Friday, March 13, 2026

THE BACKLIST (Parody)

What follows is a parody of The Blacklist, the long-running James Spader  Netflix thriller in which a cultivated, dangerous, oddly charming mastermind presents the FBI with a secret list of criminals and insists on working through one young woman in particular. The series ran for a decade and became known for its mixture of murder mystery, conspiracy plotting, high-flown menace, and Spader’s unmistakably chilly performance style. Here the parody transfers the ominous machine from blood-spattered international crime to a better home for Spader - the absurdly overcivilized world of book publishing.

###





THE BACKLIST

One-Page Series Treatment

Logline
When a polished, mysterious figure from the hidden world of publishing abruptly surrenders to authorities, he offers to expose an entire network of literary fraud, corruption, and career manipulation using a secret roster of names known as the Backlist. He will cooperate on one condition: he speaks only to a young editorial assistant no one expected to matter.

Premise
For generations, publishing has disguised itself as a civilized profession built on discernment, taste, and modest cardigans. But beneath that surface lies a far less innocent world: forged manuscripts, ghostwritten memoirs, estate warfare, reputational blackmail, and old grievances preserved with acid-free care.

At the center of the story is Sebastian Blackwell, an elegant and unnervingly self-possessed literary operator whose reputation hovers somewhere between kingmaker, fixer, and curated menace. Blackwell has spent decades shaping careers, reviving forgotten authors, suppressing dangerous papers, and understanding where the bodies are buried—sometimes literally in archives, more often figuratively in acknowledgments.

One day he turns himself in to a shadowy Interpol unit concerned with fraud and intellectual crimes and announces that he is ready to help. He possesses a list of names—editors, memoirists, agents, estate managers, biographers, scholars, dealers, and prize insiders—each connected to a hidden scandal in the respectable world of letters.

But Blackwell insists on dealing with only one person: Emma Vale, a bright, under-credited editorial assistant whose greatest professional gift is noticing what everyone above her has somehow agreed not to notice. Why he has chosen her is unknown. 

Tone and Style
The Backlist is a prestige thriller that treats publishing scandals with the gravity of international espionage. The world is one of old bookshops, rare manuscripts, discreet auction rooms, literary townhouses, inherited correspondence, and conversations so polite they barely conceal blackmail. The series plays its absurd premise completely straight, which is precisely what makes it funny.

Series Engine
Each episode centers on one name from the Backlist: a memoirist whose past has been assembled from other people’s notes, a revered editor who built a career on coercion, a literary executor weaponizing an archive, a prize committee quietly steered for years by one implacable figure. Blackwell guides Emma through this hidden machinery of prestige and deceit while revealing only fragments of his own agenda.

At the same time, a larger mystery unfolds: why did Blackwell surrender, why Emma, and is the Backlist truly a list of criminals—or simply a list of people Blackwell believes should be revised out of cultural history?

Why It Works
The series combines the narrative engine of a conspiracy drama with the exquisitely overfurnished world of literary culture. It offers intelligence, suspense, style, and the spectacle of people speaking about paperback rights and suppressed correspondence as though civilization itself hangs in the balance.

In short, what if the publishing industry were run exactly like an organized criminal network, but with better lighting and more tote bags?

Pilot

In the pilot, Blackwell walks into a federal office carrying a cloth bookstore bag and announces that he is prepared to discuss “the criminal afterlife of publishing.” He offers the first name on the Backlist: a beloved memoirist whose career rests on borrowed notebooks, stolen research, and a moving childhood that seems never to have happened.

Emma is brought in after Blackwell refuses to speak to anyone else. By episode’s end, one literary titan has fallen, Emma has been unwillingly promoted into danger, and Blackwell has revealed that the list is far stranger than anyone imagined.

“This,” he says, sliding across another page of names, “is only the trade edition.”


 ###

 


To: Dana
From: Kyle, Development
Re: THE BACKLIST — summary for Wednesday acquisitions
Subject: I have now read it, and therefore you do not have to

Dana,

Per your request, below is a summary of the project currently known as THE BACKLIST, which the writer appears to regard as an entirely original premium dramatic concept and not, in any sense, a title-adjacent hallucination circling some other long-running network property like a hawk over a valet stand.

The premise, as submitted with complete conviction, concerns a mysterious, hyper-literate man named Sebastian Blackwell who abruptly surrenders himself to a vaguely federal publishing-related task force and offers to expose a hidden underworld of corruption, fraud, coercion, forgery, and reputation-laundering within the book industry. He claims to possess “a backlist,” meaning a secret roster of dangerous targets drawn from the worlds of trade publishing, literary estates, memoir fraud, weaponized blurbs, and out-of-print titles with explosive legal implications. He will cooperate only with one young woman, specifically an under-credentialed but intuitively gifted editorial assistant named Emma Vale, for reasons that are initially mysterious and later, even more mysterious.

So yes: structurally, tonally, and in the cadence of its central relationship, it is uncannily familiar, except that instead of international criminals we have embittered biographers, forged first editions, corrupted prize committees, copyrights scandals at Frankfurt, and a man who can apparently destroy careers by correctly identifying the provenance of an inscription on a 1963 galley copy. The script is written in a style I can only describe as “velvet panic.” Every line is delivered as though the fate of Western civilization depends on subsidiary rights in paperback reissue territories. There are long monologues about literary envy. Book jacket copy is edited with the tension of hostage negotiations. There is, and I am not exaggerating, a reveal framed with the gravity of a political assassination, except the underlying offense is prestige memoir embellishment.

And yet—and this is the difficult part—I regret to report that it is not completely insane. Or rather, it is insane in a disciplined way. The writer has committed so completely to the bit that the project begins to generate its own absurd legitimacy. One can, against one’s better judgment, imagine an audience for a show that treats publishing scandals as organized crime, particularly if cast with enough seriousness and photographed like a European conspiracy thriller. The central character is written as catnip for a certain kind of actor: omniscient, mannered, faintly amused, emotionally inaccessible, devastating with a pause. Emma, meanwhile, is less flamboyant but usefully grounded, which gives the piece a possible engine beyond the baroque speeches about first printings and moral rot in the galley process.

The problem, as I am sure will arise approximately four minutes into Wednesday’s meeting, is that the project’s “originality” exists in a state best described as aggressively deniable. Nobody in the material seems aware that an audience may notice the resemblance between “a notorious, cultivated mastermind with a secret list, who surrenders and insists on speaking only to a young female professional” and, well, something they may already have passively absorbed over ten seasons while folding laundry. 

The title does not help. In fact the title appears to stride into legal exposure with a smile and a scarf.

But perhaps this is less a plagiarism problem than a highly specific delusion in presentation. The material reads as though the writer discovered suspense television and the London Review of Books on the same weekend and concluded that no one had ever before combined charismatic menace with administrative paperwork.

My practical recommendation is: do not buy this as presented, but also do not dismiss it too quickly, because buried under the obvious issue is a possibly viable half-hour satire or limited series about the criminal psychology of prestige publishing. If someone could detach it from its current dead-serious mythology and lean into the absurdity, there may be something here.

I will present this professionally on Wednesday, although I need the record to reflect that there are some assignments in this job for which USC did not prepare me.

Best,
Kyle


 

Thursday, March 12, 2026

The Economist Humorous Guide to the Email Opening

 https://www.economist.com/business/2026/03/05/a-short-guide-to-email-opening-lines

A short guide to email opening lines

“I hope you are well” and other classics

|3 min  THE ECONOMIST

If an alien were shown the typical first sentences of work emails, what might it conclude? Since so many messages start with the hope that the recipient is well, an extraterrestrial might at first assume that most humans are either recovering from illness or about to take to their sickbeds. But even if it were to realise that this was largely a matter of etiquette, it would miss the nuances of each opening gambit. Until now.

I hope you are well

Ostensible meaning: I hope you are well.
Actual meaning: None. It’s just throat-clearing. Do not write back and give the other person a bulletin on your health.

I hope this email finds you well.

Ostensible meaning: I hope you are well.
Actual meaning: I have not been in touch for a while and am not even sure you are in the same job. Plus I have a vague idea that this formulation makes me sound professional. Either way, I’m still totally uninterested in your health.

Hope all well.

Ostensible meaning: I hope you are well.
Actual meaning: We both know this sentence is totally formulaic, so I’m cutting it down to the bare minimum. If time is really pushed, I might say “Hope all OK”, and save myself two characters.

Nice to e-meet you.

Ostensible meaning: We’ve just been introduced by a third party and I’m pleased to make your acquaintance. 
Actual meaning: No email can substitute for an in-person encounter. Only when we have shaken hands and stared into the whites of each other’s eyes and taken the full measure of each other will we have properly met. I also send e-cards and shop on e-commerce sites and still think of Amazon as an e-tailer. I have clear memories of the 1980s.

Nice to “meet” you.

Ostensible meaning: We’ve just been introduced by a third party and I’m pleased to make your acquaintance.
Actual meaning: I’m an appalling pedant. I have clear memories of the 1970s.

I hope you had a good weekend.

Ostensible meaning: We’re both well-rounded individuals with fulfilling lives outside work. 
Actual meaning: It’s Monday morning and I cannot be bothered to write “I hope you are well” for the billionth time.

I hope your week is off to a good start.

See above, but it’s Monday afternoon.

I hope your week is going well.

It’s now Tuesday, Wednesday or Thursday.

I hope you have had a great week.

Guess what? It’s Friday.

I hope you’re having a great weekend.

See above, but I have no sense of work-life boundaries.

I hope this email isn’t interrupting anything urgent.

Ostensible meaning: I am respectful of your time.
Actual meaning: I have no idea how email works.

Apologies for sending you an out-of-the-blue email.

Ostensible meaning: This may look an awful lot like spam but is actually a message from a real person who appreciates how busy you are.
Actual meaning: This may look an awful lot like a message from a real person who values your time but it’s still spam.

I’m going to spare you the preamble and cut to the chase.

Ostensible meaning: You’re busy, I’m busy. Let’s behave like the professionals we are and get right down to business.  
Actual meaning: The expectations of a meaningless first sentence are so deeply embedded that I am going to spend as much time skipping the pleasantries as the pleasantries would have taken.    


Some emails do genuinely avoid the throat-clearing, and plunge straight in. There are several explanations for this. One is that the correspondents involved are in close contact: they know that the other person is well. Another is that the sender has worked out that the typical first sentence really is unnecessary. Another is that the writer dislikes the recipient but knows that putting “I hope you are unwell” would be taking things too far. Which is it? Even humans struggle to work that one out. ■

FCGR Polymorphisms, FDA, Genentech, LDTs, Circa 2008 - Full Chat GPT Dialogs

 


Around 2005 to 2015, there was a laboratory developed test that claimed to identified patients in which success with a genentech drug could be ruled out. The drug might’ve been Rituxan. He’s off label non-FDA claims made Genentech unhappy. They may have even complained to FDA or they certainly complained in the trade press. Can you identify the diagnostic test?

Yes — the test you’re probably remembering was PGxPredict:RITUXIMAB, marketed by PGxHealth (a division of Clinical Data, later tied to Clinical Data/PGxHealth branding). It was launched in 2007 as a pharmacogenetic test meant to predict response to rituximab in follicular non-Hodgkin lymphoma, based on the FCGR3A 158V/F polymorphism.

This also fits your memory of Genentech getting unhappy. In its 2008 citizen petition to FDA,

https://www.aab.org/images/aab/pdf/Genentch%20FDA%20Petition.pdf

https://www.ncbi.nlm.nih.gov/books/NBK220030/  Natl Acad Sci 

2014 DNA Cell Biol LIU 158VF and Ritxuimab and MetaAnalysis

 Genentech argued that predictive LDTs used to make therapeutic decisions should face FDA review, and the petition specifically discussed PGxPredict:RITUXIMAB as an example. Genentech objected to claims that the test could identify which lymphoma patients were more likely to respond to Rituxan, arguing the supporting data were not rigorous enough. The National Academies workshop summary quotes Genentech’s representative criticizing the assay and notes that the maker claimed it could let physicians “confidently predict” rituximab response.

So while I can’t prove from the sources in front of me that FDA took a direct enforcement action against that specific assay, the test that best matches your description is PGxPredict:RITUXIMAB. The broader dispute was important enough that it became part of the public debate over LDT oversight, predictive claims, and drug-diagnostic co-development.

What happened to pgxhealth

PGxHealth basically ceased to exist as an independent diagnostics business when its parent, Clinical Data, changed strategy. In late 2010, Clinical Data sold PGxHealth’s genetic testing and pharmacogenomic biomarker business — including the FAMILION line and reimbursement contracts — to Transgenomic for about $15.5 million. Clinical Data said explicitly that this sale completed its transformation into a pharmaceutical company.

At about the same time, PGxHealth, LLC itself was effectively repurposed on the pharma side. SEC filings show that Trovis Pharmaceuticals LLC was formerly known as PGxHealth, LLC, which tells you the brand/business was being folded into Clinical Data’s drug-development effort rather than continuing as the old pharmacogenomics testing business.

Then, in 2011, Forest Laboratories acquired Clinical Data for about $1.2 billion, mainly to obtain Viibryd (vilazodone) and the associated pharma pipeline. By that point, the original PGxHealth diagnostics operation had already been sold off, so what remained was absorbed into the broader pharma transaction.

So the short historical arc is: Genaissance assets → PGxHealth under Clinical Data → diagnostics business sold to Transgenomic in 2010 → remaining pharma-focused parent sold to Forest in 2011. In other words, PGxHealth did not disappear because one famous test failed; it disappeared because its parent company pivoted away from diagnostics and toward therapeutics, then got acquired.

If you want, I can also trace what became of the specific PGxHealth tests like FAMILION or PGxPredict:RITUXIMAB after the Transgenomic deal.

Yes thx

Yes. The short version is:

FAMILION lived on; PGxPredict:RITUXIMAB seems to have faded out.

After Clinical Data sold PGxHealth’s diagnostics business to Transgenomic in late 2010, the acquired assets explicitly included both the FAMILION inherited-cardiology tests and the biomarker assets behind the PGxPredict drug-response tests. Transgenomic then publicly promoted the FAMILION line in 2011, which suggests that the cardiogenetics business was the more durable, commercially central piece of what it bought.

By contrast, I do not see evidence that PGxPredict:RITUXIMAB became an enduring commercial product after the sale. I can confirm it was launched in 2007 and remained well known enough to be cited in later policy and reimbursement literature as an example of a PGx test, but I am not finding strong evidence of continued market presence or later relaunch under Transgenomic. That usually means it was either de-emphasized, quietly discontinued, or left as legacy IP rather than a growth product. I would treat that as the most likely interpretation, though I can’t prove the exact discontinuation date from the sources I found.

The corporate chain after that was fairly straightforward. Transgenomic later merged with Precipio in 2017, so Transgenomic itself did not remain a long-term standalone home for these assets.

So, practically speaking:

FAMILION / inherited cardiology tests
These were the part that clearly had continuing commercial life after the PGxHealth sale. They were integrated into Transgenomic’s specialty diagnostics business and actively expanded in 2011.

PGxPredict:RITUXIMAB
This appears to have become more of a historical footnote in the LDT / companion-diagnostic debate than a successful long-lived product line. It remained cited in the literature, but I do not see evidence it matured into a durable commercial franchise.

So the answer is not that both lines vanished overnight. It is more that the inherited disease testing franchise survived, while the rituximab-response assay seems to have withered commercially.

I found clear evidence for the 2010 sale, the continuation of FAMILION, and the later Transgenomic-Precipio merger, but not a definitive public notice saying “PGxPredict:RITUXIMAB was discontinued on X date.”

This seems to be an unfavorable or inconclusive later study of the gene in question, when studied in a large larger population. Could you discuss. 
CITE:
FCGR3A 158V/F polymorphism and response to frontline R-CHOP therapy in diffuse large B-cell lymphoma Fen Liu et al. DNA Cell Biol. 2014

Yes — that 2014 Fen Liu paper is best read as a substantially negative or deflating follow-up to the earlier enthusiasm around FCGR3A 158V/F as a predictor of rituximab benefit in DLBCL.

The earlier biological idea was attractive. FCGR3A encodes FcγRIIIa, an Fc receptor involved in antibody-dependent cellular cytotoxicity (ADCC), and rituximab is an anti-CD20 antibody. The 158V variant was thought to bind IgG more avidly than 158F, so it was plausible that patients with V-containing genotypes might get more immune-mediated benefit from rituximab. That hypothesis was supported by an influential 2006 Korean study of 113 R-CHOP patients, which reported markedly higher complete response rates in V/V patients than in F/F patients, although without a survival difference.

What Fen Liu et al. did in 2014 was important because they tried to test that signal in a larger and more skeptical framework. In their own retrospective cohort of 164 newly diagnosed DLBCL patients treated with R-CHOP, they found no association between FCGR3A genotype and overall response rate or complete response rate. They then added a meta-analysis totaling 731 cases, and again found no significant association between the polymorphism and response in the main genetic models. Their conclusion was blunt: no clear relationship between FCGR3A 158V/F and response to frontline R-CHOP.

So in practical terms, the 2014 paper says: the early positive story did not hold up well when examined in a broader dataset. That does not mean the biology was foolish. It means the biology was probably too simple for the clinical setting. In frontline DLBCL, patients are not receiving rituximab alone; they are getting R-CHOP, where chemotherapy contributes heavily to outcome. Once you mix rituximab with multi-agent chemo, any modest Fc-receptor effect may be diluted, masked, or swamped by other determinants of response such as tumor biology, IPI risk, cell-of-origin subtype, dose intensity, and host factors. The paper itself notes that prior studies had been conflicting and that the earlier positive Asian studies were relatively small.

There is one nuance. Fen Liu et al. did report that the F/F genotype was associated with shorter progression-free survival, with borderline significance overall (p=0.05) and significance in the non-GC subtype (p=0.04), but they found no overall survival association. That kind of isolated secondary signal is interesting biologically, but it is not the same as a robust predictive biomarker for clinical use. It looks more like a hypothesis-generating observation than something you would build an LDT around.

So if you connect this back to the old PGxPredict:RITUXIMAB era, the implication is fairly clear: the later literature moved away from supporting a strong actionable claim that FCGR3A genotyping could tell clinicians who would or would not benefit from rituximab-based therapy. The 2014 paper did not merely fail to confirm the original excitement; it helped show why a plausible mechanistic marker can still be too weak, too inconsistent, or too context-dependent to survive as a commercial predictive test.

If you’d like, I can also turn this into a tight 150–200 word paragraph in your policy style, linking it explicitly to the hazards of premature predictive claims for LDTs.

Wednesday, March 11, 2026

CRUSH: Adverse Events (AI Hypotheticals)

AI Corner

Chat GPT 5.4

(Essay is generated by AI and discusses hypotheticals(Prompt at bottom) 

(See Sidebar, Fraud in Genomics Industry)

Introduction: From FRAUD to CRUSH

The Centers for Medicare & Medicaid Services (CMS) has long struggled with large-scale fraud schemes involving suppliers and laboratories billing for implausible volumes of services, particularly in areas such as durable medical equipment and genetic testing. One well-known example in the laboratory sector involved certain high-complexity sequencing codes—such as CPT 81408 for full gene sequencing—being billed both for medically implausible services and, in medically implausible quantities by questionable laboratories, particularly concentrated in states like Texas and Florida. 

As reported by OIG in 2023, Medicare spending on these codes briefly reached hundreds of millions of dollars per year before collapsing once medical necessity controls and enforcement actions were implemented (see graphic for code 81408 below).  However, as of 2024, fraudsters (sometimes in the same lab) simply switched to adjacent, equally costly and implausible genetic codes (see 81419, 81440, 81443, 87798 below, netting >$350M).

Against this backdrop, CMS has now launched a broad anti-fraud initiative known as CRUSH (Comprehensive Regulations to Uncover Suspicious Healthcare), intended to shift the program away from the traditional “pay-and-chase” model toward proactive fraud prevention using analytics, screening, and real-time enforcement tools. The initiative explicitly seeks stakeholder input on how CMS can strengthen its program integrity toolkit across Medicare, Medicaid, and related programs.

The motivation for this initiative is understandable. CMS reports that it has already suspended billions of dollars in suspected fraudulent payments using advanced analytics and has revoked the billing privileges of thousands of providers engaged in improper activity. At the same time, the agency has identified laboratory testing—particularly molecular and genetic tests—as an area of growing financial exposure. Although genetic tests represent only a small share of laboratory test volume, they account for a large proportion of Medicare laboratory spending. As a result, molecular diagnostics has become a focal point for program integrity discussions.

Bystander Injury? 

However, the tools CMS uses to combat fraud typically operate system-wide rather than targeting only the bad actors, which creates a significant risk of unintended consequences for legitimate laboratories. Large and well-established, well-run precision medicine companies could at least hypothetically experience what might be called “bystander injury” if aggressive anti-fraud tools are deployed broadly. Several mechanisms within the CRUSH initiative illustrate how this could occur.

1. Prepay Review.  One major risk is the expansion of pre-payment review and algorithmic claims screening. CMS is attempting to move away from retrospective audits toward real-time fraud detection based on data analytics and predictive modeling. In practice, such systems often identify statistical anomalies rather than fraud itself. Molecular diagnostics laboratories are particularly vulnerable to this approach because their tests are expensive and specialized.  Rapid adoption of a new technology, regional concentration of specific cancers, or rapid growth of a successful test could all trigger automated fraud alerts.  The risk here is that CMS might cast these measures broadly, assuring stakeholders that the safeguards would cause minimal effect on legitimate labs.  But if these triggers lead to imperfect pre-payment claim holds or are a doorway to zealous review, a financial impact on legitimate laboratories occur.

2. The Documentation Trap.  A second area of concern involves medical record documentation requirements during audits. Program integrity enforcement frequently relies on post-payment review of medical records and the authority to suspend payments when credible allegations of fraud exist. Yet molecular diagnostic laboratories are typically reference laboratories that do not maintain complete clinical records for patients. They receive specimens from oncologists or hospitals and often possess only partial documentation—such as a biopsy pathology report or test requisition form. If CMS or its contractors require comprehensive oncology records, imaging study reports, treatment plans, and physician notes during audits, even the most legitimate laboratories may struggle to obtain these materials from ordering providers. The result could be audit failures even when the underlying tests were medically appropriate.  These audit failures could then trigger adverse secondary measures, and so on.   This mismatch between audit expectations and laboratory records and workflows is already a well-recognized friction point in some coverage programs, including MolDx.

3. AI - Accurate or Awry.  Another potential unintended consequence involves the use of artificial intelligence and machine learning tools to detect fraud patterns. CMS is actively exploring AI systems capable of reviewing large volumes of claims data and assisting in medical record coding analysis. While such technologies promise efficiency, they also carry well-known limitations. Machine learning models typically flag unusual statistical patterns, but unusual patterns do not necessarily indicate fraudulent activity. Laboratories operating at the technological frontier of medicine—introducing novel genomic assays or rapidly expanding clinical adoption—may naturally produce unusual utilization patterns. If automated systems generate fraud alerts based on these patterns, legitimate laboratories could be subjected to cascades of audits, denials, or payment delays.

4. Prior Authorization.  A related risk is the potential expansion of prior authorization requirements for high-cost laboratory tests. Although CRUSH does not explicitly mandate prior authorization, anti-fraud initiatives frequently evolve in that direction as policymakers search for ways to control spending on expensive services. CMS has launched an active prior auth program called WiSER, although in its first round, it didn't yet include genetic tests.  If Medicare were to require prior authorization for molecular tests above a certain price threshold—such as $1,000 or $2,000—the operational burden on laboratories and oncology clinics could increase dramatically. Laboratories would need to build administrative teams to manage authorization requests, physicians would face additional workflow hurdles, and patient care could be delayed while approvals are obtained. For tests used in time-sensitive clinical decision making, such as therapy selection or recurrence monitoring, such delays could have real clinical consequences.

5. Enrollment barriers. Another area where overreach could occur involves provider risk classification and enrollment controls. CMS is exploring whether certain provider types should be designated as higher-risk categories for program integrity purposes. Given the high cost and rapid growth of genomic testing, molecular laboratories could easily fall into such a classification. If that occurs, laboratories could face stricter enrollment requirements, enhanced screening procedures, fingerprinting and background checks for additional personnel, higher surety bond requirements, and more frequent revalidation of Medicare enrollment.  While these measures may be justified for certain high-risk supplier categories, they could impose significant compliance burdens on legitimate diagnostics companies.

6. Ownership & structures.   Related to Point 5, the CRUSH initiative raises questions about ownership transparency and identity verification requirements for Medicare-enrolled entities. CMS has expressed concern that some fraud schemes involve complex ownership structures or foreign actors who operate outside the reach of U.S. law enforcement. The agency is therefore considering enhanced identity verification and even citizenship or residency requirements for owners of Medicare providers. While aimed at fraudulent shell companies, such rules could also affect legitimate diagnostics firms that rely on global venture capital or international investment. Many biotechnology and diagnostics companies operate with multinational investor bases, and additional ownership restrictions could complicate financing structures

7.  Enhanced payment suspension.  Activities #1-#6 may lead to #7.  Payment suspension authority also poses a potential hazard for legitimate laboratories. CMS already has the authority to suspend Medicare payments when there is a credible allegation of fraud or reliable indication of overpayment. In some past cases across the healthcare sector, this authority has been applied broadly during investigations. If statistical anomalies or algorithmic signals trigger such suspensions, laboratories could experience abrupt interruptions in cash flow while disputes are resolved. For companies performing high-volume oncology testing, where Medicare revenue can reach tens or hundreds of millions of dollars annually, even temporary or mistaken payment suspensions could have serious financial implications.

.

In summary, the CRUSH initiative addresses a genuine problem. Fraud schemes involving phantom laboratories, telemarketing genetic testing scams, and abusive billing practices have imposed significant costs on the Medicare program. However, the enforcement mechanisms used to combat fraud—data analytics, pre-payment review, enrollment screening, documentation audits, and ownership restrictions—often operate broadly across entire sectors rather than targeting only the most egregious offenders. For legitimate molecular diagnostics laboratories, the resulting “bystander effects” could include increased audit risk, expanded documentation requirements, algorithmic payment holds, administrative burdens from prior authorization, and stricter enrollment controls. Policymakers therefore face a delicate challenge: designing fraud-prevention systems that successfully eliminate clearly fraudulent actors without inadvertently creating substantial compliance friction for the very laboratories responsible for advancing precision medicine.


SIDEBAR - Lab Genetics Fraud (see source here)

Fraudulent uncontrolled payments circa a billion dollars for 81408.   This chart shows 81408; the same labs billed much additional money under adjacent codes 81407, 81406.  The outpouring of bogus funds continued til 2022; I wrote about it from fall 2020 onward.  Click to enlarge.

Similarly unbelievable growth in "impossible codes" for the Medicare program, primarily in Texas and Florida, in 2024 (!!!!).   No lessons learned from the billion-dollar losses in 2022. Click to enlarge.



One of the biggest Medicare codes in 2024 was "Other pathogen 87798," at $450M, an explosion of +200M in 24 months.   




##

Prompt

CMS has bad problems with fraud - fraudulent DME, or fraudulent labs in Texas and Florida billing huge amounts of dollars on medically unbelievable codes like 81408, long gene full sequencing, which reached $300M per year in CMS and then plummeted to zero with medical necessity controls. CMS is rolling on a big program CRUSH as in PDFs. This SHOULD be designed to attack only obviously fraudulent nonsensicla labs in TX and FL. but what are the risks of problems and overreach affecting good bona fide labs like say natera, guardant, caris, etc. One risk is random audits which require lots of layers of medical records the labs don't have. Another risk is punshing prior auth with AI on all lab tests over $1000. These are nightmare scenarios for legit labs. plesae discuss risks for legit labs (unintended consequences or bystander injuries so to speak)

https://chatgpt.com/c/69b06aec-4f70-83e8-a952-0c5ef76d919e



Saturday, March 7, 2026

Joan Didion: The Ralph's at Sunset and Fuller

 


Joan Didion published her first two collections of essays as, The White Album, and, Slouching Toward Bethlehem.   In which essay in her early work does she discuss going to the Ralph’s on Sunset Boulevard at Fuller in Hollywood wearing a bathing suit?

####

The episode you’re thinking of appears in “The White Album,” the title essay of Joan Didion’s 1979 collection The White Album.

In the opening section of that essay, Didion describes the disorienting atmosphere of Los Angeles in the late 1960s—Hollywood parties, recording studios, the Manson murders, and the general sense that ordinary social rules had become unstable. As part of that portrait, she recounts going to a Ralphs supermarket on Sunset Boulevard at North Fuller wearing only a bathing suit and a thin cotton skirt, and noticing that no one seemed to find this unusual. The moment serves as a small but telling example of how social boundaries in Los Angeles had become oddly fluid.

Her point is less about the outfit than about the atmosphere of the time:

  • everyday behavior felt slightly surreal,
  • social expectations seemed loosened or irrelevant,
  • and people moved through public space with a kind of detached indifference.

The anecdote appears very early in the essay as part of the famous opening passage:

“We tell ourselves stories in order to live…”

From there she moves through a collage of scenes—Jim Morrison recording sessions, Huey Newton’s trial, the Manson murders, Hollywood parties, and her own nervous breakdown—to illustrate how fragmented the culture felt.

So the answer:

   Essay: The White Album

   Collection: The White Album (1979)

It’s a good example of Didion’s method: a tiny observational detail—a grocery trip in a bathing suit—quietly revealing something larger about Los Angeles culture and the psychological mood of the late 1960s.

If you’d like, I can also point out three or four other small LA moments in that essay that work the same way (the Doors studio scene, the Malibu house, the Black Panthers interview), because they’re almost constructed like film cuts.

———-

[This beautiful answer is actually wrong, the description of going to the supermarket in her bathing suit is in her first book, Slouching to Bethlehem, in the chapter, Los Angeles Notebook. The same chapter is also famous for a several page description of the alleged grand and adverse effects of Santa Ana wins on the human psyche.]

Friday, March 6, 2026

Genomic Health OIG Penalty (no admission of error)

This case involved no admission of error by Genomic Health.

###

Before 2018, Medicare had a rule known as the “14-day rule” that governed billing for laboratory tests associated with hospital encounters. If a test was ordered within 14 days of a patient’s hospital discharge, the test was considered part of the hospital service bundle, meaning the hospital—not the outside laboratory—had to bill Medicare and use its reimbursement to pay the genomic test laboratory. For expensive genomic tests performed by outside reference laboratories, this created operational and financial tension because hospitals were often reluctant to assume financial responsibility for these tests.

Genomic Health, the company that developed the Oncotype DX cancer genomic assay (later acquired by Exact Sciences in 2019), became the subject of a federal investigation over how it handled this rule. According to the U.S. Department of Justice, between roughly 2008 and 2020 the company engaged in practices designed to bypass the 14-day rule. Prosecutors alleged that Genomic Health billed Medicare directly for tests that should have been billed to hospitals, and that the company encouraged providers to cancel and reorder tests after the 14-day window so that the laboratory could bill Medicare directly. The government also alleged that the company sometimes did not pursue payment from hospitals for tests ordered within the 14-day window, which prosecutors characterized as potentially providing improper financial benefits to hospitals.

In October 2023, Genomic Health agreed to pay $32.5 million to resolve these allegations under the False Claims Actwithout admitting liability. The settlement resolved whistleblower lawsuits that had been filed earlier and covered billing practices related to Medicare claims for genomic testing. The case became a notable example within the molecular diagnostics industry because it illustrated how the pre-2018 Medicare billing structure created significant incentives and compliance risks around the timing of genomic test orders. 

The rule itself was subsequently modified by CMS in 2018 to allow certain molecular pathology tests, particularly those performed by independent laboratories, to be billed directly by the performing laboratory rather than bundled into the hospital payment, when the specimen came from a hospital outpatient.

Sources

https://www.justice.gov/usao-edny/pr/genomic-health-inc-pay-325-million-resolve-allegations-relating-submission-false

https://www.justice.gov/archives/opa/pr/genomic-health-inc-agrees-pay-325-million-resolve-allegations-relating-submission-false

Sidebar
see also topic of "surgeon initiated ordering."  https://ascopost.com/News/58066