Medical Device User Fee Deal Announced

Medical device companies have agreed to pay almost $1 billion in user fees to the Food and Drug Administration (FDA) between 2018 and 2022 in a deal announced last week. This is a 68 percent increase over the $595 million the industry pays under the current user fee agreement settled in 2012. These user fees will provide resources to reduce the total review time for devices. Independent analyses will also be conducted to examine how the agency manages the review process. FDA has committed to providing industry with feedback at least five days before meetings regarding forthcoming applications, and to testing how real-world evidence can support pre-market requirements. Further details about the agreement will be published for public comment in the coming weeks, and final recommendations are scheduled to be delivered to Congress in January 2017. The FDA still has to finalize negotiations with the drug industry. The user fee programs are expected to be combined into a single legislative package and passed before the existing agreements expire on September 30, 2017.

CMS Releases 2015 ACO Data

Accountable care organizations (ACOs) reduced Medicare program spending by $466 million in 2015, according to new data released by the Centers for Medicare and Medicaid Services (CMS) last week. This is an increase over the $411 million saved during the previous year. The 392 Medicare Shared Savings Programs (MSSP) cut spending by $429 million, while the 12 Pioneer ACO models saved $37 million. In total, thirty percent (or 125 ACOs) reduced spending enough to qualify to receive a share of the savings. More ACOs shared savings in 2015 compared to 2014, and CMS notes that those ACOs with more experience tend to perform better over time. Of the MSSP ACOs that started in 2012, 42 percent qualified for shared savings payments, compared to only 21 percent of those ACOs that started in 2015.

Upcoming Congressional Hearings and Markups

House Committee on the Budget hearing titled “Center for Medicare and Medicaid Innovation: Scoring Assumptions & Real-World Implications;” 10:00 a.m., 210 Cannon Bldg.; September 7

House Committee on Veterans’ Affairs hearing titled “From Tumult to Transformation: The Commission on Care and the Future of the VA Healthcare System;” 10:30 a.m., 334 Cannon Bldg.; September 7

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