy.

Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately.

Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 9%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly.

Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies - Other malignancies (range, 5% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4% to 13%).

Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

RESONATETM-2 was a multicenter, randomized 1:1, open-label, Phase 3 trial of IMBRUVICA® vs chlorambucil (N=269) in frontline CLL/SLL patients ≥65 years1

PROLONGED PROGRESSION-FREE SURVIVAL

EXTENDED OVERALL SURVIVAL IMBRUVICA® significantly extended overall survival vs chlorambucil

IMBRUVICA® significantly extended PFS vs chlorambucil

Statistically significant reduction in risk of death1

56% HR=0.44 (95% CI: 0.21, 0.92)

41%

of patients crossed over to IMBRUVICA® Estimated survival rates at 24 months

95% IMBRUVICA® (95% CI: 89, 97)

84% chlorambucil

PRIMARY ENDPOINT: PROGRESSION-FREE SURVIVAL (PFS)

(95% CI: 77, 90)

• Median follow-up was 18 months2

SECONDARY ENDPOINT: OVERALL SURVIVAL (OS)

• IMBRUVICA® median PFS not reached1 • Chlorambucil median PFS was 18.9 months (95% CI: 14.1, 22.0)1

• Median follow-up was 28 months1

• PFS was assessed by an Independent Review Committee (IRC) per revised International Workshop on CLL (IWCLL) criteria1

Adverse reactions ≥20% across CLL/SLL registration studies1 • • • •

Neutropenia Thrombocytopenia Anemia Diarrhea

• • • •

Musculoskeletal pain Nausea Rash Bruising

Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, and WM) were neutropenia* (64%), thrombocytopenia* (63%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (29%), nausea (29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia (21%). *Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).

The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%).

Approximately 6% (CLL/SLL), 14% (MCL), and 11% (WM) of patients had a dose reduction due to adverse reactions.

Approximately 4%-10% (CLL/SLL), 9% (MCL), and 6% (WM) of patients discontinued

To learn more, visit

IMBRUVICAHCP.com © Pharmacyclics LLC 2016 © Janssen Biotech, Inc. 2016 08/16 PRC-02111

• Fatigue • Pyrexia • Hemorrhage

due to adverse reactions. Most frequent adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.

CYP3A Inducers - Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.

Please see the Brief Summary on the following pages.

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC 2016.

2. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425-2437.

Brief Summary of Prescribing Information for IMBRUVICA® (ibrutinib) IMBRUVICA® (ibrutinib) capsules, for oral use See package insert for Full Prescribing Information INDICATIONS AND USAGE Mantle Cell Lymphoma: IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials [see Clinical Studies (14.1) in Full Prescribing Information].

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) [see Clinical Studies (14.2) in Full Prescribing Information].

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion: IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion [see Clinical Studies (14.2) in Full Prescribing Information].

Waldenström’s Macroglobulinemia: IMBRUVICA is indicated for the treatment of patients with Waldenström’s macroglobulinemia (WM) [see Clinical Studies (14.3) in Full Prescribing Information].

CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in up to 6% of patients.

Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA. The mechanism for the bleeding events is not well understood.

IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding [see Clinical Studies (14) in Full Prescribing Information].

Infections: Fatal and non-fatal infections have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 29% of patients [see Adverse Reactions]. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA. Evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA. Monitor complete blood counts monthly.

Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed.

Atrial fibrillation should be managed appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines [see Dosage and Administration (2.3) in Full Prescribing Information].

Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA. Adjust existing anti-hypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (range, 5 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4 to 13%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Administration of ibrutinib to pregnant rats and rabbits during the period of organogenesis caused embryofetal toxicity including malformations at exposures that were 2-20 times higher than those reported in patients with MCL, CLL/SLL or WM. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations].

IMBRUVICA® (ibrutinib) capsules ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions] • Infections [see Warnings and Precautions] • Cytopenias [see Warnings and Precautions] • Atrial Fibrillation [see Warnings and Precautions] • Hypertension [see Warnings and Precautions] • Second Primary Malignancies [see Warnings and Precautions] • Tumor Lysis Syndrome [see Warnings and Precautions] Clinical Trials Experience: Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.

Mantle Cell Lymphoma: The data described below reflect exposure to IMBRUVICA in a clinical trial that included 111 patients with previously treated MCL treated with 560 mg daily with a median treatment duration of 8.3 months.

The most commonly occurring adverse reactions (≥ 20%) were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting and decreased appetite (see Tables 1 and 2).

The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) were pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue, and skin infections.

Fatal and serious cases of renal failure have occurred with IMBRUVICA therapy. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 9% of patients.

Adverse reactions from the MCL trial (N=111) using single agent IMBRUVICA 560 mg daily occurring at a rate of ≥ 10% are presented in Table 1.

Table 1: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with MCL (N=111) All Grades Grade 3 or 4 Body System Adverse Reaction (%) (%) 5 51 Gastrointestinal Diarrhea 0 31 disorders Nausea 0 25 Constipation 5 24 Abdominal pain 0 23 Vomiting 1 17 Stomatitis 0 11 Dyspepsia Infections and Upper respiratory tract 0 34 infestations infection 3 14 Urinary tract infection 7 14 Pneumonia 5 14 Skin infections 1 13 Sinusitis 5 41 General disorders and Fatigue 3 35 administration site Peripheral edema 1 18 conditions Pyrexia 3 14 Asthenia 0 30 Bruising Skin and 3 25 subcutaneous tissue Rash 0 11 Petechiae disorders Musculoskeletal and Musculoskeletal pain 37 1 connective tissue Muscle spasms 14 0 disorders Arthralgia 11 0 4 27 Respiratory, thoracic Dyspnea 0 19 Cough and mediastinal 0 11 Epistaxis disorders Metabolism and Decreased appetite 21 2 nutrition disorders Dehydration 12 4 Nervous system Dizziness 14 0 disorders Headache 13 0 Table 2: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Patients with MCL (N=111) Percent of Patients (N=111) All Grades Grade 3 or 4 (%) (%) Platelets Decreased 57 17 Neutrophils Decreased 47 29 Hemoglobin Decreased 41 9 * Based on laboratory measurements and adverse reactions

IMBRUVICA® (ibrutinib) capsules

IMBRUVICA® (ibrutinib) capsules

Ten patients (9%) discontinued treatment due to adverse reactions in the trial (N=111). The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred in 14% of patients.

Patients with MCL who develop lymphocytosis greater than 400,000/mcL have developed intracranial hemorrhage, lethargy, gait instability, and headache.

However, some of these cases were in the setting of disease progression.

Forty percent of patients had elevated uric acid levels on study including 13% with values above 10 mg/dL. Adverse reaction of hyperuricemia was reported for 15% of patients.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: The data described below reflect exposure in one single-arm, open-label clinical trial and three randomized controlled clinical trials in patients with CLL/ SLL (n=1278 total and n=668 patients exposed to IMBRUVICA). Study 1 included 51 patients with previously treated CLL/SLL, Study 2 included 391 randomized patients with previously treated CLL or SLL who received single agent IMBRUVICA or ofatumumab, Study 3 included 269 randomized patients 65 years or older with treatment naïve-CLL or SLL who received single agent IMBRUVICA or chlorambucil and Study 4 included 578 randomized patients with previously treated CLL or SLL who received IMBRUVICA in combination with bendamustine and rituximab or placebo in combination with bendamustine and rituximab.

The most commonly occurring adverse reactions in Studies 1, 2, 3 and 4 in patients with CLL/SLL receiving IMBRUVICA (≥ 20%) were neutropenia, thrombocytopenia, anemia, diarrhea, musculoskeletal pain, nausea, rash, bruising, fatigue, pyrexia and hemorrhage. Four to 10 percent of patients receiving IMBRUVICA in Studies 1, 2, 3 and 4 discontinued treatment due to adverse reactions. These included pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each). Adverse reactions leading to dose reduction occurred in approximately 6% of patients.

Study 1: Adverse reactions and laboratory abnormalities from the CLL/SLL trial (N=51) using single agent IMBRUVICA 420 mg daily in patients with previously treated CLL/SLL occurring at a rate of ≥ 10% with a median duration of treatment of 15.6 months are presented in Tables 3 and 4.

Table 3: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with CLL/SLL (N=51) in Study 1 Body System Gastrointestinal disorders

Infections and infestations

General disorders and administration site conditions Skin and subcutaneous tissue disorders Respiratory, thoracic and mediastinal disorders Musculoskeletal and connective tissue disorders Nervous system disorders Metabolism and nutrition disorders Neoplasms benign, malignant, unspecified Vascular disorders

Adverse Reaction Diarrhea Constipation Nausea Stomatitis Vomiting Abdominal pain Dyspepsia Upper respiratory tract infection Sinusitis Skin infection Pneumonia Urinary tract infection Fatigue Pyrexia Peripheral edema Asthenia Chills Bruising Rash Petechiae Cough Oropharyngeal pain Dyspnea Musculoskeletal pain Arthralgia Muscle spasms Dizziness Headache Decreased appetite

All Grades Grade 3 or 4 (%) (%) 59 4 22 2 20 2 20 0 18 2 14 0 12 0 47 22 16 12 12 33 24 22 14 12 51 25 16 22 14 12 25 24 18 20 18 16

2 6 6 10 2 6 2 0 6 0 2 0 0 0 0 0 6 0 2 0 2 2

Second malignancies*

12*

0

Hypertension

16

8

* One patient death due to histiocytic sarcoma.

Table 4: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Patients with CLL/SLL (N=51) in Study 1 Percent of Patients (N=51) All Grades (%) Grade 3 or 4 (%) 69 12 53 26 43 0

Platelets Decreased Neutrophils Decreased Hemoglobin Decreased

* Based on laboratory measurements per IWCLL criteria and adverse reactions.

Study 2: Adverse reactions and laboratory abnormalities described below in Tables 5 and 6 reflect exposure to IMBRUVICA with a median duration of 8.6 months and exposure to ofatumumab with a median of 5.3 months in Study 2 in patients with previously treated CLL/SLL. Table 5: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm in Patients in Study 2

Body System Adverse Reaction Gastrointestinal disorders Diarrhea Nausea Stomatitis* Constipation Vomiting General disorders and administration site conditions Pyrexia Infections and infestations Upper respiratory tract infection Pneumonia* Sinusitis* Urinary tract infection Skin and subcutaneous tissue disorders Rash* Petechiae Bruising* Musculoskeletal and connective tissue disorders Musculoskeletal Pain* Arthralgia Nervous system disorders Headache Dizziness Injury, poisoning and procedural complications Contusion Eye disorders Vision blurred

IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%)

48 26 17 15 14

4 2 1 0 0

18 18 6 9 6

2 0 1 0 1

24

2

15

1

16

1

11

2

15 11 10

10 1 4

13 6 5

9 0 1

24 14 12

3 0 0

13 1 1

0 0 0

28

2

18

1

17

1

7

0

14 11

1 0

6 5

0 0

11

0

3

0

10

0

3

0

Subjects with multiple events for a given ADR term are counted once only for each ADR term.

The system organ class and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms

IMBRUVICA® (ibrutinib) capsules Table 6: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Study 2 IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Neutrophils Decreased 51 23 57 26 Platelets Decreased 52 5 45 10 Hemoglobin Decreased 36 0 21 0 * Based on laboratory measurements per IWCLL criteria.

Study 3: Adverse reactions described below in Table 7 reflect exposure to IMBRUVICA with a median duration of 17.4 months. The median exposure to chlorambucil was 7.1 months in Study 3.

Table 7: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm in Patients in Study 3 IMBRUVICA Chlorambucil (N=135) (N=132) All Grades Grade 3 or 4 All Grades Grade 3 or 4 Body System (%) (%) (%) (%) Adverse Reaction Gastrointestinal disorders Diarrhea 42 4 17 0 Stomatitis* 14 1 4 1 Musculoskeletal and connective tissue disorders Musculoskeletal pain* 36 4 20 0 Arthralgia 16 1 7 1 Muscle spasms 11 0 5 0 Eye Disorders Dry eye 17 0 5 0 Lacrimation increased 13 0 6 0 Vision blurred 13 0 8 0 Visual acuity reduced 11 0 2 0 Skin and subcutaneous tissue disorders Rash* 21 4 12 2 Bruising* 19 0 7 0 Infections and infestations Skin infection* 15 2 3 1 Pneumonia* 14 8 7 4 Urinary tract infections 10 1 8 1 Respiratory, thoracic and mediastinal disorders Cough 22 0 15 0 General disorders and administration site conditions Peripheral edema 19 1 9 0 Pyrexia 17 0 14 2 Vascular Disorders Hypertension* 14 4 1 0 Nervous System Disorders Headache 12 1 10 2 Subjects with multiple events for a given ADR term are counted once only for each ADR term.

The system organ class and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms Study 4: Adverse reactions described below in Table 8 reflect exposure to IMBRUVICA + BR with a median duration of 14.7 months and exposure to placebo + BR with a median of 12.8 months in Study 4 in patients with previously treated CLL/SLL.

IMBRUVICA® (ibrutinib) capsules Table 8: Adverse Reactions Reported in at Least 10% of Patients and at Least 2% Greater in the IMBRUVICA Arm in Patients in Study 4

Body System Adverse Reaction Blood and lymphatic system disorders Neutropenia* Thrombocytopenia* Skin and subcutaneous tissue disorders Rash* Bruising* Gastrointestinal disorders Diarrhea Abdominal Pain Musculoskeletal and connective tissue disorders Musculoskeletal pain* Muscle spasms General disorders and administration site conditions Pyrexia Vascular Disorders Hemorrhage* Hypertension* Infections and infestations Bronchitis Skin infection* Metabolism and nutrition disorders Hyperuricemia

Ibrutinib + BR Placebo + BR (N=287) (N=287) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%)

66 34

61 16

60 26

55 16

32 20

4 <1

25 8

1 <1

36 12

2 1

23 8

1 <1

29

2

20

0

12

<1

5

0

25

4

22

2

19 11

2 5

9 5

1 2

13 10

2 3

10 6

3 2

10

2

6

0

The system organ class and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms <1 used for frequency above 0 and below 0.5% Atrial fibrillation of any grade occurred in 7% of patients treated with IMBRUVICA + BR and 2% of patients treated with placebo + BR. The frequency of Grade 3 and 4 atrial fibrillation was 3% in patients treated with IMBRUVICA + BR and 1% in patients treated with placebo + BR. Waldenström’s Macroglobulinemia: The data described below reflect exposure to IMBRUVICA in an open-label clinical trial that included 63 patients with previously treated WM. The most commonly occurring adverse reactions in the WM trial (≥ 20%) were neutropenia, thrombocytopenia, diarrhea, rash, nausea, muscle spasms, and fatigue.

Six percent of patients receiving IMBRUVICA in the WM trial discontinued treatment due to adverse events. Adverse events leading to dose reduction occurred in 11% of patients.

Adverse reactions and laboratory abnormalities described below in Tables 9 and 10 reflect exposure to IMBRUVICA with a median duration of 11.7 months in the WM trial.

IMBRUVICA® (ibrutinib) capsules

IMBRUVICA® (ibrutinib) capsules

Table 9: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with Waldenström’s Macroglobulinemia (N=63) All Grades Grade 3 or 4 Body System Adverse Reaction (%) (%) Gastrointestinal disorders Diarrhea 37 0 Nausea 21 0 Stomatitis* 16 0 Gastroesophageal 13 0 reflux disease Skin and subcutaneous Rash* 22 0 tissue disorders Bruising* 16 0 Pruritus 11 0 General disorders and Fatigue 21 0 administrative site conditions Musculoskeletal and Muscle spasms 21 0 connective tissue Arthropathy 13 0 disorders Infections and infestations Upper respiratory tract infection 19 0 Sinusitis 19 0 Pneumonia* 14 6 Skin infection* 14 2 Respiratory, thoracic and Epistaxis 19 0 mediastinal disorders Cough 13 0 Nervous system disorders Dizziness 14 0 Headache 13 0 Neoplasms benign, Skin cancer* 11 0 malignant, and unspecified (including cysts and polyps) The system organ class and individual ADR preferred terms are sorted in descending frequency order. * Includes multiple ADR terms.

dose AUC values of 1445 ± 869 ng • hr/mL which is approximately 50% greater than steady state exposures seen at the highest indicated dose (560 mg).

Avoid concomitant administration of IMBRUVICA with strong or moderate inhibitors of CYP3A. For strong CYP3A inhibitors used short-term (e.g., antifungals and antibiotics for 7 days or less, e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin) consider interrupting IMBRUVICA therapy during the duration of inhibitor use. Avoid strong CYP3A inhibitors that are needed chronically. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

Patients taking concomitant strong or moderate CYP3A4 inhibitors should be monitored more closely for signs of IMBRUVICA toxicity [see Dosage and Administration (2.4) in Full Prescribing Information].

Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A [see Dosage and Administration (2.4), and Clinical Pharmacology (12.3) in Full Prescribing Information].

CYP3A Inducers: Administration of IMBRUVICA with rifampin, a strong CYP3A inducer, decreased ibrutinib Cmax and AUC by approximately 13- and 10-fold, respectively.

Avoid concomitant use of strong CYP3A inducers (e.g., carbamazepine, rifampin, phenytoin, and St. John’s Wort). Consider alternative agents with less CYP3A induction [see Clinical Pharmacology (12.3) in Full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary: IMBRUVICA, a kinase inhibitor, can cause fetal harm based on findings from animal studies. In animal reproduction studies, administration of ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 2-20 times the clinical doses of 420-560 mg daily produced embryofetal toxicity including malformations [see Data]. If IMBRUVICA is used during pregnancy or if the patient becomes pregnant while taking IMBRUVICA, the patient should be apprised of the potential hazard to the fetus.

The estimated background risk of major birth defects and 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.

Animal Data: Ibrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 10, 40 and 80 mg/kg/day. Ibrutinib at a dose of 80 mg/kg/day was associated with visceral malformations (heart and major vessels) and increased resorptions and post-implantation loss. The dose of 80 mg/kg/day in rats is approximately 14 times the exposure (AUC) in patients with MCL and 20 times the exposure in patients with CLL/SLL or WM administered the dose of 560 mg daily and 420 mg daily, respectively. Ibrutinib at doses of 40 mg/kg/day or greater was associated with decreased fetal weights. The dose of 40 mg/kg/day in rats is approximately 6 times the exposure (AUC) in patients with MCL administered the dose of 560 mg daily.

Ibrutinib was also administered orally to pregnant rabbits during the period of organogenesis at doses of 5, 15, and 45 mg/kg/day. Ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal variations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased resorptions and post-implantation loss. The dose of 15 mg/kg/day in rabbits is approximately 2.0 times the exposure (AUC) in patients with MCL and 2.8 times the exposure in patients with CLL/SLL or WM administered the dose of 560 and 420 mg daily, respectively.

Lactation: Risk Summary: There is no information regarding the presence of ibrutinib or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for IMBRUVICA and any potential adverse effects on the breastfed child from IMBRUVICA or from the underlying maternal condition.

Females and Males of Reproductive Potential: Pregnancy Testing: Verify the pregnancy status of females of reproductive potential prior to initiating IMBRUVICA therapy.

Contraception: Females: Advise females of reproductive potential to avoid pregnancy while taking IMBRUVICA and for up to 1 month after ending treatment. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

Males: Advise men to avoid fathering a child while receiving IMBRUVICA, and for 1 month following the last dose of IMBRUVICA. Pediatric Use: The safety and effectiveness of IMBRUVICA in pediatric patients has not been established.

Geriatric Use: Of the 839 patients in clinical studies of IMBRUVICA, 62% were ≥ 65 years of age, while 21% were ≥75 years of age. No overall differences in effectiveness were observed between younger and older patients. Grade 3 or higher pneumonia occurred more frequently among older patients treated with IMBRUVICA [see Clinical Studies (14.2) in Full Prescribing Information].

Table 10: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Patients with WM (N=63) Percent of Patients (N=63) All Grades (%) Grade 3 or 4 (%) Platelets Decreased 43 13 Neutrophils Decreased 44 19 Hemoglobin Decreased 13 8 * Based on laboratory measurements.

Additional Important Adverse Reactions: Diarrhea: Diarrhea of any grade occurred at a rate of 43% (range, 36% to 63%) of patients treated with IMBRUVICA. Grade 2 diarrhea occurred in 9% (range, 3% to 15%) and Grade 3 in 3% (range, 0 to 5%) of patients treated with IMBRUVICA. The median time to first onset of any grade diarrhea was 12 days (range, 0 to 627), of Grade 2 was 37 days (range, 1 to 667) and of Grade 3 was 71 days (range, 3 to 627). Of the patients who reported diarrhea, 83% had complete resolution, 1% had partial improvement and 16% had no reported improvement at time of analysis. The median time from onset to resolution or improvement of any grade diarrhea was 5 days (range, 1 to 418), and was similar for Grades 2 and 3. Less than 1% of patients discontinued IMBRUVICA due to diarrhea.

Visual Disturbance: Blurred vision and decreased visual acuity of any grade occurred in 10% of patients treated with IMBRUVICA (9% Grade 1, 2% Grade 2). The median time to first onset was 88 days (range, 1 to 414 days).

Of the patients with visual disturbance, 64% had complete resolution and 36% had no reported improvement at time of analysis. The median time from onset to resolution or improvement was 29 days (range, 1 to 281 days).

Postmarketing Experience: The following adverse reactions have been identified during post-approval use of IMBRUVICA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary disorders: hepatic failure (includes multiple terms) Respiratory disorders: interstitial lung disease (includes multiple terms) Metabolic and nutrition disorders: tumor lysis syndrome [see Warnings & Precautions] Skin and subcutaneous tissue disorders: anaphylactic shock, angioedema, urticaria DRUG INTERACTIONS CYP3A Inhibitors: Ibrutinib is primarily metabolized by cytochrome P450 enzyme 3A (CYP3A). In healthy volunteers, co-administration of ketoconazole, a strong CYP3A inhibitor, increased Cmax and AUC of ibrutinib by 29- and 24-fold, respectively. The highest ibrutinib dose evaluated in clinical trials was 12.5 mg/kg (actual doses of 840 – 1400 mg) given for 28 days with single

IMBRUVICA® (ibrutinib) capsules Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in ibrutinib exposure. Following single dose administration, the AUC of ibrutinib increased 2.7-, 8.2- and 9.8-fold in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment compared to subjects with normal liver function.

The safety of IMBRUVICA has not been evaluated in cancer patients with mild to severe hepatic impairment by Child-Pugh criteria.

Monitor patients for signs of IMBRUVICA toxicity and follow dose modification guidance as needed. It is not recommended to administer IMBRUVICA to patients with moderate or severe hepatic impairment (ChildPugh class B and C) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) in Full Prescribing Information].

Plasmapheresis: Management of hyperviscosity in WM patients may include plasmapheresis before and during treatment with IMBRUVICA. Modifications to IMBRUVICA dosing are not required.

PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).

• Hemorrhage: Inform patients of the possibility of bleeding, and to report any signs or symptoms (severe headache, blood in stools or urine, prolonged or uncontrolled bleeding). Inform the patient that IMBRUVICA may need to be interrupted for medical or dental procedures [see Warnings and Precautions].

• Infections: Inform patients of the possibility of serious infection, and to report any signs or symptoms (fever, chills, weakness, confusion) suggestive of infection [see Warnings and Precautions].

• Atrial fibrillation: Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort [see Warnings and Precautions].

• Hypertension: Inform patients that high blood pressure has occurred in patients taking IMBRUVICA, which may require treatment with antihypertensive therapy [see Warnings and Precautions].

• Second primary malignancies: Inform patients that other malignancies have occurred in patients who have been treated with IMBRUVICA, including skin cancers and other carcinomas [see Warnings and Precautions].

• Tumor lysis syndrome: Inform patients of the potential risk of tumor lysis syndrome and report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions].

• Embryo-fetal toxicity: Advise women of the potential hazard to a fetus and to avoid becoming pregnant during treatment and for 1 month after the last dose of IMBRUVICA [see Warnings and Precautions].

• Inform patients to take IMBRUVICA orally once daily according to their physician’s instructions and that the capsules should be swallowed whole with a glass of water without being opened, broken, or chewed at approximately the same time each day [see Dosage and Administration (2.1) in Full Prescribing Information].

• Advise patients that in the event of a missed daily dose of IMBRUVICA, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Patients should not take extra capsules to make up the missed dose [see Dosage and Administration (2.6) in Full Prescribing Information].

• Advise patients of the common side effects associated with IMBRUVICA [see Adverse Reactions]. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Advise patients to inform their health care providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions].

• Advise patients that they may experience loose stools or diarrhea, and should contact their doctor if their diarrhea persists. Advise patients to maintain adequate hydration.

Active ingredient made in China.

Distributed and Marketed by: Pharmacyclics LLC Sunnyvale, CA USA 94085 and Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044 Patent http://www.imbruvica.com IMBRUVICA® is a registered trademark owned by Pharmacyclics LLC © Pharmacyclics LLC 2016 © Janssen Biotech, Inc. 2016 PRC-02066

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RESERVE YOUR SPACE IN CAPG HEALTH 2017 SPRING 2017 Quality-Infused Fee-for-Service or New Payment Models: Which Way to Go? Editorial and advertising due Friday, December 16, 2016

SUMMER 2017 / ANNUAL CONFERENCE ISSUE Organizational Quality Editorial and advertising due Friday, April 28, 2017

FALL 2017 / CAPG COLLOQUIUM ISSUE Homebound Health Editorial and advertising due Friday, September 1, 2017

30% DISCOUNTS FOR ANNUAL CONTRACTS. SPECIAL DISCOUNTS FOR CAPG MEMBERS. For editorial guidelines contact Daryn Kobata capghealth@capg.org Editorial Departments: Upcoming Events | Names in the News | Member Spotlight For Advertising Information : capghealth@ gmail.com Valerie Okunami, Publisher 916-761-1853

CAPG Member Spotlight MHMD Clinical Programs Committee Serves as System-Wide Quality Engine MHMD, the Memorial Hermann Physician Network, is a clinically integrated physician organization comprising almost 4,000 physician members, representing employed, independent, and University of Texas Health faculty physicians. MHMD physicians participate in the design and development of evidence-based medicine offered at Memorial Hermann Health System facilities located across the Houston area.

Chris Lloyd

“Several years ago, this organization made significant strides with physicians by implementing a ‘compact,’ which outlined the commitment of physicians and MHMD leadership to each other,” said Chris Lloyd, Sr. Vice President and CEO, MHMD. “We use the compact to guide us and make sure we are following through on our commitment to our physicians in everything we do.”

One of the commitments by the physicians is to attend meetings and feedback sessions and to share ideas while collaborating with colleagues and hospitals.

One way they are able to contribute is by participating in the Clinical Programs Committee (CPC) structure, which has functioned as the clinical arm of MHMD.

Charlotte Alexander, MD

With physician representation from all Memorial Hermann hospitals, the CPC partners with Memorial Hermann Health System, aligning the quality and safety programs of the health system and the physician organization. Under the CPC umbrella, there are now more than 50 specialty subcommittees and task forces with more than 450 affiliated physicians, nurses, pharmacists, care managers, and administrators, representing each of the hospitals within Memorial Hermann. Each subcommittee supports the Memorial Hermann vision of advancing the health of our community by implementing evidencebased measures and metrics related to managing the health of populations.

continued on next page Fall 2016

CAPG HEALTH l 31

CLINICAL INTEGRATION

Physician Compact A COMPACT BETWEEN MHMD AND ITS PHYSICIAN MEMBERS With Clinical Integration, MHMD has introduced a new model of providing care to the Greater Houston community – an interdependent network of physicians that collaborate with each other and the Memorial Hermann Healthcare System to provide better quality, highly efficient, more cost-effective care. The Clinical Integration model demands physician accountability, technology infrastructure, and substantial investment of time and resources by both MHMD and its physicians.

Clinical Integration thus enables the delivery of better care by its physicians, leading to collective negotiating with health plans for contracts that return enhanced value to MHMD physicians. The compact that follows identifies a reciprocal set of commitments and accountabilities between MHMD’s elected leaders and the physician members. It is designed to support the organization and its members to achieve the MHMD strategic vision and build capacity to respond effectively to future challenges and opportunities.

Compact Attributes

1PROVIDE EVIDENCE-BASED CLINICAL CARE / GOVERNANCE

4 DEMONSTRATE COMPASSION AND RESPECT

Physicians: provide evidence-based clinical care

Physicians: demonstrate compassion and respect

• • • •

• To better understand experience and perspectives of patients, other physicians and healthcare professionals and MHMD • To resolve any conflict that may arise in a collegial, effective manner • To follow the MHMD professional code of conduct in all relationships with physicians, nurses, personnel and patients

Practice according to current evidence and best practices Participate in robust, clinical educational programs and peer reviews Achieve and maintain competency and board certification Meet mutually agreed upon regulatory, quality, re-credentialing and safety goals

MHMD: provide excellent governance • Abide by all tenets of Physician’s Commitment in this compact • Maintain primary loyalty to the member physicians, nurture their success, and act consistently in their best interests including in their relationships with the hospital system • Apply current knowledge and relevant best-practices to guide contract negotiations and bonus compensation models in a way that is both equitable and aligns economic incentives to improve care • Support physicians to become knowledgeable about the issues and trends that will affect our success • Ensure effective mechanisms are in place to foster physician involvement in the organization’s work and in decisions that affect them and MHMD’s success.

2 BE TRANSPARENT Physicians: be transparent • Share with MHMD quality data from my practice on a timely basis • Disclose interests in entities or activities potentially detrimental to the mission, vision, and/or goals of MHMD

MHMD: be transparent • Use a transparent, criteria-based, fair-process approach for making decisions likely to have significant impact on physician practice and MHMD’s success as a physician organization • Provide timely and clear information regarding all MHMD membership criteria • Provide timely and clear information regarding all quality performance measures • Provide timely and clear information regarding all agreed upon benchmarks and scoring criteria • Provide timely and clear information regarding remediation requirements and procedures • Provide timely and clear information regarding the status of contract negotiations with health plans, all resulting contract terms, conditions, requirements, fee schedules and pay for performance distribution methodology • Provide timely and clear information regarding MHMD’s budget and financial performance.

3 COLLABORATE Physicians: collaborate • With physician colleagues and other caregivers to enhance the value of our care • With MHMD elected leaders by seeking communication, engaging in decisions and aligning behavior with commitments made by MHMD on their behalf • With our hospitals to improve the safety and efficiency of patient care • With health plans to improve care and align economic incentives • With patients and our community to improve health

MHMD: collaborate • With physicians to provide up-to-date clinical information, education and decision support that will facilitate the implementation of evidence-based medicine in their practices • With physicians by providing timely reports regarding their performance on agreed upon quality and efficiency programs • With physicians to help them achieve quality and efficiency goals • With physicians by providing services that ease the administrative burden of practice and address their practice needs • With physicians by providing education and support to help them meet regulatory, quality and safety requirements

32 l CAPG HEALTH

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MHMD: demonstrate compassion and respect • Create clinical programs that support physicians in all practice settings • Seek to understand and consider how the organization’s decisions will impact on the practice and professional satisfaction of our physician members • Advocate consistently for physicians in ways that advance the needs and enhance the success of all parties.

5 BE ACCOUNTABLE Physicians: be accountable • To integrate feedback to improve performance • To achieve agreed upon quality and efficiency standards, thus promoting the health of the entire Houston community • To assist colleagues to improve clinical performance

MHMD: be accountable • Seek feedback from physicians regarding how well the board is meeting its obligations as outlined in this compact • Provide effective practice management tools to ease the administrative burden of both clinical practice and MHMD’s quality performance measures • Maintain the confidentiality and security of the quality improvement data obtained from physician practices • Maintain the confidentiality and security of fee information and billing data obtained from physician’s practices • Provide timely and accurate performance feedback.

6 MAINTAIN PROFESSIONALISM Physicians: function as a member of the MHMD team • Participate in clinical committees and leadership development • Attend and participate in appropriate meetings • Accept that nonparticipation in these meetings means forfeiture of direct influence on decisions and acceptance of those decisions made by MHMD physician peers

MHMD: foster a team spirit • Implement approaches to communication likely to engage individual and small groups of doctors, including enabling meeting attendance by electronic means • Ensure physician meetings are well planned and worthwhile expenditures of physician time • Ensure that new members of MHMD receive a robust orientation program regarding our mission, vision, goals and compact • Create leadership training programs for physicians desiring professional growth to enhance the MHMD vision

7SUPPORT INNOVATION Physicians: support innovation • • • • • •

Evaluate and implement evidence-based emerging technology including “cyber connectivity” Adapt to more effective ways of practicing medicine Exhibit creativity in seeking innovative solutions and new opportunities Share best practices with the organization Maintain openness and adaptability to change Participate in new studies and protocols

MHMD: support innovation • Set an “innovation agenda” to seek, import and foster the adoption of relevant best practice innovations from within and outside our organization • Nurture our relationship with The University of Texas Health Science Center at Houston (UTHealth) Medical School to help physicians stay current with leading practice and technology and to enable MHMD physicians to participate in clinical trials led by UTHealth • Encourage and support MHMD physicians in the evaluation and implementation of evidence-based emerging technology including “cyber connectivity” • Encourage and support MHMD physicians in adapting to more effective ways of practicing medicine

continued from page 31

The Clinical Programs Committee is delegated by the health system to direct the system-wide quality engine and does so by involvement in the six “Ps”: • Protocols—Creating and measuring evidence-based medicine practices and order set templates • Performance—Setting and monitoring progress against established quality standards and protocols • Products—Driving the standardization of vendors, formularies, supply chain decisions • Payment—Setting and reviewing pay for performance goals, co-management agreements, accountable care organization (ACO) project metrics, and patientcentered medical home (PCMH) elements • Projects—Including developing an emergency department to emergency department (ED to ED) transfer policy, setting criteria for computerized tomography (CT) head scans in pediatric head trauma, creating standardized order sets for use in in observation units, and standardizing credentialing and privileging requirements throughout the system • Program Rationalization—Consolidating and concentrating clinical service delivery “Providing the CPCs with the authority to lead change in the quality of care engaged physicians in the process because they could see their input was valued,” said Lloyd.

Accomplishments of the various CPC committees in 2015 include: • Development of a compassionate extubation policy that focuses on consistently making the withdrawal of mechanical ventilation at the end of life as comfortable and peaceful as possible, for patients and families alike • Standardization of perioperative glucose management to proactively manage glucose levels for optimal patient outcomes • Implementation of protocols to enhance patient safety where the pain scale overlaps, preventing any pain medication duplication • Proposed development of a consistent perioperative clinic process to be offered at all hospitals in order to improve clinical outcomes, decrease resource utilization, and provide greater patient-centered continuity of care throughout preoperative, intraoperative, and postoperative periods

• Adding duration to inpatient antibiotic orders to avoid unnecessary risk of antibiotic resistance • Limiting admission orders by ED physicians to those required for safe patient transport only • Standardization of the peer review process and changing its focus to performance improvement rather than corrective action • Proposing standardization of intensive care unit physician staffing requirements Further, the committees and task forces are now addressing many multidisciplinary issues such as postacute care transitions and services, enhancements in information technology, detection and management of sepsis, and prevention of deep vein thrombosis.

As healthcare moves into population health management, accountable care, and risk-based contracting, the CPC role is broadening further as the various committees proactively formulate performance improvement projects and work with employers and payers to make healthcare better, less costly, and more accessible to all. Committee members, together with nearly 2,000 of their colleagues, constitute the physician component of the Memorial Hermann ACO. The actions of the CPC committees are submitted to the System Quality committee and are shared with the Medical Executive Committee at each hospital for their approval and implementation. Not only has this structure provided physicians with the authority they need to direct the quality of care provided to patients, but it also has improved the patient’s experience.

The consequence for the physicians is that they now see themselves as part of a large system doing things to truly improve health in ways that could never be accomplished without such collaboration. “Our doctors from all of our medical staffs throughout the Houston area now know, respect, share ideas with, and learn from each other,” said Charlotte Alexander, MD, MHMD President and Board Chair. “The work of these committees has contributed to the quality care provided to patients of Memorial Hermann and has resulted in unprecedented success in the Medicare Shared Savings Program, as well as many other areas.”

In its first three years of participation in the Medicare Shared Savings Program, the Memorial Hermann ACO saved more than $200 million in the cost of care. The Clinical Programs Committee continues to partner with Memorial Hermann, aligning quality and safety programs of the system and the physician organization while preparing for the future of the healthcare industry. o

Fall 2016

CAPG HEALTH l 33

ORGANIZATIONAL MEMBERS Accountable Health Care IPA George M. Jayatilaka, MD, CEO Druvi Jayatilaka, Vice President

M E M B E R S

Advanced Medical Management, Inc.

Kathy Hegstrom, President Access Medical Group/Access Senior Health Care • California IPA • Community Care IPA • Future Care IPA • MediChoice IPA • Premier Care IPA • Seoul Medical Group

Adventist Health Physicians Network IPA Arby Nahapetian, MD, CMO Jim Agronick, VP, IPA Operations

John M. Williams, PharmD, CEO Polly Chen, Director of Operations

Choice Medical Group

Manmohan Nayyar, MD, President Marie Langley, IPA Administrator

Cigna Medical Group

Edward Kim, President and General Manager Kevin Ellis, DO, CMO

Citrus Valley Independent Physicians

Gurjeet Kalkat, MD, Executive Medical Director Martin Kleinbart, DPM, Chief Strategy Officer

Colorado Permanente Medical Group, P.C.

Richard Sankary, MD, President Scott Ptacnik, COO

Margaret Ferguson, MD, President and Exec. Medical Director Dan A. Oberg, CFO and VP Corporate Development

Alameda Health Partners

Conifer Health Solutions

Affinity Medical Group

William Peruzzi, MD, Chairman David Cox, Treasurer/CFO

AllCare IPA*

Matt Coury, CEO Randy Winter, MD, President

Allied Physicians of California Thomas Lam, MD, CEO Kenneth Sim, MD, CFO

Allina Health System

Rod Christensen, MD, VP of Medical Operations Brian Rice, MD, VP Network/ACO Integration

AltaMed Health Services Corporation* Castulo de la Rocha, JD, President and CEO Martin Serota, MD, CMO

• Greater Covina Medical Group • HealthCare Partners, IPA, AZ and NY • Heritage Physician Network • Heritage Victor Valley Medical Group • High Desert Medical Group • Lakeside Community Healthcare • Lakeside Medical Group • Regal Medical Group • Sierra Medical Group

High Desert Medical Group

Charles Lim, MD, FACP, Medical Director Anthony Dulgeroff, MD, Assistant Medical Director

Hill Physicians Medical Group, Inc.* David Joyner, CEO Amir Sweha, MD, CMO

Iora Health, Inc.

Rushika Fernandopulle, CEO Dave Fielding, CFO

John Muir Physician Network Lee Huskins, President and CAO Ravi Hundal, MD, CFO

Megan North, CEO AltaMed Health Services • Exceptional Care Medical Group • Family Choice Medical Group • Family Health Alliance • Mid Cities IPA • OmniCare Medical Group • Premier Care of Northern California • Saint Agnes Medical Group

Lakeside Community Healthcare

Continucare Corporation

Jean Shahdadpuri, MD, MBA, CMO Varsha Desai, COO

Alfredo Ginory, MD, CMO Gemma Rosello, VP

DaVita HealthCare Partners*

Don Rebhun, MD, National Medical Director Jim Rechtin, SVP Corporate Strategy ABQ Health Partners, Division of DaVita HealthCare Partners • Colorado Springs Health Partners • HealthCare Partners • HealthCare Partners Nevada • HealthCare Partners South Florida • JSA Medical Group, Division of DaVita HealthCare Partners • The Everett Clinic

Jonathan Gluck, Counsel

Lakeside Medical Group, Inc. Lakewood IPA

Alamitos IPA • St. Mary IPA • Brookshire IPA

Leon Medical Centers, Inc.

Rafael Mas, MD, SVP and CMO Julio G. Rebull, Jr., SVP

Loma Linda University Health Care

J. Todd Martell, MD, MBA, Medical Director

Maverick Medical Group

Warren Hosseinion, MD, Chairman Mark C. Marten, CEO

Angel Medical Group Michael Gitter, MD, President

Desert Oasis Healthcare

Carl Westerhoff, EVP

Marc Hoffing, MD, Medical Director Dan Frank, COO

AppleCare Medical Group, Inc.*

Dignity Health Foundation

Bruce Swartz, SVP, Physician Integration

Lynn Stratton Haas, CEO Gary Proffett, MD, Medical Director SeaView IPA • Valley Care IPA

Edinger Medical Group

MedPoint Management

George Christides, MD, CMO Trish Baesemann, President

Austin Regional Clinic

Norman Chenven, MD, CEO and Founder Kerry Rosker, Executive Administrative Coordinator

Bakersfield Family Medical Center Carol L. Sorrell, RN, COO Ju Hwan Lee, MD, Medical Director

Bayhealth Physician Alliance, LLC

Evan W. Polansky, JD, Executive Director Joseph M. Parise, DO, Medical Director

Beaver Medical Group*

John Goodman, CEO Raymond Chan, MD, VP, Medical Administration and CMO

C A P G

Chinese Community Health Care Association

Brown & Toland Physicians* Richard Fish, CEO

California Pacific Physicians Medical Group, Inc. Dien V. Pham, MD, CEO Carol Houchins, Administrator

CareMore Medical Group

Sachin Jain, CEO Tom Tancredi, Dir. of Practice Operations

Catholic Health Initiatives*

Matthew C. Boone, MD, Executive Medical Director Denise McCourt, COO

Pedro Rodriguez, HMA Board Member Mark Hillard, President

Kimberly Carey, President Rick Powell, MD, CMO Accountable Health Care IPA • Bella Vista Medical Group IPA • Centinela Valley IPA • El Proyecto Del Barrio, Inc. • Global Care Medical Group IPA • HealthCare LA IPA • Jewish Home for the Aging IPA • Pioneer Provider Network, A Medical Group, Inc. • Premier Physicians Network • Prospect Medical Group, Inc. • Redwood Community Health Network • Watts Healthcare Corporation

Equality Health - Q Point

MemorialCare Medical Group*

Steven Dorfman, MD, President Yvonne Sonnenberg, Executive Director

Mark Schafer, MD, CEO Laurie Sicaeros, COO, VP of Physician Alignment

Everett Clinic, P.S., The*

Memorial Hermann Physician Network - MHMD

El Paso Integral Care, IPA Rafael Armendariz, DO Tony Martinez

Empire Physicians Medical Group*

Adrianne Wagner, Quality Improvement Consultant Manager Shashank Kalokhe, Associate Administrator of Value-Based Contracting and Coordinated Care

Christopher Lloyd, EVP and CEO Shawn Griffin, Chief Quality and Informatics Officer

Facey Medical Foundation*

Erik Davydov, MD, Medical Director

Randall Curnow, MD, President Michele Montague, COO

Golden Empire Managed Care, Inc.*

Meritage Medical Network

Good Samaritan Medical Practice Association

Mid-Atlantic Permanente Medical Group, PC

Michael Myers, CEO

Nupar Kumar, MD, Medical Director

Don Lovasz, President, Clinically Integrated Network Chris Stanley, MD, VP of Care Management Architrave Health • Arkansas Health Network • Colorado Health Neighborhoods • KentuckyOne Health Partners • Mercy Health Network • Mission HealthCare Network PrimeCare Select • St. Luke’s Health Network • TriHealth • UniNet

Greater Newport Physicians Medical Group, Inc.*

Cedars-Sinai Medical Group*

Guthrie Medical Group

Central Ohio Primary Care Physicians, Inc.

Hawaii Pacific Health

Children’s Physicians Medical Group

Heritage Provider Network*

John Jenrette, MD, EVP, Medical Network Stephen C. Deutsch, MD, Chief Medical Director J. William Wulf, MD, CEO Michael Ashanin, COO

Leonard Kornreich, MD, President and CEO

Chinese American IPA

George Liu, MD, PhD, President and CEO Peggy Sheng, COO * Indicates 2015 - 2016 Board Members

34 l CAPG HEALTH

Fall 2016

MED3000

Diane Laird, CEO Adam Solomon, MD, CMO

Group Health Physicians Steve Tarnoff David Kauff, MD

Joseph A. Scopelliti, MD, President and CEO Frederick J. Bloom, MD, President Kenneth B. Robbins, MD, CMO Maureen Flannery, VP Clinic Operations Richard Merkin, MD, President Richard Lipeles, COO Affiliated Doctors of Orange County • Arizona Priority Care Plus, AZ • Bakersfield Family Medical Group • California Coastal Physician Network • California Desert IPA • Coastal Communities Physician Network • Desert Oasis Healthcare

Mercy Health Physicians

Wojtek Nowak, CEO J. David Andrew, MD, Medical Director Bernadette Loftus, MD, Associate Executive Director for MAS Jessica Locke, Special Assistant

Molina Medical Centers*

Keith Wilson, MD, CMO Gloria Calderon, Vice President of Clinic Operations

Monarch HealthCare*

Bart Asner, MD, CEO Ray Chicoine, President and COO

Monterey Bay IPA

James N. Gilbert, MD Michele Wadsworth, Network Management Associate

Mount Sinai Health System, New York, NY

Andrew Snyder, MD, President, Mount Sinai Health Partners IPA; EVP and Chief Clinical Integation Officer, Mount Sinai Health System Niyum Gandhi, EVP and Chief Population Health Officer

MSO of Puerto Rico

Richard Shinto, MD, CEO Raul Montalvo, MD, President

Muir Medical Group, IPA

Riverside Medical Clinic

The Portland Clinic

NAMM California*

Riverside Physician Network

The Vancouver Clinic, Inc., P.S.

St. Joseph Heritage Healthcare*

Torrance Hospital IPA

Ute Burness, RN, CEO Steve Kaplan, MD, President

Leigh Hutchins, President and COO Verni Jogaratnam, MD, CMO Coachella Valley Physicians of PrimeCare • Mercy Physicians Medical Group • Primary Care Associated Medical Group • PrimeCare Medical Group of Chino • PrimeCare Medical Network • PrimeCare of Citrus Valley • PrimeCare of Corona • PrimeCare of Hemet Valley • PrimeCare of Inland Valley • PrimeCare of Moreno Valley • PrimeCare of Redlands • PrimeCare of Riverside • PrimeCare of San Bernardino • PrimeCare of Sun City • PrimeCare of Temecula • Redlands Family Practice Medical Group

New West Physicians, PC

Thomas M. Jeffers, MD, President and Chair Ruth Benton, CEO

Northwest Permanente, P.C. Harry Stathos, VP and CFO

Northwest Physicians Network of Washington, LLC Rick MacCornack, PhD, CEO Scott Kronlund, MD, CMO

Omnicare Medical Group

Toni Chavis, MD, President Ashok Raheja, MD, Medical Director

One Medical Group, San Francisco

Tom Lee, MD, Founder and CEO Brendhan Green, VP Contracting and Reimbursement Strategy

The Permanente Medical Group, Inc. Oakland (North)* Michelle Caughey, MD, Associate Executive Director Suketu Sanghvi, MD, Associate Executive Director

Physicians DataTrust

Kathi Toliver, VP of IPA Administration Lisa Serratore, COO Greater Tri-Cities IPA • Noble AMA IPA • St. Vincent IPA

Physicians Choice Medical Group of San Luis Obispo John Okerblom, MD, President Barbara Cheever, Executive Director

Physicians Medical Group of Santa Cruz Marvin Labrie, CEO Nancy Greenstreet, MD, Medical Director

Physicians Choice Medical Group of Santa Maria John Okerblom, MD, President Barbara Cheever, Executive Director

Physicians of Southwest Washington, LLC Melanie Matthews, CEO Gary R. Goin, MD, President

PIH Health Physicians

Rosalio J. Lopez, MD, SVP and CMO Ramona Pratt, RN, COO, Group Operations

Pioneer Medical Group, Inc.* John Kirk, CEO Jerry Floro, MD, President

Preferred IPA of California

Mark Amico, MD, MPH, Medical Director Zahra Movaghar, Administrator

ProHEALTH Care Associates David Cooper, MD Walter LeStrange, EVP and COO

Prospect Medical Group*

Jeereddi Prasad, MD, President and Acting CMO AMVI/Prospect Medical Group • Genesis Healthcare of Southern California, A Medical Group • Nuestra Familia Medical Group • Pomona Valley Medical Group • Prospect HealthSource Medical Group • Prospect NWOC Medical Group • Prospect Professional Care Medical Group • Prospect Provider Group RI, LLC • Prospect Provider Group CT, LLC • Prospect Provider Group CTW, LLC • Prospect Provider Group NJ, LLC • Prospect Health Services TX • StarCare Medical Group • Upland Medical Group, a Professional Medical Corporation

Providence Health & Services

Bill Gil, Chief Executive of Medical Foundations

Providence Medical Management Services

Phil Jackson, Chief Integration and Transformation Officer Korean American Medical Group • Providence Care Network

Renaissance Physician Organization Clare Hawkins, MD, IPA Board Chair Whitney Horak, President

River City Medical Group, Inc.

Keith Andrews, MD, Medical Director Kendrick T. Que, COO

Steven Larson, MD, Chairman Judy Carpenter, President and COO Howard Saner, CEO Paul Snowden, CFO

Kevin Manemann, President and CEO Khaliq Siddiq, MD, CMO Hoag Medical Group • Mission Heritage Medical Group • St. Mary High Desert Medical Group

St. Vincent IPA Medical Corporation

Jeffrey Hendel, MD, President Leesa Johnson, Director of IPA Operations

San Bernardino Medical Group James Malin, CEO Thomas Hellwig, MD, President

Sansum Clinic*

Kurt Ransohoff, MD, President and Medical Director Vince Jensen, COO

Santa Clara County IPA (SCCIPA)*

J. Kersten Kraft, MD, President of the Board Lori Vatcher, CEO

Santé Health System, Inc.

Scott B. Wells, CEO Daniel Bluestone, MD, Medical Director

Scripps Coastal Medical Center

Anthony Chong, MD, CMO Tracy Chu, Assistant VP of Operations

Scripps Physicians Medical Group Joyce Cook, CEO James Cordell, MD, Medical Director

Sharp Community Medical Group*

Paul Durr, CEO Christopher McGlone, COO Arch Health Partners • Graybill Medical Group

Sharp Rees-Stealy Medical Group* Stacey Hrountas, CEO Alan Bier, MD, President

Southeast Permanente Medical Group, Inc., The

Michael Doherty, MD, Executive Medical Director and Chief of Staff

Southern California Permanente Medical Group* Diana R. Shiba, MD, Comprehensive Opthamologist Dept.

James Malone, Medical Group Administrator

Southwest Medical Associates

Jeffrey Cleven, MD, CMO Dick Clark, CEO Mark Mantei, CEO Alfred Seekamp, MD, CMO

Norman Panitch, MD, President

Triad HealthCare Network, LLC

Thomas C. Wall, MD, Executive Medical Director Steve Neorr, VP, Executive Director

UC Irvine Health

Manuel Porto, MD, President and CEO, Sr. Associate Dean of Clinical Affairs Pat Dolphin, Chief Ambulatory Officer and Executive Director of University Physicians and Surgeons

UCLA Medical Group*

Sam Skootsky, MD, CMO Kit Song, MD, Medical Director of Surgical Services

USC Care Medical Group, Inc. Donald Larsen, MD, CMO

Valley Organized Physicians William Torkildsen, MD Sarah Wolf

Verity Medical Foundation Dean M. Didech, MD, CMO Mathew Abraham, CAO

WellMed Medical Group, P.A.

George M. Rapier III, MD, Chairman and CEO Carlos O. Hernandez, MD, President

CORPORATE PARTNERS abbvie Anthem Blue Cross of California athenahealth Boehringer Ingelheim Pharmaceuticals, Inc. Evolent Health Humana, Inc. Merck & Co. Nestle Health Science Novartis Pharmaceuticals Novo Nordisk Patient-Centered Primary Care Collaborative Quest Diagnostics Sanofi, US SCAN Health Plan Shionogi, Inc.

ASSOCIATE PARTNERS

Michael Van Duren, MD, VP, Sutter Health Larry de Ghetaldi, MD, Division President, Palo Alto Medical Foundation Central Valley Medical Group • East Bay Physicians Medical Group • Gould Medical Group • Marin Headlands Medical Group • Mills-Peninsula Medical Group • Palo Alto Foundation Medical Group • Palo Alto Medical Foundation • Peninsula Medical Clinic • Physician Foundation Medical Associates • Sutter East Bay Medical Foundation • Sutter Gould Medical Foundation • Sutter Independent Physicians • Sutter Medical Foundation • Sutter Medical Group • Sutter Medical Group of the Redwoods • Sutter North Medical Group • Sutter Pacific Medical Foundation

Arkray ArroHealth Astellas Pharma US, Inc. AstraZeneca Pharmaceuticals Avanir Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals Bio-Reference Laboratories, Inc. Bristol-Myers-Squibb Easy Choice Health Plan, Inc. Genentech, Inc. Incyte Corporation Johnson & Johnson Family of Companies Kaufman, Hall & Associates Kindred Healthcare, Inc. Lumara Health, a Division of AMAG Pharmaceuticals Pfizer, Inc. Ralphs Grocery Company Sunovion Pharmaceuticals Inc. Surgical Care Affiliates, Inc. The Doctors Company Vitas Healthcare Corporation of California

Swedish Medical Group

AFFILIATE PARTNERS

Robert B. McBeath, MD, President and CEO Greg Griffin, COO

Summit Medical Group, PA

Jeffrey Le Benger, MD, Chairman and CEO Jamie Reedy, MD, VP of Population Health and Quality

Sutter Health Foundations & Affiliated Groups*

Meena Mital, MD, Medical Director Bela Biro, Admin. Director, Accountable Care Services

Synergy HealthCare, LLC

James Jones, MD, Chairman of the Board Chris H. Keffer, VP, Network Operations

SynerMed*

James Mason, President and CEO George Ma, MD, Medical Director Alpha Care Medical Group • Angeles IPA • Crown City Medical Group • EHS Inland Valleys IPA • EHS Medical Group – Central Valley • EHS Medical Group – Los Angeles • EHS Medical Group – Sacramento • Employee Health Systems • IPA of Georgia • MultiCultural IPA • Pacific Alliance Medical Center • Southern California Children’s Network

Tenet Healthcare

Jacob Furgatch, CEO Ronald Kaufman, CMO

Acurus Solutions, Inc. Aetion, Inc. Alignment Healthcare Altura ASPiRA LABS Axene Health Partners Cal INDEX Children’s Hospital Los Angeles Medical Group CVHCare Global Transitional Care Honor Mills Peninsula Medical Group Nifty After Fifty Monarch LLC Partners in Care Foundation

Pharmacyclics, Inc. PsycheAnalytics, Inc. Redlands Community Hospital Saint Agnes Medical Group SullivanLuallin Group Ventegra, LLC Fall 2016

CAPG HEALTH l 35

Creating Five-Star Care Coordination

BY LAURA JACOBS, PRESIDENT, AND MEGAN CALHOUN, MANAGER, GE HEALTHCARE CAMDEN GROUP

As organizations see revenue increasingly moving to risk-based or shared savings models, they come face-to-face with the need to change the underlying processes and mechanisms through which care is provided. The importance of astutely negotiating the terms and scope of the risk-based arrangements cannot be underscored enough. But even with clear payment terms, the real “risk” is in not paying attention to the core care models that drive outcomes, cost, and the patient experience.

This shift requires a cultural change throughout the organization. Staff must embody, and processes support, a dedication to the patient’s needs above all else, including any necessary follow-through or handoffs to other care team members. This philosophy and the associated care coordination behavior patterns can be daunting; it may seem as though the workload has increased while time and resources have decreased.

Laura Jacobs

The key is in redesigning roles, responsibilities, and focus to reprioritize activities and optimize team capabilities. It’s important to have a laser focus on the data, tasks, and systems that will truly drive and sustain change. Care coordination doesn’t need to be introduced for all patients, and not all patients require these services. Below are five key steps to consider when beginning or enhancing organizational care coordination.

STEP #1: IDENTIFY THE BURNING PLATFORM Behavior modification is dependent on a change in established goals and incentives.

Educating clinicians and staff on why change is imminent and the positive impact it can have on patients and staff is an important component of care coordination.

Engage clinicians and other key stakeholders in identifying the opportunity and designing the new model. Most will admit that current processes are fragmented and not ideal; however, they often say it’s “the other guy” who needs to change.

Only through a process to universally identify the vision and critical elements of success is there a chance of sustaining positive change. Leadership must be crystal clear about the importance of this effort. Team members must buy into the fact that care coordination is a necessity, not a choice, to advance the success of the organization. Individual and organization-wide goals may need to be edited to incorporate this message, and overcommunication of this philosophy is critical. If a risk-based or shared-savings contract is in place or in development, make sure its quality and efficiency measures are consistent with organization-wide objectives to align the vision.

STEP #2: DETERMINE THE OPPORTUNITY Executing a data-driven approach to care coordination is imperative. Evidencebased models for care have been researched and published for numerous chronic conditions, care transitions, readmission prevention, and more, all of which can seem attractive to an organization excitedly launching a care coordination initiative.

However, an organization new to the model cannot tackle everything. Instead, review and analyze historical clinical and financial data to highlight areas for opportunity. An 36 l CAPG HEALTH

Fall 2016

Megan Calhoun

initial, high-level population stratification that includes key clinical outcomes and utilization metrics can typically point to the patient population for whom care coordination can make the greatest impact. For those organizations that already have this discipline, look for areas of high variation in cost/quality outcomes or where total costs of care stubbornly refuse to bend toward the goal.

STEP #3: RESEARCH AND DESIGN

“Educating

clinicians and staff why change is imminent and the positive impact it can have on patients and staff is an important component of care coordination.

Engage clinicians and other key stakeholders.”

As mentioned, there already has been significant research into models of care that have been proven to affect outcomes. Start here! Research what has worked in similar geographic/ socioeconomic markets with a similar healthcare environment and build your care coordination models based on previously established programs and protocols. If you are a care coordination novice, you won’t gain any benefit by designing innovative care pathways; instead, use proven techniques and approaches as a baseline and spend resources on staff education and implementation efforts.

Once the care model is instituted, you can implement modifications or enhancements to suit your environment or patient population. When selecting and designing a care coordination model, define what success looks like and establish key performance indicators on which that success can be measured. Sharing performance against these targets across the organization will help foster the spread of internal best practices.

STEP #4: RESTRUCTURE ROLES, RESPONSIBILITIES, AND RECRUITING EFFORTS Nothing will get done without the infrastructure to sustain and scale care coordination initiatives.

Staffing, the use of data and analytics, and defined communication pathways are integral to turn design into an operational program. The care management organizational structure may need to be revised, with each role assigned clearly delineated responsibilities.

It may be appropriate to redeploy resources within the organization, based on licensure and training, and to recruit members for appropriately staffed care teams.

Identifying how, when, and what data is required at all points along the continuum will help to limit reporting

and analytics to meaningful, actionable data that improves clinical outcomes and population health status.

The establishment of an organizationwide communication plan will also ensure that the care coordination objectives are spread across all departments and levels of staff. The plan should not only describe expected programmatic and staffing responsibility changes, but also the established metrics of success and performance expectations.

STEP #5: REVISIT, REASSESS, REVISE

The design and implementation of care coordination programs and processes is an evolution, not a revolution—a constant work in progress that requires regular performance improvement initiatives. Accountability must continue.

Identify a governing body or committee to regularly review performance on the established success metrics and conduct root cause analysis when performance is not as expected after behavior and process changes. This governing body should not hesitate to recommend changes, as needed, or act on a remedial action policy for clinicians or staff whose behavior is not enabling care coordination success. It may also be necessary to train (or retrain) staff on roles, responsibilities, and appropriate use of tools. It is important to provide sufficient training and clearly set performance expectations before asking team members to take on a new and improved role.

Moving to risk—whether in the form of capitation, shared savings, or even bundled payment—should not be viewed simply as a new payment model. It requires systems and an organizational orientation to changing and reinforcing a new model of care. And accomplishing this takes more than utilization management or incentive structures alone. It requires an organizational “reset” to utilize data, deploy resources, and orient caregivers to a “five-star” system of care coordination that minimizes care silos and truly places the patient at the center. o Laura Jacobs and Megan Calhoun will present a preconference, Coordinated Care 101, on Wednesday, September 28, from 9:00 am to noon at the CAPG Colloquium. Visit capgcolloquium.com for more information.

Fall 2016

CAPG HEALTH l 37

Evolution of the Capitated/Delegated Model in California and Beyond

BY JIM AGRONICK, VP, IPA OPERATIONS, ADVENTIST HEALTH PHYSICIANS NETWORK IPA

This article provides a retrospective look at the development of the capitated/ delegated model1 in California, the factors that led to its early success between 1970 and the early 1990s, and the potential emergence of capitation models in other parts of the country in 2016.

A LOOK BACK TWO DECADES In a 1997 article sponsored by the Kaiser Family Foundation and written by Lawrence Casalino, MD, PhD, and James Robinson, PhD, MPH (“The Evolution of Medical Groups and Capitation in California”), the authors cite two factors that led to creation of capitated arrangements between newly created health maintenance organizations (HMOs) and a number of medical groups in California in the mid-1970s. First, the passage of the Federal HMO Act of 1973 established criteria to become a “federally qualified HMO” and allowed such an HMO to “mandate” an employer. This mandate required employers with 25 or more employees that offered traditional health insurance to include a federally qualified HMO option. Second, and perhaps more important, was the fear that Kaiser Permanente would start to use this mandate provision with large employers to move market share away from other HMOs and the large medical groups.

In an unprecedented level of cooperation, several Southern California medical groups formed a consortium (the Unified Medical Groups) to contract on their behalf with three newly launched health plans: Blue Cross Communicare (eventually Health Net), Maxicare, and PacifiCare. In Northern California, a similar process occurred with multiple medical groups joining forces to create the United Medical Clinics to contract with a new Blue Cross plan called TakeCare.2 38 l CAPG HEALTH

Fall 2016

from “Aside extraordinary

THE EXPERIMENT SUCCEEDS

At the time, none of these partners had any appreciation of how significant the capitated model would become and the enormous changes it would bring to the California market.

Aside from extraordinary collaboration among the large medical groups and newly launched health plans, a number of factors allowed this “experimental model” to take hold, grow, and ultimately flourish. High healthcare premiums (higher than indemnity insurance) led to well-funded professional capitation rates and well-funded hospital risk pools.3 With such healthy funding levels, it was almost impossible to fail, once the medical groups actually began to make efforts to manage the care.4

collaboration among large medical groups and newly launched health plans, a number of factors allowed this ‘experimental model’ to take hold, grow, and ultimately flourish.”

In addition, the health plans offered to fund some of the operating expenses during the early years,5 and provided additional financial assistance in the form of capitation carve-outs (certain high cost ancillary services were paid at fee-for-service rates outside of capitation)6 and relatively inexpensive reinsurance to cover high-cost cases.7 Finally, these medical groups benefited from a long learning curve: while HMO enrollment at these medical groups grew steadily, the growth was not so rapid as to outstrip the ability of each group to develop utilization management systems and other infrastructure to manage both the professional and inpatient costs.8 In the relative safety of this evolving environment, these medical groups developed systems for measuring and managing both utilization and quality. This led to increased profitability (especially from hospital risk pool surplus sharing), which allowed them to expand, become larger,

and use their greater size to negotiate more favorable arrangements with the health plans and with their independently contracted specialists.

MEDICAL GROUPS BEGAN TO MANAGE CARE Under this model, utilization management was delegated to the medical groups, who developed various processes to support better management of the care and costs for their patient populations. They began with basic utilization review of all specialty referrals, mainly as a cost control mechanism. This helped them understand utilization patterns and differentiate between “good utilizers” and “poor utilizers.” The next logical step was to develop reporting capabilities to support analysis of cost and utilization trends. With objective data in hand, the groups now had the ability to moderate the practice patterns of their primary and specialty care physicians, negotiate more favorable rates with physicians, and begin eliminating certain specialists on the basis of poor utilization performance.

These efforts were not limited to just the outpatient setting, as the medical groups had financial incentives to improve inpatient costs as well. They began with daily nurse review9 of all inpatients and expanded their oversight through the evolving use of physicians devoted entirely to managing inpatients—ultimately known as “hospitalists.”10 THE HEALTHCARE WORLD IN 2016 As noted, conditions in the California healthcare marketplace in the 1970s-1980s were ideal to support development of the capitated/delegated model. While the healthcare industry has changed dramatically over the past two decades, much of this early approach to managing care is still applicable in 2016. Also, any organization embarking on this path today has access to a wealth of information from the experiences of other organizations—both their successes and failures.

At the same time, the general environment is considerably different from the 1970s and 1980s. With passage of the Affordable Care Act as well as the Medicare Access and CHIP Reauthorization Act, the landscape is much more fertile for a variety of volume-to-value plays that will include capitation. Across the country, we are seeing networks developing around the Medicare accountable care organizations (ACOs), a variety of commercial ACOs, and the emergence of clinically integrated networks (CINs). In some areas outside of California, capitated/ delegated models are beginning to take hold.

For any new organizations considering a foray into a capitated/delegated model, a number of key conditions

must exist to support its development and growth.

First and foremost, there must be a state regulatory framework that allows the health plans to delegate risk to other entities. Also needed are local health plans willing to delegate both the risk and the administrative responsibility, and to offer incentives for quality improvement at the provider organization level.

With the appropriate conditions in place, at least three building blocks are necessary to ensure initial success.

Sufficient capital is needed to fund the start-up, develop infrastructure, and cover any losses—especially during the early stages when capitated enrollment is lower. The provider organization must have a sufficient number of primary care providers (PCPs) and specialists to provide a full scope of care for the target population. The final building block: an affiliation with a local hospital/health system committed to supporting this venture and the concept of volume to value. This can’t be a “fill-the-beds” strategy.

Early in the development process, it is essential to identify and recruit seasoned lay and medical leadership to guide the provider organization. While there may be local market talent who can quickly climb the learning curve, another option is to recruit leadership from a market where the capitated/delegated model is already well established.

This leadership will need to lay the groundwork for the provider organization in two ways: by implementing a single electronic medical record (EMR) platform that supports connectivity among physician offices, hospital, and ancillary services and by developing a robust analytics capability (data is “king” in the volume-to-value paradigm). Building on the utilization management efforts of the early pioneers in the capitated/delegated model, the provider organization leadership will be implementing care management programs that address the healthcare needs of the top 1 to 2 percent of most costly patients within their population (those with complex needs), the next 10 to 15 percent with chronic conditions, and the remainder with more routine healthcare needs. These programs will become even more important as the industry witnesses a continued shift from treatment in the inpatient to the outpatient setting.

Today’s capitated/delegated model must be willing to embrace a team approach with physicians, nurses, pharmacists, social workers, therapists, care navigators, and other health professionals all working at the top of their licenses and/or capabilities. The ongoing shortage of physicians in primary care and some specialties makes this an imperative. continued on page 50 Fall 2016

CAPG HEALTH l 39

Creating Practical Solutions to Enhance Patient Outcomes Within Coordinated Care Organizations Q&A WITH RAJESH GADE, MD AND JANELLE HOWE, HEALTHCARE PARTNERS, A DAVITA MEDICAL GROUP, CONDUCTED BY JEREMY RICH, MD, HEALTHCARE PARTNERS INSTITUTE FOR APPLIED RESEARCH AND EDUCATION

How did you initially test whether coordinated care could improve health outcomes?

HealthCare Partners, a DaVita Medical Group, and DaVita were separate organizations when we began working on the End Stage Renal Disease (ESRD) program. We both recognized that patients with ESRD are one of Medicare’s most chronically ill and vulnerable populations. We also recognized that when these patients transition to kidney failure, they may no longer maintain their relationship with their primary care physician.

There was a need to supplement high quality kidney care with strategies focusing on primary care to ensure that health issues were being addressed and care coordinated between specialists as needed.

VillageHealth launched a demonstration project with the Centers for Medicare & Medicaid Services (CMS) to test whether coordinated care models could improve patient health outcomes, enhance quality of life, and reduce preventable medical costs. Over the fiveyear demonstration period, VillageHealth’s patient outcomes exceeded Medicare ESRD benchmarks, proving that ESRD patients could benefit from coordinated care.

Rajesh Gade, MD

How has VillageHealth grown since then?

In 2011, the project converted to a Medicare Advantage ESRD Chronic Special Needs Plan (SNP) product offered by SCAN Health Plan in partnership with DaVita VillageHealth. By 2013, enrollment was up 300 percent since inception. The next year, VillageHealth, SCAN, and HealthCare Partners, a DaVita Medical Group opened a second ESRD SNP in Southern California. We leveraged HCP’s care model to include nurse practitioners (NPs), hospitalists, and other healthcare professionals. By adding team members who provide preventive care, VillageHealth could now do more to keep patients out of the hospital as clinically appropriate.

Janelle Howe

This improvement is part of our overall strategy to move from a coordinated care model that works in some places to an integrated kidney care model that works everywhere, and can be adapted for all ESRD patients. After seven years of research and refinement, VillageHealth continues investing in its care model, integrating more seamlessly with dialysis clinics, and improving coordination with nephrologists and other specialists.

What was the thinking behind this program in a capitated, risk-based environment?

HealthCare Partners, a DaVita Medical Group has been operating in a full-risk environment for years. The ESRD program was designed and launched following a successful chronic obstructive pulmonary disease program we created, evaluated, refined, and disseminated. We built on these strategies, aware of the clinical challenges faced by these vulnerable patients and our opportunities for impacting patient care. Through

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Jeremy Rich, MD

VillageHealth, we expanded to a new patient population, targeting patients with Medicare coverage, on Medicaid, and not used to coordinated care.

The combined program incorporated the experience of the VillageHealth programs and the experience of HealthCare Partners, a DaVita Medical Group’s ESRD program, maximizing the use of NPs and care coordinators combined with VillageHealth nurses and infrastructure. It is an opportunity to learn both a slightly different model and how to leverage and maximize the use of other teammates. This was the first joint program between DaVita and HealthCare Partners, a DaVita Medical Group after they merged.

We also wanted to discover a way to provide the full spectrum of care in an outpatient setting. Our patients spend 12 to 15 hours a week in a dialysis clinic—the last thing they want is to go to another provider. Many do not go to other providers even when they really need it. We wanted to bring as much necessary care to them as we could.

How were you able to enhance participation of team members, payors, purchasers, and partners?

Main selling points were improving quality and access to care and lowering overall cost of care—easy sells in any value-based environment. Leaders in the organization saw this as an effort to improve outcomes and bed days. The main challenge was getting nephrologists on board. We explained our mission: that we as physicians, NPs, and nurses are here to supplement their work so they can focus on kidney care. Over time they realized our program was a high-value addition.

What else was done to maintain robust relationships and address challenges?

We held several large group meetings with local nephrologists to create a sense of team and get valuable feedback. We were reducing hospitalizations significantly, which was great for the patients, but it did reduce the amount of inpatient consults nephrologists were able to bill for. This is the issue with the fee-for-service world— providers do not necessarily get rewarded for better outcomes and better care. To balance that, we put in place a quality incentive program, which allowed nephrologists to benefit from improved outcomes and care—such as lower central venous catheterization rates and higher home modality penetration.

How did you move this idea forward to the operations, implementation, and refinement phases?

The team composition was formed from design meetings.

NPs and VillageHealth nurses manage a specific patient geography with both in-person engagement of patients

within the dialysis centers and with follow-up care. Care coordinators support not only the team, but also patient and dialysis center needs to ensure seamless delivery of services. We established forums for these teams of VillageHealth nurses and NPs to work with care coordinators and to improve processes. The concept was based on working with engaged teammates who communicate well, accept feedback, and act on it promptly.

Critical feedback came from many at the front line, enabling the program to quickly change and adapt to meet their needs.

Change management can be challenging when rolling out high-risk wellness programs. How can your experiences shape broad dissemination to other organizations?

Implementation is based on teammate trust and creating a sense of “buy-in” ownership from all parties. The keys are communication and feedback and working with other stakeholders. The culture at VillageHealth supports teammate trust and communication. Their history of regular program launches has resulted in best practices for bringing new teams together and encouraging growth and change.

While forums for discussion were critical, equally important was engaging and strengthening the relationships with teammates.

What specific operations does VillageHealth undertake to help reduce avoidable readmissions, length of stay, and emergency department visits?

It is a multi-prong effort based on delivering quality care, seamless access for the patient to reach the NP and support staff, and creating a system where NPs review admissions and high-risk patients. We surround them with a team that can work together to solve problems, leverage the hospitalist program we have in place, and communicate consistently with the patient, specialist, and clinic on who to contact and where to go for care.

For an unmanaged patient, it is easy to fall through the cracks. There are multiple providers who may not communicate; on average six to eight medications per patient, with each new medication having the potential of contraindications with the current set; and, of course, transition between lots of care settings. We have built an environment that closes these gaps through intense clinician focus, integrated electronic medical records, and often relentless communication.

Teammates focus on post-discharge patients and ensure their seamless transition from the hospital to the dialysis center. For example, their vascular access for dialysis or fluid overload may be problematic. The nephrologists provide continued on page 50 Fall 2016

CAPG HEALTH l 41

Integrating Behavioral and Primary Healthcare: An Intricate Partnership with Provider and Patient Payoffs

BY VALERIE GREEN-AMOS, MD, PRESIDENT, MOLINA MEDICAL GROUP

We are lucky to be in a pivotal time in which the way primary care providers are being trained to approach patient care is evolving. A renewed focus on the whole patient—one including behavioral and mental health concerns—is the new standard of care. At Molina Medical Group, this change has spawned implementation of integrated healthcare teams throughout Molina Medical clinics that make collaborative primary care a daily reality, one that strives to achieve the quadruple aim of better health outcomes, better patient experience, lower costs, and clinician and staff satisfaction.

integrated “Truly care looks at the whole patient objectively and offers solutions on an individual basis, addressing all concerns that impede a positive outcome—from environmental to medical.”

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Many chronic disease states frequently are seen concurrent with mental health issues or are compounded by socioeconomic concerns. In these difficult cases, solving only one of three issues doesn’t result in a favorable patient outcome, since each feeds into and affects the other. If a patient is offered weekly therapy sessions and a prescription, but has no way of getting to appointments and cannot afford the medication, no solution has been found. Truly integrated care looks at the whole patient objectively and offers solutions on an individual basis, addressing all concerns that impede a positive outcome—from environmental to medical.

At the Molina Marysville clinic in California, we created a team-based approach to integrated care for especially complex patients. These patients usually have significant chronic illnesses, combined physical and mental health issues, frequent emergency room visits, and complex psycho-social-financial problems.

Tackling these complicated patient cases has been made easier by our clinic employing a holistic approach. The team includes a primary care physician, licensed social worker, case manager, clinical pharmacist, and behavioral health specialist, who all work closely together and meet often to discuss patients, plan for their needs, and weigh intervention strategies.

Patients are seen weekly, depending on their needs. A licensed vocational nurse serves as the face of the clinic, coordinating care and greeting patients as they call or stop in with more emergent concerns. Patients are assured that their team is accessible to them when needed, while the clinic team members also consult with patients by phone as they tackle health and mental challenges. This teamwork is marked by a true respect for the specific skill sets we each bring and the unique contributions we can make together to patient care.

Molina recently brought under its umbrella Pathways, a behavioral healthcare company, with the primary aim of facilitating integrated care throughout our clinics. The wide implementation of integrated care throughout Molina’s 20 clinics, including five with telemedicine connectivity, is based on well-documented improvement in outcomes across many prevalent and costly chronic conditions— including hypertension, diabetes, coronary heart failure, and asthma.

Over 3,500 patients are actively seeking care, with an average of more than 500 patient visits per week. The Molina clinics have discovered one further benefit of provider collaboration that was less expected: greater provider satisfaction. Being part of a highfunctioning team brings a level of satisfaction that is sometimes difficult to find as a provider working alone. It’s encouraging to know some issues that previously weren’t able to be addressed or brought to attention are now handled by the other talented members of my team. The exposure to these providers, and to their practices for patient care, has improved my own ability to provide excellent care.

Molina’s experience in implementing collaborative teams has revealed three critical components of the team-based approach: • Strong clinical leadership and open exchange of knowledge by team members • Routine or daily provider huddles • Participation in ongoing education that emphasizes collaboration, integration, and coordination The providers in Molina’s Marysville clinic have found a better way to serve their patient population and, in turn, those patients have expressed greater satisfaction with their care. The integration of behavioral and primary care has changed the game in our clinic. So many patients who might otherwise have fallen through the cracks are getting the attention and care they need and, as providers, we enjoy the benefit of sharing knowledge and decision making as a team. It’s a win-win. o

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Fall 2016

CAPG HEALTH l 43

The Domino Effect of the Affordable Care Act

BY R O B F R A N C I S , C H I E F O P E R AT I N G O F F I C E R , T H E D O CTO R S C O M PA N Y

Like falling dominos, changes from the Affordable Care Act (ACA) are pushing primary care physicians (PCPs) and patients into other forms of healthcare delivery, which in turn affects patients’ access to care and drives some to new provider options. These massive changes to our healthcare system bring both benefits and risks.

PCPs are in short supply in many regions of the country, a trend that is expected to continue. PCP income had been rising slightly each year; however, a 0.5 percent raise in Medicare reimbursement set for 2016–19 by the Medicare Access and CHIP Reauthorization Act (MACRA) turned into a 0.3 percent pay cut when the Medicaid rate increases enacted as part of the ACA expired. Those Medicaid reimbursement cuts and a barrage of other payment reductions implemented by the Centers for Medicare & Medicaid Services (CMS) trumped the proposed MACRA gains and are chipping away at PCPs’ pay.

CONSOLIDATION SHOWS NO SIGN OF SLOWING DOWN A physician in a solo or small practice often finds it difficult to survive, let alone thrive, as growing government regulation increases reporting requirements and requires implementation of expensive electronic health record systems. It’s not surprising that PCPs are increasingly leaving their own practices for larger groups, hospital employment, and new forms of practice that enable them to spend more time with fewer patients. Each option promises a better work-life balance.

Some PCPs opt for retirement, but then face the reality that finding a junior associate or buyer for small practices is difficult as consolidation continues and 44 l CAPG HEALTH

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payers opt for narrower networks. Closing established practices impacts patients’ access to primary care, as does selling or consolidating with larger practices.

The new owners may not be in the same insurance networks, and patients must find a new provider who relies on medical records, not a long-term doctorpatient relationship—which could potentially result in overlooked signs of illness.

NEW PRACTICE MODELS EMBRACED A growing number of PCPs are leaving traditional practice for concierge medicine or direct primary care, two cash-based practice styles that involve physicians significantly reducing the number of patients in their practice. Driving this trend is the approximately 20 million newly insured patients who have entered the healthcare system since the implementation of the ACA. This influx has resulted in longer wait times for appointments and shorter visits with the doctor.

Both concierge and direct primary care provide their patients with greater physician access and more personalized care. In direct primary care, the patient often pays a monthly fee and can opt out at will.

Insurance is not accepted, so direct care physicians don’t need an office manager to file insurance claims.

In a concierge-style practice, patients pay an annual fee or retainer, which may or may not be in addition to other charges. Insurance may be billed as well.

The American Association of Private Medicine, a professional association of physicians practicing concierge or direct care medicine, says that the number of retainer-based practices in the U.S. has grown 25 percent annually since 2012, reaching about 12,000 doctors in 2016.

The move to concierge medicine and direct primary care has benefits for physician and patient. In both models, the physician is in better control of his or her income and spends more time with each patient.

Having fewer patients and a potentially deeper relationship with each may lower the risk of adverse events, which benefits the patient and could lead to

“It’sthatnotPCPssurprising are increasingly leaving their own practices for larger groups, hospital employment, and new forms of practice that enable them to spend more time with fewer patients.”

lower malpractice premiums for the physician.

However, this trend could lead to another domino falling. As more PCPs leave traditional practice for other models, patients unwilling or unable to pay for concierge medicine or direct primary care must find other providers—of which there are fewer.

Patient frustration can reach a boiling point when an appointment can’t be scheduled within a reasonable time frame or when patients must spend hours on the phone to find a PCP in the local area willing to take new patients.

PATIENT CARE GOES RETAIL Patients are beginning to seek care from retail outlets such as Walmart, CVS, and Walgreens. In addition, new smartphone apps can put patients in video contact with physicians or advanced practice providers (APP) to assess their condition. Retail clinics today represent about 2 percent of primary care services in the U.S. However, utilization is expected to grow as patients are unsuccessful in finding convenient care elsewhere, retail locations expand their care offerings, and traditional health systems link with retail clinics.

APP, not a physician. Even patients with a regular PCP may frequently see an APP, such as a nurse practitioner (NP) or physician assistant (PA). APPs, employed by doctors to help with large patient volume, perform routine and complicated medical services for hospitals and medical practices across the country. The number of PAs in the U.S. has increased 36.4 percent over the last five years; the number of NPs has doubled in the past 10 years.

The trend toward retail clinics and greater use of APPs comes with increased risks. The absence of an ongoing relationship with a single provider may result in little or poor communication and coordination among providers and a lack of continuity of care—a potentially harmful situation for the patient.

When PCPs hire APPs, they assume additional risks because the PCP is vicariously liable for the actions of each APP. According to closed claims data compiled

by The Doctors Company and the industry trade group Physician Insurers Association of America (PIAA), most malpractice claims attributed to APPs can be traced to clinical and administrative factors that potentially could have been identified and remedied by the employing physician or hospital. Therefore, malpractice premiums may need to be reviewed and revised for physicians employing a large number of APPs, commensurate with the increased risk.

The dominos continue to fall, impelling PCPs out of traditional practice and patients to concierge medicine, direct primary care, larger group practices, retail clinics, and APP-based care. While the benefits of these changes are many, whether they outweigh the potential risks to both patients and physicians has yet to be seen. o

These clinics provide what patients want: convenience, quick access, and affordability. They also cause some traditional PCPs to alter the way they practice to meet patient demands and needs in a similar way as their competitors.

At retail clinics, patients are more likely to be seen by an Fall 2016

CAPG HEALTH l 45

Home Healthcare: Playing a Critical Role in New Physician Practice and Payment Models

BY TRACEY MOORHEAD, PRESIDENT AND CEO, VISITING NURSE ASSOCIATIONS OF AMERICA

Healthcare delivery and payment continue to evolve with clear goals toward improved outcomes and reduced costs. Success against these goals is measured across delivery sites and provider types by quality measure sets and resource use. Improved collaboration and coordination have repeatedly been demonstrated as critical to success. Yet one segment of qualified, skilled, and existing providers has not gained the seat at the table necessary to truly engage and support progress toward the goals of quality improvement and cost reduction.

care “Home-based providers are a critical resource for health and hospital systems, physician provider groups, and community care models.”

Home-based care providers, including Medicare-certified home health agencies, are a critical resource for health and hospital systems, physician provider groups, and community care models. Demographics make the case for increased utilization of skilled home-based care clinicians: the Silver Tsunami of Baby Boomers entering Medicare; declining numbers of primary care and geriatric physicians; increasing prevalence of chronic disease and associated comorbidities and complications; shifting sites of care from ambulatory to community settings, including the home; and an increasing desire by Medicare beneficiaries to remain in their own homes.

Align these trends with fact: the existence of nearly 12,000 Medicare-certified home health agencies as recognized by the Medicare Payment Advisory Commission (MedPAC); documented quality improvement programs and measures, including Medicare’s Home Health Star Ratings program; alignment of Star Ratings measures with existing physician quality reporting measures; and reduced costs associated with home-based care over ambulatory or institutional post-acute settings for many patient populations.

Clearly, physician practices should consider home-based care providers important partners as they weigh practice redesign to meet quality measures established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and implemented through either the Merit-Based Incentive Payment System (MIPS) or Alternative Payment Model (APM) quality measures.

For example, a recent demonstration project—Independence at Home—proves the value of home-based care for Medicare beneficiaries. This value-based care model, authorized by the Affordable Care Act, is designed to deliver at-home primary care services to patients who suffer from multiple chronic diseases. The program, already extended beyond the original three-year authorization, has continued to improve beneficiary outcomes and reduce Medicare spending.

In fact, the Centers for Medicare & Medicaid (CMS) recently released its analysis that the demonstration project had saved Medicare $10 million during the second year alone. Independence at Home reduced 30-day readmission rates, shortened times to complete medication review and identification post-hospitalization, reduced inpatient and emergency department utilization for certain conditions, and improved patient preference recognition by providers.

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Physician groups have also partnered directly with individual home health agencies to achieve similar results.

In 2012, Dartmouth-Hitchcock Medical Center, a Pioneer Accountable Care Organization (ACO) program, partnered with Concord Regional Visiting Nurse Association (VNA) to reduce hospitalizations for Medicare beneficiaries with multiple chronic conditions.

Dartmouth-Hitchcock physicians identified and referred certain patients to Concord Regional VNA for medication reconciliation and care coordination visits, through both electronic and in-person communications. During the project’s first year, rehospitalization rates for referred patients went down from 27 percent to 24 percent, patient ability to take oral medications correctly increased from 28 percent to 58 percent, and patient satisfaction on specific care issues increased from 81 percent to 87 percent. Initially limited to only three Dartmouth-Hitchcock clinics, the program’s success led to expansion among all primary care physicians within the Medical Center.

Importantly, Dartmouth-Hitchcock provided all funding for the home health agency services through Pioneer ACO per-patient fees.

Christiana Care Health System’s Department of Family and Community Medicine collaborated with the Christiana Care VNA to develop a home-visit program for frail elderly beneficiaries in Wilmington, Delaware. The program has enrolled over 1,000 patients in three years with a goal to reduce avoidable hospital admission and readmission rates, as well as to reduce emergency department visits.

The program resulted in an 11 percent decline (from 33 percent to 22 percent) in 30-day hospital readmission rates and a three percent drop (from 12 percent to nine percent) in emergency department visits. The health system funded the program internally, demonstrating a clear understanding of the value of integrating home-based care for certain patient populations.

for patients from the hospital to various post-acute care settings, the average Medicare payment per episode by first PAC setting, and the average readmission rate for related conditions within the CMS Comprehensive Care for Joint Replacement model. The data make a clear correlation between patients entering home care following a hospital stay and cost savings to the Medicare program averaging $5,000 per episode.

Under MACRA, physician practices must choose from between two payment model tracks. CMS estimates the majority of physicians will opt for the MIPS track rather than the APM. MIPS includes outcomes measures for cost, quality, advanced care information, and clinical practice improvement activities. These measures include common home-based care practices such as communication, care coordination, beneficiary engagement, patient safety, falls assessment, and medication reconciliation and adherence.

Bonuses or penalties for achievement on these measures could reach up to nine percent of physicians’ Medicare reimbursements.

Physician practices should carefully review the MIPS measures and align partnerships with home-based care providers to support progress toward the goals of improved outcomes and reduced costs of care. Home-based care providers stand ready, willing, and proven to drive physician group success under MACRA. o Tracey Moorhead will participate in a CAPG Colloquium panel, Innovative Approaches to Post-Acute Care in a RiskBearing World, on Thursday, September 29, at 3:15 pm.

Visit capgcolloquium.com for more information.

More recently, the Alliance for Home Health Quality and Innovation released data analysis that found the use of home health after a hospital stay is associated with costeffective care and lower readmission rates for Medicare patients who have undergone major joint replacement surgery. The analysis examined the distribution of discharges Fall 2016

CAPG HEALTH l 47

Brown & Toland Physicians and Aetna Continue Successful Accountable Care Collaboration

BY PAMELA LAESCH, MD, CHIEF MEDICAL OFFICER, AND STEPHANIE MAMANE, VICE PRESIDENT OF PAYER CONTRACTING AND ACO, BROWN & TOLAND PHYSICIANS

“

The accountable care program has resulted in a 5 percent decrease in avoidable inpatient admissions and a 7.5 percent decrease in readmissions for Aetna’s PPO clients.”

Brown & Toland Physicians, an independent practice association of more than 1,500 physicians in the San Francisco Bay Area, has been at the forefront of accountable care initiatives for almost five years. The organization expanded its 20-plus year relationship with Aetna three years ago by creating an accountable care program, which has resulted in a 5 percent decrease in the number of avoidable inpatient admissions and a 7.5 percent decrease in the rate of inpatient readmissions for Aetna’s preferred provider organization (PPO) clients.

Brown & Toland has experience in managing patient populations in various shared-risk and full-risk products and, in 2012, was the only healthcare organization in Northern California to participate in the Centers for Medicare & Medicaid Services Innovation Center’s Pioneer Accountable Care Organization (ACO) program. Since it was founded in 1992, Brown & Toland has continuously improved its infrastructure so it can manage the needs of multiple populations in different commercial and senior health plan products.

Working together, Brown & Toland and Aetna have incorporated the cost and quality accountability model, as well as coordinated care, into Aetna’s commercial PPO products.

The coordinated care model draws from Brown & Toland’s proven care management services that have achieved better quality outcomes and cost savings for many employers and payers across multiple lines of business.

The collaboration significantly improved efforts to assist Aetna members in receiving outpatient services from preferred, cost-effective facilities that resulted in lower overall costs, including lower member out-of-pocket costs. In the third year of the collaboration, through interventions, education, and outreach, the number of outpatient radiology services performed at these facilities increased by more than 8 percent.

In addition to savings on outpatient radiology costs, the generic prescribing rate for the population improved significantly, increasing by more than 9 percent from the first year of the program to the end of the third year.

Mutual accountability in the payer-provider relationship is critical to achieving consistent positive results across various metrics. With enrollment in ACO programs expected to grow in the next few years, establishing a shared goal in the accountable care collaboration between payers and providers that ties to the Triple Aim—better patient experience, better population health, and lower cost of care—has proven to be a formula for success. o 48 l CAPG HEALTH

Fall 2016

Pamela Laesch, MD

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4373

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-1

4013

-2

3923

-3

3833

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3743 25

30

35

40

45

50

55

60

65

70

75

80

85

3653

Age (years) SOS Results: 4116 (m/s) T-score: -0.4 (Number of standard deviations from the mean of healthy young adults) Z-score: 0.3 (Number of standard deviations from the mean of age-matched population)

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Fall 2016

CAPG HEALTH l 49

Evolution of the Capitated Model...continued from page 39

Finally, we must all embrace the rapid emergence of mobile health, where consumers rely on mobile devices to research all sorts of health information and, increasingly, to obtain their actual medical treatment.

The biggest advantage for any start-up organization in 2016 is the vast amount of knowledge available from numerous organizations that have passed this way long before, making the learning curve not nearly as steep or long. That said, there is a big difference between textbook learning and actually developing the processes and systems and evolving those over time. Without question, the next five to 10 years will be a transformative time for our industry as provider organizations create new care models to meet the needs of a very diverse population. o

Creating Practical Solutions...continued from page 41

another layer of monitoring, and we can expedite treatment to correct these issues as identified.

In prominent value-based environments, how are clinical metrics tracked, refined, and evaluated, and progress monitored?

Metrics are housed within our report center. We review them with the operations teams and NP staff, along with support staff, to show them areas where we are improving and ones that need more attention. We focus not only on “hard” metrics, such as length of stay and readmission rate, but also quality metrics such as catheter rates and infection rates.

How does your organization achieve cost savings and/or positive return on investment for project sustainability?

Leveraging the right teammate for the right role; i.e., do you need a physician doing this? Can an NP with appropriate physician oversight provide expanded clinical capacity? This also pertains to care coordinators and nurses, whereby all teammates are doing the appropriate level of work they are qualified to under proper guidance. You build your support and cost structure for these things, and this leveraging ensures you can make them cost-effective. Inherent disadvantages of setting up a special-needs plan are high fixed costs. In the beginning, these costs are spread out across a small population of members, so we have to invest money until we reach a sufficient scale of patients.

What are the key clinical, administrative, and health policy accomplishments thus far?

This project has fostered an environment of cooperation, teamwork, and refinement among DaVita; corporate HealthCare Partners, a DaVita Medical Group; and local 50 l CAPG HEALTH

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Definition: “Capitated/delegated model”—where an organized physician group (medical group, independent practice association, or hybrid) that includes primary care physicians and all key specialties is delegated for the medical and administrative responsibility of providing professional and outpatient ancillary services in exchange for a monthly per-member permonth payment (a capitation payment). Under this model, hospital services are often the financial responsibility of the health plan that enters into a risksharing model with the medical group, where hospital costs are compared to a budget and the medical group participates in both the surplus and deficit sharing.

1

Lawrence Casalino, MD, PhD, and James Robinson, PhD, MPH, “The Evolution of Medical Groups and Capitation in California,” Kaiser Family Foundation, 1997, 8-9.

3 Ibid., 10-11.

4 Ibid., 11, 13.

5 Ibid., 8.

6 Ibid., footnote 3, 46.

7 Ibid., 9.

8 Ibid., 10.

9 Ibid., 32.

2

10

Ibid., #4, 34.

clinical regions. We have observed reductions in readmission rates and cost of care while enhancing quality and the impact of integrated kidney care on these populations. With a nurse and NP coordinating care, more time out of the hospital means more time spent with loved ones. We are able to help our patients reach their personal goals, such as going back to work or getting a kidney transplant.

There is a Japanese saying, “Fall seven times, stand up eight, life begins now.” What were the principal barriers of this program, and how did you facilitate practical solutions?

Potential barriers can be addressed by transparent communication to obtain information from stakeholders.

With any new insurance plan, there is a barrier of education and getting patients and providers comfortable with the structure. We were dealing with assumptions regarding SCAN and HealthCare Partners, a DaVita Medical Group; providers who typically did not “take” SCAN or were not in the HealthCare Partners, a DaVita Medical Group network assumed that this was true for the new plan. We had to continuously educate providers on the differences with this new program, which significantly expanded access. o Dr. Rajesh Gade is a Medical Director and Janelle Howe is Senior Director of Health Enhancement, both at HealthCare Partners, a DaVita Medical Group. Dr. Jeremy Rich is Director of the HealthCare Partners Institute for Applied Research and Education and can be reached at jrich@healthcarepartners.com.

Acknowledgments: Special thanks to Choi Siegel, GNPBC, Nurse Practitioner Manager, HealthCare Partners, a DaVita Medical Group, and Mesbah Ahmad, Director of Clinical Operations, DaVita VillageHealth, for their valuable contributions. We gratefully acknowledge our patients, their caregivers, and our teammates who partner together for enhanced health and wellness.

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CAPG HEALTH l 51

Making the Shift to Alternative Payment Models Brown & Toland Physicians and our network of doctors are uniquely positioned to impact the total cost of care and improve patient quality outcomes as reimbursements move to risk-adjusted payment and alternative payment models.

As a physician-led organization, we have succeeded in saving on healthcare costs and improving patient outcomes. We have achieved this through the use of technology, care management programs, enhanced operations and incentives, all to ensure our physicians receive reimbursements tied to outcomes and the risk-severity of care delivered to their patient populations.

This “recipe for success” works well. The Voice of Accountable Care, CAPG, has named Brown & Toland an “Elite” medical group for 10 consecutive years. Brown & Toland also participates in numerous accountable care projects for HMO and PPO patients, and the company generated more than $15 million in savings and improved care for more than 17,000 Medicare patients in the Centers for Medicare & Medicaid Services’ Pioneer Accountable Care program.

Brown & Toland’s successful accountable care track record will help our doctors navigate healthcare payment reform and continue to serve patients in the community. To learn more about Brown & Toland Physicians and our programs, visit brownandtoland.com.

Keeping the San Francisco Bay Area healthy for more than 20 years

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