Permanent rules reward standing capability: stop running access as a series of projects

Two institutions, one message

Two items in this week's records look unrelated. On 5 November CMS finalised a permanent framework for the Medicare Drug Price Negotiation Program, setting lasting policies for negotiating prices of high-cost drugs. Prices taking effect from 2029 are covered, and CMS says manufacturers get more predictability. The same day it published final rule CMS-4215-F, which covers both the negotiation programme and the Medicare Prescription Drug Benefit Program. Also that week, the MHRA opened a new application cycle for its MHRA-NICE real-world evidence scientific dialogue, which it now runs as an established offer after a pilot.

The common thread is that experiments are hardening into infrastructure. My argument is that market access, HTA and pricing teams should treat this as a change in how they are organised, not just as news. When rules were provisional, it was defensible to staff negotiation and evidence dialogue as projects: a team assembled for a deadline, then disbanded. Permanent rules and standing services reward standing capability.

What permanence changes

Start with the US. A permanent framework means the negotiation question is no longer whether a product might one day be caught, but how every long-range plan should carry it. I would not pretend to know the mechanics from the records. The material available gives the headline and the intent of predictability, not the rule text. But the direction is clear enough to act on. A pricing forecast that treats Medicare negotiation as a scenario, rather than a base-case feature for prices from 2029, now looks out of date.

The UK offer makes the same point on the evidence side. A scientific dialogue that has moved from pilot to established service is something a team can build a routine around. Real-world evidence plans can be drafted to be tested with a regulator and an HTA body together, rather than assembled after a payer objects. The MHRA has added application details and an expression-of-interest form for the newest cycle. What the dialogue will deliver for any individual sponsor is not something the records tell us, and we should not claim otherwise.

Even a smaller item fits the pattern. Sera Prognostics reports Florida as the second state Medicaid programme to cover its preterm birth risk test, while it starts a CE Mark submission for a kit-based version. Coverage for products like this accrues one payer at a time, and the evidence story has to survive each conversation. A company that rebuilds that story for every payer pays the project tax repeatedly.

The strongest counter-argument

The best objection is that permanent does not mean stable. A final rule can be challenged, amended or overtaken by later rulemaking, and CMS has also proposed a separate rule, CMS-3484-P, on cutting administrative requirements in Medicare and Medicaid, whose details are not yet clear from the material available. Investing in standing capability around a framework that may shift risks building the wrong thing. The MHRA-NICE service is a single-country offer, and the records give no outcomes for it.

That is fair, and it argues for building capability around the questions rather than the current wording of the rules. Evidence plans, price-erosion modelling and payer-ready dossiers hold their value if details move. A team that already runs them as routine can adapt to a rule change faster than one starting from scratch each cycle.

Recommendation

Give negotiation exposure and evidence generation named, permanent owners, with budgets that do not depend on a launch calendar. Reading the CMS final rules closely, rather than relying on summaries, should be the first task of the new owners. Then decide which products and markets justify entering the MHRA-NICE cycle.