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Tuesday, September 10, 2024 8:46:44 PM
“(Bloomberg Intelligence) - Ardelyx, Akebia Therapeutics and other makers of oral-only, end-stage renal disease (ESRD) drugs will likely see Congress pass legislation during the lame duck session
that blocks an administrative proposal to move the therapies out of the Medicare Part D program. Some lawmakers have expressed concerns with the regulatory decision, and a delay won't impact federal finances. Passing the bill would remove some near-term uncertainty around utilization and
pricing for newer drugs. (09/04/24)
1. Lawmakers Ramp Up Scrutiny of Regulatory Change Ramped-up congressional oversight of Medicare's implementation effort to incorporate oral-only drugs into the ESRD payment bundle should generate enough headline noise to keep the issue front-and-center for action during the lame-duck session. Lawmakers continue to raise concerns about the regulatory change, and have requested information from the Biden administration on the implementation process. But with only a handful of legislative weeks scheduled in September, major policy changes won't make it to the president's desk before Congress adjourns for election
campaigns. The policy change will likely be folded into a broad-based year-end omnibus bill with other member
priorities such as PBM regulation changes and legislation curtailing biotech research with China.
(09/04/24)”
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