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Transcription

Milena: Hello and welcome to Avalere’s sixth episode in a series of podcasts focused on COVID-19. My name is Milena Sullivan, and I am a principal on our Policy practice here at Avalere. I am joined today by my colleagues Lance Grady, who leads Avalere’s Commercial and Regulatory Strategy Practice, and Chad Brooker, an associate principal on our policy team. In today’s episode, we will discuss how the COVID-19 pandemic affects oncology care and delivery broadly and impacts to the Oncology Care Model specifically.

Milena: Lance, I am going to start with you. The COVID-19 pandemic represents an unprecedented time in medicine, and that is particularly true for oncology care. Patients with cancer are at higher risk for COVID-19 and are more susceptible to infections than most individuals, which necessitates a new approach to treatment and care delivery. Can you talk a little bit about some of the key challenges that we are seeing and the implications for access and outcomes?

Lance: Thank you, Milena. Glad to join you and Chad in today’s discussion! This is a great question. And one I may not be fully able to address. I am not a clinician; I do not work for a hospital or oncology clinic–nor am I a cancer patient. But we all have relatives, friends, and colleagues who are feeling the impact of COVID-19 directly. As you stated, it is a very difficult time for our healthcare market right now, including the management of cancer patients. Specifically, a combination of factors must be considered when adjusting to approaches for managing cancer patients, such as patient acuity, any underlying conditions, co-morbidities, and stages of the disease. Other factors, such as geographic location or region of care, are critical in understanding which healthcare resources, like physician offices or hospitals, are available. Where these regions are relative to COVID-19 escalation or flattening the curve phase, there will be impacts on cancer management and care for patients that must be considered.

Recently, the American College of Surgeons adjusted guidelines and recommendations pertaining to surgery for breast cancer and colorectal cancer. Sequencing of surgery, therapy or intervention, and perhaps more aggressive treatment in an agentive setting are being considered. These are the decisions being reached by experts, oncologists, and patients and their families as they evaluate options to care during the COVID-19 pandemic.

Milena: Thank you, Lance. As oncologists try to triage their patients and make difficult clinical decisions, from a resource perspective, how would they react as they are facing staffing challenges and new demands that have been disruptive to their usual care protocols?

Lance: Community oncology has already significantly invested in medical home management and total care management for cancer patients. It is patient care that begins at the point of referral to point of diagnosis, including treatment and survivorship management. It is a holistic approach that many community oncology practices have deployed, and with that there is significant investment in resources.

If you look at the recent OCM, participants are contractually required to administer 24/7 access for patients–electronic health records and other continuous improvement initiatives to automate and advance practice management, practice systems, and patient navigation services to holistically manage their patients. These are all significant investments and efficient use of these resources but are not fully leveraged to the degree that they were prior to the COVID-19 pandemic.

Additionally, care coordination between labs or diagnostics, sites of care, imaging, pharmacy, and pharmacy dispensing are all challenges impacting oncology care and patient care. Administration of infusion drugs and the ability for a patient to to ambulate and access safe physician care are also being disrupted. These are challenging times not only for community oncology, but for hospital and healthcare system-based oncologists. Many resources that oncologists have relied on historically are being challenged by the decreased demand of care and shift of resources elsewhere to address COVID-19.

Milena: You mentioned the OCM and oncology medical homes that practices have heavily invested in. The OCM just entered its final and critical year, while stakeholders and CMS have been working on the policy design of its successor, the Oncology Care First (OCF) Model. Can you speak about some of the potential impact on participating practices in the OCM as they face additional demands and risk?

Lance: Certainly! This is a hard question. Any healthcare entity trying to assess population management or considering prediction of cost or of healthcare resource utilization is challenged right now, particularly for many OCM participants bearing risk for the first time in this calendar year in a prediction model during a time of great unpredictability. I suspect that many OCM participants are concerned with the downside risk ramifications, just like a health plan or health system would also be concerned about unpredictable risk in resource management. A recent National Association of Accountable Care Organizations (ACOs) survey found that 56% of risk-based Medicare Shared Savings Program (MSSP) ACOs are somewhat likely to very likely to leave the MSSP by the May 31 deadline.

As you point out Milena, it is a very critical year as a precursor to the OCF Model. And along the proposed timeline by the Centers for Medicare & Medicaid Innovation (CMMI), it is proposed that participants take on downside risk in the next iteration, OCF. Which means OCM participants in year 1, beginning January 1, 2021, in the OCF Model, are being asked to take on downside risk with no knowledge or experience in how they might perform in downside risk currently in the OCM model, at a time of disruption due to COVID-19.

It is very challenging from a risk and performance perspective. We know that OCM is triggered by chemotherapy or oral administration that begins a 180-day treatment episode for a Medicare beneficiary. If that patient is triggered and treated and not followed for maintenance therapy or evaluation from their oncologist, then the prediction cost–normally in a 6-month episode–of cancer care management is skewed.

CMMI and OCM participants will need to collaborate and work together to identify any lack of predictiveness as well as disruption in performance calculations due to COVID-19. We have seen the administration state that they may offer additional guidance pertaining to Advanced Alternative Payment Models. We are all anxious to hear what they have to say in that next announcement.

Milena: Along those lines, we have seen that the U.S. Department of Health and Human Services (HHS) has taken quick steps to waive various administrative requirements in order to increase access to medical services during this time of national emergency. Chad, can you speak to some of those flexibilities and waivers as they relate to cancer care and the ability of cancer patients to receive their prescribed therapies?

Chad: Of course. Thank you for that question, Milena. And thank you, Lance, for giving us a great introduction into the topic and some of the concerns. I think you are exactly right that CMS has taken unprecedented steps, largely with the goal to ensure individuals can continue to access care. This allows providers the ability to continue to deliver and coordinate care while minimizing the risk of exposure to COVID-19. If we think about the actions largely, the best way to describe these steps is flexibility. Most of CMS’s recent actions do not require plans or providers to act in a specific way. Instead, the actions aim to increase flexibility for payers and a broader range of providers to support access to care and informed patient treatment decisions without care delivery or reimbursement concerns – especially in the Medicare Fee-For-Service (FFS) program. Reducing regulatory requirements around site of care, utilization management, timing of prescription drug fills, drug delivery, remote patient engagement, and contracting can help with treatment adherence for Medicare beneficiaries, especially with provider-administered drugs. Several of the new flexibilities are important for oncology care. We have seen some of the recommendations that Lance mentioned, around treatment delays. CMS’s flexibilities will hopefully allow providers to make informed decisions on where and how to treat patients.

One of the interesting new flexibilities is care delivery in a home-based setting, sometimes known as home infusion. It is more commonly covered in the commercial market and some Medicare Advantage plans, but it has historically been limited in Medicare FFS. Medicare FFS limits the benefits and reimbursement to patients who are home bound, meaning it is unsafe for these beneficiaries to leave their home to access care. Importantly, it has been restrictive in which drugs it applies to and how coverage will be received for services and goods needed for the infusion. While the 21st Century Cures Act will fix some of this, it will not be in effect until 2021, and even then it will be limited to infusions using a pump.

The CMS made a couple of changes that are relevant to some oncology providers. Not to say that these options will be right in all cases, but it is in the aim of the flexibility that I spoke to earlier.

• First are changes to supervision requirements, allowing providers to contract out with home infusion vendors or home health vendors and use telehealth to supervise treatment in the patient’s home. This does not require the physician to be physically present, rather monitor remotely, maintaining as much of the current patient-provider relationship as possible, as well as the current coverage and reimbursement process.
• The other relates to the broadened definition of home bound patients to potentially expand the list of covered patient services under Medicare. This may allow some patients to receive home infusion services from a home infusion vendor. However, there are still a lot of unanswered questions.

There are associated logistical challenges and home infusion vendor contracting requirements to navigate. However, providers have these additional elements to consider when treating their patients. Providers will also still be able to bill under incident-to. And, in some cases, such as how national coverage and local coverage suspensions might impact drugs under the home infusion benefit or in other cases where it may be better to transition care to a home infusion vendor, the supervision changes will be the biggest factor for oncology providers, especially if a patient cannot ambulate for an infusion.

Milena: Thank you, Chad. It sounds like this current environment and crisis is forcing all stakeholders to quickly diagnose and close gaps and challenges for patient access.

So, I am going to close today’s podcast with a question to both of you. Do you see potential for any of these temporary flexibilities and waivers to be maintained beyond the pandemic, if they in fact have an impact on improving access for patients? Lance, I’ll start with you.

Lance: Absolutely! I think we have experienced a catalyst for change. Unfortunately, it has been through a very difficult pandemic, but it has created opportunity for care coordination and healthcare, especially through the patients’ perspective. Even prior to COVID-19, the administration and healthcare in the United States was broadly moving in bipartisan and bicameral support to address value-based care. In order to address and advance value-based care and high-quality care, additional flexibilities may also need to be addressed, such as:

• Broadening safe harbors in the Anti-Kickback Statute (AKS)
• Further relaxing care coordination between physicians and providers
• More sophisticated ways for care coordination communication without breaching patient privacy for the purpose of moving care and options for care to the consumer

We have seen this movement in mobile health and telehealth and advancements in digital medicine. We know this is an area of focus and innovation that hospitals, health systems, health plans, and providers are investing in. Arriving in a better place post-pandemic, assuming COVID-19 acts as a catalyst to advance changes in care coordination and providing greater flexibilities to the consumer and patient–that would be a silver lining.

Milena: Thank you, Lance. Chad?

Chad: What Lance shared is spot on. To add, we have seen a lot of the flexibilities and positioning with respect to putting patient and provider in the driver seat for some time now. Telehealth is not a new phenomenon, although I think COVID-19 is changing how health is viewed. We are likely to see increased adoption and this adoption sticking around. We might see coverage and utilization changes related to telehealth to continue after COVID-19. One thing I would like to add, related to the new flexibilities around the Office of Inspector General (OIG), is that we need new flexibilities for providers, suppliers, and manufacturers to help patients.

As Lance mentioned, some of the federal regulations, like the AKS, are minimizing the amount of support that can be provided around care coordination and access. A lot of this is because HHS has historically focused on impacts to utilization instead of the impacts to valued-based care or savings related to outcomes and managing chronic conditions. There is a lot room for the CMS to add flexibilities, especially during the public health emergency, to ensure patients and providers have the necessary support and tools–whether for ambulating to an in-home facility or receiving telehealth services for patients to receive care at home.

We have been working on several strategies related to the OIG for some time. We have even seen recent reforms related to the OIG from last year, but none of them go quite far enough and are still fairly restricted. It will be interesting to see if COVID-19 ends up being a catalyst for some new flexibilities around provider and patient support. This will be interesting to watch, especially as we transition to more value-based and coordinated care.

Milena: Great! Thank you, Lance and Chad, for your timely insights, and thank you all for tuning in. Please feel free to visit our COVID-19 Intel Center for more episodes and additional information, as well as Avalere’s analytics on oncology care and the OCM. Thank you very much!