Category Archives: Advocacy

2018 Quality Payment Program Rule Highlights

By Blair Burnett, ACCC Policy Analyst

On Thursday, Nov. 2, 2017, the Centers for Medicare & Medicaid Services released the 2018 final rule for the second year of the Medicare Access & CHIP Reauthorization Act (MACRA) Quality Payment Program (QPP). While we were disappointed by some policies in the 2018 rule, in general, the final rule signals a continued commitment to increased flexibility and reduced administrative burden for clinicians.

Starting in 2019, Medicare-participating clinicians will have to choose whether they will participate in the new QPP through one of two tracks: the fee-for-service based Merit-Based Incentive Payment System (MIPS) or through an Advanced Alternative Payment Model (APM). Clinicians should be reporting measures now (in 2017) for payment adjustments that will occur in 2019. If you are not aware of your obligations under the QPP, be sure to familiarize yourself as soon as possible – most clinicians should be reporting on three MIPS categories (quality measures, advancing care information, and clinical practice improvement activities) now for changes that are coming in 2019.

The final rule that outlines the QPP program in 2018 significantly reduces the number of providers subject to scoring under the MIPS track of the QPP. In 2018, any clinician with less than $90,000 in Medicare Part B allowed charges or fewer than 200 Part B beneficiaries will be exempt from MIPS reporting (previously this “low-volume threshold” was $30,000 in Part B charges and 100 Part B patients). With these changes, it is estimated that 123,000 providers will be excluded from MIPS scoring. CMS is also expanding access to reporting under the Advanced Alternative Payment Model (APM) track of the QPP. Clinicians who are participating in the Medicare Shared Savings Program (MSSP) Track 1+ as well as the Next Generation ACO Model and the Comprehensive Primary Care Plus (CPC+) program will all now qualify for QPP reporting as an advanced APM. CMS estimates that about 185,000 to 250,000 clinicians will now be eligible for reporting under an advanced APM, creating more competition within the MIPS track. CMS also expanded the option of reporting as virtual groups for physicians in groups of 10 or fewer and added bonus opportunities for small practices and clinicians treating complex patients.

CMS also eases reporting requirements around electronic health record (EHR) use, allowing MIPS-eligible physicians to be able to use 2014 or 2015 editions of certified EHR technology to meet the Advancing Care Information (ACI) category. Additionally, clinicians across the U.S. who were significantly affected by Hurricanes Harvey, Irma, and/or Maria are eligible to apply for an ACI hardship exception. These affected clinicians are eligible to apply for reweighting of the MIPS reporting requirements for quality, cost, and improvement activities categories for the 2018 performance period. The deadline to apply for both exemptions is December 31, 2017.

Despite these flexibilities, ACCC is disappointed to see that CMS has moved up the timeline to hold clinicians accountable for the cost of care they provide. Originally CMS had proposed that the cost category under MIPS be weighted at zero in 2018, however the final rule requires that cost account for 10% of the MIPS score in 2018. Additionally, despite opposition from ACCC and many stakeholders, CMS also finalized that Part B drug revenue will be subject to the MIPS adjustment, which is not what we believe Congress intended and breaks from past precedent in CMS policies.

We expect QPP participation and requirements will continue to evolve in the coming years, but be sure to prepare yourself now – these changes to Medicare reimbursement are around the corner.

ACCC members are invited to join us for a webinar on Wednesday, December 6, 2017, from 3-4 PM EST, for an in-depth analysis of the CY 2018 QPP final rule and how these changes may impact providers and their cancer program or practice. Learn more and register (log in required).

CMS Finalizes CY2018 OPPS & PFS Rules

By Blair Burnett, ACCC Policy Analyst

Bipartisan healthcare talks may have stalled in Congress as tax reform takes center stage, but the Centers for Medicare & Medicaid Services (CMS) finalized the CY 2018 Hospital Outpatient Prospective Payment Systems (OPPS) and Physician Fee Schedule (PFS) rules last week, bringing big changes to Medicare reimbursement in 2018. For highlights, read on.

2018 OUTPATIENT PROSPECTIVE PAYMENT SYSTEM HIGHLIGHTS
Overall, in 2018, CMS will increase OPPS payment rates by 1.35 percent.

340B – Most notably, the 2018 OPPS rule finalized substantial cuts to Part B drug reimbursement for 340B hospitals. Starting January 1, 2018, 340B entities will be paid Average Sales Price (ASP) minus 22.5 percent, instead of ASP plus 6 percent, for separately payable drugs that were acquired under the 340B Program, excluding drugs on pass-through status and vaccines. Most 340B entities are included in this reduction; however, for 2018 there are exemptions for rural sole community hospitals (SCHs), PPS-exempt cancer hospitals, and children’s hospitals. In the final rule, the agency reserves the right to revisit these exemptions in 2019. Drugs not purchased under the 340B Drug Pricing Program will continue to be paid at ASP plus 6 percent.

Early estimates suggest that this cut will produce $1.6 billion in savings which will be redistributed through a 3.2 percent increase in payment for non-drug items and services across all hospitals.

Operationally, CMS will also require the use of a modifier to identify whether a drug was purchased under the 340B Drug Pricing Program. One modifier will be required for hospitals that are subject to the payment reduction and another modifier for hospitals who are exempt from the payment reduction but still acquire drugs under the 340B Program.

ACCC and many other stakeholder groups advocated strongly against this proposal and hoped for a more constructive policy conversation about real reforms to the 340B program. Several hospital groups, including the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), and America’s Essential Hospitals, are considering a lawsuit to stop CMS from finalizing these reductions.

Drug Packaging – Under the prospective payment system, CMS has continually put forward policies that move OPPS toward bundled payments. In 2015, CMS conditionally packaged payment for ancillary services assigned to an APC group with a geographic mean cost of $100 or less, but excluded low-cost drug administration services. In 2018, CMS is finalizing its policy to conditionally package payment for low-cost drug administration services.

In 2018, CMS also extends non-enforcement of direct supervision requirements for outpatient therapeutic services for Critical Access Hospitals (CAHs) and rural hospitals with 100 or fewer beds in 2018 and 2019. Additionally, the agency is making changes to the date-of-service policy (i.e., the “14-day rule”) so that, in general, labs can bill Medicare directly for advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests.

2018 MEDICARE PHYSICIAN FEE SCHEDULE HIGHLIGHTS
Overall, in 2018, CMS will increase physician payment rates by 0.41% with no combined impact on hematology/oncology and an estimated 1% increase for radiation oncology and radiation therapy centers.

Payment Rates for Non-excepted Off-campus Provider-Based Hospital Departments – CMS is finalizing a reduction to payment rates for services provided at non-excepted off-campus hospital outpatient provider-based departments (i.e., off-campus facilities that began billing under OPPS after Nov. 2, 2015). Payment rates for services provided at these facilities will change from 50 percent of the OPPS rate to 40 percent of the OPPS rate. The agency states that this payment decrease is meant to “level the playing field” between hospitals and physician practices by promoting “greater payment alignment.”

Biosimilars – In a reversal of agency policy, CMS also finalizes a policy that each biosimilar product will receive its own unique reimbursement code. This is a departure from a policy in the CY 2017 OPPS Final Rule requiring that biosimilar products that rely on a common reference product be grouped into the same payment calculation for determining a single ASP payment limit.

Telehealth Services Expansion – In the 2018 PFS, CMS significantly expands telehealth services, adding numerous codes to the telehealth services list – including new codes for visits to determine low dose computed tomography eligibility, interactive complexity, health-risk assessments, care planning for chronic care management, and psychotherapy for crisis. To reduce the administrative burden for providers, CMS is also finalizes a proposal that will not require reporting a telehealth modifier on future telehealth claims.

Additionally, CMS finalizes that practitioners will be required to begin reporting consultation of appropriate use criteria (AUCs) beginning in 2020.

ACCC members are invited to join us for a webinar on Wednesday, November 29, 2017 from 3-4 PM EST, for an in-depth analysis of how these final 2018 payment rules may impact your cancer program or practice. Learn more and register.

Are We There Yet? Approaching a Bipartisan Compromise on Healthcare

By Blair Burnett, ACCC Policy Analyst

U.S. CapitolAfter a flurry of activity on healthcare over the past couple of months, a bipartisan proposal may be making gains in Congress. The highlights:

October 12, 2017 – The Trump Administration released an executive order that laid the groundwork for big changes to the Affordable Care Act (ACA) marketplaces including less comprehensive plans offered through associations of small employers as well as a push for increased use of short-term medical coverage. This could essentially create an alternative insurance market that would not have to comply with many of the consumer protections created under the ACA, and would likely attract healthier, less costly consumers, which would drive up premiums in the current exchanges. Later that evening, the Administration announced it would immediately end cost-sharing reduction (CSR) payments used to subsidize healthcare costs for low-income individuals on the exchanges. The legal battle around CSRs has been playing out in the courts since 2014, with some arguing that the payments are illegal because they were not appropriated by Congress. Analysis from the Congressional Budget Office (CBO) predicts large premium increases for exchange plans in 2018 and beyond, as insurers attempt to cover the loss of the CSR payments and some consider leaving the marketplaces all together.

October 17, 2017 – The following week, Chairman and Ranking Member of the Senate Health, Education, Labor, and Pensions Committee (HELP), Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), announced a bipartisan bill designed to provide temporary stability in the marketplaces.

Key tenets of the Alexander-Murray proposal include:

  • Continued Funding for CSR Payments: CSRs would continue to be funded through 2019. For states where insurance regulators are pressing individual insurers to decline this payment, no funding would be issued.
  • Restoration of ACA Enrollment Funding: Any state participating in an exchange would see restoration of over $100 million in outreach and enrollment funding through 2019. This proposal also seeks transparency with open enrollment advertising and outreach with a mandated reporting timeline.
  • Preexisting Conditions & Essential Health Benefits Coverage Requirements: Under this bipartisan proposal, insurers would not be able to waive the ACA preexisting conditions or ten Essential Health Benefits (EHBs), which became coverage requirements under the ACA, as previous ACA reform/replace bills have sought to do.
  • Section 1332 Waivers Support: This proposal would streamline the waiver process and make it easier for states to acquire and maintain 1332 waivers. These allow states to implement their own health insurance programs as long as they meet thresholds for coverage and affordability that are similar to those achieved under the ACA.

Despite early support among both Democrats and Republicans in the Senate and pushing healthcare reform forward, last week President Trump signaled a singular focus on tax reform while meeting with Congressional leadership, suggesting there may not be a clear path forward. The Alexander-Murray proposal would also likely face an up-hill battle in the House where Majority Leadership is still focused on ACA repeal and replace. On October 25, the Congressional Budget Office (CBO) released an initial impact analysis of this proposal citing a deficit reduction of nearly $4 billion through 2027. Even with that news, the likelihood of this bill to move on its own appears slim; the most likely pathway for this proposal to become law, if at all, will be tacking it on to a “must pass” end of year funding bill.

Regardless of how – or when – the short-term stabilization package moves, the Administration’s announcement to end the CSR payments has already made an impact. Early estimates show that premiums for a silver-level plan in 2018 will increase 34%, higher than the average 25% increase we saw in 2017, and not all enrollees will qualify for the premium tax credits used to offset these market increases.[1] Without CSR payments, insurers will also likely continue to exit ACA exchanges in many states, leading to states with fewer options and an unstable market overall. For cancer patients, and those battling chronic illnesses, efforts by the Administration to loosen regulatory requirements around comprehensive coverage and decisions to end critical funding streams to assist insurers in providing meaningful coverage for the costliest consumers is particularly troubling and will mean higher cost plans and fewer options.

And, amid all this uncertainty, Open Enrollment season is upon us. The Enrollment Period for ACA Exchanges has been scaled back to 45 days under the current administration, and will occur from November 1 through December 15, 2017.

ACCC will continue to monitor any legislative progress of the bipartisan market stabilization bill and continue to advocate for comprehensive, affordable insurance options for all cancer patients. For more on what ACCC needs to see in any ACA reform proposal, see our Health Reform Principles for Cancer Patients.


[1] avalere.com/expertise/managed-care/insights/silver-exchange-premiums-rise-34-on-average-in-2018

National Oncology Conference—What’s New About “How To”?

by Amanda Patton, ACCC Communications

Something exceptional happened at last week’s ACCC 34th National Oncology Conference.

No, not the exceptional conference attendance of nearly 800 multidisciplinary oncology professionals for a “how to” focus on cancer care delivery.

No, not the exceptional sessions with practical “how to’s” for improving processes, patient satisfaction, quality reporting, data collection, and workflow. And no, not the stellar 2017 Innovator Award winner presentations with their exceptional solutions and actionable takeaways for advancing patient care in the community. And not the Spotlight Sessions, with peer-to-peer sharing of quick-takes on exceptional “how to’s” addressing hot topic issues in oncology care delivery.

The “exceptional” we’re referring to is something else:  A theme heard across multiple conference sessions. Something connecting the past, the present, and the future of cancer care delivery.

What’s New about “How To”?
In this blog post, ACCCBuzz is talking about an “exceptional” theme that surfaced in session after session of the ACCC 34th National Oncology Conference: Improving connections between the “art” and the “science” of medicine to improve care delivery.

At this “exceptional” time in healthcare—with unprecedented uncertainty on ACA reform, payment models, and costs, along with exponential scientific advancement and information overload—during last week’s conference, presenter after presenter touched on the compelling need to humanize medicine to help both providers and their patients. A number of speakers described how a new strategy, program initiative, workflow, or process change grew from an “Aha” moment triggered by an encounter with or experience of a single patient.  An interaction that stopped them in their tracks and connected them to new ways of thinking about care delivery.

One step toward humanizing medicine that echoed across sessions was the power of stories. For many of the presenters, either listening to or sharing a story, led to change. Attendees learned firsthand how sharing your story can empower cancer programs, providers, and patients.

For cancer programs, telling your story is at the heart of advocacy efforts, Tennessee Oncology CEO Jeffrey Patton, MD, told attendees, in welcoming them to Nashville. In today’s swiftly shifting healthcare environment, it’s critical for community oncology to have a voice. “No one is going to tell our story for us,” he said, reminding attendees that their experiences need to be included in the healthcare reform conversations occurring both locally and nationally.

Dr. Steven Eisenberg sharing the healing power of music.

For cancer care providers, sharing a story, an anecdote, or even a favorite song can be a simple step toward humanizing the provider-patient relationship. Featured speaker medical oncologist and “song-cologist” Steven Eisenberg, DO, California Cancer Associates for Research & Excellence, told how a pivotal interaction with Flavvy, an 80-year-old stage IV cancer patient who refused to let her medical problems diminish her vibrant love of life, changed his life and his approach to practicing medicine. “It freed me up to be a doctor who was in partnership with my patients. Rather than being separate from them, I started working with them,” he said.

By telling their story, cancer patients can help themselves, help others facing cancer, and help their care team understand who they are and what is important to them. Breast cancer survivor Brianne Joseph, LPI, owner of Sly Fox Investigations and author of Punk Azz Cancer, How Dare You! How to Turn Your Pain into Power, shared her story as a young adult breast cancer survivor, and included the voices of other young women survivors in her down-to-earth talk. “Everyone can see the scars from the mastectomy, but the scars that are the hardest to heal are the ones you can’t see,” she reminded attendees, urging better support for and communications with patients.

In Friday’s final conference session, the “art” and “science” of medicine were brought together in a powerful documentary, “Intentional Healing,” produced by Vanderbilt-Ingram Cancer Center radiation oncologist Mark Stavas, MD. The film follows famed Nashville music producer Jesse Boyce as he contemplates his own mortality after a diagnosis of terminal prostate cancer. Through the film we see how his art—creating music—was one of the ways Mr. Boyce pursued “intentional healing.” Afterward, an attendee asked how Dr. Stavas, whose practice is palliative radiation oncology, handles burnout and loss in his professional life. Making the film, sharing the patient’s story through art, has helped him to heal, Dr. Stavas said.

“Medicine cures, but art nourishes the soul.”

Exceptional.


Stay tuned to ACCCBuzz for more highlights from select ACCC 34th National Oncology Conference sessions.

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.

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.

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].