p.1 American Society of Hematology - Webinar on the Oncology Care Model – Thursday April 9, 2015 Operator: Good afternoon and thank you for standing by. Welcome to the webinar for Medicare Oncology Care Model, What It Is and What It Means for Practice. During the presentation, all participants will be in listen only mode. If you would like to ask a question during the webinar, please use the chat feature located in the lower left corner of your screen. If you need to reach out to an operator at any time, please press *0. As a reminder this conference is being recorded, Thursday April the 9th, 2015. I would now like to turn the conference over to the moderators, Dr. Steven Allen, please go ahead. Steven Allen: Good afternoon, everyone. This is Steven Allen, I'm the associate chief at the division of hematology at the Monter Cancer Center, part of the North Shore-LIJ Health System. Thank you for joining us on today's webinar on the oncology care model and what it means for practice. This webinar will feature presentation by the team from the Center for Medicare and Medicaid Innovation that is charged with working on specialty care models and in particular in developing and implementing new oncology care models. This webinar is part of a series focused on the practice of hematology covering the issues related to payments and coverage, as well as the practical use of newly approved drugs. The learning objectives of this webinar are: To describe how payments and quality assessment work in the new oncology care model, and to provide practices with the resources to make a decision about participating in the oncology care model. [pause] Steven: Today's webinar will be approximately one hour in duration. I will begin with introductory remarks. This will be followed by a presentation from the team at CMMI. We will close with a moderated question and answer session. Patients with blood cancers are complicated. Everyone on this call knows the issues. Variable response rates to treatment, the side effects, the management of expectation. The complicated situation of these patients is in some ways maybe even more confusing by our rapidly expanding understanding of the genomic background of this diseases and the treatment pathways that are being opened by them. The rapid installing improvements in care for these diseases is something about which hematologists are incredibly proud. All of this made the members of the committee on practice somewhat wary when we first heard that CMMI was developing an oncology care model. We have too often seen that discussions on cancer reimbursement focus on the more common cancers such as lung and colon while ignoring p.2 the realities of blood cancer. We were concerned about how a model might affect specialized centers and whether patients might be put in a difficult situation. We were fortunate to be able to take those concerns directly to the architects of the model. Over a year ago, the committee began to speak to the staff at CMMI about where blood cancer stood in their thinking. While ASH is not endorsing this model, we do feel fortunate the staff at CMMI has been so open to our feedback. This webinar is yet another example of that openness. While our conversations have focused on the role of blood cancer, we know that few if any of your practices are restricted only to blood cancer. So we have asked CMMI staff to cover the model in its entirety. We ask those listening to consider this in the context of the larger payment reform that we're sure to see. While we do not know what will happen with the Oncology Care Model, we know that the pressure for increased accountability will not relax. At this point, I'd like to turn things over to Dr. Heidi Schumacher from CMMI to begin the presentation. Heidi? Heidi Schumacher: Hi, thanks so much, Dr. Allen. This is Heidi Schumacher. I am one of the folks from the CMS Oncology Care Model program team. I am joined by several of my colleagues here who will walk through a basic overview of the model and hope to address some of your questions and then look forward to hearing more of your questions towards the end. I will turn it over to Laura Mortimer. Laura Mortimer: Thank you, Heidi. Hello, everyone. My name is Laura Mortimer. I work on the Oncology Care Model team as well. I would like to thank, first of all, the American Society for Hematology for inviting us to present and for coordinating today's webinar. We're very excited to share the oncology model to all of you, and we look forward to answering your questions in the presentation. During this webinar we'll provide an overview of the Oncology Care Model, or OCM, for both payers and physician practices and also explain the application process. The OCM Request For Applications (RFA), Frequently Asked Questions (FAQs), and other model materials are all posted on our website, so please refer to those documents if you have additional questions following today's presentation. We'll also provide our contact information for the OCM team as well as that website address at the end of this presentation. Please do feel free to email our inbox anytime with questions. First some brief background on the CMS Innovation Center. The Center was established by the Affordable Care Act in 2010 to develop and test innovative healthcare payment and delivery models within Medicare, Medicaid, and CHIP. We work with a broad range of stakeholders to create, implement, and evaluate new models. We currently have dozens of models in progress and are beginning to scale our most successful ones in order to expand healthcare innovation that works. p.3 We promote all the priorities you see listed on the screen through our different models. The Innovation Center's payment models promote the broader Health and Human Services goals as recently outlined by Secretary Burwell: better care, smarter spending, and healthier people. Our models range in focus and scope and include Accountable Care Organizations (ACOs), primary care transformation, bundled payments, and now a new emphasis on specialty care. The center currently has two specialty care models in our portfolio, one for ESRD, and now one for oncology care. The specialty care model group at CMMI got significant input from many different stakeholders including patient advocates, physicians, oncologists, and payers after we shared our design paper publically last August. Since then we have worked with many different groups to incorporate feedback and fine tune the oncology model to best meet everyone's goals. And we look forward to continuing those conversations with our applicants and participants as we all work together over the next few years. CMMI chose oncology care as the next specialty model area for several reasons. First, and most importantly, cancer affects millions of American families. Over 1.6 million Americans are diagnosed with cancer every year, and nearly half of those patients are over 65 and Medicare beneficiaries. As you all know well, cancer is a complex disease that can be very expensive for patients and other payers. The Innovation Center sees a tremendous opportunity to promote its healthcare goals through an oncology payment model. OCM is a five year model that focuses on episodes of care. The goals of the model are to appropriately align financial incentives to improve care coordination, appropriateness of care, and access for beneficiaries undergoing chemotherapy. In the model these incentives encourage participating practices to work collaboratively to manage the complex needs of their cancer patients and to use services and treatments that have shown to improve health outcomes. OCM, as I said, is an episode-based model that defines episodes as six-month periods of care following the initiation of chemotherapy. There's no limit to the number of episodes that beneficiaries may trigger during the five-year model period. Practice transformation is really key to this model. So participating practices will engage in transformation to improve the quality of the care they deliver by meeting a defined set of OCM practice requirements which we'll talk about in a bit. Finally, OCM is a multi-payer model, meaning that commercial payers and others are invited to participate along with Medicare by aligning components of their payment models with the Innovation Center’s. By engaging other payers we increase the opportunity to transform care across a broader patient population by providing robust support to our participating practices. Participants in OCM are physician practices that are Medicare providers and furnish chemotherapy. We've received several questions so far regarding which physician practices may participate in the model, and in short we welcome and encourage all chemotherapy providers to participate, including those who practice at cancer centers. p.4 The main exceptions here are practices that are owned or formerly affiliated with PPS-exempt institutions (including PPS-exempt cancer hospitals, Critical Access Hospitals, and FQHCs), and that's due to differences in the payments for services. There is must more detail on eligibility in the RFA and FAQs, and we're happy to answer more questions at the end of the presentation about practice eligibility. A key feature of OCM is our practice requirements, as I mentioned. All practices are expected to engage in these requirements and in care transformation as demonstrated through this list, which I'll outline here. The first requirement is to provide patients in the model with 24/7 access to a clinician who has real-time access to those patients' medical records. Cancer patients’ complex medical needs don't arise during normal business hours. So we expect clinicians to be available to provide medical advice whenever patients need it. The second requirement is that practices must use an ONC certified electronic health record, and has passed the stage two of Meaningful Use by the end of the third performance year. As a step towards this goal, practices must attest to stage one by the end of year one. Please note that the Meaningful Use requirements may be updated based on future HHS rulemaking during the model. The third requirement is that practices must use data for continuous quality improvement. The Innovation Center will provide participating practices with quality and cost data throughout the model to aid in this improvement, and our Learning and Diffusion team will provide additional support services to practices including collaboration opportunities with other model participants. The model will also feature webinars to help practices analyze and utilize all the data that we provide to improve the quality of care they deliver. The fourth requirement is for practices to provide the core functions of patient navigation. Practices are required to provide patient navigation services to all patients in the model. You can find a sample list of patient navigation functions from the National Cancer Institute in an appendix of the model RFA. Participating practices are not required to hire additional staff to perform these functions. Next, practices must create a care plan for OCM patients that contains the 13 elements of the Institute of Medicine care plan. Patients should be actively engaged in creating this plan. Please again, see the appendix in the RFA for the specific components of this care plan. The final practice requirement is to treat patients with therapies consistent with nationally recognized clinical guidelines and to report which guidelines practices follow. If practices don't follow either NCCN or ASCO guidelines, then they must provide a rationale for not doing so. In addition to the physician practices, non-Medicare payers may also participate in OCM. From this point forward in the webinar we'll designate between OCM Fee For Service or OCM-FFS, and OCM for other payers. These other payers may include commercial payers, including Medicare Advantage plans, state Medicaid agencies, or other governmental payers such as TRICARE or state employee health plans. The main goal of including these payers in the model is to work with them to transform oncology care for patients throughout the broader population. p.5 We believe that a high level of collaboration between Medicare FFS and other payers will allow OCM to drive comprehensive care transformation and redesign at the practice level. To help practices and payers coordinate their OCM participation we'll publish a list of payers and practices who submit letters of intent to participate and agree to public posting on the OCM website. These lists will be posted one week after the respective payer and practice LOI submission deadlines. Payers will sign Memoranda of Understanding with CMS and are required to align with OCM FFS on several key features of the model. These alignment areas include participating in OCM for its full five years, implementing the same practice requirements as OCM FFS, and including a payment approach that uses both payments for enhanced services and for performance, the two prongs of OCM payment approach. Other payers must share their payment methodologies with the Innovation Center and share some aggregate level data that is collected during the model. The next several slides pertain only to OCM FFS, but not the other payer arm of the model. I'll refer to it as OCM, although other payer's models may share many of these same details and elements. The target population of OCM is Medicare beneficiaries who have Medicare FFS as their primary payer with both A and B coverage, and who receive chemotherapy treatment for cancer from a participating OCM practice. Additional details including some restricted patient populations are listed here in our RFA. We define episodes as six-month periods of care following the initiation of chemotherapy treatment for any type of cancer. A list of qualifying chemotherapy drugs is included in the RFA. OCM is a total cost of care model, meaning that the cost of all the Medicare A, B, and D services will be included in the cost of care of the episode. My colleague Dan will explain a bit more about OCM's payment methodologies in the next few slides. Beneficiaries may trigger more than one six-month episode during OCM's five year performance period depending on their treatment needs and timing. So for example, if a beneficiary triggers an episode by receiving chemotherapy on January 1, that episode will conclude on June 30th. If the beneficiary continues receiving chemo after June 30th, she would trigger a second episode. There may be breaks in between episodes if notes from the therapy services are furnished. Now I'll turn it over to my colleague Dan Muldoon who will discuss the OCM payment methodologies. Dan Muldoon: Thanks, Laura. I'm here to talk about the two-pronged payment approach that CMS will be taking in OCM FFS. The two high-level payment approaches include a payment for enhanced services (a per-beneficiary-per-month [PBPM] payment) and a payment for performance. The PBPM payment is a $160 monthly payment for the enhanced services required for participation in OCM, things like 24/7 access to a clinician that has access to the beneficiary's medical record, or the increased patient navigation services. p.6 Practices will be eligible to bill for this PBPM payment once per month for each of the months that a beneficiary is in an OCM episode (as long as he or she is not in hospice). The other part of our payment approach is the performance-based payment. That payment provides an incentive to improve the quality of care and to lower the total cost of care by coordinating care and providing patient navigation, by expanding access to clinicians outside of working hours, and by preventing unnecessary inpatient or emergency department visits. The performance-based payment will be a retrospective payment that we calculate by comparing the actual expenditures that occur during episodes against a target price that we calculate for each episode based on historical data, and then also how the practice performs on a range of quality measures. The benchmark or target price for the episodes will be calculated for each episode that occurs at a participating practice. We'll base that on historical claims data from beneficiaries receiving chemotherapy prior to the start of OCM. We'll group those claims into episodes, and then through all of that data, we'll adjust for geographic variation in Medicare pricing. Those benchmarks will be trended to the applicable performance period, and will be risk adjusted based on a variety of claims-based factors. Once we trend that to the performance period, we'll apply a discount. An example here, if the benchmark was $100, we would apply a discount of four percent, so that would represent savings to Medicare for that episode, and then come with a target price of $96. We would then look during an episode to see how much actual spending occurred, and then we would reconcile that against the target price. As an example, again: if the actual spending were $90 during an episode (versus a target price of $96), then the practice would be eligible to receive a performance-based payment of up to $6. Practices are eligible for up to the full amount of the performance-based payment depending on how they perform on quality measures. OCM-FFS also features two different risk arrangements, or tracks, that practices are eligible to choose. The first two years of the model for all practices will feature one-sided risk, in which participants are eligible for a performance-based payment if they reduce expenditures for episodes within a semi-annual performance period below their target prices, but are not responsible to pay Medicare back if actual expenditures exceed the target price. In the first risk arrangement option, practices can remain in the one-sided risk arrangement for the entirety of the model. In this risk arrangement, we take a four percent discount in the calculation of all target prices. Practices who elect for the one-sided risk option still must qualify for a performance-based payment by the end of the third year of OCM performance period. The other risk arrangement option is that practices can transition into a two-sided risk arrangement after the first two years of the model. In this arrangement, participants are responsible to pay back Medicare if actual expenditures during a performance period exceed that target price, again after netting out across all episodes that occur in a given performance period. To incentivize practices to make the transition into the two-sided risk arrangement, we would take a lower discount of 2.75 percent for Medicare . p.7 Such practices must still achieve the requirement of achieving a performance-based payment at least once prior to the end of the third year in order to remain in the model. Now, we'll talk a little bit more about how we're going to set benchmark prices. The benchmarking will be based on historical expenditure data. We'll be using those historical practice data, and then also regional or national data, as necessary, to increase precision. The reason for incorporating regional/national data is to be able to better identify the risk adjustment factors that have a predictive capacity for episode expenditures. As certain practices may have insufficient data to reliably determine which risk adjustment factors predict expenditure variability, we acquire additional data by utilizing claims from non-participating practices. We'll be using all this data in order to come up with a valid risk adjustment methodology. Once we risk adjust, we'll then trend into the applicable performance period. As mentioned before, that participants in the same risk arrangement all have the same discount. So practices in the one-sided risk get a four percent discount, and those in two-sided risk get a 2.75 percent. We'll also be including beneficiaries who are participating in clinical trials. They'll be included in OCM, and then also as part of the benchmarking process. Some details on risk adjustment: we haven't finalized the list of factors that we'll be using to risk adjust and are actively performing this analysis, and we'll be able to share more details as we have them. The possible risk adjustment factors include things like beneficiary characteristics. If there's a difference in the expenditure patterns by age, or by gender, versus cancer, those would be important features we'd want to capture. Also, the episode characteristics, such as whether the first episode represents the first line of chemotherapy, as opposed to a second or third episode, and potentially episodes that have occurred in different stages of the treatment that a beneficiary receives for their cancer. Cancer type disease characteristics will be important adjustment factors, also. Although, again, as you see, below, the risk adjustments will be limited, in the first year, to those factors that we can identify in historical claims data. That means that we'll have to wait, potentially until subsequent years to incorporate other factors that are not captured in historic claims data, such as cancer stage. We'll use those data to set more accurate benchmarks later on in the model. Now, I'd like to turn it over to my colleague, Andrew York, who will be discussing the quality measures that are included in OCM. Andrew: Thanks, Dan. Thanks, everyone, for giving us the chance to speak here today. I'm going to be talking about the monitoring and quality aspect of the model. As we've mentioned, because this is a two-part model, it's going to be important to document and measure quality as much as possible. Our quality strategy aligns with the overall CMS and the HHS Quality Strategy, and we intend ,as we’re able, to capture measures related to all six of the CMS quality domains. We are going to be collecting quality data from a number of different sources, including practice-reported data, Medicare claims data and patient surveys. Finally, we may be one of the p.8 first CMS models to collect clinical data, because we're going to be capturing cancer stage and other diagnostic information as part of this model. We tentatively decided to include a little over 30 quality measures, though most of those measures are claims-based and measure things like utilization. Eight of those measures are going to be used to adjust for performance-based payment, and the rest of those measures are going to be used for overall model monitoring. It's also important to note that this is a tentative list. We’re still seeking recommendations on these measures, including those that should be added or removed from both the payment portion or the overall monitoring portion of the model.. We will provide you with a final list of those quality measures before practices sign any formal practice agreements. Now, we will go briefly through these eight measures tied to the calculation of the performancebased payment. The ones that are going to adjust payment are going to be: 1) the number of ED visits per FFS beneficiary; 2) the number of hospital admissions per FFS beneficiary; 3) percentage of all Medicare FFS beneficiaries managed by the practice admitted to hospice for less than three days; 4) number of Medicare FFS managed in a practice who receive more than one ED visit in the last 30 days of life; 5) percentage of face-to-face visits with FFS beneficiaries in which a plan of care is documented for pain and pain intensity is quantified; 6) score on a patient experience survey; 7) percentage of face-to-face visits with FFS beneficiaries in which the beneficiary is administered an approved patient reported outcomes tool 8) percentage of FFS beneficiaries that receive psychosocial screening and intervention at least once per episode. These eight measures are going to be used to develop the performance multiplier. When Dan talked about performance-based payment being adjusted, it will be based on these measures. The way the performance multiplier is going to look is going to be very similar to what you'll see in the ACO and Comprehensive Primary Care Initiative models. The practice is going to receive a score on each payment-related measure, and that's going to be compared to national data, when available, to determine a percentile. That percentile will align with quality points. Then the quality points earned for each measure are going to be added up to create a total quality score. That quality score is going to mapped to a percentage of the performance-based payment. Again, the methodology is still under development, and will be finalized before practices sign final practice agreements. As I mentioned, the metrics that are not used in those top eight performance-based measures are going to be used for monitoring and evaluation. That's an important part of this model, because we want to see how the incentives in this model adjusts practice and changes practice patterns. p.9 We're going to be tracking things like claims data. We'll be using patient surveys to ensure that patients are still having a good experience. We're going to be doing site visits. We will be doing analysis of quality measurement data. We'll also be doing time and motion studies to see how staff time towards different activities changes over time. We'll also be doing medical record audits and tracking of patient complaints and appeals as part of the site visit element of the model. The model's also going to employ a non-randomized research design, used to match comparison groups, for detecting these changes in utilization, cost, and quality that can be attributed to the model. Another important aspect of all of the models here is at CMMI is the Learning and Diffusion aspect. We're trying to take lessons learned from this model and share best practices among the practices that are participating and practices that are outside of the model. Once we've learned about the successes of the model, we want to share that information. The other important thing to point out is that we want all of the practices that participate to be successful. We'll work through this Learning and Diffusion system to try to support practices, and to make sure that they're meeting all the requirements, providing high-quality care, and achieving success in this model. That support is going to come through the form of topic-specific webinars that allow participants to learn from each other. We also will have an online portal to support learning for shared resources, tools, and ideas, action groups, where groups can share ideas. Then finally, we will also have coaching to help practices overcome barriers to improving. One issue that's coming up more and more among the CMMI models is overlap with other programs. The Oncology Care Model can overlap with the shared savings programs. Practices that are participating in ACO or other shared savings models are allowed to participate in OCM. We're happy to go over the details of how that would work. The one model that practices are not allowed to participate in is the Transforming Clinical Practice Initiative. Practices would need to choose one model or the other. Finally, there are a number of management payments that are starting to come out of the Physician Fee Schedule, such as the Chronic Care Management and the Transitional Care Management codes. Practices and physicians who are in the model cannot bill those services for beneficiaries that are in the model. But other outside physicians are allowed to bill for those services if they're providing adequate management services. Again, if you have any questions about overlap, we're happy to provide any details. Now I'm going to turn it back over to my colleague Laura Mortimer to close up the presentation. Laura: Thank you, Andy. These final two slides are about the OCM application process for both payers and practices. This process has two parts, both of which are entirely electronic. The first is that applicants must submit electronic letters of intent or LOIs. The LOI PDF form can be downloaded from our website, completed electronically, and then emailed back to the innovation center as attachments. The payer LOIs, please note, are due today by 5:00 PM. p.10 The practice LOIs are due by May 7th. The Innovation Center, as we said, will publicly post the list of payers and practices who submit LOIs and who agree to public posting on our website. The payer list will be posted about a week from now. The practice list will be posted around May 14th. We post those lists so that payers and practices have a chance to coordinate their OCM participation prior to the application deadline. Practices are strongly encouraged to participate in OCM with multiple payers, to increase the opportunity for successful practice transformation. Practices will receive additional points in their application review for applying with multiple payers. Applicants who submit timely LOIs will then be sent an authenticated web link and a password with which to access and complete the electronic application. Application templates are now available on the OCM website for anyone to view. Please note that these are not actual applications, so do not submit these templates. They are for your reference only, so that you can prepare your application answers prior to receiving the actual application. Again, only applications submitted through the authenticated web link will be accepted. We've listed the major components of both the payer and practice applications on this slide. Please do note that practices will need to submit letters of support for all payers with whom they apply for OCM participation. Again, please reference all model materials on our website for additional details on the LOI and application process. That concludes our presentation. Now, we will turn it back over for questions. We thank you for the questions that you've submitted so far, and look forward to answering the ones that have been come in during the presentation. Moderator: Thank you very much. Once again, a reminder to the audience to utilize the chat boxes, submit your questions. We will address these during the question and answer session. We already have a number of questions, but please continue to submit your questions. To open up the questions, let me ask the CMMI team. In addition to traditional community-based practices, which hospital-owned practices are eligible to participate in this model? Katie Cox: Hi, this is Katie Cox. Hospital-owned practices or hospital-based practices are eligible to participate in OCM, as long as the affiliated hospital is paid by Medicare under the inpatient and outpatient Prospective Payment System. Similarly, practices that partner with a hospital for the infusion of chemotherapy are eligible to participate as long as the partnering hospital is paid on the IPPS/OPPS. We also go into detail and answer these questions really thoroughly in the FAQs document on the model website. Moderator: Thank you. Will practices be given access to claims information, so that they can know how much is being spent on patients and services? p.11 Dan Muldoon: We're still working through exactly what level of granularity we'll be able to share with practices and whether or not that will include access to the raw claims data. But we're actively engaged, trying to assess the variation in the capacity of different types of practices to handle different levels of data, be it in a processed report after CMS analyzes claims data, Excel spreadsheets, or access to the raw claims data. We're trying to assess that and then determine what combination of data and information from us will work the best for the most practices. That's something that we anticipate having more details about in the near future, but don't have a lot of detail at this point. Moderator: The model requires a palliative care consult. Is that performed by the oncologist him or herself, or do they have to get a formal palliative care consult from a specialist? Andrew York: This Andrew York. This is one of the measures still under development. It was proposed by a stakeholder group, and it's still being developed. The idea behind it was that someone other than the oncologist would have to provide that palliative care consultation, though it's something that we're still working through. There are some scenarios where you can see patients with very early stage cancer that may not necessarily need that palliative care consultation to begin with. The full definition of that measure will be provided to practices before the model starts. I also want to emphasize that this is still a tentative list, so you have the opportunity to provide feedback. There's a chance that this measure may not go forward, though it's currently under development. Moderator: There seems to be a lot of concern about expenditures and what is counted in the episode. Does the set of expenditures included in the episode include all Medicare expenditures or the cancer-related expenditures? For example, if you have a patient who has a stroke five months after chemotherapy treatment has ended, are those expenditures related to the stroke included? Dan Muldoon: This is Dan Muldoon again. Yes, we would be including those expenditures that were related to the stroke and all Medicare fee-for-service expenditures that occurred during the six-month period of time. To assuage concerns about those outliers due to having a stroke, a car accident, or an AMI, we're planning to implement a process called Winsorization, which is truncating expenditures at certain high and low levels. There we would look at the national distribution of episode expenditures that occurred. If perhaps the 95th percentile of episode expenditures for a given cancer type was $85,000, then once the episode expenditures exceeded that threshold, the practice would no longer be at financial risk for expenditures above that threshold. p.12 We would there use the national distribution of episode costs to determine those thresholds and then limit or fully relieve practices from bearing risks or expenditures outside of those thresholds. Moderator: Will there be any adjustments of these thresholds for the varying costs of drugs and treatments? New drugs come out to the market, sometimes with very high prices. Is there any accounting for that? Ron Kline: Good afternoon. This is Ron Kline. The issue of new technologies and specifically new medications has come up a lot. We are still working through a methodology here at CMMI to address that. Probably the most important thing for me to say is that it's definitely on our radar screen. We don't want to penalize a practice or a physician for providing state-of-the-art care to their patient. At the same time, we want to continue to incentivize efficient drug use. The answer is yes, we're aware of it, and no, we have no specifics at this time. Moderator: Another question. What about bone marrow transplant patients? Are they included in this model? Ron Kline: As Dan Muldoon mentioned, all costs that accrue to a Medicare beneficiary during that six-month episode will be counted in the model. That's the nature of the technology we have to use to look at expenditures. Bone marrow transplant patients are included in the model. We're currently working with ASH and some members of ASH to try to become aware of different criteria for bone marrow transplants so we can set the benchmarks appropriately. Heidi Schumacher: This is Heidi Schumacher. Keep in mind that any expenditures within an episode would only be counted if the episode were triggered by chemotherapy in an outpatient setting. Inpatient chemotherapy will not trigger an episode. It's only Part B or D chemotherapy that will trigger an episode. For example, if a patient were getting outpatient chemotherapy infused at the practice or hospital-based infusion center or self-administered Part D chemo, an episode would be triggered. If, then, within the subsequent six month episode, that patient went in for a bone marrow transplant, those costs would be included in that episode’s costs. Moderator: There's a big emphasis on compliance with national guidelines. How will practices demonstrate that they are meeting that requirement? Does that reporting have to be on each individual patient? Andrew York: This is Andy York. For the guidelines, this is going to be a scaled approach. What we're looking for in the beginning, until EHRs and our data collection tool are fully developed, is an attestation that the therapy that is being used is according to clinical guidelines, or to report why this patient is not receiving therapy according to guidelines. That's going to escalate over the course of the model. p.13 Once we move further into the model, we hope that practices will be able to report which guideline that they would be following, or document why they would not follow a guideline, within a portal system as part of our data collection throughout the model. Heidi Schumacher: I'll jump in to reiterate what Andy said. We expect folks to be able to report who is and is not on guideline. We also by no means want to give the impression that we expect every single person to be on guidelines. We recognize that there will be certain clinical situations, co-morbidities, et cetera, that render a patient inappropriate for a particular therapy on guideline. That's OK, but the goal, overall, is to say, "How can we move the cancer care delivery system more towards a consistent evidence base?" This is one piece of that. Moderator: In addition to intravenous chemotherapy, would all chemotherapy (including oral) be included in the model? Ron Kline: This is Ron Kline again. Oral chemotherapy will be included as a trigger and as part of the cost of the model. We have a fairly comprehensive list of chemotherapy that's in the RFA that people can look at. The question of non-chemotherapy agents, and there's overlap with some of the immunotherapies, will be addressed on a specific, case-by-case basis. Moderator: There's been some concern with financial effects on patients of the novel model PBPM/ care management payment. Would that affect the out-of-pocket costs for the patients in any way? Do they have to pay co-insurance? Laura: This is Laura Mortimer. You're referring to the per-beneficiary, per-month payment of $160 dollars, which practices will bill to Medicare, the same as they would bill any other fee-for-service claim. The answer to your questions is no. There will be no patient cost-sharing on those PBPMs, so no co-insurance or co-pays. Moderator: We've gotten one question wondering whether we're going to count only those ED visits and hospitalizations that are specific to cancer, or whether we'll monitor for any cause. Laura Mortimer: As others have said, all costs will be included in this total cost of care for beneficiaries during episodes. All of those costs that you mentioned, Heidi, would be taken into account for total cost of care. All ED visits and hospitalizations, no matter if cancer based or not, will also be included in the associated quality measurements. Moderator: Dan, I'll look to you for a couple of benchmark-related questions. We've gotten a couple questions on whether episode benchmarks will be specific to a given cancer type, or whether there will be one broad practice-specific benchmark. Dan Muldoon: We do envision making adjustments for different cancer types. There, we're working to identify how many cancer types we're able to construct credible benchmarks for. p.14 For beneficiaries with cancer types that have insufficient episodes in order to calculate a credible, specific benchmark, practices would still provide the enhanced services and bill for the PBPM. However, the practice would not be accountable for the total cost of care and wouldn’t be eligible for a performance-based payment for those beneficiaries. The expenditures associated with them would not cost against the practice, nor would the practice have a target amount for them. But, for the high-volume cancers -- breast, lung, leukemia, colorectal, et cetera – we would anticipate having sufficient volume to be able to make cancer-specific benchmarks. Moderator: Great, thanks. A follow-up question that another attendee asked was what historical period benchmarks will be based on, and whether they will be re-based or adjusted each year. Dan Muldoon: Thanks, Heidi. We haven't pinned down the exact historical period, but it'll probably be the three-year period for which we have complete data for all the episodes that initiated during that three-year period. That might look something like all episodes that initiated between 2012 and 2014 or mid-2012 to mid-2015, so three years, likely, worth of episodes. We'll go back to that period and group claims together into what would have been episodes of care, if the Oncology Care Model had been running, all the same inclusion/exclusion criteria for episodes, and then use that as our baseline. We don't anticipate rebasing (or changing) benchmarks as the model moves on but we will be trending those figures to the performance period. Those trend factors account for changes in expenditures and cost inflation that occurs between the baseline and performance periods. Moderator: One last question for you, Dan, and then we'll move on to some other folks. One person asked, "Will both risk arrangement tracks begin with one-sided risk and a four percent discount? Or will those that choose two sided risk do so from the beginning?” Dan Muldoon: All practices will be in one-sided risk (with a four percent discount) for the first two years of the model regardless of whether they elect to switch to the two sided risk track in the beginning of the third year of the model. Moderator: Andy, I'll look to you. A couple folks have asked some questions about the performance multiplier. We haven't finalized our methodology there but can you give a little bit more detail about how the performance multiplier might be structured? Andrew York: I apologize for not being able to provide more detail, although as you mention, our methodology is not yet finalized. Must a practice meet the threshold on all measures in order to qualify for the performance based payments? As it is now, we're not really looking at weighing any measure more than the others, although that is not necessarily confirmed. The total adjustment is going to be based on this overall quality score, which is going to be the quality points added up for each measure. p.15 Thus, a practice can fail to score well on one measure and still receive a performance based payment. We don't want you to lose your entire payment system because of shortcomings on one aspect of care. I hope that addresses some of the concerns of the group. Moderator: With all of these methodology questions, you hear us a lot of times say, "We're working on the methodology. It's not yet finalized." We currently understand that practices will want more technical details prior to signing formal model agreements. We do, of course, plan to provide much more technical detail, including all of the methodologies, prior to the point of agreements. Katie and Laura, I will look to you two for a couple questions about applications. First of all, someone asked if a practice has multiple sites, would they all enroll together and submit applications together, or would they submit separate applications? Katie Cox: Sure, this is Katie. Multiple sites under an applicant practice must all enroll if they're under the applicant TIN. A practice cannot select certain sites under their TIN to enroll in the model. However, if certain sites are under different TINs, and they wished to participate, those practices would need to apply separately. Thus, practices must submit one letter of intent and likewise one application for each TIN (or taxpayer ID number). There are options for practices to pool with other practices for purposes of benchmarking and performance payments, which we discussed a bit in the slides. I'm happy to talk in more detail about that if folks are interested. Moderator: Great, and then another application question. A couple of folks have written in wondering if they are able to apply and sign up later for the model or if this is the only application period. Katie Cox: This is Katie, again. This is the only application period. All interested practices are required to submit an LOI. Those letters of intent are nonbinding, but in order to be considered for participation in the model at any point, you must submit an LOI and then, following that, an application. There will not be a later period of application. As a reminder, the LOI due date for practices is May 7th. Applications are due June 18th. Moderator: If a practice does not submit an LOI, can it still apply for the model? Katie Cox: No, they cannot. Laura Mortimer: Just an added plug at the end here. Even if you're thinking about participating but aren't 100 percent sure, we strongly encourage you to submit a letter of intent. You can find the document for submission on our website. It really asks for very minimal information, mostly contact information and information about your locations. It's nonbinding but is required to apply to participate. p.16 Moderator: I'll take one last question that came in about when practices will be expected to sign contracts. We don't have an exact date, but it will likely be late this year, in preparation for the performance period beginning in spring of 2016. Steven Allen: That's perfect timing because our time is almost up. Thank you. As you sign off, you will be redirected to a brief survey. Please take a few moments to complete this. ASH greatly appreciates your feedback. Thanks, again, to our speakers for their excellent presentation and to the audience members for their attention.