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Access for 21st Century Cures: Updating Medicare’s Approach to Coverage and Payment

WASHINGTON -- A bipartisan, broad-based effort is needed to ensure better access to the robust pipeline of new medical technologies unleashed, in large part, by the 21st Century Cures Act, health care leaders and researchers write in a Health Affairs blog published Wednesday.

The authors urge that health care stakeholders and federal agencies, particularly the Centers for Medicare & Medicaid Services (CMS), be supported in ongoing efforts to provide transparent, timely and scientifically up-to-date processes for coding, coverage and payment for these new technologies.  These efforts also would help in developing the best clinical evidence to inform policy and decision making for the nation’s 115 million Medicare and Medicaid beneficiaries.

“Bipartisan efforts by Congress and recent administrations have resulted in an unprecedented pipeline of innovative medical technologies, many of which are expected to enter the market,” said Mark McClellan, director of the Duke-Margolis Center for Health Policy. “Yet, no concerted effort exists to bolster the processes and infrastructure needed to address what happens as these technologies are approved for use – that is, the processes around coverage and payment that are critical for timely and efficient patient access to new technologies.”

McClellan co-authored the blog with fellow former FDA Commissioner Scott Gottlieb, Duke-Margolis researcher Morgan Romine, former FasterCures executive director Tanisha Carino and president and CEO of Friends of Cancer Research Jeff Allen.

The authors lay out both the challenges and a potential path for improving access and restraining costs with better, more informed use of new technologies, regardless of what happens on such controversial issues as medical product pricing.

“CMS has a foundation for addressing the predictability, coordination, and impact of its processes related to access and evidence on medical technologies,” the authors state. “However, while a number of pathways exist to support these activities, these efforts are limited and have not kept up with the rapid progress in technological innovation or enhanced regulatory expertise, now available comparatively at FDA.”

Recent activities by both the Trump Administration and Congress suggest the potential for a more robust initiative to update CMS processes, capabilities and stakeholder engagement. While issues involving CMS and new technology certainly are not without controversy, addressing them has the potential for wide support.

“Our review suggests that challenges remain in bringing coverage and evidence processes sufficiently up to date through the same kind of bipartisan progress that has bolstered technology development and marketing approval,” the authors said. “Fulfilling the promise of 21st century, innovative care will require further steps to address issues related to technology access at CMS and throughout the U.S. health care system.”

CONTACT: Patricia Green (Duke-Margolis Center)
(202) 791-9561 (o); (301) 520-6482 (c)