ASTRO Blog

April 2019

Paving the Way to Better Detection, Novel Treatments and Artificial Intelligence

A look back at the 2018 ASTRO Annual Meeting Presidential Symposium

By: Sanjay Aneja, MD; Michael Dominello, DO; Tim Lautenschlaeger, MD, PhD; Marc Mendonca, PhD; Stephen Shiao, MD, PhD, on behalf of the Promoting Science through Research and Training (PSRT) subcommittee of the ASTRO Science Council

Last October, nearly 11,000 radiation oncologists, residents, physicists, dosimetrists, nurses, industry representatives, other staff and students attended ASTRO’s 60th Annual Meeting. The Presidential Symposium centered around the overall meeting theme of “Translating Discovery to Cure,” with a decidedly forward-looking slate of topics. The Symposium was organized into four sessions, each with a unique theme. With planning well underway for this year’s Annual Meeting and a full slate of exciting research to be presented, we wanted to look back at the 2018 symposium and what the themes raised mean for the field.

Theme 1) Immunotherapy

Dr. Silvia Formenti opened the immunotherapy session with a nod to the past, reminding us that the critical role of the immune system in regulating the response to radiation was recognized more than 40 years ago and that many preclinical models later, we have finally begun to see those primordial seeds bear fruit. She described how early work with anti-CTLA-4 in murine models culminated in a successful human trial of anti-CTLA-4 (ipilimumab) and radiation in non-small cell lung cancer (Formenti et al. Nat Med 2018).

Surgical oncologist Dr. Jennifer Wargo told the incredible success story of immunotherapy in melanoma, particularly anti-PD-1 therapy, all while emphasizing the current challenges of employing immunotherapy including identifying biomarkers of response/toxicity and understanding immunotherapy resistance. Though biomarkers such as PD-L1 expression in tumors, intratumoral immune cell infiltrates and mutational burden have begun to emerge, these remain imperfect and imprecise. However, new biomarkers, namely the gut microbiome, were identified by her group and others as being the next frontier of both biomarker and therapeutic exploration (Gopalakrishan et al. Science 2018). Other therapeutic avenues being explored include combination therapies with immunotherapies, chemotherapy and radiation with toxicity being the key hurdle to overcome.

The final speaker, Dr. Zachary Morris, made the case for the potential of radiation as the perfect partner to immunotherapy. He showed preclinical data that demonstrated the multiple mechanisms by which radiation can interface with the immune system including reducing intratumoral immune suppression and activating inflammatory pathways to produce an anti-tumor immune response. This radiation-induced immune response could be augmented by combining it with immunotherapies, particularly checkpoint blockade (Twyman-St Victor et al. Nature 2015, Morris et al. Cancer Immunol Res 2018). The preclinical data strongly supports the notion that radiation and immunotherapy can synergize, but also highlights questions about how best to combine radiation and immunotherapy.

In sum, the potential for radiation and immunotherapy is vast, but we need to support and promote future studies to answer key issues including site selection, dose, fractionation and timing that will be critical to successfully incorporating radiation into immunotherapy paradigms.

Theme 2: Virally induced cancers

From hepatocellular carcinoma to anal cancer, to Merkel cell carcinoma, it is estimated that less than 10% of human cancers are virally induced. This statistic however does not begin to describe the morbidity and mortality of viral oncogenesis in terms of global impact. For example, cervical cancer represents the fourth most common cancer in women worldwide. Per the World Health Organization, of the estimated more than 270,000 deaths from cervical cancer every year, more than 85% of these occur in less developed regions. While we hope and expect that continued focus on vaccination, screening and decreasing HPV/HIV coinfection will improve these statistics, the current numbers are staggering.

Beyond recognizing this problem and its impact, the following questions were proposed:

  • Is it clinically important to confirm a viral association and perform viral typing?
  • What is the role of radiotherapy in the management of these disease processes and how is it modulated once there is a known viral association?
  • Do we understand and recognize the pitfalls and limitations in our knowledge in this arena?
 

It was suggested that while in the past we have treated malignancy as a function of location, how might this change when we consider a viral association? For example, should one treat a p16 positive nasopharyngeal cancer like a nasopharyngeal cancer or like any other HPV related head and neck cancer?

To grow as a field, suggestions moving forward included close observation and scrutiny of the data combined with a spirit of open-mindedness, communication and collaboration.

Theme 3: Artificial Intelligence

In addition to being a focus of the presidential symposium, Artificial intelligence (AI) was prominently featured among multiple educational sessions and abstracts within the newly established Digital Health and Informatics tract. Although AI has been an established field since the 1950s, there has been a renewed focus on the applications of AI over the last five years, primarily driven by three factors:

  • Increased digitization of healthcare data has provided a wealth of information which can be used to train AI algorithms to perform healthcare tasks.
  • Advances in computation have allowed more ease in storing and analyzing large amounts of heterogenous digitized healthcare data.
  • Advances in the methods in which we analyze data, specifically in the fields of machine learning and deep learning, have improved the ability of AI solutions to mimic human intelligence.
 

Dr. Kristy Brock from MD Anderson Cancer Center discussed the differences between AI, machine learning and deep learning, providing a background to AI for those who were unfamiliar. AI is a subfield of computer science which employs any rule-based learning. Machine learning is a sub-field with AI where algorithms attempt to learn from user-defined variables/features. Deep learning is a more nuanced form of AI where algorithms still learn from data, but do not require any user-defined variables and features.

Applications of AI within radiation oncology are already present in auto-segmentation programs, image reconstruction and image classification. We can expect even more AI driven solutions within radiation oncology which will attempt to improve outcome prediction and bottlenecks in practice workflows.

Theme 4: Liquid biopsies and cancer care

Blood-based circulating tumor DNA (ctDNA) testing is routinely used in patients with advanced solid tumors for mutation detection to establish eligibility for certain targeted therapies. Use of these tests can often avoid invasive tissue biopsies and its spatial heterogeneity issues. While the percentage of tumor DNA in the blood of patients with widely metastatic disease is often 10% or greater, tumor DNA is less reliably picked up in the blood of patients with early stage cancers using current detection approaches. However, as introduced by Dr. Park and expertly narrated by Drs. Rosenfeld and Diehn, there are many potential applications for ctDNA testing in patients with non-metastatic disease, including cancer screening, therapy response monitoring and recurrence monitoring.

As assay technology improves, some of these applications are expected to become feasible and ready for clinical evaluation. Efforts by the speakers’ laboratories have demonstrated approaches to create ever more sensitive ctDNA assays that soon might approach the levels of performance potentially useful for early stage patients. For example, exploiting the slight size differences of ctDNA versus other cell-free DNA in blood can significantly enrich for ctDNA, which in turn reduces sequencing cost and allows for deeper analysis.

Research demonstrated that ctDNA based minimal residual disease determination after completion of therapy is highly prognostic in many solid tumors, including nasopharyngeal, non-small cell lung, breast, pancreas and colon cancer. Presented unpublished data suggests that ctDNA assessment during radiation therapy might be of prognostic significance, which could be used for adaptive radiation therapy in the future.

Overall, liquid biopsy technology has great promise and new applications are likely to be developed for patients with non-metastatic disease in the near future, several of which might be of relevance to the radiation oncologist. Prospective studies are needed to establish clinical utility and more research is necessary to further develop technologies for the most challenging applications.

The 2018 ASTRO Annual Meeting Presidential Symposium highlighted areas of rapid change and opportunity for radiation oncology. As we move through 2019, we look forward to assessing the progress and impact of these four areas on daily radiation oncology practice and seeing the latest research presented at ASTRO’s 61st Annual meeting in Chicago.

Stay tuned for a series of blogs featuring the exciting changes coming to the 2019 Annual Meeting and Presidential Symposium!

Posted: April 30, 2019 | 0 comments


Prior Authorization: Denial by delay

By Vivek Kavadi, MD

"Honestly, why do you need prior authorization for my cancer treatment? It is not elective!" This comment from one of our radiation patients represents the frustrations of many patients across the country. As vice-chair of the Payer Relations Subcommittee (PRC), I frequently receive complaints from ASTRO members about the negative effects that the prior authorization process has on their practice and their patients. In the recent ASTRO Prior Authorization Survey, an overwhelming majority of respondents reported that their patients experience delays in care. Nearly three quarters of these radiation oncologists also said that their patients regularly express concern over these delays.

I work in a cancer center where the radiation treatment area is in the same location as chemotherapy infusion. This provides for seamless coordination and patient convenience. However, when prior authorization for radiation is delayed, treatment with chemotherapy is also delayed. Combined modality treatment requires a lot of coordination. Radiation is daily and many infusions last several days. We often like to start both treatments on a Monday or Tuesday. Recently, treatment starts have become very unpredictable. It is not a rare circumstance where delays of one to two weeks occur due to prior authorization issues.

This issue remains at the forefront for radiation oncologists and the entire house of medicine, which led to ASTRO signing on to the Consensus Statement on Improving the Prior Authorization Process. The Consensus Statement outlines five areas for improvement for prior authorization programs. One area, the message of Transparency and Communication Regarding Prior Authorization, is extremely resonant in our current environment. Prior authorization requirements and rationale must be easily accessible to providers and patients. Perhaps most important, is the area discussing Continuity of Patient Care that emphasizes that prior authorization should not interrupt appropriate medical services, potentially causing harm and distress to patients.

My experiences are not unique; this issue affects us all. Last fall, more than 500 ASTRO members urged their members of Congress to sign the Roe-Bera Prior Authorization Letter, which called on the Centers for Medicare and Medicaid (CMS) to regulate Medicare Advantage plans’ use of prior authorization and ensure these requirements do not create barriers to care. PRC continues to engage with the American Medical Association and other stakeholders to reform prior authorization practices. ASTRO’s Government Relations team is working with our Hill champions to address prior authorization issues. We frequently provide updates in ASTROgrams and What’s Happening in Washington, so be sure to read those publications.

How has prior authorization impacted the way you practice? Let us know in the comments, or email  healthpolicy1@astro.org.

Posted: April 24, 2019 | 0 comments


Transportation help for patients: Where the rubber meets the road

By Dave Adler, ASTRO Vice President of Advocacy

Radiation oncologists looking to provide their patients with local transportation services to access their clinics should closely examine a new road map for health care providers.

For rural radiation oncology patients, travelling long distances on a daily basis for weeks can often be a significant road block in completing radiation treatment regimens. Time away from work and the costs of travel quickly add up for these patients, many of whom are lower income. As part of the new ASTRO Rural Radiation Oncology Initiative, some members have asked whether providing transportation services to shuttle patients to their daily treatments constitutes a beneficiary inducement under the Anti-Kickback Statute (AKS).

As background, beneficiary inducement rules prevent providers from offering patients remuneration that they know is likely to influence the selection of a provider. While designed to protect patients and the Medicare program from abusive practices, some policymakers and providers, particularly in rural and underserved areas, expressed concern that the rules lacked street smarts and restricted access where there was a low risk of abuse.

On January 6, 2017, the Department of Health and Human Services Office of Inspector General  issued new rules that codified new safe harbors and exceptions to the beneficiary inducement provisions. Thanks to the changes, a local transportation program may provide free transportation to and from health care provider appointments for established patients of a provider. According to Crowell Moring LLP, ASTRO’s outside legal counsel firm, to be protected under the safe harbor, transportation services must follow these rules of the road:

  • Free or discounted transportation services may be provided to patients to travel to and from appointments with health care providers or suppliers.
  • The availability of free or discounted local transportation services cannot be determined in a manner related to the past or anticipated volume or value of federal health care program business to or from an individual or entity.
  • The transportation services made available cannot consist of air, luxury or ambulance transportation.
  • A transportation program or the availability of transportation services cannot be publicly marketed.
    • Marketing includes posting signage in public areas, including waiting rooms or lobbies of provider locations, posting online or otherwise communicating en masse the existence a transportation program or available transportation services.
    • To ensure no public marketing, the availability of free or discounted transportation services should be discussed with a patient only based on a reasonable belief that the individual patient both: (1) is currently a patient of the affiliated provider, and (2) needs free or discounted transportation services to be able to keep his appointments.
  • Transportation services may be made available only to established patients of the health care provider location to which they require transportation. A patient is considered “established” after he or she selects and initiates contact with a provider to schedule an appointment.
  • The entity making arrangements for the transportation must also be the entity bearing the costs of the services. The cost burden cannot be shifted to a federal health care program.
  • Services must be offered to patients only for the purpose of obtaining medically necessary items and services.
  • A slightly less extensive set of requirements apply to a “shuttle service” that runs along a pre-established route.
  • Transportation services can only be available for distances up to 25 miles in urban areas and 50 miles in rural areas.

 

While the rules could put some radiation oncology clinics on easy street to provide transportation services to patients, there is concern that the 50-mile restriction for rural areas will stop traffic. We’re interested in hearing from members on these issues, including:

  • Are these rules right up your alley and allow your practice to provide enhanced transportation services?
  • Is the 50-mile restriction a dead end for reaching patients in rural areas?
  • Have you identified any innovative approaches that are the ticket to ride for providing transportation services to patients in rural areas?

 

Enter your response in the comment section below, we look forward to your feedback.

Before putting the pedal to the metal to offer local transportation, ASTRO members should avoid blind alleys by consulting their practice’s legal counsel to ensure compliance with the new rules and other relevant regulations.

Posted: April 16, 2019 | 0 comments


How two radiation oncology facilities increased practice efficiency, patient safety and company culture

An interview with Yoichi Watanabe, PhD, and David Hong, MD
By Randi Kudner, Senior Quality Improvement Manager

Yoichi Watanabe, PhD, has been involved in various aspects of radiation oncology accreditation in his many years at the University of Minnesota in Minneapolis. David Hong, MD, became interested in practice accreditation during his residency days at New York-Presbyterian Brooklyn Methodist Hospital and now works with Southeast Radiation Oncology Group in Charlotte, North Carolina. Both sat down with ASTRO’s Senior Quality Improvement Manager, Randi Kudner, to discuss the importance of accreditation and the practical improvements it can provide.

How did you become interested in practice accreditation?

DH: My department was due for re-accreditation towards the end of my second year in residency. It was the first I’d ever heard of the topic and I was surprised to learn that there were so many items material to the operation of radiation oncology practices that I’d never heard of or thought about. Figuring it would be better to learn about these sorts of things during residency than later as an attending, I approached our department chair Hani Ashamalla, MD, and asked to help. A year later, Dr. Ashamalla forwarded me an ASTROgram soliciting committee volunteers and encouraged me to apply. I was accepted by the Accreditation Committee and have since gained an appreciation that despite institutional variation, we all follow the same fundamental process of care and share similar day-to-day concerns.

YW: The University of Minnesota started the accreditation process in December 2015. At that time, accreditation was not popular among radiation oncology facilities in the Midwest, particularly in Minnesota. However, we saw an increasing concern for the safety of treatment in both the radiation oncology community and the potential patient population and felt the need to reexamine our current practice from a more objective point of view. Given the increased focus on safety and quality improvement in the field, we chose ASTRO’s Accreditation Program for Excellence (APEx®) since the program was built upon Safety is No Accident: A Framework for Quality Radiation Oncology Care. Because APEx was new and no other institution in our area had such an accreditation, we envisioned an opportunity to prove the excellence of our practice. We expected at least two benefits with the application process. First, it would help to improve the quality of our clinical practice. Second, it could serve as an advertisement for our facility because of the strict accreditation requirement focused on the safety of radiation therapy. The fact that determinations in APEx are established through a committee review of a blinded facility report made it even more appealing for us as an objective program.

What is the value of accreditation in a radiation oncology practice?

YW: Accreditation is an external validation of quality, demonstrating the practice’s compliance with standards and best practices. The process allows for an objective, outside perspective that helps a practice identify strengths and weaknesses. It also shows patients that they can trust an organization and demonstrates to a community that the practice wants to provide the highest quality care possible. They respect that a practice has voluntarily undergone the process of meeting rigorous standards.

DH: It’s all about the effort put in. Done well, undergoing accreditation allows a radiation oncology practice to critically analyze, codify and improve policies and procedures, reduce variation through standardization of processes, and help establish a framework and culture of safety that can guide future practice improvement efforts. This does require a significant commitment of time and resources, but it’s a worthy investment. Providing this sort of structure was crucial to making our department a better place to work.

Both of you have gone through accreditation and been involved with APEx. What areas have you seen improve the most within your practice?

DH: The biggest change I witnessed was reduced friction and overall stress levels due to improved intradepartmental communication. Team members had a clearer understanding of what needed to be done and when. Patient wait times were reduced and our machines ran on schedule more often with less overtime and missed family time. Dosimetrists were able to deliver better plans faster after developing patient-specific planning directives. We were able to review our compliance and billing mechanisms and significantly improve our revenue cycle, primarily by improving documentation, pre-authorization, activity capture and auditing processes. We did not routinely use an incident learning system, but if we had, I believe that our rate of near-miss events would have been reduced dramatically. I could keep going, but in the end, I felt that going through an accreditation process served as a catalyst for improving most aspects of our practice’s operations over time.

YW: The review of procedure documents also significantly improved our practice. Our facility had most of the required documents already written, however, the policies and procedures were difficult to locate because of the lack of proper document management. Some had not been updated and others were never approved by management, so those were not officially used. The document preparation process was one of the most rewarding tasks because it required our team members to work together and understand our clinical process better while identifying our shortcomings and weaknesses. Through this exercise, our culture of teamwork was further improved for higher quality care.

Although we were proud of the quality care we provided to the patients, APEx made us identify and correct many deficiencies in our practice. We made changes and improvements in our daily practice, including:

  • Adding radiation therapists to increase the number of staff available for treatment and simulation.
  • Rewriting many existing, and developing many new, policy and procedure documents to clarify the procedures and meet the APEx requirements.
  • Introducing a daily morning huddle to discuss the clinic schedule on that day.
  • Forming a departmental safety committee; we meet quarterly to discuss the incidents reported to our incident reporting system and identify ways to improve the process.
  • Adding an additional weekly chart round meeting to spend more time in reviewing treatment plans and the contours drawn by physicians for peer review of treatment planners and physicians.

Now we are more confident in our ability to provide the best care and service to our patients among many institutions in our local region and beyond.

Thank you both for sharing your insight into practice accreditation. There are many aspects for a practice to consider, and hopefully your experience will help other practices. Other than what you have already shared, what are your final comments?

YW: The most important requirement for successful completion of the accreditation process is the availability of a leader who drives the entire practice to work toward the goal. This encouragement and leadership will result in a willingness of departmental staff to participate in the process with the goal of success.

DH: Aside from the practice benefits, which are many, patients and referring providers expect safe, high quality services when entrusting us with their care. A convincing way of demonstrating this is through accreditation with a rigorous program.

Join the 110 facilities who chose to strengthen their practice and demonstrate that they provide the highest quality radiation oncology care by becoming an APEx accredited facility or network.

Posted: April 2, 2019 | 0 comments


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