My eye tagged a new article in NEJM about Congress granting coverage privilege to a class of interventions, like those which have FDA breakthrough status. That's Kadakia et al. 2026.
But I'll devote 3/4 of this blog to discussing their citation #2, Kang et al., 2025, on CMS NGS claim denials.
Along the way, I noticed several interesting recent titles which I'll highlight in fine print:
- Grossman et al. (January 7) discuss "FDA law used to threaten medical practice." While it's not news that the Administration opposes transsexal healthcare especially in teens, in areas like Medicaid payments, this article says that DOJ sent "more than 20 subpoenas" to physicians or clinics focusing on the doctor's "off label' use of drugs [hormones.]
- Grossman et al here.
- Harvard's Jerry Avorn has an article, "25th Anniversry of a Nearly Unknown Health Policy Turning Point," December 17, here.
- This was a Massachusetts law for (near) universl coverage, which he sees as a direct precedent to the Affordable Care Act (ACA) in 2010. For Avorn, Massachusetts events circa 2000 (25 years) led to "Romneycare' in 2006 (20 years) and ACA (15 years).
- Sklar and Richman discuss "Financing Telehealth," January 10, here.
Technology & Medicare Coverage: Kadakia 2026 and its link to Kang 2025
Kadakia et al. write, "Automatic Medicare Coverage for New Medical Technologies — Here We Go Again." January 10, here. They oppose two specific situations ,which they treat as examples of a larger paradigm.
First, they discuss proposed legislation to give temporary coverage to approved FDA breakthrough devices. This proposal recreates a Trump I policy, MCIT, which gave coverage by regulation, and was replaced by a much weaker Biden policy (via individual NCDs) called TCET. It's been proposed a couple times and is not currently headed to any vote. The Trump CMS could do this by regulation.
Second, they discuss proposed legislation that allows CMS to write NCD's for multi cancer early detection (MCED) after FDA approval but before USPSTF approval. It does not create coverage, only the possibility of an NCD that creates coverage. This has actually been included in the current (late January) government financing bill; we'll see if it holds in the final legislation hopefully passing by January 31 (to avoid a shutdown). Read about MCED legislation at the American Cancer Society here.
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The first legislation (about BT devices) would create coverage by law, but it isn't in play for any vote. The second legislation (about MCED) would only create the right to later write an NCD, but it IS up for a vote within days.
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The Kadakia article in NEJM has an interesting Reference 2, which I hadn't seen when it came out in 2025.
- This is Kang, Odouard, Gresenz, open access, Claim Denials for Cancer-Related Next-Generation Sequencing in Medicare,
- JAMA Netw Open April 25, 2025, here.
Under the 2017 NCD for NGS in cancer patients, the claims denial rate runs about 20%. I think they may not understand claims processing as well as some of us do, but it's still worth reading. They write, "The findings suggest the continued existence of uncertainty regarding the boundaries of coverage for NGS despite the implementation of the National Coverage Determination."
SCITE says Kang has been cited 3 times in 10 months (one being Kadakia). To me, there are some ins and outs - for example, before an FDA test under the NCD gets a PLA code, CMS variably instructed MACs to process early claims with 81479 versus 81455. Nearly zero tests would have been paid by this NCD for <50 gene FDA CDx tests using NGS - yet they make significant discussion of 81445 vs 81455 denials (<50 and >50 genes).
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Here is an AI discussion of the Kang article.
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When “National Coverage”Still Means 1 in 4 Claims Are Denied
Reading Kang et al., JAMA Network Open (2025) beyond the abstract
At first glance, the headline finding—that 23.3% of Medicare cancer-related NGS claims were denied between 2016 and 2021—is already sobering. But the deeper story is not simply that denials are common. It is that denials increased after CMS issued and expanded the NCD, and that they increased in highly patterned, structurally predictable ways that tell us a great deal about how Medicare coverage actually functions in precision oncology.
The paradox at the center of the paper
The core paradox is this: NGS utilization rose sharply after the NCD, but denial rates rose as well. Before the 2018 NCD, denial rates were 16.8%. After the initial NCD they climbed to 20.3%, and after the 2020 amendment they reached 27.4%.
This immediately tells us something important: the NCD did not act as a “safe harbor.” Instead, it appears to have sharpened the boundary between what is explicitly covered and what remains discretionary, ambiguous, or locally adjudicated. In other words, the NCD clarified the inside—but in doing so, it may have made the outside more visible and more aggressively policed.
Site of service is not a technical detail—it is the policy
One of the strongest and most consistent findings is the site-of-service effect. Claims from independent laboratories were nearly three times as likely to be denied as hospital-based claims, and non-hospital physician sites were similarly exposed.
This is not plausibly explained by “worse documentation” alone. Instead, it reflects a deeper policy reality:
Hospital outpatient claims are often embedded in broader episodes of care, with diagnosis, staging, and treatment context implicitly bundled.
Independent labs submit stand-alone molecular claims, which must independently satisfy medical necessity, coverage criteria, and coding precision—often without full clinical context.
Medicare contractors have historically applied greater scrutiny to high-cost molecular services when they appear decoupled from institutional care pathways.
In practice, this means that the same test, for the same patient, ordered by the same oncologist, can face radically different payment risk depending on where it is billed. That is a structural feature of Medicare payment—not an anomaly.
Gene count as a proxy for policy anxiety
The sharp increase in denials for >50-gene panels is another signal worth lingering on. By the final study period, over 40% of these claims were denied.
Formally, this is unsurprising: large panels sit outside the cleanest contours of the NCD and are more likely to involve non–FDA-approved assays, exploratory content, or hybrid somatic/germline use. But informally, it reveals something else: gene count has become a surrogate for payer uncertainty.
Large panels trigger multiple latent concerns at once:
- off-label use,
- uncertain actionability,
- research-adjacent intent,
- and the specter of “screening-like” behavior.
The paper shows that coverage anxiety scales with panel size, even when the underlying clinical question may be reasonable. This is an important reminder that technical sophistication does not translate into payment confidence.
“Diagnosis” as the new denial language
One of the more subtle but telling findings is the shift in denial reason coding. Before the NCD, denials were most often labeled “lack of medical necessity.” After the NCD, they were more often labeled as “diagnosis-based” denials.
This matters because diagnosis-based denials often function as policy shorthand, not clinical judgment. They can reflect:
- stage mismatches (e.g., not clearly metastatic),
- germline vs somatic ambiguity,
- or simple failure to map neatly onto enumerated coverage categories.
In other words, the denial reason changed, but the underlying uncertainty did not disappear—it was reclassified.
Financial liability: the quiet third actor
The median charge for a denied claim was $3,800, framed by the authors as an upper bound on potential patient or provider liability. But even as an upper bound, this figure matters.
For patients, it intersects with:
- Advanced Beneficiary Notices,
- uneven understanding of downstream financial risk,
- and the chilling effect on future testing.
For providers and laboratories, it shapes:
- conservative ordering behavior,
- internal coverage heuristics,
- and selective avoidance of borderline-eligible populations.
The paper does not—and cannot—trace where liability ultimately lands. But it convincingly shows that the financial shadow of NGS is not theoretical.
What this paper really tells us about NCD 90.2
Perhaps the most important contribution of this study is what it implies about how national coverage determinations function in complex, fast-moving technologies.
The NCD did not fail in a narrow sense; it did what NCDs often do:
it created a bright core of national coverage, and
left a large penumbra of local discretion.
But precision oncology lives largely in that penumbra.
This analysis shows that uncertainty is not eliminated by national policy—it is redistributed. It migrates to:
- site of service,
- panel size,
- test iteration,
- and local contractor interpretation.
Why this matters now
For anyone involved in molecular diagnostics commercialization, Medicare coverage strategy, or clinical pathway design, this paper is less a retrospective than a warning signal.
As CMS moves toward more conditional coverage, evidence-linked registries, and real-world data requirements, denial risk may become an even more active policy tool—not a passive byproduct.
The authors cautiously suggest registries and decision aids. One could go further: coverage for NGS increasingly behaves like a managed benefit without calling itself one.
And that, ultimately, is the key takeaway that lies beyond the abstract.
Citations to Kang
Melly et al, 2025 Epilepsia Open
Elbhiry et al., 2025 Diagnostics
Kadakia et al., 2026 NEJM
