April 27, 2018

What CMS and FDA announced at Datapalooza: First-ever release of Medicare Advantage data, AI regs, and more

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    After an initial delay, CMS on Wednesday announced it will begin releasing Medicare Advantage (MA) encounter data to researchers, Modern Healthcare reports.

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    CMS Administrator Seema Verma made the announcement at the annual Health Datapalooza conference on Wednesday, where FDA officials also announced new plans to promote artificial intelligence (AI) and digital health tools, Politico's "Pulse" reports.

    CMS to share MA data

    Verma during the conference unveiled the Data Driven Patient Care Strategy, under which the agency will allow researchers to access claims data for MA, which according to ProPublica covers more than a third of Medicare's 58 million beneficiaries. Verma said CMS is launching the strategy as part of the MyHealthEData initiative, which Verma and Jared Kushner—director of the White House Office of American Innovation—announced last month.

    Under the new strategy, CMS has made available to researchers a preliminary version of 2015 MA encounter data. Verma said CMS plans to release a final version of the 2015 MA encounter data later this year. According to FierceHealthcare, the agency was scheduled to release the data last year, but they delayed the release date in response to concerns about the data's accuracy.

    According to a CMS fact sheet, the encounter data includes "detailed information about services provided to beneficiaries enrolled in a managed care plan under the [MA] program in calendar year 2015." Specifically, the data include information generated by health care providers that documents clinical conditions and items and services delivered, according to America's Health Insurance Plans, MedCity News reports.

    Verma said CMS plans to make new MA encounter data available annually. In addition, she said CMS plans to release CHIP and Medicaid data in 2019. "The data has the potential to help produce better, more targeted treatments for these patients, improving their quality of life while at the same time reducing costs," she said.

    According to Modern Healthcare, researchers will be required to sign a data user agreement with the Research Data Assistance Center to access the 2015 encounter data. But, according to Axios' "Vitals," those who do so will be able to more accurately assess the value and quality of MA plans.

    Researchers applauded the announcement, "Pulse" reports. For instance, Lindsey Leininger of Mathematica in a tweet wrote, "This is a tremendously big deal in health policy analytics."

    FDA looks to promote AI, digital health tools

    Separately, FDA Commissioner Scott Gottlieb during the conference said his agency plans to release a series of guidance documents that aim to speed digital health innovation, CQ Health reports.

    According to CQ Health, Gottlieb said FDA will release guidance documents on how:

    • FDA reviews tools such as AI and medical software;
    • Manufacturers can include software in the drug development process; and
    • Qualified manufacturers can tweak products involving AI and machine-learning without needing additional approval from FDA.

    In terms of AI, Gottlieb said FDA is working to provide a "new regulatory framework" that will allow the agency to keep up with technological advances and "promote innovation in this space." He said FDA "expects to see an increasing number of AI-based submissions in the coming years, starting with medical imaging devices, and we're working with experts in the field."

    Gottlieb also said FDA would work on regulations for certain digital health tools, such as software and apps that look to promote medication adherence. Gottlieb also said FDA's drug center would begin to consider how it would regulate digital-drug combination products, according to "Pulse."

    In addition, Gottlieb introduced a new process for manufacturers to submit premarket safety reports in digital data sets. Gottlieb said the new process will replace FDA's previous process for such submissions, which involved paper and PDF documents. Gottlieb said the new process will save FDA hundreds of hours monthly on administrative reviews.

    Further, Gottlieb said FDA has a working draft model for a precertification pilot, which would allow pre-approved companies to receive waived or streamlined pre-market reviews if they are deemed to have effective development processes in place. FDA is seeking public feedback on the pilot, which it hopes to launch by the end of 2018.

    Gottlieb also said FDA in partnership with the private sector will launch a "data science incubator" to assist in the research of breakthrough therapies for diseases such as cancer. He said the incubator will conduct work on many initiatives, including identifying trends in tumors through medical imaging  (Baker, "Vitals," Axios, 4/27; Baum, MedCity News, 4/27; Dickson [1], Modern Healthcare, 4/26; Dickson [2], Modern Healthcare, 4/26; Sullivan, The Hill, 4/26; Baum, MedCity News, 4/26; Diamond, "Pulse," Politico, 4/27; CQ Health, 4/26 [subscription required]; Stankiewicz, FierceHealthcare, 4/26; Ornstein, ProPublica, 6/29/17; CMS fact sheet, 4/26).

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