Bruce Feinberg, DO, vice president and chief medical officer for Cardinal Health Specialty Solutions, recently chaired a discussion centered on the flurry of megamergers in healthcare: Walmart and Humana, Aetna and CVS, Cigna and Express Scripts, and Amazon and PillPack.

Panelists Michael Kolodziej, MD, FACP, an oncologist who is now vice president and chief innovation officer with ADVI Health; Dana Macher, senior vice president at Avalere Health; and Mark Soberman, MD, MBA, FACS, medical director of the Oncology Service Line and physician executive at Monocacy Health Partners, Frederick Regional Health System, discussed these developments and what they mean for cancer care delivery, in light of pressures on the oncologist at the practice level.

Kolodziej offered background on how the 1980s and 1990s brought the early waves of change to oncology, as practice management companies sought to help physician groups bring economies of scale to their business operations, as well as assist in dealing with pharmaceutical companies. The “bigger is better” concept began to prevail, even before the pressures of the 340B drug discount program—which Macher said brought a whole new set of challenges.

Soberman noted that the model changed on the pharmaceutical side as well. Research and development, once done all in-house, now occurs in small biotechs that take on the early risk before being acquired by larger companies.

The nature of today’s consolidation is different, Macher said. “A lot of that was horizontal,” she continued. “Now, we’re looking at a very different type of consolidation...with a lot of vertical integration going on.”

Goals have changed, too, Soberman said. The first wave of managed care in the 1990s was strictly about cost containment, and “there was not a lot of emphasis on outcomes and on quality of care.” Health systems are now doing what the practice management companies once did: looking for ways to find savings and do things differently, even if it is not within the hospital walls.

The Shift to Quality and Vertical Integration 

Today’s emphasis on outcomes will manifest itself in a host of ways, from where care takes place to breaking down barriers be- tween retail and healthcare functions. Kolodziej said payers realize there is only so much money to be made managing claims—and Macher agreed, costs themselves must come down. The difference today is that data can reveal how to do this.

“The big driver now, in terms of why it’s happening more, is that we have the capability. We have the data that are driving these mergers and acquisitions,” she said.

Models like Geisinger—fully integrated payer and provider systems&mdash;are pointing the way for others. Although the Department of Justice (DOJ) rejected mergers of the largest national payers&mdash;Anthem and Cigna, Aetna and Humana&mdash; because these deals would deplete choice in certain markets, the DOJ has allowed recent vertical deals to go through. The panelists generally thought the recent megamergers made sense.

Soberman called the Amazon—PillPack deal “brilliant,” and Feinberg noted the obvious need for Amazon to gain pharmacy licenses in all 50 states to realize its ambitions of becoming an online pharmacy.

Kolodziej liked the merger between Walmart and Humana as it brings together a retailer that is already in the pharmacy space with a payer heavily invested in Medicare Advantage. He sees opportunities for in-store chronic disease care, where nutritionists can assist clients with healthy food shopping. Plus, Walmart is accessible in states with high rates of chronic disease. “As somebody said to me once, there are many places in America where Walmart is a heck of a lot closer than your doctor’s office,” he said.

Macher noted that the Express Scripts and Cigna deal made more sense after Express Scripts severed its relationship with Anthem, which is now building its own pharmacy benefit manager (PBM). Kolodziej, who previously worked for Aetna, said CVS was always the PBM of choice for that payer, so this merger makes sense. Soberman said he is watching the situation with UnitedHealth and Optum, and Feinberg agreed, adding, “I’ve heard rumors they’re not going to be in the payer business much longer.”

As these transactions unfold, Kolodziej said 2 things are essential to make them work: (1) attention to outcomes and (2) attention to cost. Soberman said large employers are finally starting to create innovative contracts around these bottom lines, and Feinberg agreed that employers “are going to be the catalyst that’s going to push this forward.”

Kolodziej said physicians and oncologists in particular are “intimidated” by the prospect of a merger between Aetna and CVS (the American Medical Association opposed it), because they believe it “is going to do nothing but empower the health plans to exercise increased leverage over their day-to-day life.” Soberman pointed out the transaction is dwarfed by Medicare, which already has great power over the lives of physicians, and Feinberg wondered aloud what will come of the effort by Berkshire Hathaway, Amazon, and JP Morgan Chase, who have engaged Atul Gawande, MD, MPH, to design a joint venture to shake up healthcare.

However, Soberman said it is more important to pay attention to the direct contracting relationships happening between Home Depot and Cleveland Clinic for heart surgery, or MD Anderson and other employers for specialty cancer care. Feinberg was not so sure—he said employers have been pretty unwilling to directly manage costs, save for few, such as Boeing.

Although the panelists agreed the jury was still out on the venture between Berkshire, Amazon, and JP Morgan Chase, they wondered whether the midsize employers—those with 5000 to 10,000 workers who Feinberg said pay for 60% of healthcare in the United States&mdash;would ever exercise leverage over costs. Kolodziej said most rely on third-party consultants or administrators, but innovators like Amazon could change things.

Integrated Delivery Networks and the Oncology Care Model

What makes a hospital an “integrated delivery network” (IDN), and what does this mean for cancer care? Soberman said hospitals realized that they are not islands of care, and in time they may not even be the anchor. “I think oncology has been the poster child for this,” he said, offering examples of how groups like the Cleveland Clinic now organize care around a patient's disease, not "radiation oncology" or "surgery."

Feinberg asked what components are needed to be an IDN, and Macher replied that breadth of services matters. Kolodziej noted that hospital systems have been buying nursing homes, which is significant because under the Oncology Care Model (OCM), the cost of postacute care is significant—and can be hard to control. “Nobody asked the oncologist which nursing home to send the patient to because the hospitals don’t care what the model says about what nursing home to use,” he said. “But hospitals have caught on to this.”

The discussion also noted that the IDN movement has brought about hospital closures in rural areas. The push-and-pull over how many services health systems can provide, and where, is an ongoing issue. Will there be freestanding emergency departments? Will we see more systems like Geisinger in Pennsylvania and Kaiser as it exists in California?

In oncology care, the 340B program has changed the dynamic by driving consolidation of practices into hospital systems—until recently, care in hospital-owned facilities was reimbursed at much higher rates than care in community settings.

Although 340B is not solely responsible for the change in where care occurs, Feinberg said, “There has been a significant shift in the site of care for cancer patients, where 80% of it 5 to 10 years ago was being provided in the community setting in private practice clinics, now it’s half that number today. The half that’s not there is being treated at a site of care, usually in a facility owned by an IDN, however we define it.”

Soberman called it “unreasonable” to pay more for care in different settings, and that his health system put care in a setting where the physician fee schedule applied, because “we want to be less expensive, not more expensive.”

IDNs that are not all working in concert can present challenges for practices enrolled in the OCM, Soberman said, because “it makes the medical oncologist responsible for a whole lot of things they have no control over.”

Macher agreed. The OCM is transforming patient care, she said, but from a financial perspective, it still has some flaws. “There are a lot of kinks to be worked out in the [OCM] and they’re working hard to do that.”

Changes in reimbursement, stresses from 340B, adapting to technology, and the modern challenges of running a practice have all contributed to the loss of small 3-to-5-member oncology practices, Feinberg said, asking the panelists to comment.

“The burnout factor, interestingly, is not just a private practice phenomenon,” Soberman said. “It’s just the emotional toll that being a cancer care provider takes.”

More must be done to improve working conditions and increase the time providers spend with patients, not on paperwork or in front of a computer. “Getting that joy of practice back in is a real challenge,” he said.

Kolodziej agreed that the electronic health record is a huge problem, and Feinberg agreed that hiring a scribe does not completely eliminate the problem.

Can an IDN do a better job than the traditional practice? Feinberg focused on the term “patient engagement” and asked, what does this really mean? Macher said it can mean many things, but “the one that certainly bubbles to the top is adherence ... and having the ability to engage the patient at certain points along the continuum if they’re not adhering to their therapy.”

IDNs excel here due to technology and care coordination. But, Feinberg said in his conversations with community oncologists, being close to patients is exactly why they are best for this role.

“I’ll offer a cynical response that, at this point, most technology solutions have been embraced by the well, the worried, and the wealthy,” Feinberg said, “but not by the patients who really need them.”

Macher and Kolodziej said this will change as millennials move through the healthcare system, because they are heavier users of technology. “They care less that their doctor went to Harvard and more that their doctor answered their email,” he said.

“I would say the world is changing, and it’s going to change in ways that we cannot predict,” Kolodziej said.

Articles

Evidence-Based Oncology

Mergers, New Locations for Care, and the Oncologist

Brian Koffman, MDCM, DCFP, DABFM, MS Ed, Medical Director, CLL Society

As someone treated with chimeric antigen receptor (CAR) T cells, what do you do regarding follow-up? What is your physician keeping an eye out for?

Since CAR T is a new therapy, and the first genetic therapy that’s been approved in the United States by the FDA, I’m being followed for 15 years. Which I’m very happy about, because if I’m being followed for 15 years, that will mean I’m 82 years old, so it means I’ve lived 15 years with this.

I’m being followed to see are there any undiscovered adverse events that we don’t know about. It is gene therapy, I have foreign genes in my body, that’s why it’s a chimera—a mix of 2 different creatures in me. So I have foreign protein in me. Is this going to cause a problem? Other gene therapies have been disastrous in the past. So far with CAR T things have gone well. But is there something that’s going to pop up 5 years from now, 10 years from now? We really don’t know the answer to that. So that’s one thing that I’m being looked at for.

The other thing is how persistent are the CAR T cells themselves? There’s not clarity on how important that is in terms of the duration of the response. So, some people lose their CAR Ts and they still have very durable responses and other people have persistent CAR Ts, but the cancer comes back.

And that leads to the other big question: Do I remain in a complete response? Or is the cancer creeping back again? That’s the main thing that they want. So, in CLL [chronic lymphocytic leukemia], the responses have tended to be quite durable for most patients. But in other blood cancers, sometimes people get a deep response—MRD [minimal residual disease] undetectable&mdash;but the disease can be back again in 6 months. So I think that those are the things that they’re looking for.

Plus, the usual kind of things. Am I getting more infections? Am I getting anemic? Am I getting problems with my platelets? Things like that. The follow-up isn’t too onerous. I essentially get a physical exam and blood work once a year.

What have been the benefits and the challenges of being treated with CAR T therapy?

CAR T therapy is very early in its development. So, making a decision to jump into CAR T therapy has inherent risks associated with it. But I decided the risks were worth the potential benefits, which would be an extremely durable response. There are a number of concerns about that. The first is that we don’t know yet how to predict who is going to respond well to CAR T. We also don’t know who is going to get quite toxic from CAR T. These things are not yet predictable, although they’re working on it.

The other thing is, except really for a handful—and I’m talking a couple of patients&mdash;we don’t have much data beyond 2 years out. The bulk of people have been treated in the last 2 years, so the 2-year data [are] encouraging. And there’s a handful of patients who are 5, 6, 7 years out [who] are doing well, but I wish there were hundreds of patients, and I wish they were 30 years out and I could see that data. That’s another issue.

When you enter CAR T therapy, there’s this ironic twist, and that is you’re hoping that you’re going to get sick, because the sickness means that when these CAR Ts, which have been re-engineered to attack your cancer—they’re serial killers&mdash;they’re going in and killing off your cancer cells. And you get pretty darn sick when all this killing is going on in your bone marrow and in your blood and your lymph nodes are shrinking and your spleen. And this is called cytokine release syndrome. Cytokines are these enzymes that are re- leased when there’s an inflammatory process going on, and it’s like the worst flu that you ever had, and most people need to be hospitalized for this. And you’re kind of hoping that you get it, but not get it too bad, because if you don’t get it&mdash;that doesn’t mean the CAR Ts aren’t working&mdash;but generally, you have to get a little bit of the cytokine release to get the benefit of the CAR Ts.

Beth Wittmer, RN, OCN, Manager of Care Management at Florida Cancer Specialists and Research Institute

It’s very strange to get a therapy that you hope you get sick with, because that means that it’s working. Having said that, and I was extraordinarily sick, I had a really bad time, but I got what I came for. When I was restaged, this cancer, which was 60% of my bone marrow, was gone to the best testing of something called MRD undetectable, or minimal residual disease undetectable, down to 1 in 100,000 or maybe 1 in 1 million cells. They could not find it anywhere in my blood or my bone marrow.

How are patients educated on the risk of neutropenia when they’re treated for cancer? 

Any patient coming to Florida Cancer Specialists does education prior to starting or on the day of starting their chemotherapy, but there are many that are oral patients that maybe don’t ever go into a treatment room. So, our care management department helps manage all of those patients, and with that, we talk about the side effects of chemotherapy, with neutropenia being one of the most potentially lethal to them. So we talk about those precautions and we sort of have templates built, as well as patients calling in after hours, and we have a neutropenia protocol that we follow as well.

Are there strategies to treat patients quickly in the office before they have to go to the emergency department (ED) if they have neutropenia? 

And that’s our goal: to try to keep them out of the ED. So, one, being proactive in calling the patient. If they finish the treatment, so this is from the care management perspective, the nurse is calling the patient to see how they’re doing, what kind of adverse effects they’re having. Fever, of course, is the number 1 sign to watch for with neutropenia.

And as their white cells drop, their neutrophils drop. Neutrophils are your front line of fighting off an infection. So if you don’t have the neutrophils there, the body’s response is different. It doesn’t say, “Hey, guys, we need your help from the macrophages and everybody else to come in and help surround the infection.”

Also, educating on foods that they should avoid: raw foods; raw vegeta- bles, especially salad; berries, because they’re a little harder to wash, they can carry bacteria that normally our gut can handle, but someone who’s neutropenic can’t.

So just making them aware of what to be cautious about. Check your temperature and report any symptoms that you’re having. And then, if we can, we take them in to see the physician, into our own clinics, if we can help that. Either bringing them in for potentially reviewing their [complete blood count] again, putting them prophylactically on antibiotics. Sometimes those are done [intravenously] in the clinic, as well.

Interviews from Patient-Centered Oncology Care® 2018. 

AJMCtv® Interviews, PCOC 2018

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

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

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

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

At the 2018 meeting of 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

Mergers, New Locations for Care, and the Oncologist

AJMCtv® Interviews, PCOC 2018

Therapeutics

Reporting and Design

Oncology Payment Models

Looking Ahead

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