Medicare drug price negotiation with every figure traced, signed and ready before 1 March
A complete, traced negotiation file ahead of every CMS deadline.
See one case, screen by screen ↓Software that helps a manufacturer whose drug CMS has selected for the Medicare Drug Price Negotiation Program build and defend its submission: the Negotiation Data Elements, the evidence on therapeutic alternatives and the offer and counteroffer that follow. Medicare Drug Price Negotiation adds six agents that map, collect, reconcile, summarise and draft, while section owners sign and the CFO certifies.
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When CMS selects a drug for the Medicare Drug Price Negotiation Program, the manufacturer has about four weeks — from the selected drug list on 1 February to 1 March — to submit the Negotiation Data Elements: non-FAMP, R&D costs and recoupment, current unit costs of production and distribution, prior federal financial support, patents and exclusivities, market and sales data, and the evidence on therapeutic alternatives. Every figure lives in a different system and belongs to a different team — government pricing, the plant, R&D finance, legal, HEOR — and a named officer must certify the whole file.
Today it is assembled in spreadsheets, email threads and shared folders, and where each number came from stays in people's heads. Overhead allocations, failed-product R&D and distribution cost are judgement calls built from ledger extracts; one duplicated line moves a unit cost, and nobody can see why later. Then, under a 30-day counteroffer clock, CMS asks follow-up questions and the team reconstructs the answers. Late or withheld information can cost up to $1 million a day; knowingly false information, up to $100 million an item.
Estimated split for one selected drug's negotiation data file, by hand and with the solution.
Six agents map, collect, reconcile, summarise evidence and draft the counteroffer; section owners sign and the CFO certifies.
Veltara Therapeutics' VLT-260 — Tarvessa (relvanostat) tablets, 10 mg and 20 mg, for heart failure with preserved ejection fraction — was selected for initial price applicability year 2029 on 1 February 2027. It is Wednesday 17 February. Here is what happens next, screen by screen, in the working solution.
Nadia's home is a countdown board. Across the top: 12 days to the negotiation data due on Mon 1 Mar, internal cut-off Wed 24 Feb; 104 days to CMS's initial offer, with the ceiling of $459.30 a bottle already worked out; 134 days to the counteroffer, 7 of 8 arguments drafted; 256 days to the end of negotiation. Below, the 44 data elements sit as tiles in seven form sections, each filling as it is sourced, reconciled and signed. 41 of 44 are ready.
“All 44 sources re-collected overnight; 43 unchanged.”
Three elements are still open: unit cost of production for the 10 mg bottle of 30, pending FDA applications awaiting Owen Castillo's signature, and the real-world comparative effectiveness study awaiting Dr. Priya Anand. Nadia clicks the amber tile. The number trace opens beside the board: plant costing system, extract PCS-ROLLUP-2026 across 38 batches, and a roll-up of $14.82 against $14.27 in the ledger — over the $0.01 tolerance.
If CMS asks: “Prepared once the difference is resolved.”
The trace page lays the figure out as a chain — source system, extract, ledger tie, signature, the CMS form field — and breaks the bottle into its seven components, roll-up against ledger. Six agree to the cent: active ingredient $6.12, excipients $0.38, compression and coating $2.41, packaging $1.09, QC release testing $0.55, QA and batch release $0.86. Allocated plant overhead reads $3.41 in the roll-up and $2.86 in the ledger.
The reconciler reads the roll-up for batches VR-2611 to VR-2648, then cost centre 4410 — Raleigh solid dose, 2026 actuals. It compares the seven components, searches 412 lines of the overhead pool journals and finds JE-26-118734, “QC release testing, 2026”, $902,000: the same testing is also charged direct to each batch at $0.55 a bottle. It proposes $14.27, which ties to the ledger to the cent.
“Proposed: $14.27 a bottle · Ties to the ledger to the cent · owner decides.”
Nadia accepts the proposed $14.27 and sends it to Ji-woo Park, who owns the unit-cost section. Ji-woo signs at 09:16. The tile turns green, the board reads 42 of 44, and the trace now carries a prepared answer for CMS, component by component, including the note that an earlier roll-up counted QC testing twice and was corrected before certification.
The Number reconciler never changes a figure: the owner accepts and signs.
Every figure in the data file opens the same way. Failed and abandoned products, $341.0M, comes from extract RDL-ALLOC-FAIL: three discontinued programs on the same target — VLT-214, VLT-233 and VLT-247 — allocated by VLT-260's share of direct spend in that class, 38.6 %. Tomás signed it on 10 Feb. The trace shows where the figure is used, including counteroffer argument 1, and what to say if CMS asks.
History of this figure: mapped 2 Feb, first collected 4 Feb, ledger tie confirmed, signed 10 Feb, re-collected 14 Feb — unchanged.
The Evidence summariser read 126 sources and cited 38. Against four therapeutic alternatives — the SGLT2 inhibitor class, generic spironolactone, loop diuretics and standard care — RELAY-HF (n = 4,212) shows heart-failure hospitalisation 18 % lower than placebo on top of standard care (HR 0.82, 95 % CI 0.74–0.91), and KCCQ 5.8 points better at 12 months. The VERITY registry analysis of 18,940 Medicare-age patients (22 % lower hospitalisation) stays out of the file until Priya's review on Thursday.
“From cited sources only · no QALY-based measures.”
Average non-FAMP for 2026 is $612.40; seven years since approval, under 12, puts the applicable percentage at 75 %; the Part D net price after rebates is $471.80. The ceiling, the lower of the two, is $459.30. A simulated initial offer of $318.00 takes Part D revenue from $693.5M to $467.5M; the draft counteroffer of $402 holds $590.9M. Draft 3 of the justification sets out eight statutory factors, seven of them drafted, each figure linked to its trace.
Factor 8, real-world effectiveness: “Held back until HEOR signs the VERITY analysis (22 % lower hospitalisation). The drafter does not use unsigned figures.”
The certification screen lists each section with its owner and signature: Non-FAMP, unit costs, R&D, market data and federal support all signed. Two remain — real-world comparative effectiveness with Dr. Priya Anand, and pending FDA applications in Leah Morgan's patents section — each with a Remind button. Helen is due to certify on Fri 26 Feb; until all 44 are signed, her Certify button stays locked and reads “2 open”.
“Certifies that the information is accurate and complete. Knowingly false information can cost up to $100 million per item.”
The timeline holds the statutory dates for initial price applicability year 2029 and the plan worked back from them: all 44 elements signed by Wed 24 Feb, three business days before; the director approves Thu 25 Feb; the CFO certifies and the file is submitted Fri 26 Feb. Then the initial offer by Tue 1 Jun, the counteroffer about 1 Jul, negotiation ending Sun 31 Oct, and the maximum fair price published Tue 30 Nov.
Owners are reminded 7, 3 and 1 day before an internal date; the director is told at 2 days. Statutory dates are read-only.
The same negotiation data file, seen by five of the people who carry it — what the four weeks looked like, and what they look like now.
Six agents map, collect, reconcile, summarise evidence and draft the counteroffer; section owners sign and the CFO certifies.
Maps each required data element to its definition in the current CMS guidance, quoted word for word, and to its owner, its system of record and its calculation method.
Pulls each figure from its system — cost ledger, plant costing, government pricing, sales data, patent docket, grants — stamps the query and time, re-collects every night at 06:00 and reports any figure that changed.
Ties every figure to finance's ledger at component level and explains any difference line by line — duplicates, periods, allocations, currency — proposing a corrected figure with the journal references.
Reads trials, labels, guidelines and real-world studies on the therapeutic alternatives and writes plain-language answers to CMS's evidence questions, each claim cited to its passage.
Drafts the counteroffer justification one statutory factor at a time, using only signed figures and reviewed evidence, and links every figure to its trace.
Holds the statutory dates for the cycle, sets the internal cut-off three business days before each CMS deadline, reminds owners at 7, 3 and 1 day and escalates to the director at 2 days.
The CFO certifies the file. The agents propose; a named person decides.
Ask about any figure, deadline or argument in the file — or ask for a draft. Every answer points to the trace it came from.
Why did unit cost of production drop to $14.27?
The plant costing roll-up counted QC release testing twice: once as a direct lab charge ($0.55 a bottle) and again inside the plant overhead pool, journal JE-26-118734. Removing the duplicate brings the 10 mg bottle from $14.82 to $14.27, which ties to cost centre 4410 in the ledger to the cent. Across 1.64 million bottles that is $902,000 of cost that would have been certified twice.
What is left before 1 March?
Three of 44 elements are open, 12 days before the deadline and 7 before the internal cut-off on Wed 24 Feb: unit cost of production, 10 mg (reconciling, Ji-woo Park), pending FDA applications (Owen Castillo to sign) and real-world comparative effectiveness (Dr. Priya Anand, review Thursday).
If CMS asks how failed-product R&D was allocated, what do we say?
Three discontinued programs on the same target — VLT-214, VLT-233 and VLT-247 — cost $883.4M in all. We allocated them by VLT-260's share of direct spend in that target class, 38.6 %, giving $341.0M. The method is costing policy FIN-COST-07 and was signed by Tomás Rivera on 10 Feb.
Draft the counteroffer argument on unmet need
Drafted as factor 6. It rests on three traced figures: about 164,000 Medicare enrollees on Tarvessa, the 18 % lower heart-failure hospitalisation in RELAY-HF, and benefit that holds in patients aged 75 or older and with kidney disease, where the alternatives are often unsuitable. The real-world figure stays out until HEOR signs it. It is waiting for Owen Castillo's review.
12 screens from the working solution, on its sample data. Pick one to see it large.
How the file is built, checked and signed for every selected drug — all settings, saved as new versions.
| Setting | Default | Choose from |
|---|---|---|
| Tolerance per unit | $0.01 | $0.00 · $0.01 · $0.05 |
| Tolerance for totals (R&D, revenue and rebates) | 0.1 % | 0.05 % · 0.1 % · 0.5 % |
| Re-collect every source | Nightly 06:00 | Nightly 06:00 · Twice a day · On demand |
| Internal cut-off | 3 business days before each CMS deadline | 2 · 3 · 5 business days |
| Remind owners | 7, 3 and 1 days before an internal due date | 7, 3, 1 days · 3, 1 days |
| Escalate to the director | 2 days | 1 day · 2 days · 3 days |
| Sources allowed in the dossier | Peer-reviewed + regulator | Peer-reviewed + regulator · Any cited |
| QALY-based measures | Always off | Excluded by statute; the summariser never uses them |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (Social Security Act §1197 via the Akin Gump guide to the IRA — up to $1 million a day for late or withheld information, up to $100 million an item for knowingly false information; CMS HPMS instructions — negotiation data due 1 March). People, companies, products and studies named on this page are fictional — characters and sample data in the working solution.
Software that helps a manufacturer whose drug CMS has selected for the Medicare Drug Price Negotiation Program build and defend its submission: the Negotiation Data Elements, the evidence on therapeutic alternatives and the offer and counteroffer that follow. Medicare Drug Price Negotiation adds six agents that map, collect, reconcile, summarise and draft, while section owners sign and the CFO certifies.
The Form mapper maps each data element to its definition, owner and system. The Source collector pulls each figure read-only and stamps the query and time, and the Number reconciler ties every figure to finance's ledger, explaining any difference line by line. Each element's owner then signs it.
Yes. Every figure opens to its trace — source system, extract, ledger tie and signer — with an answer prepared for CMS. In the working solution, the failed-product R&D figure comes with its allocation method, the three programs behind it and the date it was signed.
The Evidence summariser drafts cited answers to CMS's evidence questions from trials, labels, guidelines and real-world studies, using only peer-reviewed, regulator and study-report sources and no QALY-based measures. The HEOR lead signs every summary, and an unsigned figure stays out of the file.
It works out the ceiling price from the traced non-FAMP and Part D net price, lets you simulate CMS's initial offer, and drafts the counteroffer justification factor by factor from signed figures only. Counsel reviews every draft, and nothing is sent to CMS from the solution.
No. The agents read every source system read-only and propose corrections; the owner accepts and signs. They never change a figure, never move a statutory date and never send anything to CMS.
Yes. Each section's owner signs its elements, counsel signs the legal elements and reviews every counteroffer draft, the director approves the file, and only the CFO, as certifying officer, can certify it — once every element is signed.
The Agentic Solution Engine builds and deploys it from your requirements and documents — the current CMS guidance and form, your costing policy and the systems behind each data element — and it goes live once every quality gate has passed. We will walk you through it on your own figures first.
Every GVD sentence linked to its source and checked against the label.
1-min demoRebate Claims ValidationEvery rebate invoice line checked, every dispute backed by its clause.
1-min demoPayer Contract ManagementEvery payer contract turned into cited terms, every deadline tracked
1-min demoWe'll run Medicare Drug Price Negotiation on your own data elements and the systems they come from.