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Affordable Care Act's Impact on Cancer Research, Data Sharing Discussed at AACR Annual Meeting

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NEW ORLEANS (GenomeWeb) – The Affordable Care Act (ACA) has now been in effect for six years, during which time its effects on insurance premiums, US healthcare spending, and health outcomes have been studied and debated by various groups.

At the annual meeting of the American Association for Cancer Research in New Orleans this week, a panel of researchers discussed the law's provisions, as well as their impact on cancer research and prevention, and on sharing of information between researchers and between academia and industry.

Gilbert Omenn, director of the Center for Computational Medicine and Bioinformatics at the University of Michigan, began by listing ACA provisions that have an impact on how cancer is researched and how it can be prevented. In fact, Omenn said, most of the law's regulations — including the ones that mandate coverage for all people, coverage for preventive care and immunizations, keeping young adults on their parents' health plans, no coverage lifetime limits, and no prohibitions against pre-existing conditions, requirements for cost efficiencies, and quality measurements — contribute to clinicians' ability to prevent the development of cancer in patients, or to catch it early and treat it more efficiently.

The University of Texas MD Anderson Cancer Center's Ernest Hawk expanded on these points, saying that although we don't yet have outcome data to really show how the ACA is affecting prevention, incidence, outcome, or improved health, there are some surveys that are proving promising.

For example, he said, many provisions in the ACA are directly related to cancer prevention (i.e. access to screening), and many are indirectly related (i.e. smoking cessation programs, depression treatment, etc). Statistics show that from 2013 to 2015, the number of people with access to preventive care has almost doubled from 71 million to about 140 million, Hawk added. Coverage for the HPV vaccine has gone up, as have the rates for colon cancer screening, particularly in populations that are less educated or who had previously counted cost as a barrier to getting screened. Smoking cessation ad campaigns are also having a large impact on people quitting or intending to quit, Hawk said — there's been a 17 percent increase in the rate of quit attempts.

However, there has been no difference in the rate of breast cancer screening, Hawk added. Congress has redirected money from prevention and the public health fund to serve other needs, and sequestration had cut several million dollars from the budget for prevention and screening programs. In states that have yet to expand Medicare, the impact of prevention has been limited, he said. In particular, women in non-expansion states have significantly lower odds of receiving pap smears and mammograms.

But although it's still too early to gauge the full impact of the ACA on prevention, it has changed the philosophy of US healthcare, Hawk said, elevating prevention as a priority, providing improved access to preventive services, promoting workplace wellness, emphasizing the community's role in prevention, and encouraging heavy investments in the primary care workforce. Vice President Biden's cancer moonshot program is a "huge opportunity" to carry the cause of prevention forward, he added.

William Dalton, CEO of M2Gen, a for-profit subsidiary of the Moffitt Cancer Center, delved more directly into four different metrics of cancer research and how they've each been affected by the ACA, and the specific requirements of the American Recovery and Reinvestment Act of 2009 (ARRA): clinical trials, comparative-effectiveness research, translational research, and prevention.

For clinical trials, it was hoped that the provisions of the ACA requiring insurers pay for patients' routine care would enable more people to sign up for and participate in trials. However, though the studies that have followed this metric are mostly anecdotal or incomplete, a recent University of Kansas study shows that 63 percent of clinical trial patients are still being denied standard-of-care coverage, Dalton said, adding, "We still have a long way to go — and the ambiguity in the law needs to be addressed because it's being used by the insurance companies to deny coverage."

In terms of comparative-effectiveness research, the work is progressing a little more steadily, Dalton said. The Patient-Centered Outcomes Research Institute created under the ACA has helped clinicians determine which treatments have value and which are the right therapies for various patients. A recent Government Accountability Office review of PCORI said its goals were being met, particularly those initiatives that are meant to engage and enhance research and patient perspective, Dalton said. "It's a work in progress, but they're on their way," he added.

For translational research, the National Institutes of Health's Cures Acceleration Network and the National Center for Advancing Translational Sciences was meant to bridge the valley between researchers and industry in order to put preclinical data to use in the clinic. However, Dalton said, recent surveys show the public/private partnership needs work, and a recent US Senate report suggested that CAN has shown success in the lab but has not advanced far enough to attract significant investment from the private sector.

Finally, when it comes to prevention, Dalton said, studies are showing that preventive care is not being fully addressed, as many insurance companies are still not covering preventive tests and patient monitoring.

Dalton also spoke about the importance of building a health research informatics platform that could use electronic healthcare records to enhance quality of care, engage and inform patients, and exchange data between research centers. Though this process has begun, it has been stymied by certain challenges.

"There's still very little sharing of information and few existing standards," he said. "The EHRs have been driven by medical/legal considerations and less by the clinical needs. They have created more work for the clinician at the point of care, and it has not lived up to the desire of engaging the patient and enhancing communication between clinical and patient."

However, he added, the problem isn't one of technology but of culture. "How are we sharing data and how much are we willing to share?" Dalton asked. "Just data dumping isn't going to work." The future, he said, needs to be based "on a hybrid model of data sharing," taking into account the federated system of data privacy, but also sharing information between research institutions where need be.

To that end, there are already some initiatives taking place to encourage the sharing of data and information. In a poster session at the conference on Sunday, the International Cancer Genome Consortium announced plans to launch the International Cancer Genome Consortium for Medicine (ICGCmed), a collaborative project meant to link genomics to clinical information and health.

ICGCmed will draw on the database of genomic discoveries of the ICGC, which has been mapping 25,000 different cancer genomes in 50 different tumor types since its inception in 2007. This data is freely available to researchers around the world, ICGC said.

ICGC believes that linking its data with clinical information can accelerate efforts for prevention, early detection, and diagnosis and prognosis, and can help clinicians choose the most effective therapies for patients' diseases.

"ICGC was a major advance in cataloging a large number of gene alterations from different types of cancers," Fabien Calvo, CSO of Cancer Core Europe and the lead author of the ICGCmed white paper, said in a statement. "By collecting clinical information from large cohorts of patients who were classified as having the same types of cancer coupled with extensive genomic information, ICGCmed will allow us to determine genetic elements of the efficacy of treatment, and root out the causes of resistance to therapy. Ultimately, this will allow patients to receive the right treatment and for their treatment to be adapted effectively."

Researchers working with ICGCmed must also agree to share data while also protecting the privacy of study participants, ICGC added.

In a separate presentation, the National Cancer Institute's Zhining Wang talked about the progress being made on NCI's data-sharing module, the Genomic Data Commons. The module is meant to be a unified data repository with a mission of widely sharing information gleaned from genomics research.

The data, once uploaded, is harmonized by the system and made more user friendly before being made available for download. The point, Wang said, is to turn a data warehouse into a knowledge base. In order to do that, there are several requirements, for example, molecular data must be associated with clinical data in order to be uploaded on the site, he said.

NCI is planning a soft launch for the GDC in early May 2016 to test the system with a limited amount of users. The official launch is set for early June, when the NCI will open the system to anyone who wants to submit relevant data.