Blog posts that are not press releases.

Expanding Options: What’s Next for Biosimilars in Oncology?

The COVID-19 pandemic has negatively impacted industries worldwide, and healthcare has not been immune. Oncology practices in particular are looking to recoup dollars lost to a decline in patient visits and, as the economy weakens and unemployment rises, patients are looking for financial assistance and relief from high-cost medications.

The current environment could lead to a spike in biosimilar use, which can increase economic efficiency without sacrificing patient safety and satisfaction. But oncology practices should not view biosimilars as just a temporary alternative. Rather, these options could become part of the ongoing strategy long after the intensity of the pandemic wanes and the economy rights itself.

And while they offer plenty of advantages for practices and patients, working with biosimilars can be complex and may require the need of a partner to help streamline the process.

The Positives of Biosimilars

The biggest advantage of biosimilars is the savings, with some priced at 20% to 40% lower than the existing reference product. Those prices will continue to decrease as the market becomes more saturated, increasing competition.

Biosimilars go through a different regulatory pathway to demonstrate similarity to a reference product. The FDA’s determination of biosimilarity is based on the totality of the evidence, which includes an extensive analytical comparison to show that the proposed biosimilar and reference products are highly similar in structure and function. Animal, human pharmacologic, immunologic and additional clinical data are added as needed to the analytical data in a stepwise fashion. This allows for a shorter approval time and lower costs to develop a product with no meaningful clinical difference.  

Consequently, oncologists can trust that there is no drop in the effectiveness and safety of the biosimilar drug while realizing the cost advantages for both the practice and patients.

Economically, oncologists benefit because the reimbursement for biosimilars is based on the average sales price plus 6% of the reference product, leading to small incremental profits for the practice. Because biosimilars are cheaper in cost, that eventually leads to savings on out-of-pocket costs for the patient.

The Need for a Network

While working with biosimilars can yield positive results, they also come with their own set of complexities that some independent practices may not have the bandwidth or expertise to handle.

Payer formularies vary widely as they relate to biosimilars. While one insurer may approve one biosimilar for specific indications, another may use a different one. Keeping up with these formulary variances is a daunting task for the average resource-strapped oncology practice; many either avoid using biosimilars or find themselves stuck in the administrative back and forth of claims denials.

American Oncology Network (AON) improves this outlook for its practice network through management and oversight of approved biosimilars. Our team keeps physicians current on formularies by insurer, streamlining processes and improving cash flow for practices and patients alike.

In addition, AON offers better buying and negotiating power, which leads to the purchase of more economical biosimilars. From an operational standpoint, AON alleviates a practice’s operational burdens by taking care of the drug purchasing and contracts.

If patients are wary about biosimilars, AON’s board-certified oncology pharmacists can assist in putting their minds at ease. Many independent practices lack the resources or manpower to create promotional collateral, instead relying on materials provided by the manufacturer—many of whom have had to shut down promotional departments due to COVID-19. AON can help educate patients on biosimilars with informative literature that is thorough but also written on a level that consumers can easily digest.

Cancer patients are dealing with enough stress – the last thing they need to do is worry about the safety and efficacy of their medications. Our team ensures patients know that biosimilars have the same potency, purity and safety as the reference medications.

The New Standard

The current global pandemic has underscored the clinical and financial advantages of biosimilars. Oncology practices should also consider how they may benefit from their use after the COVID-19 crisis is over.

By leaning on established networks such as AON to ease administrative burdens associated with using biosimilars, oncology practices can realize the benefits of expanded options for themselves and the patients in their care.

Oncology Care First: The Wave of the Future

With COVID-19 on the forefront of everyone’s mind, it is difficult to remember that the decade started out with an uplifting headline in cancer care: the largest single year drop in cancer mortality.  We also saw emergence of the next generation oncology model, Oncology Care First (OCF), which comes on the heels of a successful first-of-its-kind model, the Oncology Care Model (OCM).

As you shuffle through the countless articles, studies, and theories, there are many factors that play into the reduction in cancer deaths, many associated with science, demographics, society, and a change in the delivery of healthcare. Regardless of why, the news is a welcome development at a time when the nation is in the midst of a pandemic that continues governing our lives.

I am fortunate to be a frontline witness to one of the best stories in cancer care to hit our inboxes, thanks to my role within American Oncology Network (AON), one of the fastest growing oncology networks in the nation. I am charged with protecting community oncology by securing funding through revenue cycle processes. However—and more importantly—my role challenges me to think about how cancer care is constantly changing in our drive for better outcomes, enhanced delivery methods, lower costs, and a focus on value, which in turn requires that we challenge the “norm” of reimbursement methodologies.

A Quest for Innovation

Since its inception in 2018, AON has helped lead the charge to create new methodologies through key payer partnerships such as with the Center for Medicare & Medicaid Innovation (CMS Innovation Center) and its Oncology Care Model (OCM). This commitment to change has helped drive AON’s growth. For example, its involvement with OCM was an important factor behind the decision by Genesis Cancer Center—which has been part of OCM since the initiative began in 2016—to partner with our network.

Born out of a group of seasoned oncology professionals seeking to create a first-of-its-kind oncology focused value-based model, AON ensures that its practices have a seat at the table to participate in models with the potential to transform cancer care. This includes the OCM, which permitted oncology providers to improve health outcomes for cancer patients through specific reimbursement methodologies that reward value over volume. And, as its network proliferates, the AON philosophy provides its oncology partners with the flexibility to change with emerging methodologies such as Oncology Care First (OCF), introduced by CMS Innovation Center in late 2019.

As AON develops an oncology network that, while geographically diverse, is interconnected through a rapidly growing dichotomy of oncologists and a cancer team focused on building an infrastructure to support declining cancer rates, partnerships and advanced reimbursement methodologies like the OCF are key. Payment models are complex, and the most critical part of these models permits the autonomous delivery of cancer treatments and support services—something AON continuously promotes among our local care teams.

Benefitting Physicians, Patients and Outcomes?

So now the question is whether there is a correlation between the adoption of a first-of-its-kind oncology focused payment reform model and the historic decline in cancer mortality rates. Within this next payment model, it is proposed that physicians who participate in OCF will still have the freedom to manage patient care and run their practices as they see fit. However, with OCF, they have better access to a pool of data from OCM that can guide clinical and administrative decisions and connect any dots between the model and outcome trends.

With this next generation of reimbursement, AON’s focus is on infrastructure development to support the balance between the various elements that consumers expect: value, outcomes, accuracy and timeliness. All of which is more important than ever. The network’s model is positioned to support this shift in attention as we can deliver the administrative expertise, infrastructure, and economies of scale necessary to optimize the transition to value-based care initiatives like OCF.

Wave of the Future?

OCF has great potential to be a win for independent practices, their physicians and, most importantly, their patients. This is particularly true for those that partner with networks like AON. Doing so not only streamlines participation in initiatives like OCF with access to administrative expertise and the technology required for data collection requirements, but it also helps optimize involvement by offering turnkey access to newly covered benefits like extended care services in areas such as nutrition, anxiety and depression.

Most importantly, it is a partnership that puts them on solid footing for the future by reducing costs and improving quality of care—without sacrificing their clinical autonomy.

The Benefits of Community-Based Clinical Trials

May is National Cancer Research Awareness Month and the ideal time to explore the crucial role clinical trials play in the field of oncology. Thanks to ongoing research and discovery, the industry has witnessed a host of medical breakthroughs, including development of new medications and therapies that can advance cancer treatments and help better the lives of cancer patients.

Community-based research offers a notable advantage to smaller, independent practices primarily due to one factor: patients do not have to travel far to participate in a clinical trial, which can boost enrollment and advance scientific knowledge.

While this helps practices overcome one of the greatest hurdles to getting clinical trials off the ground, they must still be well-prepared and properly equipped before moving forward—and most will benefit from a partner capable of streamlining their efforts.  

Trial Prep

Conducting clinical trials, whether in a lab or a small practice, is not for the faint of heart. First, physician groups need to catch the eye of clinical trial sponsors, who tend to gravitate toward larger practices with more expansive patient pools. The best way to do this is through a proven track record, which of course requires successful completion of at least one study.

Training and education are also required. Physicians and research professionals interested in running a clinical trial must undergo mandated training through the FDA’s Office of Good Clinical Practice (OGCP), which must be updated on a regular basis. And though not required, it is important that clinic staff on both the administration and clinical sides of the house be educated on the nuances of conducting a trial. This will help ensure compliance with required protocols.

Also, while many clinical trials have similar administrative requirements, oncology-focused research is unique because patients are facing a life-threatening illness. Not only is it more difficult to identify the right pool of potential participants, it also requires the right tools and extra time to ensure they are fully informed and able to make educated decisions about their involvement.

Through consent forms and in-person meetings, physicians need to work one-on-one with the patients to outline clinical protocols, risks, and benefits of the trial. It’s important for patients to understand that they are under no obligation to take part in any clinical trial and can withdraw at any time and for any reason. This is true for any trial – but because oncology trials involve severe and life-threatening illness, it is especially important to be candid and thorough with cancer patients.

Practices should also be prepared to dedicate additional resources for the increased administrative tasks, particularly patient-related documentation and record-keeping that accompany clinical trials.

Streamlined Partnership

Partnering with a network such as the American Oncology Network (AON) can streamline the clinical trial process, making it possible for independent practices to play a role in advancing cancer therapies. We not only support the heavy lifting on the administrative side, but also supply expertise and technology to help practices host more complex and, ultimately, more successful trials. For example, we bring to the table the equipment necessary to assist with blood and tissue sampling and testing, which allows practices to carry out certain trials that would otherwise be out of reach.

One of our most unique assets to a practice, however, is the ability to take a patient’s molecular characteristics and match them with a specific clinical trial. We use technology to help us identify those patients that match a study’s criteria and would potentially benefit most from participating. For example, use of EHRs and other systems enables us to match patients with trials based on criteria such as molecular defects or a change in tumor type.

Through AON’s streamlining efforts, we can help practices conduct their own trials, regardless of size, and help build their research programs. When it comes to community trials, working with AON provides access to over 35 years of expertise to assist in this area.

We also offer a high level of flexibility that lets us support practices engaged with clinical trials when the unexpected happens, like the current pandemic. COVID-19 has put a temporary hold on enrollment for some trials because of an inability to supply certain drugs, while others have paused their trials because patients aren’t able to travel or come in for regular lab work and other assessments required in all trials.

At AON, however, many of our trials are still up and running because they can operate remotely. Physicians and clinical trial coordinators within practices can securely access patient records and meet with trial participants via telehealth. Through the pandemic, we have worked closely with our research partners to make sure they can continue all required monitoring of our research through secure remote access.

The Case for Community

Community-based clinical trials come with many benefits for independent practices. They enable patients to be matched with potentially life-saving research while staying within the comfort and familiarity of their oncologist’s office. Because this can accelerate enrollment, community-based trials often yield faster results—helping to move the science forward.

But running clinical trials can be an arduous and resource-intensive process. A network like AON, with its technology and decades of experience, can help streamline the process, putting clinical trial work within reach of even the smallest practices.

Advancing Interoperability to Enhance Cancer Care

Providers may have collectively breathed a sigh of relief when the U.S. Department of Health & Human Services (HHS) extended the deadline for complying with new interoperability regulations. However, relaxing enforcement does not lessen the urgency around ensuring the secure exchange of and access to patient information.

In the field of oncology, interoperability is especially critical as access to comprehensive data not only impacts direct patient care, but also the clinical research that leads to life-saving treatment breakthroughs. Without the ability to share patient information across different channels, little progress can be made in our approach to cancer.

Interoperability Roadmap

In early March, HHS released two wide-ranging Final Rules around interoperability – one each from The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS). These rules direct implementation of interoperability provisions spelled out in the 21st Century Cares Act to promote data exchange between providers and ensure patients can access their medical and claims information through application programming interfaces (APIs).

In April, the decision was made to extend compliance deadlines and relax enforcement for six months. As a result, providers have until November to comply with the ONC’s interoperability and information blocking rule, and implementation of CMS’s provisions for sharing admission, discharge and transfer notifications by Medicare providers goes into effect in spring 2021.

Even with the delay, the pressure on healthcare organizations across the board to step up their interoperability game remains intense. And for good reason: Having secure access to comprehensive patient information whenever and wherever it is needed is foundational to advancing the industry’s performance goals related to everything from quality of care and clinician workflow to population health strategies and scientific advances.

Eliminating Barriers

When it comes to interoperability, the seemingly insurmountable challenge for many small, independent oncology practices is the significant resource commitment required to update technology, build interfaces and ensure security. Even developing policies and procedures to guide data sharing and use can consume resources many small practices simply cannot spare.

This is where the right partner can make a huge difference. At American Oncology Network (AON), we have our own integration team to take the burden off our practices’ internal resources. Our team is able to install/upgrade and create the necessary interfaces quickly to ensure the secure flow of data between practices, hospitals, labs, pharmacies and other organizations within our network and each practice’s region—all guided by prevailing best practices to ensure optimal outcomes.

Our streamlined, scalable resources help advance interoperability and put critical patient data at clinicians’ fingertips, helping to drive improvements in patient care and clinician workflows. It also gives our practices a significant competitive edge in the market.

Improving Practices

More comprehensive patient data naturally informs better diagnostic and treatment decisions. It allows clinicians to closely monitor the effectiveness of drug therapies and allows for a more tailored approach to care, which can lead to better outcomes. On the research side, the ability to securely share deidentified patient data with AON’s research partners supports advances in cancer drugs and other therapies.

Interoperability also helps improve the way we practice medicine by streamlining workflows. The ability to access comprehensive and current patient information in one place, including histories, lab results and demographics, saves a tremendous amount of time that can instead be spent on actual patient care.

Moving Forward

Interoperability will undoubtedly remain an industry priority for the foreseeable future. While forward progress has been made, we have a long way to go before achieving full, meaningful interoperability. The guidance provided by ONC and CMS helps, as does seeing the benefits of broader data sharing firsthand.

We are currently dealing with an unprecedented explosion in the volume of data, and we are seeing a monthly increase in research, outcomes information, lab tests and drug development. The ability of healthcare organizations to analyze this data on the fly will soon become critical.

The rapid advancement of technologies like artificial intelligence and machine learning will soon translate into even diagnostic support tools for physicians, adding further urgency to finding ways to deliver health information in an easily digestible manner. Meaningful aggregation of data is an absolute necessity, but it cannot happen without strong interoperability and collaboration between systems, healthcare organizations and government.

Overcoming cost and resource barriers by partnering with a network like AON can help independent oncology practices realize those benefits faster—and more economically—than they can on their own. The key is experienced implementation teams, economies of scale and a commitment to ensuring clinicians can focus on the patient, not the technology.

Addressing Oncology Care Continuity During a Public Health Crisis

Crisis situations often call for creative solutions in healthcare and lean on the true strength of provider-patient relationships. While the stress of the COVID-19 pandemic is experienced across all walks of life, those with chronic or life-altering illnesses face unique challenges.

Care delivery for these patients cannot be put on hold. When dealing with a health crisis of such monumental proportions, oncology practices must identify ways of keeping patients safe and on track to achieve optimal outcomes. For cancer patients, the best approach ensures the full spectrum of care is addressed, including treatment, nutritional and emotional support.

Rolling with the Changes

Amid stay-at-home and social distancing orders, oncology practices remain essential and cannot simply shut their doors. Instead, providers need to adapt the way they run their practice while still maintaining continuity of care.

Our providers at American Oncology Network (AON) have deferred non-critical visits, such as six-month and annual follow-ups, but are continuing to see patients who are undergoing treatment or are newly diagnosed. In addition, we check with patients prior to each visit to determine if they are experiencing any symptoms associated with the virus – such as fever, cough, shortness of breath – and require they wear a mask to their appointment. One AON practice in Columbus, Ohio, screens patients for symptoms in a tent outside their facility before allowing them inside. All staff members have their temperatures taken daily, before and after each shift, and non-essential visitors are required to wait outside the clinic.

Amid industry shortages, our procurement team has done a tremendous job of ensuring our practices have the supplies they need to keep their facilities clean to ensure the safety of our patients – even going “old school” to overcome the lack of pre-packaged disinfectant wipes by utilizing paper towels and  FDA approved cleaning solvents.

The Rise of Telehealth

Telehealth, which allows patients and physicians to communicate through videoconferencing, is experiencing a significant surge in utilization – not only because the COVID-19 pandemic has made it a necessity to conduct patient appointments remotely, but also because the Centers for Medicare and Medicaid Services has relaxed reimbursement requirements, with many commercial plans following suit. Telehealth is expected to remain popular even after the pandemic is gone.

Our physicians understand the benefits of developing personal relationships with each of their patients, which typically begin with a face-to-face visit. Over time, however, as the bond between doctor and patient grows stronger, telehealth may become a very viable alternative where appropriate. This current health crisis has simply accelerated its acceptance and adoption. And while there are some long-term issues to figure out, the COVID-19 pandemic has taught us that telehealth is essential to maintaining patient access to high-quality care.

Unfortunately, as could be expected, many small, independent community practices lack the IT expertise, bandwidth or technology to implement telehealth quickly enough to effectively serve their patients. Thankfully, because of the existing infrastructure and technical expertise at AON our growing network of more than 130 providers was able to offer virtual appointments via telehealth to their patients within a span of four days and all locations are conducting these types of appointments daily.

Compassionate and Patient-centric

While telehealth has become an essential part of practicing medicine, our practices haven’t lost sight of the emotional needs and mental health of our patients. AON addresses this through triage nurses and social workers proactively reaching out to patients suffering from depression or struggling with the isolation that comes with the current social distancing measures.

I cannot stress enough, especially under these circumstances, the importance of why we are in this business – to provide our patients with the best care possible.

Our patients are at the center of everything we do and every decision we make. Now, they need us more than ever. We are taking every possible step to continue providing exceptional care, safely and compassionately.

Genesis Cancer & Blood Institute Teams Up with American Oncology Network to Advance Quality Care, Improve Bottom Line

With two full-time centers in Arkansas, Genesis Cancer and Blood Institute has spent more than 30 years providing care to thousands of patients in Hot Springs and the surrounding communities. The organization approaches care with all aspects of treatment in mind by encouraging positive attitudes, improving medicinal and nutritional therapies and maintaining a warm and comfortable setting.

Genesis physicians emphasize clinical trials and education, and closely onitor results from trials performed domestically and internationally. Along with its dedication to research, Genesis Cancer and Blood Institute prioritizes community involvement. It works closely with Our Promise, a non-profit committed to helping local cancer patients with practical assistance, as well as the American Cancer Society and other charitable endeavors.

Drivers and Key Criteria for Successful Telehealth Programs

The onset of the COVID-19 pandemic has brought telehealth and telemedicine to the forefront of the American healthcare industry. Through laptops, tablets and a host of other devices, telehealth allows physicians to examine and diagnose their patients remotely to comply with current social distancing guidelines and combat the spread of this highly contagious and deadly virus.

Even before COVID-19 made its way to the United States, the American Oncology Network (AON) was advancing use of telehealth as an effective element of its care management services, using video conferencing to connect patients with nutritionists. This has proved beneficial for our practices who now need to ramp up telehealth systems quickly in response to the pandemic to ensure continuity of care and optimal safety for their patients.  

Strong systems that are easy to use and can adapt quickly to change are crucial to the design of successful telehealth programs, especially at a time when demand is at an all-time high.

Ramping Up Quickly

Implementing an effective telehealth system is a complex, resource-intensive undertaking. It’s a cross-functional effort requiring clinical, operational and technical teams to work together to prepare technologies, workflows and staffing models. Proper codes must be added, financial teams brought up to speed and staff trained on electronic medical records (EMR) and telehealth platforms. It can take weeks or months – and prove quite costly – for the average private practice. In addition, small, independent practices rarely employ full-time IT or security staff, necessitating help from outside professionals who are not likely to be familiar with oncology. This not only increases costs, but also lengthens implementation time.

However, AON providers were able to rapidly start treating their patients, drawing on our team’s expertise and scalable system designs. As demand for telehealth skyrocketed, we quickly identified an appropriate vendor, wrapped up the paperwork and helped our practices onboard the new system in less than 20 hours. After four days of training, our provider groups were seeing patients. So far, they have amassed 2,717 virtual visits – and counting.

In addition, practice administrators and providers have peace of mind knowing that our security experts are aligning systems with the latest best practices and can address potential issues in hours rather than days.

Keeping it Simple

When it came to choosing a telehealth solution, AON wanted a partner that was flexible, scalable and could adapt very quickly to change. Most importantly, we wanted to keep the system simple for physicians and their patients.

On the physician side, it was important that the solution offer streamlined navigation so providers could fire up their device and be on time for scheduled appointments. For patients, we wanted to minimize effort and resource requirements. As such, any device – laptop, cellphone, tablet, etc. – equipped with a camera and microphone allows them to log on and speak with their physician. Our systems do not require installation of any additional programs or apps – we simply send patients a link that runs natively in a browser, making telehealth easy and accessible for everyone to use, no matter how savvy they are when it comes to technology.

Customers Come First

The strength of AON isn’t just our systems, but the customer-first approach that drives our IT department. That’s why we were able to shift gears so quickly to handle the swift changes brought about by COVID-19, and why we were able to train more than 130 physicians and mid-level providers in one weekend, rather than our normal load of about 10 providers over the course of a week. Nursing professionals and social workers have since been added to training, expanding the spectrum of possible telehealth services.

We have providers of all different stripes when it comes to technology proficiency – and it doesn’t matter. AON is here to equip our practices with whatever they need, whether that means installing cameras or enabling secure online meetings.

While telehealth has its limits – physicians can’t physically examine their patients – the COVID-19 pandemic has underscored its effectiveness at supporting certain care processes. However, to be successful, a telehealth system must be implemented with patients and providers at the forefront, and it needs to be able to adapt to change. In preparation for expected surges in patients and the future of healthcare, oncology practices are wise to consider a strong partner to help guide the telehealth process.