Author Archives: Amanda Patton

Just Breathe—Listening to the Patient’s Perspective

October is Breast Cancer Awareness month. In this guest blog post, breast cancer survivor Meredith Goldberg shares her perspective on the importance of making space to “just breathe.”  

By Meredith Goldberg

There was a moment when the voice on the other end of the line told me, “I’m sorry to tell you this, but you have cancer,” that I thought for sure that I was part of a very elaborate prank.

Breast cancer? Me? I’m only 32 years old. They must have the wrong number. They must have the wrong person.

“Ms. Goldberg, are you there?” the voice on the line asked.

No such luck.

As the nurse began telling me what I needed to do next, the biopsy that needed to be performed, the surgeon that needed to be found, I stood in the kitchen of my best friend’s house, frozen. I should have been writing down her instructions. I should have put her on speaker so my best friend could have heard any of this info, but I didn’t. I was in shock.

This was the first in a string of moments during my cancer “journey” (for lack of a better word) where I was inundated with information that eventually just escaped my brain. And it was all information that I needed, information that was crucial to my course of treatment and subsequent wellness routine.

As I moved through my cancer “journey,” I found that this happened to me often. I would be sitting with my surgeon, my plastic surgeon, my radiologist, my naturopath, my whomever, and suddenly I was staring out the window with the “Farmer in the Dell” on a loop in my head. It wasn’t because I was bored; far from it. These were the people tasked with keeping me alive, the people making sure that I made it to my 33rd birthday, and beyond. I wanted to listen, really I did, but I became so overwhelmed on certain occasions that I just mentally shut down.

The argument could be made that I should have spoken up. I should have said, “Excuse me, can you repeat that?” and that is an accurate statement. But there is something about sitting across from a medical professional that can be super intimidating, especially if you are a person that up until the age of 32 had never even had a cavity.

It wasn’t until I had what I like to call “the talk” with my oncologist about my course of chemotherapy that I first experienced one of my doctors taking a step back. He could sense the fear in my face.  He could see the tears streaming down my cheeks as he told me that I was about to undergo 12 rounds of chemo, 6 Herceptin-only rounds that would have no effect on my body, but that the 6 rounds of Taxotere, Carboplatin, and Herceptin that would precede the Herceptin-only therapy would leave me completely bald.

“Ok, that’s enough for today,” he said as he closed my ever-expanding file. “You’ve had enough. We can talk more next week. I don’t want to overwhelm you.”

He was a little too late with the overwhelming, but I appreciated the break.

From that point on, I learned that I had every right to say, “Hey, you know what? I’ve had enough.” And to my surprise (and delight) my doctors honored my feelings and took a step back.

At the end of the day, I always appreciated the sense of urgency that was applied to my treatment and the time that was put into creating my care plan, but what I appreciated even more was when we closed my file for the day, sat back and just took a deep breath.


Meredith Goldberg is the author of From Cocktails to Chemotherapy: A Guide to Navigating Cancer in Your 30’s, now available on Amazon.

The Ongoing Journey: Improving Molecular Biomarker Testing in NSCLC

By ACCC Provider Education

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.


Stay tuned for more actionable strategies for process and quality improvement from the upcoming ACCC 34 National Oncology Conference, Oct. 18-20, in Nashville, TN. Learn more.

Go to Gemba? Here’s Why

By Cynthia Jones, BSHA, CPHQ

Quality

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.

Learn more about strategies and solutions for improving the patient experience at the upcoming ACCC 34th National Oncology Conference, Oct. 18-20, 2017, in Nashville, TN.
View the agenda.

 

Reaching Out: Cancer Program-Community Collaborations for Health Equity

By ACCC Communications

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

To combat cancer disparities in North Carolina, Duke Cancer Institute decided to engage the community and create meaningful, collaborative relationships with local agencies, residents, and cancer care providers. The result was the Office of Health Equity and Disparities (OHED), which developed a five-step blueprint for cancer programs to engage their communities proactively, increase minority engagement, and improve the quality and scope of patient care. For their efforts, Duke Cancer Institute will be honored with a 2017 ACCC Innovator Award during the upcoming ACCC 34th National Oncology Conference in Nashville, Tenn.

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.

ACCCBuzz: What are you excited to share with the attendees at the ACCC 34th National Oncology Conference this October?

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.

 

360-Degree Perspective from the ACCC Institute for Clinical Immuno-Oncology Policy Summit

By Amanda Patton, ACCC Communications

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:

360-Degree Perspective

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.

Staying the Course: The Role of Oral Oncology Nurse Navigators

By Virginia Vaitones, MSW, OSW-C

The development and use of oral agents in treatment for oncology and blood disorders has exploded over the last decade and half. Today, these agents bring many benefits to patients and cancer care staff, but along with those benefits come challenges.

Then . . . and Now
Thinking back to 2001, for example, when capecitabine, the first oral chemotherapy for the treatment of metastatic colorectal cancer was approved, Medicare covered 80% and the beneficiary’s co-insurance was 20%. A patient could simply take the prescription to the local pharmacy and get it filled. The relatively modest financial impact and the ease with which the patient could access the medication made me excited about the use of oral agents. And at the time, there was much discussion about oral agents being the treatment of choice in the future.

Nearly two decades later, we now have more than 50 U.S. Food and Drug Administration-approved oral anticancer agents.  Over that same time span, as we all know, our healthcare landscape has become increasingly complex, as have our anti-cancer therapeutic regimens. Currently, capecitabine is 1 out of only 5 oral chemotherapy that is covered by Medicare at 80%. Patients and providers today often face challenges in accessing and affording costly new oral agents. Patient understanding of and adherence to complex treatment regimens can also be a barrier to effective treatment. As a result, ensuring quality care for patients receiving oral agents often requires a coordinated effort by innovative and creative cancer practices and programs.

The September/October edition of Oncology Issues highlights two such programs. One program is a large physician practice in central New York with an in-house dispensary; the other is a large outpatient hospital network serving two states, Kentucky and Southern Indiana, also with an in-house dispensary. The first step for both was consulting with their stakeholders to identify how care needs to be delivered and monitored. In both instances, on-going patient support and education were identified as key in establishing trust and compliance with the patient and their caregivers. The answer for both programs? Creating an oral oncology nurse navigator program that ensures care coordination, provides a single point of contact for patients and providers, and has led to improved patient care and satisfaction.

As we engage in the complex delivery system of value-based, patient-centered care, the Association of Community Cancer Centers continues to develop tools and resources for cancer care providers seeking to implement or enhance their oral oncolytic programs. Explore peer-to-peer resources, including webinars, white paper, and patient education materials, available through the ACCC Education initiative Steps to Success: Implementing Oral Oncolytics.

Approximately 25-30 percent of the new cancer treatments in the pipeline are oral agents; cancer programs and physician practices will continue to need a well-coordinated team effort to ensure patient safety and satisfaction.


Virginia Vaitones, MSW, OSW-C, is a past president of the Association of Community Cancer Centers (ACCC)  and the Association of Oncology Social Work (AOSW). She is currently serving as chair of the ACCC Editorial Committee. 

The 34th ACCC National Oncology Conference, Oct. 18-20, offers the Oncology Pharmacy Education Network (OPEN) Pre-Conference, including a session on a comprehensive, collaborative, pharmacist-led oral chemotherapy program. Learn more here.  View the full conference agenda.

ACCC Comments to CMS on Quality Payment Program Proposed Rule

By Blair Burnett, ACCC Policy Analyst

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.  

ACCC will update our membership when we see a final rule from CMS. Read our full comments.

Dietitian as Navigator: A Winning Combination

By Kelay Trentham, MS, RDN, CSO

Compass pointing at answers-SMALLIn 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.

For more, learn about a weekly outpatient nutrition clinic for head and neck cancer patients developed by 2014 ACCC Innovator Award winner Beaumont Cancer Institute, Royal Oak, MI.

CMS Proposed 2018 Medicare Rules: What Lies Ahead?

By Leah Ralph, Director of Health Policy, ACCC, and Blair Burnett, Policy Analyst, ACCC

Healthcare costsHere in Washington, D.C., as we count down the days remaining in the Congressional August recess, the Centers for Medicare & Medicaid Services (CMS) has reminded us that big changes in healthcare are not limited to the political brinkmanship of ACA repeal. On July 13, 2017, the agency released its CY 2018 proposed Hospital Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) rules. The proposed OPPS rule was the big news this year, signaling major changes may be in store for hospital reimbursement in 2018. The agency is proposing significant reduction in payment for drugs purchased under the 340B Drug Pricing Program and for 2018, CMS is proposing further reimbursement reductions for new off-campus provider-based departments (PBDs).

Holy OPPS!
The 340B Drug Pricing Program, created in 1992, requires drug manufacturers to provide outpatient drugs at a discounted price to eligible healthcare facilities who are generally providing care to a certain percentage of indigent patients. While the 340B program has grown, and reform has been widely debated by policymakers over the past decade, CMS’ rule proposes to fundamentally alter the way providers will get reimbursed for drugs purchased through the program. It’s worth noting though that 340B oversight is under the jurisdiction of the Health Resources & Services Administration (HRSA), an agency of the U.S Department of Health and Human Services, and not under CMS purview.

For 2018, under the OPPS CMS proposes to reduce Medicare reimbursement for separately payable drugs without pass-through status purchased through the 340B Program from average sale price (ASP) plus six percent to ASP minus 22.5 percent. Further, because CMS cannot currently identify 340B drugs in Medicare OPPS claims data, CMS also proposes to require that hospitals submitting claims for separately payable drugs not acquired through the 340B program use a modifier on the claim to be reimbursed at ASP plus six percent.

Medicare’s HOP Panel Weighs In
ACCC continues to work through the details of the proposal and meet with policymakers and other stakeholders to put forward meaningful, workable solutions for reforming the 340B program. Most recently, on August 21, ACCC and other stakeholders testified at Medicare’s Advisory Panel on Hospital Outpatient Payment (HOP) meeting, outlining the deleterious impact this proposal would have on cancer programs participating in the 340B program. (ACCC also testified against the agency’s proposal to related to packaging Level 1 and 2 drug administration services, more on this below.) At the conclusion of the meeting, the HOP Panel voted to recommend to CMS that the agency drop the current proposal to cut 340B payments.

To learn more about CMS’ proposal and ACCC advocacy efforts, join us in Nashville, Oct. 18-20 at the 34th ACCC National Oncology Conference.

And There’s More
Another significant proposed change relates to packaging of drug administration services. Currently CMS excludes packaging of low-cost drug administration services (i.e., costing less than or equal to $100) from the ancillary services packaging policy. For 2018, the agency is proposing to package Level 1 and 2 drug administration services when these services are performed with another separately payable service, but pay for them separately when performed alone. CMS believes that this “conditional” packaging of drug administration services will promote equitable payment between physician offices and hospital outpatient departments. ACCC disagrees with the agency’s rationale and will be urging CMS not to finalize this policy.

Opportunity to Comment on 14-Day Rule
In the 2018 proposed OPPS rule, CMS is also soliciting comments on the “14-Day Rule.”  This is a policy that determines when a hospital may bill Medicare for a clinical diagnostic laboratory test versus when the laboratory performing the test may bill Medicare directly. CMS is considering potential modifications to the “14-Day Rule” that would allow labs to bill Medicare directly for molecular pathology tests and advanced diagnostic laboratory tests. ACCC played an active role in requesting that this policy be reopened for public comment.

Moving to the Proposed 2018 PFS Rule: CMS Proposes Change to Site-Neutral Payment
For 2018, CMS is proposing to further reduce reimbursement for non-excepted off-campus provider-based departments (PBDs). [Notably, this provision is included in the PFS proposed rule, despite impacting facilities traditionally billing under the OPPS, because in 2017, the PFS was the “applicable payment system” for these non-excepted PBDs and CMS reimbursed them under the PFS at non-facility rates.] Read on for details.

In the 2018 PFS  rule, CMS  proposes to significantly change last year’s site-neutral payment policy and further reduce reimbursement for non-excepted off-campus provider-based departments (PBDs). In general, these are entities that began billing Medicare as an off-campus PBD after November 2015.  For these non-excepted PBDs, the agency is proposing to decrease payment from 50% to 25% of OPPS rates. The agency is basing this proposed rate reduction on a comparison of payment rates for clinic and office visits under both payment systems (i.e., the OPPS and PFS). CMS expressed concern that paying 50% of the OPPS rate might result in payments for items and services that are greater than would otherwise be paid to physician offices under the PFS. Early analysis by ACCC, however, shows that reimbursement at 25% of OPPS will be well below PFS rates for certain services.

Of note: In the proposed rule, CMS does not address whether the payment reduction for drugs acquired under the 340B Program or the modifier for drugs not acquired under that program would apply to these non-excepted office-campus provider-based departments

More on the 2018 Proposed PFS Rule
While, overall, the Physician Fee Schedule was fairly quiet this year, one notable provision is CMS’ approach to payment for biosimilars. For 2018, the agency is proposing to continue its approach (from 2016) that biosimilars will generally share a single HCPCS code and that these products will be grouped into the same payment calculation for the purposes of determining a single ASP payment limit. While CMS isn’t officially opening this policy for comments, the agency requests feedback on how this already-implemented policy will impact the ability to create a competitive marketplace and encourage innovation in the biosimilars market.

Big Picture
Overall, CMS estimates that OPPS payments will increase by nearly two percent next year (except for the impact of the 340B proposal), while under the proposed PFS, payment rates will see no change for hematology/oncology and a one percent increase for radiation oncology in 2018.

Let Us Hear From You
CMS is taking comments on both the OPPS and PFS CY 2018 Proposed Rules through Sept. 11, 2017, and, importantly, also seeking open-ended comments from the public on policies that would maintain flexibility and efficiencies in the Medicare program while reducing unnecessary burdens for clinicians and patients. ACCC is busy drafting its comments and we want to hear from you. Please contact Leah Ralph, Health Policy Director, at lralph@accc-cancer.org with your input. We also encourage you to submit comments directly to CMS at regulations.gov.

 

Taking Lung Cancer Screening on the Road

Carolinas HealthCare System, Levine Cancer Institute will be honored with a 2017 Innovator Award at the ACCC 34th National Oncology Conference in Nashville, in October, for their development of the first mobile CT unit for lung cancer screening in the U.S., bringing state-of-the-art technology to rural communities. 

By Mellisa Wheeler, BSW, MHA, and Derek Raghavan, MD, PhD

As the oncology community is well aware, despite improvements to the early diagnosis, systemic immunotherapies, and gene-directed treatments of lung cancer, mortality rates remain high for this disease. A number of factors underlie this high death rate: the nature and natural history of the disease itself, poor access to care among continuing and recent smokers, lack of health education, fiscal and cultural issues, social stigma, and geographical isolation, among others. When patients present with Stage 1 (localized) lung cancer, surgical cure is possible in more than 50% of cases; when patients present with metastatic disease, for practical purposes, cure is highly unlikely.

Given that geographical isolation and barriers to care access are such important determinants of outcome, the Levine Cancer Institute sought to develop a program that would help to identify and eliminate barriers in high-risk and underserved communities.

Supported by a grant from the Bristol-Myers Squibb Foundation and in collaboration with Samsung and Frazerbilt, Levine Cancer Institute has developed the first mobile CT lung cancer screening unit in the United States.

Our mobile screening vehicle consists of a conventional low-dose Samsung CT unit mounted onto a robust, well-sprung truck body, with a built-in clinical space.  Initial testing has demonstrated the fidelity of the unit, as well as the lack of impact of on- and off-road transportation on the functionality and image quality of the scanner.

We have also created a mechanism for electronic image transfer for reporting at a central location by the staff of partner radiology groups like Charlotte Radiology, Stanly Imaging, and Shelby Radiological Associates. Watch our video and learn more.

The entire program, one of several lung cancer projects of different types supported by the Bristol-Myers Squibb Foundation, is directed toward underserved and under-privileged populations. Our program includes several social components, including outreach and education on lung cancer screening for local physicians, nurse navigation and education, patient outreach with smoking cessation programs, and meticulous follow-up to avoid the loss of patients with identified lesions. Carolinas HealthCare System, the largest safety-net health organization in the Carolinas, has committed to providing optimal care to any patients shown to have lesions requiring further investigation, irrespective of their ability to pay; this care includes follow-up and repeat scanning; biopsy; and surgical, radiation, or systemic treatment.

We have already identified cases of early stage disease that have been directed towards definitive and hopefully curative treatment. In addition to the potential to improve patient outcomes, surgical treatment of early stage lung cancer is far less costly to the community than palliating the disease via systemic therapy. Through our program, we anticipate much improved outcomes for lung cancer treatment at a substantially reduced cost in the community.


Mellisa Wheeler, BSW, MHA, is Disparities & Outreach Manager, Levine Cancer Institute, and Derek Raghavan, MD, PhD, FACP, FRACP, is President, Levine Cancer Institute, Carolinas HealthCare System.

Hear details on the Levine Cancer Institute lung screening program and see their mobile CT unit at the ACCC 34th National Oncology Conference in Nashville, Oct. 18-20. Browse the full agenda.