Challenges in Oncology Practice

Increasing financial and administrative pressures—made worse by the federal sequester and continued rollout of the 2010 Affordable Care Act (ACA)—have created instability and uncertainty for oncology practices nationwide. To better understand how oncology practices are adapting to these stressors, the American Society of Clinical Oncology (ASCO) launched the National Census of Oncology Practices to collect practice-level data on the organizational, staffing, and service changes of oncology practices across the United States.

For an expert interpretation of the census data and its impact on independent oncology practices, we discussed the current state of oncology practice with Anupama Kurup Acheson, MD, medical oncologist at Providence Cancer Center Oncology and Hematology Care Clinic and 2013-2014 Chair of the ASCO Clinical Practice Committee. Acheson’s expert analysis covers practice trends, cost pressures, sequestration, healthcare reform, consolidation, genetic testing, new care delivery models, payment reform, accelerated drug approvals, clinical trials, and quality and value measures.

What are the principal cost pressures affecting independent oncology practices?

Reimbursement for patient care from Medicare poses a major challenge, especially as the medications and technologies we use are big-ticket items. The system has not been able to keep up with the upward cost curve. Also, with doctors facing the constant specter of severe cuts, the sustainable growth rate (SGR) formula represents an enormous impediment to successful healthcare delivery and payment reforms that can improve the quality of patient care while lowering growth in costs. The system is flawed and in need of a major overhaul, and it’s never been more important for oncologists to play a role in shaping the future of the payer system while also ensuring we are able to deliver high-quality, high-value care.

Another trend is that newer drugs typically cost a lot. Some specialty drugs, which are especially complex, also require management, particularly of toxicity. Different pharmacies offer varying levels of support, and so it’s very much part of our job to assist our patients while also helping them work out insurance coverage. This involves a major effort on the part of our office staff to accommodate payers, who request information in different ways; it’s not consistent.

Practices are also bearing the burden of the cost of some of these drugs. Chemotherapy drugs comprise the largest single expense for community oncology practices. These costs include purchasing the drugs, special storage and inventory costs, safe handling, and specialized staff to mix and administer the drugs as well as to monitor the patient during treatment. The federal sequester has also had a significant impact on the bottom line.

In a recent ASCO survey on the effects of sequestration, of the more than 500 practices that responded, 80% said they’d been impacted in some way. Fifty percent said they could not continue to care for Medicare patients without supplemental insurance, and about half said they were redirecting 10% to 50% of their patients to hospitals for chemotherapy. Around 14% said they were no longer taking Medicare patients.

What impact is the ACA having on independent oncology practices?

Under the ACA, physicians must participate in the Physician Quality Reporting System (PQRS) by 2015. The good news is that the Centers for Medicaid & Medicare Services (CMS) has released criteria criteria for the approval of existing, qualified registries as a reporting device under the PQRS. ASCO is working with CMS to ensure that our Quality Oncology Practice Initiative (QOPI) would meet these requirements. A major issue the law did not address is the SGR formula. This reimbursement formula is really flawed, especially in light of expected increases in costs and the aging of the population. Physicians would like to get away from the SGR, as it creates intense instability within oncology and the larger practice environment. We are aware that we will be seeing more patients under ACA, but we’re still waiting to see when and how the law will have an impact on practices.

What are recent trends in services that independent practices are providing, and what market or regulatory forces are driving these?

Last year, ASCO launched its first national oncology census to better understand these trends and found that just over 40% of practices were providing chemotherapy onsite, almost 30% were offering social services, and 23% nutritional counseling (see Figure). A quarter of practices had lab services onsite, and 26% were involved in clinical trials. The 2013 census is now open and we will be looking to its results for trend analysis. One aspect of practice we want to track is the increasing use of advanced practice providers (APPs), specifically nurse practitioners and physician assistants. In an ASCO study released in the fall of 2011, we learned that nonphysician nonphysician practitioners were seeing patients at office visits independently of physicians, although a physician was on hand. Notably, 98% of patients polled in one survey recognized that the provider they saw was not a physician, and the average satisfaction score (92.5%) indicated that they were extremely satisfied with their care from a team that involved physicians and APPs. Practices in which the APPs worked with all physicians were nearly 20% more productive than practices where APPs worked with select physicians. A 2007 ASCO workforce study also found that practices involving APPs have higher visit rates than those that do not.

Broadly, what we’ve all known is that beyond delivering chemotherapy, services such as counseling, nutritional guidance, and social services are all highlights of quality oncology care. Independent practitioners provide them in a range of ways—some smaller practices use outside providers, including hospital services, while larger practices have them onsite. But everyone feels these are essential. We need to stay tuned, however, to see what effects the sequester will have on these services.

What sort of consolidation are you seeing among practices? How are independent practices managing to go it alone and what are the implications for services provided?

In the past 2 or 3 years we’ve been seeing a lot more consolidation as doctors transition out of community practice. One of the prime drivers of the recent census was to get a better handle on this trend, and from last year’s survey (http://bit.ly/asco_survey) we saw considerable movement. We’re seeing a lot of mergers, especially in metropolitan areas. Larger practices reported plans to purchase smaller ones, while smaller ones said they were more likely to close. Again, the sequester is having an impact. In order to survive in this environment, solo practices are paying close attention to information provided to them by community oncology consortiums on how practices across the country are coping. They are able to manage some costs by joining together;

group purchasing for drugs is an example.In terms of providing multidisciplinary care, independent practices recognize the value of interacting with specialty providers given the complexity of disease, and while this takes more time, they see it as a necessity. What sort of momentum is there behind new care delivery models such as patient-centered medical homes (PCMHs) and accountable care organizations (ACOs)?

Over the past few years, there has been a lot of talk about developing new models and growing calls for more pilot testing, with the understanding that these new models would require a wholesale change in how we practice medicine. In cancer care, however, it’s important to keep in mind that a onesize-fits-all approach will not work. ASCO would look for a menu of options:

different types of models that will support the level of care we need to provide. In the near-term, we’re looking for more pilot testing of clinical pathways to guide evidence-based care and patient-centered medical homes. However, we recognize that these models may make sense in some parts of the country and not in others. These pilots, which require a significant commitment of time and resources on the part of practices, are still in the early stages. But we are very encouraged. Going forward, we need to make sure the menu is developed thoughtfully and that we put in place a transition period so that we can fully assess how they are working. In general, oncologists must continue to tie the work they do to what’s important to patients. We need to be

more careful about utilization of tests and services, making sure that whatever we order is meaningful. A lot of positives will come out of this.

What’s happening on the payment reform front?

As the Medicare population grows, reimbursements for services are not keeping up with cost increases and we are bearing a large part of the added cost. So we are very encouraged at ASCO to see an appetite in Congress to reform unworkable aspects of the current payment system, including the SGR model and the fee-for-service system, which requires a wholesale change. Importantly, more elected representatives are reaching out to us for feedback, asking for our ideas about alternatives to SGR, for example. And we are putting pen to paper.

ASCO’s Payment Reform working group is examining proposals for different payment models. We’ve developed a set of principles, which we believe should underpin any new payment system. We believe any new payment system should be tied to quality improvement, be physician-led, not add to the deficit, and provide a transition period to allow for additional testing. The House Energy and Commerce Committee has asked ASCO to provide feedback on its draft legislation. We’ve been supportive of the legislative proposals that encourage all specialty physicians to participate in a quality assessment and clinical improvement program. Patient outcomes, with quality as the underlying goal, must drive these changes. To ensure value, physicians must make sure that the services we provide are clinically meaningful. The challenge is that there is so much variance among patients that care must be tailored accordingly. Also, these new models must work in relation to private payers; care has to be consistent across the patient population. But we do find that private insurers are interested in clinical pathways.

What is the impact on practices of new drug approval processes, including the FDA’s accelerated approval pathways? Are there increased responsibilities and risks as a result of these changes?

It’s very encouraging that the FDA is using regulatory flexibility to speed up the approval process for breakthrough therapies for life-threatening diseases. ASCO supports this and has worked closely, for example, with the agency’s Office of Hematology and Oncology Products to host workshops to advance surrogate end points for use in specific cancer types to enable use of the accelerated approval mechanism. In each case, how quickly these drugs are approved depends on the data and how easy they are to collect. The FDA has demonstrated the ability to approve agents on the basis of trials that involve a relatively small number of participants. This translates to earlier access to the agents, but this does place the responsibility on us as clinicians to closely monitor patients for unexpected side effects and on organizations like ASCO to advise our members that they may have to change treatment plans if there are adverse effects or drugs are not working. We also need to keep a close eye on information from clinical trials, understanding that use of agents in this setting is experimental, even if the agent is already approved for a different indication. Particularly in the case of agents approved via the accelerated approval mechanism, the approval is granted on the basis of a surrogate end point that is reasonably likely to predict clinical benefit. We need to stay in touch with confirmatory studies and data from these trials to understand whether the agent meets the clinical benefit expectation.

Are independent oncologists enrolling their patients in clinical trials? What are the practice implications?

Independent oncologists are interested in enrolling their patients in clinical trials, and just over a quarter of practices say they are involved in them. But there are significant additional costs associated with conducting clinical trials, and the National Cancer Institute (NCI) doesn’t adequately reimburse for trials conducted through the Cooperative Group system. Changes the NCI and Cooperative Groups are implementing are helping to streamline the system and standardize the process, but the costs of conducting NCI-funded trials are not adequately compensated. This means practices lose money. In ASCO’s survey on the sequester, a quarter of practices polled said they had stopped participating in them because of funding costs. Patients who are enrolled in trials need to be closely monitored, and nurses and other staff must take the time to counsel them. In addition, clinical trial participation involves staff with specialized expertise, increased data collection, facilities to store records and investigational agents, and time and space to accommodate auditors. On another note, ASCO is in the process of developing recommendations that will help design trials with more clinically meaningful outcomes. We are hoping that trial sponsors will use these recommendations to prioritize development of trials with outcomes that hold greater clinical benefit. In addition, another ASCO group is examining eligibility criteria with the goal of limiting exclusionary criteria that prevent patients from qualifying for trials. If eligibility is so stringent, it makes screening incredibly challenging and raises questions about how widely applicable a given treatment is down the road.

How are oncologists improving the quality and value of the care they provide, and how are they measuring their performance?

The QOPI is the first national program in oncology. It covers the spectrum of practice/diagnosis, treatment, and assessment—and a range of services, including psychological counseling and end-of-life care. QOPI includes 160 quality measures, including 26 core measures. There are 17 standards alone for safely administering chemotherapy. It’s a rigorous process, but it gives practices that participate detailed reports on how they’re performing compared with national averages. And it’s an excellent way to manage quality care and a valuable learning tool. To date, 850 practices are registered with QOPI and 180 have gone through the process and received certification. On the quality front, ASCO has just launched a prototype health information computer network called CancerLinQ that will collect and analyze individualized patient data from millions of visits and provide practitioners clinical guidance for real-time personalized care. For example, by inputting tumor characteristics, the provider would receive recommendations on what personalized therapies to pursue based on expert guidelines. This is a new way to get doctors information they can use in real time. They can also explore the database, which includes data on patient characteristics, treatments, and outcomes from a variety of sources to identify real-world trends. The system will also provide feedback on the services performed based on QOPI quality measures.

What is the impact of genetic testing on both oncology practice and care?

Tests such as companion diagnostics, biomarker tests, and next-generation sequencing allow us to provide more personalized care. These tests hold incredible promise to help us deliver molecularly targeted agents to the appropriate patient population, particularly with next-gen sequencing tests; however, they are not always available to community-based oncologists, and also may not be eligible for insurance coverage. We also need to be mindful of clinical utility. Some tests and use of molecularly targeted agents are of questionable applicability. It’s important to be clear about tests and procedures that provide meaningful clinical information to direct choice of treatment. We are in an era of rapidly expanding knowledge of the molecular basis of cancer, and it is important that we are clear about the difference between research, emerging data, and evidencebased care, so that we accurately present risk and benefit information to patients. As part of the American Board of Internal Medicine’s “Choosing Wisely” campaign, ASCO developed a “Top 5” list of procedures and tests whose use should be questioned. More generally, everyone looks to genetic testing for simple answers, but they are not always available. Just because we know A, B, C, and even D about a patient, there maybe other factors driving their cancer, including environmental inputs. Going forward, this is another area where CancerLinQ should shed some light as we are able to aggregate data quickly on treatment outcomes in the larger population of cancer patients.

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