CMS Will Take Money Off the Table Overnight. Putting It Back Takes Years.
On July 2, CMS proposed cutting what it pays for 340B-acquired drugs from ASP plus 6% to ASP minus 33.4%. On the same page, in the same document, it proposed tripling the annual clawback rate on a prior budget-neutrality remedy, compressing a repayment timeline that was set to stretch into the 2040s down to roughly 2029. That's not incremental rulemaking. That's CMS deciding a number was wrong and moving to fix it, fast, with real dollars attached.
Three pages later, in the same rule, CMS looked at the $127.14 per square centimeter flat rate it imposed on every skin substitute product in January — regardless of FDA regulatory pathway, regardless of clinical evidence, regardless of whether a product is a 361 HCT/P or a PMA-cleared device — and left it exactly where it was. Second year running. Same justification both times: not enough claims data yet. Differentiated rates, the thing CMS itself proposed and then delayed, now wait for CY2028.
Same Rule, Two Postures
Put those two decisions next to each other and the pattern isn't subtle. CMS found a number it didn't like - the 340B acquisition spread - and moved on it inside a single rulemaking cycle. CMS has a number that a peer-reviewed clinician survey, published this month in the Journal of Wound Care, now directly links to authorization delays, treatment denials, and wound-clinic closures - and it's held that number flat for two cycles running, citing a data gap it has had over a year to close.
This is exactly what BTK's Reimbursement Index is built to isolate: which companies are exposed to a rate CMS treats as fixed, and which are exposed to a payment mechanism CMS treats as negotiable. A company like MiMedx, regulated as a 361 HCT/P, sits at High CMS Risk in that framework — fully exposed to a rate CMS has shown no urgency to revisit. A company like Avita Medical, holding PMA-level evidence, sits at Low risk — structurally better positioned for whenever differentiation actually arrives. That gap has been visible in the scoring since January. CMS just spent a week confirming it isn't in a hurry to close it.
The Third Data Point
Then there's Elevance. Same week, different rulebook entirely: CMS extracted $342 million from Elevance Health over Medicare Advantage billing overcharges affecting roughly 2 million beneficiaries - a threat of enrollment freezes in February that turned into a nine-figure settlement by July. That's not OPPS, that's not CAMPs, that's a completely separate enforcement track. But it's the same agency, the same week, moving with real speed and real teeth on a billing-accuracy question.
Three CMS actions. One week. Two of them decisive. One of them, the one actually closing wound clinics right now, deliberately parked for another eighteen months.
This Isn't Inconsistency. It's a Choice.
CMS is not an agency that lacks the capacity to act quickly — it proved that twice in the same document, in the same week it also proved it on a completely different enforcement track. What it lacks is any urgency tied to the CAMPs rate specifically. That's worth sitting with. The claims-data justification CMS keeps repeating is not a resourcing constraint. It's a stated preference for how much evidence it wants before it moves on a cost to itself, compared to how little it apparently needs before it moves on a cost to somebody else.
For manufacturers and providers still modeling CY2028 as the date this gets fixed: nothing about this week's rule gives that date any more certainty than it had in January. CMS has now shown, twice, that it will hold a documented-harm situation at arm's length as long as it wants to. Plan accordingly, not hopefully.
That's not a story that shows up in a press release. It shows up when you read three separate filings, a nine-figure enforcement settlement, and a peer-reviewed survey against each other, inside the same seven days - and know before the market does which companies are exposed and which aren't. That's the entire reason the BTK Intelligence platform exists. CMS Risk scoring, by company, live - not reconstructed after the fact on a Friday. If you're not already tracking it that way, start here: intelligence.belowtheknee.co →
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See you Friday.
-Scott