health
Volume 11 • No. 2 Summer 2017
Annual Conference Issue
Robert E. Moffit, PhD Federal Tax Policy: The Unfinished Business of Health Care Reform, p.12
Risk Contracting in Medicare Advantage Improves Survival, p.18
An IPA’s Rationale in Pursuing Alternative Payment Models, p.20 For your organization, KNOWING is transformative.
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CAHPS® and HEDIS® are registered trademarks of the National Committee for Quality Assurance (NCQA). table of contents 4 4 written permissionisstrictly prohibited. Reproduction inwhole or inpartwithout All rightsreserved. its authorsarenottheresponsibilityof Opinions expressedorfactssuppliedby © 2017, CAPG Health CAPG Health CAPG accuracy ofthearticles publishedin precautionistakentoensurethe Every class mailpaidinJeffersonCity, MO onrequest.Advertising rates Bulkthird two years;$3singlecopy. Subscription rates: $32peryear;$58 [email protected] For advertising, pleasesendemailto 1620, Los Angeles, CA90017 CAPG Health, 915 Wilshire Blvd., Suite orc/o inquiries [email protected] Please sendpressreleasesandeditorial capghealth.com Phone 916.761.1853 PO Box 674, Sloughhouse, CA 95683 Valerie OkunamiMedia Health CAPG Bart Wald, MD Diane Stewart Mosini Sinha, MD Amy Nguyen Howell, MD, MBA Robert E.Moffit, PhD Mara McDermott Melanie LiteMatthews Aloke K.Mandal, MD, PhD Joshua Liberman, PhD Sayeed Khan, MD Scott C. Howell, DO Dilesh Doshi, PharmD Don Crane Bill Barcellona Amy Adome, MD, MPH Contributing Writers Nelson Maldonado Editorial Assistant Kobata Daryn Editor Managing Partners KayPayne,Mary Arch Health Amy Nguyen Howell, MD, MBA Lura Hawkins, MBA Editorial Board Advisory Don Crane Editor-in-Chief Valerie Okunami Publisher l capg health health capg CAPG Health Health CAPG Magazine. ispublishedby Magazine Magazine. health Magazine. Summer 2017 Summer T CAPG MemberList 24 Alternative Payment Models An IPA’s in Rationale Pursuing of Physicians Southwest Washington: Spotlight Member CAPG 20 Status Check MACRA Federal P 16 Darned So are “Why P 14 Upcoming E 10 Names intheNews 8 From thePresident 6 Departme C Robert O olicy Briefing he Unfinished hanging n the C the ’s SecondYear: Implementation P olicy Update rovider Directories H vents ard to Get E . Moffit, PhD ov F n ederal R t er er ight?” s B 12 usiness of Health T ax Policy: 26 Improves Survival R 18 f Outcomes—A Holistic Approach Holistic Outcomes—A Patient Superior and Quality Organizational 34 Value California in Healthcare Improve Members CAPG and Collaborative Quality California 32 Rates Screening Cancer Colorectal Boosts Engagement Patient Improving 30 P A 28 H R hysician Burnout esearch P esearch isk Contracting in n Urgent Case: ealth M ealth eat anagement Challenges anagement u artnerships T artnerships re s T reating and C M are Reform edicare edicare ackle P ackle A P dvantage dvantage reventing opulation opulation
From the President A Message from Donald Crane, President and CEO, CAPG
CAPG members and friends,
Welcome to the CAPG Health 2017 Conference edition. This special issue includes several articles contributed by speakers at the CAPG Annual Conference 2017. I hope they’ll inspire and engage you, whether you’re able to attend the conference in person or in spirit.
The Conference theme—From Volume to Value in the New World Order: What Now?—reflects the current embattlement of healthcare under a new administration. With the Affordable Care Act’s fate still up in the air, many are feeling anxious and wondering in particular if the move to Donald Crane, CAPG President and CEO value will go on.
CAPG is committed to ensuring it does. In spite of the political fighting, the value movement has drawn strong bipartisan support, shown in the near-unanimous Congressional passage of MACRA (the Medicare Access & CHIP Reauthorization Act). This almost unheard-of accord confirms that 1) While they disagree on the how-to of healthcare reform, both parties agree it’s imperative; and 2) Both recognize what CAPG members have long known: Moving to alternative payment models is a proven nonpartisan solution for improving care delivery and cutting costs.
Our resolve to stay the course is more important than ever. CAPG continues to strongly advocate for value, as well as develop education and resources to help physician groups thrive in MACRA and APMs. Along with the Annual Conference and CAPG Colloquium (www. capgcolloquium.com), November 8-10, we recently launched our complimentary Educational Series 2017: Quality Payment Program Webinars with CMS (www.capg.org/qpp). Under a cobranding agreement with the Centers for Medicare & Medicaid Services, the webinars combine the agency’s MACRA expertise with CAPG members’ knowledge of its implementation on the ground. I also invite you to visit capg.org to find additional resources and publications such as our Guide toAPM s, Risk Readiness Tool, and Pharmacy Case Studies.
Regardless of the political ups and downs, CAPG is convinced that value will win the day—and we’ll continue working hard to advance the movement and help our members succeed. o
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The MemorialCare Medical Group office, located in Welcome to Our Newest Members Suite 2100, is staffed with 15 healthcare providers including board-certified OB/GYNs, certified nurse CAPG warmly welcomes these members who have midwives, and board-certified primary care physicians recently joined: specializing in family medicine, internal medicine and pediatrics. Laboratory, digital x-ray, ultrasound, non- Organizational Members stress test services and retail pharmacy services are Advantage Medical Group, LLC, Orlando, FL available on-site for patient convenience. For more Agilon Health, Long Beach CA information, call 1-800-MEMORIAL (636-6742). Jade Health Care Medical Group, Inc., San Francisco, CA OCMMC also was recently recognized for its dedication New England Quality Care Alliance, Braintree, MA to patient safety with an “A” Hospital Safety ScoreSM Primary Care of St. Louis, LLC, Ballwin, MO by The Leapfrog Group, an independent national PriMed Physicians, Cincinnati, OH nonprofit run by employers and other large health Tri Valley Internal Medicine Group, Murrieta, CA benefit purchasers.
Corporate Partner “We are extremely proud to receive another top Continuum Health Alliance, Marlton, NJ grade in patient safety, which validates our tireless commitment to the well-being of our patients and Affiliate Partners served communities,” said Marcia Manker, CEO of Canvas Medical, San Francisco, CA OCMMC. “Providing the highest quality care and patient Synergy Pharmaceuticals. Rossmoor, CA safety remains among our top priorities and it is our responsibility to continue to enhance our efforts.” Associate Partner An “A” grade is one of the most meaningful honors HealthAxis Group, LLC, Tampa, FL a hospital can achieve, and one of the most valuable indicators for patients looking for a safe place to receive care. The Hospital Safety Score, the gold News from Orange Coast Memorial standard rating for patient safety, is compiled under Medical Center guidance of leading patient safety experts and administered by The Leapfrog Group. The first and only Orange Coast Memorial Medical Center (OCMMC), part hospital safety rating to be peer-reviewed in the Journal of the Southern California–based MemorialCare Health of Patient Safety, the Score is free to the public and System, recently opened a Health and Wellness Pavilion at designed to give consumers information they can use 18035 Brookhurst Street, Fountain Valley. The new facility to protect themselves and their families when facing a provides the community access to high-quality medical hospital stay. care and specialty services: o • memorialCare Medical Group • Orange Coast Memorial Center for Spine Health • memorialCare Heart and Vascular Institute • Orange County Brain and Spine Group • Orthopedic Surgery, Sports and Pain Center • Orange Coast Memorial Outpatient Pharmacy • pain Medicine Associates • the Coast Resource Center • Community Conference Center
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Transactions involving securities are completed through Brown, Gibbons, Lang & Company Securities, Inc., an affiliate of Brown Gibbons Lang & Company LLC and member FINRA. bglco.com 10 10 l capg health health capg upcoming events C C Tr C Wednesday, September 27 anHum Reso C Wednesday, September 27 Gene Diego, locationSan Wednesday, September 20 S Riverside, T I Sacramento, location T S Web T C P T C Wednesday, P T S Wednesday, P C T C Web T F C Saturday, June 24 C Denver, Web C C nlan uesday, September 19 uesday, September 12 uesday, September 5 uesday, July 11 hursday, hursday, hursday, July 20 e u r h AP AP AP AP AP AP an Die tate Gove tate Policy o o olo ont alifo linical d ansfo capgcolloquium.com capgcolloquium.com Washington, Wednesday-Friday, November 8-10 CA capg.org/qpp 2;October Friday, December 1 Friday, July 7; Friday, September 15; Quality CA ima blic Relations an a mm mm Summer 2017 Summer E E E G G G G G G e acerm u x x x r PG PG r r r A d r ittee ittee M al Policy acts a al Me nnual Conference 2017 r
y Emp g arriott Denverarriott A A d M nia C Edu P C ationrm ugust 24 ugust 17 Qu o Re o Re ission Inn ayment olloq A A a ugust 23 ugust 16 r r i ality tical C r m cational H e P n ur o e Re C g g yatt yatt be m mm o ionalg Meetin ionalg Meetin T ces ces P r ent P ui C mm r BD T rogram Webinars with C actice R L g s C BD o C um ittee egency on Capitol ea T h a ionalg Meetin mm ollabo ittee ech Center C r i p 2017 d d r o e S — ittee Ma e o mm C e r S gr o r s o r ies 2017ies ittee mm h u a r keting i m t ative p h ittee
s C M e o r onday, H mm n ill M ittee S C C C Web T A Chicago, location T Mi C Wednesday, 4 October C P T P P T N Oakland, T Gene Web T F H T T Web T S P T S C T S L Wednesday, November 1 P C T C C T C Orlando, location T S P T N uesday, 10October uesday, 3 October uesday, 3 October uesday, November 28 uesday, November 14 uesday, 17October uesday, 10October hursday, 5 October hursday, September 28 hursday, December 14 hursday, December 7 hursday, November 30 hursday, 19October hursday, 12October ocation exas Re exas e ortland, location ortland, hiladelphia, location hoenix, location hiladelphia, location r h AP AP AP AP PM o o tate Policy tate Gove ollabo o o ont alifo linical ouston, location o o d d ima a u u mm mm r r west Re west E E E G G G G e acerm u t t t t C x x x r h h h h r r r o ittee e al Policy acts east Re east al Me west Re west east Re east west Re west r y T r H mm nia BD cial ilton Oakland C r Qu g a ative ittee ionalg Meetin r r g ality tical C m e P n ACO ionalg Meetin o T C T T be T T m BD g g BD BD mm o g BD g BD BD r ent P ionalg Meetin ionalg Meetin C ionalg Meetin mm r ionalg Meetin T T actice
L s C o BD BD C ittee ea h a o mm A ittee r i irport mm p d r e — ittee e o C r ittee gr N Tr o s o mm h ansfo a r i m t p h ittee
s C e o r mm n ationrm ittee Colloquium 2017
Healthcare Reform: The Saga Continues November 8-10 | Washington, DC Register now! capgcolloquium.com
Featured Sessions
Representative Joseph R. Swedish Greg Walden, R-OR Chairman, President, and CEO, Keynote Address Anthem, Inc.
Senator Ron Wyden, Panel: Is Past Prologue? D-OR Moderated by Donald Crane, Keynote Address President and CEO, CAPG
Healthcare Reform Pearls of Wisdom: Debate—R vs. D Extraordinary Innovations Moderated by John Michael in Coordinated Care Gonzalez, Principal, Peck Moderated by Mara McDermott, Madigan Jones VP of Federal Affairs, CAPG
Fall 2016 capg health l 11 on the cover Changing Federal Tax Policy: The Unfinished Business of Health Care Reform
by Robert Emmet Moffit, PhD
Health care is the Rubik’s Cube of domestic policy. Policymakers struggle to neatly align measures that will expand access, control cost, and improve quality—often achieving one of these goals, but falling short on the others.
Consider the Affordable Care Act of 2010 (ACA). President Obama’s signature legislative achievement significantly expanded health insurance coverage, estimated at roughly 20 million newly insured persons (mostly through Medicaid). However, for millions of individuals, businesses, and families, it failed to control insurance costs, particularly in the individual and small group markets.
Nationwide premiums for standard plans have increased by an average of 25 percent1 and persons in those markets have experienced shocking deductibles—$6,092 for single and $12,383 for low cost “bronze” coverage, on average.2 In the ACA exchanges, competition has declined3 to the point where almost 70 percent of U.S. counties have only one or two insurers. Meanwhile, those enrolled in smaller-than-anticipated exchange “Fixing financing pools must navigate narrow networks. This year has seen 500,000 fewer enrollees than in 2016. The law’s individual mandate proved feckless. Based on 2015 data4, for example, begins with 6.5 million persons paid the mandate penalty and 12.7 million got exemptions.
fixing tax policy. Now, consider the American Health Care Act of 2017 (AHCA). In March, the House Outstanding Republican leadership unveiled the bill as the first step to repeal and replace theA CA. The AHCA turned out to be a loser on two fronts: cost and coverage. The Congressional economists of Budget Office’s initial assessment5 of the House bill was devastating. Beginning in 2018 and through 2020, health insurance premiums in the non-group market would every political jump between 15 to 20 percent—higher than even the ACA’s skyrocketing premiums. An estimated 24 million Americans would lose coverage by 2026. Congressional persuasion have conservatives were livid over the projected premium hikes, and House Speaker Paul Ryan highlighted the pulled the bill.
inequity and Collision Between Supply and Demand inefficiency Expanding access and coverage on the demand side and imposing payment and delivery reforms on the supply side cannot in themselves secure better care at lower cost. Forget of the federal high quality health care through better central planning. tax treatment Americans will benefit from a normal collision between the forces of supply and demand in the health care sector. That collision happens when consumers control the flow of of health health care dollars, including insurance dollars, and compel intense competition among both plans and providers, resulting in information on price and performance being broadly insurance.” available in a fully transparent market environment. Fixing health care delivery before fixing health care financing is putting the cart before the horse.
Fixing financing begins with fixing tax policy. Outstanding economists of every political persuasion, including the late Nobel Laureate Milton Friedman, have highlighted the inequity and inefficiency of the federal tax treatment of health insurance. By exempting money spent on employer-sponsored health insurance from any taxation, Congress continues to frustrate normal economic incentives to control health costs, either on the
12 l capg health Summer 2017 part of employers or employees. Business health benefit insurance that can be taken from job to job and through expansions, whatever their cost to businesses, became a different stages of life—where health changes and the large chunk of tax-free compensation for employees. As utilization of medical services normally increase. Michael Douglas Elmendorf, former Director of the Congressional Tanner, a senior fellow at the Cato Institute, neatly Budget Office (CBO), has observed6: summarizes the benefits of reform:
Many analysts would agree that our current tax The lesson is clear: Changing the tax treatment of treatment of health insurance is an important part of insurance will help solve two of the most important the problem, and that reforming that system would problems facing the health care system in the United be a key component of a broader solution. Reforms States. By encouraging Americans to move away from that promote broad coverage and high-value care can first-dollar third-party insurance, changing the tax code foster innovation and quality and help our health care will help reduce health care costs. Moreover, it will dollar go further. break the link between insurance and employment, thereby helping to extend coverage to the uninsured.”
Issues with Current Tax Policy If the liberal Gruber and the libertarian Tanner, the ultimate The current tax policy encourages systemic over-insurance. strange bedfellows, can agree, Congress should take note. Even routine, predictable medical services are covered by insurance, driving up health care costs. Jonathan Gruber, professor of economics at MIT, was incorrect in predicting lower costs7 in the ACA’s individual markets, but his analysis of the economic impact of the current tax policy8 is right on the mark:
The tax exclusion of employer expenditures from individual taxation has three flaws. First, $250 billion per year is an enormous sum of money which could be more effectively deployed elsewhere, especially through alternative approaches to increasing insurance coverage. Second, this is a regressive entitlement, since higher income families with higher tax rates get a bigger tax break; National Tax Credit System about three quarters of these dollars go to the top half of the income distribution. Third, this tax subsidy Congress should replace the existing tax exclusion makes health insurance, which is bought with tax- with a national tax credit system, which would address sheltered dollars, artificially cheap relative to other simultaneously problems of cost and coverage. Senator 9 goods bought with taxed dollars, leading to over- John McCain has provided a particularly attractive model insurance for most Americans. As a result of these for this approach. Individual tax relief for health insurance, limitations, no health expert today would ever set up a as Senator McCain has prescribed, would not only expand health system with such an enormous tax subsidy to a private coverage, but also reduce dependence on Medicaid. particular form of insurance. It would foster personal choice, portability, and ownership of health plans, enhancing continuous coverage and care. Households, not employers, pay 100 percent of the nation’s It would unleash intense and unprecedented competition health care costs. Because every dollar spent on health among insurance carriers, who would contract with the benefits is a dollar less for wages and other compensation, most efficient and effective medical professionals to secure the current policy contributes to sluggish wage growth. A the best medical outcomes and the highest value for health change in tax policy would help to reverse that pattern. care dollars.
Beyond undercutting rational cost control, current Such market dynamics would intensify consumer demands federal policy distorts the health insurance market, and for transparency of price and performance on the part is incompatible with fully portable and affordable health continued on page 36
Summer 2017 capg health l 13 Policy Briefing “Why are Provider Directories So Darned Hard to Get Right?”
By Bill Barcellona, Senior VP for Government Affairs, CAPG
Many states are grappling with the problem of inaccurate provider directories and the inability to track physician participation in health plan networks. Recently passed state and federal laws have aimed at improvement, but to date only modest progress has been made. CAPG has been in the lead nationally to develop a solution to this problem, and we have a few observations and suggestions.
We jumped into the fray in 2014 during the passage of California’s SB 137. The new law was implemented on July 1, 2016, and requires all health plans to validate their provider information at least annually. The first annual deadline, July 1, is approaching. Some issues are expected. For example, health plans have largely overlooked the fact that no matter how they handle their internal provider information validation process, every other plan does it differently.
From the provider side, it’s a mess. Most physician groups contract with 12 to 25 different plans. Complying with each plan’s vague and imprecise process is mind-bending. Individual physicians have it even worse: Typically, they directly contract with several additional PPO payers— sometimes as many as 35 total plans. Individual providers have no means to begin to comply with so many differing processes.
I attended an excellent seminar on the directory issue sponsored by the California Association of Health Plans in April—and health plan compliance staff were complaining of only 30 percent response rates from individual physicians. So, the most important point in developing a solution is that it must be simple, fast, and automated—through a single reporting portal. Physicians and physician groups need a once-and-done means of reporting.
The new directory laws across the U.S. require much more information per provider than ever before. There are commercial market standards, Medicare Advantage, and Medicaid Managed Care—and these are similar, but do contain some varying content requirements. A single reporting portal must accommodate all the information fields required under the main reporting standards.
CAPG advocated for the creation of a cloud-based, statewide multiplan directory that could act as single source of reference for payers, providers, and consumers. California’s Department of Managed Health Care (DMHC) mandated a statewide effort to develop the standards, governance, and creation of such a portal, which led to the formation of the California Provider Directory Collaborative. Work has progressed very quickly and the effort should result in active bid submittals to build and manage the new portal by the end of 2017.
Precision in defining information fields is the next most difficult issue. Something as simple as a “primary telephone number” field can elicit responses that are often 19 percent inaccurate across a reporting physician population. Many directory standards now require the listing of phone numbers at all the locations at which an individual physician practices within that plan’s network. That 19 percent number
14 l capg health Summer 2017 correlates with the incidence of physicians who practice information validation on behalf of 41 CAPG member at multiple locations. Individual physicians may not always physician groups for 13 specific health plans. You’ll notice know which number to report when they practice in a large amount of variation and omission across the plan differing locations. Forms and fields that more precisely community in the specific fields for data collection. Some define the requested information must be developed plans have been very helpful in improving the information and standardized, so responders can supply the same reporting process, while others have not. Regardless, answers to each of their contracted payers. Over time, CAPG members have found a cheap, simple way to standardizing fields for individual phone numbers, comply with the new process. Meanwhile, state regulators location phone numbers for multiple locations, multiple are watching the compliance efforts very closely. tax identification numbers, and facility names have systematically reduced errors in reported information. Fortunately, just prior to the enactment of SB 137, CAPG found a very able partner in Gaine Healthcare. Another significant problem arises from the failure of Gaine worked with our members to create a web-based plans to recognize the difference in how data should be reporting portal that acts as a registry of provider collected between an individual physician and a physician information, called Sanator. Our members subscribe group. We’ve observed several examples of plans directly to the portal and report their roster information contacting independent practice associations to obtain to Gaine. Gaine processes and reports the validated a validation of an individual physician’s direct contract roster information to all the provider group’s contracted with a PPO plan. The physician group doesn’t have the health plan payers in each required format. Gaine has contract responsibility for the individual provider and can’t also developed specific reporting standards applicable respond on their behalf. to provider group reporting that have been recognized by the California Provider Directory Collaborative. We We think the problem stems from an inability within the are now working to have these standards adopted by the plan’s various departments to link their contract database California DMHC and California Department of Insurance, to their contracted provider network information. With the later this year. Find more information at https://plus. number of tailored networks proliferating rapidly, it will google.com/communities/112670235620127621740. become critical to accurately list the physicians within narrow and specific product networks where a single plan Last year, Gaine Healthcare began providing briefings has multiple networks. The new California law requires at several of our CAPG regional meetings across the plans to send a list of individual providers (a group country. It is now engaged in several pilots between “roster”) to the provider group that correlates any variation plans and CAPG member groups to help shape the by product, network, and individual provider. So far, we’ve development of more accurate provider directory only seen a handful of plans that can accurately tie their reporting. contracted product and networks to a provider group roster. This remains one of the biggest problems for We want to thank Gaine Healthcare, the developer of the health plans to solve before they can reach compliance Sanator provider registry, for supplying the data used in with the new directory laws. this article, as well as for their superb work in solving so many of these problems for our subscribing members. The table below represents findings to date by Gaine More information on the provider directory findings is Healthcare during the first nine months of provider available at www.providerregistry.com. o
Summer 2017 capg health l 15 Federal Policy Update MACRA’s Second Year: Implementation Status Check
by Mara McDermott, Vice President of Federal Affairs , CAPG
In the shadow of the American Health Care Act (AHCA), the Medicare Access and CHIP Reauthorization Act (MACRA) has remained largely untouched. The AHCA, House Republicans’ bill to repeal and replace the Affordable Care Act (ACA), envisions significant change to the individual market and Medicaid, among other things. But efforts to repeal and replace have, to date, left untouched the delivery system reforms that were set in motion by the ACA and built upon by MACRA.
MACRA implementation and the value movement are critical to building an affordable, efficient healthcare delivery system. The value movement is intended to eliminate waste, encourage primary care and prevention, and increase accountability for quality and cost. The new system will be designed to keep patients healthier, reduce unnecessary utilization of services, and eliminate duplicative services. It will strive to ensure that patients are treated in the most appropriate, lowest-cost setting, and focus on coordinating care across different providers. The potential for the value movement is a better system of care delivery for Medicare, and eventually, across all payers.
Now entering its second year of rulemaking, the Administration has important choices to make about MACRA implementation. The choices they make can accelerate or decelerate the transformation of the healthcare delivery system.
MACRA Refresher MACRA creates two options for physician payment in traditional Medicare. The first, the Merit-based Incentive Payment System (MIPS), creates a budget- neutral pay-for-performance program for traditional Medicare. Eligible clinicians will be judged across four categories: quality, cost, improvement activities, and advancing care information (previously meaningful use). Clinicians will be arrayed based on their score across these four domains. Physicians who exceed a certain threshold of performance will receive either a zero percent update to their payment or a positive adjustment. Those below the threshold will receive a negative adjustment. In general, MIPS is “budget neutral,” which means that the money from those below the threshold forms the pool to pay bonuses to those above the threshold. If there are no “losers” there will essentially be no money to pay bonuses to “winners.”
There is one exception to this general principle, which is the exceptional performer bonus. The Centers for Medicare & Medicaid Services (CMS) has an additional pool of funds to pay out to those with exceptional MIPS scores.
The second pathway is the Advanced Alternative Payment Model (APM). Physicians who participate in advanced APMs are eligible for a five percent bonus on their Part B covered services. To achieve this bonus, the APM entity
16 l capg health Summer 2017 must exceed a certain threshold of risk – either 25 This need to move from MIPS to APMs is percent of their Part B revenue or 20 percent of their exacerbated by the flat fee schedule updates that Part B patients. A handful of models through the occur beginning in 2020. The zero percent update CMS Innovation Center and the Track 2 and Track 3 to the fee schedule, combined with small MIPS Medicare Shared Savings Program ACOs have been adjustments, means a likely difficult landscape for deemed qualifying APMs. physician payment in future years, and an additional driver toward accountable care models.
Balancing the Competing MIPS However, for CMS to achieve the promise of MIPS in Interests of Small Groups and Large its second implementation, the agency must rapidly Groups implement new, qualifying APM options. The existing For 2017, CMS announced “Pick Your Pace.” Under options do not accommodate a wide enough variety this approach to MACRA implementation, CMS of models and practice types. offered many options for physicians to phase into the Quality Payment Program (QPP). Eligible clinicians CAPG is advocating for two specific fixes in this can submit a minimum of data in 2017 (for example, regard. The first is to encourage MC S to count risk one quality measure or one improvement activity) relationships between plans and physician groups in and avoid a downward adjustment. By submitting Medicare Advantage as risk relationships toward the “something” clinicians can avoid penalties under MACRA threshold requirements. Under our concept, MIPS. to qualify as advanced alternative payment models, contracts between health plans and physician groups The policy has set a low bar for the first year of would have to meet MACRA’s criteria around (1) MACRA. As a result, CMS anticipates that very more than nominal risk; (2) accountability for quality few physicians will receive a penalty. This policy is metrics; and (3) use of certified electronic health intended to increase buy-in and reduce penalties for records. This model would increase the number solo practitioners and small groups. of physicians who can qualify as advanced APM participants and escape from MIPS. But we anticipate that the effect of this policy will be to nearly zero out the MIPS pool. Because MIPS is The second CAPG strategy is to design new budget neutral, there will be very little in the way of advanced APMs that bear significant risk. We bonus money to pay out to those that have invested have advocated for the creation of a capitated for success in CMS performance measurement accountable care model: CAPG’s Third Option. programs. While this policy choice was likely This model would fill an existing gap in the MC S necessary for the first year, when MACRA was new, it Innovation Center portfolio by providing an option is critical that CMS stays the course with the Quality for physician organizations that are ready to take a Payment Program and continues to increase the capitated payment for their Part B patients. And the requirements and the standards for performance in model would provide additional tools to encourage future years. This means phasing in the cost measure, beneficiaries to receive care within the ACO network. increasing the number of measures that must be reported, and increasing the level of accountability in Both policy changes would allow more CAPG MIPS over time. members to qualify as advanced APM participants and avoid MIPS adjustments or flat payments.
Increasing the Availability of Alternative Payment Models Conclusion In the development of MACRA’s legislative text, it As we await MACRA’s next round of regulatory seemed clear from the beginning that MIPS was implementation, we know that CMS has some difficult intended to guide physicians and physician groups to choices to make. We look forward to working with the alternative payment models and away from fee-for- Administration to share our members’ experiences service. The idea was that MIPS would become so around MIPS and APMs and to share what is working undesirable that it would serve as an additional push and what needs improvement. CAPG will continue to into models that did not use the flawed “pay per click” serve as a resource for both the government and our methodology. members as MACRA moves forward. o
Summer 2017 capg health l 17 Risk Contracting in Medicare Advantage Improves Survival
By Scott C. Howell, DO, and Aloke K. Mandal, MD, PhD
In a seminal paper, “Value-Based Contracting Innovated Medicare Advantage Healthcare Delivery and Improved Survival,”1 published in the American Journal of Managed Care, we tested the hypothesis of payer-provider risk contracting promoting high-value care within Medicare Advantage (MA). This program has grown significantly, now representing over 30 percent of allM edicare enrollees. With different statutory authority, private Medicare Advantage organizations (MAOs) perform an annual risk-adjusted competitive bid process based on a county fee-for- service benchmark.
Familiar to many CAPG members, the Centers for Medicare & Medicaid Services (CMS) reimburses MAOs with prospective, monthly, severity of illness, or risk- Scott C. Howell, DO adjusted, capitated payments. CMS adopted a risk–adjusted methodology as part of the Balanced Budget Act of 1997, in response to favorable selection bias reducing incentives for MAOs to enroll healthier members.
The subsequent Benefits Improvement andP rotection Act (BIPA) of 2000 required implementation of the hierarchical condition category (HCC) payment model, better known as the CMS-HCC model. This model recompenses MAOs based on disease burden, demographic factors, and Medicaid eligibility status. In return for providing healthcare benefits toMA enrollees during the calendar year (CY), MAOs receive risk- adjusted payments based on the CMS-HCC model during the following payment year, modified by a risk adjustment factor RA( F). The RAF coefficient is predictive of future healthcare Part C expenditures for the following year.
Aloke K. Mandal, MD, PhD Section D1854 (a)(6)(B)(iii) of the Social Security Act prohibits CMS from requiring an organization to contract with a particular healthcare provider or to use a particular price structure for payment under such a contract (the “non-interference clause”). As a result, CMS is not involved in pricing or contract discussions between MAOs and participating providers. Given the CMS-HCC model, MAOs have the unique ability to provide percent of premium contracting downstream to medical groups. This model offers both stability and transparency, enabling medical groups to typically contract between 30 percent to over 80 percent of the MAO premium. This unique contracting capability allows for downstream innovation at a local provider level—the core business unit of healthcare. Because little has been written on the impact of such risk-based contracting on generating cost efficiencies and improving clinical outcomes, it was our intent to study this aspect of the MA program.
Much has been written on cost savings and quality improvement in different delivery systems of accountable care organizations (ACOs) or the patient-centered medical home (PCMH). In many reviews, the methodology has used a future expected cost to evaluate the performance of the delivery system over a time period duration. To truly evaluate the performance of a delivery system, a control and interventional group with similar characteristics must be compared over time. The healthcare industry has developed a set of outcome measures of quality and efficiency.M any reported studies do not take the next step of asking whether these outcome measures impact the ultimate quality indicator, namely survival.
18 l capg health Summer 2017 To determine if risk-based contracting improved emergency department visits (P <.001) and inpatient clinical outcomes, we chose to analyze statistically hospital admissions (P = .002) decreased. This change similar groups of MA enrollees within one metropolitan in utilization saved $2,071,293 per 1,000 enrollees. statistical area, who were cared for by two provider Of most significance, as depicted in the right panel of groups with two different contracting arrangements. the figure, the interventional group through practice One provider group was reimbursed through a standard transformation was able to demonstrate a six percent fee-for-service schedule (control group) and another survival benefit with a 32.8 percent lower hazard of through risk-based contracting with full-risk capitation death (P <.001). (interventional group). Specifically, starting in 2009, for intervention-group MA enrollees, the MAO and a This study supports risk-based contracting by provider group agreed to full-risk capitation combined demonstrating superior clinical outcomes and a survival with a revenue gainshare. For the control group, the benefit. T he recent proposals of including 1115A MAO continued to reimburse another provider group waivers for average manufacturer prices (AMPs) in MA through fee-for-service. The two medical groups were may accelerate the development of further risk-based subsequently followed for a four-year period until contracting to achieve the Triple Aim and improve the December 31, 2012. lives of our patients. o
The interventional group used the CMS-HCC model as Scott C. Howell, DO, is Executive Medical Director, a guide to identify and stratify members with certain Heritage Provider Network. Aloke K. Mandal, MD, PhD, disease states, such as congestive heart failure, chronic is Medical Director, for the Risk, Quality, and Network obstructive pulmonary disease, and complex frail Solutions group at Optum. They will participate in a CAPG individuals who were at high risk for hospitalization. Annual Conference panel, MA Improves Survival: The Innovative processes were instituted that had been Ultimate Quality Measure, on Friday, June 23, at 2:30 pm. designed with intense outpatient management, including 1 Mandal AK, Tagomori GK, Felix RV, Howell SC. Value-Based triage systems, coordinated care, and regular contact Contracting Innovated Medicare Advantage Healthcare Delivery and Improved Survival. American Journal of Managed Care. 2017; 23(2): with high-risk individuals. e41-e49. [Initially published on January 10, 2017, as a Web Exclusive at http://www.ajmc.com/journals/issue/2017/2017-vol23-n2/value- As shown in the left panel of the figure, the interventional based-contracting-innovated-medicare-advantage-healthcare-delivery- and-improved-survival/P-1.] group increased office-based visits P( <.001) while
Left panel: A forest plot with incident rate ratios demonstrating the difference in utilization between control and intervention groups. Box sizes are proportional to the precision of the estimated outcomes, with larger boxes representing a greater degree of precision. Right panel: Kaplan-Meier survival curves for the control and intervention groups. Shaded areas represent 95% confidence intervals. A statistical difference in survival first was observed 16 months after the contracting change and continued to diverge through the remainder of the study period. Adapted from: Mandal AK, Tagomori GK, Felix RV, Howell SC. Value-Based Contracting Innovated Medicare Advantage Healthcare Delivery and Improved Survival. American Journal of Managed Care. 2017; 23(2): e41-e49.
Summer 2017 capg health l 19 CAPG Member Spotlight Physicians of Southwest Washington: An IPA’s Rationale in Pursuing Alternative Payment Models
By Melanie Lite Matthews
Established in 1995, Physicians of Southwest Washington (PSW), an independent physician association (IPA) located in Olympia, Washington, has found success in our core business line of managing global risk contracts with Medicare Advantage payers. Throughout our 21-year history, PSW has built and supported a multi-county provider network, launched and sold our ownership in a Medicare Advantage health plan, and ultimately carved out a foundation to support the physician-patient relationship in the independent practice of medicine.
Compared to other burgeoning healthcare systems in Washington State, PSW may be considered small, but nonetheless mighty. At one time it was estimated that 25 IPAs existed across Washington State; today PSW is one of only two remaining.
Navigating Change Initial steps focused As it did for many healthcare organizations, learning to navigate a significantly changing “ landscape became a strategic priority for PSW. In 2016, it also proved pivotal to on evaluating sustaining the organization’s future. Burdened by the growing realization that Medicare nearly every Advantage could no longer suffice as the IPA’s only line of business, our managing board sought to find a new direction. Board members recognized the continued implications of business activity state and federal policies facing physicians, and understood how these changes would and operation to ultimately impact the network’s physicians and practices. determine what Adaptable. Flexible. Nimble. worked, what didn’t, These are the strengths of maintaining “small but mighty” status. Our leadership and what needed understood that the ability to innovate would defineP SW’s future. Initial steps focused on evaluating nearly every business activity and operation to determine what worked, what to change to serve didn’t, and what needed to change to serve the organization’s growth and diversification. the organization’s This process included our looking to the Centers for Medicare & Medicaid Innovation (CMMI) for new healthcare models that would deliver value to stakeholders. growth and diversification.” MACRA = Physician Engagement PSW plunged head first into the world of the Medicare Access and PSW’s Review of the Next Generation ACO Model CHIP Reauthorization Act (MACRA) Opportunities Risks and Uncertainties and its pathways of Merit-based • ability to choose risk arrangement • No guarantees to the benchmark Incentive Payment System (MIPS) or • hierarchical conditional categories • New administration and risk to Alternative Payment Models (APMs). (HCC) risk adjustment in benchmarks CMMI’s longevity Over the course of a year, PSW • Waiver options for skilled nursing • early ACO reports not yielding management acted as a sponge, facilities, home health, and telehealth desired cost savings results absorbing everything that could be • Beneficiary engagement via $25 • ability to meet beneficiary learned about MACRA. coordinated care reward requirements year-over-year • prospective attribution • Challenging to change beneficiary This intensive learning enabled • multiple payment options behavior with no parameter leadership to identify that the APMs enforcements
20 l capg health Summer 2017 offered the preferred strategic considerations for both (NGACO) in 2015, but was waitlisted for a year. In hindsight, PSW and our provider network. Strategic considerations this was a beneficial move as it provided us the time to gain included PSW’s strong history of successfully managing risk, additional education and prepare for implementation relating along with the opportunity to gain five percent in additional to the identified opportunities and risks. reimbursement in future years, remove the burden of quality reporting, offer early-adopter leadership, and engage In August 2016, following acceptance to participate in the providers in common purpose and direction to meet desired NGACO model, we fervently began planning implementation results. for 2017. The timeline was short and the action list long; however, between August and December we achieved the Given that physician engagement is always a top priority for following major steps: any critical initiative being considered, we were pleasantly • Finalized NGACO provider network surprised to receive an overwhelming and positive response from PSW’s network in regard to our desire to lead the • Developed and distributed all provider network contracts MACRA effort . Years of industry changes, new models, • Conducted financial modeling and risk assessments and government requirements required many of PSW’s • launched NW Momentum Health Partners (NWMHP) independent practices to choose to either adapt to these ACO, LLC impacts by using scarce resources or accept the financial • Confirmed equity partnership risk. The introduction of MACRA and PSW’s commitment to spearhead a regional APM movement seemingly changed • established the ACO’s board of directors that position overnight. The knowledge and opportunity that Ultimately, the PSW board and ACO board agreed that healthcare providers would come together created much- the official launch of NextGenA CO would be put on hold needed momentum for engagement. until we received the final Centers forM edicare& Medicaid Services (CMS) financial benchmark files, expected in Next Generation late January 2017. This critical data would indicate the ACO Model feasibility—the “make or break”—if we were to move forward.
PSW submitted With all possible data in hand, and risk and uncertainty an application to HOW TO BE waiting in the wings, NW Momentum Health participate in the Partners ACO launched the Next Generation Next Generation ACO in February 2017. Accountable Care SUCCESSFUL continued on next page Organization model IN AN ACO
LEVERS THE ROLE OF THE ROLE OF OF SUCCESS PROVIDERS/PRACTICES NW MOMENTUM HEALTH PARTNERS
BENEFICIARY Provide beneficiaries info on the Provide effective materials for providers ENGAGEMENT Next Gen ACO and the benefit to them and practice staff for care coordination Conduct face-to-face visits to identify Promote CMS $25 member incentive needs and gaps for completing annual wellness visit – Provide health risk assessments accurate HCC coding Coordinate ancillary, home and Refer to PSW as a resource community-based services Refer to PW case management and Promote “care team” family involvement encourage member engagement Serve as conduit of communication between delivery system, patient and provider Be the resource (i.e., Medicaid coordination, advanced care planning, transportation) Identify and resolve gaps in care
PROVIDE TIMELY Same day appointments for sick call Provide material to meet practice needs ACCESS TO CARE Encourage calling after hours Share best practices How and where to access urgent care? Engage members to select PCP/specialists ER PREVENTION Utilize direct admit to preferred, Assist with Skilled Nursing Facilties Skilled Nursing Facilities direct admits Refer to ACO hospital partner Partner with Skilled Nursing Facilities, Home and Community Services, and Home Health
PRACTICE Provide PSW access to EHR system Report quality measures ENGAGEMENT Communicate concerns and Work with ACO hospital partner opportunities Support provider/practice relationships
[ O V E R ] Summer 2017 capg health l 21 continued from page 21 lives to impacting more than 22,000 member lives through a diversified number of contracts, including the Next Within the first two weeks of the launch,P SW connected in Generation ACO. We refer to this achievement and our person with more than 60 physicians, providers, and practice ongoing strategies to redefine the organization via innovation staff on what being in the ACO meant and what their roles as PSW 2.0. would be going forward. Understanding the complexities of MACRA is complicated and overwhelming for practices The CMS Next Generation ACO model fits that need.P SW’s of any size. Our commitment strategy for success is to stay learning curve has been steep, and transitioning from provider-facing, ensure consistent communication, and offer implementation to management of the ACO continues to the “ACO road show” across the network with continued be a major undertaking with questions far outweighing the education and training. answers. However, we applaud CMMI for their continued efforts to create new healthcare models that can be In addition to developing a new ACO website and distributing advantageous for so many. the CMS beneficiary letter and beneficiary cards, we created an ACO toolkit that includes a provider scorecard, As PSW navigates this relatively new model of care, we coding resources, monthly beneficiary attribution lists, and a remain positive that our network of healthcare providers is reference sheet on “How to be Successful in an ACO.” committed to transforming clinical practice with the goal of improving quality, reducing expenditures, and enhancing the The Rearview Mirror patient and provider experience. o Reflecting on the last Melanie Lite Matthews is CEO of year, it’s remarkable Physicians of Southwest Washington, a that we have grown member of CAPG. She will participate in a from taking global GOOD TO KNOW CAPG Annual Conference panel, MACRA: risk for 7,600 about your Checking in With Physician Group Leaders Medicare Advantage ACO and PSW in Year One, on Friday, June 23, at 10 am.
PLAN PSW NEXT GENERATION ACO INFORMATION
Plan type Medicare Advantage Medicare Plan names Health Alliance, Humana Next Generation ACO and Soundpath Health
Geographical area Thurston County Thurston County Patients Member Beneficiary Reimbursement PSW contract Practice’s existing Medicare contract Referrals Yes –as required No Prior authorizations Yes-as required No Claims processing Submit claims to PSW Submit claims to Medicare Credentialing Yes No Care Management Yes Yes SNF Direct Admits Yes Yes ID Cards Yes – Required Yes – Not required Annual Wellness Visit Yes Yes – $25 beneficiary incentive
ABOUT NW MOMENTUM HEALTH PARTNERS FOR MORE INFORMATION Next Generation ACO launched by NW Momentum Health Partners on February 28, 2017 NW Momentum Health Partners 64 Thurston County practices in the ACO Network: NWMomentumHealthACO.com 30 Participating Providers Physicians of Southwest 34 Preferred Providers Washington A qualifying alternative payment model, Next Generation ACO supports: Attribution: the risk-sharing model is based on beneficiary pswipa.com attribution and built around Medicare fee-for-service (FFS) payments. Medicare beneficiaries: 9,025 attributed to the ACO for 2017. 360-943-4337 Beneficiary choice: ACO Medicare patients will see no change 1-877-943-4337 (toll free) in their original Medicare benefits and retain the freedom to see any 360-754 4324 (fax) Medicare provider. 319 Seventh Avenue SE STE 201 Shared savings: Once the ACO succeeds in delivering both high-quality care and spending health care dollars more wisely, achieved savings Olympia WA 98501 will be shared.
22 l capg health Summer 2017 Join us on our journey as we reinvent health care to help keep people healthier and feeling their best.
At OptumCare®, we empower physicians to build and share best practices to improve patient care and outcomes in the communities they serve. We provide tools for modern medicine to help drive value-based care while unburdening care teams from administrative challenges. The result? More time for physicians to focus on what they value most: caring for patients.
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Visit optumcare.com to learn more.
Optum® and OptumCare® are trademarks of Optum, Inc. All other trademarks are the property of their respective trademarks. Optum is an equal opportunity employer. © 2016 Optum, Inc. All rights reserved. 24 24 l capg health health capg CAPG MEMBERS A H H A C New York, New York C San Diego, California C Bend, Oregon C Columbus, Ohio C Beverly C H Colorado A E C M C E C Cypress, California I C Oakland, California B R B Dover, Delaware B Bakersfield, California B A A Buena A L A L A M A A A M A A L A P A L A Orlando, Florida A M A L A L A ORGANIZATIONAL MEMBERS A C San Francisco, California nc. os os ong Beach, California os ong Beach, California ong Beach, California nglewood, Colorado meryville, California rchitrave ccess inole, California edlands, California ustin, lhambra, California lameda, California pple Valley, California ealth Network • ealthCare Network ealth lameda Health Partners ssociation ustin Regional pple ngel Medical Group ltaMed Health llina Health llied Physicians of ll gilon Health ffinity Medical Group dventist Health Physicians dvantage Medical Group, dvanced Medical Management, ccountable Health eaver Medical Group* hinese hinese hildren’s Physicians Medical Group entral entral edars- atholic Health areMount Medical, P anopy Health alifornia Pacific Physicians Medical Group, rown & ayhealth Physician akersfield hoice Medical Group ediChoice I ount inneapolis, odesto, California C A A A are ngeles, California ngeles, California ngeles, California C P K P T M H artners • exas isco, New York ark, California are Medical Group, H O O I edical Group • Community Care I S ills, California P H C A ealth Neighborhoods • T inai Medical Group* regon hio Primary A ealth • oland Physicians* merican ommunity Health PA M F innesota • Seoul amily Medical S M T Summer 2017 Summer ystem ri A ercy I S I H C P nitiatives* rkansas P ervices ealth • UniNet linic* A rimeCare Select • St.
I M H P C C A edical Group ealth Network • A C alifornia are C lliance, are Physicians, H ealth Network • C I P orporation* I LLC K nc. C A C N entuckyOne enter are LLC etwork I nc. M PA L ission uke’s • I P I nc.* A C Covina, California C P C Sayre, Guthrie Medical Group, Newport Beach, California Group, Greater L A Good Bakersfield, California Golden M F E T Scottsdale, E E E Fountain Valley, California E Fajardo, E San Francisco, California Dignity Health P Desert A T Da M C A E C San Juan, C Denver, Colorado Boston, I St. I San Hill Physicians Medical Group, L High Desert Medical Group H Group • • Desert Oasis Desert I California Coastal Care A R Heritage Provider H Hawaii Pacific Health P M • A Group • Family Choice Group • L M H • E Group, Division of DaVita ora Health, nnovare Health orrance , California akeside Community verett Clinic H P ong Beach, California ancaster, California verett, Washington artners • Colorado Springs l ncino, California BQ acey Medical he lta ffiliated Doctors of Orange County • lliance • hoenix, alm Springs, California eseda, California quality Health - l Paso dinger Medical Group ast ealthCare eritage ssociation onolulu, olorado Permanente Medical Group, P itrus igna Medical Group ontinucare onifer Health omprehensive Geriatric edical Group edical Group • ission iami, Florida P remier Care of Northern California • Saint ealthCare L V M aso, ouis, R ita Health P H E ed C amon, California lus • Bakersfield Family P ealth verett S PA oast Medical R V ennsylvania M H H P T H O I P A amaritan Medical Practice egal E M alley nc.* M exas N I ills, California uerto H assachusetts ealthCare ealth Services • • Coastal Communities hysician Network • P ntegral rizona asis Healthcare mpire Managed id Cities I P issouri A ewport Physicians Medical awaii uerto P P artners • rizona artners, Division of DaVita M artners South Florida • JS H C I C nc. I R edical Group • Sierra H ealthcare • Greater Covina linic, P C ndependent Physicians orporation ico P igh Desert F R F S are Partners* hysician Network • California oundation ico oundation* C A olutions P PA Q H H dvocates artners, I are, N M ealthcare • Point • OmniCare ealthCare etwork* edical Group • Family S H S E ervices, ealthCare * I H xceptional Care P M ealth I H A nc.* M PA edical Group • eritage Victor Valley C C edical Group • are, are of , P L P A P artners Nevada akeside hysician Network Z and NY • M artners • I P M nc. A edical Group artners • I I rizona nc.* edical Group H nc. A
ealthCare S M M an Juan edical M M A edical P gnes edical edical H riority T ealth he C MedPoint Management Vega Medicos Glendale, California Maverick Medical Group San German, E Managed L L Doral, Florida L A L L Glendale, California L A L Visalia, California K Walnut Creek, California John Muir Physician P Jefferson Health San Francisco, California Jade Health Coachella Valley Ontario, California NA Walnut Creek, California Muir Medical Group, M New York, New York Mount M Monterey Irvine, California Monarch Health L Molina Medical R P Mid- M Methodist Novato, California Meritage Medical Cincinnati, Ohio Mercy Health Physicians T Memorial H • P P LA Barrio, Inc. • Global Care Group I A Woodland of M Valley • M P San Juan, R P Valley • P Group • ustin, California R oma akewood, California ong Beach, California oma eon Medical akewood akeside Medical Group, akeside hysicians Network • rovider Network, hysicians rimeCare of Sun City • rimeCare lamitos I ccountable edlands Family hiladelphia, goura ockville, ducational, C ealthcare Corporation ey Medical Group, oreno Valley • edical Group • onterey, California emphis, SO R I edwood Community MM PA iverside • A of Puerto Rico* A L • Jewish tlantic Permanente Medical Group, PA lta, L P P inda, California P H S C inda University Health rimeCare of Inland Valley • rimeCare of Corona • rimeCare PA ills, California M • Centinela Valley I inai Health Partners* T P alifornia* H P M M S C ennessee C aryland C uerto B uerto • St. ills, California edical Group • H electos del edical Network • L are Medical Group* P I P ommunity Healthcare P are Management and ay P e ealth Care I ennsylvania rimeCare of San Bernardino • C uerto LLC P A H P P B P C are Medical Group, rimeCare of M I rimary Care ome for the A hysicians of R ractice R P onheur Healthcare enters, M C ary I C
ico ico A M enters* edical Group of Chino • P R are* N edical Group, Inc. • rospect ico H PA etwork P M I ealth Network • Watts N rimeCare of M I nc. PA edical Group • P • Brookshire I etwork* N edical Group M A I • Bella Vista nc. PA orte, ercy R P A A P P M edlands • rimeCare of Citrus I ssociated ging I rimeCare • • nc. rimeCare of edical Group, Inc. E P l I hysicians P nc. P C PA rimeCare of T royecto Del emecula • are • PA P H P M I M P nc. rimeCare remier ealthCare E edical ioneer edical mpire H emet New England Quality Care Alliance Hoag Medical Group • Mission Heritage Medical Group • St. Tri Valley Internal Medicine Group Braintree, Massachusetts Mary High Desert Medical Group Murrieta, California New West Physicians, PC* St. Vincent IPA Medical Corporation UC Irvine Health Golden, Colorado Cerritos, California Irvine, California Northwest Permanente, PC San Bernardino Medical Group UCLA Medical Group* Portland, Oregon San Bernardino, California Los Angeles, California Northwest Physicians Network of Washington, Sansum Clinic* USC Care Medical Group, Inc. LLC Santa Barbara, California Los Angeles, California Tacoma, Washington Santa Clara County IPA (SCCIPA) Valley Care IPA Oak Street Health Foster City, California Camarillo, California Chicago, Illinois Santé Health System, Inc. Valley Organized Physicians Omnicare Medical Group Fresno, California Harlingen, Texas Lynnwood, California Scripps Coastal Medical Center Verity Medical Foundation One Medical Group Oceanside, California San Jose, California San Francisco, California Scripps Physicians Medical Group Washington Permanente Medical Group Pediatric Associates San Diego, California Seattle, Washington Plantation, Florida SeaView IPA WellMed Medical Group, PA* The Permanente Medical Group, Inc. (North)* Oxnard, California San Antonio, Texas Oakland, California Sharp Community Medical Group* Physicians DataTrust San Diego, California CORPORATE PARTNERS San Diego, California Arch Health Partners • Graybill Medical Group abbvie Greater Tri-Cities IPA • Noble AMA IPA • St. Vincent IPA Anthem Blue Cross of California Sharp Rees-Stealy Medical Group* athenahealth Physicians Choice Medical Group of San Luis San Diego, California Boehringer Ingelheim Pharmaceuticals, Inc. Obispo Continuum Health San Luis Obispo, California Signature Partners Network/Inova Health Evolent Health System* Humana, Inc. Physicians Medical Group of Santa Cruz* Falls Church, Virginia Merck & Co. Santa Cruz, California The Southeast Permanente Medical Group, Inc. Nestle Health Science Physicians Choice Medical Group of Santa Atlanta, Georgia Novartis Pharmaceuticals Maria Novo Nordisk Santa Maria, California Southern California Permanente Medical Patient-Centered Primary Care Collaborative Group* Pfizer, Inc. Physicians of Southwest Washington, LLC Pasadena, California Sanofi, US Olympia, Washington Southwest Medical Associates SCAN Health Plan PIH Health Physicians Las Vegas, Nevada Whittier, California ASSOCIATE PARTNERS Summit Medical Group, PA* Arkray Pioneer Medical Group, Inc.* Berkeley Heights, New Jersey Astellas Pharma US, Inc. Cerritos, California Sutter Health Foundations & Affiliated Groups* AstraZeneca Pharmaceuticals Preferred IPA of California Sacramento, California Avanir Pharmaceuticals, Inc. Glendale, California Bio-Reference Laboratories, Inc. Central Valley Medical Group • East Bay Physicians Bristol-Myers-Squibb PriMed Physicians Medical Group • Gould Medical Group • Marin Headlands Medical Group • Mills-Peninsula Medical Group • Palo Alto Easy Choice Health Plan, Inc. Cincinnati, Ohio Foundation Medical Group • Palo Alto Medical Foundation Genentech, Inc. Privia Medical Group, LLC • Peninsula Medical Clinic • Physician Foundation Medical Incyte Corporation Arlington, Virginia Associates • Sutter East Bay Medical Foundation • Sutter Johnson & Johnson Family of Companies Gould Medical Foundation • Sutter Independent Physicians Kaufman, Hall & Associates Prospect Medical Group* • Sutter Medical Foundation • Sutter Medical Group • Sutter Kindred Healthcare, Inc. Orange, California Medical Group of the Redwoods • Sutter North Medical Group • Sutter PacificM edical Foundation Lumara Health AMVI/Prospect Medical Group • Genesis Healthcare of Natera, Inc. Southern California, A Medical Group • Nuestra Familia Swedish Medical Group Pfizer, Inc. Medical Group • Pomona Valley Medical Group • Prospect Seattle, Washington Ralphs Grocery Company HealthSource Medical Group • Prospect Medical Group • Soleo Health, Inc. Prospect NWOC Medical Group • Prospect Professional Synergy HealthCare, LLC Sunovion Pharmaceuticals Inc. Care Medical Group • Prospect Provider Group RI, LLC • Nashville, Tennessee The Doctors Company Prospect Provider Group CTE, LLC • Prospect Provider Group CTW, LLC • Prospect Provider Group NJ, LLC SynerMed* • Prospect Health Services TX • StarCare Medical Monterey Park, California AFFILIATE PARTNERS Group • Upland Medical Group, A Professional Medical Adventist Health Plan • Alpha Care Medical Group Acurus Solutions, Inc. Corporation • Alvarado Hospital Medical Center • Angeles IPA • Alignment Healthcare Providence Health & Services Coordinated Care Plan of California • Crown City Medical Altura Group • EHS Inland Valleys IPA • EHS Medical Group – Torrance, California ASPiRA LABS Central Valley • EHS Medical Group – Los Angeles • EHS Axene Health Partners Providence Medical Management Services Medical Group – Sacramento • Employee Health Systems Canvas Medical Burbank, California • IPA of Georgia • MultiCultural Medical Group • Pacific Alliance Medical Center • Torrance Hospital IPA • XiMed Children’s Hospital Los Angeles Medical Group Korean American Medical Group • Providence Care CVHCare Network Tenet Healthcare Financial Recovery Group, Inc. Dallas, Texas Manifest MedEx Renaissance Physician Organization Mills Peninsula Medical Group Houston, Texas The Portland Clinic MyWoundDoctor Portland, Oregon River City Medical Group, Inc. Nifty After Fifty Monarch LLC Sacramento, California The Vancouver Clinic, Inc., PS* Partners in Care Foundation Vancouver, Washington Pharmacyclics, Inc. Riverside Medical Clinic Redlands Community Hospital Riverside, California Torrance Hospital IPA Saint Agnes Medical Group Torrance, California Riverside Physician Network SullivanLuallin Group Riverside, California Triad HealthCare Network, LLC* U.S. Advisors, Inc. Greensboro, North Carolina Ventegra, LLC St. Joseph Heritage Healthcare* Fullerton, California * Indicates 2017-18 Board Members
Summer 2017 capg health l 25 Research Partnerships Tackle Population Health Management Challenges
by Amy Adome, MD, MPH; Dilesh Doshi, PharmD; and Joshua Liberman, PhD
The continually evolving healthcare landscape requires partnerships between a variety of stakeholders to find evidence-based solutions to population health challenges. The road toward value-based healthcare demands unconventional thinking, bringing together interested parties across silos within health systems, in the community, and other sectors who care about achieving better health for all. To this end, Sutter Health and Sharp HealthCare have independently partnered with Janssen ScientificA ffairs on research collaborations to address important population health management questions.
Janssen recently formed the Population Health Research team to work with health systems in identifying areas of mutual interest that fill gaps in knowledge and generate evidence around best practices in providing care in a value-driven environment. Typically using data already collected by the health systems, these projects focus on the whole Amy Adome, MD, MPH patient and link together disparate data sources (e.g., survey data, clinical data, claims data, and social factors).
For leaders at Sutter Health and Sharp HealthCare, working with Janssen’s Population Health Research team provided an opportunity to expand their existing focus on advancing patient care and population health management.
“Few, if any, organizations have the resources, expertise, and experience in all the different disciplines needed to solve challenges in healthcare,” said Josh Liberman, Executive Director, Research, Development, and Dissemination at Sutter Health. “Bringing together experts from different fields and teams fosters new ideas, new ways of thinking. Despite being in different industries, we all share a common mission—to improve the health and well being of the patients we serve. Partnering helps us achieve Dilesh Doshi, PharmD that mission faster by bringing together resources, expertise, ideas, and perspectives from various organizations all working on similar challenges.”
Taking on Tough Population Health Issues Sharp HealthCare and Janssen’s research teams are studying the incremental impact of adding behavioral health data to a readmission risk model used to identify inpatients at high risk for 30-day readmissions.
“Progressive health systems across the country understand the need to utilize more predictive analytics techniques to better serve populations so their interventions of care can be effective and truly drive the value proposition,” said Amy Adome, Senior Vice President, Clinical Effectiveness at Sharp HealthCare. “One of the challenges they face is allocating the required time and resources towards identifying feasible evidence- Joshua Liberman, PhD based solutions in an environment where reimbursement models are not yet well aligned to easily allow for the necessary resource allocation. The research partnership between Sharp and Janssen enabled both parties to share the responsibility, expertise, and resource burden in studying an issue of mutual interest.”
In another initiative, Janssen’s research team is also working with researchers at Sutter Health’s Palo Alto Medical Foundation Research Institute (PAMFRI) to identify
26 l capg health Summer 2017 dimensions of patient Informing Future Improvements By working experience and in Patient Care “ satisfaction associated This approach to research partnerships allows Janssen to together to with adherence to generate meaningful insights using unique data sources, medications for generate rigorous which can help inform future clinical development plans, cardiometabolic as well as better understand unmet medical needs in evidence, diseases. its therapeutic areas of interest. By working together to Already, both research generate rigorous evidence, Sharp, Sutter, and Janssen Sharp, Sutter, efforts have started aim to identify approaches that are generalizable across and Janssen to generate learning. systems and can help drive improvements in patient care. Interim results were For instance, insights from the project with Sharp are aim to identify recently presented being used to inform and guide their ongoing readmission at peer-reviewed reduction strategies, including optimization of the care approaches that conferences, including pathway for discharged inpatients. the 2017 Health Care are generalizable Systems Research Further impact can be driven by disseminating study across systems Network meeting March findings to other health systems and healthcare 21-23 in San Diego. stakeholders through conference presentations and and can help drive Study lead Kristina posters, and, ultimately, publishing results in peer-reviewed Greenwood, PhD, manuscripts. Beyond adoption of more evidence-based improvements in Outcomes Research practices by individual health systems, the bigger vision Specialist, Sharp is to serve up evidence-based solutions that influence patient care.” HealthCare, and Cecile changes in healthcare policy for the benefit of the society Davis, MSN, PHN, RN- at large. o BC, Manager with the Sharp Care Transitions Program, and Joy LaMori, MHS, Amy Adome, MD, MPH, is Senior Vice President, Clinical MBA, Director, Population Health Research, Janssen Effectiveness at Sharp HealthCare in San Diego, California. ScientificA ffairs, presented preliminary findings from their Dilesh Doshi, PharmD, serves as Senior Director, project, “Using Data Analytics and Innovation Partnerships Population Health Research with Janssen Scientific Affairs, to Reduce Hospital Readmissions: Can Behavioral Health LLC, based in Titusville, New Jersey. Joshua Liberman, Data Improve Predictive Accuracy?” as part of a panel PhD, is Executive Director, Research, Development, and presentation entitled Innovative Uses of Data Dissemination for Sutter Health, Walnut Creek, California. Sources.
Earlier data from the Sutter-PAMFRI research project were shared in an oral presentation at the Society for Medical Decision Making 38th Annual North American Meeting, held in October 2016 in Vancouver, British Columbia. The presentation, “Patients’ Involvement in Treatment Decision-Making is Associated with Improved Adherence to Chronic Disease Medications in an Ambulatory Care Setting,” was given by study lead Robert Romanelli, PhD, MPH, Assistant Scientist at PAMFRI as part of a set of sessions focused on chronic disease management.
Summer 2017 capg health l 27 An Urgent Case: Treating and Preventing Physician Burnout
by Amy Nguyen Howell, MD, MBA
Today’s political climate evokes feelings of chaos and uncertainty regarding healthcare policy and clinical developments. Polarizing political debates often overshadow real-life issues affecting countless lives. And I’m not talking about patients—I’m referring to doctors on the frontlines of patient care.
The growing problem of physician burnout is real. It exists in thousands of offices nationwide. Don’t ignore it, because it won’t go away on its own. Instead, it will grow like an unwanted weed and may kill like a contagion if left untreated. Physician burnout can manifest itself in a lack of enthusiasm for work, growing cynicism about patients or career, and a poor sense of self-worth. It also can lead to poor job performance and in serious cases, suicide.1 Alarmingly, feelings of burnout have become more prevalent over time, increasing twofold from 2011 to 2015, according to a Mayo Clinic study.2 Administrators and healthcare experts have been trying to solve this problem on an “Physicians individual, case-by-case basis. Meanwhile, a case is warranted to work together as a community to identify root causes and manage burnout must lead and on an organizational level. We cannot afford to sit advocate for idle as this issue grows into a national epidemic.
As a practicing female physician in our current needed resources, schizophrenic healthcare state, I’m frightened at serving as leading the statistics and stories about burnout. While I battle daily with issues like equality, women in the examples in workplace, and millennial philosophies, I’m sobered hourly by the stories on physician shortage, career our clinics to unfulfillment, and physician suicide. It’s predicted that in a mere eight years we adopt practice may have a shortfall of around 17,000 transformation primary care physicians, as our growing population ages and more programs and physicians and internists processes into our will be needed.3,4 daily routines.” More and more colleagues are turning to part- time or non-clinical positions because they’re faced with physician burnout and are ill-equipped with adequate resources for sustainability and growth.
28 l capg health Summer 2017 Studies have shown that primary care physicians have Empowering physicians to take action to reduce burnout issues with clinician satisfaction. For example, in a and increase practice satisfaction is expressed by survey of nearly 500 internists and family physicians, several commentators calling for society to value the 48 percent found the work pace chaotic, 78 percent well being of physicians and other healthcare team felt little control over their work, and 30 percent were members, to fulfill the Quadruple Aim.10,11 CAPG is likely to leave their practice within two years.5 Another going on its third year with our Primary Care Practice study found that 30 to 40 percent of doctors feel they’re Transformation Program, which is designed to innovate definitely burning out.6 This problem not only threatens practices to improve care delivery while reducing physician recruitment and retention, it also increases burnout at all career stages. medical errors, reduces quality of care, lowers patient A 2013 article in the Annals of Family Medicine12 satisfaction, reduces patient adherence to treatment describes practical ways in which medical offices can care plans, and reduces patient empathy.5,7,8 make practice more joyful through workflow redesigns Physician “unwellness” has many root causes, often that reduce practice hassles. CAPG’s experience with related to time pressures: insufficient time to spend practice transformation parallels their findings. Greater with patients or away from the office. Competitors for delegation of tasks to other members of the patient care that time include hassle factors, such as administrative team, smarter use of the EHR, and pre-visit planning burdens and inefficiencies introduced by electronic (a.k.a. “the huddle”) are just a few of the tools that our health records (EHR), superimposed on the increasing members have used to increase satisfaction and regain needs of a sicker, more engaged patient population.9 control over their time at work. Additional influences are decreasing autonomy, This new approach to managing workflow requires increasing payment inequity, and greater physical another cultural change that must begin with executive disconnection from colleagues as professional work shifts from the hospital to the community. continued on page 46
C.R. BURKE MARIELLA CUMMINGS BILL GIL VINOD JIVRAJKA, MD JOHN M. KIRK
ROBERT J. MARGOLIS, DONNA J. MILLS CHARLES E. PAYTON, ROBERT SEVERS BART WALD, MD, MBA MD MD, MBA consulting On the road to risk? CAPG Consulting can help you accelerate your journey. Our team of executives has decades of success in risk-based care delivery at leading physician organizations. To get connected with one of our experts, please contact Nelson Maldonado, 213.239.5041 or [email protected]. Visit us online at capg.org/consulting.
Summer 2017 capg health l 29 Improving Patient Engagement Boosts Colorectal Cancer Screening Rates
By Mohini Sinha, MD
Today’s emphasis on quality is driving a renewed focus on prevention and early detection of disease—including colorectal cancer (CRC), which is the second-leading cause of cancer-related death in the United States, with annual treatment costs totaling more than $14 billion.1,2 Screening procedures play a critical role in helping to prevent CRC and to detect precancerous polyps so they can be removed. According to the American Cancer Society, 90 percent of CRC deaths can be prevented with early screening.3
Rates of recommended screenings in people aged 50 to 75 have been increasing but still lag behind goals set by the National Colorectal Cancer Roundtable (NCCRT).4 In order to raise these rates, healthcare efforts must include a strategy to motivate difficult- to-engage patients to complete their screening. Monarch HealthCare, an independent physician association and part of OptumCare®, piloted an innovative colorectal screening program in 2016 in which we sought to eliminate barriers to screening in this population.
Other healthcare organizations have found success with targeted efforts to activate difficult-to-engage patients, with some approaches resulting in screening-rate increases as high as 15 percent.5 In this article, we share outcomes and lessons learned from our pilot, conducted at three of our healthcare practices in Orange County, California.
Guided by Best Practices In partnership with Genentech, we implemented our initiative using resources and best practices outlined in Genentech’s Love Your Colon CRC screening program (www.loveyourcolon.org). This program contains tools designed to activate patients, along with an associated guide for health systems to consider when developing their own processes for patient outreach and screening.6 Genentech was responsible for the creation of the Love Your Colon tools, while Monarch practices were fully accountable for implementation of the program.
We knew that a successful screening program deploys the right interventions at the right time. At each of the three pilot offices, we made observations about primary care authorization processes, timing of referrals, and workflow efficiency. These reviews enabled us to optimize a cancer screening process flow and develop standard operating procedures for documenting screening information in the electronic health record.
Monarch HealthCare’s central office identified screening candidates, with patient eligibility determined according to American Cancer Society colorectal cancer screening criteria.7 Identified candidates received a letter from Monarch’s quality medical
30 l capg health Summer 2017 director, informing them they were due for screening. Candidates who did neither within three months of The letter contained key messages—based on work by program initiation automatically received an FOBT kit in the NCCRT, a coalition of colorectal cancer screening the mail. experts4—designed to help patients understand the need for screening, anticipate objections, and The central program coordinator also informed provider motivate them to get screened. In addition to the staff members of patients’ CRC screening preventive letter, candidates also received a graphically driven care gap. Providers were given the educational educational brochure that employed the same core brochure and the patient-navigation call script to use messages. in conversations with screening candidates who came into the office for an unrelated illness or to discuss With consent from their primary care providers (PCPs), colorectal screening with their PCP. candidates were preauthorized for a colonoscopy and directed in the letter to schedule a consultation with a Positive Outcomes gastroenterologist (GI). Our hope was that this “fast- track” approach, bypassing the PCP, would remove a By the end of the program, the combined screening time-related barrier to adherence. rate at the three pilot sites rose from 51 percent at baseline to 68 percent. At the onset, 219 patients After the mailing, all screening candidates who had had been identified as eligible for screening but not scheduled an appointment within two weeks nonadherent; by the end, 32 percent of them received a phone call from Monarch’s central program completed either an FOBT or a colonoscopy (Table coordinator, who used a patient-navigation call script 1). Among patients completing colonoscopies, polyps to answer questions and address objections to CRC were removed in 17 and none were found to be screening. The goal was to ensure that the patient malignant. either scheduled a screening consultation or consented to complete a fecal occult blood test (FOBT) kit. continued on page 48
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Summer 2017 capg health l 31 California Quality Collaborative and CAPG Members Improve Healthcare Tirelessly defending the practice of Value in California GOOD MEDICINE. By Diane Stewart and Bart Wald, MD We’re taking the mal out of malpractice insurance. The California Quality to promote practice transformation. In 2016, CQC By constantly looking ahead, we help our members anticipate Collaborative (CQC) published a summary of best practices from 23 provider issues before they can become problems. And should frivolous and CAPG share a organizations participating in the Intensive Outpatient claims ever threaten their good name, we fight to win—both mission to improve the Care Program (IOCP), a Center for Medicare & Medicaid in and out of the courtroom. It’s a strategy made for your quality and value of Innovation (CMMI) Innovation Award winner, and its IOCP success that delivers malpractice insurance without the mal. healthcare provided Toolkit, aimed at building programs for medically complex See how at thedoctors.com to patients through Medicare patients. Physician groups can gain insights clinically integrated into how to best manage patients with complex needs by and coordinated care. downloading the toolkit at www.calquality.org.
A multi-stakeholder Last year CQC also summarized interview findings Diane Stewart improvement from leading accountable care organizations (ACOs) organization, CQC and provider organizations addressing cost of care is housed at the in Managing Cost of Care: Lessons from the Field. In Pacific Business addition, the collaborative engaged 13 delivery systems Group on Health and 3,036 clinicians in practice transformation, including and partners with monthly reporting on 13 Triple Aim measures. Also in other improvement 2016, CQC prepared 55 organizations for the Health organizations, Homes program in California, a federal initiative to including CAPG, to help states develop models designed to improve care assist healthcare coordination and reduce costs for high-need Medicaid leaders in adopting populations. system changes to This year offers physician groups many new Bart Wald, MD significantly improve clinical outcomes, opportunities to participate and improve their practices, patient satisfaction, and affordability. Many CAPG including: members take advantage of CQC training programs Complex Patients: Building Care Solutions for to create scalable, measurable improvement in clinical Older Adults with Complex Needs is an action- quality, patient experience, and cost of care—a reflection oriented learning community targeting the medically of the collaborative’s decade of working with physician complex senior population. Building on the successful groups to advance efficient, quality healthcare. work of the IOCP, CQC is expanding the model to This past year saw tremendous progress, and 2017 include the latest research on how to identify and offers even greater opportunities for physician groups. engage providers and patients, and create a strong Here is a quick look back at 2016 accomplishments and business case for program sustainability. Organizations important resources for physician groups, along with a experimenting with better ways to work with high-need, snapshot of opportunities ahead. high-cost patients will work together to provide better care for those patients with the most complicated needs, CQC recently released a 2016 Impact Report and consuming the highest amount of resources. For summarizing the work of 135 organizations, including more information, contact Margie Powers, mpowers@ many CAPG members, to improve cost of care and calquality.org. care coordination for medically complex patients and continued on page 50
32 l capg health Summer 2017
6072_CA_CAPG_Health_PD_Sum2017_f.indd 1 4/12/17 6:51 AM Tirelessly defending the practice of GOOD MEDICINE.
We’re taking the mal out of malpractice insurance. By constantly looking ahead, we help our members anticipate issues before they can become problems. And should frivolous claims ever threaten their good name, we fight to win—both in and out of the courtroom. It’s a strategy made for your success that delivers malpractice insurance without the mal. See how at thedoctors.com
Summer 2017 capg health l 33
6072_CA_CAPG_Health_PD_Sum2017_f.indd 1 4/12/17 6:51 AM Organizational Quality and Superior Patient Outcomes—A Holistic Approach
by Sayeed Khan, MD
Managed health organizations across the country have been asked to improve overall quality in an effort to ensure that excellent care is available to all patients, regardless of income. Utilizing measures such as Healthcare Effectiveness Data and Information Set (HEDIS) scores to quantify the care patients receive allows the Centers for Medicare & Medicaid Services to compare plans directly and reimburse organizations like Molina Medical Group (MMG) based on actual patient outcomes.
Molina Medical Group has taken a holistic approach to improving organizational quality, an approach that directly relates to a better patient experience and improved health outcomes—ensuring MMG members that they are getting the most from their benefits.
“Delivering quality care is part of Molina’s corporate DNA,” said Carrie Harris- Muller, Senior Vice President, Care Delivery and Strategic Partnerships at Molina Healthcare. “Our business was created to serve patients, so incentives to improve the “Delivering quality of care are beneficial to our business and our members.” quality care is Better Scores = Better Business part of Molina’s The key thing to focus on in terms of organizational quality improvement is that there are no losers. The more organizations improve their processes and HEDIS scores, the corporate DNA. better care and attention they provide to members. It’s a win-win.
Our business Molina offers a direct-delivery system of 26 company-owned-and-operated primary and specialty care clinics in California, Florida, Michigan, New Mexico, Utah, and was created to Washington. In each of these clinics, the focus is on the motto, “Every visit is a golden serve patients, opportunity.” Every visit is a chance to provide quality care and health enhancement. “Even if a patient comes in for a sore throat, it’s an opportunity to review their chart so incentives and ensure they are up to date on all their shots and health measures,” said Andrew Reno, Associate Vice President of Quality for Care Delivery, MMG. to improve the Prior to every appointment, clinic medical assistants examine a patient’s chart for quality of care are any missing health screenings. This chart “triage” allows the assistant and doctor to provide the best possible service based on the most recent health information beneficial to our available for each patient. business and our MMG’s policy of never turning away an appointment means that same-day and next-day appointments are often available to members, and these quick-turnaround members.” visits provide a face-to-face chance for providers to assess issues beyond the one for which the patient walked in. The increased focus on patient history and health measures is paying off—the California clinics have already received recognition for increased HEDIS measures. This isn’t just good for Molina—it also translates directly into improved patient health outcomes and satisfaction. Our Press Ganey customer service scores are consistently improving and remain in the high 80s. Our culture of customer service is to ensure every visit delivers high-quality, cost-effective care.
34 l capg health Summer 2017 No “Slipping through the Cracks” other places, patients are mailed or emailed a survey to We utilize a community engagement team to identify evaluate their visit. members in need and make sure they find their way to Molina CareConnections employs a workforce of nurse a clinic. MMG has developed partnerships with local practitioners focused on catering to patients’ needs, mammography mobile units and retina scan mobile units including meeting them in a familiar environment. In to identify members with unaddressed issues so they get recognition of the value of delivering care to patients the care they need. The goal is to offer on-site services where they feel both safe and secure, providers have that can address all member healthcare needs in an visited patients in their van, at a local McDonald’s, and easily accessible way. even at a community shelter. CareConnection’s nurse practitioners educate all patients on the importance of Patients are the Customers completing a healthcare screening exam and describe in detail how they can access additional care services. “Every patient’s time is valuable,” said Reno. “We really It is common to find patients unaware of the extent of strive to demonstrate that we understand that.” In available services. In addition to providing a wellness addition to the chart triage performed before every visit, exam, the nurse practitioner can complete several quality the in-office team prepares that patient, walking them measures, including HgbA1C, retinal screenings, PHQ9 through every detail of their visit, including next steps screening, urine microalbumins and protein, and diabetic and any necessary follow-up care, to provide a positive foot exams, as well as advise on the proper way to obtain patient experience. In Washington, the increased focus a fecal occult blood screening. on service has dramatically decreased the “no-show” rate to below 20 percent, while in New Mexico, the rate It’s critical to remember that healthcare is essentially a has fallen from 50 percent to 22 percent in less than two customer-service business. This focus is allowing Molina years. Medical Group to improve member health outcomes while improving our business at the same time. In order to gauge the level of patient satisfaction, many o clinics have implemented a post-visit survey, which some Sayeed Khan, MD, is President, Molina Medical Group. states administer before patients leave the office. In
Summer 2017 capg health l 35 Changing Federal Tax Policy...continued from page 13 as the funding base. Executed in a fiscally responsible way, with appropriate offsets in federal spending, such of plans and medical professionals alike. Equity in the a policy not only would improve our fellow Americans’ application of the tax policy would create a level playing access to better health care, but would better integrate field—essential for a functioning market—with the younger and healthier persons into the nation’s health government no longer able to favor one type of health insurance pools, exerting a welcome downward insurance over another or one class of consumers over demographic pressure on average claims costs. another. A genuinely open and competitive market for No magic bullet exists in health care policy, and that health insurance, fostered by individual tax relief, would includes changing federal tax policy. That is why health also exert a powerful downward pressure on health care reform will remain a process, rather than a single costs. legislative event. o Short of a comprehensive overhaul of the federal tax Robert Emmet Moffit, PhD, is a Senior Fellow at The policy, Congress should provide individual tax relief for Heritage Foundation’s Center for Health Policy Studies. those who cannot get health insurance through the place He will present a CAPG Annual Conference keynote of work, such as those struggling with shocking health address, Market-Based Health Reform: A Process, Not insurance costs in the relatively small individual market. an Event, on Friday, June 23, at 1:00 pm. Although the individual market covers only about 7 10 percent of the total insured population, this assistance References would achieve elemental fairness in the tax treatment of 1 Robert Pear, Some Health Plan Costs to Increase by an Average of 25 health insurance. Because of the ACA’s income eligibility Percent, U.S. Says, The New York Times, October 24, 2016. https:// standards, many middle class taxpayers do not get any www.nytimes.com/2016/10/25/us/some-health-plan-costs-to- tax relief to offset their premium costs. Employers and increase-by-an-average-of-25-percent-us-says.html?_r=1 employees of small businesses, where job-based coverage 2 Kev Coleman, “Aging Consumers without Subsidies Hit Hardest by 2017 Obamacare Premium & Deductible Spikes,” HealthPocket, is not economically feasible, also need relief. Individual tax October 26, 2016. https://www.healthpocket.com/healthcare-research/ relief for health insurance would be ideal for them. infostat/2017-obamacare-premiums-deductibles#.WRjoTVPysyl 3 Edmund Haislmaier and Alyene Senger, “The 2017 Health Insurance The AHCA’s age-based tax credit proposal is conceptually Exchanges: Major Decrease in Competition and Choice,” The Heritage sound—health care costs rise with age—but it should Foundation, January 30, 2017. http://www.heritage.org/health-care- be more generous than the proposed annual credit of reform/report/the-2017-health-insurance-exchanges-major-decrease- $4,000 for the small number of persons over the age competition-and-choice of 60 enrolled in the individual market. In the meantime, 4 Alyene Senger, “CBO Report is a Score of Partial Repeal, Not ‘Repeal and Replace’,” The Daily Signal, January 17, 2017. http://dailysignal. Congress could preserve the existing employment-based com/2017/01/17/cbo-report-is-a-score-of-partial-repeal-not-repeal- tax regime for employees of large businesses, thus and-replace/ avoiding any disruption. Still, Congress should at least 5 Congressional Budget Office, American Health Care Act, March 13, impose a simple cap on the tax exclusion for high cost 2017. https://www.cbo.gov/publication/52486 health plans, encouraging more cost-effective and flexible 6 Douglas Elmendorf, “Options for Controlling the Cost and coverage, such as high deductible, consumer-driven health Increasing the Effectiveness of Healthcare,” Testimony before the Subcommittee on Health, Committee on Energy and Commerce, U.S. insurance. That would result in a systemic downward House of Representatives, March 10, 2009. https://www.cbo.gov/ pressure on health care costs. publication/41167?index=10016 7 Avik Roy, “How Obama Care Dramatically Increases the Cost of Help for All Economic Levels Insurance for Young Workers,” Forbes, March 22, 2012. https:// www.forbes.com/sites/theapothecary/2012/03/22/how- For middle class Americans, tax relief can take the form of obamacare-dramatically-increases-the-cost-of-insurance-for-young- workers/#6a94c15f7e46 a nonrefundable tax credit. 8 Jonathan Gruber, testimony before U.S. Senate Finance Committee, Low-income individuals should be integrated into the May 12, 2009, https://www.finance.senate.gov/imo/media/doc/ Jon%20Gruber.pdf private health insurance market, which would provide them 9 the same access to private physician networks that serve Nina Owcharenko and Robert Moffit, “The McCain Health Care Plan: More Power to Families,” The Heritage Foundation, October 15, 2008. their fellow citizens. http://www.heritage.org/health-care-reform/report/the-mccain-health- care-plan-more-power-families The best mechanism to accomplish that integration is 10 “Health Insurance Coverage of the Total Population 2015,” Kaiser through a new “premium support” program—in effect, a Family Foundation, http://kff.org/other/state-indicator/total-population/? refundable tax credit, using Medicaid acute care spending dataView=1¤tTimeframe=0&sortModel=%7B%22colId%22:%22 Location%22,%22sort%22:%22asc%22%7D
36 l capg health Summer 2017 B:8.375 in T:8.125 in S:7.25 in
CHOOSE IMBRUVICA® FOR:
• Oral, once-daily dosing1 • 7 approvals in less than 4 years2-5 • More than 30,000 patients treated since approval6* B:11.125 in T:10.875 in S:9.875 in
*Based on IMS data November 2013 to January 2017.
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Please see Important Safety Information on back page, and accompanying Brief Summary.
Date: 05/19/17 Customer Code: PRC-02820 We Are Alexander #: 784557 File Name: PRC-02820_784557_v1a (PG 1 Right Hand Start) Brand: Imbruvica Size: 8.125" x 10.875" Colors: CMYK Description: Choose Imbruvica For: Pub: CAPG Health (Summer 2017 Issue) K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R B:8.375 in T:8.125 in T:8.125 in S:7.25 in S:7.25 in
7 FDA approvals for IMBRUVICA® in less than 4 years
SLL MZL MCL after CLL after one prior one prior 2L+ CLL with 17p WM 1L CLL CLL/SLL anti-CD20-based deletion in combination therapy therapy with BR
2009 November February July January March May 2017 Clinical trials 2013 2014 2014 2015 2016 2016 Approved for patients with of ibrutinib marginal zone lymphoma (MZL) Approved for patients with Approved for Approved for Approved for patients Approved for frontline Approved for initiated7 who require systemic therapy mantle cell lymphoma (MCL) patients with chronic patients with with Waldenström’s treatment of patients treatment of patients 1 1 and have received at least one who have received lymphocytic CLL with macroglobulinemia (WM) with CLL with small lymphocytic 1 1 1 prior anti-CD20-based therapy at least one prior therapy1 leukemia (CLL) 17p deletion lymphoma (SLL) who have Accelerated approval was Accelerated approval was Approved for use in received at least granted for this indication granted for this indication based 3 combination with BR for one prior therapy 1 based on overall response rate. on overall response rate. patients with CLL/SLL Continued approval for this Continued approval for this indication may be contingent indication may be contingent upon verification and upon verification and description of clinical description of clinical benefit in benefit in a confirmatory trial1 a confirmatory trial1 B:11.125 in T:10.875 in S:9.875 in
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IMPORTANT SAFETY INFORMATION Atrial Fibrillation - Atrial fi brillationbrillation andand atrialatrial flflut utterter (r (range,ange, 6% 6% to to 9%) 9%) have have If this drug is used during pregnancy or if the patient becomes pregnant while taking DRUG INTERACTIONS occurred in patients treateded wwithith IMIMBRUVICABRUVICA®, paparticularlyrticularly iinn papatientstients with cardcardiaciac this drug, the patient should be apprised of the potential hazard to a fetus. Advise men WARNINGS AND PRECAUTIONS CYP3A Inhibitors - Avoid coadministration with strong or moderate CYP3A inhibitors. risk factors, hypertension, acute infections, and a previous history of atrial fi brillation. to avoid fathering a child during the same time period. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose. Hemorrhage - Fatal bleeding events have occurred in patients treated with Periodically monitor patients clinically for atrial fi brillation. Patients who develop IMBRUVICA ®. Grade 3 or higher bleeding events (intracranial hemorrhage arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea ADVERSE REACTIONS CYP3A Inducers - Avoid coadministration with strong CYP3A inducers. [including subdural hematoma], gastrointestinal bleeding, hematuria, and post- should have an ECG performed. Atrial fi brillation should be managed appropriately The most common adverse reactions (≥20%) in patients with B-cell malignancies SPECIFIC POPULATIONS procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events and if it persists, consider the risks and benefi ts of IMBRUVICA® treatment and (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%), thrombocytopenia* (62%), of any grade, including bruising and petechiae, occurred in approximately half of diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (30%), Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic follow dose modifi cation guidelines. ® ® impairment. In patients with mild impairment, reduce IMBRUVICA dose. patients treated with IMBRUVICA . Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%). The mechanism for the bleeding events is not well understood. IMBRUVICA® may with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 * Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant hemoglobin decreased). months). Monitor patients for new-onset hypertension or hypertension that is not References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017. 2. FDA ® The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL therapies and patients should be monitored for signs of bleeding. Consider the adequately controlled after starting IMBRUVICA . Adjust existing antihypertensive Press Release November 2013. FDA approves Imbruvica for rare blood cancer. https://www. ® benefi t-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and postsurgery medications and/or initiate antihypertensive treatment as appropriate. patients were pneumonia (7%), abdominal pain (5%), atrial fi brillation (5%), diarrhea mdstrat.com/fda-approves-imbruvica/. Accessed May 5, 2017. 3. FDA Press Release February (5%), fatigue (5%), and skin infections (5%). depending upon the type of surgery and the risk of bleeding. Second Primary Malignancies - Other malignancies (range, 3% to 16%) including 2014. FDA approves Imbruvica to treat chronic lymphocytic leukemia. https://wayback.archive-it. Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in org/7993/20161023125547/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of IMBRUVICA®. The most frequent second primary malignancy was non-melanoma MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and ucm385764.htm. Accessed May 5, 2017. 4. FDA Press Release July 2014. FDA expands approved use of Imbruvica for chronic lymphocytic leukemia. https://wayback.archive-it. progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii skin cancer (range, 2% to 13%). hypertension (5%). ® org/7993/20170112222839/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ pneumonia (PJP) have occurred in patients treated with IMBRUVICA . Evaluate Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients ucm406916.htm. Accessed May 5, 2017. 5. FDA Press Release January 2015. FDA expands patients for fever and infections and treat appropriately. IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), approved use of Imbruvica for rare form of non-Hodgkin lymphoma. http://www.fda.gov/ Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia appropriate precautions. Monitor patients closely and treat as appropriate. 9% (MCL), and 9 % (WM [6%] and MZL [13%]) of patients discontinued due to NewsEvents/Newsroom/PressAnnouncements/ucm432123.htm. Accessed February 9, 2017. 6. Data adverse reactions. Most common adverse reactions leading to discontinuation were on fi le. Pharmacyclics LLC.7. Gayko U, Fung M, Chow F, et al. Development of the Bruton’s tyrosine (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, Embryo-Fetal Toxicity - Based on fi ndings in animals, IMBRUVICA® can cause fetal pneumonia, hemorrhage, atrial fi brillation, rash, and neutropenia (1% each) in CLL/SLL kinase inhibitor for B cell malignancies. Ann NY Acad Sci. 2015;1358:82-94. 0% to 13%) based on laboratory measurements occurred in patients treated with harm when administered to a pregnant woman. Advise women to avoid becoming ® patients and subdural hematoma (1.8%) in MCL patients. The most common adverse single agent IMBRUVICA . Monitor complete blood counts monthly. pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash 1L=fi rst line, 2L=second line, BR=bendamustine and rituximab. (1.6% each) in WM and MZL patients.
© Pharmacyclics LLC 2017 © Janssen Biotech, Inc. 2017 05/17 PRC-02820
Date: 05/19/17 Customer Code: PRC-02820 We Are Alexander #: 784557 File Name: PRC-02820_784557_v1a (PG 2-3 Spread) Brand: Imbruvica Size: 8.125" x 10.875" Colors: CMYK Description: Choose Imbruvica For: Pub: CAPG Health (Summer 2017 Issue) K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R B:8.375 in T:8.125 in T:8.125 in S:7.25 in S:7.25 in
7 FDA approvals for IMBRUVICA® in less than 4 years
SLL MZL MCL after CLL after one prior one prior 2L+ CLL with 17p WM 1L CLL CLL/SLL anti-CD20-based deletion in combination therapy therapy with BR
2009 November February July January March May 2017 Clinical trials 2013 2014 2014 2015 2016 2016 Approved for patients with of ibrutinib marginal zone lymphoma (MZL) Approved for patients with Approved for Approved for Approved for patients Approved for frontline Approved for initiated7 who require systemic therapy mantle cell lymphoma (MCL) patients with chronic patients with with Waldenström’s treatment of patients treatment of patients 1 1 and have received at least one who have received lymphocytic CLL with macroglobulinemia (WM) with CLL with small lymphocytic 1 1 1 prior anti-CD20-based therapy at least one prior therapy1 leukemia (CLL) 17p deletion lymphoma (SLL) who have Accelerated approval was Accelerated approval was Approved for use in received at least granted for this indication granted for this indication based 3 combination with BR for one prior therapy 1 based on overall response rate. on overall response rate. patients with CLL/SLL Continued approval for this Continued approval for this indication may be contingent indication may be contingent upon verification and upon verification and description of clinical description of clinical benefit in benefit in a confirmatory trial1 a confirmatory trial1 B:11.125 in T:10.875 in S:9.875 in
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IMPORTANT SAFETY INFORMATION Atrial Fibrillation - Atrial fi brillationbrillation andand atrialatrial flflut utterter (r (range,ange, 6% 6% to to 9%) 9%) have have If this drug is used during pregnancy or if the patient becomes pregnant while taking DRUG INTERACTIONS occurred in patients treateded wwithith IMIMBRUVICABRUVICA®, paparticularlyrticularly iinn papatientstients with cardcardiaciac this drug, the patient should be apprised of the potential hazard to a fetus. Advise men WARNINGS AND PRECAUTIONS CYP3A Inhibitors - Avoid coadministration with strong or moderate CYP3A inhibitors. risk factors, hypertension, acute infections, and a previous history of atrial fi brillation. to avoid fathering a child during the same time period. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose. Hemorrhage - Fatal bleeding events have occurred in patients treated with Periodically monitor patients clinically for atrial fi brillation. Patients who develop IMBRUVICA ®. Grade 3 or higher bleeding events (intracranial hemorrhage arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea ADVERSE REACTIONS CYP3A Inducers - Avoid coadministration with strong CYP3A inducers. [including subdural hematoma], gastrointestinal bleeding, hematuria, and post- should have an ECG performed. Atrial fi brillation should be managed appropriately The most common adverse reactions (≥20%) in patients with B-cell malignancies SPECIFIC POPULATIONS procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events and if it persists, consider the risks and benefi ts of IMBRUVICA® treatment and (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%), thrombocytopenia* (62%), of any grade, including bruising and petechiae, occurred in approximately half of diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (30%), Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic follow dose modifi cation guidelines. ® ® impairment. In patients with mild impairment, reduce IMBRUVICA dose. patients treated with IMBRUVICA . Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%). The mechanism for the bleeding events is not well understood. IMBRUVICA® may with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 * Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant hemoglobin decreased). months). Monitor patients for new-onset hypertension or hypertension that is not References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017. 2. FDA ® The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL therapies and patients should be monitored for signs of bleeding. Consider the adequately controlled after starting IMBRUVICA . Adjust existing antihypertensive Press Release November 2013. FDA approves Imbruvica for rare blood cancer. https://www. ® benefi t-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and postsurgery medications and/or initiate antihypertensive treatment as appropriate. patients were pneumonia (7%), abdominal pain (5%), atrial fi brillation (5%), diarrhea mdstrat.com/fda-approves-imbruvica/. Accessed May 5, 2017. 3. FDA Press Release February (5%), fatigue (5%), and skin infections (5%). depending upon the type of surgery and the risk of bleeding. Second Primary Malignancies - Other malignancies (range, 3% to 16%) including 2014. FDA approves Imbruvica to treat chronic lymphocytic leukemia. https://wayback.archive-it. Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in org/7993/20161023125547/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of IMBRUVICA®. The most frequent second primary malignancy was non-melanoma MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and ucm385764.htm. Accessed May 5, 2017. 4. FDA Press Release July 2014. FDA expands approved use of Imbruvica for chronic lymphocytic leukemia. https://wayback.archive-it. progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii skin cancer (range, 2% to 13%). hypertension (5%). ® org/7993/20170112222839/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ pneumonia (PJP) have occurred in patients treated with IMBRUVICA . Evaluate Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients ucm406916.htm. Accessed May 5, 2017. 5. FDA Press Release January 2015. FDA expands patients for fever and infections and treat appropriately. IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), approved use of Imbruvica for rare form of non-Hodgkin lymphoma. http://www.fda.gov/ Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia appropriate precautions. Monitor patients closely and treat as appropriate. 9% (MCL), and 9 % (WM [6%] and MZL [13%]) of patients discontinued due to NewsEvents/Newsroom/PressAnnouncements/ucm432123.htm. Accessed February 9, 2017. 6. Data adverse reactions. Most common adverse reactions leading to discontinuation were on fi le. Pharmacyclics LLC.7. Gayko U, Fung M, Chow F, et al. Development of the Bruton’s tyrosine (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, Embryo-Fetal Toxicity - Based on fi ndings in animals, IMBRUVICA® can cause fetal pneumonia, hemorrhage, atrial fi brillation, rash, and neutropenia (1% each) in CLL/SLL kinase inhibitor for B cell malignancies. Ann NY Acad Sci. 2015;1358:82-94. 0% to 13%) based on laboratory measurements occurred in patients treated with harm when administered to a pregnant woman. Advise women to avoid becoming ® patients and subdural hematoma (1.8%) in MCL patients. The most common adverse single agent IMBRUVICA . Monitor complete blood counts monthly. pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash 1L=fi rst line, 2L=second line, BR=bendamustine and rituximab. (1.6% each) in WM and MZL patients.
© Pharmacyclics LLC 2017 © Janssen Biotech, Inc. 2017 05/17 PRC-02820
Date: 05/19/17 Customer Code: PRC-02820 We Are Alexander #: 784557 File Name: PRC-02820_784557_v1a (PG 2-3 Spread) Brand: Imbruvica Size: 8.125" x 10.875" Colors: CMYK Description: Choose Imbruvica For: Pub: CAPG Health (Summer 2017 Issue) K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R Brief Summary of Prescribing Information for IMBRUVICA® (ibrutinib) IMBRUVICA® (ibrutinib) capsules IMBRUVICA® (ibrutinib) capsules, for oral use See package insert for Full Prescribing Information Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can INDICATIONS AND USAGE cause fetal harm when administered to a pregnant woman. Administration Mantle Cell Lymphoma: IMBRUVICA is indicated for the treatment of of ibrutinib to pregnant rats and rabbits during the period of organogenesis patients with mantle cell lymphoma (MCL) who have received at least one caused embryofetal toxicity including malformations at exposures that prior therapy. were 2-20 times higher than those reported in patients with hematologic Accelerated approval was granted for this indication based on overall malignancies. Advise women to avoid becoming pregnant while taking response rate. Continued approval for this indication may be contingent IMBRUVICA and for 1 month after cessation of therapy. If this drug is used upon verification and description of clinical benefit in a confirmatory trial during pregnancy or if the patient becomes pregnant while taking this drug, [see Clinical Studies (14.1) in Full Prescribing Information]. the patient should be apprised of the potential hazard to a fetus [see Use in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: IMBRUVICA Specific Populations]. is indicated for the treatment of patients with chronic lymphocytic leukemia ADVERSE REACTIONS (CLL)/small lymphocytic lymphoma (SLL) [see Clinical Studies (14.2) in Full The following adverse reactions are discussed in more detail in other Prescribing Information]. sections of the labeling: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p • Hemorrhage [see Warnings and Precautions] deletion: IMBRUVICA is indicated for the treatment of patients with chronic • Infections [see Warnings and Precautions] lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion [see Clinical Studies (14.2) in Full Prescribing Information]. • Cytopenias [see Warnings and Precautions] Waldenström’s Macroglobulinemia: IMBRUVICA is indicated for the • Atrial Fibrillation [see Warnings and Precautions] treatment of patients with Waldenström’s macroglobulinemia (WM) [see • Hypertension [see Warnings and Precautions] Clinical Studies (14.3) in Full Prescribing Information]. • Second Primary Malignancies [see Warnings and Precautions] Marginal Zone Lymphoma: IMBRUVICA is indicated for the treatment of • Tumor Lysis Syndrome [see Warnings and Precautions] patients with marginal zone lymphoma (MZL) who require systemic therapy Clinical Trials Experience: Because clinical trials are conducted under and have received at least one prior anti-CD20-based therapy. widely variable conditions, adverse event rates observed in clinical trials of a Accelerated approval was granted for this indication based on overall drug cannot be directly compared with rates of clinical trials of another drug response rate [see Clinical Studies (14.4) in Full Prescribing Information]. and may not reflect the rates observed in practice. Continued approval for this indication may be contingent upon verification Mantle Cell Lymphoma: The data described below reflect exposure to and description of clinical benefit in a confirmatory trial. IMBRUVICA in a clinical trial that included 111 patients with previously CONTRAINDICATIONS treated MCL treated with 560 mg daily with a median treatment duration of None 8.3 months. WARNINGS AND PRECAUTIONS The most commonly occurring adverse reactions (≥ 20%) were thrombo- Hemorrhage: Fatal bleeding events have occurred in patients treated with cytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage peripheral edema, upper respiratory tract infection, nausea, bruising, [including subdural hematoma], gastrointestinal bleeding, hematuria, dyspnea, constipation, rash, abdominal pain, vomiting and decreased and post procedural hemorrhage) have occurred in up to 6% of patients. appetite (see Tables 1 and 2). Bleeding events of any grade, including bruising and petechiae, occurred in The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) approximately half of patients treated with IMBRUVICA. were pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue, and The mechanism for the bleeding events is not well understood. skin infections. IMBRUVICA may increase the risk of hemorrhage in patients receiving Fatal and serious cases of renal failure have occurred with IMBRUVICA antiplatelet or anticoagulant therapies and patients should be monitored for therapy. Increases in creatinine 1.5 to 3 times the upper limit of normal signs of bleeding. occurred in 9% of patients. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days Adverse reactions from the MCL trial (N=111) using single agent IMBRUVICA pre and post-surgery depending upon the type of surgery and the risk of 560 mg daily occurring at a rate of ≥ 10% are presented in Table 1. bleeding [see Clinical Studies (14) in Full Prescribing Information]. Infections: Fatal and non-fatal infections have occurred with IMBRUVICA Table 1: Non-Hematologic Adverse Reactions in ≥ 10% of Patients therapy. Grade 3 or greater infections occurred in 14% to 29% of patients [see with MCL (N=111) Adverse Reactions]. Cases of progressive multifocal leukoencephalopathy All Grades Grade 3 or 4 (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in Body System Adverse Reaction (%) (%) patients treated with IMBRUVICA. Evaluate patients for fever and infections Gastrointestinal Diarrhea 51 5 and treat appropriately. disorders Nausea 31 0 Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including Constipation 25 0 neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and Abdominal pain 24 5 anemia (range, 0 to 13%) based on laboratory measurements occurred in Vomiting 23 0 patients treated with single agent IMBRUVICA. Stomatitis 17 1 Monitor complete blood counts monthly. Dyspepsia 11 0 Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have Infections and Upper respiratory tract occurred in patients treated with IMBRUVICA, particularly in patients infestations infection 34 0 with cardiac risk factors, hypertension, acute infections, and a previous Urinary tract infection 14 3 history of atrial fibrillation. Periodically monitor patients clinically for atrial Pneumonia 14 7 fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, Skin infections 14 5 lightheadedness) or new onset dyspnea should have an ECG performed. Sinusitis 13 1 Atrial fibrillation should be managed appropriately, and if it persists, General disorders and Fatigue 41 5 consider the risks and benefits of IMBRUVICA treatment and follow administration site Peripheral edema 35 3 dose modification guidelines [see Dosage and Administration (2.3) in Full conditions Pyrexia 18 1 Prescribing Information]. Asthenia 14 3 Hypertension: Hypertension (range, 6 to 17%) has occurred in patients Skin and Bruising 30 0 treated with IMBRUVICA with a median time to onset of 4.6 months subcutaneous tissue Rash 25 3 (range, 0.03 to 22 months). Monitor patients for new onset hypertension or disorders Petechiae 11 0 hypertension that is not adequately controlled after starting IMBRUVICA. Musculoskeletal and Musculoskeletal pain 37 1 Adjust existing anti-hypertensive medications and/or initiate anti- connective tissue Muscle spasms 14 0 hypertensive treatment as appropriate. disorders Arthralgia 11 0 Second Primary Malignancies: Other malignancies (range, 3 to 16%) Respiratory, thoracic Dyspnea 27 4 including non-skin carcinomas (range, 1 to 4%) have occurred in patients and mediastinal Cough 19 0 treated with IMBRUVICA. The most frequent second primary malignancy disorders Epistaxis 11 0 was non-melanoma skin cancer (range, 2 to 13%). Metabolism and Decreased appetite 21 2 Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently nutrition disorders Dehydration 12 4 reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely Nervous system Dizziness 14 0 and treat as appropriate. disorders Headache 13 0 IMBRUVICA® (ibrutinib) capsules IMBRUVICA® (ibrutinib) capsules
Table 2: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Table 3: Non-Hematologic Adverse Reactions in ≥ 10% of Patients Neutrophils in Patients with MCL (N=111) with CLL/SLL (N=51) in Study 1 (continued) Percent of Patients (N=111) All Grades Grade 3 or 4 All Grades Grade 3 or 4 Body System Adverse Reaction (%) (%) (%) (%) Metabolism and Decreased appetite 16 2 Platelets Decreased 57 17 nutrition disorders Neutrophils Decreased 47 29 Neoplasms Second 12* 0 Hemoglobin Decreased 41 9 benign, malignant, malignancies* unspecified * Based on laboratory measurements and adverse reactions Vascular disorders Hypertension 16 8 Ten patients (9%) discontinued treatment due to adverse reactions in the * One patient death due to histiocytic sarcoma. trial (N=111). The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading Table 4: Treatment-Emergent* Decrease of Hemoglobin, Platelets, to dose reduction occurred in 14% of patients. or Neutrophils in Patients with CLL/SLL (N=51) in Study 1 Patients with MCL who develop lymphocytosis greater than 400,000/mcL have Percent of Patients (N=51) developed intracranial hemorrhage, lethargy, gait instability, and headache. However, some of these cases were in the setting of disease progression. All Grades (%) Grade 3 or 4 (%) Forty percent of patients had elevated uric acid levels on study including Platelets Decreased 69 12 13% with values above 10 mg/dL. Adverse reaction of hyperuricemia was reported for 15% of patients. Neutrophils Decreased 53 26 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: The data Hemoglobin Decreased 43 0 described below reflect exposure in one single-arm, open-label clinical * Based on laboratory measurements per IWCLL criteria and adverse reactions. trial and three randomized controlled clinical trials in patients with CLL/SLL (n=1278 total and n=668 patients exposed to IMBRUVICA). Study 1 Study 2: Adverse reactions and laboratory abnormalities described below included 51 patients with previously treated CLL/SLL, Study 2 included 391 in Tables 5 and 6 reflect exposure to IMBRUVICA with a median duration of randomized patients with previously treated CLL or SLL who received single 8.6 months and exposure to ofatumumab with a median of 5.3 months in agent IMBRUVICA or ofatumumab, Study 3 included 269 randomized patients Study 2 in patients with previously treated CLL/SLL. 65 years or older with treatment naïve-CLL or SLL who received single agent IMBRUVICA or chlorambucil and Study 4 included 578 randomized Table 5: Adverse Reactions Reported in ≥ 10% of Patients patients with previously treated CLL or SLL who received IMBRUVICA in and at Least 2% Greater in the IMBRUVICA Treated Arm combination with bendamustine and rituximab or placebo in combination in Patients with CLL/SLL in Study 2 with bendamustine and rituximab. IMBRUVICA Ofatumumab The most commonly occurring adverse reactions in Studies 1, 2, 3 and 4 (N=195) (N=191) in patients with CLL/SLL receiving IMBRUVICA (≥ 20%) were neutropenia, Body System All Grades Grade 3 or 4 All Grades Grade 3 or 4 thrombocytopenia, anemia, diarrhea, musculoskeletal pain, nausea, rash, Adverse Reaction (%) (%) (%) (%) bruising, fatigue, pyrexia and hemorrhage. Four to 10 percent of patients Gastrointestinal receiving IMBRUVICA in Studies 1, 2, 3 and 4 discontinued treatment due disorders to adverse reactions. These included pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each). Adverse reactions leading to Diarrhea 48 4 18 2 dose reduction occurred in approximately 6% of patients. Nausea 26 2 18 0 Study 1: Adverse reactions and laboratory abnormalities from the CLL/SLL Stomatitis* 17 1 6 1 trial (N=51) using single agent IMBRUVICA 420 mg daily in patients with Constipation 15 0 9 0 previously treated CLL/SLL occurring at a rate of ≥ 10% with a median duration Vomiting 14 0 6 1 of treatment of 15.6 months are presented in Tables 3 and 4. General disorders and Table 3: Non-Hematologic Adverse Reactions in ≥ 10% of Patients administration site with CLL/SLL (N=51) in Study 1 conditions Pyrexia 24 2 15 1 All Grades Grade 3 or 4 Body System Adverse Reaction (%) (%) Infections and infestations Gastrointestinal Diarrhea 59 4 disorders Constipation 22 2 Upper respiratory tract 16 1 11 2 Nausea 20 2 infection Stomatitis 20 0 Pneumonia* 15 10 13 9 Vomiting 18 2 Sinusitis* 11 1 6 0 Abdominal pain 14 0 Urinary tract infection 10 4 5 1 Dyspepsia 12 0 Skin and Infections and Upper respiratory subcutaneous infestations tract infection 47 2 tissue disorders Sinusitis 22 6 Rash* 24 3 13 0 Skin infection 16 6 Pneumonia 12 10 Petechiae 14 0 1 0 Urinary tract infection 12 2 Bruising* 12 0 1 0 General disorders and Fatigue 33 6 Musculoskeletal and administration site Pyrexia 24 2 connective tissue conditions Peripheral edema 22 0 disorders Asthenia 14 6 Musculoskeletal Pain* 28 2 18 1 Chills 12 0 Arthralgia 17 1 7 0 Skin and Bruising 51 2 Nervous system subcutaneous tissue Rash 25 0 disorders disorders Petechiae 16 0 Headache 14 1 6 0 Respiratory, thoracic Cough 22 0 and mediastinal Oropharyngeal pain 14 0 Dizziness 11 0 5 0 disorders Dyspnea 12 0 Injury, poisoning Musculoskeletal and Musculoskeletal pain 25 6 and procedural connective tissue Arthralgia 24 0 complications disorders Muscle spasms 18 2 Contusion 11 0 3 0 Nervous system Dizziness 20 0 Eye disorders disorders Headache 18 2 Vision blurred 10 0 3 0 IMBRUVICA® (ibrutinib) capsules IMBRUVICA® (ibrutinib) capsules
Subjects with multiple events for a given ADR term are counted once only Study 4: Adverse reactions described below in Table 8 reflect exposure for each ADR term. to IMBRUVICA + BR with a median duration of 14.7 months and exposure The body system and individual ADR terms are sorted in descending to placebo + BR with a median of 12.8 months in Study 4 in patients with frequency order in the IMBRUVICA arm. previously treated CLL/SLL. * Includes multiple ADR terms Table 8: Adverse Reactions Reported in at Least 10% of Patients Table 6: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or and at Least 2% Greater in the IMBRUVICA Arm Neutrophils in Patients with CLL/SLL in Study 2 in Patients with CLL/SLL in Study 4 IMBRUVICA Ofatumumab Ibrutinib + BR Placebo + BR (N=195) (N=191) (N=287) (N=287) All Grades Grade 3 or 4 All Grades Grade 3 or 4 Body System All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Adverse Reaction (%) (%) (%) (%) Neutrophils Decreased 51 23 57 26 Blood and lymphatic Platelets Decreased 52 5 45 10 system disorders Hemoglobin Decreased 36 0 21 0 Neutropenia* 66 61 60 55 * Based on laboratory measurements per IWCLL criteria. Thrombocytopenia* 34 16 26 16 Study 3: Adverse reactions described below in Table 7 reflect exposure to Skin and IMBRUVICA with a median duration of 17.4 months. The median exposure to subcutaneous tissue chlorambucil was 7.1 months in Study 3. disorders Rash* 32 4 25 1 Table 7: Adverse Reactions Reported in ≥ 10% of Patients and at Least 2% Greater in the IMBRUVICA Treated Arm Bruising* 20 <1 8 <1 in Patients with CLL/SLL in Study 3 Gastrointestinal disorders IMBRUVICA Chlorambucil (N=135) (N=132) Diarrhea 36 2 23 1 Body System All Grades Grade 3 or 4 All Grades Grade 3 or 4 Abdominal Pain 12 1 8 <1 Adverse Reaction (%) (%) (%) (%) Musculoskeletal and Gastrointestinal connective tissue disorders disorders Diarrhea 42 4 17 0 Musculoskeletal 29 2 20 0 Stomatitis* 14 1 4 1 pain* Musculoskeletal and Muscle spasms 12 <1 5 0 connective tissue General disorders disorders and administration Musculoskeletal pain* 36 4 20 0 site conditions Arthralgia 16 1 7 1 Pyrexia 25 4 22 2 Muscle spasms 11 0 5 0 Vascular Disorders Eye Disorders Hemorrhage* 19 2 9 1 Dry eye 17 0 5 0 Lacrimation increased 13 0 6 0 Hypertension* 11 5 5 2 Vision blurred 13 0 8 0 Infections and Visual acuity reduced 11 0 2 0 infestations Skin and Bronchitis 13 2 10 3 subcutaneous Skin infection* 10 3 6 2 tissue disorders Metabolism and Rash* 21 4 12 2 nutrition disorders Bruising* 19 0 7 0 Hyperuricemia 10 2 6 0 Infections and infestations The body system and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. Skin infection* 15 2 3 1 * Includes multiple ADR terms Pneumonia* 14 8 7 4 <1 used for frequency above 0 and below 0.5% Urinary tract infections 10 1 8 1 Atrial fibrillation of any grade occurred in 7% of patients treated with Respiratory, thoracic IMBRUVICA + BR and 2% of patients treated with placebo + BR. The and mediastinal disorders frequency of Grade 3 and 4 atrial fibrillation was 3% in patients treated with IMBRUVICA + BR and 1% in patients treated with placebo + BR. Cough 22 0 15 0 General disorders and Waldenström’s Macroglobulinemia and Marginal Zone Lymphoma: The administration site data described below reflect exposure to IMBRUVICA in open-label clinical conditions trials that included 63 patients with previously treated WM (Study 5) and 63 Peripheral edema 19 1 9 0 patients with previously treated MZL (Study 6). Pyrexia 17 0 14 2 The most commonly occurring adverse reactions in Studies 5 and 6 Vascular Disorders (≥ 20%) were thrombocytopenia, diarrhea, neutropenia, fatigue, bruising, hemorrhage, anemia, rash, musculoskeletal pain, and nausea. Hypertension* 14 4 1 0 Nervous System Nine percent of patients receiving IMBRUVICA across Studies 5 and 6 Disorders discontinued treatment due to adverse reactions. The most common adverse reactions leading to discontinuation were interstitial lung disease, Headache 12 1 10 2 diarrhea and rash. Adverse reactions leading to dose reduction occurred in Subjects with multiple events for a given ADR term are counted once only 10% of patients. for each ADR term. The body system and individual ADR terms are sorted in descending Study 5: Adverse reactions and laboratory abnormalities described below frequency order in the IMBRUVICA arm. in Tables 9 and 10 reflect exposure to IMBRUVICA with a median duration * Includes multiple ADR terms of 11.7 months in Study 5. IMBRUVICA® (ibrutinib) capsules IMBRUVICA® (ibrutinib) capsules
Table 9: Non-Hematologic Adverse Reactions in ≥ 10% Table 11: Non-Hematologic Adverse Reactions in ≥ 10% in Patients in Patients with WM in Study 5 (N=63) with MZL in Study 6 (N=63) (continued) All Grades Grade 3 or 4 Body System Adverse Reaction All Grades Grade 3 or 4 Body System Adverse Reaction (%) (%) (%) (%) Gastrointestinal disorders Diarrhea 37 0 Metabolism and Decreased appetite 16 2 Nausea 21 0 nutrition disorders Hyperuricemia 16 0 Stomatitis* 16 0 Hypoalbuminemia 14 0 Gastroesophageal 13 0 Hypokalemia 13 0 reflux disease Vascular Disorders Hemorrhage* 30 0 Skin and subcutaneous Rash* 22 0 Hypertension* 14 5 tissue disorders Bruising* 16 0 Respiratory, thoracic Cough 22 2 Pruritus 11 0 and mediastinal Dyspnea 21 2 General disorders and Fatigue 21 0 disorders administrative site Nervous system Dizziness 19 0 conditions disorders Headache 13 0 Musculoskeletal and Muscle spasms 21 0 Psychiatric disorders Anxiety 16 2 connective tissue Arthropathy 13 0 The body system and individual ADR preferred terms are sorted in descending disorders frequency order. Infections and infestations Upper respiratory * Includes multiple ADR terms. tract infection 19 0 Table 12: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Sinusitis 19 0 Neutrophils in Patients with MZL in Study 6 (N=63) Pneumonia* 14 6 Skin infection* 14 2 Percent of Patients (N=63) Respiratory, thoracic and Epistaxis 19 0 All Grades (%) Grade 3 or 4 (%) mediastinal disorders Cough 13 0 Platelets Decreased 49 6 Nervous system disorders Dizziness 14 0 Hemoglobin Decreased 43 13 Headache 13 0 Neutrophils Decreased 22 13 Neoplasms benign, Skin cancer* 11 0 * Based on laboratory measurements. malignant, and Additional Important Adverse Reactions: Diarrhea: Diarrhea of any grade unspecified (including occurred at a rate of 43% (range, 36% to 59%) of patients treated with cysts and polyps) IMBRUVICA. Grade 2 diarrhea occurred in 9% (range, 3% to 14%) and Grade The body system and individual ADR preferred terms are sorted in 3 in 3% (range, 0 to 5%) of patients treated with IMBRUVICA. The median descending frequency order. time to first onset of any grade diarrhea was 10 days (range, 0 to 627), of * Includes multiple ADR terms. Grade 2 was 39 days (range, 1 to 719) and of Grade 3 was 74 days (range, 3 to 627). Of the patients who reported diarrhea, 82% had complete resolution, Table 10: Treatment-Emergent* Decrease of Hemoglobin, Platelets, 1% had partial improvement and 17% had no reported improvement at time or Neutrophils in Patients with WM in Study 5 (N=63) of analysis. The median time from onset to resolution or improvement of any Percent of Patients (N=63) 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. All Grades (%) Grade 3 or 4 (%) Blurred vision and decreased visual acuity of any grade Platelets Decreased 43 13 Visual Disturbance: occurred in 10% of patients treated with IMBRUVICA (9% Grade 1, 2% Grade Neutrophils Decreased 44 19 2). The median time to first onset was 85 days (range, 1 to 414 days). Of the Hemoglobin Decreased 13 8 patients with visual disturbance, 61% had complete resolution and 38% had * Based on laboratory measurements. no reported improvement at time of analysis. The median time from onset to resolution or improvement was 29 days (range, 1 to 335 days). Study 6: Adverse reactions and laboratory abnormalities described below in Postmarketing Experience: The following adverse reactions have been Tables 11 and 12 reflect exposure to IMBRUVICA with a median duration identified during post-approval use of IMBRUVICA. Because these of 11.6 months in Study 6. reactions are reported voluntarily from a population of uncertain size, it is Table 11: Non-Hematologic Adverse Reactions in ≥ 10% in Patients not always possible to reliably estimate their frequency or establish a causal with MZL in Study 6 (N=63) relationship to drug exposure. Hepatobiliary disorders: hepatic failure Body System Adverse Reaction All Grades Grade 3 or 4 (%) (%) Respiratory disorders: interstitial lung disease Gastrointestinal Diarrhea 43 5 Metabolic and nutrition disorders: tumor lysis syndrome [see Warnings & Precautions] disorders Nausea 25 0 Dyspepsia 19 0 Immune system disorders: anaphylactic shock, angioedema, urticaria Stomatitis* 17 2 Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome (SJS), Abdominal pain 16 2 onychoclasis Constipation 14 0 DRUG INTERACTIONS Abdominal pain Upper 13 0 CYP3A Inhibitors: Ibrutinib is primarily metabolized by cytochrome P450 Vomiting 11 2 enzyme 3A (CYP3A). In healthy volunteers, co-administration of ketoconazole, General disorders and Fatigue 44 6 a strong CYP3A inhibitor, increased Cmax and AUC of ibrutinib by 29- and administrative site Peripheral edema 24 2 24-fold, respectively. The highest ibrutinib dose evaluated in clinical trials conditions Pyrexia 17 2 was 12.5 mg/kg (actual doses of 840 – 1400 mg) given for 28 days with single Skin and Bruising * 41 0 dose AUC values of 1445 ± 869 ng • hr/mL which is approximately 50% greater subcutaneous tissue Rash* 29 5 than steady state exposures seen at the highest indicated dose (560 mg). disorders Pruritus 14 0 Avoid concomitant administration of IMBRUVICA with strong or moderate Musculoskeletal and Musculoskeletal pain* 40 3 inhibitors of CYP3A. For strong CYP3A inhibitors used short-term connective tissue Arthralgia 24 2 (e.g., antifungals and antibiotics for 7 days or less, e.g., ketoconazole, disorders Muscle spasms 19 3 itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin) consider interrupting IMBRUVICA therapy during the duration of inhibitor Infections and Upper respiratory tract use. Avoid strong CYP3A inhibitors that are needed chronically. If a infestations infection 21 0 moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose. Sinusitis* 19 0 Patients taking concomitant strong or moderate CYP3A4 inhibitors should Bronchitis 11 0 be monitored more closely for signs of IMBRUVICA toxicity [see Dosage and Pneumonia* 11 10 Administration (2.4) in Full Prescribing Information]. IMBRUVICA® (ibrutinib) capsules IMBRUVICA® (ibrutinib) capsules
Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these Monitor patients for signs of IMBRUVICA toxicity and follow dose contain moderate inhibitors of CYP3A [see Dosage and Administration (2.4), modification guidance as needed. It is not recommended to administer and Clinical Pharmacology (12.3) in Full Prescribing Information]. IMBRUVICA to patients with moderate or severe hepatic impairment CYP3A Inducers: Administration of IMBRUVICA with rifampin, a strong (Child-Pugh class B and C) [see Dosage and Administration (2.5) and Clinical CYP3A inducer, decreased ibrutinib Cmax and AUC by approximately 13- and Pharmacology (12.3) in Full Prescribing Information]. 10-fold, respectively. Plasmapheresis: Management of hyperviscosity in WM patients may Avoid concomitant use of strong CYP3A inducers (e.g., carbamazepine, rifampin, include plasmapheresis before and during treatment with IMBRUVICA. phenytoin, and St. John’s Wort). Consider alternative agents with less CYP3A Modifications to IMBRUVICA dosing are not required. induction [see Clinical Pharmacology (12.3) in Full Prescribing Information]. PATIENT COUNSELING INFORMATION USE IN SPECIFIC POPULATIONS Advise the patient to read the FDA-approved patient labeling (Patient Pregnancy: Risk Summary: IMBRUVICA, a kinase inhibitor, can cause Information). fetal harm based on findings from animal studies. In animal reproduction • Hemorrhage: Inform patients of the possibility of bleeding, and to report studies, administration of ibrutinib to pregnant rats and rabbits during the any signs or symptoms (severe headache, blood in stools or urine, period of organogenesis at exposures up to 2-20 times the clinical doses prolonged or uncontrolled bleeding). Inform the patient that IMBRUVICA of 420-560 mg daily produced embryofetal toxicity including malformations may need to be interrupted for medical or dental procedures [see [see Data]. If IMBRUVICA is used during pregnancy or if the patient becomes Warnings and Precautions]. pregnant while taking IMBRUVICA, the patient should be apprised of the • Infections: Inform patients of the possibility of serious infection, and potential hazard to the fetus. to report any signs or symptoms (fever, chills, weakness, confusion) The estimated background risk of major birth defects and miscarriage suggestive of infection [see Warnings and Precautions]. for the indicated population is unknown. In the U.S. general population, • Atrial fibrillation: Counsel patients to report any signs of palpitations, the estimated background risk of major birth defects and miscarriage in lightheadedness, dizziness, fainting, shortness of breath, and chest clinically recognized pregnancies is 2-4% and 15-20%, respectively. discomfort [see Warnings and Precautions]. Animal Data: Ibrutinib was administered orally to pregnant rats during the • Hypertension: Inform patients that high blood pressure has occurred period of organogenesis at doses of 10, 40 and 80 mg/kg/day. Ibrutinib at a in patients taking IMBRUVICA, which may require treatment with anti- dose of 80 mg/kg/day was associated with visceral malformations (heart and hypertensive therapy [see Warnings and Precautions]. major vessels) and increased resorptions and post-implantation loss. The • Second primary malignancies: Inform patients that other malignancies dose of 80 mg/kg/day in rats is approximately 14 times the exposure (AUC) have occurred in patients who have been treated with IMBRUVICA, in patients with MCL and 20 times the exposure in patients with CLL/SLL or including skin cancers and other carcinomas [see Warnings and WM administered the dose of 560 mg daily and 420 mg daily, respectively. Precautions]. 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 • Tumor lysis syndrome: Inform patients of the potential risk of tumor exposure (AUC) in patients with MCL administered the dose of 560 mg daily. lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Ibrutinib was also administered orally to pregnant rabbits during the period Precautions]. of organogenesis at doses of 5, 15, and 45 mg/kg/day. Ibrutinib at a dose • Embryo-fetal toxicity: Advise women of the potential hazard to a fetus and 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 to avoid becoming pregnant during treatment and for 1 month after the increased resorptions and post-implantation loss. The dose of 15 mg/kg/day last dose of IMBRUVICA [see Warnings and Precautions]. in rabbits is approximately 2.0 times the exposure (AUC) in patients with MCL • Inform patients to take IMBRUVICA orally once daily according to their and 2.8 times the exposure in patients with CLL/SLL or WM administered the physician’s instructions and that the capsules should be swallowed dose of 560 and 420 mg daily, respectively. whole with a glass of water without being opened, broken, or chewed at approximately the same time each day Lactation: Risk Summary: There is no information regarding the presence of [see Dosage and Administration ibrutinib or its metabolites in human milk, the effects on the breastfed infant, (2.1) in Full Prescribing Information]. or the effects on milk production. • 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 The development and health benefits of breastfeeding should be considered to the normal schedule the following day. Patients should not take extra along with the mother’s clinical need for IMBRUVICA and any potential adverse effects on the breastfed child from IMBRUVICA or from the capsules to make up the missed dose [see Dosage and Administration underlying maternal condition. (2.6) in Full Prescribing Information]. • Advise patients of the common side effects associated with IMBRUVICA Females and Males of Reproductive Potential: Pregnancy Testing: Verify [see Adverse Reactions]. Direct the patient to a complete list of adverse the pregnancy status of females of reproductive potential prior to initiating drug reactions in PATIENT INFORMATION. IMBRUVICA therapy. • Advise patients to inform their health care providers of all concomitant
Contraception: medications, including prescription medicines, over-the-counter drugs, Females: Advise females of reproductive potential to avoid pregnancy while vitamins, and herbal products [see Drug Interactions]. 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 • Advise patients that they may experience loose stools or diarrhea, and this drug, the patient should be informed of the potential hazard to a fetus. should contact their doctor if their diarrhea persists. Advise patients to maintain adequate hydration [see Adverse Reactions]. Males: Advise men to avoid fathering a child while receiving IMBRUVICA, and for 1 month following the last dose of IMBRUVICA. Active ingredient made in China. Pediatric Use: The safety and effectiveness of IMBRUVICA in pediatric Distributed and Marketed by: patients has not been established. Pharmacyclics LLC Sunnyvale, CA USA 94085 Geriatric Use: Of the 905 patients in clinical studies of IMBRUVICA, 62% and were ≥ 65 years of age, while 21% were ≥75 years of age. No overall Marketed by: differences in effectiveness were observed between younger and older Janssen Biotech, Inc. patients. Anemia (all grades) and Grade 3 or higher pneumonia occurred Horsham, PA USA 19044 more frequently among older patients treated with IMBRUVICA. Patent http://www.imbruvica.com Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic IMBRUVICA® is a registered trademark owned by Pharmacyclics LLC impairment study, data showed an increase in ibrutinib exposure. Following single dose administration, the AUC of ibrutinib increased 2.7-, 8.2- and © Pharmacyclics LLC 2017 9.8-fold in subjects with mild (Child-Pugh class A), moderate (Child-Pugh © Janssen Biotech, Inc. 2017 class B), and severe (Child-Pugh class C) hepatic impairment compared to PRC-02461 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. Partners.CAPG.Full.Pg.Ad.2017_2.OL.indd 1 5/9/17 1:42 PM An Urgent Case...continued from page 29 optimize health outcomes. We need to place greater leadership, translate into operational implementation, value in performance measurement and quality and lead to a shift from the physician’s traditional improvement, including advocating that provider mindset of “If I don’t do it myself, it won’t get done or experience be valued as a key metric, whether in done right,” to comfort with delegating tasks to other evaluating healthcare organizations (insurers, hospitals, care team members qualified to perform them.13 This physician groups) or initiatives that potentially add to the change is at the core of the patient-centered medical workload and time demands of physicians. home model that several CAPG practices have adopted. In short, practice transformation requires four main Transforming practices into models that support components: physician wellness demands adequate resources and 1. Executive leadership a sizable capital investment. The return on investment 2. Technology and business case both exist.14 Moreover, physicians must lead and advocate for needed resources, serving 3. Care management army as leading examples in our clinics to adopt practice 4. Performance measurement and quality transformation programs and processes into our daily improvement routines. We need to change the culture in which we have been delivering healthcare because it no At CAPG, we believe in our doctors. We believe they’re longer works. To do so requires data and technology the future leaders, and we continue to advocate for the to effectively monitor and improve our processes by fulfillment of the profession, as we educate and provide creating a robust digital infrastructure and increasing our physician organizations with the necessary tools data velocity among providers. to carry out the honorable work of caring for patients. We are here to develop resiliency within physicians and In a sense, we need to deploy a “care management their practices by improving the work environment for army” because sometimes it takes a village to manage the entire care team. In doing so, we hope to bring light population health and perform predictive modeling to and solutions to the gnawing issue of physician burnout
Educational Series 2017: Quality Payment Program Webinars with CMS REGISTER Advancing Care Information—How to Implement NOW! the New Meaningful Use Component of MIPS capg.org/qpp Friday, July 7 • 3:00-4:30 pm Eastern, 12:00-1:30 pm Pacific Ashby Wolfe, MD Elizabeth Holland Larry deGhetaldi, MD Ray Manahan Chief Medical Officer, CMS Senior Technical Advisor, CMS President, Palo Alto Medical Senior Director of Region IX Foundation Santa Cruz at Government Programs, Sutter Health Providence Health & Services
Please join us for a complimentary webinar series with the Centers for Medicare & Medicaid Services (CMS), designed for physician groups implementing MACRA through the Quality Payment Program. Through a co- branding agreement, the sessions combine CMS expertise on MACRA’s content with CAPG members’ knowledge of how clinicians are responding on the ground. Learn more: capg.org/qpp or Dr. Amy Nguyen Howell, [email protected] / 213.239.5051
Friday, September 15 Monday, October 2 Friday, December 1 Improvement Activities—How to Advanced Alternative Payment How to Control Costs for the MIPS Select Measures and Position Your Models—The Good, Bad, and Ugly Resource Use Component Organization for APMs
46 l capg health Summer 2017 by developing programs that give agency to physicians 7. Alison Murray, et al, Doctor Discontent: A Comparison of Physican Satisfaction in Different Delivery Settings, Journal of General Internal to make the practice of medicine more rewarding and Medicine, 2001:16,452. http://onlinelibrary.wiley.com/doi/10.1046/ fulfilling. j.1525-1497.2001.016007452.x/abstract 8. BE Landon, et al, Leaving Medicine: the consequences of physician You can find more information on CAPG’s Practice dissatisfaction, Medical Care, March 2006. http://onlinelibrary.wiley. Transformation Program at capg.org/transformation and com/doi/10.1046/j.1525-1497.2001.016007452.x/abstract on CAPG’s Educational Series at capg.org/qpp. o 9. Tait D. Shanafelt, Liselotte N. Dyrbye, Christine A. Sinsky, et al. Relationship between clerical burden and characteristics of the electronic environment with physician burnout and professional Amy Nguyen Howell, MD, MBA, FAAFP, is Chief Medical satisfaction. Mayo Clinic Proceedings, 2016;91(7):836–848. www. Officer for CAPG. mayoclinicproceedings.org/article/S0025-6196(16)30215-4/abstract 10. Thomas Bodenheimer, Christine A. Sinsky, From Triple to 1. Definitive Healthcare, The Hidden, Growing Problem of Physician Quadruple Aim: care of the patient requires care of the provider, Burnout, https://www.definitivehc.com/hospital-data/the-hidden- Annals of Family Medicine, 2014;12(6):573–576, http://www. growing-problem-of-physician-burnout. annfammed.org/content/12/6/573.full 2. Andis Robeznieks, Physician Burnout Continues Upward Trend: 11. William M. Spinelli, The Phantom Limb of the Triple Aim. Study, Healthcare Financial Management Association, published January Mayo Clinic Proceedings, 2013;88(12):1356–1357, http://www. 19, 2017. https://www.hfma.org/Content.aspx?id=52164,. mayoclinicproceedings.org/article/S0025-6196(13)00737-4/ 3. Jack Colwill, James. W. Cutice, Robin L. Kruse, Will a Generalist abstract Physician Supply Meet Demands of an Increasing and Aging 12. Christine A. Sinsky, Rachel Willard-Grace, Andrew M. Schutzbank, Population, Health Affairs, May 2008. http://content.healthaffairs.org/ et al. In search of joy in practice: a report of 23 high-functioning content/27/3/w232.full primary care practices. Annals of Family Medicine, 2013;11(3):272– 4. Stephen Petterson, et al, Estimating the Residency Expansion 278. http://www.annfammed.org/content/11/3/272.full Required to Avoid Projected Primary Care Physician Shortages by 2035, 13. David Margolius and Thomas Bodenheimer, Transforming Primary Annals of Family Medicine, March/April 2015. http://www.annfammed. Care: From Past Practice To The Practice Of The Future, Health org/content/13/2/107.full Affairs, May 2010 http://content.healthaffairs.org/content/29/5/779 5. Mark Linzer, et al, Working conditions in primary care: physician 14. Daniel J. Maeng et al, Reducing Long-Term Cost by Transforming reactions and care quality, Annals of Internal Medicine, July 7, 2009, Primary Care, American Journal of Managed Care, March 16, 2012. 151: 28-36. https://www.ncbi.nlm.nih.gov/pubmed/19581644 http://www.ajmc.com/journals/issue/2012/2012-3-vol18-n3/ 6. Liselotte N. Dyrbye and Tait D. Shanafelt, Physician Burnout: a reducing-long-term-cost-by-transforming-primary-care-evidence-from- Potential Threat to Health Care Reform, JAMA 2011;305:2009. https:// geisingers-medical-home-model www.ncbi.nlm.nih.gov/pubmed/21586718
HEALTH LEADERSHIP CONSULTANTS
Bart Wald, MD, MBA Consulting Services Pamela Wald, MD
• Physician Group Development and Health Care System Integration • Creating Physician Accountability and Performance Management • Population Health Management Strategies Dr. Bart Wald, leader • Health Care Executive and Physician Leadership Dr. Pamela Wald, former in physician group Development Kaiser Permanente Physician development, CAPG Executive with extensive consultant and former • EHR Optimization and Change Management experience in integrated CAPG Chairman of the Strategies health care systems Board • Customer Service and improving physician performance
Contact [email protected] 626-319-4949
Summer 2017 capg health l 47 Improving Patient Engagement...continued from page 31 reported that the outreach tools were highly effective at Table 1. Outcomes at end of pilot increasing patient awareness and activating them to get screened. Providers also reported having more frequent Number of identified 219 (100 percent) screening conversations with patients during the pilot. screening candidates (SCs) Number of SCs who followed 119 (54 percent) Second, patients reported that the outreach tools were up with a PCP or GI more effective at motivating them to receive screening Number of SCs who 69 (32 percent) than information they had received in the past. Finally, completed screening given the limited use of FOBTs in pilot sites (from January Completed screenings: type Colonoscopy = 28 (41 through June 2016, only 0 percent to 2 percent of patients of screening tests percent) completed FOBTs), it stands to reason that the availability Flex sigmoidoscopy = 0 and promotion of the FOBT during the pilot may have been (0 percent) one of the key drivers in increasing screening rates. FOBT = 41 (59 percent) Number of SCs who had 17 Lessons Learned polyps removed We also attribute the higher screening rate in part to best Number of SCs with positive 0 practices that were built into the program. Those practices, FOBT tests and the valuable operational lessons that emerged, include: Number of SCs diagnosed 0 with colorectal cancer Best practice 1: Establish measurable goals. At the three pilot sites, we sought to bring screening rates closer to the Although it is difficult to attribute the increase in average NCCRT goal of 80 percent of eligible patients screened screening rate to any single intervention, information by 2018.4 This was a patient-centered, aspirational goal, gathered through formal surveys after the pilot completion rather than one based on meeting requirements of a quality gives us some clues. First, pilot site providers and staff measure.
48 l capg health Summer 2017 Best practice 2: Provide screening candidates with all The activities we undertook are applicable across health available testing options. At-home testing kits for patients systems. Our next step will be to test this program at other who did not want to complete a colonoscopy removed a sites, removing a few of the manual outreach steps that significant barrier for difficult-to-engage patients, leading would cause significant hurdles to scalability.o to higher screening rates. Mohini Sinha, MD, is Quality Medical Director at Monarch Best practice 3: Analyze workflows and establish formal HealthCare in Irvine, California. processes. Prior to this pilot, we did not have oversight References over the patient screening journey (i.e., identifying eligible 1. American Cancer Society: Cancer Facts & Figures 2017. . https://www. patients and following them through to completion of cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/ screening). This exercise enabled us to codify a workflow, annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed April 13, 2017. integrate it into each office’s processes, and close a 2. Mariotto AB, Yabroff R, Shao Y, Feuer EJ, Brown ML. Projections of the fundamental gap in quality of care. cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-128. Best practice 4: Use a centralized patient navigator. By 3. American Cancer Society: Can colorectal polyps and cancer be found moving the burden of patient outreach and follow-up to early? https://www.cancer.org/content/cancer/en/cancer/colon-rectal- the central office, provider staff could devote more time cancer/detection-diagnosis-staging/detection.html. Revised March 2, 2017. Accessed March 31, 2017. to patient care, allowing us to use our patient navigator to 4. National Colorectal Cancer Roundtable: Tools & resources: 80% by fullest capacity. 2018 communications guidebook: recommended messaging to reach the unscreened. http://nccrt.org/tools/80-percent-by-2018/80-by-2018- Through a concerted effort to motivate difficult-to-engage communications-guidebook. Accessed April 4, 2017. patients, colorectal cancer screening rates meaningfully 5. Arif K, Hufford D, Debose R. Colon cancer screening: home testing improved by the end of the pilot. We believe that the Love increases patient activation. CAPG Health. 2016;10(2):30-31. Your Colon program tools and suggestions for workflow 6. Love Your Colon. http://www.loveyourcolon.org. Accessed April 4, 2017. optimization effectively contributed to this outcome. 7. American Cancer Society: Recommendations for colorectal cancer early detection. https://www.cancer.org/cancer/colon-rectal-cancer/detection- Genentech plans to expand the program tools from the diagnosis-staging/acs-recommendations.html. Revised March 1, 2017. pilot into additional Love Your Colon program resources. Accessed April 4, 2017.
ANNUAL CONFERENCE
THEdate! 2018
APRIL 19-21, 2018 MANCHESTER GRAND HYATT SAN DIEGO, CALIFORNIA
Summer 2017 capg health l 49 California Quality Collaborative...continued from page 32 Transformation Initiative provides coaching and peer- to-peer network support for provider organization leaders Managing Cost of Care: Cost of Care CQC will launch and funding to hire practice coaches to work intensively Action Community , a 15-month program to address with practices. The network also provides data feedback on drivers of utilization and cost. Collaborative activities a set of Triple Aim measures common across value-based include a pre-work diagnostic to help participants target payment programs in Medicare, commercial, and Medicaid opportunities, in-person learning sessions with experts lines of business, and supports provider organizations to to help teams execute on targeted priorities, dedicated strengthen internal reporting systems to practices. For coaches to support teams and troubleshoot barriers, and more information, contact Diane Stewart, dstewart@ supplemental webinars to learn more about promising calquality.org. practices from the field. For more information, contact Sandy Newman, [email protected]. CQC also offers a variety of learning opportunities on such topics as medication adherence and motivational Practice Transformation: CQC is one of 29 Practice interviewing. Keep in touch by visiting www.calquality.org. o Transformation Networks selected by the Centers for Medicare & Medicaid Services (CMS) as part of its Diane Stewart is Senior Director and Dr. Bart Wald is Transforming Clinical Practice Initiative. CQC’s Practice Medical Director at the California Quality Collaborative.
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50 l capg health Summer 2017 CAPG Annual Conference 2017 June 22-24 | San Diego, California
Thank you to our Conference premier sponsors for your support!
Diamond Sponsors Platinum Sponsors Aetna AbbVie Alignment Healthcare BlueCross BlueShield Association Anthem Blue Cross of California Novo Nordisk athenahealth, Inc. Gold Sponsors Blue Shield of California Boehringer Ingelheim Cigna Pharmaceuticals, Inc. Health Net of California COPE Health Solutions Humana, Inc. Deloitte Molina Healthcare Johnson & Johnson Novartis Phamaceutical Corp. Family of Companies OptumCare L.A. Care Health Plan UnitedHealthcare Sheppard Mullin Formula for Success in New Payment Models
The new Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which moves the physician payment model away from fee-for-service to value-based patient care, has some healthcare professionals understandably concerned about adding another twist to healthcare reimbursements. At Brown & Toland Physicians, providing value-based care to patients is a familiar practice. Many of our physicians are already meeting MACRA requirements through the use of e-tools, improved quality clinical practices and effective management of costs.
With Brown & Toland’s experience across numerous value-based accountable care projects for HMO and PPO patients, we have fine-tuned the formula for delivering high-quality, cost-effective care while succeeding in risk-adjustment payments models. One such example includes our participation in the CMS Pioneer Accountable Care program, which generated more than $15 million in savings for the care of 17,000 patients.
It is accountable care experiences like this that will help physician-led groups and their partners find the winning formulas for success in the new payment models to come.
To learn more about Brown & Toland Physicians and how we have achieved success through value-based payment models, please visit our website at brownandtoland.com.
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