Category Archives: ACCC News

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.

 

Chemotherapy Drug-Specific Education: Putting Information at the Patient’s Fingertips

As we continue to better understand the many diseases encompassed under the name, “cancer,” we are also seeing an increase in the number and complexity of anti-cancer treatments. These exciting advances are taking place while cancer programs are striving to empower patients with education about their diagnosis and treatment journey and continually improve the patient experience of care. In this guest blog post, Dr. James Weese, vice president, Aurora Cancer Care, describes his program’s 2017 ACCC Innovator Award winning approach.

By James Weese, MD, FACS

The Challenge
Oncologists, nurses, and other cancer care staff across the country work tirelessly to find the best way to deliver a patient’s treatment plan, including the type of chemotherapy treatment recommended and side effects patients may experience. In the aftermath of hearing the words, “You have cancer,” the life-changing ripple effects of that diagnosis can make it challenging for patients and their families to absorb all the details and fully understanding the treatment plan that’s ahead.

At Aurora Cancer Care, we wondered how we could provide better information in a consistent manner to patients across our large geographical area. Information that could be delivered in the office and reviewed in the comfort of the patient’s home. We offer cancer care in 19 communities from the Wisconsin-Illinois border all the way up to Marinette, Wisconsin, and diagnose nearly 8,000 new cases each year.

That’s a lot of people who need to hear consistent messages and in a way that’s convenient for them.

Our team at Aurora Cancer Care set out to address this challenge while creating a more meaningful experience for patients and their families. Under the leadership of Kerry Twite, MSN, RN, a certified oncology clinical nurse specialist with Aurora Cancer Care, a series of more than 125 educational videos were developed to provide a more personalized experience to patients. Four key principles guided the development of the video series:

  1. All patients need basic information about chemotherapy prior to treatment.
  2. Most drugs today are given in combination with other drugs.
  3. Patients want to share educational information with family and friends who may not be able to attend each appointment.
  4. Patient education from nursing teams can vary depending on multiple factors, including available time, location, and number of other potential interruptions during the session.

The Video Solution
With these tenets in mind, our team developed more than 125 chemotherapy educational videos featuring Aurora Cancer Care physicians, nurses, and other staff. Each education video a patient receives includes three videos:

  • First, a chemotherapy video explains basic principles of chemotherapy, including how it is administered (oral or intravenous), the different types of drugs, and potential side effects and complications.
  • Then, a video provides specific information about each drug the patient will receive.
  • Finally, a “Cancer SOS” video, details for patients how to manage their care at home and when to call their physician or go to the emergency room.

All the educational videos are housed on a password-protected website. When patients receive their treatment plan, they are emailed a link and password to the specific drug treatment that they will be receiving. Patients can then watch the video before their next appointment in the comfort of their home, and they can also share the video with family and friends who may have questions. Patients can then come to their next appointment with specific follow-up questions. Patients and families can access and watch each video as many times as they wish.

Learn more on our education program in this video.

Results
Patients have shared with our nursing team how helpful they’ve found these videos in preparing themselves (and their families) for the road ahead. More engaged patients mean higher patient satisfaction scores, and we’ve certainly seen that too, though it’s very early in the roll-out of the video series to see a major shift.

Our video series has also allowed nursing staff to focus on other educational tasks during the patient’s appointment while still ensuring consistent educational information for patients is provided throughout the treatment process.

At Aurora Cancer Care, our focus rests solely on the delivering the best care possible to patients throughout our region and helping them fight and overcome the disease. We are honored to be named the recipient of a 2017 ACCC Innovator Award for our patient educational video series, and hope it might inspire other cancer centers to explore similar educational tools for patients.

Learn more about how we developed our video series during our presentation at the ACCC 34th National Oncology Conference, Oct. 18-20, in Nashville, TN.


James Weese, MD, FACS, is vice president, Aurora Cancer Care, Milwaukee, Wisc.

Meet all of the ACCC 2017 Innovator’s at the ACCC 34th National Oncology Conference in Nashville. Browse the full agenda. Early bird registration rates run through Monday, August 21.

Providing Support to Oncology Professionals

By Virginia Vaitones, MSW, OSW-C

Hands offering supportHealthcare professionals are known for hiding their grief. There is an unspoken (though outdated!) code that we must be strong. Or, put another way, that we just need to get used to it.

But with increased recognition of the high risk for burnout among healthcare professionals, this “old code” is coming under scrutiny.

Writing about “professional grief,” Elizabeth Clark, PhD, ACSW, MPH, former executive director of the National Association of Social Workers observes that “professional grief is generally hidden grief, grief that is internalized and not openly expressed . . . . There’s no natural outlet and demands of work overshadow it.” Grief that is stuffed away can and will accumulate which can lead to helplessness, hopelessness, anger, detachment, and burnout. Read more.

Serving on the frontlines of care, oncology nursing staff often build relationships with patients (and their families) who they often see for weeks and months. Not surprisingly, research has shown these healthcare professionals may be at risk for burnout syndrome.

At Sarah Cannon Cancer Institute at Johnston-Willis Hospital in Richmond, Virginia, the chaplain and social worker knew that “. . . more needed to be done to provide intentional, self-care opportunities for staff allowing them to break through layers of grief and become emotionally and spirituality stronger.”  With input from the oncology nurses serving on a bereavement committee, the program has developed the Reflection Service for staff only. In their article in the current edition of Oncology Issues, “Normalizing Feeling of Grief and Loss in Oncology Nurses,” Jennifer Collins, MDiv, MS, BCC, director of Pastoral Care at HCA, CJW Medical Center, and Sandra Tan, MSW, LCSW, ACHP-SW, a licensed clinical social worker at Sarah Cannon Cancer Institute at Johnston-Willis Hospital, share how their program has created a “safe space” for oncology nurses to reflect, share, and grieve in their cancer center. Read their story.

Those of us working in cancer care know that in the coming years, we are facing projected workforce shortages while our aging population will bring an increase in cancer diagnoses.  As the field of oncology grapples with these challenges and plans for the future, I think we can all agree that replacing the “old code” with a “new code” addressing and mitigating the risk of burnout among healthcare professionals is essential.


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. 

ACA Repeal Efforts Stalled in Washington

by Blair Burnett, Policy Analyst, ACCC

U.S. Capitol

Despite much debate, healthcare reform remains in flux in Washington after a round of critical votes in the U.S. Senate this week. In the latest effort to repeal the Affordable Care Act (ACA), on Tuesday, July 25, the U.S. Senate voted 51-50, with Vice President Mike Pence breaking the tie vote, for a motion to proceed, which set up a process allowing for open debate and amendments to the AHCA, the House version of ACA repeal, on the Senate floor.

On Tuesday evening, the U.S. Senate brought to the floor their latest version of the Better Care Reconciliation Act (BCRA) with the added Cruz Amendment, allowing for sale of low-cost insurance plans if insurance policies that comply with the “essential services” provision of the ACA are also sold. The bill needed 60 votes to pass, but only received 43.

Debate continued Wednesday, July 26, and the U.S. Senate brought a repeal only bill to the floor, the Obamacare Repeal Reconciliation Act (ORRA), without language of a replacement effort. The vote, 45-55, showcased the lack of support among either party to vote for healthcare reform without actionable legislation.

As of Thursday, July 27, Senators were still in debate, bringing various amendments to floor for a vote. Late Thursday evening, a “skinny bill” was brought forth, that sought to roll back both the individual and employer mandate from the ACA. The text of this bill was not made available for public review, but besides repeal of the individual and employer mandate, left much of the ACA in place. When brought to a vote in the U.S. Senate, the bill failed, with a 49-51 vote in dissension of passage.

CBO estimates stated that the number of individuals insured would have decreased by 16 million by 2026 if the “skinny bill” were to pass and continue to become formal legislation. In the same time frame, the CBO estimates stated the federal deficit would have decreased by $142 billion, and premiums would have increased by an average of 20 percent.

For now, ACA repeal efforts and larger healthcare reform has stalled. More changes are certain to come from the Hill in the coming months as bipartisan healthcare reform legislation is expected to be drafted. Based upon the four pillars of ACCC’s health reform principles, a “skinny repeal” of the ACA would likely have destabilized current insurance markets, and placed increased burdens on cancer patients, specifically, elderly, low-income Americans accessing insurance in the individual and non-group markets. This week, ACCC joined over 30 other provider and patient groups to advocate against a skinny repeal of the ACA bill.

Senate Social Media Campaign - Skinny Repeal 7-27-17
As new legislation is brought forth, ACCC will continue to monitor and analyze impacts healthcare reform will have on cancer patients across the country.


ACCC members can gain an in-depth understanding of how CMS’ proposed CY 2018 Medicare rules will impact oncology by participating in ACCC’s August 9 webinar, “CMS Proposed 2018 OPPS & PFS Rules: What You Need to Know.” Learn more [member log-in required].

House Subcommittee Hearing Focuses on HRSA’s Oversight of 340B

by Blair Burnett, Policy Analyst, ACCC

U.S. CapitolThis week, the U.S. House of Representatives Subcommittee on Oversight and Investigations, of the Energy and Commerce Committee, chaired by Rep. Tim Murphy (R-PA), held a hearing titled, “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” Health Resources and Services Administration (HRSA) is the agency within the U.S. Department of Health and Human Services that currently oversees the 340B Drug Pricing Program. The program’s inception in 1992 sought to provide discounted outpatient drugs to “covered entities” (DSH facilities, rural referral centers, freestanding cancer centers, non-profit hospitals, etc.) who provide a certain level of care to Medicaid and low-income Medicare patients, allowing covered entities to stretch scarce federal resources to provide affordable prescription drug coverage to all patients.

The hearing, convened on Tuesday, July 18, addressed how HRSA’s oversight can improve review of eligible healthcare facilities utilizing the program in the face of continued expansion of facilities that qualify. As of October 2016, there are 12,168 covered entities utilizing the 340B Drug Pricing Program, and this number has quadrupled since 2011. The hearing also sought to explore how HRSA can be more transparent with 340B Drug Pricing Program reporting, calling attention to gaps in current data collection efforts.

Witnesses who testified at the hearing included:

  • Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, U.S. Department of Health and Human Services;
  • Debbie Draper, Director, Health Care, Government Accountability Office (GAO); and,
  • Erin Bliss, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General (OIG), U.S. Department of Health and Human Services.

Both the office of the GAO and HHS OIG have done significant work with the 340B Drug Pricing Program, and the witness testimony spoke to the recommendations both have made to HRSA. Both offices have also repeatedly reviewed HRSA’s regulatory capabilities with the 340B Drug Pricing Program and stated the need for more robust oversight. Based upon witness testimony and member questioning, key takeaways include:

  • Possible bipartisan legislation efforts that seek to grant HRSA more oversight of the 340B Drug Pricing Program.
  • Increased transparency from HRSA on 340B Drug Pricing Program costs and rules.
    Multiple members called for insight into how covered entities are utilizing any savings accrued from the 340B Drug Pricing Program. Within the current oversight from HRSA, there are no guidelines on how covered entities utilize or report 340B Drug Pricing Program savings.
  • Additional hearings to examine the 340B Drug Pricing Program within the subcommittee bringing in physicians and hospital executives to ask healthcare facilities how they are utilizing savings acquired from the 340B Drug Pricing Program.

Notably, this hearing convened shortly after the July 13 release of the Centers for Medicare & Medicaid Services (CMS) proposed 2018 Outpatient Prospective Payment System (OPPS) rule, which calls for a drastic reduction in Medicare Part B payments for outpatient drugs to all covered entities utilizing the 340B Drug Pricing Program from average sale price (ASP) plus 6 percent to ASP minus 22.5 percent in an effort to reign in the program. Rep. DeGette (D-CO), Rep. Schakowsky (D-IL), and Rep. Pallone (D-NJ) voiced concern over this proposal and called for bipartisan support to make meaningful reforms to the 340B Drug Pricing Program to ensure HRSA oversight is effective in aligning transparency as well as improved facility and overall data audits.

As policymakers continue to shine the light on the 340B program, over the next several weeks ACCC will continue to monitor efforts to reform the program and evaluate the impact the OPPS proposal will have on ACCC membership. Along with other stakeholders and coalition partners, we will be forcefully advocating for policies that are in the best interest of all community-based providers and their patients.


ACCC members can gain an in-depth understanding of how CMS’ proposed CY 2018 Medicare rules will impact oncology by participating in ACCC’s August 9 webinar, “CMS Proposed 2018 OPPS & PFS Rules: What You Need to Know.” Learn more [member log-in required].