On Thursday, Nov. 2, 2017, the Centers for Medicare & Medicaid Services released the 2018 final rule for the second year of the Medicare Access & CHIP Reauthorization Act (MACRA) Quality Payment Program (QPP). While we were disappointed by some policies in the 2018 rule, in general, the final rule signals a continued commitment to increased flexibility and reduced administrative burden for clinicians.
Starting in 2019, Medicare-participating clinicians will have to choose whether they will participate in the new QPP through one of two tracks: the fee-for-service based Merit-Based Incentive Payment System (MIPS) or through an Advanced Alternative Payment Model (APM). Clinicians should be reporting measures now (in 2017) for payment adjustments that will occur in 2019. If you are not aware of your obligations under the QPP, be sure to familiarize yourself as soon as possible – most clinicians should be reporting on three MIPS categories (quality measures, advancing care information, and clinical practice improvement activities) now for changes that are coming in 2019.
The final rule that outlines the QPP program in 2018 significantly reduces the number of providers subject to scoring under the MIPS track of the QPP. In 2018, any clinician with less than $90,000 in Medicare Part B allowed charges or fewer than 200 Part B beneficiaries will be exempt from MIPS reporting (previously this “low-volume threshold” was $30,000 in Part B charges and 100 Part B patients). With these changes, it is estimated that 123,000 providers will be excluded from MIPS scoring. CMS is also expanding access to reporting under the Advanced Alternative Payment Model (APM) track of the QPP. Clinicians who are participating in the Medicare Shared Savings Program (MSSP) Track 1+ as well as the Next Generation ACO Model and the Comprehensive Primary Care Plus (CPC+) program will all now qualify for QPP reporting as an advanced APM. CMS estimates that about 185,000 to 250,000 clinicians will now be eligible for reporting under an advanced APM, creating more competition within the MIPS track. CMS also expanded the option of reporting as virtual groups for physicians in groups of 10 or fewer and added bonus opportunities for small practices and clinicians treating complex patients.
CMS also eases reporting requirements around electronic health record (EHR) use, allowing MIPS-eligible physicians to be able to use 2014 or 2015 editions of certified EHR technology to meet the Advancing Care Information (ACI) category. Additionally, clinicians across the U.S. who were significantly affected by Hurricanes Harvey, Irma, and/or Maria are eligible to apply for an ACI hardship exception. These affected clinicians are eligible to apply for reweighting of the MIPS reporting requirements for quality, cost, and improvement activities categories for the 2018 performance period. The deadline to apply for both exemptions is December 31, 2017.
Despite these flexibilities, ACCC is disappointed to see that CMS has moved up the timeline to hold clinicians accountable for the cost of care they provide. Originally CMS had proposed that the cost category under MIPS be weighted at zero in 2018, however the final rule requires that cost account for 10% of the MIPS score in 2018. Additionally, despite opposition from ACCC and many stakeholders, CMS also finalized that Part B drug revenue will be subject to the MIPS adjustment, which is not what we believe Congress intended and breaks from past precedent in CMS policies.
We expect QPP participation and requirements will continue to evolve in the coming years, but be sure to prepare yourself now – these changes to Medicare reimbursement are around the corner.
ACCC members are invited to join us for a webinar on Wednesday, December 6, 2017, from 3-4 PM EST, for an in-depth analysis of the CY 2018 QPP final rule and how these changes may impact providers and their cancer program or practice. Learn more and register (log in required).
After a flurry of activity on healthcare over the past couple of months, a bipartisan proposal may be making gains in Congress. The highlights:
October 12, 2017 – The Trump Administration released an executive order that laid the groundwork for big changes to the Affordable Care Act (ACA) marketplaces including less comprehensive plans offered through associations of small employers as well as a push for increased use of short-term medical coverage. This could essentially create an alternative insurance market that would not have to comply with many of the consumer protections created under the ACA, and would likely attract healthier, less costly consumers, which would drive up premiums in the current exchanges. Later that evening, the Administration announced it would immediately end cost-sharing reduction (CSR) payments used to subsidize healthcare costs for low-income individuals on the exchanges. The legal battle around CSRs has been playing out in the courts since 2014, with some arguing that the payments are illegal because they were not appropriated by Congress. Analysis from the Congressional Budget Office (CBO) predicts large premium increases for exchange plans in 2018 and beyond, as insurers attempt to cover the loss of the CSR payments and some consider leaving the marketplaces all together.
October 17, 2017 – The following week, Chairman and Ranking Member of the Senate Health, Education, Labor, and Pensions Committee (HELP), Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), announced a bipartisan bill designed to provide temporary stability in the marketplaces.
Key tenets of the Alexander-Murray proposal include:
Continued Funding for CSR Payments: CSRs would continue to be funded through 2019. For states where insurance regulators are pressing individual insurers to decline this payment, no funding would be issued.
Restoration of ACA Enrollment Funding: Any state participating in an exchange would see restoration of over $100 million in outreach and enrollment funding through 2019. This proposal also seeks transparency with open enrollment advertising and outreach with a mandated reporting timeline.
Preexisting Conditions & Essential Health Benefits Coverage Requirements: Under this bipartisan proposal, insurers would not be able to waive the ACA preexisting conditions or ten Essential Health Benefits (EHBs), which became coverage requirements under the ACA, as previous ACA reform/replace bills have sought to do.
Section 1332 Waivers Support: This proposal would streamline the waiver process and make it easier for states to acquire and maintain 1332 waivers. These allow states to implement their own health insurance programs as long as they meet thresholds for coverage and affordability that are similar to those achieved under the ACA.
Despite early support among both Democrats and Republicans in the Senate and pushing healthcare reform forward, last week President Trump signaled a singular focus on tax reform while meeting with Congressional leadership, suggesting there may not be a clear path forward. The Alexander-Murray proposal would also likely face an up-hill battle in the House where Majority Leadership is still focused on ACA repeal and replace. On October 25, the Congressional Budget Office (CBO) released an initial impact analysis of this proposal citing a deficit reduction of nearly $4 billion through 2027. Even with that news, the likelihood of this bill to move on its own appears slim; the most likely pathway for this proposal to become law, if at all, will be tacking it on to a “must pass” end of year funding bill.
Regardless of how – or when – the short-term stabilization package moves, the Administration’s announcement to end the CSR payments has already made an impact. Early estimates show that premiums for a silver-level plan in 2018 will increase 34%, higher than the average 25% increase we saw in 2017, and not all enrollees will qualify for the premium tax credits used to offset these market increases. Without CSR payments, insurers will also likely continue to exit ACA exchanges in many states, leading to states with fewer options and an unstable market overall. For cancer patients, and those battling chronic illnesses, efforts by the Administration to loosen regulatory requirements around comprehensive coverage and decisions to end critical funding streams to assist insurers in providing meaningful coverage for the costliest consumers is particularly troubling and will mean higher cost plans and fewer options.
And, amid all this uncertainty, Open Enrollment season is upon us. The Enrollment Period for ACA Exchanges has been scaled back to 45 days under the current administration, and will occur from November 1 through December 15, 2017.
ACCC will continue to monitor any legislative progress of the bipartisan market stabilization bill and continue to advocate for comprehensive, affordable insurance options for all cancer patients. For more on what ACCC needs to see in any ACA reform proposal, see our Health Reform Principles for Cancer Patients.
Resonating across sessions at last week’s 34th ACCC National Oncology Conference: EHR issues. One sentence takeaway: As data collection and reporting requirements multiply, the ideal oncology EHR solution remains elusive.
Here’s a snapshot of what we heard during Friday’s panel discussion on “Strategies for Optimizing Your EHR”: the good, the bad, and, yes, the getting better.
Control, or lack thereof. Sometimes a cancer program or practice has successfully tailored their EHR to meet their operational, programmatic, and reporting needs—only to have the health system or hospital opt for a completely new system.
Interoperability. While Friday’s panel discussion revealed some steps to successful EHR utilization for reporting, panelists also spoke about ongoing challenges, including having to work with several EHRs on a daily basis. “Multiple EHRs require a lot of flexibility, especially for oral medications,” said panelist Linda Frisk, PharmD, Arizona Oncology Associates, PC.
Too many portals. Oncology staff may use three different EHRs on a daily basis, plus some additional portals, for example, for specialty pharmacy. For providers, this can result in “password overload,” commented panelist Rachel Lawlor, MHA, RN, OCN, Cancer Care at Mosaic Life Care.
“Very labor intensive process.” This phrase cropped often during conference sessions–not just during Friday’s panel discussion–usually in reference to ongoing struggles to extract some types of data for reporting. In some instances, at least some data extraction is still a manual effort.
Provider compliance. Although several recent studies point to EHRs and increased “box checking” as contributing to physician burnout, panelists agreed that physician buy-in is critical to optimizing EHR utilization. “You really need to get buy-in from physicians,” said Judy Stone, CMPE, Stamford Hospital.
To get the most from your EHR, “make sure your physicians are filling in queryable fields. Make sure all the data that we can query is in there,” said Linda Frisk, PharmD. One example of leveraging EHRs to improve patient care: the ability to query ‘KRAS’ and have all the progress reports with KRAS come up.
Oncology is different. “It is simply critical to make your IT department aware of what a cancer center does and how very different we are from other divisions of the hospital and other outpatient departments,” said Judy Stone, CMPE. If your IT department doesn’t know what oncology does, invite them to observe for a day or two.
Here to stay. Data collection, analytics, and quality reporting are key requirements as healthcare moves away from fee-for-service into the value-based care environment. “Reporting quickly, efficiently, and in a way you can understand will be critical for our future,” said Linda Frisk, PharmD. EHR optimization should ultimately result in more accessible data to use both operationally and for quality reporting, and demonstrate value. “I think patients want to see value,” she said.
No, not the exceptional conference attendance of nearly 800 multidisciplinary oncology professionals for a “how to” focus on cancer care delivery.
No, not the exceptional sessions with practical “how to’s” for improving processes, patient satisfaction, quality reporting, data collection, and workflow. And no, not the stellar 2017 Innovator Award winner presentations with their exceptional solutions and actionable takeaways for advancing patient care in the community. And not the Spotlight Sessions, with peer-to-peer sharing of quick-takes on exceptional “how to’s” addressing hot topic issues in oncology care delivery.
The “exceptional” we’re referring to is something else: A theme heard across multiple conference sessions. Something connecting the past, the present, and the future of cancer care delivery.
What’s New about “How To”?
In this blog post, ACCCBuzz is talking about an “exceptional” theme that surfaced in session after session of the ACCC 34th National Oncology Conference: Improving connections between the “art” and the “science” of medicine to improve care delivery.
At this “exceptional” time in healthcare—with unprecedented uncertainty on ACA reform, payment models, and costs, along with exponential scientific advancement and information overload—during last week’s conference, presenter after presenter touched on the compelling need to humanize medicine to help both providers and their patients. A number of speakers described how a new strategy, program initiative, workflow, or process change grew from an “Aha” moment triggered by an encounter with or experience of a single patient. An interaction that stopped them in their tracks and connected them to new ways of thinking about care delivery.
One step toward humanizing medicine that echoed across sessions was the power of stories. For many of the presenters, either listening to or sharing a story, led to change. Attendees learned firsthand how sharing your story can empower cancer programs, providers, and patients.
For cancer programs, telling your story is at the heart of advocacy efforts, Tennessee Oncology CEO Jeffrey Patton, MD, told attendees, in welcoming them to Nashville. In today’s swiftly shifting healthcare environment, it’s critical for community oncology to have a voice. “No one is going to tell our story for us,” he said, reminding attendees that their experiences need to be included in the healthcare reform conversations occurring both locally and nationally.
Dr. Steven Eisenberg sharing the healing power of music.
For cancer care providers, sharing a story, an anecdote, or even a favorite song can be a simple step toward humanizing the provider-patient relationship. Featured speaker medical oncologist and “song-cologist” Steven Eisenberg, DO, California Cancer Associates for Research & Excellence, told how a pivotal interaction with Flavvy, an 80-year-old stage IV cancer patient who refused to let her medical problems diminish her vibrant love of life, changed his life and his approach to practicing medicine. “It freed me up to be a doctor who was in partnership with my patients. Rather than being separate from them, I started working with them,” he said.
By telling their story, cancer patients can help themselves, help others facing cancer, and help their care team understand who they are and what is important to them. Breast cancer survivor Brianne Joseph, LPI, owner of Sly Fox Investigations and author of Punk Azz Cancer, How Dare You! How to Turn Your Pain into Power, shared her story as a young adult breast cancer survivor, and included the voices of other young women survivors in her down-to-earth talk. “Everyone can see the scars from the mastectomy, but the scars that are the hardest to heal are the ones you can’t see,” she reminded attendees, urging better support for and communications with patients.
In Friday’s final conference session, the “art” and “science” of medicine were brought together in a powerful documentary, “Intentional Healing,” produced by Vanderbilt-Ingram Cancer Center radiation oncologist Mark Stavas, MD. The film follows famed Nashville music producer Jesse Boyce as he contemplates his own mortality after a diagnosis of terminal prostate cancer. Through the film we see how his art—creating music—was one of the ways Mr. Boyce pursued “intentional healing.” Afterward, an attendee asked how Dr. Stavas, whose practice is palliative radiation oncology, handles burnout and loss in his professional life. Making the film, sharing the patient’s story through art, has helped him to heal, Dr. Stavas said.
“Medicine cures, but art nourishes the soul.”
Stay tuned to ACCCBuzz for more highlights from select ACCC 34th National Oncology Conference sessions.
The treatment of non-small cell lung cancer (NSCLC) has rapidly evolved over the last several years as new molecularly targeted therapies have been approved by the U.S. Food and Drug Administration (FDA). Among these therapies are novel drugs that target EGFR, ALK, and ROS1 mutations in patients with NSCLC. Anticipating that advances in lung cancer care will be driven by molecularly-targeted therapies, in 2014, eight ACCC member programs participated in Learning Labs for Process Improvement, an ACCC initiative focused on improving molecular biomarker testing in patients with NSCLC.
Participating programs’ improvement plans were based on the 2013 College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) “Molecular Testing Guideline for Selection of Lung Cancer Patients for Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitors.” These guidelines addressed key questions including:
When should molecular testing NSCLC be performed?
How should EGFR and ALK testing be performed?
Should other genes be routinely tested in lung adenocarcinoma?
How should molecular testing of lung adenocarcinomas be implemented and operationalized?
These cancer programs have been on an ongoing journey to improve their molecular biomarker testing processes and to ensure that patients are receiving the most precise care based on actionable test results.
Earlier this year, ACCC had an opportunity to follow up with three of the cancer programs that participated in the 2014 Learning Labs process improvement program. Each program reviewed their current molecular testing processes for patients with advanced NSCLC. They also reviewed their biomarker testing rates from 2016 and found that they had sustained their process improvements by embracing a culture of continuous improvement that is led by clinical champions, administrative support, and refined processes. Their clinical goals have focused on ensuring that a consistent and timely process for biomarker testing and interpretation will guide the use of targeted therapies for appropriate patients. Their programmatic goals have focused on improving the quality and quantity of lung biopsy tissue samples sent for testing, standardizing their biomarker testing process for NSCLC, and tracking biomarker testing as a quality measure. Read the case studies from the following programs:
As cancer programs continue their journey to improve how they provide precision medicine for patients with advanced NSCLC, pathologists are becoming more involved to ensure that the right tests are being ordered for appropriate patients. Radiologists, pulmonologists, and surgeons are collaborating and sharing best practices for obtaining better biopsy samples for molecular testing. Medical oncologists are leading complex discussions around the role of expanded molecular testing as newer targeted therapies emerge on the horizon. Cancer teams are also actively discussing the role of broader next-generation sequencing (NGS) and liquid biopsy (circulating tumor DNA tests) as they manage patients with NSCLC. New targeted therapies are constantly emerging and clinicians must also be aware of when to look for treatment resistance and switch therapies to maximize clinical efficacy.
ACCC encourages member programs to utilize the resources that have been developed that can help them integrate, optimize, and track biomarker testing processes for patients with NSCLC. ACCC, LUNGevity, CHEST, and CAP have partnered on a NSCLC process improvement toolkit for molecular testing. Access the toolkit on the ACCC eLearning Portal.
After nearly seven years as a quality leader in the outpatient oncology setting, I still remember my first days as a newcomer to ambulatory cancer care. I had many years of experience in large acute care hospitals, where quality roles are fairly well defined and quality priorities are well known: Risk, mortality, readmissions, cost, regulatory needs, and data-driven metrics are the norm.
However, one measurement is important in all care settings—patient perception.
Coming from an inpatient background, I was the new kid on the block. I needed to not only explain what I was doing there in the outpatient setting, but also engage cancer program staff so that they would lead the process of identifying quality priorities in their unique areas of cancer care.
One of the first requests in my new role came from the radiation oncology manager and team. They were struggling with patient perception survey results, which were below the organization’s goal. Nothing they did seemed to make a difference.
As a quality officer, I could see numerous areas of improvement; however, it was not my job to fix things, but rather let them discover the issues and gaps that were right in front of them every day.
It was time to go to gemba.
Walking the Walk A Japanese word meaning “go to the place” or “place where work is done,” gemba is a Lean process that asks unbiased observers to see what is happening around them. Put simply, during a gemba walk, participants “go see, ask why, and show respect.” They walk through the processes of care, ask why things are being done that way, and respectfully take notes without confrontation.
I scheduled a one-hour gemba walk with the radiation oncology team.
My instructions were simple. I asked the team to split up and work in pairs, and then divided the pairs into two groups. Each pair was given a pen and a pad of paper. One group was asked to tour the cancer care facility as the health system VP, and the other as a patient newly diagnosed with cancer or their family member. This way your perspective shifts and you’re seeing facilities and workflow from a business, competition, and especially a patient perspective. Patients and their loved ones are not only absorbing life-changing information, they are also looking for the best place for treatment.
From their assigned perspectives, the radiation oncology staff observed their care environment. They sat in the waiting room, rode in a wheelchair, laid on a radiation table, waited in an exam room, and scanned the facility from ceiling to floor. They took notes, and then came back together an hour later to discuss their findings.
When the notes were compiled, they had around 100 observations. As they sat in chairs, they noticed the need for cleaning and maintenance. When they laid on the treatment tables, they noticed cords and cobwebs. They saw outdated magazines, overfilled trash cans, broken tiles in the bathroom, walls in need of repair, crooked pictures; as busy providers they walked by all of these things every day, but when asked to look as patients and leaders, the need for change became apparent.
We took these observations and turned them into data points that showed our highest areas of need, and we triaged action plans to address the identified issues. Staff learned how to request facility repairs and act on their observations instead of walking by. Their perspective changed. And so did their patient perception scores, improving over time to meet—and even exceed—their organization-wide goal.
The role of quality leader is not necessarily to fix things. Often, it is to help others see existing problems for themselves. Through gemba walks, management and staff can learn to by stepping outside of their daily routine and seeing their facility and their workflow with new perspective.
ACCC member Cynthia Jones, BSHA, CPHQ, is a Certified Professional in Healthcare Quality, Cancer Quality Program, REX Cancer Center, UNC REX Healthcare.
No matter the cancer site or type of treatment, negative outcomes are disproportionately prevalent in underserved communities. For instance, a recent report finds that in the Appalachian Region, cancer mortality rates are 10 percent higher than the national rate, and the cancer mortality rate in that region is 15 percent higher in rural counties than in metro counties.1
ACCCBuzz talked with Nadine J. Barrett, PhD, MA, MS, the Director of OHED and one of the architects of the five-step roadmap, about the importance of community collaboration and vital measures any cancer program can take to address the prevalence of negative outcomes in minority communities.
ACCCBuzz: What is the importance of community collaboration in addressing health disparities and health equity in cancer care?
Nadine J. Barrett, PhD, MA, MS: The community plays a critical part in cancer care across the spectrum—from education and screening to survivorship. The relationships between the community and health systems are critical in terms of access to care and the barriers that may prohibit some from fully accessing services. Collaborating and engaging with our community partners lets us find what innovative programs and services can be developed or enhanced to improve access to care within in the context of our cancer centers, no matter how small or large.
Typically , we come with this top-down approach with our community and patients, where what’s of value to them—their decision making, their thoughts, their ideas—wasn’t being captured. If we don’t create opportunities to learn from each other and work together toward a solution, then we’re fighting an uphill battle.
ACCCBuzz: So community collaboration is essential to delivering truly patient-centered care?
Dr. Barrett: Absolutely. Focusing on health equity and disparities also helps us to understand and appreciate the social and historical relationship that diverse populations have with their community cancer centers and health systems. If a patient in the community doesn’t trust the health system or believe that the health system is only advocating on behalf of their own needs and interests, those perceptions will affect how they talk about cancer screening and diagnosis with their families, friends, and loved ones – ultimately impacting the perceptions and screening behaviors of their family, friends and the broader community. Collaborating with trusted members and organizations with the community is critical to changing this narrative through authentic collaborations and communications.
ACCCBuzz: Why do you think community-based and academic cancer programs make a good partnership in addressing health disparities?
Dr. Barrett: We asked one of our community health centers what our partnership should look like. It was clear to us that there were resources and expertise they had with a given community, and there were resources and expertise we had with degrees of care. The closer we work together and align our priorities, the more we can leverage our expertise toward addressing the needs in their community.
For example, with the Commission on Cancer, when we do community health assessments, we can work together to understand a community’s cancer care needs and implement strategies and research to address them. Large academic centers are able to capture and analyze data. Why not leverage our respective strengths to capture that data? The second part of that is thinking about research, how we can engage our community and patients in research and clinical trials. These collaborations allow us to meet several needs simultaneously. We are able to identify and meet patient and community needs, organizational accreditation, and institutional needs. A win-win for all.
Watch this video to learn more about the Duke OHED comprehensive program for community engagement.
ACCCBuzz: What can other cancer care programs take away from your work at Duke, in terms of improving health equity and disparity?
Dr. Barrett: With our comprehensive program, any and all parts can be modified to suit the size, needs, and capacity of community cancer program structures. For example:
Creating a community advisory council goes such a long way in addressing health disparities. Working together to identify needs, learn from each other, and gain insight into the challenges and opportunities to improve community health in cancer, and to make the appropriate linkages and support programs to address them. A partnership with a community advisory council can go miles in advancing health equity.
From there, you have to figure out how to conduct needs assessments in such a way that the patients, community, and organization’s needs are met, based on aligned priorities. You then can use the assessment as a blueprint to address needs regardless of the size of the organization.
The third area is creating sustainable programs, services, and research opportunities that reflect the outcomes from the assessment findings.
All of these components need to be explored and modified based on the individual structure of local cancer programs.
Dr. Barrett: One of the things I’m most excited about sharing is how empowering this experience is. It’s so rewarding to know that the work we are doing is reaching such a diverse population—black, white, Latino, Asian, LGBTQ, Muslim, poor. There’s a generational difference now, too. We have young people advocating at the college level. It’s like we are in the midst of a community culture shift; we are building together across the spectrum of age, race, and ethnicity.etc. to advance health equity in cancer services.
Reference 1. Appalachian Regional Commission. Health Disparities in Appalachia. PDA, Inc., Cecil G. Sheps Center. August 2017. Available online here.
On August 15, 2017, Dr. Barrett was appointed to the Patient-Centered Outcome Research Institute (PCORI) Advisory Panel on Addressing Disparities.
Meet Dr. Barrett and hear more about the Duke Cancer Institute’s five-step process for implementing a health disparities and equity Health Disparities & Equity Program at the 34th ACCC National Oncology Conference in Nashville, Oct. 18-20. Learn more.
On August 30, the U.S. Food and Drug Administration (FDA) approved the first CAR Chimeric Antigen Receptor (CAR) T-cell therapy, tisagenlecleucel (Kymriah). With this approval of the first cancer gene therapy in the U.S., immuno-oncology took a historic step forward.
Later that same day, in a press release titled, “Innovative Treatments Call for Innovative Payment Models and Arrangement,” the Centers for Medicare & Medicaid Services (CMS) congratulated the scientists and researchers involved in the development of the new treatment, while emphasizing the agency’s on-going commitment to working with stakeholders on “innovative payment arrangements.”
In hindsight, opening remarks at the ACCC Institute for Clinical Immuno-Oncology (ICLIO) Policy Summit held less than two weeks earlier, seem prophetic: “Immunotherapy is a hallmark of what’s going on in oncology. . . wonderful, but expensive new therapies, how are we going to make this work? ” said Lee Schwartzberg, MD, FACP, ICLIO Advisory Committee Chair. Dr. Schwartzberg is Chief, Division of Hematology/Oncology, The University of Tennessee; Medical Director, The West Clinic.
“Immuno-oncology presents remarkable opportunities and challenges at the same time,” said ACCC President Mark Soberman, MD, MBA, FACS, welcoming participants to the Summit. “We have to figure out how to leverage immuno-oncology for our patients in a very sustainable way in our cancer eco-system.” Dr. Soberman is Medical Director, Oncology Service Line; Chief Physician Executive, Monocacy Health Partners, Frederick Regional Health System.
The by-invitation only, August 18, 2017, ICLIO Policy Summit brought together oncology stakeholders including representatives from patient advocacy groups, pharmacy, research, government, industry, oncology clinician leadership, oncology nursing leadership, and a payer representative to share perspectives on current real-world challenges in immuno-oncology through the lens of:
Clinical and Policy Issues
Alternative Payment Models
Application and Impact of Quality Measures
Payer Management of I-O (Immuno-Oncology)
Future Challenges and Opportunities
Watch video for comments from ICLIO Policy Summit participants:
The ICLIO Policy Summit discussion by these diverse stakeholders revealed a 360-degree perspective on the current landscape for the translation of immunotherapy from bench to bedside. Top-level themes from the Summit are highlighted below:
Biomarkers.All stakeholders concur that there is a pressing need to identify biomarkers for immuno-oncology agents in order to address the issue of identifying those patients mostly likely to benefit from being treated with an I-O agent and to help mitigate cost.
Education.New agents are emerging with new mechanisms of action, and combinations and sequencing of immuno-therapy agents are on the horizon. Understanding of side effects, late effects, and long-term effects, and the nuances of immunotherapy delivery for patients in the community continues to evolve. On-going education is imperative, not just for the multidisciplinary oncology team but also for other providers who care for these patients (e.g., primary care, endocrinologists, pulmonologists, radiologists, emergency department staff) and for the patients who will receive these therapies and their caregivers.
Community Perspective.The arrival of new immuno-oncology agents has fundamentally changed the landscape of clinical practice over the past three years. In the community setting, programs need to “take a systematic approach to I-O implementation,” commented community-based provider. P&T Committees must have the capacity to address issues around appropriate use, inventory management, and cost of expensive new and emerging I-O agents to avoid financial toxicity for patients, providers, and institutions.
More Evidence Needed. I-O is far from plateauing, participants agreed, but more evidence is needed around combination therapy and sequencing of these agents. “We don’t know which combinations are superior and which are superior to single agents,” commented a clinician participant. But that evidence “is coming very quickly,” he added. “I think combinations are going to be important,” commented a research clinician, “rational combinations,” adding that the “PD-1 pathway is foundational.”
Access to I-O therapies. Prior authorizations continue to be a barrier to access, stakeholders agreed. Pharmacy and PBM participants, in general, indicated that they follow the lead of the NCCN Drugs & Biologics Compendium, but the high-cost of these agents leads to critical pharmacy issues of how to afford these expensive therapies and how the cancer program’s physicians will use them.
Discussion of pathways, pre-authorizations, and “totality of the evidence” for FDA approval (the summit discussion touched on expedited clinical review for I-O based on review of the ‘totality of evidence,’ as is currently the case for FDA review of biosimilar agents)—brought the conversation back to biomarkers. “We need to focus on biomarkers. . . selecting the right patients for the right agents,” emphasized a researcher participant. And he added, “We need multiple modalities because cancer is very clever.”
Clinical Trial Enrollment.Referencing a recent New York Times article, participants cited the challenge of accruing patients to the many open immuno-oncology trials. At the same time, greater access to I-O clinical trials in the community setting may lessen access barriers to these agents for some patients, commented a researcher participant.
Risky Business: Alternative Payment Models.Discussion of alternative payment models (APMs) focused primarily on the CMS Oncology Care Model (OCM). Summit attendees participating in the OCM agreed that during the first year of the model, efforts centered largely on “getting all the mechanisms in place”—readying practice infrastructure for OCM requirements. With that accomplished, priorities for OCM practices include reducing inpatient admissions and ER visits, and avoiding adverse events. However, participants agreed that the need to address issues around high-cost anticancer agents is nearing. In a risk-sharing payment model, it will be critical to find methods to sustain small and large practices, commented a physician leader.
Stakeholders agreed that a challenge with OCM design is that the episode being measured is too brief; it does not follow the patient’s entire cancer journey. Outcomes such as cure or disease-free survival, for example, are not included in the OCM. “The model looks at cost, not value,” noted a participant.
Still, the OCM provides a path toward demonstrating attributes of patient-centered care that are components of the new value-based payment models, participants said.
Quality Measures & I-O. Coming to consensus on quality measures in oncology remains a challenge. Patient advocate stakeholders pointed to the study by Basch and colleagues presented at ASCO 2017 showing that just by tracking patient-reported outcomes (PROs), patients lived longer. From the patient advocate perspective quality measure concerns are multifold, including:
Tension between the driving trend in oncology toward standardized measure sets (pathways, etc.) and precision medicine, i.e., the need to support appropriate variation in order to individualize patient care.
Current patient satisfaction measurement tools that do not assess what really matters to patients (e.g., quality of life and outcomes).
Quality measures that assess process (much of which is already being done), rather than outcomes measures that would be tangible to patients (e.g., staying out of the hospital).
In response, patient advocacy groups are developing their own quality measures based on what patients’ say is important to them, including not just clinical measures but quality of life measures such as disruption to work, childcare, and transportation to treatment.
Payer Management of I-O.As the current healthcare reimbursement landscape continues to evolve, key concerns identified during the ICLIO Summit were:
The need for biomarkers for patient selection to ensure those most likely to benefit from the I-O therapy will receive it and those who won’t, don’t.
The need for the healthcare system to be more nimble and adaptable in “looking at good data.”
One of the biggest challenges for clinicians is variation in coverage under different health plans. As an example, a provider sees five different patients with the same cancer type, each with a different health plan, each with its own coverage options and requirements. The end result: guidelines to reduce variation are not working, commented a health system executive.
Prior authorizations creating barriers to access and uncertainty for patients, providers, and practices. “We’re taking on risk with . . .value-based payment, but we’re still saddled with prior authorization. Maybe it should be one or the other,” said a clinician leader.
Managed care organizations and others are looking at how to bundle oncology products into trend management pools.
Looking to the Future
The final discussion block looked to the future. In a lightening round, Summit participants were asked to share their perspectives one key challenge or opportunity for immuno-oncology in the near future—summed up in a sentence or two. Their responses offer a final 360-degree look ahead at real-world issues facing immuno-oncology:
We need to develop a quality measure that is “patient returns to functional status.”
In the value discussion, there is realistic, and then there is reality. A lot of what becomes value is tied to your resources. [Many times] in medical situations, that’s not taken into consideration.
Future treatment decisions informed by biomarkers and life circumstances.
View all navigators as integral parts of the cancer care system.
Adapt [the] delivery system to be more nimble to adopt major advances.
We need to look at real-world evidence for comparative effectiveness. We have to go beyond the regulatory system to really understand the value in the community that each agent brings.
Will we have enough doctors, nurses, social workers, and navigators to treat patients with these complex therapies?
We need to develop and implement patient-reported outcomes, and we need to understand the real cost of care.
Between academic programs, the federal government, [industry], and the community, we need to get more serious around biomarker development and who is most likely to benefit from expensive therapies and those not likely to benefit.
Clinical trials. . . how can we bring clinical trials to community hospitals? We need a process to open clinical trials [so that the community can] benefit from access to these drugs early on.
Evidence generation. . . stakeholders need to generate evidence.
Preparing the nursing workforce [to move] from a disease-state specific [care model] to a more biomarker-driven model.
Form follows function; if the future of medicine is biomarker driven, then resources have to be organized along that line.
Greater investment in analytics so that we can get more nimble feedback; greater degree of analytic support.
Establish and maintain a national registry to capture and analyze data from real-world care.
In closing the ICLIO Policy Summit, Advisory Committee Chair Lee Schwartzberg, MD, FACP, thanked participants: “We come from different points of view, but we have common ground. . . . Communication is the way we’re going to go forward with new therapies in [our] complex [healthcare] system.
The ACCC Institute for Clinical Immuno-Oncology is the only comprehensive initiative to prepare multidisciplinary cancer care providers for the complex implementation of immuno-oncology in the community setting. View ICLIO’s robust resources, webinars, education offerings, and more, on the ICLIO website accc-iclio.org.
On August 21, 2017, ACCC submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s proposed 2018 updates to the Quality Payment Program (QPP), a two-track value-based reimbursement system created by the Medicare Access and CHIP Reauthorization Act (MACRA). The two tracks in which eligible clinicians can opt to participate are the enhanced fee-for-service based Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs), which require clinicians to take on more than nominal risk.
Under the QPP, 2017 performance will affect Medicare payments for all eligible clinicians in 2019. While many ACCC members have said they’re somewhat familiar with the program, others don’t feel quite as prepared to meet the specific program requirements.
In our comment letter, ACCC asked CMS for continued flexibility and additional clarity on how the MIPS adjustment will be applied in 2018. ACCC requested that:
CMS should continue to offer clinicians maximum flexibility in participating in the QPP, including through broad availability of alternative reporting options such as virtual groups, facility-based scoring, and MIPS APM reporting and scoring.
ACCC urges CMS to continue expanding the use of flexible reporting options that allow clinicians in diverse practices and communities across the country to participate in the QPP. Many ACCC practices are also currently participating in MIPS APMs, such as the Oncology Care Model (OCM), that do not currently qualify for the Advanced APM incentive outlined in the current proposal. ACCC advocates for more flexibility in what qualifies as an advanced APM and a continued flexible approach to allow clinicians to participate in the QPP to the best of their ability and in a manner that reflects the nature and priories of their practice and their patients.
CMS should finalize the increase in the low-volume threshold to $90,000 in Part B allowed charges and 200 Part B beneficiaries and clarify that the $90,000 threshold does not include the cost of drugs billed directly by clinicians.
ACCC supports increasing the threshold that exempts clinicians from the QPP based on a low revenue and patient volume because it allows practices with tighter resources to still successfully participate without fear of lower performance scores. We also ask CMS to clarify that the cost of the drugs billed directly by clinicians under Part B will not count towards the revenue threshold.
CMS should finalize its proposal to assign a weight of 0% to the cost performance category for CY 2018 and carefully implement the cost score in the future so that clinicians are assessed and scored against their peers and only for the costs of care for which they are responsible.
ACCC supports CMS’ proposal to delay scoring clinicians on cost for 2018 and urges CMS not to impose cost of care payment adjustments without accurate methodology. When considering how to assess cost under MIPS, we hope that CMS will: ensure fair beneficiary attribution for overall cost measures, establish narrowly tailored episode-based measures, apply its discretion to reweight performance categories, and recognize the variable nature of costs through appropriate risk and specialty adjustments and exclusion of outliers.
Importantly, CMS should clarify that MIPS payment adjustments will not apply to Part B payments for drugs billed directly by clinicians.
ACCC strongly opposes applying the MIPS payment adjustment to Part B payments for drugs and urges CMS to clarify that the adjustment will not apply to drug payments. We are concerned that the application of MIPS adjustments to Part B drug payments would represent an unjustified change in agency policy, create incentives for clinicians to focus on cost of treatment rather than whether it is clinically appropriate, and create new barriers to access for patients.
In cancer care, the use of patient navigators has grown substantially over the past decade. In 2012, the American College of Surgeons Commission on Cancer added Standard 3.1 requiring that accredited programs have a patient navigation process in place.
While the navigator’s role and responsibilities may vary from institution to institution, clinical navigators typically:
assess patients’ clinical, financial, spiritual, and other needs;
ensure patients are referred for appropriate supportive care services such as financial counselors, social workers or psychologists, palliative care, and rehab services;
provide needed patient education on their disease and its treatment;
assist patients in overcoming barriers to care; and
assist in discharge and advanced care planning.
Given this list, it may come as no surprise that nurses and social workers are often in navigator roles. Some programs may also employ non-clinical navigators who assist patients with some services, as is the case with the American Cancer Society’s resource navigators, who educate patients about ACS and other community resources. Patient navigation often involves a variety of multidisciplinary team members, with nurse or social work navigators referring patients to physical therapists or dietitians for their specialized care, for example.
For diagnoses that require intensive nutritional support, such as head and neck or esophageal cancer, a Registered Dietitian Nutritionist (RDN) can effectively serve as a patient’s principal navigator, as these patients may see the RDN as often, if not more often, than other team members. In initial medical and radiation oncology consults, these patients are often told that they will need a feeding tube. For many patients, the idea of having or using a feeding tube can be frightening and overwhelming. Prior to receiving feeding tube education, patients may have many concerns such as that the tube is very large and cumbersome, how it might impede normal daily activities, that tube placement is permanent, or that they or their caregiver(s) won’t be able to learn how to use it. Meeting with an RDN for immediate education can allay any fears and concerns about this component of their care plan and reduce distress. In addition, the RDN can reassure patients and caregivers that he or she is available to assist with any questions about using the tube throughout the course of treatment. Further, the RDN navigator can assure the patient that their experience and training places them in a unique position to best advocate for the patient with respect to nutrition support issues.
The RDN’s knowledge base makes this member of the cancer care team an excellent fit for ensuring coordination of care with a patient’s home infusion agency. An RDN navigator can work with the medical team to ensure proper documentation so that enteral feedings are covered by insurance, assist patients with locating donated tube-feeding supplies and formula in the event of limited or a lack of coverage, and work with pharmacy services to get medications converted to crushable or liquid forms for use in feeding tubes. In addition, the RDN navigator would continue to see the patient regularly during the transition from tube feeding back to an oral diet, coordinating care with the speech therapist or surgeon as needed. For example, after esophagectomy, patients experience significant changes in oral diet tolerance and may require considerable education and coaching to adapt to their “new normal.”
Much like the nurse or social worker navigator, the RDN would refer patients to other disciplines when needed, such as to an RN for education about port placement, to a social worker or financial counselor for financial concerns, or to rehabilitation services (physical and/or lymphedema therapy). For some patients, intensive nutrition support may be required from before treatment until long after treatment is completed, making it a central component of care that an RDN is well equipped to navigate.
For cancer patients requiring intensive nutritional support, having an RDN serve as the patient’s navigator can be a winning combination, improving care and the patient experience.
ACCC member Kelay E. Trentham, MS, RDN, CSO, is a past chair of the Oncology Nutrition Dietetic Practice Group of the Academy of Nutrition and Dietetics. She is currently an oncology dietitian at MultiCare Regional Cancer Center in Tacoma, WA.