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2020 in Washington: another shot at drug pricing legislation, user fees and 21st Century Cures 2.0

Congress and U.S. voters could make decisions in 2020 that fundamentally reshape biopharma strategies

The year ahead in Washington will start with an attempt to find middle ground on restructuring the way Medicare pays for medicines, and will end with politicians making plans to implement mandates to control drug prices. In between and out of the limelight, reforms will be crafted that are intended to bring the regulation of diagnostics into the 21st century and pave paths to the integration of digital technologies into routine medical care.

Drug pricing policies that will be debated in congressional and presidential elections could shape for a generation how science is turned into medicines and how American patients access therapies.

In the short-term, there’s a chance for a congressional compromise on legislation that, if enacted, would cap out-of-pocket costs in Medicare Part D, change the Part B reimbursement formula, and possibly limit Part D price increases.

These changes are far less dramatic than those that will be promoted on campaign trails, but they are nonetheless important for patients and the biopharma industry.

An out-of-pocket cap would reduce financial hurdles that force seniors to make impossible choices, such as between paying for medicines and groceries. Curbing price increases would help Medicare patients whose copays and deductibles are based on list prices.

All of the leading Democratic candidates have vowed to give HHS the power to negotiate, or set, Medicare drug prices.

The fate and timing of Medicare drug reforms are uncertain -- they’ll only happen if Democrats and Republicans feel that they won’t give the other party an electoral advantage -- but there is no doubt that FDA user fees will expire in

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