Tag Archives: cost of cancer care

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.

A Financial Advocate’s Six Steps to Cost Transparency

By Clara Lambert, Oncology Financial Navigator

Form-with-stethoscopeThe challenges of today’s healthcare environment mean that every patient with cancer can benefit from financial navigation. At some point during their treatment, most patients will have questions about their billing, and how it will affect their personal finances. Make sure your financial navigation process includes meeting with each new patient face-to-face. Whether this meeting is scheduled after their first appointment with the oncologist, or after their chemotherapy teaching and prior to beginning treatment, this face-to-face conversation is an opportunity for financial advocates to introduce themselves, explain their role, and help the patient feel more comfortable asking questions about costs of care early on rather than later when it may be too late to access assistance.

Here are six steps financial advocates can take toward cost transparency.

Step 1. Review All Insurance Benefits.

Before meeting for the first time with a new patient, financial advocates should review all of the patient’s insurance benefits.  This should be a comprehensive review conducted with the patient’s treatment plan in mind. Look at all hospital, medical, and pharmaceutical benefits, as the patient’s treatment could encompass some or all of these benefits.

Step 2. Work with Your Pharmacist & Chargemaster to Develop Price Estimates for More Common Treatments.

Developing price estimates for common treatments can help financial advocates streamline the financial navigation process.  At my facility, our pharmacist worked with our oncologists to develop the most common treatments for each diagnosis following NCCN Guidelines. The financial team is then able to work with that information to develop the price estimates.

Step 3. Personalize the Price Estimate to the Patient.

Taking the insurance review and the previously developed price estimates into account,  financial advocates can develop a personalized price estimate specific to each patient. You may want to develop a form to populate with this information so if the patient wants a copy of the information, it’s ready to go.

Step 4. Always Have a Plan in Mind.

Now that you have reviewed the patient’s benefits and prepared a personalized price estimate for the patient, you are almost ready for that first meeting.  Before meeting with a patient, you should prepare a plan outlining potential assistance.  Be sure your plan includes all of the qualification requirements for financial assistance and also verify that the fund is still open and accepting new applications. This advance work will help streamline the patient meeting, and allow you to start any applications immediately if the patient qualifies and is interested in pursuing financial assistance.

Step 5. Meet With The Patient.

From your very first meeting with the patient, it’s important to build a relationship. In this face-to-face meeting you will be getting to know the patient, as well as letting the patient know that you are there to help. You will need to make sure that your conversations are compassionate and understanding.

During the meeting, you will review the patient’s insurance benefits and the cost estimate for their plan of treatment.  There is often some patient education to help the patient understand his or her insurance benefits. As part of this meeting, complete a financial screening and begin the application process for the programs that the patient qualifies for.  The patient may be feeling overwhelmed with information, so preparing a checklist for the patient to identify any missing items will help them comply with supplying the information. It is best to submit an application for financial assistance when everything is complete, as many foundations will not look at an application until they have received all the required information.

Step 6. Follow Up & Track.

Many programs provide instant approval. For those programs that do not, you will need to set a follow-up reminder.  I typically follow up weekly.  If you receive a denial that you disagree with, know the appeal process, and begin immediately.  Once the application has been approved, make sure you notify the patient and billing personnel, and track the information to show the cost savings to your patient and your facility.

Guest blogger ACCC member Clara Lambert is an oncology financial navigator with Cancer Services at Munson Medical Center, and an active member of the ACCC Financial Advocacy Network (FAN).  Learn about upcoming ACCC FAN Case-Based Workshops here. Explore all of the ACCC FAN resources for oncology financial advocates here.

Making the Case for Oncology Financial Navigation

Dan-Sherman-150x170By Dan Sherman, MA, LPC, Guest Blogger

Yes, it’s that time of year again. Open enrollment for health insurance plans spans the range of employer-based policies, ACA policies, and the host of Medicare options available to Medicare beneficiaries. For many this is a dreaded period of time; they are forced to make important decisions about their finances and health coverage without having a core understanding of insurance terminology and how these policies will affect their access to care. For many there is little understanding of how the basic terms “deductible,” “max out of pocket,” “co-pays,” and “co-insurance” may affect the financial well-being of the enrollee. Nor do many understand the differences between HMO, PPO, POS, HSA, or PFFS, and how these differences may play a major role in the financial well-being and access to care for the oncology patient. Unfortunately, for far too many patients confusion leads to decision paralysis; they end up making no choice at all, or keeping the plan they have even though it may not be in their best interest. A time that should be viewed as an opportunity ends up being a time of dread and frustration, resulting in less than optimal coverage for care the patient desperately needs.

Changing the Paradigm

We, who are in the business of assisting oncology patients, also need to be in the business of changing this scenario from a time of dread and angst to a time of opportunity and hope. However, in order to accomplish this, many in the oncology community need to take ownership of the fact that we have aided in the mass confusion that our patients experience when it comes to understanding their health insurance policy. How often do we respond to a confused patient with the well thought out answer, “You will need to call your insurance company with that question”? How often do well-intentioned staff encourage patients to go through the cumbersome process of applying for Medicaid even though they do not qualify for this benefit in the first place? Have you tried to make sense of an itemized bill? It’s time that we in the medical field acknowledge that we are often just as confused about the health insurance policies as our patients.

Facing the Problem

Acknowledging this problem is the first step toward solving the problem of financial toxicity. So, let’s face it! Navigating the financial ramifications of cancer care is complex! If it were simple, we would be seeing much less financial toxicity in the oncology setting. Patients and providers alike are getting lost in a maze of health insurance policies, enrollment guidelines, and assistance programs, all requiring different information for successful enrollment. The rules governing Medicare Part D, with the initial coverage, coverage gap, catastrophic coverage levels, co-pay assistance guidelines, and steps to qualify for extra assistance programs, are overwhelming for most individuals. Up to 35 percent of new oncology products are oral medications covered by Part D, with 11 out of 12 of these medications costing more than $100,000 a year. It is essential that we understand the core benefits of patients’ insurance policies and help these patients apply for programs that are the most appropriate and readily available to meet their specific needs. All too often I have seen patients refuse oral treatment recommendations due to cost; only to find out that if these patients had received comprehensive financial navigation, they would have had access to these medications without significant cost-sharing responsibilities.

Then there is the complexity of choosing Medicare plans. Have you tried to explain the coverage differences between Medicare Advantage, Medigap, employer-based plans, and Medicaid? The fact is that Medicare beneficiaries who choose from a list of 30 to 60 different coverage options, many with significant cost-sharing responsibilities, need advice from someone with significant experience with these options, particularly in terms of how those policies cover cancer treatments. The oncology community is seeing similar trends with the health insurance exchanges under the Affordable Care Act (ACA). Patients are overwhelmed and confused about the enrollment process and the choices of coverage policies available to them.

Helping Patients Navigate the Maze

When patients are left on their own to wade through the 50+ Medicare options; the extra help program for Part D; co-pay assistance programs; premium assistance programs; ACA enrollment guidelines; the choices of bronze, silver, gold, or platinum plans; and available out-of-pocket subsidies, they will likely experience financial toxicity as they journey through cancer treatment. One of the main tools I use when providing financial navigation services to oncology patients is taking advantage of open enrollment and educating the patient on better options available to them in the context of their medical condition. Our patients need not only high-quality medical care provided in a compassionate environment, they need expert financial navigation services to help reduce the very real side effect of financial toxicity.

I contend that we need to see open enrollment as an opportunity for education and a way to decrease financial toxicity. So, let’s change the mindset of open enrollment from a time of dread to a time of opportunity so our patients suffer less, and providers get paid for the services they provide.

An important resource in this effort is ACCC’s Financial Advocacy Network, which provides tools, resources, and education for oncology team members involved in helping patients with issues related to the costs of cancer diagnosis and treatment.

Dan Sherman, MA, LPC, is a clinical financial consultant for Mercy Health Saint Mary’s, The Lacks Cancer Center, Grand Rapids, MI. He is also founder and president of The Navectis Group, a consulting company that assists oncology providers in implementation of financial navigation programs. Mr. Sherman serves on the Advisory Committee for ACCC’s Financial Advocacy Network.

Lessening the Financial Side Effects of Care

by Amanda Patton, Manager, Communications, ACCC

Health Care ReformNo one would argue with the fact that stresses related to the financial burden of the cost of cancer treatment are the last thing cancer patients and their families need.  And yet, according to the most recent ACCC Trends in Community Cancer Centers survey, 88 percent of respondent cancer programs reported seeing more patients needing help with prescription drug expenses, co-pays, and co-insurance.

According to a study from Duke University, many cancer patients would  like to talk about the cost of treatment with their healthcare providers, but for a variety of reasons, these conversations often do not happen.

However, this may be changing.  Along with renewed emphasis on the importance of distress screening and meeting the psychosocial needs of patients comes an increased awareness of the importance of enabling patients to focus on healing rather than on struggling with the financial side effects of care. Many cancer programs are adding staff to serve as financial advocates to help patients and their families; others are working to provide these services with existing staff.

ACCC’s newly released 2014 Patient Assistance and Reimbursement Guide is a user-friendly resource designed to help cancer programs in this effort. This is the fourth year ACCC has published the guide, which is available in both a print and digital format and includes links directly to patient assistance programs, the forms patients and providers need, and much more. The guide includes information on pharmaceutical and non-pharmaceutical patient assistance programs and reimbursement resources, as well as:

  • Financial counselor and patient advocate position descriptions
  • A tool to estimate patient responsibility of treatment costs
  • A charge capture flow chart
  • A patient assistance checklist for uninsured patients
  • A co-pay assistance checklist.

ACCC offers additional resources through its Financial Information and Learning Network, which includes online courses and tools for providers to help in providing patients with financial assistance services. Finally, an upcoming session on “Financial Advocacy: Improving the Patient Experience”  at the ACCC 40th Annual National Meeting will discuss strategies to meet patients’ evolving financial advocacy needs.