America's healthcare system costs too much, not just for patients who become ill but also for medical students who must pay for their own training and oncology practices trying to navigate payment models that ask them to take on risk associated with the eye-popping costs of cancer drugs.

The major alternative payment model (APM) put forth by Medicare, the Oncology Care Model (OCM),

 doesn’t tell practices how they are doing until after the fact. This puts practices at risk for things beyond their control, said Barbara McAneny, MD, a New Mexico oncologist/hematologist who is the current president of the American Medical Association (AMA).

McAneny shared her diagnosis for the current crisis in US healthcare, as well as a prescription—a new real-time oncology payment model led by physicians&mdash;in her keynote address to attendees at Patient-Centered Oncology Care

 (PCOC) 2018, the annual meeting presented by 

, which took place November 16, 2018, at Sofitel Philadelphia, in Pennsylvania. 

Healthcare has reached a crisis point because payers are controlling the process and doctors are being driven away by administrative burdens and burnout, McAneny said. Medical education is extremely expensive, and young doctors enter professional life burdened with $200,000 or more in debt that limits their options. “We can’t afford to train someone for 10 to 12 years and then drive them crazy so they quit,” she said.

Yet, that’s what’s happening to so many physicians, and it’s contributing to physician shortages. “It used to be we had to push doctors out the door at age 70,” McAneny said. Now, too many get into their 50s and have had enough of the documentation burdens that today’s electronic health systems demand. As PCOC Chairman Joseph Alvarnas, MD, of City of Hope, would ask later in the day, “How do we get to a future that isn’t built on people working until midnight?”  

McAneny became well known for developing the COME HOME model at her New Mexico practice,

which saved $2100 annually per patient by prioritizing triage protocols, clinical pathways, same-day appointments, and better patient education—all with the goal of keeping patients out of the emergency department and avoiding hospital stays. “We created savings through the things that the doctors can control,” she said.

The OCM does much of this, but it adds features McAneny does not like. Although the model keeps people out of the hospital, it adds documentation that she finds burdensome.

“My [electronic medical record] is really good at managing patients one at a time,” but it is not as good at population health, she said.

But the bigger challenge is the way the model handles drug costs. McAneny said Medicare “lowballs” these costs, and the Indian Health Service, which covers many of her patients, is even worse.

Oncologists are put in the position of taking on risk and becoming miniature insurers, when they don’t have actuaries or reserves to predict who will come through the door, much less to absorb losses. As a result, more and more independent physician practices are being bought up by hospitals, which doubles the cost of care.

And who is making money? McAneny showed a slide that reported Anthem Blue Cross and Blue Shield reporting a record profit.

“Everybody is familiar with these stories, with what’s going on in oncology with the site-of-service differential,” she said, referring to reimbursements for care at a hospital versus a community oncology clinic. “It has to change. This cannot go on.”

If nothing changes, McAneny said, healthcare costs will crowd out everything else in the federal budget, and that will not be acceptable or sustainable. She pointed out incongruities in federal policy that will pay to amputate a foot for someone with diabetes but bankrupt a person who needed insulin that could have prevented that complication.

“What patients want is not healthcare, but health,” she said.

The AMA is pushing for changes that give physicians more control over healthcare, from rethinking medical education to putting doctors at the center of healthcare delivery. To that end, McAneny noted that CMS’ emphasis on the Medicare Shared Savings Program (MSSP), delivered through accountable care organizations, has never quite achieved what she managed to do with COME HOME.

Instead of $2100 in savings per patient, MSSP puts physicians through enormous expense and incon- venience to achieve $313.7 million in savings for CMS. “That’s a lot if you won the lottery but not if you’re running Medicare—$36 per patient is 1 office visit,” McAneny said.

In cancer care, McAneny and a coalition of oncology practices, called the National Cancer Care Alliance, have stepped forward with a different APM called MASON (Making Accountable Sustainable Oncology Networks),

 which seeks to create real-time quality measurement so that practices can respond to outliers and problems right away, not months or years after the fact.

The model “creates an accurate cost target that will be a valuable tool for optimizing patient manage- ment while avoiding actuarial risks of adverse patient clinical characteristics,” the proposal states. “Practices will be at risk only for factors they can control, thereby avoiding damage to the oncology care delivery infrastructure across the country.” The model will incorporate the multiple data points that bombard physicians today and allow for personalization based on patient characteristics. 

At the time of PCOC, McAneny was preparing to present the model to the Physician-Focused Payment Model Technical Advisory Committee (PTAC), which is empowered to approve doctor-driven payment models. On December 11, 2018, PTAC approved MASON by a 7-0 vote.

 But thus far, CMS has not approved any APMs that have been through PTAC.

If MASON succeeds, it will be a step toward letting physicians return to their core mission, McAneny said. “We need doctors and hospitals to take care of patients.”REFERENCES:

Oncology Care Model. CMS website. innovation.cms.gov/initiatives/oncology-care/. Updated January 4, 2019. Accessed January 6, 2019.

Barbara L. McAneny, MD, inaugurated as 173rd president of the AMA [press release]. Chicago, IL: American Medical Association; June 12, 2018. ama-assn.org/press-center/press-releases/barbara-l-mcaneny-md-inaugurated-173rd-president-ama. Accessed January 6, 2019.

The COME HOME model. COME HOME website. www.comehomeprogram.com/index.php/come-home-practices/. Accessed January 6, 2019.

Morse S. Anthem profits skyrocket 234%. Healthcare Finance News. healthcarefinancenews.com/news/anthem-profits-skyrocket-234. Accessed January 6, 2019.

MASON: Making Accountable Sustainable Oncology Networks. HHS website. aspe.hhs.gov/system/files/pdf/255906/ProposalIOBS.pdf. Published

	February 18, 2018. Accessed January 6, 2019.

Firth S. PTAC OKs new payment model for community oncology. MedPage Today website. medpagetoday.com/publichealthpolicy/medicare/76857. Published December 11, 2018. Accessed January 6, 2019.

Articles

Evidence-Based Oncology

The major alternative payment model  put forth by Medicare, the Oncology Care Model, doesn’t tell practices how they are doing until after the fact. This puts practices at risk for things beyond their control, said Barbara McAneny, MD, a New Mexico oncologist/hematologist who is the current president of the American Medical Association (AMA).

Keynote Speaker: AMA's McAneny Calls for Real-time Oncology Payment Model Led by Physicians

Keeping Ahead of the Curve in the Transition to Oncology Value-Based Payment

At a session of Patient-Centered Oncology Care

 panelists shared their views on the future of oncology value-based payment models and how they, as payers and providers, can help advance these models.

Moderator Joseph Alvarnas, MD, started the discussion by acknowledging how keynote speaker Barbara McAneny, MD, had laid out a framework of challenges in balancing value and sustainability with better outcomes and patient experience. He asked the panel about the definition of value-based care, which he called “part platitude, part wastebasket.”

Although value-based care is “a hodgepodge of models,” explained Samuel Young, MD, MBA, CPE, senior medical director, Medicare Florida Blue, its core intent is to improve patient health outcomes and quality of life for patients at lower cost. Marcus Neubauer, MD, chief medical officer, The US Oncology Network, agreed with that assessment and added that value-based care arose because the current fee-for-service system is unsustainably expensive. Neubauer sees CMS as the major catalyst for the conversion to the alternative of value-based care and said that The US Oncology Network supports being part of that transition.

Circling back to the meeting’s theme, Michael Ruiz de Somocurcio, MBA, vice president, payer and provider collaboration at New Jersey—based Regional Cancer Care Associates, said that value must have the patient front and center because improving quality of care is not simply about checking a box. Fortunately, taking patient-centered steps like keeping patients out of the hospital has a ripple effect that improves care quality and lowers costs.

Complicating the matter is that the goal of improved outcome is defined differently for each patient, added James Helstrom, MD, MBA, chief medical officer, Fox Chase Cancer Center. Cancer type and stage will determine whether a patient is concerned with quality of life or is just trying to attain survival. Young agreed that there needs to be a condition-specific approach to measuring cost and quality.

Another issue, according to Young, is that incentives are misaligned from the patient, payer, and provider perspectives. Commercial plans have members who frequently change jobs and plans, meaning they may not reap long-term financial benefits after paying the up-front cost of a treatment, but they still want providers to act in the best interest of their patients.

Doing the right thing for patients is what actually led physicians in The US Oncology Network to become interested in value-based care before it became “trendy,” said Neubauer. They recognize they have a responsibility to manage cost of care and are taking steps to do so, leading him to conclude that any efforts to change culture must be physician led.

Helstrom agreed about the importance of provider-led change, saying that edicts from administrators automatically engender resistance. He suggested that by keeping costs out of the discussion and simply encouraging administrators to do the right thing clinically, cost reductions would typically follow. Ruiz de Somocurcio added that value-based changes must also fit within physicians’ workflow and should optimally be supported by hiring nurses, social workers, or patient navigators to alleviate physician burden.

Another “tremendous hurdle” to broader adoption of value- based care is full data exchange and transparency, said Young, which is hindered by the limitations of electronic health records. Having fully transparent 2-way data exchange will not only allow physicians to compare their cost and quality metrics with their colleagues’, allowing their competitive natures to drive improvement, but also would enable consumers to choose their providers on objective performance measures instead of word of mouth.

A discussion about value in cancer care could not omit drug prices, as Alvarnas mentioned the expensive new treatments that are resulting in better outcomes but also skyrocketing costs. Neubauer explained the role of providers in controlling drug costs; although they cannot promise payers that they will not use checkpoint inhibitors, they can commit to using them responsibly and identifying patients who are not likely to benefit.

Ruiz de Somocurcio offered a different perspective, saying that a focus on other low-hanging fruits is more likely to yield savings than uncontrollable drug costs. His organization is looking into the use of new biosimilars but is also identifying cost-cutting methods like reducing emergency department visits, performing office-based imaging instead of hospital-based scans, and using pathways to reduce variation in care.

Bringing the conversation back to the theme of the meeting, Alvarnas asked how the panelists work toward including patient goals in the value equation. Neubauer explained that his system has implemented treatment plans to formally outline a road map before starting treatment so patients and care providers can refer to it.

“In our transition to value-based care, I’ve seen patient experience improve,” Neubauer attested.

From the payer perspective, Young explained that as a custodian of members’ health data, his organization has launched data platforms that give patients a “virtual care community” that ties together patients’ life plans with opinions from their family members, social workers, and other stakeholders, allowing the care provider to access all of that input and bring it into the care discussion.

“Ultimately, this falls on us to bring together all these information sources so that everyone can see what’s best for the patient,” he said.

When Alvarnas asked the panelists to provide their final thoughts, each of them agreed that the shift to value is not going away. Ruiz de Somocurcio emphasized that value is here to stay, giving the example of the mandatory radiation oncology bundles announced by HHS Secretary Alex Azar on November 8, 2018.

In terms of the larger shift toward value, Ruiz de Somocurcio said, “you don’t want to be last in line when that happens, so it’s time to do it now.”

Learning to Manage Data and Code for Comorbidities Is Critical for OCM Success

Caffrey M, Inserro A. Azar announces mandatory oncology payment model is coming. 

 website. ajmc.com/newsroom/azar-announc- es-mandatory-oncology-payment-model-is-coming. Published November 8, 2018. Accessed January 6, 2019.

Data is of critical importance in the Oncology Care Model (OCM)—and CMS shares a lot of data with participating practices&mdash;but managing that data and using it to improve performance can be challenging, according to panelists at Patient-Centered Oncology Care

Typically, data can be difficult to access and integrate, explained Charles Saunders, MD, chief executive officer (CEO) of Integra Connect. He explained that some electronic health record (EHR) systems are better than others at giving up data, but most systems are not very good at all. Sometimes this is because EHR vendors are purposefully uncooperative and do not want to share information, but EHRs also were not built with data sharing in mind.

Saunders said that most practices do not have any experience in managing or understanding Medicare data, which is fairly high in quality. Aaron Lyss, MBA, director, value-based care, Tenessee Oncology, added that managing data is one of the areas in which his organization has probably made the most progress.

“The volume of claims data that we get through OCM is certainly at the outset daunting, like drinking from a firehose, but over time it’s become an incredible asset to our organization,” explained Lyss.

Seeing and managing the claims data has given Tenessee Oncology a better understanding of policy issues of payment models and given the practice more confidence in participating in these models, Lyss said.

Rene&#769; Frick, senior director, network innovations and partnerships, BlueCross BlueShield of South Carolina (BCBSSC), noted that her company has a lot of claims information but that the payer is trying to integrate with practices to get clinical data and view the full picture of care. Another challenge is that even when the payer provides practices with data they seek, those practices do not always know what to do with the information to improve care.

BCBSSC has 8 practices participating in OCM, including Carolina Blood and Cancer Care (CBCC), where Kashyap Patel, MD, is the CEO.

One of the things BCBSSC has found is that patients are going outside their regular practices to the emergency department (ED). According to Patel, CBCC has been focusing on reducing ED visits, hospitalizations, and number of days in the hospital. Frick added that these are areas BCBSSC is looking at with most of its practices, because they are aspects the practices can control. These were some of the low-hanging fruits that CBCC focused on, and now it is focused on indexing comorbidities.

Recording morbidities and Hierarchical Condition Category (HCC) codes is crucial for success in OCM, explained Saunders. CMS sets the practice target price based on a risk model that includes HCC coding, but oncologists tend to undercode patients. Integra’s analysis found that in 27% of cases, oncologists were recording just 1 HCC code or comorbidity and that in 17% of cases, there were no HCC codes or comorbidities at all.

“That means in over 40% of the cases, it’s either 0 or 1, and for a [patient with] lung cancer who’s between the ages of 65 and 85, you know that’s not realistic,” Saunders said. “That means that their target price is set inappropriately low, so it’s not surprising they can’t achieve that target price.”

Patel said that his practice created small laminated cards that list the common comorbidities and HCC codes, and each physician was given multiple cards to keep in their coat pocket, at their house, in their office, and anywhere else. But it remains a challenge, he admitted. Every week, physicians in the practice meet and improve but will then start to forget to record the comorbidities. 

Doing a better job of coding is one of the many cultural changes required in OCM, the panelists agreed.

“I think the behavior change in physicians has been a chal- lenge,” Patel said. “I have to say my team is very well organized, very cooperative...but, including me, we have [been] programmed [and] we have to decondition ourselves and, really, recondition to look at this value-based care.”

At Tenessee Oncology, the practices show the physicians how they are all performing so there is transparency in the organization. For physicians who want to improve their performance, one-on-one meetings are available, Lyss explained.

“It’s kind of old-fashioned, but I think it’s worked well,” Lyss said.

Although Saunders acknowledged the cultural transformation that the practices represented on the panel had undergone, he noted that such transformation has been variable across the country. He outlined the difference between 1 practice with more than 200 oncologists that had been able to invest in infrastructure to achieve success and compared it with a smaller practice that did not have that capability and was so busy taking care of patients that the physicians could not become experts in Medicare or the model.

However, he also highlighted the differences Integra has seen between community-based and health system—based practices.

“Surprisingly, or maybe not surprisingly, the communi- ty-based ones are doing a better job of controlling the costs than the hospital-based ones,” Saunders said. “And we see ones [in which] there is a big difference between those that use organized care pathways [and] ones that don’t.”

The panelists concluded by discussing what is next in the OCM, which is scheduled to eventually shift to 2-sided risk. Originally, the model called for 20% downside risk, which is the stop-loss limit, but CMS recently brought the risk down to 8%. Although that is better for practices, Lyss said it was the difference between “completely absurd to 50% as absurd but still absurd.”

That said, Tenessee Oncology has been meeting frequently since CMS announced the change, and the practice believes that the economics of the new arrangement look better not just for Tenessee Oncology but for many of the practices. The organization has figured out that if it just matches its current perfor- mance, it will stand to do better in the 2-sided risk arrangement.

However, for many practices, the stop-loss adjustment is not enough, Saunders acknowledged.

“It’s still a level where if you really think your practice is going to get anywhere near that stop-loss, you’re not going to do that 2-sided risk arrangement,” he concluded. “It’s just a nonstarter.”

Updates on the Oncology Care Model from the Patient-Centered Oncology Care® meeting.

Oncology Payment Models

Lessons From a Texas Oncology Practice Within an Integrated Network

In the era of value-based care, community oncology practices are challenged to develop the infrastructure for quality reporting practices. How can practices do this and stay independent?

For 19 oncology practices across 17 states, the solution comes from being part of a clinically integrated network (CIN). The Quality Cancer Care Alliance (QCCA), which began with conversations in 2014, formally became a CIN in February 2018.

, the chief executive officer of a QCCA member practice, Barry Russo of the Center for Cancer and Blood Disorders in North Texas, described how this geographically diverse group of practices had come together around a common set of values, recognizing the need to work together to achieve the scale needed for CMS quality reporting programs.

The idea of a “super group,” Russo explained, would allow these practices to join forces for benchmarking, to share best practices, and to be served by committees covering education, data sharing, purchasing, research, quality, and value-based care.

“Each member is at a different phase of maturity in quality reporting,” he said, which pres- ents challenges but is also part of the point—for community oncology practices to survive, they must learn from others.

When members of the super group pull together data from across the network, “they are working to have the kind of data they need, and the business intelligence to foster a value-based environment,” said Russo.

One thing the QCCA collectively does is unravel contracts with electronic health record vendors that make it difficult or impossible for practices to get back their own data in a usable way for quality reporting purposes. “How do you not have access to your own clinical data? Believe it or not, there is a lot of this out there,” Russo said.

The QCCA also helps practices get both clinical data and claims data, which can inform a practice about a few different things. “In our practice, we noticed that patients with COPD [chronic obstructive pulmonary disease] had a lot of hospitalizations,” said Russo. In following up on these patients through the claims data, Russo and his colleagues realized “many of these people weren’t being seen by a pulmonologist.”

So, if these patients had breathing problems, “they just went to the emergency department [ED].”

Once the practice identified the 35% of their patients with COPD who were not seeing a pulmonologist, they made an effort to make referrals. The practice did the same for patients with congestive heart failure—the oncologists referred these patients to a cardiologist. “We wouldn’t have that information without the claims data,” Russo said.

Russo said most practices have had little or no experience with value-based care. “We needed to do a lot of education on what that meant,” he said. Launching quality reporting initiatives can be “time-consuming and costly, especially if the practice hasn’t invested in that at all.”

In some cases, technical hurdles were the challenge, but in others, there were emotional decisions, such as moving the entire network to a single group purchasing organization to save money on drugs. “These were emotional decisions at the grassroots levels of the practice, and the hurdles are often huge,” he said.

It became clear that that the legal structure of the CIN was essential. And that meant agreeing to defined initiatives: clinical pathways, triage pathways, data integration, research, analytics, quality benchmarks, and value-based programs such as risk assessment and member match, the latter being a tool to account for members who are in the ED or the hospital.

For Russo’s Center for Cancer and Blood Disorders, using clinical pathways was not much of a leap, as the practice had implemented pathways 13 years ago. “In today’s world, it surprises me that there are practices that have not implemented pathways,” he said.

A key step, however, was moving triage out of the chemotherapy area and putting it in administration. The practice had to create incentives to keep patients out of the ED so that triage became a quality indicator and did not consist simply of answering the phone.

So, what is the CIN accomplishing? Russo outlined several milestones:

; the rest have scheduled implementation.

compliance is mandatory across the CIN, as this is a key quality indicator.

Today, 90% of the member practices contribute to 

 for benchmarking and enrollment in future clinical trials. This has allowed talks with a manufacturer for a value-based contract for a specific drug.

 are under way for an artificial intelligence risk assessment tool that will include special pricing for members of the CIN. Practices that are in the CIN and also enrolled in the Oncology Care Model (OCM) through CMS are taking part in a Member Match pilot that identifies attributed patients who show up in the ED.

The risk assessment tool builds predictive models, including information that may seem to have little to do with a patient’s medical history—such as tax data&mdash;but is proving to be 100% correct in predicting which patients will be readmitted and highly predictive (89%) on which ones will be diagnosed with depression. The QCCA is still evaluating vendors for analytic and actuarial support, to offer the predictive tools needed for practices to take on risk, Russo said.

He spoke of the need to deal directly with employers, who are increasingly cost-conscious. “Seventy percent of the market is self-funded,” he said. “Many of them have purchased second opinion programs specifically related to cancer ... but many programs have low utilization.” Once patients enter a facility certified by the National Cancer Institute, where costs are higher, “they never leave.” Employers are asking if there are ways through value-based care “where the cost structure may be a little more reasonable,” noted Russo. Through the CIN, the practices of QCCA get the volume of data across a large geographic landscape and the support of established vendors for analytic support, the ability to take on 2-sided risk in the OCM, and perhaps the ability to join with another CIN while publishing meaningful data.

He said the CIN offers his practice the chance to stay independent while still “getting bigger” from the standpoint of having services at scale. Sharing information means knowing right away when new drugs come out, what a payer’s policy is, or how a patient’s genomic fingerprint affects what kind of therapy they should have. The physician can have this information immediately.

The bottom line, Russo said, is that “all this stuff has to happen at the point of care.”

QCCA evolves to become the first national clinically integrated network in oncology [news release]. Puyallup, WA: PRNewswire; February 21, 2018. prnewswire.com/news-releases/qcca-evolves-to-become-the-first-national-clinically-integrated-network-in-oncology-300602217.html. Accessed January 14, 2019.

Using Clinical Pathways to Improve Quality of Care, Prepare for Value-Based Future

During a session at Patient-Centered Oncology Care

panelists drew on their own experiences of utilization and innovation of clinical pathways and pushed back against criticisms about the systems.

Clinical pathways are not “cookie-cutter medicine,” said Robert Daly, MD, MBA, medical oncologist, Memorial Sloan Kettering Cancer Center, who explained that the idea behind pathways is not that they will cover all patients, but that they will be able to guide decision making for most of them. Daly added that many pathway vendors have different levels within the pathway that account for nuances and comorbidities, and this allows physicians to make alterations to the treatment plan.

“I don’t really see it as cookie-cutter medicine; I see it more as advancing quality of care by better understanding what is the best treatment for those patients at that particular point in time and understanding that not all patients will be able to go along those pathways,” he said.

According to Lawrence N. Shulman, MD, deputy director, clinical services, Abramson Cancer Center, University of Pennsylvania, clinical pathways have also been criticized as another unfunded mandate that creates more work for over-burdened faculty. But, he said, the faculty at the University of Pennsylvania Health System have embraced their clinical pathways, which members of the hospital system created themselves.

With the belief that the main goal of the clinical pathways process is to change the culture of healthcare delivery, the hospital system brought faculty members together to dig in to why they treat certain diseases the way they do. The faculty also reviewed recent literature.

Similarly, Levine Cancer Institute, part of Carolinas HealthCare System, also developed its own pathway system with input from the faculty. Meeting once a month, the faculty update the pathways and determine which practices are preferred and which are acceptable based on the parameters of the patient, explained Edward S. Kim, MD, chair, solid tumor oncology, Levine Cancer Institute.

An important aspect of the pathway system is that it’s nimble, Kim said. This allows for new drug and treatment information to be added quickly and seamlessly. He used the example of when there was a shortage of the chemotherapy etoposide. The faculty were able to quickly remove the drug from the pathway system so that a physician didn’t order it and then find out it was not available.

The University of Chicago Medicine uses Via Oncology’s commercial system, an acquired third-party vendor-implemented system, which lets physicians dip a toe into the water of pathways while also allowing for some customization, said Blase N. Polite, MD, MPP, associate director, Center for Clinical Cancer Genetics, assistant professor of medicine, University of Chicago.

All panelists agreed that the pathway systems brought attention to the heterogeneity of care happening among doctors and allowed for collaboration and consensus going forward. “I think what we’ve emphasized is, with growing networks, it’s unconscionable for us to put the University of Chicago brand in place in a suburb of Chicago, and then people come there and don’t get the same care” as in the city, said Polite. “It’s also a way of protecting and customizing your brand.”

Both Shulman and Kim pointed to their pathway systems as being empowerment tools for their healthcare system, particularly for physicians at community cancer centers. “At most of the community hospitals, our oncologists are general oncologists, and it’s hard for them to keep up in all the different diseases of the patients they treat, so the pathways have really been invaluable,” said Shulman.

The clinical pathways systems also allow community practices to offer precision medicine, said Kim. Within the Levine Cancer Institute’s clinical pathway system, there is an approved genomic test for solid tumors that allows any physician in the healthcare system to order the test.

In response to a question asking how to change physician culture from “all of us do this differently” to adherence to the pathways, Daly said that in an institution, it is essential to identify who the thought leaders are and get their buy-in. Once the leaders start using the pathway to improve care, it will disseminate, he said. If you rush the implementation without the buy-in, he warned, you risk the stability of the project.

Switching gears to alternative payment models (APMs), the panelists agreed that clinical pathways have the potential to prepare healthcare systems for a risk-bearing future.

“I’m a big fan of the value-based pathway concept,” said Polite. “Where pathways are right now, I think they’re in their infancy. But I do believe that they have the potential to be our answer to the drug utilization issue for all the APMs we’ve been discussing, because once you start incorporating value into it, you’re seeing that this is going to be the number-1 thing on the pathway because of what it does in terms of the total cost of care, efficacy, and toxicity, and you start driving decisions that way.”

He added that if CMS’ Center for Medicare & Medicaid Innovation wants healthcare systems to take on 2-sided risk, drugs need to be taken out of the model, and if drugs are taken out of the model, there needs to be an alternative: holding physicians accountable for utilization with pathways.

Updates on reporting otucomes and pathway design from Patient-Centered Oncology Care®.

Reporting and Design

Pharmacists Address Ways to Monitor Patients, Reduce Waste Through Medically Integrated Pharmacy Model

Pharmacists representing diverse health systems discussed their role in the transition to a medically integrated pharmacy model for oral cancer therapies at a session of Patient-Centered Oncology Care

Moderator Michael J. Reff, MBA, RPh, executive director and founder, National Community Oncology Dispensing Association, began by noting the geographical and system-level diversity the 4 panelists represented. He asked each person to discuss examples of progress and benefits of the medically integrated pharmacy model within their health systems, focusing on management of oral therapies for cancer.

Allison Trawinski, PharmD, MBA, specialty pharmacy manager and PGY1 community residency director, University of Rochester (UR) Medical Center, explained that integrating 6 clinical pharmacists integrated the clinic leads to more personalized services. Each patient has 1 dedicated pharmacist and 1 dedicated pharmacy technician, so patients know exactly who to go to when they need help.

For Neil Nebughr, RPh, previously at Utah Cancer Specialists, now associate director, Market Acces and Strategic Accounts at Sanofi, marker of success is simple: getting patients their medications. The practice sees 50% to 60% of the cases at its 9 locations, making it Utah’s largest independent oncology practice. It has worked with regional payers to help accomplish the goal of patient access.

Eileen Peng, PharmD, pharmacy manager and director, pharmacy services at Regional Cancer Care Associates, described how the community-based oncology organization created a collaborative pharmacy team to work with care providers, triage nurses, and patients to ensure safe, effective treatment.

According to Howard Cohen, MS, BSPharm, FASHP, director, oncology pharmacy, Smilow Cancer Hospital at Yale New Haven Health, the transition to a medically integrated pharmacy model came about when the academic health center realized it needed to better support its patients after discharge and throughout the entire care continuum.

“We’re dealing with hazardous medications,” Cohen said, referring to oral oncology therapies, “so we have to provide the same level of vigilance for those patients even though they’re transitioning from care to the home.”

When Reff asked about efforts to “go beyond the first fill” by extending continuity of care via a medically integrated pharmacy model, most of the panelists mentioned that the model helped them review each order and monitor each patient. Eventually, the pharmacists focused on following pathways based on clinical circumstances, not just filling prescriptions for the sake of filling them. They also described how medical integration allowed prescribers to quickly adapt dosing regimens to address any toxicities that might arise.

The experts stressed the importance of receiving buy-in from all stakeholders, including pharmacists, payers, and drugmakers. Trawinski described how the pharmacists in her system took the lead on creating treatment plans for the new and improved care pathways, which helped standardize care, and Nebughr said that the state pharmacy board and retail pharmacists came on board with the model because they saw that it resulted in high-quality care and filled an important need.

For Peng, information from the electronic health record (EHR) was crucial in getting payers to buy in to the integrated model. By showing payers data on how the pharmacists stopped unnecessary fills for patients on medication holidays or adjusted regimens for those who experienced toxicity, they proved to payers that “being able to give patients the best and the most appropriate treatment, safe treatment, improved outcomes,” she said.

“These are tremendous examples of leading institutions that are promoting this medically integrated pharmacy team model,” Reff said. “The benefits transcend all of the stakeholders but are centered solely on the patient.” By having the right systems and people in place to prevent unnecessary fills, he said, “you remove the cost and the toxicities, and you’re promoting a better collaborative relationship with the payers or employers.”

He asked the panelists to describe the major challenges they face with the integrated model and how these might change as cancer therapies evolve. According to Trawinski, the biggest barrier is access to medication, but the UR program has a leg up on the competition in the eyes of drug manufacturers: “[It’s] important to them that we have a fast turnaround time, that we have a lower abandonment rate, and that we’re able to manage [adverse] effects a lot faster and easier than the mail-order pharmacies.”

The discussion also covered the challenge of financial toxicity and obtaining assistance for patients, especially in light of diminishing foundation support. None of the panel- ists had easy solutions for this issue; Peng noted that her staff spends more time getting financial support than providing clinical services. Nebughr said that Utah Cancer Specialists has doubled the number of employees who help with obtaining financial assistance. However, he said, a benefit of the medically integrated pharmacy model is that if a patient cannot afford a certain medication, their provider will be informed right away and can choose an alternative therapy.

Cohen reported that capturing prescriptions is a challenge for organizations that are spread out across a state, but being medically integrated and having a single EHR helps address that challenge. After creating a pathway for oral chemotherapy treatment plans, Smilow Cancer Hospital implemented a system that automatically sends each prescription order to a basket, after which they are reviewed by a clinical oncology pharmacist for clinical appropriateness and then sent to their specialty pharmacy.

“In doing this, we’re able to capture those prescriptions, and we’re able to monitor those patients whether the patient gets that prescription filled or not at our site,” he explained.

Reff summarized, based on the panelists’ stories, that if a pharmacy wants to become medically integrated, it must leverage the power of the EHR—otherwise, it’s no better than any other pharmacy. Leveraging that internal power, he said, is “critical to elevating our collective games to tell a story of quality and value.”

The Doctor as Patient: Life During and After CAR T-Cell Therapy

For 38 years, Brian Koffman, MDCM, DCFP, DABFM, MS Ed, was a family physician—caring for patients young and old, rich and poor, and, as he wrote in his blog, “those with poor health choices and health fanatics, many omnivores and a few fellow vegans, professional athletes, weekend warriors, and couch potatoes.”

For nearly 4 years, he wore a second hat—that of chief medical officer and executive vice pres- ident of the nonprofit CLL Society.

 It’s a job he never expected to have but one he embraced after founding the group following his own diagnosis with chronic lymphocytic leukemia (CLL) in 2005. In December 2018, Koffman gave up private practice to focus on the CLL Society full-time.

A month prior, he shared with the audience at Patient-Centered Oncology Care

 what it was like to be a doctor who was also a patient, and no ordinary one at that. Koffman was the 37th of 40 patients in a clinical trial at the Fred Hutchinson Cancer Research Center in Seattle, Washington, where he received treatment with an experimental chimeric

antigen receptor (CAR) T-cell therapy developed there in collaboration with Juno Therapeutics (since acquired by Celgene and, in turn, Bristol- Myers Squibb).

For Koffman, CAR T-cell therapy has meant a complete change of fortune. “I had every bad marker in CLL,” he said, outlining his journey with a very aggressive form of cancer, including a trial and ultimate failure on ibrutinib. “If you look at the data, I’m supposed to have been dead 10 years ago.”

Koffman likened both the process of getting treatment and its effects to “the worst flu you could get.”

When the treatment is first administered, it seems very “anticlimactic,” he said. But then, the waiting begins, and patients know they are anticipating the flu-like symptoms to appear to show that the cancer cells are being attacked.

Things can turn ugly quickly, Koffman said. He stayed in a hotel near Fred Hutchinson and was hospitalized twice, and his wife intervened when the cognitive effects left him unable to make decisions. Admittedly, for a physician, that was tough.

He doesn’t sugar-coat the ordeal that CAR T-cell treatment is, but afterward, “I was in the deepest remission you could possibly get,” he said.

“Does that mean I’m cured? We don’t know.”

Because the inflammatory response of the therapy, cytokine release syndrome (CRS), can be so severe, patients receive cardiac and psychological screening before the expensive therapy is administered (approved products cost as much as $475,000 for just 1 dose of the treatment). A caregiver is required; Koffman’s wife saw him through stretches where he experienced neurotoxicity so severe, “I [believed I] was in some museum in [Washington State’s] Olympic peninsula, talking to monks in caves.”

Therapies are now available to reverse some of the harshest effects of CRS, Koffman explained. Also, he said, scien- tists now understand that they can tone down the blast of T cells that patients receive without losing the treatment’s effect. “There used to be some hesitance,” he said. “There is less hesitancy now. You don’t want to lose the patient to save the cure.”

At one point, Koffman developed an arthritic condition and had to go through physical therapy to regain his strength. But it was worth it.

“CAR T-cell therapy is not a wimpy therapy,” he said. “The adverse events I wouldn’t wish on anybody, but they’re almost always reversible.” And, unlike with transplants, there is almost no graft-to-host response.

Physicians are making progress in stratifying who will have the harshest CRS responses and learning to prevent them (results of studies presented in December 2018 at the American Society of Hematology meeting showed that using ibrutinib with CAR T-cell therapy can miti- gate reactions).

 As his life returned to normal, Koffman turned his attention to sharing his experience with other physicians and patients. He even served as a coauthor on an article about his own case.

 Through the CLL Society, he travels to meet with patient groups and has set up a program by which patients who don’t live near a major academic center can consult with experts remotely.

He has spoken with officials at CMS, where reimbursement for CAR T-cell therapy remains unresolved and means some children in Medicaid with acute lymphoblastic leukemia cannot gain access to treatment.

Right now, “hospitals are losing money doing this therapy,” he said. “This [therapy] is game-changing. Prices will come down as more people enter the market.”

Koffman B. Closing one door, opening another. Learning from and about cancer (chronic lymphocytic leukemia or CLL). CLL Society website bkoffman.blogspot.com/. Published December 12, 2018. Accessed January 15, 2019.

CLL Society website. cllsociety.org/. Accessed January 15, 2019.

Juno Therapeutics highlights progress with best-in-class strategy in B-cell malignancies at ASH [news release]. Seattle, WA: BusinessWire; December 6, 2016. businesswire.com/news/ home/20161206006261/en/Juno-Therapeutics-Highlights-Progress-Best-in-Class-Strategy-B-Cell. Accessed January 15, 2019.

Pagliarulo N. Bristol-Myers’ gamble on Celgene pipeline products. BioPharma Dive website. biopharmadive.com/news/ bristol-myers-gamble-on-celgene-pipeline-prospects/545244/. Published January 4, 2019. Accessed January 15, 2019.

Columbus G. Ibrutinib/CAR T cell combo active in CLL. OncLive® website. onclive.com/conference-coverage/ash- 2018/concurrent-ibrutinib-and-cd19targeted-car-tcell-therapy-shows-early-tolerability-high-orr-in-cll. Published December 2, 2018. Accessed January 15, 2019.

Chung SH, Hughes G, Koffman B, Turtle CJ, Maloney DG, Acharya UH. Not so crystal clear: observations from a case of crystalline arthritis with cytokine release syndrome (CRS) after chimeric antigen receptor (CAR)-T cell therapy [published online October 5, 2018]. Bone Marrow Transplant. doi: 10.1038/ s41409-018-0357-4.

Therapeutic updates from Patient-Centered Oncology Care® 2018.

Therapeutics

Barriers to the Future of Oncology Value-Based Care Are Complex but Can be Overcome

At the 2018 meeting of Patient-Centered Oncology Care

, panelists looked to the future and offered predictions on the path of oncology value-based care.

Moderator Joseph Alvarnas, MD, of City of Hope began by listing some words and phrases that stood out to him, representing important ideas during the day’s presentations: practice transformation, data, risk, scalability, patient experience, burdens versus rewards. “If we’re going to create a future system that makes sense, we’ve got to address all these things at some level,” he said, “or we end up with a system that’s not even a partial fix to the issues we face today, much less those that will come tomorrow.”

He turned to the conference’s keynote speaker, Barbara L. McAneny, MD, president, American Medical Association, for her thoughts on the first element of practice transformation and where she foresees it heading.

Foremost on her mind, she said, was the “alarming” trend of oncology practice acquisitions by health systems, plans, or investors that are more focused on profits than on patient care. This threatens the sustainability of independent practices, which she considers the most high-quality, cost-effective site of service. On a more specific level, McAneny spoke of the need for CMS and other payers to understand that “transformation takes time and money and a significant amount of effort” and that more patience might be warranted when evaluating restructuring efforts.

Alvarnas picked up on something McAneny mentioned—“there is a cost to getting this right that involves investment”&mdash;and asked panelist Michael Kolodziej, MD, FACP, vice president and chief innovation officer, ADVI Health LLC, how to bring physicians into the transformation without imposing unbearably high costs of time and burden on them.

Kolodziej offered that it’s important to “recognize that technology has to be an enabling tool, as opposed to an impediment.” He said that this became especially clear to him as he heard the grievances of his wife, who is an oncologist, when her practice migrated to a new electronic health record (EHR) system. He also spoke of a need to standardize processes—beyond EHR systems&mdash; to improve care and “use technology and data to understand the optimal way to treat each individual patient.”

He added that he thinks these efforts will largely be funded by the private sector, not by physicians, and that reaching the goals of value-based oncology will require some big changes, both in terms of payment models and the amount of attention it gets in Washington, DC. Most of the focus is on drug prices, Kolodziej said, not more specific issues, such as the unintended consequences of a Competitive Acquisition Program, which could be an alterna- tive to the buy-and-bill system of acquiring Medicare Part B drugs in cancer care.

For a different perspective on the investments needed to provoke transformation, the conversation turned to Brian Loy, MD, physician lead, oncology, laboratory, and personalized medicine, Humana. He explained that as a payer placing bets on solutions to a problem, he sees opportunities for a variety of stakeholders, including employer groups, to assign themselves roles and determine how to pay for new models of care. Otherwise, he said, it’s like “delivering furniture to someone’s new house when they’re still pouring the foundation.”

As the only nonphysician on the panel, Christian Downs, JD, MJHA, executive director, Association of Community Cancer Centers, offered his view on the barriers to success under the Oncology Care Model (OCM). Considering the tremendous amount of work invested by the Center for Medicare & Medicaid Innovation to launch and maintain the model, as well as the time put in by physicians responding to OCM requirements, he is not convinced that improvements in experience have been worth this amount of effort, he said. In addition, he sees the need for reforms that cut across disciplines and look at the total cost of cancer care instead of breaking costs down by specialty.

Another barrier, according to McAneny, is the head-spinning rate of change in value-based care models like the OCM. “People invest in this, and they create relationships with payers and with other physicians, and they restructure their practice, and then before we even have time to see whether it’s going to work, we are already rearranging it to the next flavor of what the value-based care will be,” she said. “We need to have the ability to have some time to actually see if something works before we change the rules of the game the next time around.”

It’s also a challenge for physician practices to balance the demands of Medicare and commercial payers. “Everyone has different quality measures, different pathways, different values. We have to get some consistency, because otherwise physicians feel like they have 50 people shouting their priorities at them every day,” McAneny said.

In discussing how to fix these problems, Kolodziej called CMS “the natural convener” because it has the bulk of patients and drives much of the healthcare conversation, but he worried that the lessons learned and potential achievements would be drowned out by political considerations. Loy added that many of the steps toward improvement in oncology consume time and resources and require finesse, such as shared decision making, patient value discussions, and advanced care planning.

Circling back to the discussion about burdens on physicians, Downs voiced concerns about rates of burnout and stress on physicians in cancer care workforce. With every new payment model announced, he said, he fears that more older oncologists will lean toward retirement and more medical school students will choose other specialties.

Alvarnas proposed a hypothetical for Kolodziej: If he could magically transform himself into CMS Administrator Seema Verma or HHS Secretary Alex Azar, what would he do? Though Kolodziej quipped that he’s not interested in that hypothetical, he offered a suggestion of increasing transparency and dialogue between healthcare delivery professionals on the front lines and the decision makers within the federal agencies and commercial payers. He also said that CMS should sit down with the tech industry more than it already has in its efforts to regulate telemedicine and health information technology.

“We’re not going to get anywhere unless we can really adopt a collaborative approach to this,” Kolodziej warned, and he reminded all stakeholders to keep in mind the goal of giving the best care possible no matter where a patient lives. “Irrespective of how sophisticated the doctor is in that area or what kind of support the hospital system is given, irrespective of all that stuff, we want to make sure that we don’t have a 2-tier delivery system.”

Finally, Alvarnas asked the panelists to channel their inner psychic and predict if these issues will have been solved 10 years from now. Downs thought that things will have improved, although not achieved perfection, helped in part by the technology that is being developed now “from a data standpoint, particularly around social determinants of health and risk stratification,” he said.

Loy concurred that social determinants of health are an important frontier that will be more fully explored, and he posited that the healthcare system must find sustainable ways to finance new technologies.

Kolodziej’s answer was succinct and not entirely optimistic: “We will deliver much better, much more personalized care to our patients irrespective of where they live, but we will still not know how to pay for that care.”

In McAneny’s view of the future, as we cope with the current funding crisis, we will see “the pendulum swinging back from aggregation into some disaggregation, so that we recognize that healthcare is local and that we build new structures” for sharing data and best practices.

“I’m an oncologist, so I’m an optimist,” she concluded. “I think that we will pull it together and come up with a system where we’re delivering healthcare to everybody at an affordable manner, because we have to, and we will have tried everything else first.”

Alvarnas concluded the session by thanking the panelists and tying their discussion back to the name of the conference.

What Oncology Care Management Means to Providers, Patients

“What was so inspirational is that the conference is called the Patient-Centered Oncology Care

Various stakeholders discuss the future of oncology care at the Patient-Centered Oncology Care® meeting. 

Editor’s Note: After this issue went to press, Wes Hall passed away February 20, 2019, after living more than 5 years with stage IV stomach cancer. He was active in the Community Oncology Alliance Patient Advocacy Network and supported participation in clinical trials.

Patient-Centered Oncology Care 2018

Keynote Speaker: AMA's McAneny Calls for Real-time Oncology Payment Model Led by Physicians

Oncology Payment Models

Reporting and Design

Therapeutics

Looking Ahead

AJMCtv® Interviews, PCOC 2018

Mergers, New Locations for Care, and the Oncologist