Category Archives: Advocacy

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].

Update from Capitol Hill

By Brittney Fairman, MPS, MA, ACCC Policy Analyst

U.S. CapitolAt the end of last week, it was anticipated that the U.S. Senate would hold a vote on the Senate Republicans’ revised version of the Better Care Reconciliation Act (BCRA) today, Tuesday, July 18. However, over the weekend,  Senator John McCain (R-AZ) underwent an emergency surgery and Senate Majority Leader Mitch McConnell (R-KY) announced that the vote on BCRA would be postponed until Senator McCain’s return to Washington, D.C. With two Senators, Rand Paul (R-KY) and Susan Collins (R-ME), already openly opposed to voting ‘Yes’ on BCRA—Senator McCain’s absence would have put the Republican Senators’ vote on the bill at risk.

In order to continue the repeal and replace of the Affordable Care Act (ACA), Senate Republicans would need at least 50 of the 52 Senate Republicans to vote in favor of BCRA.

On Monday evening, the bill took another turn when Senator Mike Lee (R-UT) and Senator Jerry Moran (R-KS) jointly announced their opposition of a motion to proceed on the revised healthcare bill. These two additional defections on Senator McConnell’s bill means the Senate Majority does not currently have the votes to even begin debate on the legislation to repeal and replace the Affordable Care Act (ACA).

So at this point, the future of BCRA remains uncertain. On Monday evening, Majority Leader McConnell stated, “Regretfully, it is now apparent that the effort to repeal and immediately replace the failure of Obamacare will not be successful.” President Trump has suggested the Senate Majority move forward in repealing the ACA without immediate replacement.  In this scenario, the Senate would vote in the coming days on a bill which would delay the ACA’s repeal for two years as Republicans work on individual bills to dismantle the current healthcare law.

ACCC will continue to monitor the Senate’s actions and keep ACCC members posted with the latest updates.

What Happened in Washington This Week

By Brittney Fairman, MPS, MA, ACCC Policy Analyst

U.S. CapitolIt’s been quite a week in Washington, D.C.  Let’s recap.

On Wednesday, July 12, the Centers for Medicare & Medicaid Services (CMS) held the latest in a series of webinars explaining the agency’s proposed rule for CY 2018 updates to MACRA’s Quality Payment Program. If you missed ACCC’s webinar on the implications of this proposed rule, members can access the webinar, presentation slides, and a summary [login required].

On Thursday morning, July 13, U.S. Senate Republicans unveiled their revised draft of the Better Care Reconciliation Act of 2017 (BCRA). The updated bill is the latest effort to repeal and replace the Affordable Care Act (ACA), and we continue to have concerns about the erosion of protections for cancer patients in the exchange marketplaces. ACCC is continuing to monitor the effort on the Capitol Hill and measure the evolving legislation against ACCC’s health reform principles.

Then later that same day, the Centers for Medicare & Medicaid Services (CMS) released the proposed CY 2018 Hospital Outpatient Prospective Payment System rule and CY 2018 Physician Fee Schedule rule. ACCC is currently analyzing both rules and will provide in-depth information to members on the impact on oncology. At first glance, the proposed, significant cuts to hospitals in the 340B Program and to new outpatient facilities cause concern, particularly for small, rural cancer programs and programs in vulnerable communities without other sources of healthcare. Stay tuned for information on the date and time of an upcoming ACCC members-only webinar on these proposed rules.

Also Happening on Capitol Hill
So this week, while much of the nation’s attention has been focused on Congressional action on ACA repeal and replace, and many healthcare providers awaited CMS’s release of the proposed 2018 Medicare rules, it’s important to note that another significant piece of legislation moved forward on Capitol Hill. On July 12, the U.S. House of Representatives passed the FDA Reauthorization Act (HR 2430). This legislation includes important bills for cancer care, including the Research to Accelerate Cures and Equity (RACE) Act and reauthorization of the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The User Fee Program plays an important role in the timely review of new drug applications and patients’ ability to access novel therapies.

The “RACE” Act is a bill which has important implications for the fight against childhood cancer. The legislation specifically updates the 2003 Pediatric Research Equity Act (PREA), which requires studies of adult drugs in adolescents during a drug’s development process.

PREA has experienced success in providing important information on a drug’s use in children in hundreds of cases; but, it has not yet been applied to pediatric cancer drugs. It is well known within the oncology community that many pediatric cancer patients are typically treated with “off-label” adult drugs. Under the RACE act, the FDA will be given authority to require a pediatric investigation into adult drugs if those drugs use molecular targeting and that same target is “substantively relevant” to the continuance of a pediatric cancer. If passed in the U.S. Senate, this act will permit clinicians to know the dosage, safety and efficacy in pediatrics and grant accurate labeling for use on children. Additionally, the RACE act will mandate that molecular targeting drugs be given an orphan designation to go through a pediatric investigation.

As summer in Washington continues to heat up, ACCC is closely monitoring legislation on Capitol Hill and performing an in-depth analysis of CMS’s proposed rules for 2018. Stay tuned for updates.

 

ACA Repeal & Replace Update: Senate Republicans Put Their Cards on the Table

By Brittney Fairman, MA, MPS, Policy Analyst, ACCC

U.S. CapitolLast Thursday, June 22, Senate Republicans publicly unveiled their discussion draft legislation titled, the Better Care Reconciliation Act—their version of the House’s recently passed American Health Care Act (AHCA) (H.R. 1628). Neither bill was drafted under regular order, as Republicans try to maintain steam in pushing forward with the repeal and replacement of the Affordable Care Act (ACA). Unfortunately, for multiple stakeholders, including many of those within the cancer care community, it is questionable how much the Republican Caucus sought patient and provider feedback to incorporate into their bills.

Although there was much speculation that the Senate version of the AHCA would undergo an entire re-write, the legislation released last week represents more of a fine-tuning of the House AHCA bill. Much of the Senate draft’s language reflects that found within the AHCA. The Senate bill contains various tax cuts for mostly high-income Americans; maintains the elimination of the individual and employer mandates; proposes less generous premium subsidies for those with lower household incomes; holds onto the AHCA’s similarly deep cuts to the Medicaid program—phasing out the expansion over three years and transitioning to a capped financing structure which essentially re-shapes the program’s funding; changes state adjustment-of-age bands by allowing insurers to increase the ACA’s ratio from allowing insurers to charge up to three times more for older individuals to permitting insurers to charge up to five time more; and still allows states to apply for waivers to overhaul their insurance markets (including the option of ending the essential health benefit requirement and potentially reinstating annual and lifetime coverage gaps).

There are, however, several notable changes within the “draft” Better Care Reconciliation Act signaling some improvement from the House bill. This Senate version would require insurers to cover people with pre-existing conditions and ban them from charging higher premiums because of their health history. But there is a caveat—there would not be an essential health benefit (EHB) requirement. This means that insurers would be able to offer less comprehensive policies that may or may not cover a patient’s treatment for pre-existing condition(s). Additionally, for individuals with household incomes between 100 percent and 200 percent of the federal poverty (FPL), authorized funding for cost-sharing reductions (CSR) payments would continue until 2020.

On Monday, June 26, the nonpartisan Congressional Budget Office (CBO) released a CBO score for the Senate legislation that finds the bill would result in 22 million more uninsured Americans by 2026, relative to the number under current law. This is slightly fewer than the increase in the number of uninsured estimated for the House-passed AHCA legislation.  According to the CBO score under the Better Care Reconciliation Act, by 2026 an estimated 49 million people will be uninsured, compared to the 28 million who will be uninsured that year under the current law.

A vote on the Senate bill is expected this week, leaving Senators with a relatively short window for reviewing the bill and also leaving stakeholders limited time to weigh in on the bill’s negative consequences for healthcare.

In a statement, the Association of Community Cancer Centers (ACCC) has expressed deep disappointment in the Senate’s draft legislation both in terms of policy and process, noting that the bill violates ACCC’s health reform principles.  ACCC believes this bill would be devastating for cancer patients and their families, and urges lawmakers to vote against the Better Care Reconciliation Act of 2017.  ACCC members can contact their Senators here.


Editor’s note: This post was updated on 6/26/17 to reflect release of the CBO score for the Better Care Reconciliation Act of 2017.

ACCC Expresses Serious Concern Over the AHCA

By Leah Ralph, Director of Health Policy, ACCC

U.S. CapitolOn May 4, 2017, the U.S. House of Representatives narrowly passed the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the Affordable Care Act (ACA). The bill now heads to the Senate, where it faces significant concerns over the projected decrease in coverage and increase in cost, and will likely undergo a substantial re-write.

While the bill faces uncertainty, the Association of Community Cancer Centers (ACCC) remains very concerned about the impact the AHCA, as currently written, would have on cancer patients’ ability to access comprehensive, affordable health insurance coverage. The bill violates a number of ACCC’s health reform principles, which were central to our recent advocacy efforts on Capitol Hill.

Previous Congressional Budget Office (CBO) reports estimate that 24 million more Americans will be left without coverage under the AHCA, while disproportionately increasing out-of-pocket costs for elderly, low-income Americans in the individual and non-group markets. Recent amendments to the bill also weaken protections for patients with pre-existing conditions, like cancer, and the requirement that insurers cover defined Essential Health Benefits, such as cancer screenings. The current legislation also effectively rolls back the Medicaid expansion and proposes to fundamentally restructure the Medicaid program, inevitably shifting costs to the states and squeezing Medicaid benefits for low-income cancer patients across the country.

ACCC will continue to work with Congress to advocate for meaningful health reform policies that protect patient access to appropriate, affordable health insurance coverage and decrease costs for the patient and the healthcare system.

ACCC urges its membership to contact their Senators opposing the bill as currently written.