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Evidence-Based Oncology
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A rundown of sessions at The Community Oncology Alliance (COA) annual meeting, held April 27-28, 2017, near Washington DC. This year’s theme was Fueling the Cancer Moonshot.
Oncologists Believe Achieving Cancer Moonshot Goals Should Start in the Community
Former Vice President Joe Biden's Cancer Moonshot initiative1 placed significant emphasis on the role of cancer centers in improving the nature of oncology care delivery in the country, ultimately to improve patient outcomes. However, community oncologists believe that they are in a very good position to lead the way.
Joining this discussion at the 2017 Community Oncology Conference, April 27-28, in National Harbor, Maryland, were William Harwin, MD, president and managing partner, Florida Cancer Specialists; Edward Licitra, MD, PhD, chief financial officer and director of revenue cycle, Central Jersey Division, Regional Cancer Care Associates (RCCA); and R. Steven Paulson, MD, President, Texas Oncology. Debra Patt, MD, MPH, MBA, vice president, Texas Oncology, moderated the discussion.
When asked about the role played by each of the practices in fueling Cancer Moonshot, Harwin said that many different factors can influence Cancer Moonshot, including developing a patient care system. “We have about 50 patient managers, many of whom work remotely,” he described. “We also have an active phase I unit on site, and that’s one of our biggest initiatives.”
As a result of requirements of the Oncology Care Model (OCM),2 Harwin’s organization also has a care management team. “They are available 24 hours and provide triage, which is very valuable for our patients,” he said. The team members, Harwin added, adhere to protocols developed for triage management and psychosocial support.
Paulson noted, however, that the challenge with OCM is the upfront investment for additional staffing, to ensure that reporting requirements and change implementation can be met. Paulson also addressed the importance of extending clinic hours to avoid emergency room visits.
“OCM has given us the ability to focus and change culture,” Licitra emphasized. He explained that the changes that a practice infuses to meet OCM requirements are not restricted to Medicare patients; they extend to other patient populations as well. “While it is a work in progress, we are trying to centralize our processes,” he said, adding that RCCA is working with Innovative Oncology Business Solutions, co-founded by Barbara McAneny, MD, to bring this about.
“How important is research for your practice and how have you built it into your practice?” Patt asked the panelists. Licitra noted the importance of data integration to improve patient outcomes. RCCA is assembling all the genomics and proteomics information on patients and then trying to identify ways to improve outcomes. “We are using tools to understand both clinical and financial outcomes,” he added. “We need people to realize the value of community oncology and they come to us and give us the opportunity to care for them,” Licitra said.
Paulson explained that Texas Oncology has built relations with hospitals, clinics, and the pharmaceutical industry to help support their in-house research efforts. “We try to create a situation where the best molecules are accessible to our patients,” he said. He is, however, concerned with the low rate of clinical trial enrollment, especially among newly diagnosed patients.
Challenges to Delivering Research in the Community Setting
Patt indicated that in addition to operational costs, individual clinicians contributing time presents challenges. “What are the other challenges that you face and how can they be overcome to facilitate research in the community clinic?” she asked.
Harwin said that his practice uses a clinical trial navigator, and it also employs Flatiron Health’s OncoAnalytics platform.3 “But we cannot replace physicians,” Harwin said, emphasizing the need to raise awareness through fellowship programs.
“Patient identification and physician engagement are key,” said Licitra, indicating that modifying physician compensation models can have a significant impact. Paulson agreed with Licitra. “You can change reimbursement models to include financial incentives for participating in clinical trials,” he said, noting that community clinics should work towards the goal of providing patients access to a research platform.
Clinical trials enable huge savings because you don’t have to pay for the drugs, Harwin said. To ensure timeliness of acquiring information, “We have our own molecular testing facility,” Paulson said. It helps the clinic, too, to better aggregate the patient’s molecular data along with clinical information. “We have also created an outpatient interventional radiology facility, which costs half of what we would pay for if the patient goes to a hospital,” he added.
Patt noted the importance of clinical decision support, which allows quality improvement, faster treatment by helping with prior authorization, and better outcomes. She also emphasized the importance of telehealth for practices with multiple sites. “We can’t have every expert at every site of care, and we need to identify ways to bridge geographical gaps,” she explained, adding that telehealth services need to grow quickly “because we may not provide all services at every site across large practices.”
Licitra believes that curing cancer and curing the cancer care delivery systems are the targets of reimbursement models, and they are both significant challenges. However, Paulson said that even if doctors do not like these changes, it is important to climb on board since the OCM is fueling the opportunity to bring about changes.
Pratt noted the importance of community oncologists “telling their story.” “We need to allocate more time to this,” she said.
REFERENCES
1. Dangi-Garimella S. The fate of Cancer Moonshot in 2017. The American Journal of Managed Care® website. http:// www.ajmc.com/newsroom/the-fate-of-cancer-moonshot-in-2017. Published November 11, 2016. Accessed April 28, 2017.
2. Dangi-Garimella S. Will a payer-provider collaboration guarantee OCM success? Am J Manag Care. 2016;20(SP16):SP616-SP617.
3. Dangi-Garimella S. Flatiron’s EHR platform for OCM participants promises to foster value-based care. The American Journal of Managed Care® website. http://www.ajmc.com/newsroom/flatirons-ehr-platform-for-ocm-participantspromises- to-foster-value-based-care. Published July 28, 2016. Accessed April 28, 2017.
Linking Claims, Clinical Data Is Essential for a Learning Health System
“Big data” is a term used as commonly as the term “value” in cancer care. However, similar to value, the interpretation of big data can vary, according to Robert Green, MD, vice president of clinical strategy and senior medical director at Flatiron Health. Is the rubber meeting the road with big data in cancer care? “No … rather, not yet,” Green said at the 2017 Community Oncology Conference, held April 26-27 in National Harbor, Maryland.
Green explained that in order to make data from electronic health records useful, real-world quality data play an important role. However, it is also important to link clinical and claims data. “That’s where the future is,” he said.
Quoting quantitative scientist Gary King, PhD, from Harvard University, who said, “Big data is not about the data,” Green explained that it’s about using the data to generate meaningful insights. “At Flatiron, we define big data based on its complexity, rather than the volume.”
The focus should be on leveraging the data for high-value care, on improving outcomes, and accelerating clinical work, Green explained.
“We are being asked to develop interventions that will affect care and the financial viability of our practices,” he said. “To achieve this, we need to feed all this information back into our system to improve work flow…the concept of a learning system.”
He believes that processing structured data is key to be able to use these data, often described as “data scrubbing.” But a lot of information is not structured—such as pathology or physician notes—and a method needs to exist to extract this information.
“Unstructured data are typically hard to get at, and it’s not possible to get these data into a structured form, accurately, and use them to generate feedback and improve care,” he said.
Green told the audience, most of whom were oncology care providers, that although most providers think they are good at what they do for patients, “I don’t believe the metrics that I am reporting on are really bringing value to the patient because I checked the required box, such as measuring pain medication.” So, he asked, how do providers find out if they are taking good care of their patients?
Fill in the gaps.
He stressed that filling in data gaps is very important to be able to mine high-quality data, and this means combining unstructured data with raw structured data.
Identify cohorts.
Identify the appropriate patient cohort on which to conduct analyses. Defining the cohort is important when measuring quality to report on metrics.
Develop an analysis plan.
Develop, document, and apply a rigorous plan. It is easy to miss the right answer if the data are not thoroughly evaluated, he said.
Case study 1.
Green then provided a case study on assessing clinic adherence to EGFR and ALK testing in non—small-cell lung cancer (NSCLC). Analysis of Flatiron’s database found that only 21% of patients were tested across the network of practices that were conducting this genetic test.
“But when we drilled down even more, the median testing rate was 16%—some clinics were testing 100% while others were only testing infrequently,” he said.
So there was significant variance across clinics, which was apparent only when Flatiron analyzed the data at the individual clinic level.
Case study 2.
Green showed that in their 2012-2014 data set, KRAS testing rates for colorectal cancer were 71% in 2012 and then just 57% in 2014. The variability was 90% to 35% across 21 clinics, and testing rates rose with later lines of therapy: 62% at first-line and 90% by third-line and above.
“Such detailed information can influence how we collect, analyze, and report on quality metrics and how it ultimately affects reimbursement in that practice,” Green said.
To highlight the importance of linking clinical and claims data, Green compared the value that claims data bring to quality analysis, and he also noted specific challenges. While claims data do provide insight into the total cost by disease type, and help identify cost drivers, drug compliance rates, and information on hospitalization and emergency department visits, that information is not sufficient, Green said. Claims data, he added, lack attribution and don’t have enough clinical depth to have a real influence on cost.
“There’s also data latency…claims data are not as recent as a clinic would like,” he added.
Circling back to how he kicked off his presentation, Green said “It’s not about the data, it’s about what you do with them.” He predicted that measurement and reporting of physician and clinical performance will soon become routine; personalized risk assessment will be essential for process improvements and to maximize returns; and outcomes improvement will become the expectation.
“You don’t know how well your patients are doing unless you try to measure their performance,” Green said, and he outlined what is needed to generate real- world quality data:
Oncology Practice Administrators Discuss Early Findings From the OCM
Oncology practices that are participating in the Center for Medicare & Medicaid Innovation’s Oncology Care Model (OCM) have started receiving performance feedback from CMS. At the 2017 Community Oncology Conference, held April 26-27 at the Gaylord National Resort & Convention Center in National Harbor, Maryland, practice administrators from 2 community clinics discussed the changes they made to their practices to accommodate the reporting requirements and the follow-ups they have planned as they work to implement changes.
The panel, moderated by Robert Baird, Jr, RN, MSA, CASC, CEO, Dayton Physicians Network, included Alti Rahman, MHA, MBA, CSSBB, practice administrator, Oncology Consultants, and Anne Marie Rainey, MSN, RN, CHC, compliance and quality control officer, Clearview Cancer Institute.
When queried on how their practices accommodated participation in OCM, Rainey said that as with any new program, “You think it’s going well some days, but on other days you don’t.” She explained that while there are a lot of positives to participating in OCM, “We have had to also work to make changes to make this sustainable for our practice—not just OCM, but other reporting requirements as well.”
For Oncology Consultants, the initial challenge was the review of the entire quality reporting aspect within their practice. “We developed 2 teams: the first looked at the clinical data and the second focused on quality aspects,” Rahman said. The leads of the 2 teams made sure that operational changes matched the reporting, Rahman said, “which helped meet the OCM reporting and quality initiatives across our primary and satellite sites.”
According to Rainey, an open-door policy and an emphasis on communication have been keys to success. “We found out early on that in addition to e-mail updates, monthly and quarterly meetings worked well to provide continuous quality feedback for each department,” Rainey said. “We have found unique ways to make this work.” Both agreed that adequate staffing was essential to meet the quality and reporting requirements of OCM.
Challenges to Meeting OCM Requirements
When Baird asked Rainey and Rahman to identify the major challenges they have faced over the past year with OCM implementation, Rainey noted that workflow changes were the hardest barrier to overcome. The staff harbored a lot of resistance. Associates felt “we were just adding care plan steps or clicks within the workflow. That was initially huge, but we have overcome most of that, although there will always be room for improvements,” she said.
Rahman identified staffing, infrastructure, and information technology needs as the challenges, a majority of which he said were related to operational and reporting requirements. Another major challenge was getting a grip on the cost of managing the manual abstraction of data from the electronic health records. “We had to look at the costs of manual versus automated data abstraction,” he said.
Constructive Lessons Learned
Rainey identified a big advantage of the patient-centered aspect of OCM. “It forced us to communicate more with our patients and document things that were historically not documented,” she said. “For example, we were not documenting advance care directives for our patients.”
The clinic identified this as an area that needed improvement, and now 75% of their Medicare patients have these directives documented. “It can be uncomfortable for our staff as well as for patients, but we are proud that we have championed this,” she said.
Both Rahman and Rainey reiterated that communication across the various departments in their respective organizations was key to identifying problem areas and working to implement changes. Baird was curious to find out the patient feedback when informed that the clinic would be participating in a new type of reimbursement model. “We opted to mail a letter to Medicare and on-chemotherapy patients,” Rainey told the audience. While they had a lot of questions initially, they were also happy to see more information on their care plan and medications, she said.
Rahman’s practice devised a strategy to make the information about the reimbursement model more patient-friendly. “The letter can be dense, and so we created a cartoon to help patients understand their plans better. We needed to supplement the letter and explain it better,” he said.
OCM Feedback
The first wave of OCM feedback reports, for practices that had 6-month chemotherapy episodes, are out. Rainey said that while the reports were initially a bit overwhelming, she soon noticed trends as they dug deeper. “We noticed that E&M [evaluation and management] visits were high for our practice and when we looked closer, it helped us locate an outlier physician,” Rainey pointed out. She also explained how the practice placed triage pathways in place to reduce the number of hospital and emergency depertment (ED) visits for patients who were troubled with nausea, vomiting, and diarrhea.
“We need to get a deeper dive into this, with the help of data analytics companies, to avoid a knee-jerk reaction so we could plan this out better,” Rainey added.
Rahman’s practice also focused on ED utilization, and their clinic was able to pinpoint the exact dollar amounts associated with patient visits to various hospitals across Houston, and the variations seen for the same treatment. “But we have to partner with analytics companies and we’d need these data more frequently,” he said.
Rahman emphasized that while his practice has extended hours, raising patient awareness to call or come to the clinic instead of visiting a hospital or the ED is vital.
Congressman, Pharmacist, and Lawyer Debate PBMs, Drug Prices at Annual COA Meeting
With drug price debates escalating daily, stakeholders in healthcare, particularly in cancer care, have been very vocal about who should take the blame and bring about changes to reduce the cost of care for patients. A white paper commissioned by the Community Oncology Alliance has aimed the spotlight on practices by pharmacy benefit managers (PBMs) that prevent reductions in drug prices.1
At the 2017 Community Oncology Conference, held April 26-27 at the Gaylord National Resort & Convention Center in National Harbor, Maryland, panelists discussed the evolution of PBMs, how their role has changed over the years, and the resulting impact on drug prices and patient access.
Participating in the discussion were the Honorable Earl L. “Buddy” Carter, US House of Representatives (RGA); Steven D’Amato, BSPharm, executive director, New England Cancer Specialists; and Jonathan E. Levitt, Esq, founding partner, Frier Levitt. Frier Levitt helped develop the COA white paper on PBMs. Joshua Cox, PharmD, BCPS, director of pharmacy, Dayton Physicians Network, moderated the discussion.
Cox provided a historic perspective on how PBMs came to be. “In the early 1960s, PBMs played a very important role in the drug distribution network—they brought in technology that impacted the drug supply chain,” he said. Over time, however, with consolidations, their patient networks grew and PBMs played a greater role in negotiations. The Federal Trade Commission realized soon enough the conflict of interests resulting from the ensuing PBM—manufacturer alliance, and it was eventually broken up, Cox said.
Today, through mergers and acquisitions, PBMs are vertically integrated into the healthcare system, and every major PBM owns a specialty or mail-order pharmacy, Cox said, asking the panelists to comment on how they see this impact the healthcare system.
“Escalating prices of prescription medications has shone the light on this issue with PBMs,” Carter said. It is the most talked-about topic in Congress, where lawmakers are now looking at the escalating costs and the reasons behind them, he explained, adding that “transparency is the key here.” Three PBMs controlling 80% of the market is not competition in any sense, Carter said. “We need to break that.”
He then cited the example of how pharmaceutical manufacturer Mylan, manufacturer of the EpiPen—which is used to treat life-threating allergic reactions— was abusing the system with its EpiPen price increase.2
“PBMs are not focused on patient care, and we have access issues that we constantly face in our clinic,” D’Amato explained, adding that patient care is affected because the patients are often forced to go through a PBM to get their drug, instead of at the point of care like they provide. “On a weekly basis, my pharmacists come to me with this information,” D’Amato added, saying that PBMs are diverting prescriptions from their clinic for financial gains, which is unethical, he said.
Levitt explained that the PBMs’ practice of using protected health information for marketing purposes is illegal under HIPAA and under many state laws. This “prescription trolling” should not be accepted by clinics, he said. Another question that he raised was, “Where do the DIR [direct and indirect remuneration] fees gathered by PBMs go?” The power to take away 60% to 70% profitability of a prescription is the power to exclude a community practice from the Medicare network, Levitt explained. PBMs have also tried to limit network access and pushed network terminations, he added.3
Cox asked the panelists that as clinics get a better understanding of DIR fees, “How can a pharmacy make a rational decision?” “DIR fees associated with quality metrics are not working,” D’Amato explained, adding that larger clinics might be losing millions of dollars in DIR fees. “It’s not a sustainable business model,” agreed Carter.
Levitt explained that this can ultimately impact patient access, especially when a pharmacy might be one of a few providers of certain exclusive drugs. “So, 6% DIR fees on a drug might put a pharmacy underwater,” he said.
D’Amato also indicated that a PBM cannot compete with the patient care and patient safety issues that a community practice at the point of care manages. “A PBM does not have that kind of management skill or even the relation with the patient. In my mind, we are the ones that should be providing this service,” he added.
Addressing the PBM tactic of “gag orders,” whereby a PBM can prevent a pharmacy from educating patients on where they can find the drug at a cheaper price, Carter said, “We are working to eliminate this gag order.”
The panelists agreed that while PBMs have a tremendous influence on healthcare, they need to bring in more transparency. “We will continue to press on this in Congress. The executive branch is in tune with what’s going on here. We may see something evolve out of that,” Carter told the audience.
REFERENCES
1. Mattina C. Report commissioned by COA explores “murky” world of pharmacy DIR fees. The American Journal of Managed Care® website. http://www.ajmc.com/newsroom/report-commissioned-by-coa-explores-murky-world-of-pharmacy-dir-fees. Published February 2, 2017. Accessed April 27, 2017.
2. Dangi-Garimella S. Mylan faces product recall and lawsuit over PBM deal. The American Journal of Managed Care® website. http://www.ajmc.com/newsroom/mylan-faces-product-recall-and-lawsuit-over-pbm-deal. Published April 4, 2017. Accessed April 27, 2017.
3. Dangi-Garimella S. CVS reverses decision on physician dispensing of oncology drugs. The American Journal of Managed Care® website. http://www.ajmc.com/newsroom/cvs-reverses-decision-on-physician-dispensing-of-oncology-drugs. Published November 1, 2016. Accessed April 27, 2017.