Moonshots and Memos: Looming Changes in Oncology
In 1971, President Richard Nixon declared “war on cancer,” and millions of dollars poured into research for new cures for the disease. However, it was not until the early 1990s that we started to see cancer and its symptoms and side effects become more manageable in the outpatient setting, in the community where patients lived and worked. It took years for the “war on cancer” to take root.
The Moonshot Initiative
In January 2016, President Barack Obama called on Vice President Joe Biden to lead a national “Moonshot” initiative to eliminate cancer as we know it. So far, the White House has committed $1 billion to start this effort. That initial funding will support a Cancer Moonshot Task Force, new funding for the National Institutes of Health (NIH), budget support in 2017 for NIH and the US Food and Drug Administration (FDA), and new cancer research initiatives in the Department of Defense and the Department of Veterans Affairs. Within the Department of Health & Human Services, new research efforts will target early cancer detection; cancer prevention and the development of cancer vaccines, cancer immunotherapy, and combination therapies; the genomic analysis of tumors and surrounding cells; enhanced data-sharing; creating an oncology center of excellence within the FDA; pediatric cancer; and a new Vice President’s Exceptional Opportunities in Cancer Research Fund.
The expectation of White House staff is that this announcement and the jump-start funding will spur rapid expansion of private investments into the National Cancer Moonshot. Indeed, we have already started to see announcements of complementary initiatives by M.D. Anderson Cancer Center and others. Patrick Soon-Shiong, MD, the entrepreneur founder of NantWorks, has gathered a coalition of academic institutions, health insurers, and pharmaceutical companies—called Cancer Moonshot 2020—to target advances in immunotherapies.
What will all this mean to physicians and their staff, caring for patients on a daily basis? Not much, initially. If an oncology team is part of a larger academic institution, the team and their patients may be involved in expanded data collection and research studies. Even community oncology practices that are part of research networks are likely to see some degree of involvement as the Moonshot-related initiatives take flight.
The irony for patients with cancer is that while this major national initiative is launched in the search for new advances in cancer care, the day-to-day management of oncology care continues to become more and more restrictive. At a time when we are encouraging the flow of data between the entire healthcare community, physicians are being asked to submit data manually from their own electronic health records systems into different portals for multiple insurance companies. And at a time when we are seeking clarity in evidence for patient care, physicians are being asked to consider multiple evidence-based clinical pathways from a variety of health insurance plans. Therefore, it is likely that patients with the same type of disease could well end up with different preferred treatments as outlined by their various insurers and pathways, which leads to serious questions regarding the evidence used to define those preferred treatments.
Implications for Oncology Practices
What can your oncology practice or cancer center do to support the goals of a Moonshot possibility but also protect your operations and your patients from the daily care-related burdens and restrictions?
First, protect quality and evidence. Understand what is being asked from you in terms of data, and how they will be used.
Volunteer to be involved in the initiative, from the ground up, to add your perspective and to keep the frontline voice of oncology care at the table.
Consider carefully what data are being requested and why, and take appropriate action. Some payer portals seek to collect significant clinical information about the patient. If most patients are receiving treatment with regimens that the physician already knows are not going to meet the insurer’s preferred treatment criteria, some physicians are choosing to only enter the data of those patients who fit the criteria. Indeed, some insurers have noted that clinical data collection will be used in the future to support evidence-based coverage policy. At some point, it is also possible that insurers will review participation rates in these portals as part of the criteria for provider network eligibility, so it would be advisable to clearly understand any portal used to collect patient data, and the parameters under which it is being established.
What goes out should come back. If your practice data are being aggregated or being used for any purpose by an outside entity, your practice has the right to request reports and the return of data in kind. Trends, benchmarks, and comparisons are all going to be calculated; your practice should be able to receive and learn from those reports as well. If you are exchanging clinical data with an employer, payer, or a health system, it is time to request additional information in return for your own analytics. The rates of patient hospitalizations, other clinical services, disease trends, and benchmarks may all be tracked in that organization, and are of value to oncologists in improving the value of the care for their patients.
CMS’s Memo on Reimbursement
A flurry of activity and speculation followed the brief posting of a memo in early February 2016 from the Centers for Medicare & Medicaid Services (CMS) to Medicare contractors to process payments. The memo appeared on the CMS website, and was later described as a premature posting. It was taken down after the press and the oncology community took notice and started commenting on the memo. However, the posting of the memo lasted long enough for a flurry of discussions and reviews about its intent, legality, and appropriateness to ripple through the health policy and oncology community.
The memo told Medicare contractors to create a system that would allow the government to reimburse physicians for Medicare Part B drugs (those administered by physicians) at varying rates per geographic location. This initiative was described as a pilot study to assess how limiting reimbursement for specific Part B drugs beyond legislated ASP (average sales price) plus 6% rates could affect the physician’s choice of drugs.
The important takeaway from this news, regardless of whether the memo ends up as established policy, is that despite all the national attention and focus on value and evidence in the management of cancer care and a very expensive moonshot that seeks to collect information to help us eliminate cancer, for many payers, including Medicare, the management of oncology still comes down to trying to influence physicians financially to choose one drug versus another.
However, that focus does not discuss the effectiveness of a particular drug, the cost of comparable alternatives, or the handling and overhead costs of the drug. It also does not recognize the physician’s cognitive role in medical decision-making, nor the complexity of tailoring a treatment regimen to an individual patient’s need.
Take Part in the Discussion
Whether the CMS memo was an exploration of options or was a mistaken early disclosure of an impending new policy does not matter. What does matter is that we are fighting the war against cancer on many fronts, and the launch of a moonshot to eliminate cancer as we know it pales beside the day-to-day struggle to deliver appropriate care in the face of rigid management that continues to focus solely on only one aspect of a very complex disease.
Physicians may struggle with the rigid management of cancer care, but patients bear the brunt of the policy impact. When we meet with our legislators and with CMS, and even folks in the White House, these are valid points to discuss.