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NCCN Academy Explores the Latest Health Care Trends Affecting Cancer Care Today

By Katie Kiley Brown, NCCN Communications Manager

NCCN Academy for Excellence & Leadership in Oncology: School of Pharmaceutical & Biotech Business took place at The Rittenhouse in Philadelphia, PA, on Tuesday, July 12, 2016. Moderated by Clifford Goodman, PhD, The Lewin Group, NCCN Academy gives pharmaceutical and biotechnology professionals a rare opportunity to view the oncology space and its future and current operations issue from the provider, advocacy and payer perspective.

Real World Trends Impacting Cancer Care – Cost, Reimbursement, and Policy

The day’s first session, “Real World Trends Impacting Cancer Care – Cost, Reimbursement, and Policy,” featured the following panelists:

  • Gwen Darien
    Executive Vice President for Patient Advocacy
    National Patient Advocate Foundation
  • Bruce J. Gould, MD
    Medical Director
    Northwest Georgia Oncology Centers, P.C. (NCOG)
  • Tim Gronniger
    Deputy Chief of Staff
    Centers for Medicare & Medicaid Services (CMS)
  • Stephen S. Grubbs, MD
    Vice President
    ASCO
  • Kavita Patel, MD
    Nonresident Senior Fellow
    Brookings Institution
  • Warren Smedley, MSHA
    Service Line Director, Cancer & GI Services
    University of Alabama at Birmingham
    Comprehensive Cancer Center

     

Dr. Goodman opened the panel with a discussion of alternative payment models by asking Dr. Gould—who is instrumental in the development of the Oncology Medical Home (OMH) model—to describe his experience with the model thus far.

“It’s going beyond my initial dreams,” said Dr. Gould. He explained that moving the direction of the OMH was natural, as his practice was already implementing many of the policies while, at the same time, was under reimbursement pressure. He went on to explain the OMH has a triple aim to enhance patient experience, reduce cost, and realign reimbursement so high-quality practices receive favorable reimbursements as opposed to practices that are not using resources wisely.. He added that the OHM and the Oncology Care Model (OCM), for all practical purposes, overlap.

Alternative payment systems, do not incorporate the elements of the OMH, added Dr. Grubbs.

The panelists agreed that OMH is a successful way to move toward an alternative payment model that focuses on the patient’s experience and high-value, high-quality care. 

“[OMH is] getting medical oncologists to think about total cost of care beyond the oncology setting,” said Dr. Patel. She explained that there is a clear overwhelming desire among providers to be within these models; however, there are challenges within the model for smaller, community-based practices.

“Are there early signs that OMH is working?” Dr. Goodman asked Mr. Gronniger.

“Such robust interest demonstrates that there is a desire to improve care in this way,” said Mr. Gronniger. There is still a lot of road to travel, though, he added.

Dr. Goodman then asked the panel to discuss the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA).

The Medicare Access and CHIP Reauthorization Act (MACRA) redefines how Medicare will reimburse oncologists, and other provider, for certain care they provide starting in January 2019. This legislation repeals the Sustainable Growth Rate reimbursement adjustment formula for the Medicare Physician Fee Schedule and aims to promote a value-based practice environment ensuring high-quality and affordable health care.

Included in MACRA is a new Medicare Quality Payment Program, in which payments made to providers, including oncologists, who bill under the Medicare PFS will be adjusted through either the Merit-Based Incentive Payment System (MIPS) or participation in advanced Alternative Payment Models (APMs), such as the Oncology Care Model (OCM). Data from physician services in 2017 must be submitted to the Centers for Medicare and Medicaid Services (CMS) in 2018. CMS will evaluate these data and use them to make payment adjustments starting in 2019.

“MACRA has changed the whole landscape,” said Dr. Grubbs. The intent of recent health reform such as MIPS is to get all practices on alternative payment models within the next five years and OCM is an option. He added that, practices will have to take on two-sided risk in which, in addition to reimbursement for quality outcomes, penalties will be applied for non-adherence.

“Is this a good-news environment for patients?” Dr. Goodman asked Ms. Darien.

“Ultimately, it’s a great-news environment for patients…we appreciate the switch from volume to value,” she answered. Ms. Darien added that stakeholders tend to spend a majority of time talking about payment, but patients are concerned about value. She noted the need to collect patient-reported outcomes and capture measurements that are most important to the patients.

On-site, point-of-care collaboration among all stakeholders is of utmost importance in proper execution of a model based on value and quality, explained Mr. Smedley. To provide comprehensive, multidisciplinary care for the patient, the providers must engage all partners, in order to ascertain not only significant comorbidities but also symptoms of distress and depression, he said.

Mr. Smedley added that a multidisciplinary approach to cancer care is a significant challenge to large institutions, let alone smaller private oncology practices.

Regarding another recent U.S. health care policy announcement, Dr. Goodman asked Mr. Gronniger to discuss the recent CMS Medicare Part B demonstration.

“How is it going…are you surprised by pushback or stakeholder response?” asked Dr. Goodman.

“We are never surprised by pushback,” said Mr. Gronniger. CMS is now reviewing more than 1,300 comments on the Part B Demonstration and taking a hard look at small practices and access to care, he said.

“Maintaining and improving patient access to care are a top priority at CMS,” he added.

There are tensions that come with phase I of the Part B Demonstration for both industry and physicians, explained Dr. Patel.

Dr. Gould explained that there is a lack of collaboration and transparency around the Part B Demonstration. He added that drug cost control will be incredibly difficult in oncology as there are no substitutions for $100K drugs.

Where the focus needs to be is on phase 2 of the Part B Demonstration, explained Dr. Patel. Unfortunately, she expounded, the intense focus on the first phase of the program could undermine the second phase of the program, which focuses on value-based purchasing.

As patients, said Ms. Darien, we are concerned about the unintended consequences of the rollout, especially the shift in site of care. Potentially, she said, this could have real, critical, unintended consequences because some patients will not be able to afford to get to their doctor or pharmacist.

As earlier in the day, the panelists called for collaboration among all industry stakeholders to try and solve some of these problems.

“Drug spend is 18 – 20% of total cost of care in oncology. We need to focus on the other things as well—the process of delivering care,” said Mr. Smedley.

Dr. Goodman turned the conversation over to value frameworks in oncology, noting their emergence and prominence in the market in the past year.

Dr. Grubbs described the ASCO Value Framework with Net Health Benefit score, noting that it is intended to allow patients and physicians to discuss treatment benefit versus toxicity, adding cost to the mix. He noted that the original version was published, allowing for a comment period, after which it was refined and just recently republished.

“They are not ready for the bedside yet,” said Dr. Grubb. He said that ASCO continues to work to improve the Framework for its ultimate goal: a way to measure the total benefit a patient will get from Considering toxicity and cost.


“[Value frameworks are] a step in the right direction…but, patients and providers are speaking two different languages,” said Ms. Darien. The impetus for creating these frameworks is good, but today there is a lack of patient voice in the frameworks, she explained.

Regarding the implementation and use of the value frameworks in practice, Mr. Smedley noted that both providers and patients could use training on how to use them appropriately.

“This all came out of the private sector. Are you cheering for this?” Dr. Goodman asked Mr. Gronniger.

“We absolutely support seeing these developments,” he said.  If a patient or provider wants to make an informed decision, there really is a lack of good information on cancer, he said. Getting better and more information out there and available about prices and courses of treatment is beneficial, added Mr. Gronniger.

Ending on a look ahead, Ms. Darien identified one important element that all stakeholders will get right in order to succeed: “We managed to meaningfully engage patients and value the patient voice.”

Meet the Guidelines Panel Experts

The second session of the day featured experts from NCCN and NCCN Member Institutions who are instrumental in the development of NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and their derivative products.

Dr. Goodman moderated the roundtable discussion, which included the following panelists:

  • Timothy J. Eberlein, MD
    Director, Alvin J. Siteman Cancer Center
    Spencer T. and Ann W. Olin Distinguished Professor
    Bixby Professor and Chairman, Department of Surgery
    Siteman Cancer Center at Barnes-Jewish Hospital
    and Washington University School of Medicine

    Chair, NCCN Board of Directors
    Member, NCCN Guidelines Steering Committee
  • David S. Ettinger, MD
    Professor of Oncology
    The Sidney Kimmel Comprehensive
    Cancer Center at Johns Hopkins

    Member, NCCN Board of Directors
    Chair, NCCN Guidelines Panels for Antiemesis,  Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer, Occult Primary, and Thymomas and Thymic Carcinomas
    Member, NCCN Guidelines Panels for Lung Cancer Screening
  • Richard I. Fisher, MD
    President, Chief Executive Officer, and Cancer Center Director
    Fox Chase Cancer Center
    Member, NCCN Board of Directors
    Member, NCCN Guidelines Panel for Non-Hodgkin’s Lymphomas
  • Jack Skinner, PhD
    Oncology Scientist, Imaging Compendium
    National Comprehensive Cancer Network
  • Susan G. Urba, MD
    Professor, Medical Oncology
    University of Michigan Comprehensive Cancer Center
    Member, NCCN Guidelines Panels for Adult Cancer Pain, Antiemesis, Palliative Care, and Survivorship

 

Dr. Goodman commenced with a discussion about the composition of NCCN membership.

“How do you determine a new member?” he asked Dr. Eberlein.

Dr. Eberlein, chair of the NCCN Board of Directors, explained that the addition of new NCCN Member Institutions is part of the organization’s strategic plan, noting that there are no specific criteria for new members. He explained that the decision is dependent upon a particular institution’s ability to provide new and diverse expertise on NCCN Guidelines® panels, as well as unique aspects that the institution can bring to NCCN, such as strong survivorship and/or palliative care programs, research expertise, and diverse community presence.  

As far as adding new representation on the NCCN Guidelines panels, Dr. Ettinger explained that new members oftentimes will be asked to recommend specialists for the panels, such as interventional radiologists.

In July 2016, NCCN was recognized by CMS as a provider-led entity for the development of imaging appropriate use criteria (AUC) as part of the recent CMS mandate for the development of advanced diagnostic imaging, explained Dr. Skinner. In order to meet CMS requirements, NCCN panels must include multidisciplinary members, including primary care physicians (PCPs).

The addition of PCPs indeed strengthens the Guidelines panels, explained Dr. Urba. PCPs, she said, play a unique role on the panels—like patient advocates—because they identify particular issues seen in the community settings, particularly in supportive care. PCPs remind the panel that certain recommendations may not always be possible or accessible, said Dr. Urba.

Regarding evidence from outside organizations, “what sort of evidence are you seeking or do you use?” asked Dr. Goodman.

“We don’t seek information from outside groups,” answered Dr. Ettinger. “They submit.”

Dr. Ettinger explained that, first and foremost, the panels want to see evidence—particularly from randomized trials—that shows improved outcomes for a particular agent or intervention. However, he added that in some cases, FDA approves agents without a peer-reviewed manuscript, and, if the panel is in consensus, such agents may be added as a recommendation within the Guidelines. Additionally, Dr. Ettinger noted that in rare diseases, it is unlikely to see Phase III, randomized trial data. In those cases, he said, panelists must rely on lower levels of evidence and clinical expertise.

“How do you weigh the evidence?” Dr. Goodman asked Dr. Fisher.

“Moving from the highest level of evidence to a lower level depends on the drug’s clinical impact,” said Dr. Fisher. “If a new agent amplifies the response rate, we are willing to take less evidence.”

“The golden standard has been randomized trials,” added Dr. Urba. She explained, however, that in supportive care, the panelists measure as scientifically as possible; the high-level data is not always available.  

“It all comes down to the level of consensus based on clinical judgment and available clinical evidence,” said Dr. Urba.

Dr. Eberlein said that the key to the NCCN Guidelines is that they are dynamic and that the panels of experts are constantly reviewing and updating the recommendations.

Dr. Goodman turned the conversation toward big data in oncology. “Why big data now?” he asked.

Dr. Ettinger said that the more information that providers have about patients, the better they will be able to help the patients. However, he noted that the process is “trying to swim upstream.” “If we could have all the patient information in front of us and make judgments on that, it would be great,” he said.

Regarding the use of claims data, Dr. Fisher explained that using a database for which is not originally intended is not always appropriate, noting that insurance companies collect claims data and it is imported without understanding of medicine and its complications.

Dr. Goodman asked the panelists what the NCCN stance is on biosimilars in cancer care.

According to the panelists, it is a complicated issue.

Dr. Fisher explained that a biosimilar is not a generic drug—it is a small molecule agent as opposed to a large molecule. Moreover, FDA, he said, does not require repeat pivotal trials to prove effectiveness, which is a large issue for manufacturers because they are unable to provide data on analogous or improved outcomes when compared with agents that are already available. The drug cost will be lowered approximately 20 – 30 percent, but the cost of the original drug will also lower once it comes off patent, said Dr. Fisher. Therefore, a physician is left with a choice between two agents—one with proven effectiveness and one with lack of data that happens to be a bit cheaper, he said.

Dr. Eberlein explained that NCCN’s consideration of biosimilars is left to the particular expert panels that will debate and weigh available evidence.

Dr. Eberlein also referred to the inclusion of next generation sequencing in the Guidelines. He said, again, that recommendations for next generation molecular sequencing in the Guidelines will be on a panel-by-panel basis.

Dr. Ettinger added that NCCN does not need a separate next generation sequencing panel; however, there is a need for molecular profiling recommendation within the individual panels, if appropriate.

An issue with next generation molecular sequencing is the expense, noted Dr. Urba. She explained that, in her experience treating esophageal cancer, there indeed is benefit to testing, but cost is an issue.

Upcoming innovation, such as biosimilars, next generation sequencing, and liquid biopsies, must all have evidence to support their effectiveness in order to be considered by the NCCN Guidelines panels, said Dr. Ettinger.

The NCCN Guidelines with NCCN Evidence Blocks™ were launched in October 2015 and illustrate five key measures of value for chemotherapy regimens in the Guidelines: effectiveness, safety, quality and quantity of evidence, consistency of evidence, and affordability.

Dr. Urba explained that the availability of the NCCN Evidence Blocks™ can be particularly useful for physicians who are looking at a treatment plan with a variety of regimens with the same category of evidence. The Evidence Blocks will help sort through options that are already NCCN approved and base the final recommendation on what may be best for the patient. “I hope [they] are working for practical decision-making,” she said.

Dr. Goodman asked Dr. Skinner to expound on other derivative products available today.

Dr. Skinner noted that the data and recommendations within the library of NCCN Guidelines are being reapplied for various stakeholder groups through a variety of products, including the NCCN Drugs & Biologics Compendium (NCCN Compendium®), the NCCN Biomarkers Compendium®, the NCCN Chemotherapy Order Templates (NCCN Templates®), the NCCN Framework for Resource Stratified Guidelines (NCCN Framework), the NCCN Guidelines for Patients®, and, most recently available to the public, the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC).

“There is nothing in these products that is not represented in the corresponding NCCN Guidelines themselves,” said Dr. Skinner.

“There is a lot more riding now on what the Guidelines panels do. Given the weight placed on the panels, how do we ensure transparency,” Dr. Goodman asked Dr. Eberlein. 

“The ability to assure transparency and lack of biases is incredibly important,” said Dr. Eberlein. He explained that every panel member must document any conflict of interest and that this data is being compared with publicly reported databases. NCCN pays strict attention to potential conflicts of interest, and in the past individuals have been removed from the panels, he said.

 

In closing, Dr. Goodman asked the panel to consider one potential change that will take the use of the NCCN Guidelines to a new level.

The panelists responded along the same lines, explaining the importance of digitization of the NCCN Guidelines in order for the integration into electronic databases to ensure providers’ ability to access recommendation at point-of-care in everyday treatment settings, as well as the importance of their acceptance by national and international organizations.

Pathways, Protocols, and Guidelines in Oncology

The day’s third panel, “Pathways, Protocols, and Guidelines in Oncology,” included the following panelists:

  • Virginia Calega, MD
    Vice President, Strategic Clinical Solutions
    Highmark
  • William Flood, MD
    Chief Medical Officer
    Eviti
  • Nicole L. Hartung, MD
    Medical Director, Quality

MN Oncology Hematology

  • Andrew Hertler, MD
    Chief Medical Officer
    New Century Health
  • Daniel P. Mirda, MD
    Oncology & Hematology
    St. Josephs Health
    President
    Association of Northern California Oncologists (ANCO)
  • Bhuvana Sagar, MD
    National Medical Director, Oncology Program
    Cigna Healthcare

 

Dr. Goodman opened the third module by asking the panelists what distinguishes pathways from guidelines.

The panelists agreed that pathways were subsets of existing treatment guidelines.

“Guidelines, which NCCN pioneers, have set the stage for evidence-based medicine,” said Dr. Mirda. A pathway is a completely difference concept because it is a smaller subset, he said. Guidelines have standardized medicine and narrowed the approach to cancer treatment for patients in the appropriate setting—pathways are limiting the approach, he added.

Eviti does not use ‘pathways’ per se, but rather, they start with an evidence-based “web” of treatment, explained Dr. Flood.

One of the important points to discuss regarding pathways is the reimbursement model that goes along with it, added Dr. Flood. On one hand, there are models such as UnitedHealthcare’s in which all treatments within the NCCN Compendium are covered, and then there is the Anthem Quality in Oncology model that reimburses everything under their policy, but has financial incentive if a provider is using their pathway treatment, he explained.

Dr. Goodman asked Dr. Calega how, at Highmark, they use pathways. She explained that Highmark previously employed a pathways program based on retrospective claims that was not meeting the needs of the marketplace. It was important for Highmark to be anchored by NCCN Guidelines and have transparency so that could see how they were performing, she said. To meet these needs, Highmark is piloting the McKesson Specialty Health Value Pathways;  provider participation is voluntary, she said

It is important to Highmark, said Dr. Calega, that the pathways system is integrated into EHR providing a measure of feedback that tracks performance.

A majority of Cigna’s business is with accountable care organizations (ACOs), said Dr. Sagar, therefore, it is imperative to be able to generate data to show that patients are receiving the best care for the best outcome possible. For the most part, she added, Cigna uses NCCN Guidelines as a baseline for their medical home model.

Dr. Goodman asked the panelists to consider, as pathways narrow down the NCCN Guidelines recommendations, do they preserve physician autonomy while still benefiting the patients.

Dr. Hartung believes they do. At MN Oncology Hematology, she said, their practice adheres to NCCN Guidelines 95 percent across the board and, at the present time, the practice adheres 90 percent to pathways.

Multiple pathways within practice is a challenge, said Dr. Hertler, but we have dealt with different formularies with different payers for years. “This is not a new problem,” he said. Data lacks in advanced-line therapies, creating treatment principles rather than drug pathways, he said.

In third- and fourth-line therapy, providers see the highest-cost care, added Dr. Hartung. This is the point in treatment, said Dr. Hartung, where we need to discuss a patient’s values—what they want—and practice comprehensive end-of-life care. She noted the importance of looking at quality metrics for end of life, such as chemotherapy within the last 14 days and ICU stays, which are incredibly cost burdensome and oftentimes are not in the patient’s wishes.

Value and preferences from patients are really important, said Dr. Goodman. “Who and where are these decisions made?” he asked.

“You can have pathways and protocols, but that has to be part of a larger, multidisciplinary care team to deal with the financials, behavioral health issues, and adding on to pathways to quality measures,” said Dr. Calega.

Looking at Medicaid, Medicare, and insurance populations, Dr. Hertler said there is no doubt that variance exists in use of certain medications for the same clinical situations. There are subtle influences on physicians that they do not even realize exist, he said.

“Pathways are great, but there has to be a team-based approach…like the OCM model,” said Dr. Sagar. She described that, at Cigna, they are concerned about patient education and strive for patients to receive information about their cancer, their stage, whether it is curative, and what they can expect.

Additionally, Dr. Sagar reiterated the earlier point that there is not enough evidence for later-line treatment, stating that palliative care should be offered earlier, rather than when the patient reaches end of life.

Panelists explained the importance of transparency when using pathways or guidelines in treatment, noting that recent mandates require proof of adherence to guidelines.

The Oncology Care Model, explained Dr. Hartung, requires treatment in accordance with national guidelines, and an e-mail conversation is required when a provider requests to treat a patient off of NCCN Guidelines for a particular disease.

“Transparency does make a difference,” said Dr. Calega. She added that in the past providers did not have the opportunity to review performance data. Now, she said, the data is available, and it is helpful for the physicians to see where they deviate from the recommendations.

“Have pathways achieved cost reductions or savings to payers?” asked Dr. Goodman.

With pathways, cost savings are realized on the payer and provider sides, said Dr. Calega. She added that the transparency allows for confidence in the pathways process and noted that the pathways currently being piloted by Highmark allow users to easily distinguish which regimens are within NCCN Guidelines and those on or off pathway. The tool, she said, was developed alongside providers and their feedback has been included in development. 

The real goal of pathways is standardization, said Dr. Mirda. Cost savings are inherent in pathways, he said, but the most valuable part of pathways is the standardization of treatment for patients with cancer.

Pathways are an obvious choice for payers because they provide a financial incentive for regimens within a guideline that provide less toxicity with similar efficacy, said Dr. Sagar. The same approach can be taken with supportive care an end-of-life care, she explained.

Dr. Goodman asked the panel to discuss the inclusion of genomic profiling and personalized medicine in pathways.

The panel agreed that genomics should be part of pathways, ideally as part of an integrated decision support tool for use at point of care.

 “Pathways are a clinical decision support tool,” said Dr. Calega. “They do not replace clinical decision-making.”

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The next NCCN Academy will be held in conjunction with the NCCN 22nd Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care in Orlando, Florida, on March 22, 2017.

About NCCN Academy
Through the interactive program of NCCN Academy, pharmaceutical and biotech professional will learn from key stakeholders what they view to be the most pressing issues in oncology today and how to apply this knowledge to create mutually successful working relationships. Pharmaceutical and biotechnology professionals are given the rare opportunity to view the oncology space, its future and its current operational issues from the provider and payer perspectives. Participants will improve their working knowledge of key business, policy, overage, reimbursement, informational, and operational issues in oncology and will gather valuable insights materials to developing effective strategies for navigating the various constituencies in cancer care.

Professionals from marketing, sales, medical affairs, clinical research, policy and government affairs, and other business areas will better be able to serve their customer with improved knowledge of real-world oncology issues after completion of this program.