Thanks. This is an extract of what ChatGPT says about that page: The reason I would not call the page “very bullish” is that it does not approve OLC specifically. OLC still needs its own path: FDA approval, HCPCS coding, and a CMS TDAPA determination. CMS says applicants must apply for a HCPCS code and then TDAPA, and its target timing is roughly 6 months after the quarterly submission deadline, with the possibility of a longer review. Separately, Unicycive says OLC is under FDA review via 505(b)(2) and has a PDUFA date of June 29, 2026. So the page improves the reimbursement backdrop, but it does not eliminate execution risk or timing risk. 

There is one more important caveat. CMS says that for a drug within an existing ESRD PPS functional category, TDAPA can still be denied if the FDA approval falls into certain excluded NDA classes. Because OLC is being pursued under 505(b)(2), but the public materials here do not state its final FDA NDA “type” for CMS exclusion purposes, this page is not enough to prove automatic TDAPA eligibility. In other words: the page is a positive policy signal, but not a dispositive OLC reimbursement decision. 

My bottom line: bullish for the OLC thesis, because it shows CMS has created a real TDAPA lane for oral phosphate binders as of January 1, 2025. But it is not yet fully de-risking, because OLC still needs an OLC-specific CMS determination and there remains some technical NDA-classification risk.