Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs

Transcription

1 AIS s Management Insight Series Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs Adapted from an AIS Webinar presented by Jennifer Malin, M.D., Ph.D Medical Director of Oncology Anthem, Inc. Edited by Erin Trompeter, Managing Editor, AIS GC5P05

2 AIS s Management Insight Series is designed to provide practical solutions to complex business challenges with the help of the industry s most insightful advisors and managers. See a full list of titles in this series at Other Related Publications from AIS Specialty Pharmacy News Drug Benefit News Specialty Pharmacy Trends and Strategies Health Plan Week AIS s Value-Based Care News Call , or visit the MarketPlace at for a catalog of AIS books, newsletters, Webinars, Web and looseleaf services, and other information products. This publication is designed to provide accurate, comprehensive and authoritative information on the subject matter covered. However, the opinions contained in this publication are those solely of the authors and not the publisher. The publisher does not warrant that information contained herein is complete or accurate. This book is published with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent person should be sought. ISBN: Copyright 2015 by Atlantic Information Services, Inc. All rights reserved. No part of this publication may be reproduced, stored on a retrieval system or transmitted by any means, electronic or mechanical, including photocopying and transmittal by FAX, without the prior written permission of Atlantic Information Services, Inc. For information regarding individual or bulk purchases, contact Atlantic Information Services, Inc., th Street, NW, Suite 300, Washington, DC ( ; ).

3 Table of Contents Introduction... 1 Cancer Care Challenges... 3 The Oncology Practice Perspective... 7 The Treatment Pathways Approach... 9 The Anthem Program Question and Answer Session Appendix A: Anthem and AIM Specialty Health Pathways Worksheets Appendix B: AIS Coverage of Pathways and Health Plan Management of Oncology Care CareFirst, P4 Launch RA Clinical Pathways Program That Incorporates Disability Score...41 Prime Therapeutics Says It Plans to Have Preferred CML Products...45 Health Plan Explores Change in Physician Reimbursement to Improve Cancer Care...46 Florida Blue Teams With Hospital System, Oncologists to Form Cancer-Focused ACO...49 Oncology, Biomarkers May Be Specialty Drug Pipeline Standouts...52 Cardinal Reports Data on RA Clinical Pathways Program...55 Louisiana Blues Plan Will Work With Cardinal, Physicians on Oncology Pathways...56 Plans Are Expected to Step Up Oncology Management Strategies...59 As Oncology Drug Spend Rises, Payer Management Will Increase...62 Florida Blue and Moffitt Cancer Center Launch ACO Focused on Oncology Care...64 CareFirst RA Clinical Pathways Program Gets Providers On Board, May Expand to GI...66 Clinical Pathways Reduced Costs of Care 15%; Success Led to Medical Home Pilot...67 Biomarkers, Specific Pathways Are Influencing Cancer Care More...69 Current State of Cancer Care Has Challenges...70 Spending on Oncolytics Has Slowed, But More New Drugs Are Launching...71 WellPoint Turns to Pathways to Improve Cancer Care, Costs...74 Horizon Invests in Oncology Firm COTA to Help Docs Offer Patient-Centered Care...77 UnitedHealthcare Launches Bundled Payment Pilot With MD Anderson...80 CMS Will Launch Five-Year Oncology Care Initiative in Tennessee Blues Launches Pilot With Tennessee Oncology...83 Appendix C: CMS Oncology Care Model Documents... 85

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5 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 1 Introduction While the field of oncology has seen enormous innovation as of late, the average monthly cost for an oncology drug has doubled over the last 10 years to approximately $10,000 today, and 1,500 people in the U.S. continue to die from cancer each day. To make sure patients are getting the most appropriate evidence-based care that is still cost-effective, some payers have turned to the use of pathways, which set forth certain treatment options and provider payment arrangements. Working with its AIM Specialty Health subsidiary, Anthem, Inc. joined that movement in This report, Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs, discusses the specifics of the program, its expectations in terms of outcomes and cost control, some lessons that it has already learned and changes already made in the initial plans. The publication provides valuable, practical intelligence and training on topics such as: u The motivation behind the Anthem program; u The insurer s original plan, and how the pathways already have expanded since the program started; u The specifics of how the program works, including how providers know if a treatment regimen is on-pathway; u The role providers play in the pathways; u How Anthem has communicated with providers as it rolls out the program; and u How this program compares with other pathways programs and the pros and cons of different models. The report was updated and adapted from a Feb. 18, 2015, webinar sponsored by Atlantic Information Services, Inc. At the webinar, Anthem s Cancer Care Quality Program: A Blueprint to Improve Care and Reduce Costs, Jennifer Malin, M.D., Ph.D, medical director of oncology at Anthem, discussed the specifics of her health plan s successful implementation of the Cancer Care Quality Program. Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs also includes questions posed by the webinar attendees and answers provided by Malin. Appendices filled with relevant background coverage of industry developments and other resources give insight into the evolving world of pathways and other quality programs in the oncology space. They include: u Appendix A: Anthem and AIM Specialty Health Pathways Worksheets, templates prepared by Anthem and AIM Specialty Health for physicians to use to chart pathways for patients.

6 2 AIS s Management Insight Series u Appendix B: A collection of articles tracking developments on pathways and other oncology programs from AIS s leading health business newsletters Drug Benefit News and Specialty Pharmacy News. u Appendix C: CMS Oncology Care Model Documents, which described CMS s new Oncology Care Model, announced in February Erin Trompeter Managing Editor Atlantic Information Services, Inc.

7 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 3 Cancer Care Challenges One of the key issues in cancer care is that the quality of care is inconsistent. While new innovative therapies and higher-cost therapies abound, one constant background issue is that not every patient receives state-of-the-art care. Numerous studies have shown that up to one in three people treated with chemotherapy do not receive a treatment regimen that is consistent with current best-practice medical evidence. These patients are receiving treatment, but they may not be: (1) getting the most effective therapy for their cancer; (2) receiving the optimal dose of the treatment regimen; or (3) receiving appropriate supportive care to help mitigate side effects, or the supportive care they re getting is unnecessary and is causing side-effects and leading to extra cost. Other issues that have been highlighted more recently are the number of hospitalizations during treatment and ER visits, some of which may be unavoidable, but many could be prevented by using less toxic (but still effective) treatment regimens, providing more appropriate supportive care, such as anti-emetics and white blood cell growth factors, or by improving patients access to their clinical teams. In addition, many treatments patients receive are unnecessary and wasteful and expose patients to side effects that in turn result in additional cost and care burden. And patients sometimes also face unintended personal consequences when they are prescribed excessive treatments, like having employment terminated for missing too much work due to CT scans that are not recommended as a best practice for a particular cancer. With the rapid increase in the number of new cancer therapies approved over the last decade, there have been dramatic increases in cost for cancer care at the same time consumers share of costs for health care are rising (see box, next page).

8 4 AIS s Management Insight Series At Memorial Sloan-Kettering, the monthly price of treatment has risen from the 1980s, where a typical treatment was less than $100, into the 1990s, where the increase jumped to $500-$1,000. In 2014, most treatments exceed $10,000 a month. Just over the last decade, the cost of treatment with newly approved FDA drugs for cancer has doubled. Some of these therapies have had a huge impact on patients lives,

9 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 5 rendering formerly fatal illnesses into chronic diseases, but of the 13 therapies approved by the FDA in 2012, only one extended survival by more than six months, and two extended survival by only four to six weeks, at an average monthly cost of $6,000. IOM Report Charts New Course The Institute of Medicine released a report in 2013 highlighting that a new course was needed for a system in crisis and summarizing that care often lacks a patientcentered focus. Many patients do not receive palliative care to manage their symptoms and side effects from treatment, and decisions about care often are not based on the latest scientific evidence. The IOM report recommended the following: u A national quality reporting program with meaningful quality measures regarding cancer care. u A focus on improving the affordability of cancer care by leveraging existing efforts to reform payment to eliminate waste. u Reimbursement alignment to reward affordable patient-centered high-quality care. The IOM report highlighted the importance of aligning reimbursement to support higher quality and lower cost of care, which had not been commonly included together. Before, there was a perceived trade-off, where focus on cost led to decreased quality. The report also suggested that new payment models would need to be developed to reach the goal of high-quality, affordable and accessible cancer care.

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11 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 7 The Oncology Practice Perspective Generally, U.S. oncology practices must purchase the drugs that they infuse into patients for their cancer treatments, and are then reimbursed by Medicare and other payers at the average sales price (ASP) plus a margin over that sales price of the drug. Medicare initially paid a margin of 6% but that figure has decreased to around 4%. For private payers, the figure may be 6% or greater, and individual practices may be able to negotiate contracts to drive the percentage higher. This practice has been referred to as the buy-and-bill model and in many ways has been blamed for a lot of issues in the oncology space. Oncology practices are dependent on the revenue from drugs to deliver the services to patients (see box, below). The typical oncology practice has seven full-time employees per physician because these complex patients require a lot of care coordination as they are receiving toxic treatments with many side effects. Any reimbursement system that decreases the revenue from drugs to practices must have a way to make up that revenue so that the practices can continue to provide care to patients. Of Anthem s members receiving cancer treatment via surgery, chemotherapy, radiation or any combination thereof, chemotherapy and supportive care drugs represent approximately 25% of the cost for all members with cancer and active treatment. Because these costs are rising dramatically, Anthem needed to ensure that its strategy provided members the most successful and cost-effective care. The insurer decided to develop a reimbursement model that would provide additional pay for practices when they shifted to providing cancer care that is value-based and patient-centered.

12 8 AIS s Management Insight Series Past initiatives to reform oncology payment included the Medicare Modernization Act (MMA) of 2005, one of the first efforts to change reimbursement for oncology. The act changed the way Medicare and then other payers reimbursed oncologists for drugs in the buy-and-bill model. Prior to the MMA, oncology practices had generally been reimbursed at some version of ASP, so there was a large margin between the acquisition cost for the practice and what it was reimbursed, although this was highly variable. With the MMA, manufacturers were required to report to CMS every quarter on their actual ASP. In this context, there have been a number of different population-based risk sharing arrangements between providers and payers that aren t necessarily focused on oncology, although a couple of pilot oncology accountable care organizations (ACOs) have been created. However, oncology is often included in many of these other agreements since the Affordable Care Act was passed. In some models, medical groups take on capitation for populations that includes oncology care. For many ACOs, cancer care is one of the most expensive conditions among the members enrolled. Another reimbursement approach is an episode-based payment model, which can take many forms. Some include the drug cost in the episode payment: A practice might get a set fee of $50,000 for a treatment of lung cancer, and that figure would include all of the visits, as well as the drug costs. More commonly, however, episode-based payments include the visits and other aspects of care, but the drugs are still reimbursed separately, either at cost or still at some ASP+ margin. One example of this scenario is a UnitedHealthcare pilot that included an episode-based payment, separate drug reimbursement at cost, and a shared savings component.

13 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 9 The Treatment Pathways Approach Treatment pathways have been used by a number of large practices, including U.S. Oncology, and well-known health plans. For example, Blue Cross Blue Shield of Michigan s pathways program has included various different reimbursement models tied to the pathways. Common elements to these models include: u A lump sum to the provider just for participating; u Pay-for-performance aspects, where the plan can examine whether the provider achieved a certain adherence level to pathways; and u Shared savings, so after a certain period of time, the plan performs a reconciliation to see if the pathways produce any savings, which are then shared with the participating providers. Anthem s model involves prospective enhanced reimbursement along the lines of an episode-based payment, but only when the pathway is selected. Anthem considers its model a quality initiative because it provides the insurer with a framework for starting to reward quality cancer care. Oncologists participating in the program receive additional payment for treatment planning and care coordination when they select a treatment regimen that is on pathway. Anthem implements the model through its subsidiary AIM Specialty Health via a Web-based platform that provides decision support for the quality initiative and incorporates the prior authorization process for those drugs for which Anthem has a medical policy. Through one workflow process, practices can participate in the program, obtain any needed prior authorizations and decrease their administrative burdens. The website is designed for providers, but can be accessed by the public at What Are Pathways? Pathways have been discussed in oncology for several years as one solution to helping to mitigate the cost of cancer care. In health care, pathways can have a lot of different meanings. In one scenario, pathways could be set up to try to improve care in a hospital setting by helping to decrease variation in post-operative care and move patients out of the hospital more quickly with fewer complications. Pathways are a subset of regimens supported by evidence and clinical guidelines and aligned with health plan medical policies. Pathways are intended to be applicable for 80% to 90% of patients and are selected based on: u Clinical benefit; u Side-effects or toxicities, particularly those that lead to hospitalizations and affect the patient s quality of life; u Strength of national guideline recommendations; and u Cost of regimens.

14 10 AIS s Management Insight Series In the oncology space, pathways have come to have a meaning separate from guidelines that provide a narrower range of treatment options, to take into account the best models for treating specific conditions. The goal is to expand beyond guidelines in decreasing variations in care, to improve safety and quality of care, and increase value. National Comprehensive Cancer Network (NCCN) guidelines are considered by many stakeholders to be the gold standard for guidelines in treating cancer care in the U.S. because they are so comprehensive. Take, for example, a patient who has nonsmall cell lung cancer, is a candidate for first-line platinum-based therapy and doesn t have a mutation that would indicate that they should be treated with one of the targeted therapies like Erlotinib or Crizotinib. For that patient, there are 64 different treatment regimens that would be consistent with NCCN guidelines. While NCCN provides a road map and guidance on the best treatments for patients, the guidelines don t just include the handful of regimens that would produce the best outcomes for most patients, have the fewest side effects and provide the best value. With 64 regimens, there is likely a lot of variation in terms of cost and side effects. As an example, see the box below for six of the most commonly used regimens for first-line therapy in non-small cell lung cancer. In the first column, the estimated survival, the first set of numbers is the point estimate from the most current randomized trial that included this regimen. This figure ranges from 13 months for Rx A, 10.4 months for Rx B and 13.4 months at the high for Rx E. Where the 95% survival intervals are, those intervals mainly overlap: All the therapies have survival of approximately a year.

15 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 11 Adverse events for these treatments are similar across regimens. The main differences relate to nausea and vomiting risk, which ranges from moderate to high risk and involves the type of platinum chemotherapy included in these studies. Since platinum has a high nausea/vomiting risk, carboplatin is moderate. Most of the time those are substituted one for the other in individual patients because they are considered clinically equivalent in the metastatic setting, and the oncologist will choose one or the other depending on different patient characteristics. Beyond these adverse effects, the main differences seen relate to differences of neuropathy and Grade 3 and 4 fatigue (fatigue debilitating to the point that the patient can t get out of bed). Some regimens cause slightly higher incidents of neuropathy, while other regimens bring higher incidences of debilitating fatigue, but all regimens are in the 5% to 10% range. Determining the rates of hospitalization and serious adverse events can be a challenge because of the way data are reported in clinical trials. Adverse events are reported with each event as a unit, and it s impossible to determine, for example, whether the event of dehydration in febrile neutropenia and diarrhea all happened in the same patient and led to the same hospitalization, or whether they should be counted as three separate events. Additionally, it s rare for these studies to report their hospitalization rates. In the column looking at deaths on treatment death occurring during the first three months of platinum-based therapy there are differences in the patient population. Some studies may have included patients who had brain metastasesthat were under control, so variations in the patient population could lead to difference in deaths on treatment. In parentheses are the deaths attributed to treatment by the investigators in the trial. For the most part, these range from less than 1% to 1%, although the last two regimens are 4% and 2%. Overall, there are not many variations in outcomes. The box on the next page shows the actual regimens, and the survival and death on treatment are again displayed, along with the variation in cost. For four cycles of treatment or three months of therapy, the cost ranges from $450 to $65,000, representing a huge variation in cost with minimal variation in benefit.

16 12 AIS s Management Insight Series U.S. Oncology was the first group to examine how to use pathways to improve quality of care and value, and the company published some of its results in lung cancer and colorectal cancer. The box below shows data from 2010 published in the Journal of Oncology Practice, where Marcus Neubauer described the results of U.S. Oncology s use of pathways in non-small cell lung cancer. There was virtually no difference in survival for patients treated on pathway or off pathway, but for patients treated on pathway, there was about a 30% decrease in the 12-month cumulative cost.

17 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 13 The Anthem Program Anthem approached pathways development by examining whether to partner with one of the organizations that had already developed pathways, but eventually it decided that it made sense to develop its own process. The insurer found it critical to have its pathways publicly available, where any provider or consumer could download and review them and provide feedback. AIM Specialty Health provides Anthem infrastructure support for many of its programs and is a platform practices are already accustomed to using, so the insurer can integrate the platform directly within its claim system. The insurer stressed the importance that providers wouldn t need to use a separate software platform or Web portal from the one they would be using for prior authorization. Anthem aimed to make the process seamless, so when providers selected the pathway, the claims system would know that and would be able to reimburse the S-code when the claim was submitted. For these reasons, Anthem realized it would need to develop the pathway process internally, with advice and input from external stakeholders and a group of external advisors. Anthem used a process similar to the one it has in place for its pharmacy and therapeutics committee. Internal staff oncologists, pharmacists and oncology nurses review data from clinical trials and publications for the different regimens that would be guideline-concordant for a given tumor type for which Anthem develops a pathway. Forging the Pathways The clinical evidence is summarized into detailed tables that include all of the outcomes data from the various trials, quality of life data, and data on any different major toxicities, as well as comparative effectiveness data, if any of the regimens were directly compared to any of the other regimens, as well as the outcomes of those trials. The tables also include the cost, both with supportive care as well as cost of the regimens themselves. Anthem synthesizes and reviews the evidence with a group of external advisors from across the different regions and health plan areas. Approximately half of the dozen or so advisors come from cancer centers accredited by the National Cancer Institute, or NCCN cancer centers, while half represent community oncology practices. The advisors review the regimens and data with the insurer with the goal of identifying regimens for which pathways would be appropriate for 80% to 90% of patients. By order of priority, these pathways are selected on the basis of (1) clinical benefit or efficacy, (2) side effects and toxicities, (3) the strength of national guideline recommendations and (4) cost.

18 14 AIS s Management Insight Series Pathways are intended to be applicable to 80% to 90% of patients and not 100% because it is assumed that there will be unique circumstances in which a physician would need to use a regimen that is not on pathway. In a situation where an oncologist wants to select a treatment that isn t consistent with medical policy because there is an exceptional circumstance, oncologists at AIM provide peer-to-peer counseling to discuss the case. Anthem acknowledges that an offpathway treatment is appropriate in at least 10% to 15% of cases. The box below shows four regimens included in pathways. These regimens do not just comprise the least expensive ones; they are for non-small cell lung cancer patients who don t have mutations. For this patient population, the four regimens on pathway actually translate to eight because the insurer allows the substitution of carbo-platinum or assist-platinum for each of these therapies. Providers are eligible to receive enhanced reimbursement $350 a month for a treatment month for treatment planning and care coordination when a patient is registered with the Cancer Care Quality Program, and the treatment regimen is on pathway. Anthem uses two S-codes for the enhanced reimbursement program: S0353 is used for treatment planning and care coordination at the onset of treatment, and S0354 is used for monthly management while caring for an established patient. To be eligible for this reimbursement, the practice must enter information about the member and the regimen choice through the AIM portal and select an Anthem kit treatment pathway. Any required prior authorization would be completed at the same time using the same information the provider entered into the portal.

19 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 15 Providers receive immediate approval if the information entered is consistent with the medical policy criteria for any drug with a prior authorization, and they learn if the treatment is on pathway. If the provider enters incorrect information about a treatment, he or she receives an alert about that information. If the provider cannot figure out on their own how to correct that information, nurses at AIM will reach out to the practice to help the non-clinical staff person find the pathological report and get the correct information. Upon completing this process, the provider receives a report stating that he or she is eligible to bill for the S-codes, which can be billed monthly while the member is in active treatment. Different regimens have significantly different revenue impacts for the participating practices, as seen on the left-hand graph in the box below. For Carbo/Paclitaxel, which costs $450 for four cycles, the margin is negligible, but for Carbo/Pemetrexed/ Bevacizumab at $65,000, there is almost $4,000 over three months of margin that goes to the practice. The mean revenue to the practice across these regimens is roughly $3,000, but the standard deviation is almost $1,500, depending on which regimen is selected. On the right-hand graph of the slide are the regimens; the upper sections of the bars represent the regimens that are on pathway. The existing reimbursement stays the same, but now with the additional S-code for three months, the practices on average have increased revenue, so the revenue on average across all six of these regimens is $3,900. There is substantially more revenue for regimens like Carbo/Paclitaxel and

20 16 AIS s Management Insight Series Gemcitabine as platinum on the low end. The standard deviation has decreased to $1,200 across these regimens. By providing enhanced reimbursements, Anthem was able to provide additional support for treatment and planning care coordination to the practices when they use treatments on pathway. This is designed to help providers move to prescribing in a more value-conscious way, selecting the most successful and cost-effective regimen for patients, while aiding the practice financially. Looking to the Future As of February 2015, Anthem has developed pathways for cancers that contribute to approximately 90% of its chemotherapy spend (see box, below). Anthem began in July 2014 by launching in the Midwest and Georgia with pathways for breast, colorectal cancer and lung cancer and in September added pathways for lymphoma, myeloma, ovarian cancer and pancreatic cancer. The insurer more recently added pathways for central nervous system tumors and melanoma and is next introducing pathways for chronic myeloid leukemia and prostate cancer. Anthem is in the process of developing reporting for practices and expects by the second or third quarter of 2015 that it will be able to provide information to providers about how often they are on pathway compared to the other practices in the area. The insurer is also looking to provide additional information for practices on key metrics such as ER admissions and hospitalizations during treatment, as well as end-of-life care measures.

21 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 17 Question and Answer Session Question: Is this program completely voluntary? Jennifer Malin: Yes, the program is voluntary. Oncologists who are participating in our network certainly do not have to select a pathway regimen for any patient that they don t want to. And even if they re using a pathway regimen, they don t have to submit the claim for the S-code. So that s completely up to them; we re not forcing them to participate. They do need to get prior authorization for certain drugs and the process for getting prior authorization has now moved to the AIM portal. Question: Do providers still need to get a prior authorization, even if the regimen is on pathway? Malin: Yes, they do still need to obtain a prior authorization, but the process is really integrated. So, from the providers perspective, they would come into the portal, they would enter information about the member and then confirm their benefit status. They would then enter the diagnosis and key elements of the cancer, the stage, the biomarkers, key things that are needed to make a prior auth determination as well as to determine if it s on pathway. So for example, if it was a breast cancer patient getting Herceptin, getting TCH, they would enter that information, they would enter that it s a HER2 positive patient, so the report that they would get at the end would give them the prior authorization for Herceptin, as well as tell them that they re on pathway. So it s an integrated process. Question: Does your model take into account treatment algorithms at individual cancer centers outside of NCCN? Malin: The cancer centers can use any treatment protocols that they have. We don t dictate which protocols practices use. What the program provides is an enhanced reimbursement if you re using one of the regimens that is on pathway. And so one would expect that 90% of patients, 85% of patients would be treated on one of these regimens. They re the most effective regimens and have the best side-effect profiles. There are always opportunities to select a different treatment regimen, either based on an individual cancer center s preference or an individual provider s preference for that given patient. Question: Did Anthem consult with local oncology societies in the development of pathways? And if not, has there been community resistance to the implementation of the pathways? Malin: We did not consult with local oncology community groups. We have consulted with national groups, so we ve had multiple meetings with the American Society of Clinical Oncology about the program. But we are not putting different groups in the position of having to endorse our pathways. The pathways are there, anyone can view them. And I would say for the most part, folks have probably seen that there have been a couple of letters that have been out there on the Web where we have gotten some criticism. But for the most part, now being eight months into the program, we

22 18 AIS s Management Insight Series I think have gotten four or five s on the website in response to the pathways. We ve had very good dialogue with patient advocacy groups. We ve presented the program at numerous academic medical centers around the country and received mostly positive feedback on the pathways. So there really have not been any, I would say, robust criticisms of the pathways because of their content. Question: When a physician chooses an on-treatment pathway, is there any kind of benefit in terms of financial outlay to the patient, like a lesser copayment or anything like that? Malin: Yes, from the standpoint that copayment is generally calculated as a percentage of the cost of the treatment. So if the regimen is a lower-cost regimen, then the patient, our member, is going to have a lower copay. Question: Do you have any data showing the percent usage of the Carbo/Paclitaxel combination regimen versus a more expensive regimen, before and after the guidelines were implemented? Malin: The program is still very new so we re still in the process of looking at that. Now we ll be able to look at raw utilization, but before the program was implemented, we wouldn t have information on EGFR [epidermal growth factor receptor] status and some of the other things. So we ll have much better information on the members treated in the program than we do on our baseline cases, unfortunately. Question: Are there any plans to incorporate a pathway around supportive care, such as antiemetics? Malin: We do have antiemetics and growth factors included in our utilization review processes. And one of the things that this program has allowed us to do is to really kind of key that prior authorization process to the actual regimen that the member is getting. And we are in discussions about how to broaden that. Rather than trying to have a multi-level approach to the reimbursement, what we may do is actually have quality reporting on adherence to the different supportive care quality measures. Question: How often will the pathways be evaluated? What happens when there is a market event, new data, new products, something along those lines? Malin: We review the evidence, update them with both the new evidence and the cost at least quarterly. For example, for melanoma, where a lot has been happening over the last year, our initial pathways were approved in September, if I m remembering correctly. And then we reviewed the data and updated them in November, so that was even less than three months. So, we really try to be as flexible as possible. Again, keep in mind though, physicians can always prescribe new treatments that come on board or changes in therapy off pathway. We don t in any way restrict that. So if there s a newly approved FDA drug that isn t on pathway yet, that in no way limits access to that therapy.

23 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 19 Question: The examples include only chemotherapy-based pathways, and I wanted to know how successful you have been in developing cost-effective pathways for the newer targeted therapies? Malin: If you go on the Web portal and you download the pathways you ll see that we have targeted therapies on pathways as well. Question: And then if you have the data so early on, in the markets that have already implemented the pathways, such as the central region, what has been the uptake of pathway use? What percent of oncology drug use is now going through pathway? And are you tracking any other metrics? Malin: We re initially tracking just participation rates, and so it s a little bit challenging because we have to wait for claims to run out to see what claims we get for chemotherapy and compare that to who was registered on the portal. But our estimates for the first three months of the program just when we launched was approximately 70% of our members were being registered with the portal prior to starting chemotherapy. So that was really in line with what we predicted. We estimated that in the first year it would be about 70%, and we would increase participation rates after that. And we re still in the process of trying to get the data to the point where we re very confident in it, but initial pathway adherence, again, appears to be around 50%, which is also where we predicted we would be starting from. Just to put some color around that, there s a lot of moving parts because we started with just three pathways in June, we added more in September and more in November and we ve added more regions along the way. So we have a constantly fluctuating baseline. Question: What books of business are the pathways being implemented in: commercial, qualified health plans, Medicare Advantage? Malin: They are being implemented in our commercial population both fully insured and self-funded, as well as Medicare Advantage. Question: Do the pathways also define and ask physicians to implement specific milestones within treatment, such as patient efficacy testing outcomes? Malin: Not yet. That s an excellent question and it s certainly something that we re looking toward in the future, certainly for patients with metastatic disease. But that s more for version 2.0 or 3.0; we re still in version 1.0. Question: For breast cancer, could a physician use a first-line pathway? And assuming the patient didn t respond, could they use another first=line pathway before moving to a second-line pathway? Malin: It all depends kind of on the cancer type and what the evidence-based guidelines are. For breast cancer and for many of our pathways for metastatic disease, the pathways are for first and subsequent lines of therapy and then second and subsequent lines of therapy. So that means any of those regimens you could use first, sec-

24 20 AIS s Management Insight Series ond, third, fourth line, whatever. The second and subsequent line pathways you just can t use in first line, but you can use it in any line of therapy after that. There are some cancer types, though, where the guidelines and the evidence only have a first-line regimen. And then when you aren t supposed to use any of the same regimens again, the pathways would reflect that. Question: How do providers actually demonstrate that they are really adhering to a pathway? Malin: The program is based on providers providing the information through the portal and stating the regimen they re going to follow. If they need to change regimens then they would have to come back into the portal. And clearly we re going to need to do some validation with claims and do some audits to ensure that s what s happening. Question: How is Anthem communicating the pathways program to your network oncologists? Malin: We ve had a variety of different communication approaches. First and foremost, obviously everyone gets a letter; in each region as we ve launched we ve had a series of webinars. We ve also been out in each region and most of the state oncology societies have invited us to either their biannual or annual meeting and we ve provided information on the pathways at those meetings. We ve presented at a number of national and regional meetings. So we ve really done a fairly broad outreach in terms of communication, which I think is really key to implementing a program like this. Question: How can providers be involved in reviewing and informing changes to pathways? Malin: Any provider can go on the website, download the pathways and then provide feedback using an address listed on the pathways document. Question: And how do you ensure the physicians don t just think this is a cost-saving program? Malin: I think that the intent of the program is clearly defined and at least physicians, when I have spoken to them, seem to get it. There is no question when you look at the regimens on pathways that this is not primarily about saving cost. If you look for example at the regimens for melanoma, the newly approved melanoma regimens that are tens and twenties of thousands of dollars a month are all on pathway. These are expensive therapies, but they make a big impact in patients lives. If they really looked at the details of the program, I don t think anyone would come away with the idea that this is about saving cost. It s about making sure patients have access to the most effective therapies, as well as making sure the therapeutic choices are value-driven. That s not just about saving cost. Question: Are the product pathway choices transparent to patients? Malin: Sure, the pathways are completely transparent. We ve been out there communicating about them, we encourage our providers to communicate about the program to

25 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 21 our members. We also encourage providers to communicate to our members about the current reimbursement system as well and to explain to members that the more expensive the therapy is, the more profit they re going to make on that regimen. And so we think there really should be transparency about the marketing that goes on, that the drug reps bring lunches to practices and how all of those different aspects of influencing provider behavior may be influencing the choice of therapy that a provider makes for a patient. Question: How exactly do you work with your vendor [AIM Specialty Health] on the program? Malin: We have a unique relationship with AIM because AIM is a subsidiary of Anthem. So this program is really co-developed with AIM, and we work very closely on it. AIM does provide services to other health plans in a more traditional vendor relationship. Question: What s the role of Anthem s pharmacy benefit manager, if any? Malin: There is no tie-in to our PBM on this program. Question: Why isn t adherence a factor for pathway inclusion? Malin: Adherence is a factor for pathway inclusion. Most of these regimens are [intravenous], so adherence is not as much of an issue. But certainly, when there are oral therapies, we look at adherence. And we ve considered different oral therapies for different cancer regimens where patients have to take drugs on an empty stomach or multiple times a day. Therapies that have higher cost to patients have been shown to negatively impact adherence. All of those things are discussed and considered by our external advisors as we re thinking about what goes on the pathway. So I didn t address it directly, but it is definitely a consideration and a very important consideration. Question: Has this been rolled out nationally now? And if not, when will other states go live with the pathways? Malin: We are continuing to roll it out across all of our health plans and really the reason for going region by region was just for the implementation of the program. There s been a tremendous amount of IT infrastructure in terms of integrating with the claims system and the communication rollout needed, too, which meant that we had to do this by region. We started in the Midwest and Georgia in July. We added our western states in November. New York goes live in just a couple of weeks. And then the rest of the northeast and Virginia will be in late spring, early summer. Question: How do you measure performance in a performance model? Malin: Essentially, we will be measuring adherence to pathways. And the enhanced reimbursement is based on a member-by-member basis of selecting a pathway. But the reporting that we ll be providing back to practices will provide information about their overall adherence to pathways compared to their peers, as well as their use of ER admissions and hospitalizations and their performance on NQF quality measures regarding appropriate care at the end of life.

26 22 AIS s Management Insight Series Question: Have you been able to demonstrate increases in quality and decreased cost since the pathway has launched? Malin: As I mentioned before, this is really too soon to say. Of course we re actively looking at participation and tracking adherence. But the typical treatment for a cancer patient is at least six months, so we re just now seeing patients who started that first week in July complete six months of therapy. And then it s going to be at least three months of claims for the data to be mature enough for us to start to look at it. Even for the first regions that rolled out on the first set of pathways, we re going to need at least a year s worth of data. Question: Do you have any kind of ROI [return on investment] expectations? Malin: We do, and this actually was published in the Wall Street Journal article, but we anticipate an ROI in the range of 2:1 to 3:1 when the program is fully matured, which we expect will take around four years. Question: Once all the pathways in the markets are implemented, what is Anthem going to look to do next? Do you think you might start mandating pathway use? Malin: I don t think that we would ever mandate pathway use. I think we acknowledge, and I think it s been widely acknowledged by everyone who discusses pathways, that there are always going to be patients who are not appropriate for a pathway. So we would never mandate the use of a pathway. We may start to look at paying based on performance of other quality measures that we ll be reporting. So things like ER utilization hospitalizations, quality of end of life care. We re interested in looking at how to incorporate a palliative care program along with the pathways. So we have other ideas of ways to improve quality of care that we ll be looking to implement in the program. Question: Can you speak to any integration between the pathways program and internal case management programs? And also, how are the nurses aligned? Malin: Sure, that s a great question. It s actually been one of the things that we re very excited about; one of the challenging things for case management is that typically we don t really find out about members being treated for cancer until we get claims. There are some with prior authorizations, but mostly it comes in through claims. And if you look at the research on patients with chemotherapy who have admissions and problems, 80% of the time it happens during the first two cycles. So if you aren t able to reach out to them early during the course of treatment, you ve lost much of your opportunity to intervene and help them. So with AIM, we actually are able to report over to our case managers on a daily basis so we know when patients are about to start treatment. We also have been previously leveraging the prior authorization data that we get through AIM when physicians request diagnostic imaging to evaluate a cancer, so we also provide that information to our nurses.

27 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 23 The other thing we re very excited about that we get to leverage from this program is the data that AIM collects through the program from the practices, as well as the information they get from the decision support tool that we use to support this program, which is provided by a company called eviti. It includes information about the drugs being prescribed by the practitioner. And then the eviti tool provides us with information about the toxicities of those regimens. All of that information is transmitted into the platform that our case managers use, so even if a case is already in case management or if it s a newly created case as a result of this program, the nurse has the information about the treatment, the cancer stage and any expected toxicities from the treatment when they re talking to that member. We re able to leverage that to help support our nurses with a number of tools that we ve developed with case management that include an oncology assessment, a palliative care needs assessment, a systems toolbox and other things that we developed to help our case managers be able to support our members through a really difficult time. Question: How does the Anthem program align with the new CMS oncology care model? [See Appendix C.] Malin: I think there are some really interesting ways in which they re similar and ways in which they re different. I think both programs seek to provide additional support for treatment plan care coordination by using a monthly episode-based payment. So in CMS s program that payment is $160, in our program it s $350. In order to receive the payment, CMS has asked for some structural commitments from the practice. So there s commitments regarding electronic health records, regarding having 24/7 access to a physician who has access to the medical records. The practice needs to attest that they use guidelines and report what percent of patients are treated on guidelines. The CMS program takes a more structural approach, and we have taken a more processbased and prospective approach in terms of the pathways. The CMS model includes the possibility for shared savings on the back-end, and we don t have that. The approach we have taken is based on the estimated cost of care savings with using pathways, and we have incorporated that into the seed of the practices upfront. So those are some of the key differences. Question: Will formulary decisions drive pathways via step edits? Malin: No, our formulary process remains our formulary process and our pathway process remains our pathway process. So those are different. We try to make sure they re aligned because we wouldn t want to have something in a lower tier on formulary be preferred on pathway somehow and have the oncologist be incentivized to prescribe something that was going to have a higher copay for our member. That certainly would not be in anyone s interest. But given that the approaches are pretty similar in terms of looking at the evidence and the cost effectiveness of care, we think that just by virtue of the approach, we re likely to stay aligned. I think through our formulary you are likely to start to see more active management of oncology drugs and things like formulary placement and step

28 24 AIS s Management Insight Series edits just by virtue of the fact that there are more and more oncology drugs on the market that do similar things. Four or five years ago there were relatively fewer oral oncology drugs and often they were the only drug in their class. I don t remember if we re up to five or six, but you have a lot of drugs that do the same types of thing that really have very similar outcomes in the side effect profile. And so I think that s going to lend itself to more formulary management, but that s really separate and distinct from the pathway process. Question: Is there a pathway aligned to end-of-life support? If so, what is the focus? And do pathways address inappropriate extreme efforts at the end of life? Malin: We re in the process of developing a parallel program for palliative care to help support practices in managing patients at the end of life who aren t on active treatment. Then we can both have accountability for that care, as well as provide additional support for treatment planning and care coordination when the member is no longer receiving chemotherapy. Question: Specifically, how do you account for diagnostics and testing in a given pathway? And are there specified mandates? Malin: We looked at what the biomarker results are to be able to determine what pathway a member is appropriate for. For example, there s a different pathway for HER2- positive breast cancer and HER2-negative breast cancer. However, at this point we don t mandate any specific testing. Question: I would like to get your thoughts on Anthem s willingness to incent or direct referrals to specialists, such as a gynecologic oncologist, in order to optimize outcomes. I guess the question is, who would be incentivizing? Have you incentivized referrals in the first place? Malin: I m not really aware of any programs or leverage that we have to incentivize specific providers. When someone is getting evaluated for a GYN oncology condition, we don t have access to that biopsy. We really have no way of intervening in that situation and coordinating the referral. Question: Has Anthem entertained coverage with an evidence development-like approach, maybe to allow coverage of promising cancer tests? Malin: Coverage of evidence development is an approach that Medicare has used and is something that is allowed by the Medicare statute. Our benefits language for the most part does not provide coverage for investigational and experimental therapies. And so that s really been a barrier to any of the coverage with evidence development type models. One of the challenges that we face in trying to implement something like coverage with evidence development is that as a health plan, we don t have the infrastructure to decide which are the appropriate treatments and appropriate tests, or the most promising tests that we should be using our members premium dollars to support the research efforts of.

29 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 25 If we were to develop a much broader-based program that would use premium dollars to support research into new innovative technologies, it would involve us having an infrastructure much like a big organization to do peer review and get the expertise to evaluate proposals. That would be really a major undertaking. I will say that the second piece to that is oftentimes with devices and diagnostic tests, there is a company behind that looking to make a profit if they can demonstrate a benefit. If there isn t going to be a profit or a way of sharing the returns on the investment made by having our members contribute premium dollars to that research, what s in it for them? Question: If you had a crystal ball, how much variation would you expect between pathways across different organizations, all things being equal, such as clinical, costs, etc.? Malin: I think that s an interesting question. First of all, we see a lot of variation in pathways in terms of what people call a pathway. Sometimes when people refer to something as a pathway, they re really just referring to guidelines. So the first thing to look at is how broad or narrow is a pathway? When someone says this is a pathway, are they just including all of the guideline-based, compendium-based regimens, or is it really a narrower subset? Then if you look at the other extreme, I believe when U.S. Oncology had its initial program, they got down to a single regimen on pathway. So that s sort of the first level. Those programs that are designed kind of like ours to be a subset of the overall guideline-recommended regimens, but the ones that are most effective and most cost effective. I ve looked across the ones that I ve been able to see in terms of what those pathways are. The pathways overlap probably 80% of the time, and the places where they don t overlap affect even fewer patients. So usually they overlap on all the regimens that would be the most commonly used ones anyway. The places where they don t overlap are regimens that might be used in just a handful of patients anyway. So if you re using an evidence-based approach and you re starting with the evidence and then you re looking at the cost, the pathways should be pretty similar. Question: Do you envision the Anthem pathways getting very specific for example, you use X drug in first line, so therefore you use this in second line or maintenance therapy? Malin: No. I mean, we ve really taken the approach that we re not practicing medicine, we re trying to provide some guidance for our providers on ways they can start to practice value-based care to support them. We re not interested in getting down to directing which drug or regimen patients get by line of therapy.

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31 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 27 Appendix A: Anthem and AIM Specialty Health Pathways Worksheets Reprinted with permission of Anthem, Inc. Breast Cancer Pathways Patient Name: Date of Birth: Member Number: Stage: 0 I IA IB IIA IIB IIIA IIIB IIIC IV Unknown ER: + or - PR + - HER2: IHC or FISH Line of Therapy: Adjuvant Neo Adjuvant First Line Second Line + OncotypeDx : Low* Int High Not Done/Not Reported Breast Cancer: Neoadjuvant Therapy HER2 Negative AC weekly P: doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) (every 3 weeks) followed by weekly paclitaxel (Taxol) TC: docetaxel (Taxotere) and cyclophosphamide (Cytoxan) ddac weekly T: dose dense doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) followed by weekly paclitaxel (Taxol) AC (21 day cycles): doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) Breast Cancer: Neoadjuvant Therapy HER2 Positive AC TH : doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) followed by paclitaxel (Taxol) and trastuzumab (Herceptin) TCH: docetaxel (Taxotere), carboplatin (Paraplatin) and trastuzumab (Herceptin) TCH+P: docetaxel (Taxotere), carboplatin (Paraplatin), trastuzumab (Herceptin) and pertuzumab (Perjeta) Breast Cancer: Adjuvant Therapy HER2 Negative* AC weekly P: doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) (every 3 weeks) followed by weekly paclitaxel (Taxol) TC: docetaxel (Taxotere) and cyclophosphamide (Cytoxan) ddac weekly T: dose dense doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) followed by weekly paclitaxel (Taxol) AC (21 day cycles): doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) Breast Cancer: Adjuvant Therapy HER2 Positive AC TH : doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) followed by paclitaxel (Taxol) and trastuzumab (Herceptin) TCH: docetaxel (Taxotere), carboplatin (Paraplatin) and trastuzumab (Herceptin) TH: paclitaxel (Taxol) and trastuzumab (Herceptin)** *Patients with HER2 negative, lymph node negative breast cancer with low risk OncotypeDx scores are not included in the Adjuvant Pathway. ** This regimen is considered Pathway for patients with Stage I disease and comorbidity precluding the use of more aggressive regimen options West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

32 28 AIS s Management Insight Series Breast Cancer Pathways, cont. Breast Cancer: Metastatic disease HER2 Negative First and subsequent lines of therapy (1 st line+) Doxorubicin (Adriamycin) Epirubicin (Ellence) Gemcitabine (Gemzar) Vinorelbine (Navelbine) Paclitaxel (Taxol) Capecitabine (Xeloda) Breast Cancer: Metastatic disease HER2 Positive First and subsequent lines of therapy (1 st line+) Pertuzumab (Perjeta), trastuzumab (Herceptin), and docetaxel (Taxotere) Pertuzumab (Perjeta), trastuzumab (Herceptin), and paclitaxel (Taxol) Capecitabine (Xeloda) and trastuzumab (Herceptin) Trastuzumab (Herceptin) and gemcitabine (Gemzar) Vinorelbine (Navelbine) and trastuzumab (Herceptin) Breast Cancer: Metastatic disease HER2 Positive Second and subsequent lines of therapy (2 nd line+) Ado-trastuzumab emtansine (Kadcyla) Capecitabine (Xeloda) and lapatinib (Tykerb) Capecitabine (Xeloda) and trastuzumab (Herceptin) Gemcitabine (Gemzar) and trastuzumab (Herceptin) Vinorelbine (Navelbine) and trastuzumab (Herceptin) Trastuzumab (Herceptin) monotherapy Trastuzumab (Herceptin) and lapatinib (Tykerb) *Patients with HER2 negative, lymph node negative breast cancer with low risk OncotypeDx scores are not included in the Adjuvant Pathway. ** This regimen is considered Pathway for patients with Stage I disease and comorbidity precluding the use of more aggressive regimen options West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

33 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 29 Breast Cancer Pathways: Endocrine therapy for recurrent or metastatic disease Patient Name: Date of Birth: Member Number: Menopausal Status: Pre-Menopausal Post-Menopausal Stage: 0 I IA IB IIA IIB IIIA IIIB IIIC IV Unknown ER: + or - PR + - HER2 + or - by IHC or FISH Line of Therapy: Adjuvant Neo Adjuvant First Line Second Line Third Line Third Line + Breast Cancer: Post-Menopausal ER or PR Positive Recurrent or Metastatic disease First and subsequent lines of therapy (1 st line+) Anastrozole (Arimidex) Fulvestrant (Faslodex) Letrozole (Femara) Tamoxifen Breast Cancer: Post-Menopausal ER or PR Positive Recurrent or Metastatic disease Second and subsequent lines of therapy (2 nd line +) Exemestane (Aromasin) Breast Cancer: Pre-Menopausal ER or PR Positive Metastatic disease First and subsequent lines of therapy (1 st line +) Anastrozole (Arimidex) + ovarian suppression Letrozole (Femara) + ovarian suppression Tamoxifen + ovarian suppression Breast Cancer: Pre-Menopausal ER or PR Positive Metastatic disease Second and subsequent lines of therapy (2 nd line +) Exemestane (Aromasin) + ovarian suppression Fulvestrant (Faslodex) + ovarian suppression 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

34 30 AIS s Management Insight Series Chronic Myelogenous Leukemia Pathways Patient Name: Member Number: Date of Birth: ICD-9 Code: Leukemia Phase Accelerated Phase Blast Phase Chronic Phase Line of Treatment: First Line Second Line Third Line Third Line+ Philadelphia chromosome: Positive or Negative ECOG Performance Status: Mutation: V299L T3151 Small Myelogenous Lymphoma (CML) First Line Therapy (1 st line) Imatinib (Gleevac) Dasatinib* (Sprycel) For patients with V299L mutation Small Myelogenous Lymphoma (CML)/Chronic Second and subsequent lines of therapy (2 nd line +) ** Dasatinib (Sprycel) Bosutinib (Bosulif ) Nilotinib ** (Tasigna ) For patients with V299L mutation Ponatinib (Iclusig ) For patients with T3151 mutation *For patients who are intermediate or high-risk Sokol or Hasford Score: Sokal: Intermediate Risk= ; High Risk >1.2 Hasford: Intermediate Risk= ; High Risk >1480 ** Following treatment failure, suboptimal response (defined as lack of complete hematologic response or BCR-ABL1 transcripts>10% (IS) or lack of partial cytogenetic response on bone marrow cytogenetics), or intolerance to first line of therapy West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

35 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 31 Colorectal Cancer Pathways Patient Name: Date of Birth: Member Number: Stage: 0 I IIA IIB IIC IIIA IIIB IIC IVA IVB RAS: Wild type Mutant Line of Therapy: Adjuvant First Line Second Line Third Line + Colorectal Cancer: Adjuvant Therapy FULV: fluorouracil (5FU) and leucovorin Modified FOLFOX-6*: fluorouracil (5-FU), leucovorin and oxaliplatin (Eloxatin) FLOX*: fluorouracil (5-FU), leucovorin and oxaliplatin (Eloxatin) Capecitabine (Xeloda) Colorectal Cancer: Metastatic disease RAS Wild Type (WT) or Mutant (MT) First or second lines of therapy (1 st line or 2 nd line) Modified FOLFOX-6: fluorouracil (5FU), leucovorin and oxaliplatin (Eloxatin) Modified FOLFOX-6: fluorouracil (5FU), leucovorin and oxaliplatin (Eloxatin) with bevacizumab (Avastin) FOLFIRI: fluorouracil (5FU), leucovorin and irinotecan (Camptosar) FOLFIRI: fluorouracil (5FU), leucovorin and irinotecan (Camptosar) with bevacizumab (Avastin) FULV: fluorouracil (5FU) and leucovorin FULV: fluorouracil (5FU) and leucovorin with bevacizumab (Avastin) Capecitabine (Xeloda) Colorectal Cancer: Metastatic disease RAS WT First or second lines of therapy (1 st or 2 nd line) FOLFIRI: fluorouracil (5FU), leucovorin and irinotecan (Camptosar) with panitumumab (Vectibix) Irinotecan (Camptosar) and panitumumab (Vectibix) Colorectal Cancer: Metastatic disease RAS WT or MT Third and subsequent lines of therapy (3 rd line+) Regorafenib (Stivarga) Colorectal Cancer: Metastatic disease RAS WT Third and subsequent lines of therapy (3 rd line+) Panitumumab (Vectibix) monotherapy Irinotecan (Camptosar) and panitumumab (Vectibix) * Dose & sequence of administration differ between modified FOLFOX-6 and FLOX exon 2 KRAS, non-exon2 KRAS, and NRAS mutations 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

36 32 AIS s Management Insight Series Diffuse Large B-Cell Lymphoma Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: 0 0-E 0-X 0-XE IA IA-E IA-X IA-XE IB IB-E IB-X IB-EX IIA IIA-E IIA-X IIA-XE IIB IIB-E IIB-X IB-XE IIIA IIIA-E IIIA-X IIIA-XE IIIB IIIB-E IIIB-X IIIB-XE IVA IVA-E IVA-X IVA-XE IVB IVB-E IVB-X IVB-XE Recurrent Line of Treatment: First Line Second Line Third Line Third Line+ Performance Status: Biomarkers/characteristics: CD20 positive Yes No Transplant candidate: Yes No Diffuse Large B-Cell Lymphoma: First Line (1 st Line) therapy R-CHOP 21: cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), prednisone, rituximab (Rituxan) R-CEOP: cyclophosphamide (Cytoxan), etoposide (Toposar), vincristine (Oncovin), prednisone, rituximab (Rituxan) Diffuse Large B-Cell Lymphoma: Second and subsequent line of therapy (2 nd line +) Transplant candidates R-GDP: gemcitabine (Gemzar), dexamethasone, cisplatin (Platinol AQ), rituximab OR R-GDP: gemcitabine (Gemzar),dexamethasone, carboplatin (Platinol AQ), rituximab (Rituxan) R-ICE: ifosfomide (Ifex), carboplatin (Paraplatin), etoposide (Toposar), rituximab (Rituxan) Diffuse Large B-Cell Lymphoma: Second and subsequent line of therapy (2 nd line +) R-DHAP: dexamethasone, cisplatin (Platinol AQ), cytarabine (Ara-C), rituximab (Rituxan) R-ICE: ifosfomide (Ifex), carboplatin (Platinol AQ), etoposide (Toposar), rituximab (Rituxan) Bendamustine (Treanda) and rituximab (Rituxan) R-GDP: gemcitabine (Gemzar), dexamethasone, cisplatin (Platinol AQ), rituximab OR R-GDP: gemcitabine (Gemzar),dexamethasone, carboplatin (Platinol AQ), rituximab (Rituxan) R-GemOx: gemcitabine (Gemzar), oxaliplatin (Eloxatan), rituximab (Rituxan) Rituximab (Rituxan) 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

37 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 33 Follicular Lymphoma and Marginal Zone Lymphoma Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: 0 0-E 0-X 0-XE IA IA-E IA-X IA-XE IB IB-E IB-X IB-XE IIA IIA-E IIA-X IIA-XE IIB IIB-E IIB-X IIB-XE IIIA IIIA-E IIIA-X IIIA-XE IIIB IIIB-E IIIB-X IIIB-XE IVA IVA-E IVA-X IVA-XE IVB IVB-E IVB-X IVB-XE Recurrent Line of Treatment: Maintenance First Line Second Line Third Line Third Line+ Transplant Candidate: Yes or No ECOG Performance Status: Biomarkers/characteristics: CD20 positive Gastric MALT (Mucosa-associated Lymphoid Tissue) Lymphoma: Stage IE or IIE, H. pylori positive disease Antibiotic therapy for H. pylori eradication Splenic Marginal Zone Lymphoma* or Stage IE or IIE (H. pylori negative) Gastric MALT Lymphoma Rituximab (Rituxan) Follicular (Grade I-II) Lymphoma and Marginal Zone Lymphoma First Line Therapy (1 st line) R-CHOP (21day cycles): cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), prednisone, rituximab (Rituxan) R-CVP: cyclophosphamide (Cytoxan), vincristine (Oncovin), prednisone, rituximab (Rituxan) Bendamustine (Treanda) and rituximab (Rituxan) Rituximab (Rituxan) Chlorambucil (Leukeran) Chlorambucil (Leukeran) and rituximab (Rituxan) Cyclophosphamide (Cytoxan) Cyclophosphamide (Cytoxan) and rituximab (Rituxan) Follicular Lymphoma (Grade III) First Line Therapy (1 st line) R-CHOP (21 day cycles): cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), prednisone, rituximab (Rituxan) R-CEOP: cyclophosphamide (Cytoxan), etoposide (Toposar), vincristine (Oncovin), prednisone, rituximab (Rituxan) Follicular Lymphoma Maintenance Rituximab (Rituxan) every 3 months for 2 years (8 doses) Follicular Lymphoma and Marginal Zone Lymphoma Second and subsequent lines of therapy (2 nd line +) FCM-R: fludarabine (Fludara), cyclophosphamide (Cytoxan), mitoxantrone (Novantrone), rituximab (Rituxan) Rituximab (Rituxan) R-CHOP (21 day cycles): cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), prednisone, rituximab (Rituxan) R-CEOP:cyclophosphamide (Cytoxan), etoposide (Toposar), vincristine (Oncovin), prednisone, rituximab (Rituxan) R-DHAP: dexamethasone, cisplatin (Platinol AQ), cytarabine (Ara-C), rituximab (Rituxan) R-ICE: ifosfamide (Ifex), carboplatin (Paraplatin), etoposide (Toposar), rituximab (Rituxan) Bendamustine (Treanda) and rituximab (Rituxan) R-GDP: gemcitabine (Gemzar), dexamethasone, cisplatin (Platinol AQ), rituximab (Rituxan) OR R-GDP: gemcitabine (Gemzar), dexamethasone, carboplatin (Paraplatin), rituximab (Rituxan) R-GemOx: gemcitabine (Gemzar), oxaliplatin (Eloxatin), rituximab (Rituxan) *Splenectomy is also a recommended treatment option for Splenic Marginal Zone Lymphoma 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

38 34 AIS s Management Insight Series Melanoma Cancer Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: 0 IA IB IIA IIB IIC IIIA IIIB IIIC IV Recurrent Line of Treatment: Adjuvant First Line Second Line Third Line Third Line+ Maintenance ECOG Performance Status: BRAF Status: V600E Mutation + V600K Mutation + Wild Type (no mutation) Melanoma: Metastatic Disease First and subsequent lines of therapy (1 st line +) ECOG PS: 0, 1, 2 * Ipilimumab (Yervoy) Dacarbazine (DTIC-Dome) Temozolomide (Temodar) (Oral) Melanoma: Metastatic Disease First and subsequent lines of therapy (1 st line +) ECOG PS: 0, 1, 2 BRAF mutation + Dabrafenib (Tafinlar) Melanoma: Metastatic Disease Second and subsequent lines of therapy (2 nd line +) ECOG PS: 0, 1, 2 BRAF not mutated Pembrolizumab (Keytruda) 23-24, 26 Melanoma: Metastatic Disease third (3 rd line ) ECOG PS: 0, 1, 2 BRAF mutated Pembrolizumab (Keytruda) 23-24, 26 *Regardless of BRAF status 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

39 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 35 Myeloma Cancer Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: No staging or recurrent Line of Treatment: Maintenance First Line Second Line Third Line Third Line+ ECOG Performance Status: Biomarker/characteristic: Transplant candidate Non-transplant candidate Myeloma: Primary/first line (1 st line) therapy or salvage therapy if duration of response is greater than 6 months VD: bortezomib (Velcade) and dexamethasone PAD: bortezomib (Velcade) and doxorubicin (Adriamycin) and dexamethasone CyBorD : bortezomib (Velcade), dexamethasone and cyclophosphamide (Cytoxan) Myeloma: Primary/first line (1 st line) therapy or salvage therapy if duration response Is greater than 6 months Ineligible for transplant (not ASCT candidate) MPB: melphalan (Alkeran), prednisone and bortezomib (Velcade) R + dex: lenalidomide (Revlimid) and dexamethasone Myeloma: Second and subsequent lines of therapy (2 nd line+) if duration response is less than 6 months ECOG PS: 0, 1, 2 Bortezomib (Velcade) VD: bortezomib (Velcade) and dexamethasone CyBorD: bortezomib (Velcade), cyclophosphamide (Cytoxan), and dexamethasone R + dex: lenalidomide (Revlimid) and dexamethasone Myeloma: Third and subsequent lines of therapy (3 rd line+) if disease progression < 60 days of completing last therapy ECOG PS: 0, 1, 2 Carfilzomib (Kyprolis) 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

40 36 AIS s Management Insight Series Non-small Cell Lung Cancer Pathways Patient Name: Date of Birth: Member Number: Stage: IA IB IIA IIB IIIA IIIB IV Recurrent ALK: + or - EFGR: + or - Performance status: Line of Therapy: Adjuvant First Line Second Line Maintenance Non-Small Cell Lung Cancer: Adjuvant Therapy Paclitaxel (Taxol) and carboplatin (Paraplatin) Cisplatin (Platinol AQ) and vinorelbine (Navelbine) Gemcitabine (Gemzar) and cisplatin (Platinol AQ) Non-Small Cell Lung Cancer: Metastatic disease ALK+ First line (1 st Line) Crizotinib (Xalkori) Non-Small Cell Lung Cancer: Metastatic disease EGFR+ First line (1 st line) Erlotinib (Tarceva) Afatinib (Gilotrif) Non-Small Cell Lung Cancer: Metastatic disease Non-squamous ECOG PS: 0, 1, 2 First line (1 st line) Carboplatin** (Paraplatin) and paclitaxel (Taxol) Cisplatin** (Platinol AQ) and pemetrexed (Alimta) Cisplatin** (Platinol AQ) and gemcitabine (Gemzar) Paclitaxel (Taxol) and carboplatin (Paraplatin) and bevacizumab (Avastin) Non-Small Cell Lung Cancer: Metastatic disease Squamous ECOG PS: 0, 1, 2 First line (1 st line) Carboplatin** (Paraplatin) and paclitaxel (Taxol) Cisplatin** (Platinol AQ) and gemcitabine (Gemzar) Non-Small Cell Lung Cancer: Metastatic disease Non-squamous ECOG PS: 0, 1, 2 Maintenance Continuation bevacizumab (Avastin) Continuation pemetrexed (Alimta) Switch pemetrexed (Alimta) Non-Small Cell Lung Cancer: Metastatic disease ALK+ or EGFR+ ECOG PS: 0, 1, 2 Second line (2 nd line) Carboplatin** (Paraplatin) and paclitaxel (Taxol) Cisplatin** (Platinol AQ) and pemetrexed (Alimta) Cisplatin** (Platinol AQ) and gemcitabine (Gemzar) Non-Small Cell Lung Cancer: Metastatic disease Non-squamous ECOG PS: 0, 1, 2 Second line (2 nd line+) Pemetrexed (Alimta) Docetaxel (Taxotere) Non-Small Cell Lung Cancer: Metastatic disease ECOG PS: 3, 4 Erlotinib (Tarceva) Afatinib (Gilotrif) **Substitution of carboplatin for cisplatin, and vice versa, is allowed West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

41 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 37 Ovarian Cancer Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: I IA IB IIA IIB IIC IIIA IIIB IIIC IV Recurrent Line of Treatment: Maintenance Adjuvant/Post-op Neoadjuvant/Pre-op First Line Second Line Third Line Third Line+ ECOG Performance Status: Biomarkers/Characteristics: Platinum sensitive* Platinum-refractory or resistant Ovarian Cancer: Adjuvant Therapy Stage IA/B (Grade 2 or 3) or IC (Grade 1-3) Carboplatin (Paraplatin)** and paclitaxel (Taxol) Carboplatin (Paraplatin)** and dose dense paclitaxel (Taxol) Ovarian Cancer: Adjuvant or primary Therapy Stage II, III, IV IV paclitaxel (Taxol) and Intraperitoneal (IP) cisplatin (Platinol AQ) + IP paclitaxel (Taxol) Carboplatin (Paraplatin)** and paclitaxel (Taxol) Carboplatin (Paraplatin)** and dose dense paclitaxel (Taxol) Ovarian Cancer: Recurrent Disease First or subsequent line of therapy (1 st line +) platinum-sensitive Carboplatin (Paraplatin)** and paclitaxel (Taxol) Carboplatin (Paraplatin)** and weekly paclitaxel (Taxol) Carboplatin (Paraplatin) and gemcitabine (Gemzar) Cisplatin (Platinol AQ) and gemcitabine (Gemzar) Ovarian Cancer: Recurrent Disease Second or subsequent line of therapy (2 nd line+) platinum resistant Docetaxel (Taxotere) Liposomal doxorubicin (Doxil or Lipodox) Gemcitabine (Gemzar) Weekly paclitaxel (Taxol) Topotecan (Hycamtin) Vinorelbine (Navelbine) Bevacizumab (Avastin) Bevacizumab (Avastin) and paclitaxel (Taxol) Bevacizumab (Avastin) and topotecan (Hycamtin) Platinum sensitive is defined as recurrence >6 months after prior platinum based therapy ** Substitution of carboplatin for cisplatin, and vice versa, is allowed West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

42 38 AIS s Management Insight Series Pancreatic Cancer Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: IA IB IIA IIB III IV Recurrent Line of Treatment: Adjuvant/Post-op Neoadjuvant/Pre-op First Line Second Line Third Line Third Line+ ECOG Performance Status (PS): Pancreatic Cancer: Adjuvant Therapy Gemcitabine (Gemzar) FULV: fluorouracil (5FU) and leucovorin Pancreatic Cancer: Locally Advanced/Unresectable and Metastatic Disease First Line Therapy (1 st line) ECOG PS: 0, 1,2 Gemcitabine (Gemzar) FOLFIRINOX: leucovorin and fluorouracil (5FU) and irinotecan (Camptosar) and oxaliplatin (Eloxatin) Gemcitabine (Gemzar) and nab-paclitaxel (Abraxane) Pancreatic Cancer: Locally Advanced/Unresectable and Metastatic Disease Second Line Therapy (2 nd line) ECOG PS: 0, 1,2 Gemcitabine (Gemzar) OFF: fluorouracil (5FU) and leucovorin and oxaliplatin (Eloxatin) 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

43 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 39 Prostate Cancer (Adenocarcinoma) Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Stage: 0 I II III IV Recurrent Line of Treatment: Adjuvant First Line Second Line Third Line Third Line+ Maintenance ECOG Performance Status: Biomarker/characteristic: Hormone Refractory Yes or No Recurrence Risk: High Very High Intermediate Low Very Low Prostate Cancer Adjuvant Therapy Post- prostatectomy Lymph node positive disease (LN+) Goserelin (Zoladex) 3.6 mg monthly or 10.8 mg q 3 mos. Leuprolide (Eligard/Lupron) 7.5mg q mos. or 22.5 mg q 3 mos. or 30mg q 4 mos. or 45mg q 6 mos. Triptorelin (Trelstar) 3.75 mg q mos. or mg q 3 mos. or 22.5 q 6 mos. Prostate Cancer: Intermediate risk Primary treatment with radiotherapy Goserelin* (Zoladex) 3.6 mg monthly or 10.8 mg q 3 mos. Leuprolide* (Eligard/Lupron) 7.5mg q mos. or 22.5 mg q 3 mos. or 30mg q 4 mos. or 45mg q 6 mos. Triptorelin* (Trelstar) 3.75 mg q mos. or mg q 3 mos. or 22.5 q 6 mos. Prostate Cancer: High Risk (T3a or Gleason 8-10), Very High Risk (T3b-T4), and Locally Advanced Prostate Cancer (LN+) Primary treatment with radiotherapy Histrelin * (Supprelin LA) Goserelin* (Zoladex) Leuprolide* (Eligard/Lupron) Triptorelin* (Trelstar) Prostate Cancer: Recurrent and Metastatic disease Hormone Sensitive Initial therapy Docetaxel** (every 3 weeks) + ADT Histrelin * (Supprelin LA) Goserelin* (Zoladex) Leuprolide* (Eligard/Lupron) Triptorelin* (Trelstar) Prostate Cancer: Recurrent and Metastatic Disease Hormone Refractory First and subsequent lines of therapy (1 st Line+) Docetaxel** (every 3 weeks) + continue ADT Abiraterone** (Zytiga) + continue ADT Degarelix (Firmagon) + bicalutamide (Casodex) Goserelin (Zoladex) + bicalutamide (Casodex) Leuprolide (Eligard/Lupron) + bicalutamide (Casodex) Triptorelin (Trelstar) + bicalutamide (Casodex) Prostate Cancer: Recurrent and Metastatic Disease Hormone Refractory Second and subsequent lines of therapy (2 nd Line) Cabazitaxel** (Jevtana) + ADT Docetaxel** rechallenge + ADT Enzalutamide** (Xtandi) (oral) 160 mg once a day + ADT Continued ADT ** with supportive care ± dexamethasone * May be coadministered with bicalutamide (Casodex) or flutamide (Eulexin) for up to 30 days in patients who are at risk of developing symptoms associated with testosterone flare. ** ADT (androgen deprivation therapy): histrelin (Supprelin LA), goserelin (Zoladex), leuprolide (Eligard/Lupron), triptorelin (Trelstar) 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2015 AIM Specialty Health

44 40 AIS s Management Insight Series Small Lymphocytic Lymphoma/ Chronic Lymphocytic Leukemia Pathways Patient Name: Date of Birth: Member Number: ICD-9 Code: Lymphoma Stage: 0 0-E 0-X 0-XE IA IA-E IA-X IA-XE IB IB-E IB-X IB-XE IIA IIA-E IIA-X IIA-XE IIB IIB-E IIB-X IB-XE IIIA IIIA-E IIIA-X IIIA-XE IIIB IIIB-E IIIB-X IIIB-XE IVA IVA-E IVA-X IVA-XE IVB IVB-E IVB-X IVB-XE Leukemia Stage NS (No Stage) Recurrent Line of Treatment: First Line Second Line Third Line Third Line+ ECOG Performance Status: Biomarker: CD20 positive Small Lymphocytic Lymphoma (SLL)/Chronic Lymphocytic Leukemia (CLL) First Line Therapy (1 st line) FCR: fludarabine (Fludara), cyclophosphamide (Cytoxan), rituximab (Rituxan) FR: fludarabine (Fludara), rituximab (Rituxan) Obinutuzumab (Gazyva) and chlorambucil (Leukeran) Rituximab (Rituxan) and chlorambucil (Leukeran) Cyclophosphamide (Cytoxan) and prednisone Cyclophosphamide (Cytoxan), prednisone and rituximab (Rituxan) Rituximab (Rituxan) Chlorambucil (Leukeran) Small Lymphocytic Lymphoma (SLL)/Chronic Lymphocytic Leukemia (CLL) Second and subsequent lines of therapy (2 nd line +) (when not already received in first line) FCR: fludarabine (Fludara), cyclophosphamide (Cytoxan), rituximab (Rituxan) FR: fludarabine (Fludara), rituximab (Rituxan) Obinutuzumab (Gazyva) and chlorambucil (Leukeran) Rituximab (Rituxan) and chlorambucil (Leukeran) Cyclophosphamide (Cytoxan) and prednisone Cyclophosphamide (Cytoxan), prednisone and rituximab (Rituxan) Chlorambucil (Leukeran) Ibrutinib (Imbruvica) Bendamustine (Treanda) Rituximab (Rituxan) and bendamustine (Treanda) 8600 West Bryn Mawr Avenue South Tower Suite 800 Chicago, IL Appropriate.Safe.Affordable 2014 AIM Specialty Health

45 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 41 Appendix B: AIS Coverage of Pathways and Health Plan Management of Oncology Care CareFirst, P4 Launch RA Clinical Pathways Program That Incorporates Disability Score After successfully partnering on providing clinical pathways for oncology regimens, CareFirst BlueCross BlueShield and P4 Pathways launched a pathways program for rheumatoid arthritis (RA), a condition that ranks in the top three therapeutic conditions for spending among various PBMs drug trend reports. The program is taking the novel step of monitoring patient disability in order to determine medication dosing. P4, which was purchased by Cardinal Health, Inc. and operates through its Cardinal Health Specialty Solutions unit, launched its oncology pathways program with CareFirst as well. In its first year, that program saved CareFirst $8.5 million, which was 8% of its oncology costs. The RA program, which is offered on an opt-in basis, started Dec. 1, The 2011 open-enrollment period ran from Oct. 1 through Nov. 30, with enrollment dates of March 1 and Sept. 1 in As of early November 2011, almost 70 rheumatology practices and more than 100 rheumatologists had said they would participate in the program. The pathways were developed by a steering committee composed of rheumatologists within CareFirst s network. The group will meet on a regular basis to update the information as needed. The guidelines are focused on providing quality patient care, and they are based on clinical guidelines from the American College of Rheumatology, said Roshan Girglani, vice president and general manager of rheumatology for Cardinal Health Specialty Solutions, in November The committee submits its recommendations to CareFirst; after the plan approves them, the pathways are submitted to the network of providers, who can provide input on them as well. The fact that CareFirst has worked with P4 on an oncology pathways program since 2008 meant that the health insurer was able to approach the RA pathways program with the knowledge and confidence that it [i.e., a pathways program] works, says Winston Wong, Pharm.D., associate vice president of CareFirst Pharmacy Management. When the plan began working on the oncology program, it was untested and unproven. We didn t know what we didn t know, he told AIS in November With the RA program, though, CareFirst was confident it had a proven model when it initially approached the steering committee, he says. And even though the

46 42 AIS s Management Insight Series newer program has a different subset of providers, as questions came through, we could actually answer them instead of having to wait and see, Wong says. The concerns of the rheumatologists matched many of those initially expressed by the oncologists when we first presented the model. Initially the RA steering committee expressed some skepticism the concept would work, says Wong. But the oncology experience put them much more at ease, as did the fact that they could speak to their oncologist colleagues who were participating to ask any questions. Multiple Factors Make RA a Good Choice The push to focus on RA was more on our end, says Wong. P4 just happened to have the capability as well. Oncology was an obvious target for the initial program, as it had pretty high costs on the medical side, and pharmacy costs were growing. Similarly, RA was a major cost to the medical benefit and the pharmacy benefit, but the two weren t well integrated together for care, a problem that P4 can help solve, Wong explains. And we looked at utilization, and it was climbing in both. Also fueling the RA program is the explosive onset of new treatment options, which has caused a wide variance in treatment patterns, says Girglani. A shift in administrative sites from community practices to hospitals is another factor. This trend makes treatment less convenient and accessible for many patients, and it also significantly increases health care costs for payers, he told AIS. We see a tremendous opportunity to leverage clinical pathways to improve the quality and convenience of patient care while also driving down health care costs. And finally, he says, industry statistics show that approximately $10 billion is spent annually on RA medications, putting rheumatoid arthritis in the top five drug spend categories, second only to cancer treatments. The size of drug spend in this category also presents an excellent opportunity for payers to contain costs while improving patient outcomes. The RA program has a goal of 70% physician adherence to the pathways in the first year and 80% for subsequent years. It s impossible for 100% of patients to be cared for using a limited set of treatment protocols, maintains Girglani. That s why our model allows room for individualized medicine and physician discretion. We set compliance goals, but the physician has ultimate control of treatment decisions at the point of care. The approach also has ease of use and convenience for the provider top of mind. Toward that end, we leverage technology tools and our specialty pharmacy to handle all paperwork and preauthorization for participating physicians, says Girglani. We make the process as seamless as possible to save the physicians as much time as possible and free up their time to spend on patient care. All a physician has to do is send a prescription to our specialty pharmacy, and we handle all the related details, including delivering the product to the patient.

47 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 43 Pathways Incorporate Disability Score Wong explains that the RA pathways are comprehensive in that they re not just drug-related. One thing we ve incorporated is the use of a disability score. Physicians will monitor the disease s progression through patients Clinical Disease Activity Index (CDAI) scores, which measure mobility. Scoring must be completed at least every three months or every time a patient comes into the physician s office, says Wong. The steering committee determined that three months was an appropriate period of time for patients to respond favorably to a therapy, because some drugs can be slow acting, and it s important to allow each drug enough time to demonstrate efficacy. Our experience has shown that switching medication regimens inappropriately or too soon not only puts patient outcomes at risk, but it also drives up costs exponentially and unnecessarily, says Girglani. To measure CDAI scores, physicians participating in the program will be piloting an electronic tool that Cardinal says is the first of its kind that leverages touch-screen technology to increase accessibility for patients with limited dexterity. Calculating CDAI scores tells me the physician is following the disease progression of the patient, says Wong. Often, he says, monitoring the progression of RA is more subjective than objective. About 30% to 40% of the time it s objective. The goal is to have appropriate drug therapy for patients with a pretty debilitating disease state. For example, if a patient starts on a particular dose and the patient s score shows the disease is progressing, the physician may need to increase the dose. So after a patient starts on a low dose of a biologic, if we see there is a dosage increase three to four months down the line, we can look at the disease score. If it is increasing, this justifies the dosage increase, explains Wong. Likewise, if a patient gets put on a biologic, it usually takes a while for the physician to think about backing off the drug, he says. If we see a patient who goes into remission for a certain period of time, we are asking the physician to back off the current regimen to a lower dose or perhaps even discontinue the medication. Wong emphasizes that it is not our desire to go and limit medication use to patients. Whatever therapy is appropriate for the clinical presentation and state of disease by all means should be given. He points out that the earlier more aggressive therapies for RA are given, this will slow the disease s development and delay disability scores. That said, more aggressive therapy sooner doesn t mean giving them a cookbook of all therapies out there to choose from. As far as expected return on investment, we re probably looking for an ROI of about 5-8:1, says Wong, who notes that this is a little lower than what we anticipated on the oncology side. In oncology, the variability of treatment is greater than it is in RA, where the drugs are what the drugs are, he says. The cost savings are going to come from hopefully an improvement in the ability to monitor a patient s disease,

48 44 AIS s Management Insight Series including checking doses and potentially hitting a remission point. In addition, site of service is important, so when physicians do an infusion, they ll choose the most costeffective site of service. Clinical Efficacy, Safety Drive Decisions The program encourages the steering committee members to select the regimen that is clinically proven to be most efficacious, to be the safest for patients and, all other things being equal, to also consider the most cost-efficient regimen, says Girglani. We also encourage physicians to involve the patient in decisions regarding the route of administration. When infusions are required, we recommend that they be performed in the facility where the patient is most comfortable and where the costs are most efficient and that is almost always the community practice setting. According to Debbie Stern, vice president of managed care consulting firm Rxperts, Inc., managing medication dosing and site of service is not really done now. There is only so much that payers can do to manage unit costs. They re probably getting the best rates they can, and they re doing PA [i.e., prior authorization]. But after this, there s not much they can do for these patients. If there is data to support and I don t know that there is that increased dose, then this [approach] is managing outcomes, which is excellent. This is where a payer would want to be and should be. In addition, Stern told AIS in November 2011 that using CDAI scores is a step beyond. Payers don t really measure how patients are progressing. Once a patient is approved for a drug, that s it. This is a relatively unique methodology. Girglani says that the company s experience with the oncology pathways program has supported our belief that all pathways must be focused on improving outcomes. That has to be the No. 1 priority. Other lessons learned, he tells AIS, include the following: u Physicians need to lead the development of the pathways they ll be expected to follow. u Technology and other tools need to make it as efficient as possible for physicians to implement and track pathways compliance. u Pathways should be leveraged to remove administrative burdens like prior authorization. u Payers should appropriately incentivize physicians to participate. Prior experience has proven that the most successful pathways programs provide fair reimbursement for generic medications, lock in reimbursement rates for branded drugs and allow physicians to share in cost savings that are created through reduced hospitalization and drug spend.

49 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 45 Program Has Pay-for-Quality Component To that end, the RA program will reward physicians who deliver quality care, similar to the oncology pathways program. Wong says he can t give details on specific compensation levels. However, he says that with RA, if you look at how physicians are reimbursed today, it s very similar to oncology. There is an E/M [i.e., evaluation and management] code a standard professional fee plus a pretty good chunk of revenue off administering Remicade. This presents two dilemmas with reimbursement, he says. First, similar to oncology, physicians have a drug mark-up with infusions of Remicade. But with some physicians doing very few infusions, if you make the reimbursement model based upon the infusion of a drug, then the model doesn t work. To address this, he says, CareFirst and Cardinal have created a second-generation oncology program that minimizes the amount of reimbursement for drugs infused in physician offices and covers handling processes. Whether a therapy is infused or self-administered, there is the same level of incentive. The cost for complying with the pathways is loaded into the E/M codes. This approach will be applied to the RA program. So will these pathways programs continue to branch out into different disease states? Girglani tells SPN that our approach to RA pathways could be easily extended to a number of other rheumatic diseases. We believe that many of the key tenets of our initial pathways programs can work well for multiple disease states. Wong adds that he s sure there are other opportunities but he hasn t had time to think about them because he s been so focused on getting the RA program up. They always say the hardest program is the first one. I would have agreed with that four years ago, but now I think it s this one. We ve had success now we want to make sure the first one wasn t a fluke. Prime Therapeutics Says It Plans to Have Preferred CML Products Payers traditionally have been hands off when it comes to oncology management. But over the past few years, that has begun to change. With a growing array of selfadministered oral oncolytics now available, payers increasingly have been placing utilization management tactics like prior authorization on these therapies. In addition, following clinical pathways for certain cancers also has been a growing trend. But Prime Therapeutics LLC is set to take its management a step further when it comes to chronic myeloid leukemia (CML). That condition has three oral biologics Novartis Pharmaceutical Corp. s Gleevec (imatinib mesylate) and Tasigna (nilotinib) and Bristol-Myers Squibb s Sprycel (dasatinib) that have been approved by the FDA.

50 46 AIS s Management Insight Series All three are kinase inhibitors and all three rank in Prime s list of the top 10 oral brand cancer drugs in terms of cost and utilization, says Patrick Gleason, Pharm.D., director of clinical outcomes assessment for Prime. Gleason told AIS in March 2012 that we are working on preferring Gleevec or Tasigna before Sprycel for CML. He adds that he doesn t have a date of implementation. Prime s pharmacy and therapeutics committee first looked at the effectiveness and then the safety of the medications. Once those categories were considered similar enough, costs net of rebate were considered before the decision was made. The PBM follow[s] the oral cancer class more in general rather than specifically, says Gleason, and it is quickly moving to more management. At Prime, oral cancer drugs, both brand and generic, cost $1.52 per member per month. Costs for brand oncology drugs alone rose 18.9% from 2010 to And increases over the last three years were 18% each year, Gleason says. It s a unique class for cost increases, he says. Prime s average cost per claim for brand oral oncolytics was $2,750 in the first quarter of By the fourth quarter of 2011, that number had risen to $4,400. Health Plan Explores Change in Physician Reimbursement to Improve Cancer Care Although great strides have been made in the development of oncology regimens, the same cannot be said for the payment system for those therapies. Buy-and-bill remains the predominant method of reimbursing for most oncology drugs, but so-called perverse incentives within this system have brought it under plan scrutiny, particularly as more expensive cancer medications come onto the market. Lee Newcomer, M.D., senior vice president of oncology services at UnitedHealthcare (UHC) and also an oncologist, called for change in a recent Health Affairs article and spoke with AIS in April 2012 about his own plan s experience in trying to modify this approach. In late 2010, UHC unveiled a novel pilot program in which it would work with five large medical oncology groups and focus on three cancers breast, lung and colon with regimens for 19 different presentations. The groups are located across the U.S. Each group chose the regimen it felt was the best clinical approach for those presentations. The groups agreed to be in compliance with at least 85% of the selected therapies for UHC patients, with exceptions allowed for contraindications or patient enrollment in a clinical trial. Changing the selected regimens was allowed, but the same level of compliance had to be achieved. UHC pays the drug margin for each regimen determined by subtracting the average sales price from the group s usual reimbursement along with a case management fee and also pays the group for an episode time period.

51 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 47 To assess value, UHC and the participating physicians use 60 measures, which were determined through UHC discussions with all five groups early in the process. Some were obvious, says Newcomer, such as survival rates, relapse rates and total cost of care. And others were more subtle, such as epoetin usage the groups were concerned about this, so they added it to the list. We have a core set of about 20 measures that came out of the meeting, and another 40 are embellishments and expansions, he says. So far, says Newcomer, the experience has been excellent. It s a true collaboration. All the groups we have been working with have gone far and above the call of duty. With any change and this is a radical change there are always bumps in the road, so it s important to take time to fix problems. According to Newcomer, the biggest issue is we re dealing with five small businesses. All have methods of business that are slightly different [from each other]. UHC, on the other hand, is a big conglomerate with standardized processes. To that end, there have been times when we ll ask the groups to conform to certain processes. Of critical importance, he tells AIS, is making sure patients are identified right away and that they are on a regimen agreed to. If we don t discover they are eligible for 10 days, they may be on the wrong regimen or UHC may have paid claims incorrectly. UHC plans to release final results from the pilot s first year this summer. However, early findings show areas where care could be improved: u All of the groups chose a regimen of docetaxel and cyclophosphamide chemotherapy for early stage breast cancer. But among the groups, treatment costs varied by 100%. u There was wide variation in the number of radiology tests needed to evaluate new patients with breast or lung cancer, Newcomer noted in the article. He explains to AIS that there were PET scans being ordered in patients with stage 1 and 2 breast cancer, something that the American Society of Clinical Oncology (ASCO) says is not necessary. Episode payments can be increased with improved results, measured by improving patient survival or decreasing the cost of care. UHC has a database of 32,000 patients treated around the rest of the country who are not in this program with which the plan can compare results from the pilot. The database contains detailed information such as what stage the cancer was when the patient presented, as well as the current status; results of any genetic tests; and the histology. With all this information, we can put together groups of patients who are comparable, maintains Newcomer. We are comparing apples to apples. So if the pilot shows fewer hospitalizations for a particular subgroup compared with the similar group in the database, we can bump the episode payment although UHC is still trying to figure out how much. With cost savings, roughly one-third go back to the group, one-third go to the employer, and one-third go to United.

52 48 AIS s Management Insight Series Newcomer contends that UHC s approach and that of some plans that are working with physicians to implement clinical pathways are the only two new payment strategies being tested today within the oncology space. Pathways, he says, though, do not allow real-time comparisons between competing regimens. As far as next steps, UHC will add probably four or five more large groups [in 2012], says Newcomer, who notes that a Florida group just joined at the beginning of April The plan also is working on a pilot with US Oncology s Innovent program in Denver and expects to have finalized data by the end of the year. It also is working on other approaches that Newcomer can t talk about at this point. A focus on good evidence-based care can allow plans to be more selective of regimens based on cost. In addition, he says, the measurement of results is important. Does it do what it s supposed to do, including lowering costs and increasing quality? Plans considering implementing a new oncology reimbursement approach need to design it to fit with their systems. It s not important that they do it our way, but they need to sit down with oncology groups and collaborate so incentives are aligned. When costs go down, we all win. When outcomes go up, we all win. He stresses that we need a lot of experimentation of different tactics. There could be dozens of other successful ways to do this. We need to think about new approaches that will bend the cost curve. We don t want to hold up our approach as the only answer, but what we re doing could work. Asked if accountable care organizations (ACOs) and medical homes could possibly help bring down cancer care costs, Newcomer says, I do think they have the potential, particularly when it comes to a more coordinated work-up of cancer patients and a better coordinated approach to working with other specialties. For example, in an ACO, a primary care physician may say, Rather than ordering five or six tests, why don t I just send the patient to the oncologist, who may do only one or two tests, as the others could be unnecessary. Current System Is Unsustainable In the Health Affairs article, Newcomer contends that any payment system needs a broad consensus about the maximum amount of money society will pay for an additional month of life. He tells AIS that we need to have the discussion, which should probably be through a government-led approach. He points to a Health Affairs article that asks, Would you be willing to pay higher insurance premiums to get more expensive cancer regimens? Respondents said that they would, he says. If we re willing to spend more on cancer therapy and less on something else, such as highways or schools, we need to have this discussion, Newcomer asserts. Fifteen to 20 years from now, statistics show that people will need to make the average U.S.

53 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 49 salary just to pay for health care premiums. We have to have a discussion about how much we re willing to pay, a process that will be terribly difficult to do. But the alternative would be telling the next generation, Too bad about food, clothing and shelter we just have to pay for health care. Florida Blue Teams With Hospital System, Oncologists to Form Cancer-Focused ACO With an eye on reducing health care costs and improving patient outcomes, health plan Florida Blue is teaming with health care providers Baptist Health South Florida and Advanced Medical Specialties to create an oncology accountable care organization (ACO). Launched May 1, 2012, this new delivery of care model shifts toward a valuebased reimbursement while improving the overall quality of care to Florida Blue members, says Jonathan Gavras, M.D., chief medical officer and senior vice president at Florida Blue, the new name of Blue Cross Blue Shield of Florida. To address the current cost and fragmentation of health care, health care organizations must create new models of care that deliver the highest quality of care while reducing the cost burden for all stakeholders, maintains Gavras. This Cancer Care Program is an important step toward that goal. The health care industry as a whole must look beyond the fee-for-service model. This latest model for delivering services offers doctors and hospitals financial incentives to provide good quality care while keeping down costs. Because ACOs require multiple groups to provide coordinated care, the partners need to be experienced enough and cooperative enough to work together, maintains Bill Sullivan, principal consultant at Specialty Pharmacy Solutions LLC. Florida Blue likely saw those attributes in both Baptist Health South Florida and Advanced Medical Specialties. AMS s geographic coverage also well complements Baptist s service area. According to Gavras, Florida Blue has strong working relationships with Baptist Health South Florida, a health system, and Advanced Medical Specialties, an oncology practice with 17 locations in South Florida. Most recently, Florida Blue had been working closely with Advanced Medical Specialties surrounding cancer care for our members, while at the same time Advanced Medical Specialties had been working closely with Baptist Health South Florida, explains Gavras. So it made sense to all of us to come together to try to identify ways to improve the quality of care and overall positive outcomes for members in South Florida. The focus on oncology was a no-brainer considering that 12 million people worldwide receive a cancer diagnosis each year, with an associated price tag of $286 billion in medical costs and lost productivity, says Gavras. By 2030, that number is estimated to increase to 22 million people each year, with a comparable rise in costs. More

54 50 AIS s Management Insight Series than half of the cost is attributable to medical care, according to a report in The Lancet Oncology. Gavras says that 16% of the total Florida Blue medical expense is related to cancer care. Certain specialties lend themselves to this type of arrangement, says William DeMarco, president of Pendulum HealthCare Development Corp., and certain specialties don t. For instance, I don t know how you d package hematology services, he says, but he points out that OB/GYN services were packaged under a bundled payment in the 1970s. The fact that this is an oncology ACO is not surprising, contends Sullivan. In fact it makes sense to break oncology out as a separate category given its costs and some unpredictability of the severity of cases that will be managed, especially in the first year when this ACO is likely to be looking to figure out the best ways to manage and try to hit their cost targets. According to F. Randy Vogenberg, Ph.D., a principal with the Institute for Integrated Healthcare, Focusing on cancer, which is now highly guideline driven, also minimizes variation in care, which can help produce better economic and clinical outcomes. Gavras explains that Advanced Medical Specialties, as an affiliate of US Oncology, follows US Oncology Level I Pathways. However, this program is not specifically focused on pathways. The Accountable Cancer Care Program is focused on improved care coordination, care quality and shared savings. Interest Grows in Guidelines, Pathways More health plans lately have been working with physicians who are following guidelines or pathways in oncology care and offering reimbursement based on the providers compliance levels. For example, United Healthcare (UHC) unveiled a pilot program in 2010 that focused on breast, lung and colon cancer with regimens for 19 different presentations. It originally worked with five large medical groups, each of which chose the regimen it felt was the best clinical approach. UHC pays the drug margin for each regimen determined by subtracting the average sales price from the group s usual reimbursement along with a case management fee and also pays the group for an episode time period. To assess value, UHC and the participating physicians use 60 measures, which were determined through UHC discussions with all five groups early in the process. Third-party groups like P4 Pathways which offers pathways in certain cancers and rheumatoid arthritis and PathForward Oncology, which uses the Via Oncology pathways developed by the University of Pittsburgh Medical Center, offer pathways developed by physicians. P4 launched its oncology pathways program with CareFirst,

55 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 51 and in its first year, that program saved CareFirst $8.5 million, which was 8% of its oncology costs. Sullivan says that in many ways oncology is very predictable. As we ve learned recently, pathways are very specific. Based on diagnosis, they can tell you down to the number of days and strengths of doses for each cycle of therapy (which drives a significant portion of total costs). Pathways also help identify when patients start to incur more acute costs (hospital vs. office), and that helps complete the cost picture. As noted earlier, what you can t predict is the mix of patients (i.e., how many breast vs. liver vs. colon, etc. and at what stage of severity). Nonetheless, the number crunchers that work in this segment can make some fairly good estimates to develop a budget so an ACO specifically for oncology does make sense. DeMarco, who is working on two similar oncology bundled payment projects, says that cancers can be stratified first by their stage I, II, III or IV and then by factors such as the person s age and any other comorbidities and complications, and finally next treatment protocol and expected outcomes. Stage IV, for instance, factors in hospice and patient support groups, among other things. It can be very intense at this point, he says. Considering numerous measures within these four stages can help categorize patients so apples-to-apples comparisons may be made in terms of treatment, outcomes and costs, says DeMarco. Once the clinical stages are determined, then the financial expectations can be as well. It is not unexpected to see this type of a care delivery strategy married with economic incentives to deal with the global reimbursement generally offered by insurers today, contends Vogenberg. The Florida Blue ACO is focusing on the six most common forms of cancer that represent 80% of cancer types in South Florida, Gavras tells AIS. These include leukemia/lymphoma, breast cancer, lung cancer, colorectal cancer, male genitourinary (including prostate) and female genitourinary. In addition, This agreement includes all services, except particular services that are definitively unrelated to cancer care. When it comes to cancer medications, The supply chain that s in place for oncology-related drugs between pharmacies, providers and Florida Blue will remain intact. However, the costs for provider-administered drugs are included in the measurement for this program, Gavras says. Making sure the collaboration is truly delivering value will be important to demonstrate. To that end, he says, in addition to efficiency metrics, the program will measure provider performance on several mutually identified and agreed upon, industry standard quality metrics. In terms of the overall value of the ACO, Florida Blue views these programs as incremental in nature, says Gavras. As such, Florida Blue, Baptist South Florida and AMS will jointly evaluate the program using the above referenced metrics as well as

56 52 AIS s Management Insight Series additional components such as the overall patient experience and the program s ability to deliver foundational capabilities for future models. Asked for details of how the savings will be shared, Gavras says the details surrounding the shared savings are protected under the agreement between the parties. Oncology, Biomarkers May Be Specialty Drug Pipeline Standouts The current specialty pharmacy marketplace already has a tremendous impact on health plans, and the pipeline will exert even more pressure. Keeping track of certain specialty trends and planning ahead can help payers prepare for this rapidly changing marketplace, said speakers at a summer 2012 AIS webinar. In 2010, specialty pharmaceuticals reached the $100 billion mark in drug spend, noted Atheer Kaddis, Pharm.D., senior vice president, sales and marketing, for Diplomat Specialty Pharmacy, at the Aug. 29, 2012, webinar, titled Payer Strategies to Manage High-Cost Specialty Drugs Expected to Hit the Market Soon. In addition, 1% of the population is representing 20% of the total drug spend. In contrast to nonspecialty drugs, which have had a nearly zero trend over the past five years as more and more blockbuster drugs have lost their patents and faced much cheaper generic competition, the trend for specialty drugs has been in the 15% to 25% range over the same time period, said Kaddis. And it s more likely, if you combine the pharmacy benefit and the medical benefit, that the trend is 25% to 30% overall when it comes to specialty drugs. These percentages become even more significant when considering the sheer number of specialty drugs in the pharma pipeline more than 600 in Phase II and Phase III. Specialty pharmacy today represents about 25% of pharmacy spend, but it s likely to increase to 40% of total spend by 2015, Kaddis said. In addition, that spend is likely to be driven by the impact of health reform. By 2014, specialty pharmaceuticals will represent the top-selling drugs by revenue. Close to 50% of the drugs in the pipeline are oral drugs, and many are for specialty areas: oncology and immunology, which encompasses such conditions as rheumatoid arthritis, psoriasis, Crohn s disease and multiple sclerosis, explained Kaddis. The oncology space is seeing a significant shift to new oral therapies, noted Kaddis. I m not saying they re going to displace infused therapies in the future, but oral cancer treatments were virtually unheard of 10 years ago. The cancer drug pipeline will see the introduction of additional oral therapies with new mechanisms of action. He pointed out that current oncolytic therapies have had significant increases in their cost of therapy, with some treatments exceeding $100,000 per patient per year. He clarified that we don t know the costs of the drugs in the pipeline but added that

57 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 53 payers may be able to get a general idea of what they may be by comparing their place in the treatment regimen to that of existing therapies and then seeing what the prices for those drugs are. We re expecting some class expansion in certain cancers such as chronic myelogenous leukemia (bosutinib), multiple myeloma (pomalidomide) and prostate cancer (enzalutamide), among others. Existing oral therapies will face competition from orals in the pipeline expected to receive FDA approval. And the development of vaccineand gene-based therapies also is expected. So what s the bottom line within the oncology pipeline over the next 12 months? Expect cost trends to continue to be in the 15% to 25% [range] in the near future, advised Kaddis. Oral Rheumatoid Arthritis Drug Is Expected Within the immunology/infectious disease category, cost trends will be driven primarily by drugs already approved on the market, said Kaddis, but there are a few pipeline trends he is anticipating. First, We re expecting new orals for rheumatoid arthritis, with the JAK inhibitor tofacitinib potentially receiving FDA approval by the end of Multiple sclerosis likely will gain new treatments, including Aubagio (teriflunomide), which was approved two weeks after the webinar; Lemtrada (alemtuzumab); and BG-12 (dimethyl fumarate). And expect to continue the shift from intravenous immune globulin to subcutaneous immune globulin, which Kaddis says will now impact the pharmacy benefit. When it comes to planning for new entrants in various therapeutic conditions, payers, Kaddis said, need to see what your spend is in these areas today. Your demographics may impact what your spend is going to be. Payers should scrutinize the pipeline in order to focus on potential new molecular entities that may have the most impact on pharmacy and medical spend due to historical information regarding similar agents approved by the FDA, disease incidence and treatment options, and complexity of the mechanism of action and the manufacturing process, Kaddis contended. Keeping an eye on the drugs Prescription Drug User Fee Act (PDUFA) action dates should keep payers informed as to when they could enter the marketplace. Ultimately, though, payers must have a comprehensive strategy impacting both pharmacy spend and medical spend in order to manage specialty pharmaceuticals, said Kaddis. Gone are the days when we could just focus on the pharmacy benefit. Bill Sullivan, founder of and principal consultant for Specialty Pharmacy Solutions LLC and the other speaker at the webinar, highlighted some broader trends within the specialty pipeline:

58 54 AIS s Management Insight Series (1) Combination therapies: Cystic fibrosis therapy Kalydeco (ivacaftor), which was approved in January 2012 to treat people with the G551D mutation, is in trials with two co-therapies, he said. If the drug which came onto the market with an annual cost of $294,000 per person per year is approved as part of a combination therapy, it could expand the market from 4% to 90+%, which is no small issue from a payer perspective. Other combination therapies in HIV, oncology and hepatitis C also are being investigated. And it s not just the potential increase in costs for payers but the doubling of the number of medications for patients that could be issues. (2) Preventive therapies: Before 2012, there weren t too many preventive therapies in specialty categories, noted Sullivan, citing Synagis (palivizumab) for respiratory syncytial virus as an example. But since 2012, we ve seen a number of new products leap to the forefront in terms of preventive therapies, such as Truvada (emtricitabine/ tenofovir disoproxil fumarate), approved in July as a treatment to reduce the risk of HIV infection in high-risk individuals. The potential market for these therapies is massive, he said. (3) Biosimilars and follow-on biologics: This is an exciting category, Sullivan said. Biosimilars need to be shadow priced to the brand products to be economically justifiable. Some therapies that are considered biosimilar to existing biologics even though they came to market as another brand entry rather than through the biosimilar approval pathway have been priced typically within a 25% range of discount to the brand. However, potential savings are limited to a small percentage of specialty therapies for the next three to five years, he maintained. One potential issue could stem from brand products pricing strategies. Brands typically have increases [in pricing] of 10% to 30% [annually], so 25% off next year a pricing strategy that a biosimilar may take will be this year s brand price, explained Sullivan. Thus the biosimilar market may be muddied by the marketing tactics that brand manufacturers may pursue. (4) Orals vs. injectables vs. infusibles: We may see frequent combination therapies emerge across routes of administration, Sullivan said. Then it becomes even more interesting from a payer perspective. Site of service looms as the potential greatest burden, and we ll see payers struggling with how to address therapeutic regimens administered across various sites of service. (5) Biomarkers and genetic testing: According to Sullivan, One-third of the specialty pipeline therapies are being developed with companion diagnostics, such as Xalkori (crizotinib), approved Aug. 26, 2011, for the treatment of ALK-positive non-small cell lung cancer. That drug treats 3% to 5% of NSCLC patients each year. Conceptually it s a good idea because you can target the appropriateness of therapies to patients who should or should not have it, he said. However, the specificity of the testing is improving, but it is not unequivocal, creating a vexing dilemma for physicians and patients. This also has led to a question of what payers should pay for. Another trend Sullivan said he expects to see within this space is PBMs are going

59 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 55 to be taking a role in genetic testing. But will this lead to cost containment or be a cost driver? (6) Orphan therapies: The orphan market is now worth more than $50 billion in pharmacy and medical spend, with drugs such as the $400,000 per person per year Soliris (eculizumab), approved in 2007 to treat people with paroxysmal nocturnal hemoglobinuria. Manufacturers don t need a lot of patients on these drugs to recover a lot of R&D [i.e., research and development], he said. There are more than 90 orphan therapies in late-stage development, with about 30 considered blockbuster candidates. (7) Clinical pathways: With pathways, it s not so much an issue of pipeline drugs, but it s an emerging, effective approach to how drugs are managed, asserted Sullivan. The emergence of pathways is changing how prescribers pick drug regimens, as they consider guidelines and protocols based on the best research, and come to a consensus on what is the best way to manage particular conditions. Oncology management is slowly becoming proof of concept, he maintained. New drugs and indications can be rapidly integrated into pathways there is not the time lag [that often exists] of three, six or 12 months before a drug makes its way into prescribing patterns or changes the prescribing patterns of payers. Best references drive the selection of the lowest-cost, most therapeutically effective regimens, and even appropriate use of testing. Coupled with rational reimbursement, pathways are emerging in rheumatoid arthritis, multiple sclerosis and other complex diseases. Cardinal Reports Data on RA Clinical Pathways Program Although Cardinal Health Specialty Solutions may be best known for its oncology clinical pathways programs, in 2011 it launched a similar program with CareFirst BlueCross BlueShield for rheumatoid arthritis. RA consistently ranks among the top three therapeutic categories for spending among various PBM drug trend reports. The program monitors the disease s progression through patients Clinical Disease Activity Index scores, which measure mobility, in order to determine medication dosing. The pathways, which were developed by rheumatologists, are based on clinical guidelines from the American College of Rheumatology. The program launched Dec. 1, 2011, with a 2011 open-enrollment period from Oct. 1 through Nov. 30. In 2012, enrollment dates were March 1 and Sept. 1. When it launched, the program had a stated goal of 70% physician adherence to the pathways in the first year and 80% for subsequent years. Bruce Feinberg, D.O., chief medical officer, oncology at Cardinal Health Specialty Solutions, told AIS in fall 2012 that the program has seen the following results thus far: u Nearly 80% of all eligible community rheumatologists within the CareFirst network are participating in the program.

60 56 AIS s Management Insight Series u Approximately 85% of the RA drug spend by community rheumatologists in CareFirst s network is being spent on medications included in the clinical pathways program. u Approximately 1,800 unique patients are impacted by this program, and PathWare [which is Cardinal s decision support and medical benefit management system] processes approximately 800 patient records per month. u There has been an 8% increase in the use of nonbiologic disease-modifying antirheumatic drugs over the first six months of treatment. u 98% of infusions by participating providers are performed in-office (where they re most cost-effective and convenient for the patient). Louisiana Blues Plan Will Work With Cardinal, Physicians on Oncology Pathways As health plans continue to take a more active role in oncology management, clinical pathways programs are an option to which more plans are turning. Blue Cross and Blue Shield of Louisiana in October 2012 became the latest payer to contract with Cardinal Health Specialty Solutions and work with physicians to implement clinical pathways. The plan and Cardinal will put together a committee of network oncologists across the state that will identify evidence-based treatment regimens, or clinical pathways, for delivering patient care for breast, colon and lung cancers, among others, according to Cardinal. Prior to implementing the pathways program, the Louisiana Blues plan did not have an oncology management program, says Milam Ford, vice president, pharmacy services at Blue Cross and Blue Shield of Louisiana. The plan serves one out of every four residents of the state. Cancer care is on the minds of all health plans, Ford says. The oncology pipeline is large, with hundreds of compounds being studied. He explains that Cardinal shares the plan s philosophy that collaborating with the oncology community is essential in order to build trust among oncologists and encourage and support them in continuing to identify opportunities to improve quality and provide a cost-effective health benefit. La. Blues Plan Will Use Pathways The Blues plan spends tens of millions of dollars on oncology medications on behalf of our members, Ford told AIS in fall Today, the majority of this spending is on the medical side, but oncology drug spending through the pharmacy benefit is growing at a more rapid rate than through the medical benefit side.

61 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 57 The majority of Blue Cross and Blue Shield of Louisiana s oncology drug spend is on breast, lung and colon cancers, says Ford, so pathways in these areas seemed the right place to start. We plan to add additional cancers [in 2013] based on the other major diagnoses for which reducing variation will improve quality and bend the curve on the cost of cancer care. The goal is to cover the malignancies that make up 80% to 85% of the cancer care spend. The program will apply to members with a new diagnosis of one of those three cancers or members starting a new line of therapy. The plan signed a three-year agreement with Cardinal. Physician participation is voluntary, with incentives provided to the participating oncologists for adopting the pathways, says Ford. Members of the Blues plan s provider relations team and project managers from Cardinal visited physician offices in order to tell them about the program and answer any questions. The health plan says it has 100% provider participation in five of the markets it serves: Lafayette, Lake Charles, Monroe, New Orleans and Shreveport. The plan also serves the Alexandria, Thibodaux/Houma, Baton Rouge and Northshore (north of New Orleans) markets, but physician participation is lower in those areas, Ford says. The goal of this program is to work collaboratively with the oncology community to improve the consistency, quality and cost-effectiveness of cancer treatment, he explains. Successful implementation of the program is considered participating physicians maintaining an average of 80% compliance with the pathways created by a representative peer group of participating network hematologists and oncologists, says Bruce Feinberg, D.O., chief medical officer, oncology at Cardinal Health Specialty Solutions. The 80% compliance goal leave[s] ample room for physicians to provide individualized medical care that addresses the unique needs of every patient, he explains. For example, if a person has a pre-existing condition or comorbid condition that would make the pathways regimen ill advised, the physician can deviate from the pathways. Participating physicians also must agree to be measured against the pathways over time, Ford says. Network oncologists who participate in the program and meet the required measurements are eligible for certain increases in reimbursement rates for related services and drugs. Cardinal Program Started With P4 in 2008 Cardinal s pathways program started in 2008 when CareFirst BlueCross BlueShield contracted with P4 Healthcare. We worked with CareFirst to develop incentives for physicians to participate and to develop new ways to reimburse participating physicians for the care they provided to patients, explains Feinberg. We continue to experience phenomenal success with that program with physicians complying with the clinical pathways more than 90% of the time. In its first year, that program saved

62 58 AIS s Management Insight Series CareFirst $8.5 million, which was 8% of its oncology costs. Further evidence of that program s success is our launch of a similar pathways program with CareFirst in rheumatology, adds Feinberg. Since then, payers including Aetna Inc., Health Alliance Plan, Highmark Inc. and Blue Cross Blue Shield of Michigan have implemented similar pathways programs. In each of those pathways initiatives, our process has remained constant physicians lead the development of the pathways they would follow; we worked with each payer to develop incentives to encourage physicians to participate, and we experience pathways adherence rates upwards of 90%. Cardinal Health, Inc. acquired P4 s parent company, Healthcare Solutions Holding, LLC, in 2010, and since then, the company has invested additional resources in our pathways program, which has enabled us to build an even more robust offering, Feinberg says. The most significant newer facet of our clinical pathways program is the introduction of PathWare, a clinical decision support solution we introduced earlier [in 2012]. PathWare, he says, provides physicians with real-time decision support at the point of care, with access to the various clinical pathways. It also provides clinical alerts and checklists, allows Cardinal to track physician compliance with the pathways and offers prior-authorization services, among other features. Several of the plans Cardinal works with, but not all of them, use PathWare, says Feinberg. The tool is customized for each different group of physicians so physicians within each network specifically see the clinical pathways that their steering committee developed. Although each group of physicians develops its own pathways, Feinberg says that the programs tend to be 90% to 95% homologous across provider and payer networks. However, the nuanced differences are critical to physician participation, adoption and compliance. In addition, he says, those differences can be beneficial to patients. Complex cancer therapy has a learning curve just like any advanced surgery or procedure. Allowing physicians to select the equally effective treatment regimens with which they are the most familiar rather than forcing them to adopt an unfamiliar regimen decided by another doctor thousands of miles away can often translate into better patient care, he contends. Feinberg says that less than 5% of physicians leave the program, but usually due to noncompliance with the pathways. One-quarter of those who leave the program will return, after two quarters of resumed pathways compliance. According to Feinberg, All clinical pathways programs we have launched are still in operation. In addition, he says, We ve added pathways for year-two diagnosis in some programs, and we are now adding a palliative care program. It s important to understand, though, that our current pathways model addresses all patients cared for

63 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 59 in a hematology and oncology practice but the provider engagement program with robust compliance monitoring remains a bit more restricted to those malignancies that make up approximately 80% to 85% of the cancer care spend in the commercial age population. Most of the pathways programs launch with a focus on breast, lung and colon cancer and then may expand to other conditions. Each health plan can decide which cancers it wants its clinical pathways program to target, Feinberg says. He adds that four of the plans with which Cardinal works have pathways for prostate cancer, ovarian cancer, lymphoma and myeloma. As far as outcomes from these programs, Feinberg says that in addition to the results that have already been published or presented at meetings, We are currently preparing a number of studies, which we plan to submit for peer review, which demonstrate outcomes associated with our more mature clinical pathways programs. It s premature to discuss the related details at this time, but our preliminary research demonstrates promising results and ROI in terms of improved patient care and reduced health care costs. Plans Are Expected to Step Up Oncology Management Strategies Various factors will continue to exert pressure on health plans and other stakeholders within the oncology arena, according to a 2012 report by Campbell Alliance. This could prompt new collaborative efforts among these stakeholders, particularly plans, physicians and drug manufacturers. The report, titled Turning Tides: Trends in Oncology Market Access, analyzed three market trends within the oncology space: (1) Provider consolidation and site-of-care shifts, (2) Advent of oral oncolytics, and (3) Payer management and clinical pathway experimentation. Researchers also surveyed both physicians and health plans. According to the report, various factors political, socioeconomic and regulatory could increase the speed at which sites of care change over the next couple of years. Hospitals share of cancer drug spending is growing, making them an increasingly important customer segment, says the report. But hospitals tend to charge more for services than do office-based practices, and many hospitals also have access to 340B pricing, which limits what manufacturers can charge for their drugs. Add to that an economic downturn that s resulted in smaller providers either closing their doors or being purchased by larger providers or hospitals, and that makes for a pressure situation for not only community-based providers but also manufacturers and health plans.

64 60 AIS s Management Insight Series Because payers have a vested interest in retaining care in the community, drugmakers could explore opportunities for partnering with payers to prevent and mitigate these risks due to site-of-care shifts, says the report. It is difficult, if not impossible, for payers to go against macro market trends like site-of-care shift by putting in place mandates for specific drugs, said Lujing Wang, M.D., managing director at Campbell Alliance and one of the report s authors, in fall However, there are a few things that smarter payers can do/are doing to protect a decentralized provider environment: have a holistic view on reimbursement negotiating to protect a sustainable ecosystem for providers; monitor the referral-out rates from oncology practices, flag those high-risk ones, and offer them specific programs (e.g., specialty pharmacy services to remove the buy and bill from providers); and partner with state societies for guideline and pathway development to protect the local market dynamics, as Blue Cross Blue Shield of Michigan has done, he adds. The report also highlights the continued growth of the oral oncolytic class, which presents advantages and disadvantages for various stakeholders. While payers have better management strategies for drugs available through the pharmacy benefit and are able to avoid infusion costs, these therapies also boast high price tags and represent a source of rapidly increasing spend. Likely Change in Utilization Management for IV Cancer Drugs by 2014 Which utilization management tools for IV and other office-administered cancer therapeutics do you expect to increase or decrease use of by 2014? (n=38 managed care payers) Biomarkers/diagnostic tests Clinical pathways Prior authorization Increased patient cost- sharing Prior therapy requirement Mandated use of specialty pharmacy (to exclude buy-and-bill) Compendia listing/guideline requirements Case management Shift of coverage from medical to pharmacy benefit Percentage of Plans in Sample 0% 20% 40% 60% 80% 100% Increase Remain the Same Decrease Don t Know SOURCE: Campbell Alliance, Turning Tides: Trends in Oncology Market Access, released September By Lujing Wang, Terry Tao and Nicolle Hamilton. Visit

65 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 61 The report projects that as cancer becomes more of a chronic condition, plans will put tighter management tactics on conditions that have many therapeutic oral options such as renal cell carcinoma and chronic myelogenous leukemia. Due to the nature of most cancers, it is difficult for payers to explicitly prefer one oncology product over another, explains Wang. Most payers package their product preference through medical policy and clinical pathways. This could have [an] indirect effect on providers. As an example, he points to the recent decision by Memorial Sloan-Kettering Cancer Center to not offer the Sanofi colorectal drug Zaltrap (ziv-aflibercept). According to an op-ed in The New York Times written by three of the hospital s doctors, the drug is no more effective than Avastin (bevacizumab), but it costs more than twice as much. It is difficult for a payer to institute a hard and blind block on new oncology agents, but it is OK for providers to do so, points out Wang. And it could be especially toothful if done by large NCCN [i.e., National Comprehensive Cancer Network] centers. The specific reason why they did this is unknown, as the stated reason Zaltrap is twice the price as Avastin is flawed. But clinical pathway, manufacturer competitive activities, etc. could all provide incentives for such behavior. Contracting May Be Easier in Some Areas In addition, says Wang, payer contracting for oncology agents is still a novel concept for manufacturers in the U.S. But there are speculations that it could start with some categories that have mostly oral products and/or a major loss-of-exclusivity event, such as the chronic myelogenous leukemia space. And payers will likely be willing to respond to manufacturer incentives as they have been longing for such pricing competition in oncology. Most health plans surveyed by Campbell Alliance say they expect their use of various utilization management strategies will either stay the same or increase. The use of biomarkers/diagnostic tests and clinical pathways were rated the top categories expected to increase. Most current pathway programs are for breast, lung and colon cancer, and plans say they expect those to continue to be the big areas. However, by 2014, many of the respondents said they expect prostate cancer, lymphoma, myeloma and renal cell carcinoma to also have pathway programs.

66 62 AIS s Management Insight Series As Oncology Drug Spend Rises, Payer Management Will Increase As oncology represents a bigger and bigger chunk of the specialty drug arena, industry experts in January 2013 gave AIS their thoughts on what the industry may see moving forward. We will continue to see more oral therapies, which means patient compliance still will be a critical issue, says Mike Ellis, vice president for specialty and infusion at Walgreen Co. The spend on oral oncology drugs was up over 22% in 2012 and is expected to continue to experience high growth with several new entries possible in 2013, says Peter Wickersham, senior vice president, cost of care for Prime Therapeutics, LLC. Managing oncology drug therapies is becoming more accepted and is more frequently requested by payers. According to Gary Rice, vice president, clinical services for Diplomat Specialty Pharmacy, As the number of oral oncologics increases, combined with an increased emphasis to place medications on the pharmacy benefit, payers are becoming more focused and assertive about controlling medication costs in oncology. The additional [trend] of utilizing oncology clinical pathways can potentially standardize treatment variability among physicians, which can improve patient outcomes and reduce cost. Oncology clinical pathways may also reduce overall costs by decreasing the use of less-effective medications or those medications that cause side effects requiring hospitalization or other expensive healthcare interventions. Kjel Johnson, senior vice president of strategy and business development for Magellan Pharmacy Solutions, cites three oncology-specific trends for 2013: (1) site of service switch ; (2) the increasing cost trend will be a lot steeper now than in the past because there are not really any favorable generics for cancer expected in 2013; and (3) for the first time, we are seeing employer groups asking for cancer-management strategies. Initial Fill Limits Are Becoming Popular Besides site-of-care management, in which plans are looking at ways to keep patients out of the hospital for infusion and may be looking at more actively managing their infusion network, the tactic of limiting the first fill of oral oncology agents is gaining traction, says Debbie Stern, president of Rxperts, Inc. Payers and specialty pharmacies need to examine claims data to identify the value of this practice on a drug-by-drug basis, or look to peer-reviewed studies to help them formulate this strategy. Stern adds that changes in provider reimbursement to incent use of lower-cost drugs is another trend, as many payers are moving to incentive-based fee schedules for medical benefit drugs in general and oncology specifically. Physicians will get a

67 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 63 higher margin on lower-cost drugs to incent their use. The current ASP [i.e., Average Sales Price]-based reimbursement decreases any financial incentive to use these drugs. Appropriate use of palliative care and hospice will continue to be causes that payers will endorse; however, payers recognize they need to be cautious that they are not viewed as promoting death panels. Look for payers to continue lowering drug reimbursement to physicians as a means to control distribution, says Stephen Cichy, founder and managing director, Monarch Specialty Group, LLC. As a result oncologists will continue to experience tension with payers in managing the business aspects of cancer care delivery. The ongoing concern regarding payment rates for professional services and payment rates for drugs will continue to indirectly promote a shift of cancer care to alternate settings, including hospital outpatient. About half of the cancer drugs have companion diagnostics that will be approved in concert with the drug, so this will be an increasingly busy area, explains Bill Sullivan, principal consultant with Specialty Pharmacy Solutions LLC. Personalized medicine is definitely driving the oncology industry, says Michael Waterbury, president of ICORE Healthcare. The good news about this is that more of the right people are getting the drugs they need they re just expensive. Not only are [oncology medications] becoming more specialized to specific pathways, they are also coming out with companion biomarkers, which adds to their cost, notes Winston Wong, associate vice president, pharmacy management for CareFirst BlueCross BlueShield. This raises the value proposition to another level. Do you promote the use of a biomarker test to all your patients with a certain diagnosis, to identify the 5% of the population that will benefit from the new high-tech, very expensive medication? More treatment regimens will consist of combination therapies, add-on therapies and maintenance therapies terms that weren t even used in cancer more than a few years ago as companies learn more about the delivery and effectiveness of these drugs, says Waterbury. But such therapies may be priced differently depending on how they re administered. And they may raise some difficult issues. For example, as people are taking these drugs for many years, we ll need to ask hard questions, such as when should we stop administering drugs that can have serious side effects and can be very expensive. Helen Sherman, Pharm.D., vice president of Solid Benefit Guidance, says there will be more oncology drugs approved on preliminary data, for rare cancers, as third-, fourth- and fifth-line treatments and where their place in therapy and effectiveness are difficult to discern.

68 64 AIS s Management Insight Series Florida Blue and Moffitt Cancer Center Launch ACO Focused on Oncology Care As Florida Blue continues to aggressively pursue opportunities with the accountable care organization (ACO) model, it has unveiled a second cancer-focused program. The arrangement with the Moffitt Cancer Center, though, is the plan s first ACO in which it partners with a cancer-specific provider. With much of Florida Blue s membership receiving care at Moffitt, the initiative is aiming for better integrated care, quality of care and patient outcomes all of which should result in decreased medical costs. The program essentially launched Jan. 1 [2013], says Jonathan Gavras, M.D., senior vice president, delivery system and chief medical officer for Florida Blue. He told AIS in January 2013 that it will focus on the most common cancers: cancers of the male and female reproductive systems, breast cancer, gastrointestinal cancers such as colon, soft tissue cancers such as lymphomas and leukemias, and respiratory/thoracic cancers such as lung. These represent 80+% of the tumors among plan members, explains Gavras. The plan had worked with Moffitt before, and Gavras notes that the cancer center has a stellar reputation in not only the Tampa area but also nationally and internationally. In addition, Moffitt is one of only 41 National Cancer Institute Comprehensive Cancer Centers and the only one based in Florida an elite distinction that made it a desirable center with which to partner. And Moffitt over the years has been at the forefront of health care innovation and has been moving toward integrated care, so the collaboration was a great opportunity, contends Gavras. This is a win-win for both organizations as it locks in an established provider entity with Florida Blue that can keep both organizations as key players in the aged Florida market, maintains F. Randy Vogenberg, Ph.D., a principal with the Institute for Integrated Healthcare. For Florida Blue, it plays off of their administrative services and business contracting capabilities that will be more important under health reform while locking in a solid provider for an increasingly high-cost service line (cancer). For Moffitt, it immediately creates continued access through the Blues beneficiaries as a preferred network that may potentially disadvantage all other providers for cancer care. As far as outcomes, the Blues plan is expecting to see increased integration in health care, and along that line, a much tighter connection to pathways, Gavras says. Also anticipated are better outcomes in care and an improvement in quality, including a better patient experience and access to care. When these kinds of outcomes are seen, then you tend to see a decrease in health care costs. This is not the first oncology-specific ACO on which Florida Blue has collaborated. In May 2012, it launched a cancer-focused program with Baptist Health South Florida and Advanced Medical Specialties. And since then, the plan has launched full cost of

69 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 65 care ACO arrangements, notes Gavras. A lot of data analysis has been put in place, and a lot of metrics have been developed. He explains that the arrangements with Moffitt and Baptist Health/Advanced Medical Specialties are the only disease-specific ACOs that the plan is involved in at this point. The others are focused on total cost of care. Florida Blue also has some bundled payment arrangements, including an orthopedic arrangement with the Mayo Clinic. But while cancer care is a component of the care that Baptist Health provides, Moffitt is a cancer-focused entity. It s what they do, points out Gavras. With other ACOs in which the company is involved, including ones with Holy Cross Hospital in Fort Lauderdale, Baycare Health System in Tampa Bay and NCH Healthcare System in Naples, cancer is under the umbrella of the care provided. The methodologies and philosophies are pretty much the same with the two oncology ACOs, says Gavras improving the patient s experience and getting the best overall outcomes. These are quality-based initiatives. However, the groups involved are two different systems. Baptist Health is a multispecialty system, and Moffitt is a cancer system with a very regional focus, he explains. A significant amount of our membership seeks care at Moffitt, which has 330 oncology practitioners, Gavras adds. The Moffitt ACO covers the Tampa Bay area, while the Baptist Health ACO is focused on Miami. We re not looking specifically for cancer-type ACO arrangements in other parts of the state, he says, but if opportunities arise, the plan would consider them. Asked if there were any available data on the Baptist Health ACO, Gavras notes that it is still very, very early in the arrangement, and that they are just starting to look at the data now. Complicated disease states such as oncology are difficult programs to do in an ACO model. But we re pretty encouraged by what the plan is seeing so far. There will be all types and sizes of arrangements from the Blues plans like this since they want to work with all providers in both primary and specialty care arenas, Vogenberg says. As Blues plans move away from traditional insurance, they have to align networks with service offerings while watching their rising costs of care. He adds that Commercial insurance private exchanges and other retail insurance efforts as well as health purchasing groups will continue to put pressure on Blues plan premiums as well as provider reimbursement akin to CMS. It s important for health plans and providers to find collaboration opportunities if either or both are to survive the implementation of health care reform.

70 66 AIS s Management Insight Series CareFirst RA Clinical Pathways Program Gets Providers On Board, May Expand to GI Although clinical pathways for certain cancers are growing in popularity among health plans, the approach hasn t gotten much use outside of oncology. That changed, however, in December 2011, when CareFirst BlueCross BlueShield partnered with Cardinal Health Specialty Solutions on a rheumatoid arthritis (RA) clinical pathways program. Now, almost one and a half years later, Winston Wong, Pharm.D., associate vice president of CareFirst Pharmacy Management, reflects on how the program is going and tells AIS that the approach may be expanded to an additional therapeutic category. The class now has nine FDA-approved biologics that fall under both the pharmacy and the medical benefit in most plans. And with the autoimmune class consistently being cited as one of the most costly among specialty drug-treated conditions along with oncology and multiple sclerosis RA would seem like a management priority for health plans. The pathways represent a rational thought process as to how to approach the RA patient, says Wong. Currently, the pathways are delineated by class of drugs, with specific preferred medication within the class. The FDA approved the first oral RA drug, Xeljanz (tofacitinib), in November Wong tells AIS that although the steering committee which is composed of rheumatologists within the CareFirst network has reviewed the therapy, it decided not to place it in any preferred position to the injectables. However, he notes, Once a change in the pathways is decided upon by the steering committee, the change can be implemented quickly. One industry trend is site-of-service optimization for professionally administered drugs. Wong says that Site of service is a concern of ours, and our pathways call for the use of noninstitutional infusion sites. According to Bruce Feinberg, D.O., chief medical officer, oncology at Cardinal Health Specialty Solutions, 98% of infusions by participating providers are performed in-office (where they re most cost-effective and convenient for the patient). Still, says Wong, The issue we ran up against is that if the provider does not have the ability to infuse, then their options are limited in terms of practicality as to where to infuse the patient. It seems that providers really are hesitant to send their patients to another provider, of the same specialty, to administer the infusion for fear of losing the patient to that provider. Some have resorted to using a provider of a different specialty, while others installed an infusion suite. Rheumatologist buy-in with the program is critical to its success. According to Wong, The rheumatologists started the program with some skepticism; however, [they] are now genuinely accepting it. Feinberg adds that Nearly 80% of all eligible

71 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 67 community rheumatologists within the CareFirst network are participating in the program. CareFirst requires physicians to monitor patients disease progression through Clinical Disease Activity Index (CDAI) scores, which measure mobility. The steering committee settled on CDAI after CareFirst said that it wanted an objective disease progression measurement tool, says Wong. CDAI scores are still required upon every patient visit, he says. It took some time to get the providers on board for every visit, but we have been more successful towards the latter part of When the program launched, Wong said that the plan was probably looking for an ROI [i.e., return on investment] of about 5-8:1. The cost savings are going to come from hopefully an improvement in the ability to monitor a patient s disease, including checking doses and potentially hitting a remission point. Wong says that CareFirst has not yet received the ROI tabulation back from Cardinal on the RA program. We have seen an increase [of 8%] in the use of nonbiologic medications, with a slight flattening in the use of the biologics, while the CDAI scores have remained constant. It is difficult to translate these into quantifiable savings. Still, he says, CareFirst is discussing expanding the program into the gastrointestinal arena since they use many of the same biologics, although in that situation, the CDAI would not be used. Clinical Pathways Reduced Costs of Care 15%; Success Led to Medical Home Pilot When P4 Healthcare LLC launched its first clinical pathways program with CareFirst BlueCross BlueShield in 2008, its goals were to help rein in cancer care costs without sacrificing patient outcomes and get physicians on board by providing fair reimbursement. At the time, to say this was a tall order may have been an understatement, as payers traditionally had been very hands off when it came to oncology. While P4 whose parent company, Healthcare Solutions Holding, LLC, was purchased by Cardinal Health, Inc. in 2010, making P4 part of Cardinal Health Specialty Solutions and CareFirst have released data showing the savings from this program, a recent study provided third-party validation of those benefits. Additional studies from Cardinal and CareFirst as well as a medical home pilot program the two are partnering on have demonstrated that the program is meeting its goals. When the program started, it focused on breast, lung and colon cancers, which made up the bulk of CareFirst s oncology costs. Cardinal and CareFirst compared claims from January 2007 to December 2010 for patients with these cancers who were treated by physicians in the pathways program with a control group identified by

72 68 AIS s Management Insight Series Truven Health s MarketScan database. The findings show that CareFirst reduced its overall costs to treat these cancers by 15%. The overall reduction in hospital services was 7%, through a combination of decreased ER visits, decreased hospital admissions and decreased length of stay, explained Bruce Feinberg, D.O., chief medical officer, oncology for Cardinal Health Specialty Solutions, in spring We believe one of the key factors leading to fewer ER visits was the more appropriate use of medications particularly chemotherapy. He adds that while the company does not have specific information as to the lengths of stay, we intend to measure and report that level of detail in future studies. According to Feinberg, The biggest surprises [among the studies findings] were around physician behavior and reimbursement. Despite the accepted dogma that physician prescribing will follow their economic interest, we found that doctors could be paid more but prescribe less and that they could be paid less for drugs and prescribe the same. We see this as reinforcement that the evidence-based pathways were the driver of the physician behavior, not the drug reimbursement. He tells AIS that physician participation has been excellent in the community, upwards of 85% including both salaried and academic practices. Of note, he says, is that 85% of community oncologists in the network participate, but those doctors represent 95% of community oncology cancer spend. Participation in the clinical pathways programs is collaborative and voluntary, points out Feinberg. His company is working on other programs with various plans across the country, and each has financial incentives for participation, above and beyond historical reimbursements. Incentives vary from fee schedule enhancements to participation bonuses to shared savings. We encourage reimbursement methodologies that incent providers to participate and comply with clinical pathways. During the second year of the pathways program, CareFirst expanded it to 10 cancers, including prostate, ovarian, lymphoma and myeloma, notes Feinberg. In addition, in December 2011, CareFirst and Cardinal launched the first clinical pathways program for rheumatoid arthritis, which also has proven successful. Organizations Launched Medical Home Pilot Following the initial pathways program s success as measured in financial savings and physician participation and compliance, the two organizations launched a medical home pilot program in January 2011, with the hope of further decreasing cancer care costs while continuing consistency and quality of care, according to an abstract (#e17582) of a study presented at the recent American Society of Clinical Oncology meeting. The new program offered a new physician reimbursement model that shifted the source of revenue from margin on drug sales to cognitive services allowing physicians to focus on optimal patient care without the financial incentive to prescribe chemotherapy. Physicians were encouraged to commit to an intensive continuous

73 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 69 quality improvement (CQI) program, which included an end-of-life [i.e., EOL] initiative and a post chemotherapy nurse call-back program that would lower costs by decreasing emergency room and hospital admissions. Physicians who had participated in the initial pathways program were eligible to participate in the medical home pilot. Fourteen practices with 31 physicians joined the pilot. The study compared data from the pilot with data from 103 physicians from 39 practices who were not participating. And although all cancers were included in the medical home program, for the purposes of this study, we measured compliance only for breast, colon and lung cancers, says Feinberg. Findings from the study showed that the medical home provided gross savings of $2.0 million compared with the first program. Significant savings can be achieved in a provider group already compliant with a mature pathways program, concluded the study. Most of the savings was driven by a reduction in hospital events, and some savings were also created by drug margin change due to the rise in ASP [i.e., Average Sales Price], explains Feinberg. However, participating practices were promised to be made whole on drug margin delta. Another study looked at the potential cost savings of a CQI program. Of that study, Feinberg says that the two outcomes that stand out are related to nurse surveillance and end-of-life awareness. Nurse calls likely prevented five to 15 ER visits and three to 10 hospitalizations. The EOL program raised awareness of EOL options and best practices, increasing hospice referrals to 80%. However, short lengths of stay in hospice (seven days or less) and high hospitalization rates leave room for improvement. That study also revealed that only one patient out of 15 which was out of 38 patients receiving clinical interventions that involved a return visit to the provider office received chemotherapy within 14 days of death. This is significant because it challenges dogma as do many of the observations in this research, Feinberg says. Doctors did not change their care despite a dramatic change in reimbursement method. Chemotherapy was not a major expense at end-of-life hospitalization was. Biomarkers, Specific Pathways Are Influencing Cancer Care More Oftentimes oncology drugs are effective in more than one kind of cancer. And even if the company has not applied for FDA approval for other conditions, physicians may use the drugs in other areas in which they have shown some promise. At this point among the new metastatic melanoma treatments, there doesn t seem to be much, if any, off-label use of the drugs. The question really becomes globally what s going to be the role of off-label use of these expensive oral oncolytics going forward? says Michael Kolodziej, M.D., national medical director focusing on oncology solutions for Aetna Inc. I don t know, but I don t think it will be as it was in the past

74 70 AIS s Management Insight Series where there was a lot of leeway with off-label use of cancer drugs, largely because of the biomarkers associated with more drugs now. That, in turn, raises the issue of what do we do with patients with a BRAF mutation but who do not have melanoma? Kolodziej said in summer BRAF mutations occur in other cancers such as colorectal cancer. Because of this, explains Lee Newcomer, M.D., senior vice president, oncology, genetics and women s health at UnitedHealthcare, down the road we may find that we re not treating melanoma but we re treating the BRAF pathway. According to Kolodziej, the BRAF pathway is kind of complicated and branching. A lot of drugs attack different parts of the pathway. For these reasons, next-generation sequencing really has the potential to be revolutionary, maintains Kolodziej. How do we want to go forward in this world? I m not sure, he says, but it needs to ensure that the right person gets the right treatment. Current State of Cancer Care Has Challenges With enormous resources available to researchers, experts know more about cancer than ever before. Oncology drugs many of which are targeted therapies that are indicated for people with specific genetic markers dominate the pharmaceutical pipeline. To a large extent, cancer is no longer the death sentence that it once was, as two-thirds of Americans now live at least five years after a cancer diagnosis as compared to only about half in the 1970s, says the American Society of Clinical Oncology (ASCO). But that innovation comes with much higher costs for care. Various other factors are impacting the current cancer care environment, and ASCO s recently released The State of Cancer Care in America: 2014 offers a view of those. According to ASCO, which represents almost 35,000 oncologists and oncology professionals, new cancer cases will increase by 45% by 2030, as cancer becomes the leading cause of death in the U.S. At the same time, increased survivorship will mean a large population of people who will require significant, ongoing care, says the report. Its findings include the following: u With the 18 cancer treatments that the FDA approved in 2013, that brings the total number of anti-cancer drugs to more than 170. u The cancer death rate in the U.S. has decreased 20% since the early 1990s, and there are 13.7 million cancer survivors in the country. u Annual costs for cancer care are expected to be more than $173 billion in 2020, up from $104 billion in u The share of oncologists who are at least 64 years old surpassed the proportion of ones who are less than 40 years old in 2008, which is the first time that s happened.

75 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 71 This gap continues to widen, with the medical oncologists being slightly older than the general physician population, a consistent trend for the last eight years. u Most oncologists are in urban areas, but about 19% of Americans live in rural areas. More than 70 percent (2,067) of the U.S. counties analyzed had no medical oncologists at all. u From 2012 to 2013, payer mix was fairly stable. In 2013, commercial payers represented 36.09% of payers, Medicare was 48.42%, Medicaid was 11.4%, and 7.28% was uninsured/self-pay. u In 2012 and 2013, payer pressures and cost pressures were the main pressures practices cited, followed by competitive pressures. ASCO offers the following recommendations to help ensure oncology care is available: u Identify creative strategies for leveraging the oncology workforce. u Leverage technology and innovative practice models. u Monitor and address physician burnout. u Monitor and address the size and diversity of the oncology workforce. The group also recommends the following actions to help oncology care providers meet patient needs: u Payers should align payment systems with the goal of delivering high-value, patient-centered care. u Policymakers should test a range of promising cancer care delivery models that address the unique challenges of treating the disease. u Policymakers should reduce instability in federal payment systems, including repealing the Sustainable Growth Rate formula and reversing sequestration-caused cuts to Medicare. While the report is the first one on the state of cancer care that ASCO has published, the association says it will produce annual updates to it. Spending on Oncolytics Has Slowed, But More New Drugs Are Launching Costs for oncology drugs, including supportive care therapies, continue to rise, but that rate of increase has slowed somewhat. That doesn t mean, however, that we re seeing fewer cancer drugs launching but rather a decrease in use of supportive care drugs, a decline in innovative therapies for large patient populations and a rise in payer management of these treatments, according to a recent report from the IMS Institute for Healthcare Informatics. In 2013, global spending on oncology drugs not only drugs to treat a cancer itself but also supportive therapies, including brands, generics, large molecules and

76 72 AIS s Management Insight Series small molecules reached $91 billion, up from $72 billion in 2008, according to the report, titled Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report. It also shows a 5.4% compound annual growth rate for global spending on cancer drugs between 2008 and That s down from the rate of 14.2% from 2003 to 2008, indicating a moderation in the growth rate, said Murray Aitken, executive director of the IMS Institute, during a May 2, 2014, conference call to discuss the report. The growth rate has been slower in the U.S., at 3.5%. However, although the share of U.S. spending on oncology on a global scale declined 2% from 2008 to 2013, it still spent the most of any country, accounting for 41% of worldwide spending on cancer therapies in Aitken noted that fewer breakthrough therapies for larger populations and stronger payer management are helping slow costs in this country. In addition, use of erythropoiesisstimulating agents declined amidst safety concerns. Hospitals Have Higher Drug Administration Costs Than Physician Offices Hospital outpatient costs compared to physician office costs 10,000 8,000 $ Paid/Dose by Site 6,000 4,000 2,000 0 Bevacizumab Daunorubicin Epirubicin Goserelin Interferon alfa-2b Mitomycin C Pertuzumab Trastuzumab Cetuximab Doxorubicin Fulvestrant Idarubicin Leuprolide Acetate Mitoxantrone Rituximab % increase in hospital outpatient costs over physician office costs Physician office costs Hospital outpatient costs 259% 83% 975% 275% 244% 59% 135% 76% 141% 171% 141% 372% 140% 81% 85% SOURCE: IMS Institute for Healthcare Informatics, Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report, released May Visit

77 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 73 Oncology Has Seen Surge in Innovation Aitken pointed to the surge in innovation in oncology. Particularly the last couple of years, we ve had a record number of these cancer therapies reaching patients, often with a high cost but also with impressive survival benefits for those patients. In the last two years, 21 new oncology therapies have launched, including many targeted therapies and many therapies used in relatively small patient populations, he said. Clusters of innovation have transformed patient care in conditions such as metastatic melanoma, prostate cancer and lung cancer. However, that s not to say that all of the oncolytics that have launched have seen great uptake. The report notes that while therapies such as Zytiga (abiraterone acetate), which had an expansion of its indication; Kadcyla (ado-trastuzumab emtansine); and Perjeta (pertuzumab) had successful rollouts in the first 24 months since they hit the market, others were not as fortunate. Among those were Zaltrap (ziv-aflibercept) and Stivarga (regorafenib), which had strong launches, but then sales tapered off, likely due to a competitive market with established treatments for colorectal cancer. The average cost per month for a branded oncology drug in the U.S. is now approximately $10,000, said Aitken, up from about $5, years ago. When it comes to oncology drug spending, the influence of single-payer health care and associated discount mechanisms in nations other than the U.S. have driven down the list price and ultimately the net price paid, notes the report. Final prices in European countries tend to be about 20% to 40% less than prices in the U.S. Another impact on pricing is that payers that utilize health technology assessments tend to pay less than U.S. prices for their medicines, Aitken said, noting the difficulty that exists in assessing the value of treatments for cancer. Biosimilars are one factor that many stakeholders in the U.S. point to as a method of driving down specialty drug costs. But, notes the report, although the U.S. is the largest biologics market, it is lagging behind the rest of the world in the emergence of biosimilars. According to Aitken, We see the potential role for biosimilars in developed countries to be limited. As far as which drugs may get the most uptake, supportive therapies play a role in Europe, activity that we expect to see in the U.S. in the near term. In the overall U.S. oncology space, there are unique dynamics playing out, maintained Aitken. For example, changes in the structure of health care delivery are impacting the site of care for cancer treatment. The oncology arena is undergoing a shift from smaller practices to larger ones as medical groups merge and are acquired by hospital systems and other health care organizations. Accountable care organizations (ACOs) and the expansion of eligibility for 340B discount drug pricing are two drivers of this shift. In 2012, says the report, 34% of oncology practices consisted of one to two physicians, and 37% consisted of three to six. But in 2013, only 28% of these practices were

78 74 AIS s Management Insight Series one to two doctors, and 30% had three to six physicians. So while only 29% of practices in 2012 had more than seven physicians, that percentage rose to 42% in A shift in the site of care from physician offices to hospital outpatient facilities is occurring, Aitken noted. This also has an impact on reimbursement for the cost of administering oncology drugs, which, when delivered in hospital outpatient facilities, have higher reimbursement. In fact, he said, some targeted therapies cost at least double in hospital outpatient departments than in physician offices. According to the report, reimbursement levels for drug administration costs in hospital outpatient facilities are on average an incremental 189% of the level of physician office reimbursed costs for commercially insured patients under the age of 65 years. Those higher costs in the hospital outpatient setting, said Aitken, are associated with higher patient out-of-pocket costs. The report says that patients treated as outpatients in the hospital are on the hook for $134 more per dose compared with what they would pay for the same treatment in a physician office. WellPoint Turns to Pathways to Improve Cancer Care, Costs WellPoint, Inc. has joined the growing group of health plans that are turning to oncology pathways as a way to help improve members care and get a handle on costs. But it has taken a bit of a different approach from others, in that it is paying providers who use an on-pathway regimen $350 at the start of care and then every month after for either the duration of treatment or six months, whichever is shorter. That payment is in addition to reimbursement for office visits and drugs. There s no penalty if a provider chooses an off-pathway regimen. The WellPoint Cancer Care Quality Program is in response to two issues in cancer care. One is quality. Despite access to the best technology, as many as one in three people treated with chemotherapy don t get the standard evidence-based care, said Jennifer Malin, M.D., Ph.D., medical director for oncology at WellPoint, in spring The second issue is affordability. The challenge is there are many, many new therapies and technologies. Many have tremendous benefits, and many come at very high costs. Our goal is to be able to help make sure our members receive the most appropriate therapy, one that can provide the best outcomes [and at the same time] keep cancer care affordable. Administered by WellPoint subsidiary AIM Specialty Health, the program will start in Georgia, Indiana, Kentucky, Missouri, Ohio and Wisconsin and will expand to other states in 2014 and WellPoint has different claims systems in different regions for different lines of business. The Midwest states and Georgia are on the same claims system, she explains. and there are enough members within those states to support the program.

79 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 75 The initiative will start with pathways for breast, lung and colorectal cancers, which are the most common and most costly cancers for WellPoint. The three together represent about half of our costs for cancer, says Malin, who adds that the plan s spend for fully insured members is $5.4 billion on all forms of cancer care. In addition, Those three cancers also have huge variations in costs for treatments. This is an opportunity to both improve the quality of care and decrease the variation. She tells AIS that WellPoint is finalizing pathways for four other cancers. She declines to say what they are but says probably in the next month they will be unveiled. Practices Enter Regimen Into Web Portal Practices go to a Web portal and enter the treatment regimen they plan to use, as well as information such as cancer type, stage and biomarkers. If a drug requires prior authorization, that approval happens automatically through the Web portal now, Malin says. After the planned regimen is entered, the Web portal indicates whether it qualifies as an on-pathway or off-pathway approach. If it s a regimen that s not onpathway, the portal simply will say that and list all on- and off-pathway protocols. and all of the pathways are listed on a website that anyone can access. If we see patients being treated off-pathway, we won t automatically assume physicians are doing the wrong thing, she says. If we consistently see a group of patients treated off-pathway by multiple providers, we will look at this to see if it s something that needs [to be] added to the pathways. The current pathways include supportive therapies, but at this point, WellPoint does not include these drugs in its determination of whether a provider is adhering to an on-pathway regimen. Down the road, says Malin, the plan may decide to include them. Tests for biomarkers that help determine whether a person is a candidate for certain drugs are included in the program. This is one of the ways the program will help improve the quality of care [because] it s essentially impossible to stay current on developments within oncology, contends Malin. Anytime there is a genetic marker tied to a condition, WellPoint includes the genetic test to determine that in its guidelines. All three of the cancers in the initial stage of the program have biomarkers tied to them that help stratify patients and the most appropriate treatment for them. The pathways are specific to all the tumor types and mutations. That said, at this stage of the program, WellPoint mainly is collecting data around genetic testing and isn t mandating that all patients with these three cancers are tested for particular genetic markers. For example, the Web portal is set up so that after lung cancer is entered in the system, it asks what the test results were for anaplastic lymphoma kinase (ALK) mutations: positive, negative or unknown. WellPoint, says Malin, is looking at what percentage of patients have an unknown indication. and if a patient is indicated as ALK-positive and the regimen entered into the portal is not the most suitable one based on that test result, the plan would not prevent the provider

80 76 AIS s Management Insight Series from using that medication, but rather the portal would suggest using a more appropriate therapy. Down the road, the program may evolve to mandate certain testing and a more proactive approach, she says. Physicians Have Input in Program Physicians are involved in establishing the pathways in multiple different ways, Malin notes. One is reviewing national clinical guidelines. WellPoint s research group that considers side effects, benefits and costs of various regimens consists of oncologists and pharmacists. and the plan has external advisers who review the summary of evidence and the proposed pathways. Traditionally plans have been hands off when it comes to oncology management so as to not step on providers toes. Two-thirds of oncologists revenue comes from drugs, points out Malin, so they re very dependent on drug margins. The $350 payment gives them an alternate way to bring in revenue. The amount, she told AIS, was designed to, on average, keep the practice whole. If they use drugs with lower margins, their practice wouldn t bring in as much revenue so this [reimbursement] should help them be cost neutral or come out a little bit ahead. According to an FAQ about the program, providers who enter an accepted pathways regimen will need to submit claims under one of two S-codes to receive the $350 payment. While the pathways primarily consider clinical benefits, side effects and national guidelines, if all factors are equal, cost comes into the equation. Some regimens may offer equivalent clinical benefit, but differ significantly in cost, says the FAQ. When the cost of a regimen is high, the reimbursement to the servicing provider is correspondingly high. The health plan therefore considers that the reimbursement already includes compensation for cancer treatment planning and care coordination. In these circumstances, compensation for the S-codes is bundled. When a Cancer Treatment Pathway is selected, while the clinical benefit of the regimen is high, the cost and corresponding reimbursement is typically lower. Therefore, the health plan enhances the reimbursement for the regimens on Pathway through the separate S-code compensation. Among providers, for the most part, feedback has been very positive, Malin says. WellPoint s education efforts have included a series of webinars, as well as presentations at meetings of various states oncology societies. Program Helps MDs Stay Up to Date The program can help busy providers keep up to date with all of the developments occurring within the oncology space. We hear from practicing oncologists that often they don t know the costs of products new to the market, Malin says, as well as how some therapies benefits compare with those of other available drugs. WellPoint

81 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 77 wants to make sure providers have access to the best quality therapies while at the same time, when safety and efficacy are equal, have lower-cost options. According to Elan Rubinstein, Pharm.D., founder and principal of EB Rubinstein Associates, the initiative is reasonable and appropriate. The program makes great sense and is long overdue, contends Bill Sullivan, principal consultant with Specialty Pharmacy Solutions LLC. The variation in oncology treatment is excessive, and oncologists are often not up to date with the best therapy strategies and across cancer stages. What makes total sense for a stage one patient might be inappropriate for a stage four patient or vice versa. Having peer-reviewed pathways developed and maintained is a great tool. Being able to easily access this information by inputting the patient s profile and getting the best recommended drug strategy is a great example of personalized medicine. He points to the important fact that this is a carrot not a stick program. The oncologists are not being forced into a take-it-or-leave-it situation. They retain their professional discretion, but it gives them pause to consider what nationally recognized experts would recommend and why their thinking isn t in sync. It moves the needle. How does WellPoint s program compare with other pathways programs? This tracks almost exactly with the programs that I ve reviewed from companies such as Cardinal Health Specialty Solutions which got its program when it acquired Healthcare Solutions Holding LLC, parent company of pathways provider P4 Healthcare, in 2010 and New Century Health, Sullivan told AIS in spring The P4 program that Cardinal acquired also paid physicians more for adherence to approved pathways, Rubinstein tells AIS. But the WellPoint approach appears to be more simple and more transparent than was P4 s program. This approach also appears easier than United Healthcare s demonstration, in which oncologists are paid a fixed amount in advance for chemotherapy of a given type of cancer. Horizon Invests in Oncology Firm COTA to Help Docs Offer Patient-Centered Care Horizon Blue Cross and Blue Shield of New Jersey is hoping that its investment in COTA, Inc., a technology company focused on oncology management, will help it transform the delivery of health care. The deal, says the Blues plan, will help it to assist physicians in providing patient-centered care that s focused on value and not volume. The firm shares its name with its product, a cloud-based data platform that offers real-time clinical outcomes and cost-analysis data for cancer care. More than 100 practicing oncologists and national leaders in cancer biostatistics and reimbursement contributed data to it. The offering is able to sort patients according to very specific subsets of information and provide outcomes tracking in areas such as overall survival, progression-free survival and costs. When providers enter detailed information

82 78 AIS s Management Insight Series on their patients, they are able to see how that experience compares with other similar ones, which in turn allows them to make better treatment decisions by narrowing down the most effective approaches. COTA which stands for Cancer Outcomes Tracking and Analysis provides oncologists a number of actionable clinical and financial reports for the patients they are caring for, explains Kelly Choi, M.D., the firm s chief operating officer. The key is that COTA can parse down to the finest of patient subtypes within a particular type of cancer. As an example, for a particular subtype of breast cancer, an oncologist who is running a practice of multiple oncologists can see if all of their oncologists are consistently using NCCN [i.e., National Comprehensive Cancer Network]-approved regimens as well as see his/her operational efficiency and margins for the services provided for that particular subtype of breast cancer patient. The specific actions of course are unique to the practice depending on what the data shows. Horizon Supports Data Platform The company was founded in 2011 by hematologist/oncologist Andrew Pecora, M.D., who also serves as executive chairman. Pecora, who is vice president, cancer services, and chief innovation officer for the John Theurer Cancer Center in Hackensack, N.J., formed the company when he saw the major gap in data tracking and analysis, particularly within oncology, says Choi. In late September 2014, COTA closed $3.7 million in a planned $7 million Series A funding round in which Horizon was the lead investor, Choi told AIS in October While we have been active in the oncology space working with oncologists as well as other customers and partners, our recent Series A funding will allow us to further expand the COTA platform. Prior to that, private sources and Regional Cancer Care Associates, a group with more than 100 oncologists, provided COTA with a seed round of funding. Thomas Vincz, spokesperson for Horizon, told AIS that his health plan made a significant investment in COTA s business. Horizon is leading the effort to change the delivery of health care in New Jersey through patient-centered based practices that are focused on quality versus quantity of care. Horizon now has more than 500,000 of its 3.7 million members in patient-centered programs, with more than 3,700 participating physicians at 900 practice locations. This investment is a way that Horizon can assist companies with the development of software, data analytics and information services to further this effort, maintains Vincz. Glenn Pomerantz, M.D., vice president and chief medical officer of Horizon, will serve on COTA s board of directors, as will a second Horizon person who will be named later.

83 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 79 Data Will Help Transition to Value-Based Care Amidst growing concerns over skyrocketing health care costs that may not provide comparable returns on investment, more stakeholders within the industry are implementing value-based care models. COTA, contends the company, will help oncologists transition from fee-for-service care to these value-based approaches. COTA s technology provides clinical data and information services to enable realtime care management and comparison of quality outcomes between patients with specific types of cancer, says Vincz. This technology will help improve the tracking of outcome data, quality and care coordination, and standardization of the highest quality care for patients with oncologic conditions. This will allow for very specific quality and outcomes metrics to be tracked, which will support bundled payment arrangements, which are focused on reimbursement for improved quality. In the new value-based reimbursement world, oncologists will need to understand the population of patients they are managing to a very specific level in order to track progress, change treatment plans as needed, and understand and manage their costs at a much more granular level, Choi told AIS. COTA empowers users with the ability to sort cancer patients to the highest degree of specificity. Oncologists can thus glean a level of actionable and insightful analysis that no other system today can do. Choi explains that COTA is purely an outcomes and cost-tracking database. We do not publish guidelines nor make any clinical recommendations like the NCCN. We are completely compatible with guidelines and pathways since we do not tell an oncologist what to do we merely show him/her the consequences of their actions. Pricing for use of the platform remains confidential at the moment, says Choi. We charge the oncologists a nominal fee to use COTA, mainly to cover operating costs. We do not want to be a financial burden for the oncologists. We believe the payers have the most to gain from improved quality and lowering unnecessary costs, and we are pricing for health plans accordingly. She tells AIS that COTA has several pending contracts with health plans. We can t share any specific details at the moment, but [they] will be made public in the coming weeks, she adds. COTA also is looking to broaden its data. At this point, New Jersey is the primary geographical area represented in our data, but we do have a few pilots in the Southeast and a soon-to-be pilot in the West, Choi says. We absolutely expect there will be differences given we are seeing some big variance even in the state of New Jersey. However, we are waiting for a bit more data before we make any specific statements. According to Choi, We are focused right now on scaling our company. Our goal is for COTA at a national level to enable higher quality care while reducing unnecessary expenditures so that patients now and in future generations will get the care they need.

84 80 AIS s Management Insight Series UnitedHealthcare Launches Bundled Payment Pilot With MD Anderson The University of Texas MD Anderson Cancer Center and UnitedHealthcare have launched a new payment model for cancer care that s focused on quality care and patient outcomes. By providing bundled payments, the insurer continues to move away from fee-for-service payments in favor of value-based reimbursement. United and MD Anderson developed eight bundled payment models in the treatment of head and neck cancers for the pilot, which will span three years. Lee Newcomer, M.D., vice president of oncology for United, explains that MD Anderson went through an extensive process mapping out the processes involved in treating people with these cancers, including tests, treatments, supportive care and follow-up services. This means it also was able to narrow down what the needed elements of treatment are and avoid unnecessary care. Newcomer told AIS in January 2015 that the hospital actually proposed the bundled payment idea to United. After comparing the costs for each bundle with what it usually paid, United realized it could save money, while MD Anderson will be making a profit, so it was a win-win for both parties, he says. United will pay for the most effective care and reward physicians for pruning out all the stuff that was unnecessary and eliminating things that are not adding value or are duplicated. The program will include cancers of the salivary glands, oral cavity, throat and larynx. Newcomer says those head and neck cancers probably would not be our first choice for such a program, but they were chosen because those were ones for which the cancer center has mapped out treatment regimens and their costs. If the pilot goes well, United may look to expand it to include cancers with higher rates of incidence such as lung, prostate and breast, he says. Only newly diagnosed patients will be enrolled because the process flows are the easiest to map for this demographic group, says Newcomer. It s a lot harder to figure out bundled payments for patients who are already being treated. In addition, participants must have potentially curable disease, he says. No one with metastatic disease is included, so only people with those cancers that are stages 1 through 3 will be part of the pilot. In assessing outcomes, the most important factor will be patient survival and relapse rates, which United is carefully tracking, in addition to patient satisfaction, Newcomer says. In addition, the insurer will look at other factors such as the management of side effects related to the therapies. Physicians Won t Know Who Is in Pilot And although the cost for each bundle will be known up front, physicians won t know which of their patients are in the pilot. Most providers have no idea what

85 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 81 they re being paid patient by patient because each insurance company has a different contract, Newcomer explains. MD Anderson was not one of the groups that participated in another United pilot that made a single episode payment at the beginning of treatment for breast, lung and colon cancers. In fact, this is the first kind of innovative thing we ve done with an academic medical center, points out Newcomer. The new pilot and the older one are remarkably different, he asserts. The first pilot was chemotherapy only. The important thing about that is it was a single group of doctors, which was much easier to deal with. The new pilot, while under the MD Anderson umbrella, includes 11 different medical groups. MD Anderson operates as an integrated system, and physicians are employed by it, a fact that makes it easier to negotiate with. In addition, the first pilot included medical oncologists only, while multiple specialties are involved in this one. Head and neck cancers almost always involve different disciplines in medicine, he explains, so this program offers an opportunity for these providers to work together. Some similarities, though, do exist. In both, United is holding physicians accountable for the total cost of care, Newcomer says. That was true in the earlier pilot even though the medical oncologists refer those patients to other providers. United is asking providers to ask themselves, What can we eliminate that isn t adding value? How can we bring the total cost of care down? The first pilot also demonstrated the importance of measuring performance on a regular basis, an approach United is applying to the MD Anderson collaboration, he explains. CMS Will Launch Five-Year Oncology Care Initiative in 2016 On Feb. 12, 2015, CMS unveiled a multipayer initiative aimed at providing better oncology care and care coordination for Medicare fee-for-service beneficiaries but at a lower cost to the program (see Appendix C). Developed by the CMS Innovation Center, the Oncology Care Model (OCM) will reimburse providers for episodes of care in the administration of chemotherapy. Nearly all cancers will be included in the initiative, which also will allow beneficiaries to have 24-hour access to providers. Payments to providers will include financial and performance accountability, and OCM has a two-part payment system: (1) a per-beneficiary per-month payment of $160 for an episode s duration for effectively managing and coordinating care, and (2) a possible performance-based payment for episodes of care that will incentivize practices to lower the total cost of care and improve care for beneficiaries during treat-

86 82 AIS s Management Insight Series ment episodes. The latter payment will be available only for providers who care for people with high-volume cancers for which it is possible to calculate reliable benchmarks. CMS estimates that these cancers cover about 90% of Medicare fee-for-service beneficiaries who are getting chemotherapy, and the agency says it will publicize a list of these conditions before participation agreements are made. Episodes of care are for six months starting with chemotherapy administration per a Part B claim or an initial chemotherapy claim under Part D and will include all Parts A and B services a beneficiary receives during that period of time, as well as some Part D costs. Subsequent episodes beyond the initial six months are possible as well when beneficiaries continue treatment beyond that period of time. The initiative will focus on three main areas: (1) Linking payment to quality of care ; (2) Improving and innovating in care delivery ; and (3) Sharing information more broadly to providers, consumers, and others to support better decisions while maintaining privacy. Group practices and sole practitioners who provide chemotherapy for cancer treatment and are enrolled in Medicare may apply to participate in the program. If a group practice participates, all of its physicians who prescribe chemotherapy must participate. CMS also says it is seeking the participation of other payers in the model, including commercial insurers, Medicare Advantage plans, state programs, and Medicaid managed care plans. This participation, it says, will create broader incentives for care transformation at the physician practice level. Aligned financial incentives that result from engaging multiple payers will leverage the opportunity to transform care for oncology patients across a broader population. Other payers would also benefit from savings, better outcomes for their beneficiaries, and information gathered about care quality. Payers who participate will have the flexibility to design their own payment incentives to support their beneficiaries, while aligning with the Innovation Center s goals for care improvement and cost reduction. OCM will start in spring 2016 and run for five years. In the first two years, participants will have one-sided risk arrangements, under which they will not be responsible for the difference between the target price and expenditures exceeding it. Starting in the third year, participants may switch to a two-sided risk arrangement on a semiannual basis.

87 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 83 Tennessee Blues Launches Pilot With Tennessee Oncology BlueCross BlueShield of Tennessee Inc. (BCBST) is working with Tennessee Oncology, PLLC on a six-month pilot program that s focused on improving the coordination of care and outcomes for people with cancer. The plan said in February 2015 that the pilot should lead to better symptom management, fewer emergency room visits and fewer unnecessary treatments. BCBST members, it says, will also have 24/7 access to a team of care coordinators trained to help manage their care plans and answer questions. BCBST serves more than 3 million members. Tennessee Oncology has more than 80 physicians in 30 locations across middle and southeast Tennessee. The provider group is one of the nation s leading teams of cancer care specialists, nationally recognized for improving patient outcomes and patient experience, says Clay Phillips, vice president of Network Innovation at BCBST. In 2014, Tennessee Oncology began using Via Oncology Pathways to help guide evidence-based treatment that incorporates personalized patient care. Tennessee Oncology directly licenses the Web-based decision-support software system from Via Oncology LLC, which is an affiliated company of the University of Pittsburgh Medical Center (UPMC) and the University of Pittsburgh Cancer Institute. The pathways originally were developed by oncologists at the UPMC CancerCenter and now cover more than 90 percent of cancer types and all major modalities and phases of care and [are] used by oncologists around the country, says the company s website. In our partnership, we aim to build upon that foundation by expanding the Via platform and adding additional care coordination, patient management and patient engagement tools to the overall technology suite, he told AIS in February Members Will Get Individualized Care The pilot, which launched in January 2015, aligns with BlueCross mission of Peace of Mind through Better Health, explains Phillips. Through the development of these new technologies around clinical pathways and care coordination, our members who are fighting cancer will be able to get the most individualized and best care possible. That means not only improving outcomes but also improving the patient experience during their treatment. By launching this targeted pilot, we will also impact medical spending through reduced variation, improved outcomes and deeper patient engagement. While some pathways programs focus on particular types of cancer, such as lung, breast and colorectal, The pathway identification process is not limited to certain types of cancer, Phillips clarifies. He adds that oncologists and clinical experts who are constantly reviewing the latest [evidence-based medicine] content available are responsible for developing the Via pathways. Evidence-based modification to a path-

88 84 AIS s Management Insight Series way is possible, but all pathways must be [National Comprehensive Cancer Network]- compliant, and provider groups must closely engage with Via to make any pathway modifications based upon specific data seen in their patient group. Phillips says compliance can be broken down into subgroups : the capture rate and the attribution rate. The capture rate measures the number of times that an oncologist uses Via during a target patient encounter. The attribution rate measures the number of times that a patient is assigned to a pathway. Obviously the capture rate would exceed the attribution rate, he says. There are situations where it would be medically necessary for a patient to go off pathway based upon the patient s medical history, current medication regimen or other clinical factors, he adds. In the short time since we launched the pilot, Tennessee Oncology is already exceeding the Via standard in both capture and attribution rates. They have also experienced early and meaningful physician buy-in, which is vitally important to the success of the program. According to Phillips, We could consider anything with a compliance rate above 80% a successful pilot. The pilot will include the group s patients at Saint Thomas West in Nashville. After six months, outcomes data for those patients will be compared with outcomes from patients of two other Saint Thomas facilities. We will be looking for improved patient outcomes, deeper patient engagement, more robust patient management and a lower cost delta associated with Via pathways and the patient engagement platform, says Phillips. This pilot is among others that BCBST is developing with providers and plans to launch in 2015 and 2016, Phillips says. A few that are currently active are focused on palliative care, diabetes and asthma. We intend to expand on our early pilot success and will continue to grow into other verticals.

89 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 85 Appendix C: CMS Oncology Care Model Documents Contents Oncology Care Model (OCM) Request for Applications (RFA) February 2015 I. Background/General Information... 3 A. Scope... 3 B. General Approach... 3 C. Deadlines for Letter of Intent and Application... 4 II. Description of the Oncology Care Model... 4 A. Purpose... 4 B. Model Overview... 5 C. Multi-Payer Structure... 5 D. Episode Definition... 6 E. Beneficiary Alignment... 7 F. Benchmarking and Risk Adjustment... 7 Calculation of Participant Savings... 7 Risk Adjustment and Outliers... 8 G. Model Payments... 9 Performance-Based Payments... 9 Performance Multiplier... 9 Per-Beneficiary-Per-Month Payment H. Risk Arrangements I. Monitoring and Reporting J. Evaluation K. Learning System Participation L. Interaction with Other Initiatives Medicare Shared Savings Program ACOs and Pioneer ACOs Transforming Clinical Practices Initiative (TCPI) CMS Quality Measures and Physician Quality Reporting System (PQRS)... 14

90 86 AIS s Management Insight Series Medicare and Medicaid EHR Incentive Programs M. Waivers N. Termination III. Eligibility Criteria for Practices and Payers A. Eligible Payers B. Eligible Practices IV. Practice Requirements V. Submission of Letters of Intent and Applications Questions VI. Application Review and Selection Process Appendix A: Components of the Institute of Medicine Care Management Plan Appendix B: National Cancer Institute Sample Patient Navigation Activities Appendix C: Preliminary List of Quality and Performance Measures Appendix D: Preliminary List of Chemotherapy Drugs Chemotherapy Drugs Possible Chemotherapy Drugs Appendix E: Driver Diagram... 33

91 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 87 I. Background/General Information A. Scope The Center for Medicare & Medicaid Innovation (Innovation Center) at the Centers for Medicare & Medicaid Services (CMS) aims to improve the effectiveness and efficiency of specialist care with an episode-based payment model for oncology care. More than 1.6 million people are diagnosed with cancer in the United States each year. 1 Approximately half of those diagnosed are over 65 years old and Medicare beneficiaries. Cancer patients comprise a medically complex and high-cost population served by the Medicare program. Through the Oncology Care Model (OCM), the Innovation Center has the opportunity to further its three-part aim within oncology care: better care, smarter spending, and healthier people. The Innovation Center is operating this model under the authority of section 1115A of the Social Security Act. This Request for Application (RFA) is directed to practices that provide oncology care as well as public and private health care payers. The Innovation Center hopes to engage at least 100 physician practices that, in aggregate, will furnish care for approximately 175,000 cancer care episodes for Medicare beneficiaries over the course of this 5-year model. B. General Approach The goal of OCM is to utilize appropriately aligned financial incentives to improve care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy. OCM encourages participating practices to improve care and lower costs through a model that incorporates a care coordination fee and episode-based payments. The Innovation Center expects that these improvements will result in better care, smarter spending, and healthier people. Practitioners in OCM are expected to rely on the most current medical evidence and shared decision-making with beneficiaries to inform their recommendation about whether a beneficiary should receive chemotherapy treatment. OCM provides an incentive to participating physician practices to comprehensively and appropriately address the complex care needs of the beneficiary population receiving chemotherapy treatment, and heighten the focus on furnishing services that specifically improve the patient experience and/or health outcomes. OCM is intended to be a multi-payer model that includes Medicare fee-for-service (FFS) and other payers. Payers and physician practices must separately apply to participate in OCM. Payers who participate share the Innovation Center s opportunity to improve care for their beneficiaries and realize cost savings while enabling practices to make broader changes. The Innovation Center expects the subset of OCM for Medicare FFS beneficiaries (OCM-FFS) may differ in certain model design aspects, such as selection of quality and performance measures, from OCM for beneficiaries of other payers (OCM-OP). However, OCM s approach to practice transformation as described in section IV. of this RFA will be consistent across payers. 1 American Cancer Society. Cancer facts and figures Available at:

92 88 AIS s Management Insight Series OCM-FFS incorporates a two-part payment system for participating practices, creating incentives to improve the quality of care and furnish enhanced services for beneficiaries who undergo chemotherapy treatment for a cancer diagnosis. The two forms of payment include a monthly per-beneficiary-permonth (PBPM) payment for the duration of the episode, and a performance-based payment for associated episodes of cancer care. The PBPM enhanced care management payment will assist participating practices in effectively managing and coordinating care for oncology patients, while the performance-based payment will incentivize practices to lower the total cost of care and improve care for beneficiaries during treatment episodes. C. Deadlines for Letter of Intent and Application All practices and payers who wish to apply for participation in OCM-FFS must first submit a non-binding letter of intent (LOI). LOIs for interested payers are due by 5:00 pm EDT on April 9, LOIs for interested practices are due by 5:00 pm EDT on May 7, LOI forms are available for download on the Oncology Care Model website at and should be submitted by to the Oncology Care Model inbox: OncologyCareModel@cms.hhs.gov. Practices and payers that submit timely, complete LOIs will be eligible to submit applications. All applications must be submitted by 5:00 pm EDT on June 18, Applications must be completed online using an authenticated web link and password, which will be ed to applicants upon submission of a complete LOI. Only those applicants submitting a timely, complete LOI will be eligible to submit an application. Templates of the applications are available for reference only on the Oncology Care Model website. Submission of the template versions of the applications will not be accepted. II. Description of the Oncology Care Model A. Purpose The overarching aims of this model are to improve health outcomes for patients with cancer, improve the quality of cancer care, and reduce spending for cancer treatment. We expect that physician practices selected for participation in the model will be able to transform care delivery for patients undergoing chemotherapy, leading to improved quality of care for beneficiaries at a decreased cost to payers. Through this care transformation, practices participating in OCM-FFS can reduce Medicare expenditures while improving cancer care for Medicare FFS beneficiaries. Participating payers will have the opportunity to further these goals for their own beneficiaries who are cared for by practices participating in OCM. The Innovation Center sees the following as key opportunities within OCM: Promote shared decision-making, patient-centered communication, evidence-based care, beneficiary access to care, and coordination across providers and settings. Reduce complications of cancer and cancer treatments, as well as associated costs, through advanced care planning, increased use of high-value treatments, and reduction of inappropriate payment incentives.

93 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 89 Collect structured clinical data and integrate clinical trial enrollment into processes of care to facilitate quality improvement and accelerate clinical research. Support the development and reporting of meaningful outcome measures. Develop and monitor refined approaches to care delivery, which may improve the research infrastructure (for example, by facilitating improvement in the quality of evidence for existing therapies). Encourage delivery of care in the lowest-cost medically-appropriate setting. Refine a value-based payment system that encourages team-based care and workforce innovation. B. Model Overview OCM is a 5-year model, beginning in spring 2016, that creates incentives to furnish efficient, high quality care by enhancing services for beneficiaries undergoing chemotherapy for a cancer diagnosis. Participants will be physician group practices (PGP) and practitioners in solo practice (collectively referred to as practices for the purposes of this RFA) that provide care for oncology patients undergoing chemotherapy for cancer. Selected practices must meet practice requirements and satisfy the model s quality and reporting requirements to be eligible for payments in OCM-FFS. The model emphasizes care coordination and enhanced patient care through practice transformation. Practices must meet certain requirements to participate in the model and to continue to receive enhanced payment for care of their beneficiaries, including effective use of electronic health records (EHR), 24-hour access to practitioners who can consult the patient s medical record in real time, comprehensive patient care plans, patient navigators, and continuous quality improvement. OCM offers practices the opportunity to improve the quality of care for their patients, lower costs, restructure their practice to provide more comprehensive care for oncology patients, and engage with quality and cost data that will inform their care redesign. As in all Innovation Center models, participants are expected to fully engage in learning and diffusion, evaluation, and monitoring activities. The Innovation Center would consider limited model design changes following the release of this RFA if the design changes are appropriate and operationally feasible, do not have budgetary implications, and align with the model s goals of improving quality and health while lowering the cost of care for oncology patients. In addition, as the OCM is developed, CMS may incorporate a variety of program integrity or other safeguards to ensure that the model does not result in program or patient abuse. C. Multi-Payer Structure The Innovation Center is interested in testing models that engage multiple payers. Medicare FFS payments constitute only a share of any provider s revenue. Involving other payers in the model offers the opportunity to transform care on a larger scale by creating broader incentives for care transformation at the physician practice level. On average, about 50 percent of oncology practices patients are Medicare beneficiaries. While this is a significant portion of oncology patients, aligned financial incentives that result from engaging multiple payers will leverage the opportunity to transform care for oncology patients across a broader population. Other payers would also benefit from savings, better outcomes for their beneficiaries, and information gathered about care quality. Payers who

94 90 AIS s Management Insight Series participate will have the flexibility to design their own payment incentives to support their beneficiaries, while aligning with the Innovation Center s goals for care improvement and cost reduction. In order to incentivize true practice transformation, payers are encouraged to include as many cancer types as possible. Priority will be given to payers that include cancer types that cover large majorities of beneficiaries. Other payers participating in the model could include commercial health insurers, as well as state Medicaid agencies. During the selection process, the Innovation Center will favor practices based on the level of participation with other payers that is reflected in the application. The Innovation Center will enter into participant agreements with physician practices. Other participating payers will enter into agreements with practices separately. Other payers must financially incentivize the same practice requirements as described in section IV. of this RFA. Financial incentives must be aligned with the payments in OCM-FFS in that the payments provide funding during the oncology episode for enhanced services (for example, advance payment or PBPM) and for actual performance (for example, retrospective lump sum or increased monthly payments). A multi-payer model has important implications for the geographical distribution of target payerprovider markets in the model. The level of participation by other payers and the geographic reach of payers that apply to participate in the model will drive the target markets of the model. OCM will proceed as a Medicare FFS-only model in some or all markets in the event that other payer participation is lower than expected. The Innovation Center will identify payers and enter into a Memorandum of Understanding (MOU) with each to promote proper alignment with OCM. D. Episode Definition OCM-FFS targets chemotherapy treatment of Medicare FFS beneficiaries during 6-month episodes. Episodes in OCM-FFS will initiate with either an initial chemotherapy administration claim or an initial Part D chemotherapy claim. Practices beneficiaries who do not initiate chemotherapy during the performance period will not trigger an OCM-FFS episode. OCM-FFS episodes include all Medicare A and B services that OCM-FFS beneficiaries receive during the episode period. Certain Part D expenditures will also be included. Services that OCM-FFS beneficiaries receive before the initial chemotherapy claim will not be included in the OCM-FFS episode. Cancer therapies that trigger an OCM-FFS episode are composed of a comprehensive set of chemotherapy drugs, including possible chemotherapy drugs. The possible chemotherapy categorization describes chemotherapy drugs that are often used to treat cancer, but may have other important indications, such as treatment of autoimmune diseases. The inclusion of these possible chemotherapy drugs in OCM-FFS is based on the assumption that such drugs are being used to treat cancer when provided to beneficiaries who have been diagnosed with cancer. Administration of chemotherapy or possible chemotherapy drugs to Medicare FFS beneficiaries with a cancer diagnosis will trigger an episode. The chemotherapy lists exclude topical formulations of the chemotherapy drugs as a trigger, such as fluorouracil cream, because the topical formulations do not require the intensive management associated with the systemic therapies. Hormonal therapies used for cancer are included on the chemotherapy list for OCM-FFS, and trigger episodes in the same manner as other chemotherapy drugs. Preliminary lists of chemotherapy and possible chemotherapy drugs are in Appendix D.

95 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 91 OCM-FFS episodes terminate six months after chemotherapy initiation, regardless of whether the beneficiary receives chemotherapy treatment throughout the 6-month period of time or for a shorter period. Beneficiaries who receive chemotherapy after the 6-month episode may initiate a new 6-month episode. Reinitiation of chemotherapy after a gap in administration within an episode does not trigger a new episode. E. Beneficiary Alignment Medicare beneficiaries must meet each of the following criteria to be eligible for OCM-FFS: Beneficiaries are eligible for Medicare Part A and enrolled in Medicare Part B Beneficiaries do not have end-stage renal disease Beneficiaries have Medicare FFS as their primary payer Beneficiaries are not covered under United Mine Workers Beneficiaries receive an included chemotherapy treatment for cancer under management of an OCM participating practice Beneficiaries enrolled in a clinical trial for which Medicare pays routine costs would be included in OCM- FFS. Additionally, beneficiaries included in other CMS programs and Innovation Center models, including Accountable Care Organizations (ACOs), Medicare Shared Savings Program (MSSP), and the Medicare Care Choices model (MCCM), are also eligible for OCM-FFS. The implications of beneficiary alignment with multiple initiatives are further described in section II.L of this RFA. Part D is not a requirement for beneficiary eligibility in OCM-FFS. If a beneficiary is not enrolled in Part D, the beneficiary will only initiate an episode if they receive Part B covered chemotherapy, and their benchmarked and actual expenditures will be based on only Parts A and B claims. OCM-FFS aligns eligible beneficiaries receiving chemotherapy to the OCM-FFS physician practice that is actively managing each beneficiary s cancer treatment. F. Benchmarking and Risk Adjustment Calculation of Participant Savings Risk-adjusted benchmark expenditures for each OCM-FFS participating practice will be calculated based on data from a historical baseline period. Benchmarking includes the following steps: 1. Group claims from the baseline period into episodes of care for all Medicare beneficiaries who would satisfy inclusion criteria for the performance-based component of the model. 2. Calculate total Medicare expenditures for each baseline period episode identified in Step Adjust total Medicare expenditures for each baseline period episode for geographic variation.

96 92 AIS s Management Insight Series 4. Stratify baseline period episodes by combinations of risk-adjustment factors and trend episode expenditures within each combination from the baseline period to the performance year based on average expenditure growth of non-participants. After assigning a benchmark episode expenditure to all performance year episodes, each OCM-FFS participant s total performance year benchmark expenditure will be calculated by first readjusting benchmark episode costs for geographic variation and then summing the adjusted benchmark episode costs across all performance year episodes at the participant. This risk-adjusted performance year benchmark expenditures would then be reduced by the set discount percentage (which would be retained as Medicare savings) to generate a target price. 2 Performance year actual expenditures for each OCM-FFS participant will be calculated by summing total Medicare expenditures (including PBPM payments) for all performance year episodes included in the performance-based component of the model, as described in section II.G. of this RFA. The difference between the target price and the performance year actual expenditures would represent the maximum performance-based payment that the participant could achieve (which may be adjusted by the performance multiplier, as described below). When participants have insufficient cases in the baseline period to calculate reliable target prices, the benchmarking methodology leverages regional or national data to increase precision. The Innovation Center also allows participating practices to elect to be benchmarked collectively (with cases pooled as though they were a single practice) to further increase benchmarking precision. Any participant may request to be pooled with other participating practices for benchmarking purposes. For the purposes of payment, pooled practices would indicate a single practice to receive performance-based payments on behalf of the pool. Payments or losses generated by an individual practice within a pool would be netted with those of other practices within the pool. Other payers are not required to use the same benchmarking methodology. They will be required to share the methodology they develop with the Innovation Center. Risk Adjustment and Outliers The model risk adjusts for factors that affect episodic total cost of care, increasing or decreasing the performance year benchmark expenditures based on risk-adjustment factors. Risk adjustment factors will be calculated based on historical claims data from both participants and non-participants. While the specific risk adjustment factors have not yet been finalized, factors under consideration fall into the following categories: Beneficiary characteristics, such as age strata or comorbidities Episode characteristics, such as whether an episode is the first for that beneficiary Disease characteristics, such as cancer type Types of services provided, such as provision of radiation therapy or initiation with an endocrine therapy The list above includes examples of possible factors and is not exhaustive. 2 The discount is 4 percent in the one-sided risk arrangement and 2.75 percent in the two-sided risk arrangement. See the Risk Arrangements section, II.H, for additional details.

97 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 93 Risk adjustment in the first model performance year will be based solely on information available in administrative claims data. The Innovation Center is soliciting information from OCM-FFS applicants, as a part of this RFA, about risk adjustment factors that are not captured in claims data, such as stage of cancer at diagnosis, and will consider collecting this information from participants during the early part of the performance period. The Innovation Center will then consider incorporating these factors into the risk-adjustment methodology in later OCM-FFS performance years. In addition to risk adjusting participant benchmarks, OCM-FFS mitigates risk by Winsorizing 3 the total Medicare expenditures within risk-adjustment categories. This minimizes the possible effect of extreme outliers. G. Model Payments Performance-Based Payments The standard Medicare FFS payments will continue during OCM-FFS episodes. After calculating the benchmark for each OCM-FFS participant, the OCM-FFS applies a 4 percent discount to determine the target price for the participant s performance period episodes. 4 OCM sets a target price for chemotherapy episodes, which includes a discount (representing Medicare Trust Fund savings). Practices generating additional reductions in expenditures under the target price will be eligible for a semi-annual lump-sum performance-based payment for up to the full difference between target and actual expenditures. These payments will potentially be scaled down by participant-specific performance multipliers that are based on achievement and improvement on a range of quality measures, described below in the Performance Multiplier section. To limit instances in which the Innovation Center attributes savings or losses to participants based on random variation rather than actual participant performance, performance-based payments will not be made on behalf of beneficiaries with low-volume cancers for which it is not possible to calculate reliable benchmarks. Analysis of Medicare Chronic Condition Warehouse (CCW) data shows that more than 75 percent of Medicare FFS beneficiaries who initiated chemotherapy in 2010 had one of eight cancer types breast, prostate, lung, colorectal, lymphoma, leukemia, ovarian, or pancreatic. The Innovation Center will expand this list of the highest volume cancers to cover at least 90 percent of Medicare FFS beneficiaries receiving chemotherapy, and will only make performance-based payments with respect to the treatment of Medicare beneficiaries receiving chemotherapy for one of these highest-volume cancer types. This list of high volume cancers will be available to selected OCM practices prior to entering into participation agreements. Performance Multiplier OCM-FFS adjusts performance-based payments based on the participating practice s performance on a range of measures reflected in quality score. OCM-FFS participants are required to collect data on quality measures that span several domains of patient care, including communication and care 3 Winsorization is a method of adjusting statistics by trimming extreme values in the data to reduce the impact of pronounced outliers. 4 The discount is 4 percent in the one-sided risk arrangement and 2.75 percent in the two-sided risk arrangement.

98 94 AIS s Management Insight Series coordination, person- and caregiver-centered experience and outcomes, and clinical quality of care. 5 Data will also be collected from administrative claims. The selected quality measures balance the incentives for cost reduction by ensuring that participating practices meet the model s outcome goals and the process goals of patient-centered, coordinated, and clinically appropriate care. Similar to other Innovation Center models, participant performance across these quality measures, as measured by achievement and improvement relative to either other participants or national benchmarks, will be transformed into weighted scores that are summed to calculate the performance multiplier. A practice must exceed a minimum quality threshold for the practice to be eligible to receive a performance-based payment. Quality measures are one key mechanism the Innovation Center uses to verify clinical improvements, assess patient health outcomes and appropriate coordination of care, and ensure continued quality of care for beneficiaries. The Innovation Center will provide selected practices with more information regarding the methodology for quality scoring before they enter participant agreements with the Innovation Center to participate in OCM-FFS. Appendix C of this RFA includes a preliminary set of quality measures that will be used for the performance multiplier in the performance-based payment calculation. The measures may change throughout the implementation period. Participants will be notified in advance of any adjustments to the performance measures. Per-Beneficiary-Per-Month Payment OCM-FFS practices will receive PBPM payments for beneficiaries with nearly all cancer types for each of the six months of the episode, even if the beneficiary does not receive chemotherapy for the duration of the episode. The monthly PBPM fee is intended to pay for the enhanced services driven by the practice requirements, aimed at transforming practices towards comprehensive, patient-centered, and coordinated care. The OCM PBPM is $160 per OCM-FFS beneficiary per month for the duration of each 6-month episode, and remains constant for the 5-year model. Practices are required to bill monthly for the PBPM payment for each OCM-FFS beneficiary using a HCPCS G-Code created specifically for this purpose. Through ongoing monitoring, the Innovation Center will ensure that the PBPM G-Code is used appropriately for participating practices and OCM-FFS beneficiaries, and will reconcile and recoup any inappropriate payments. Payments for services during the episode, including the PBPM payment, will be included in the performance-based payment calculations. A participating practice will not receive performance-based payments until reductions in expenditures below the target price exceed the amount of PBPM payments paid to the practice. Practices that do not qualify for a performance-based payment by the end of the third performance year would be removed from OCM-FFS. In the CY 2014 Physician Fee Schedule final rule with comment period, CMS created codes for separately billable chronic care management (CCM) services starting in CY OCM-FFS beneficiaries may be 5 These domains are National Quality Strategy (NQS) domains, domains which represent the Department of Health and Human Services NQS priorities for health care quality improvement. The full list of NQS domains is: Patient Safety; Person and Caregiver-Centered Experience and Outcomes; Communication and Care Coordination; Clinical Quality of Care; Population Health; Efficiency and Cost Reduction. 6 CY 2014 PFS final rule with comment period (78 FR , Dec. 10, 2013).

99 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 95 patients with chronic conditions that qualify for CCM services as defined in the Physician Fee Schedule. Since OCM practices receive a PBPM payment for OCM-FFS beneficiaries, physicians and non-physician practitioners (NPPs) that participate in OCM cannot bill for CCM services for the same beneficiary in the same month in which they receive a OCM-FFS PBPM payment. The Innovation Center will monitor claims data for OCM-FFS beneficiaries to determine if any OCM-FFS participants bill for CCM services during a chemotherapy episode in violation of the model rules. Non-OCM practitioners could bill for CCM services for an OCM beneficiary, including during months when participating practices are billing the PBPM, if the practitioner meets criteria for CCM services without considering cancer one of the qualifying diagnoses. H. Risk Arrangements OCM-FFS features two options for risk arrangements. The first is a one-sided risk arrangement for the duration of the model, in which any OCM-FFS participant that reduces expenditures below the target price will be eligible to receive a performance-based payment. If no reductions below the target price are achieved, then the practice will not be financially responsible for expenditures over the target price. Continued participation in OCM-FFS will be contingent upon qualifying for a performance-based payment by the end of the third performance year. The second track is a phased-in two-sided risk arrangement that features one-sided risk in the first two performance years and symmetric two-sided risk thereafter, which would require the participant to pay back expenditures over the target price. After year two, participating entities will be allowed to elect to switch between the two arrangements on a semiannual basis. The discount percentage for episodes in the two-sided risk arrangement is 2.75 percent, lower than the 4 percent discount in the one-sided risk arrangement, enabling participants to earn more money through performance-based payments. There is a maximum expenditure reduction percentage per practice that limits the amount of the performance-based payments. This is not meant to limit earnings by participating practices, but rather meant to provide a program safeguard to prevent practices from reducing care to unacceptable levels. The maximum expenditure reduction percentage is set at 20 percent of the benchmark before taking the CMS discount. A maximum loss percentage of 20 percent is also applied to the two-sided risk model as a stop-loss (such that participating practices are not required to pay Medicare back for losses over 20 percent). I. Monitoring and Reporting The Innovation Center will continuously monitor physician practices participating in this initiative to ensure that access to care and quality of care are not being compromised, that practices have built the capacity and infrastructure to deliver comprehensive oncology care, and that the Innovation Center is receiving data from practices demonstrating their engagement in continuous improvement. Practices are required to report data on OCM-FFS beneficiaries to the Innovation Center on a quarterly basis. To the extent possible, the Innovation Center will use existing data and reporting systems as part of its monitoring efforts, to minimize the reporting burden on practices, providers, and patients. Certain metrics, such as stage of cancer when diagnosed, are not collected on Medicare claims, but will be reported by the participating practices in OCM.

100 96 AIS s Management Insight Series Some measures tracked by the Innovation Center will be used to calculate a practice s performancebased payment. In addition, some metrics will be tracked by the Innovation Center for monitoring purposes that will not be incorporated in the calculation of the performance-based payment. See Appendix C for a preliminary list of measures. Monitoring includes, but is not limited to, the following activities: 1. Tracking of claims data to detect possible systematic stinting on care, and to profile characteristics of OCM-FFS beneficiaries (both process and outcome measures will be examined) 2. Patient surveys 3. Site visits to verify infrastructure improvements 4. Analysis of data reported by participating practices under the model for quality measurement 5. Annual reporting on use of model funds (through OCM PBPM and enhanced payments from other participating payers) and practice s own investments to implement infrastructure enhancements required for model participation 6. Annual time-and-motion studies to document practice staff time engaging in key modelrelated activities, including care coordination 7. Other activities, such as medical record audits and tracking patient complaints and appeals In order to inform the model s evaluation, baseline data on certain measures may be collected prior to model implementation. The Innovation Center will issue quarterly monitoring reports to OCM-FFS practices describing their performance on measures that will be used for monitoring purposes and the measures that will be used as part of the performance-based payment calculation. These reports can assist practices in continuous improvement and the most effective participation in the model. Payers that participate in OCM will provide practices with performance reports to assist practices in achieving the goals of the model. Other payers may collect and produce reports on a different set of measures. J. Evaluation CMS will contract with an independent evaluator to determine the impact of OCM-FFS on health outcomes, costs, quality of care, and patient experiences. The OCM-FFS evaluation will seek to provide rapid-cycle feedback that can be used by participating practices to improve operations during the course of model implementation. Participating practices must agree to cooperate in an independent formal evaluation of the demonstration by the evaluation contractor, including sharing program data and making relevant staff of participating organizations available for site visits and/or phone calls conducted by the Innovation Center and/or its contractor. Additionally, practice staff will be surveyed to obtain their reactions to OCM s implementation, how it has changed their approach to patient care, and their satisfaction with various aspects of the model. The evaluation will also include patient surveys to document patient experiences under OCM. Participating practices will be expected to assist in facilitating the survey process. All patient surveys will be strictly voluntary. The evaluation will involve analysis of both primary data collected under the terms of the model (which may include data collected for monitoring purposes, as well as evaluation-specific data), and secondary data such as claims and enrollment records. Both quantitative and qualitative analyses will be performed.

101 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 97 K. Learning System Participation The Innovation Center is utilizing a Learning System aimed at improving the likelihood of success to reinforce OCM 7. The OCM Learning System is a continuous process with two objectives: (1) support rapid learning and practice changes resulting in improved quality of care at lower cost; and (2) capture and spread operational learning emerging from the model and participating practices. The Learning System creates an environment of shared learning through a set of action-oriented learning and diffusion activities. Data reported by participating practices and collected from Medicare FFS claims will be used to monitor performance and to guide the learning community. OCM-FFS practices are expected to participate in the results-driven learning community comprised of both didactic and peer-based learning opportunities. The OCM Learning System supports participating practices efforts to transform their practice using rapid-cycle improvement methods guided by data. OCM Learning System faculty will work with practices to develop data-based case studies, which will identify successful approaches to further build and maintain excitement and engagement, reinforce the desire to change, understand best practices, and accelerate innovation and improvement. The pool of faculty will include subject matter experts and, importantly, the OCM practices themselves who will be working together to share and adapt effective models, and serve as peer-faculty for areas in which they have the strongest capabilities. Practices are expected to complete baseline assessment and periodic reports, which will provide data to analyze strengths and areas for improvement for achieving the OCM goals. Participating OCM practices will be supported through learning communities with: Topic-specific, action-oriented webinars facilitated by faculty and offering an opportunity for practices to learn from each other what is working to reach the program aims. Topic specific Action Groups in which practices work together in on-line communities to explore critical topic areas, new ideas and build capability to deliver comprehensive oncology care. In-person and virtual site visits to better understand how practices manage services, use evidence-based care, and practice patient-centered care. Use of an on-line portal to support learning through shared resources, tools, ideas, discussions, and the sharing of novel approaches supported by data. Virtual or in-practice coaching intended to support and offer strategies for overcoming barriers to improvement. 7 The OCM Driver Diagram can be found in Appendix E.

102 98 AIS s Management Insight Series L. Interaction with Other Initiatives Medicare Shared Savings Program ACOs and Pioneer ACOs While providers participating in a CMS model, program, or demonstration involving a shared savings component may not additionally participate in a Medicare Shared Savings Program (SSP) ACO, 8 participation in OCM would not preclude participation in an SSP or Pioneer ACO. As such, the potential for overlap between the OCM and SSP ACO or Pioneer ACO providers and beneficiaries exists. OCM-FFS, SSP, and Pioneer ACO payment methodologies will account for such potential overlap to ensure that shared savings and performance based payments are not made for the same savings for the same beneficiary. The OCM-FFS performance-based payments will be eligible for inclusion in SSP ACO and Pioneer ACO shared savings calculations. Neither SSP nor Pioneer ACO Model calculations will take into account OCM-FFS discount amounts, which represent Medicare savings. Thus, the Innovation Center will perform separate calculations to identify these amounts. If a portion of the OCM-FFS discount is paid out as shared savings to an ACO under SSP or the Pioneer ACO Model, the Innovation Center will recoup the portion from OCM participants who are part of that SSP or Pioneer ACO. Transforming Clinical Practices Initiative (TCPI) Contemporaneous dual participation in both TCPI and OCM would not be allowed. Participants must choose between participating in one model or the other. CMS Quality Measures and Physician Quality Reporting System (PQRS) OCM-FFS incorporates quality measures that address person- and caregiver-centered experience outcomes, communication and care coordination in its evaluation of practice performance. See Appendix C for a preliminary list of quality measures. A number of the quality measures that OCM-FFS may monitor and evaluate are PQRS measures, such as the Plan of Care for Pain and Pain Intensity Quantified (NQF #2100) measures. CMS plans to work with external stakeholders to identify a reasonable set of quality measures to ensure that a focus on quality of care is a primary consideration in the model. Medicare and Medicaid EHR Incentive Programs Participants in OCM must be committed to the effective use of health IT prior to participation. As part of OCM, participants must attest to meaningful use of ONC-certified EHR technology that will support Stage 2 meaningful use. 9 Eligible professionals who are part of OCM practices may be eligible to participate and receive the payments from the EHR Incentive Program if they meet the Incentive Program timeline, and may also be subject to downward payment adjustments under Medicare beginning in CY 2015 for failure to demonstrate meaningful use (b)(4)(A) of the Social Security Act 9 The Medicare and Medicaid EHR Incentive Programs provide incentive payments to eligible professionals, eligible hospitals and critical access hospitals (CAHs) as they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology. Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/ehrincentiveprograms/.

103 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 99 By the end of the first performance year, practices would be required to use certified EHR technology that can support Stage 2 of meaningful use. By the end of the first performance year, eligible professionals in the practice would be required to attest to Stage 1 of meaningful use, with the intention of attesting to Stage 2 of meaningful use by the end of the third performance year. The OCM requirements related to meaningful use may be updated to align with any future CMS modifications to the program. M. Waivers The authority for this model is section 1115A of the Social Security Act (SSA). Under section 1115A(d)(1) of the SSA, the Secretary of Health and Human Services may waive such requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii) as may be necessary solely for purposes of carrying out section 1115A with respect to testing models described in section 1115A(b). For this model and consistent with this standard, the Secretary may consider issuing waivers of certain fraud and abuse provisions in sections 1128A, 1128B, and 1877 of the SSA. Waivers of sections 1848(a)(1), 1833(a)(1)(N), and 1833(b) will be necessary in order to make the PBPM payments and performance-based payments out of the Part B Trust Fund. Waivers are not being issued in this document; waivers, if any, would be set forth in separately issued documentation. Thus, notwithstanding any other provision of this RFA, individuals and entities must comply with all applicable laws and regulations, except as explicitly provided in any such separately documented waiver issued specifically for OCM pursuant to section 1115A(d)(1). Any such waiver would apply solely to OCM and could differ in scope or design from waivers granted for other programs or models. N. Termination The Innovation Center may terminate the model or a practice s or payer s participation in the model at any point during the five performance years. Reasons for termination could include but are not limited to poor performance, non-compliance with the terms and conditions of participation, failure to qualify for a performance-based payment by the end of the third performance year, sanctions and other program integrity matters, or if otherwise required under section 1115A(b)(3)(B) of the Social Security Act. The Innovation Center will provide adequate notice prior to termination. Specific reasons and procedures for termination will be clearly outlined in the practice participation agreement and payer MOU. III. Eligibility Criteria for Practices and Payers A. Eligible Payers Payers may be commercial insurers, Medicare Advantage plans, states (through the Medicaid program, state employees program, or other insurance purchasing entity), Medicaid managed care plans, state or federal high-risk pools, self-insured businesses, or administrators of a self-insured group (Third Party Administrator (TPA)/Administrative Service Only (ASO)).

104 100 AIS s Management Insight Series To be eligible for OCM, payers must be licensed to sell insurance in the state or states in which they implement the model and in good standing with the health insurance regulator of that state or states. Self-insured businesses do not need to meet this requirement, but must comply with all applicable federal laws and regulations. To participate, payers must meet the following requirements: Operational Commit to participation in OCM for its 5-year duration, and start model performance period no later than 90 days after OCM-FFS performance period Sign a Memorandum of Understanding with the Innovation Center Enter into agreements with OCM practices that include requirements to provide high quality care Share model methodologies with the Innovation Center Provide payments to practices for enhanced services and performance as described in this RFA Quality Improvement Measures Data Sharing Align practice quality and performance measures with OCM-FFS, when possible Provide participating practices with aggregate and patient-level data about payment and utilization for their patients receiving care in OCM, at regular intervals B. Eligible Practices Physician group practices (PGPs) and solo practitioners that provide cancer chemotherapies and are currently enrolled in Medicare may apply for OCM-FFS. For OCM-FFS, the Innovation Center defines a PGP as a single legal entity operating primarily for the purpose of being a physician medical group and organized as a partnership, professional corporation, limited liability company, foundation, nonprofit corporation, faculty practice plan, or similar association. The single legal entity must employ or be owned by at least two physicians and/or NPPs. All physicians and NPPs in the PGP, as defined above, who prescribe chemotherapy for cancer are included in the PGP s participation in OCM-FFS. All physicians and NPPs within the PGP who prescribe chemotherapy for cancer must reassign their individual national provider identifier (NPI) to the PGP for billing purposes. Hospital-owned practices, including on- and off-campus provider-based departments, may apply to participate in OCM if the hospital is paid by Medicare under the inpatient and outpatient Prospective Payment Systems (PPS). However, as OCM is designed to primarily target transformation of

105 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 101 independent physician-led practices, priority will be given to non-hospital-based entities in the event that CMS receives many more applications from practices than can be accepted in the model. Practices owned by or formally affiliated with PPS-exempt cancer hospitals (section 1886(d)(1)(B)(v) of the Social Security Act) are not eligible to apply. Critical Access Hospitals, Rural Health Clinics, and Federally Qualified Health Centers also cannot apply. Additionally, PGPs that partner with these institutions for the provision of chemotherapy may not participate in OCM. Finally, Maryland hospitals participating in the Maryland All-Payer Model and any physician practice located in the state of Maryland are excluded. Applicants will be screened to determine an applicant s eligibility to participate in this model. In addition, CMS may deny an application on the basis of information found during a program integrity review regarding the applicant, its affiliates, or any other relevant individuals or entities. Applicants are required to disclose any sanctions, investigations, probations or corrective action plans that have been imposed on the applicant in the last three years. The Innovation Center will enter into participation agreements with each participating practice that will provide further detail about participation in the model. A practice may not participate without signing a participation agreement with the Innovation Center. Group or solo practices may apply to be grouped together with other practices for benchmarking purposes, but are individual participants in the model with individual agreements with the Innovation Center. 10 IV. Practice Requirements Participating practices must meet certain requirements to participate in the model and to continue to receive enhanced payment for care of their beneficiaries. All of the practice requirements must be met by the end of the first quarter of the performance period for a practice to maintain eligibility to participate in OCM. Practices must demonstrate their intent to meet EHR standards prior to participation, but they do not need to demonstrate that they have met the full requirement until the end of the first performance year. OCM practice requirements are as follows: 1. Provide and attest to 24 hours a day, 7 days a week patient access to an appropriate clinician who has real-time access to practice s medical records Participating practices are required to provide OCM beneficiaries with 24 hours/7 days per week access to a practitioner who has real-time access to patients medical records. This may be in the form of remote access, including telephone access. This allows the managing practice to better address patient needs related to chemotherapy treatment, including side effects, and potentially reduces utilization of the emergency department (ED). 2. Attestation and use of ONC-certified EHRs 10 For the purposes of payment, pooled practices would indicate a single practice to receive performance-based payments on behalf of the pool

106 102 AIS s Management Insight Series Participating practices must demonstrate an increasing commitment to using electronic health records (EHR) throughout the performance years. Prior to the start of the first performance year, participating practices are required to demonstrate their intent to meaningfully use EHR technology certified under ONC s HIT Certification Program. By the end of the first performance year, eligible professionals in the practice must attest to Stage 1 of meaningful use, with the intention of attesting to Stage 2 of meaningful use by the end of the third performance year. The OCM requirements related to meaningful use may be updated to align with future CMS rulemaking. The Certified Health IT Product List (CHPL) can be found at For resources regarding transitioning to EHR and demonstrating MU, consult Regional Extension Centers resources at 3. Utilize data for continuous quality improvement In order to promote and advance best practices, participating practices are required to collect and report data on several metrics. The Innovation Center will leverage claims data and the data reported by practices to provide actionable feedback in the form of regular monitoring reports to participating practices to support continuous quality improvement. Practices are also expected to utilize their own data along with the data in the monitoring reports to continuously improve their performance and achieve the goals of OCM. 4. Provide core functions of patient navigation Participating practices are required to provide the core functions of patient navigation for all OCM beneficiaries. A sample list of activities associated with patient navigation from the National Cancer Institute is included in Appendix B. 11 Practices should provide a written description in their application Implementation Plan for how they will meet these requirements. 5. Document a care plan that contains the 13 components in the Institute of Medicine Care Management Plan Participating practices are required to document comprehensive cancer care plans for all of the patients in the model. The care plans must include the 13 elements identified in the Institute of Medicine Report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis (see Appendix A). 12 Patients should be engaged in the development of a care plan, including the decision of whether to initiate chemotherapy as a course of treatment. 6. Treat patients with therapies consistent with nationally recognized clinical guidelines Participating practices are encouraged to consult and use nationally recognized clinical guidelines for OCM beneficiaries. Practices will report when care is either consistent with clinical guidelines of the 11 National Cancer Institute Center to Reduce Cancer Health Disparities. What are Patient Navigators? Available at: 12 Institute of Medicine Report. Levit L, Balogh E, Nass S and Ganz P, ed. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis

107 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 103 American Society of Clinical Oncology (ASCO) or the National Comprehensive Cancer Network (NCCN) or when care is not in accordance with these guidelines due to specific clinical decision-making for a particular patient. A patient s participation in a clinical trial may be one reason for deviating from clinical guidelines. V. Submission of Letters of Intent and Applications All practices and payers who wish to apply for participation in OCM-FFS must first submit a non-binding letter of intent (LOI). LOIs for interested payers are due by 5:00 pm EDT on April 9, LOIs for interested practices are due by 5:00 pm EDT on May 7, LOI forms are available for download on the Oncology Care Model website at and should be submitted by to the Oncology Care Model inbox: OncologyCareModel@cms.hhs.gov. Practices and payers that submit timely, complete LOIs will be eligible to submit applications. All applications must be submitted by 5:00 pm EDT on June 18, Applications must be completed online using an authenticated web link and password, which will be ed to applicants upon submission of a complete LOI. Only those applicants submitting a timely, complete LOI will be eligible to submit an application. Templates of the applications are available for reference only on the Oncology Care Model website. Submission of the template versions of the applications will not be accepted. Payers must submit their LOIs before practices to serve two purposes. The first is to allow the Innovation Center to determine the level of interest from payers and the geographic spread of the multi-payer model. The second is to publicly release information about which payers may participate in the model to inform prospective practice applicants. Information about which payers may participate may be useful to practices in determining whether to apply. The Innovation Center will publicly post the list of payers who submit LOIs and agree to public posting on April 16, 2015, and will post the list of practices who submit LOIs and agree to public posting on May 14, These lists will appear on the OCM website at Care/ to allow interested payers and practices to engage with one another and coordinate participation in OCM. The postings will include the names, locations, and points of contact for payers and practices. Complete payer applications will include: Signed Electronic Application Form Implementation Plan Narrative Complete practice application will include: Questions Signed Electronic Application Form Implementation Plan Narrative Financial Plan Narrative Diverse Populations Narrative Letters of Support from other payers or explanation of payer support, as applicable For questions regarding OCM or the application process, OncologyCareModel@cms.hhs.gov.

108 104 AIS s Management Insight Series VI. Application Review and Selection Process The Innovation Center will only consider applications for OCM-FFS from practices and payers that have submitted an LOI and application by the deadlines listed above. Each complete and eligible practice application will be reviewed by a panel of experts from the Department of Health and Human Services, as well as other experts in the areas of provider payment policy, care improvement and coordination, and oncology care. CMS will select practices and payers to participate in OCM from among the most highly qualified applicants. In the event that CMS receives many more applications from practices than can be accepted into the model, priority will be given to independent physician-led practices. In addition to the criteria outlined in Table 1, CMS will seek to have a representative sample of participants in terms of size, geographic location, and other characteristics. Practice application selection criteria are listed in the table below. The four selection criteria are worth a total of 100 points: Implementation Plan (40 points) Financial Plan (25 points) Participation with Other Payers (30 points) Diverse Populations (5 points) Table 1 includes the practice selection criteria and information to include in the practice application for each section.

109 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 105 Table 1: Practice Selection Criteria Selection Criteria Information to Include in the Application Points Implementation Plan: Include in the Implementation Plan Narrative: 40 Presentation of a Full description of the practice s implementation plan for the realistic, sound, first two performance years of OCM, including but not comprehensive OCM limited to: implementation plan Current uses of the following or other tools to achieve that is based on current better outcomes, better care, and reduced expenditures practice capabilities for Medicare FFS beneficiaries. The practice s plans to and addresses continue to utilize or make changes to utilize these and necessary changes to other tools for the first two performance years in OCMmeet OCM objectives. FFS to achieve the model objectives: o care coordination within the practice o care coordination with other health care providers o care coordination with relevant social services o patient navigator(s)/care coordinator(s) o extended hours o care plans o clinical decision support o compliance with ASCO or NCCN clinical guidelines o quality measurement and feedback o patient engagement o patient outreach and education o shared decision making, taking into account patient preferences o supporting health information technology infrastructure o other interventions Practice requirements in section IV. of the RFA that the practice already meets, and its plans to meet the other practice requirements in OCM along with the timeline for meeting each requirement, including changes in necessary workflow, creation of new partnerships with other entities (for example, hospitals, primary care practices, other specialty physician practices, etc.), hiring and training of appropriate personnel, extending hours of access to care, etc. The likelihood that the practice s implementation plan will achieve savings for Medicare within the practice s OCM-FFS beneficiaries.

110 106 AIS s Management Insight Series Selection Criteria Information to Include in the Application Points Financial Plan: Include in the Electronic Application Form: 25 Demonstration of practice stability and soundness, as well as presentation of a realistic, sound, comprehensive OCM financial plan based on expected financial resources to support the implementation plan. Participation with Other Payers: Demonstration of significant, realistic expected multi-payer participation in OCM covering a significant fraction of the practice s patients receiving chemotherapy. Presentation of practice revenue from all payers over the preceding three years. Include in the Financial Plan Narrative: Description of any known or expected changes to practice revenue during the OCM performance years. Full description of the practice s financial plan to support the implementation plan for the first two performance years of OCM, including but not limited to: OCM-FFS PBPM payments Expected OCM-FFS performance-based payments (not paid until approximately 18 months into the performance period), including an assessment of whether these are realistic Expected enhanced and performance-based payments from other payers Practice investments Other sources of revenue Include in the Electronic Application Form: Presentation of the practice s chemotherapy patients that will be included in the model through participation in OCM with Medicare FFS and other payers. Include Other Payers Letters of Support: Attach a letter of support from each payer, other than Medicare FFS, with which the practice is applying to participate in OCM. If the practice is unable to obtain a letter of support from a payer, provide a narrative justification for not including a letter of support, including an explanation of how the practice is pursuing participation with the payer and why that payer s beneficiaries should be included in the application. 30

111 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 107 Selection Criteria Information to Include in the Application Points Diverse Populations: Include in the Electronic Application Form: 5 Demonstration that the practice manages care for diverse populations and populations with limited access to health care services and has a realistic, sound, comprehensive OCM plan for engaging these populations to address their needs. Information about practice locations in a Health Professional Shortage Area (HPSA) Patient demographics Include in the Diverse Populations Narrative: The practice s plan to treat and engage diverse and/or underserved populations during the course of OCM The practice s plan to treat and engage dual eligible beneficiaries during the course of OCM

112 108 AIS s Management Insight Series Appendix A: Components of the Institute of Medicine Care Management Plan Patient information (e.g., name, date of birth, medication list, and allergies) 2. Diagnosis, including specific tissue information, relevant biomarkers, and stage 3. Prognosis 4. Treatment goals (curative, life-prolonging, symptom control, palliative care) 5. Initial plan for treatment and proposed duration, including specific chemotherapy drug names, doses, and schedule as well as surgery and radiation therapy (if applicable) 6. Expected response to treatment 7. Treatment benefits and harms, including common and rare toxicities and how to manage these toxicities, as well as short-term and late effects of treatment 8. Information on quality of life and a patient s likely experience with treatment 9. Who will take responsibility for specific aspects of a patient s care (e.g., the cancer care team, the primary care/geriatrics care team, or other care teams) 10. Advance care plans, including advanced directives and other legal documents 11. Estimated total and out-of-pocket costs of cancer treatment 12. A plan for addressing a patient s psychosocial health needs, including psychological, vocational, disability, legal, or financial concerns and their management 13. Survivorship plan, including a summary of treatment and information on recommended followup activities and surveillance, as well as risk reduction and health promotion activities Appendix B: National Cancer Institute Sample Patient Navigation Activities Coordinating appointments with providers to ensure timely delivery of diagnostic and treatment services 2. Maintaining communication with patients, survivors, families, and the health care providers to monitor patient satisfaction with the cancer care experience 3. Ensuring that appropriate medical records are available at scheduled appointments 4. Arranging language translation or interpretation services 5. Facilitating financial support and helping with paperwork 6. Arranging transportation and/or child/elder care 7. Facilitating linkages to follow-up services 8. Community outreach 9. Providing access to clinical trials, and 10. Building partnerships with local agencies and groups (e.g., referrals to other services and/or cancer survivor support groups). 13 Institute of Medicine Report. Levit L, Balogh E, Nass S and Ganz P, ed. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis National Cancer Institute Center to Reduce Cancer Health Disparities. What are Patient Navigators? Available at:

113 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 109 Appendix C: Preliminary List of Quality and Performance Measures Purpose Quality Domain Recommended practice requirement or quality measurement NQF #/ Federal Programs Source Percentage of beneficiaries who are treated with therapies consistent with nationally recognized clinical guidelines None Given Reported by Practice Provide and attest to 24 hour, 7 days a week patient access to appropriate clinician who has real-time access to practice s medical record None Given Reported by Practice Practice Requirements None Given Attestation and Use of ONC certified EHRs Participating practices must submit all quality measures required by the program team, including those for quality monitoring and performance-based payment listed below. None Given None Given Collected by CMS N/A Provide core functions of patient navigation None Given Reported by Practice Electronically document a care plan that contains the 13 components in the IOM Care Management Plan None Given Reported by Practice Number of emergency department visits per attributed OCM-FFS beneficiary per OCM-FFS episode (Risk adjusted) None Given National Claims Data Performancebased payment Communication and Care Coordination Number of hospital admissions per attributed OCM-FFS beneficiaries per OCM-FFS episode for (Risk adjusted) Percentage of all Medicare FFS beneficiaries managed by a practice who are admitted to hospice for less than 3 days in the last 30 days of life Percentage of all Medicare FFS beneficiaries managed by a practice who experience more than one emergency department visit in the last 30 days of life None Given National Claims Data #0216 National Claims Data #0211 National Claims Data Person-and Caregiver- Centered Experience and Outcomes Percentage of OCM-FFS beneficiary face-to-face visits to the participating practice in which there is a documented plan of care for pain AND pain intensity is quantified #2100/MU Stage 2, PQRS Reported by Practice

114 110 AIS s Management Insight Series Purpose Quality Domain Recommended practice requirement or quality measurement NQF #/ Federal Programs Source Score on patient experience survey (CAHPS as modified by the evaluation contractor) None Given Collected by CMS Performancebased payment Person-and Caregiver-Centered Experience and Outcomes Percentage of OCM-FFS beneficiary face-to-face visits in which the patient is assessed by an approved patientreported outcomes tool. This would include a minimum of the PROMIS tool short forms for anxiety, depression, fatigue, pain interference, and physical function None Given Reported by Practice Percentage of OCM-FFS beneficiaries that receive psychosocial screening and intervention at least once per OCM-FFS episode None Given Reported by Practice Percentage of OCM-FFS beneficiaries with least one palliative care consultation per OCM-FFS episode None Given Reported by Practice Mortality rates of OCM-FFS beneficiaries, risk adjusted None Given National Claims Data Number of emergency department visits per OCM-FFS beneficiary in the 6 months following the OCM-FFS episode None Given National Claims Data Number of hospital admissions per OCM-FFS beneficiary in the 6 months following the OCM-FFS episode None Given National Claims Data Quality Monitoring Communication and Care Coordination Number of hospital readmissions per OCM-FFS beneficiary during the OCM-FFS episode and the following 6 months Number of ICU admissions per OCM-FFS beneficiary during the OCM-FFS episode and the following 6 months #1789/ Hospital Inpatient Quality Reporting None Given National Claims Data National Claims Data Proportion of all Medicare FFS beneficiaries managed by a practice not admitted to hospice #0215 National Claims Data Proportion of all Medicare FFS beneficiaries managed by a practice receiving chemotherapy in the last 14 days of life #0210 National Claims Data

115 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 111 Purpose Quality Domain Recommended practice requirement or quality measurement NQF #/ Federal Programs Source Communication and Care Coordination Percentage of attributed OCM-FFS beneficiaries that receive a follow-up visit from the participating practice within 7 days after discharge from any inpatient hospitalization Percentage of face-to-face encounters between an attributed OCM-FFS beneficiary and a participating practice which include medication reconciliation None Given None Given National Claims Data Reported by practice Breast Cancer: Hormonal therapy for Stage IC-IIIC (ER/PR) Positive Cancer in OCM-FFS beneficiaries #0387/ MU Stage 2, PQRS Reported by practice Breast Cancer: Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1c, or Stage II or Stage III hormone receptor negative breast cancer in OCM-FFS beneficiaries #0559/ PPS- Exempt Hospital Reporting Reported by practice Quality Monitoring Clinical Quality of Care Colon Cancer: Chemotherapy for Stage IIIA through Stage IIIC OCM-FFS beneficiaries with colon cancer Colon Cancer: Adjuvant chemotherapy is considered or administered within 4 months (120 days) of surgery to OCM-FFS beneficiaries under the age of 80 with AJCC III (lymph node positive) colon cancer #0385/MU Stage 2, PQRS #0223/ PPS- Exempt Hospital Reporting Reported by practice Reported by practice Prostate Cancer: Adjuvant hormonal therapy for highrisk OCM-FFS beneficiaries #0390/ PQRS Reported by practice Percentage of OCM-FFS beneficiaries with documented ECOG, Karnofsky, or WHO performance status assessment prior to OCM-FFS episode initiation and at episode conclusion None Given Reported by practice Population Health Percentage of OCM-FFS beneficiaries that receive tobacco screening and cessation intervention at least once per OCM-FFS episode Percentage of OCM-FFS beneficiaries that have an Influenza Immunization #0028/ MU Stage 2, PQRS #0041/ MU Stage 2, PQRS Reported by Practice National Claims Data

116 112 AIS s Management Insight Series Purpose Quality Domain Recommended practice requirement or quality measurement NQF #/ Federal Programs Source Population Health Number of OCM-FFS beneficiaries enrolled in clinical trials at any point during an OCM-FFS episode None Given National Claims Data Prescription drug utilization under Medicare Part B and Part D None Given National Claims Data Radiation utilization by OCM-FFS beneficiaries None Given National Claims Data Quality Monitoring Efficiency and Cost Reduction Imaging utilization by OCM-FFS beneficiaries Post-acute provider utilization by OCM-FFS beneficiaries None Given None Given National Claims Data National Claims Data Therapy service utilization by OCM-FFS beneficiaries None Given National Claims Data Home health services utilization by OCM-FFS beneficiaries None Given National Claims Data

117 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 113 Appendix D: Preliminary List of Chemotherapy Drugs Chemotherapy Drugs Standardized Drug Active Ingredient Name ABIRATERONE ADO-TRASTUZUMAB AFATINIB ALDESLEUKIN ALTRETAMINE ANASTROZOLE ANTINEO, NOC ARSENIC TRIOXIDE ASPARAGINASE AXITINIB AZACITIDINE BELINOSTAT BENDAMUSTINE BEXAROTENE BLEOMYCIN BLINATUMOMAB BORTEZOMIB BOSUTINIB BRENTUXIMAB BUSULFAN CABAZITAXEL CABOZANTINIB CAPECITABINE CARBOPLATIN CARFILZOMIB CARMUSTINE CERITINIB CETUXIMAB CHEMO, NOC CISPLATIN CLADRIBINE CLOFARABINE CRIZOTINIB CYCLOPHOSPHAMIDE CYTARABINE DABRAFENIB DACARBAZINE DACTINOMYCIN

118 114 AIS s Management Insight Series Standardized Drug Active Ingredient Name DASATINIB DAUNORUBICIN DECITABINE DEGARELIX DENILEUKIN DOCETAXEL DOXORUBICIN ENZALUTAMIDE EPIRUBICIN ERIBULIN ERLOTINIB ESTRAMUSTINE ETOPOSIDE EXEMESTANE FLOXURIDINE FLUOROURACIL FLUTAMIDE FULVESTRANT GEMCITABINE GOSERELIN HISTRELIN IBRITUMOMAB IBRUTINIB IDARUBICIN IFOSFAMIDE IDELALISIB IMATINIB IPILIMUMAB IRINOTECAN IXABEPILONE LANREOTIDE LAPATINIB LETROZOLE LEUPROLIDE LOMUSTINE MECHLORETHAMINE MELPHALAN MITOMYCIN MITOTANE NELARABINE NILUTAMIDE NIVOLUMAB

119 Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 115 Standardized Drug Active Ingredient Name OBINUTUZUMAB OFATUMUMAB OLAPARIB OMACETAXINE OXALIPLATIN PACLITAXEL PALBOCICLIB PANITUMUMAB PAZOPANIB PEGASPARGASE PEMBROLIZUMAB PEMETREXED PENTOSTATIN PERTUZUMAB POMALIDOMIDE PONATINIB HYDROCHLORIDE PORFIMER SODIUM PRALATREXATE PROCARBAZINE RAMUCIRUMAB REGORAFENIB ROMIDEPSIN RUXOLITINIB SORAFENIB STREPTOZOTOCIN SUNITINIB TEMOZOLOMIDE TEMSIROLIMUS TENIPOSIDE THIOTEPA TOPOTECAN TOREMIFENE TRAMETINIB TRASTUZUMAB TRIPTORELIN VALRUBICIN VANDETANIB VEMURAFENIB VINBLASTINE VINCRISTINE VINORELBINE VISMODEGIB

120 116 AIS s Management Insight Series Standardized Drug Active Ingredient Name VORINOSTAT Possible Chemotherapy Drugs Standardized Drug Active Ingredient Name BEVACIZUMAB BICALUTAMIDE CHLORAMBUCIL DIETHYLSTILBESTROL EVEROLIMUS HYDROXYUREA INTERFERON ALFA-2B,RECOMB. INTERFERON, ALFA-2A LENALIDOMIDE LEUCOVORIN MERCAPTOPURINE METHOTREXATE MITOXANTRONE NILOTINIB PEGINTERFERON ALFA-2B RITUXIMAB TAMOXIFEN CITRATE THALIDOMIDE THIOGUANINE TRETINOIN ZIV-AFLIBERCEPT *For the purposes of triggering a chemotherapy episode, the list of chemotherapies excludes topical formulations, such as fluorouracil and tretinoin cream. **The possible chemotherapy categorization describes chemotherapy drugs that are often used to treat cancer, but may have other important indications, such as treatment of autoimmune diseases.

121 Appendix E: Driver Diagram Anthem s Cancer Care Quality Program: Pathways to Improve Care and Reduce Costs 117