Summary
Wynne Health Group has updated its Legislative and Regulatory Outlook for 2019 to include changes stemming from the Administration’s Spring 2019 regulatory agenda. This documents seeks to provide a comprehensive collation of key federal health policy developments that we expect to see in the remaining months of this year.
Of note in this update, you will find that many planned regulatory developments have been delayed to subsequent months. For example, the proposed rule for the International Pricing Index Model is now delayed until August. Similarly on the drug pricing front, finalization of the proposed changes to the anti-kickback statute for drug manufacturer rebates is expected in November. Other anticipated regulatory changes have also been postponed until the 2020 rulemaking cycle, notably including the Food and Drug Administration (FDA)’s final rule that will update the definition of a “biological product.”
Additional forthcoming items are slated to provide the federal government with more expansive means for addressing the growing complexities in health care. For example, a proposed rule anticipated for July of this year is expected to explore changes to the anti-kickback statute safe harbors, aimed at equipping providers with more flexibilities to coordinate care and address social determinants of health. Moreover, we may see further developments on the federal government’s work to address complex health conditions through specialty care models in a July proposed rule.
Last, on the political front, we point to important Congressional deadlines that implicate health care policy, including the timing for FY 2020 appropriations bills, the upcoming expiration of “health extenders,” and when Congress must act to raise or suspend the debt limit. We have also included the timeline for the 2019 Democratic Presidential primary debates.