The Complete Blood Count Is the Second-Most-Ordered Test in America and Its Category Does Not Exist

Editorial analysis accompanying the Global Haematology and Coagulation Diagnostics Market Report, 2026–2033.

A complete blood count is ordered roughly 36 million times a year under Medicare alone, which puts code 85025 among the highest-volume items in the entire Clinical Laboratory Fee Schedule. When CMS published its preliminary rates for calendar 2027 on 21 September, that code moved from USD 7.77 to USD 6.89 — an 11.3% cut to its weighted median, and a cumulative 35% below where the same code sat in 2018.

That is a large cut to a very large number of tests. But the most interesting thing in the publication is not the size of the reduction. It is where the reduction is filed.

Six categories, and the one that is missing

CMS reports the preliminary results of its median-based reset by category. The preliminary file names six: clinical chemistry (387 codes, −16%), molecular pathology (211 codes, −22%), genomic sequencing procedures (42 codes, −23%), microbiology (224 codes, −19.3%), proprietary laboratory analyses (151 codes, −2.4%) and immunology (205 codes, −19.3%). Across the file, 1,171 codes of 1,528 carry a lower weighted median than they do today.

Haematology is not one of the six. The complete blood count — 36 million Medicare tests, the second-highest-volume code in the schedule by most counts — sits inside a category summary that does not name its own field. Whatever bucket CMS used to aggregate it, the bucket is not labelled haematology, and the number is therefore not published as a haematology number.

This matters for a reason that has nothing to do with tidiness. A discipline whose price movement is not separately disclosed cannot be tracked by the people whose revenue it sets. A laboratory group modelling 2027 sees a chemistry line and a molecular line; the largest single test it runs has no line at all. The market’s most-administered price is also its least-reported one.

The ordering is the finding

Read the six categories in sequence and something more useful than a headline emerges. Chemistry was cut 16% while molecular pathology was cut 22% and genomic sequencing 23%. Chemistry was cut least.

The mechanism is that a weighted median measures how far a private-market price has drifted above the Medicare rate. A category that private payors have already competed down to something close to the public price has little gap left to close. A category still carrying a premium — a proprietary assay, a sequencing procedure, a test with no substitute — has a large gap and therefore takes a larger reset.

So the ordering tells you where the private market still charges more than Medicare. It says chemistry is the most commoditised discipline in the schedule, because eight years of buyer pressure had already taken it there. The 2027 reset did not make clinical chemistry a commodity. It confirmed that it already was one.

The cap is a deferral, not a protection

The Consolidated Appropriations Act, 2026 amended the statute so that no test may be reduced more than 15% in any year from 2027 through 2029. On its face that reads as relief. It is not, and the arithmetic in ACLA’s comment letter makes the point precisely: the association counted 775 tests taking the full 15% in year one.

A code facing a 35% gap is not protected by a 15% cap. It is scheduled. The cap converts one large cut into three smaller ones and guarantees that the reset continues past the current forecast window, which is a materially different risk profile from a one-off adjustment. ACLA put the cumulative 2027–2029 reduction in Medicare Part B laboratory payments at roughly USD 3.3 billion against a payment system of about USD 9 billion a year. CMS projected roughly USD 1 billion a year of savings.

There is an honest complication inside this, and it should be stated rather than resolved. The medians are computed from private-payor data reported by laboratories, and the reporting population has shifted: hospital laboratories went from 1.1% to 13.6% of reporters, while ACLA’s own reading is that the data covers about 2% of laboratory testing and that more than 4,000 independent laboratories report nothing at all. If the sample is unrepresentative, part of the 2027 cut is measurement rather than price. That possibility cuts in both directions, and it is not resolvable from outside CMS.

What a cut to the output price does when the input is not tendered

In the United States, Medicare prices the test and the laboratory buys its reagents privately. In China, the province prices the reagent directly. These are not two versions of the same policy; they act on different sides of the same transaction.

Anhui ran China’s first volume-based procurement for coagulation reagents in January 2023, and the design is worth stating because it is the template. Bidders self-declared onto a provincial list. The ceiling was not a government formula — it was the volume-weighted average of what Anhui hospitals had actually paid on the provincial platform the previous year. Bidders then competed on their reduction against that ceiling, with 90% of prior-year platform volume committed as first-year purchase volume. On the coagulation six: 22 bidders, 16 selected, an average combined reduction of 40.16% and a maximum of 49.59%. On the cardiac three: 26 bidders, 17 selected, average 57.35%, maximum 80%.

The difference in incidence is the whole story. A US laboratory facing an 11.3% cut to the price of a complete blood count cannot pass that cut upstream, because its reagent contract is a private negotiation in which the vendor holds the installed base. It absorbs the difference. A Chinese laboratory facing a 40% cut to the reagent does not absorb it, because the cut landed on the vendor’s invoice before it reached the lab.

The margin arithmetic that follows

Sysmex’s year to March 2026 shows what compression looks like at the operating line. Group net sales fell 1.7% to JPY 500,006 million. Operating profit fell 40.8% to JPY 51,831 million. Operating margin went from 17.2% to 10.4%.

A 1.7% revenue decline does not produce a 40.8% profit decline through volume. It produces it through structure: the analyser is a fixed commitment, placed with a service network and a support obligation attached, and the reagent stream is the annuity that pays for it. When the price per result falls, the fixed half of the cost does not move with it. The instrument is already on the bench.

Two disclosures make the point by contrast. Werfen, Europe’s haemostasis specialist, grew organically 3.3% in 2025 and 6% excluding Asia, with Asia-Pacific down 10.9%. QuidelOrtho’s Labs line — Vitros, overwhelmingly US — grew 5.7% constant currency in the same period. Same industry, different exposure to the mechanism.

Why this discipline and not another

Inside the same report, haematology grows at 3.31% while haemostasis grows at 5.42%. The discipline as a whole reaches USD 10,630 million by 2033 from USD 7,620 million in 2025, a 4.25% CAGR, and its share of in vitro diagnostics falls from 7.06% to 6.30% even though its test volume compounds faster than the market’s.

The split is not about technology. A complete blood count is a fixed panel: there is no assay to add and no upgrade path to sell, so the only variable left is price. Haemostasis has a menu — D-dimer, anti-Xa, thrombophilia and factor assays, viscoelastic testing — and a new line on a requisition is a different commercial object from a cheaper version of an old one. Haematology is the discipline where the volume is the problem, because volume is what gets tendered.

What to watch

Two things, at scale. A decision by CMS to reduce rates by less than the statutory maximum — which the statute permits and ACLA has formally requested — would lift the US path by low single-digit percentages. And whether the Anhui template extends from coagulation into haematology reagent bundles; if it does, the downside case in the report, USD 10,180 million at 3.69%, is the one to use.

Everything else in this discipline moves the number by less than the rounding.

Companion analyses in this cluster

A second analysis on this market examines the arithmetic problem inside its own base — that Sysmex publishes a market size and a share claim whose product does not equal its disclosed revenue, and by how much.

Related research: Global Haematology and Coagulation Diagnostics Market, 2026–2033; Global In Vitro Diagnostics Market — the USD 108.0 billion base this discipline reconciles to; Global Clinical Chemistry and Urinalysis Market, where the same fee schedule cut 387 chemistry codes by 16%; and Global IVD Reagents and Consumables Market, which measures the layer beneath this discipline.

Also in this set: Sysmex’s Own Numbers Disagree by Thirteen Point Eight Per Cent on the Size of the Market It Leads — the arithmetic problem inside this market’s own base, and why the gap cannot be closed from outside the company.

About the method

70% secondary, 30% primary. Every figure in this article is drawn from a primary document read directly from the issuing body: the CMS preliminary CY 2027 Clinical Laboratory Fee Schedule and its fact sheet, ACLA’s comment letter, Sysmex’s consolidated results and product-type revenue series, Werfen’s 2025 results, and the Anhui provincial procurement notice as reported by People’s Daily. No market-research competitor material is cited, quoted or used to set any level.

The primary layer is 47 depth interviews across 13 markets with laboratory directors, haematology section leads, transfusion service managers, procurement officers and IVD channel partners; 29 open-ended interviews conducted around tender cycles in Chinese provincial and Gulf Cooperation Council procurement; a 176-respondent structured survey of laboratory managers in the same 13 markets on analyser replacement intent, menu expansion and reagent price expectations; and structured observation at four conferences — ISTH, ISLH, AACC and the Chinese Laboratory Medicine Congress. The primary layer establishes mechanism and sequence. It carries no figure and is not offered as a source for any number here. Counts are stated so they can be reconciled against programme records.

Sources

• Centers for Medicare & Medicaid Services — Preliminary CY 2027 Medicare Clinical Laboratory Fee Schedule Payment Rates (21 September 2026)
• American Clinical Laboratory Association — Comments on Preliminary CY 2027 Medicare CLFS Payment Rates (20 October 2026)
• Sysmex Corporation — Summary of Consolidated Financial Results, FY ended 31 March 2026
• Sysmex Corporation — Net Sales by Destination, Business and Product Type
• Werfen — Werfen reaches EUR 2.1 billion in sales (9 April 2026)
• People’s Daily, Anhui — Anhui completes China’s first coagulation and cardiac-marker IVD reagent procurement (20 January 2023)

Company and entity links

Sysmex Q7663566 · Werfen Q16797700 · complete blood count Q886518 · coagulation Q179217