Discoveries in Health Policy

CMS Releases "RAPID" Plan for Rapid, Innovative NCD's

2026-08-07T15:43:24.831-07:00

A couple months ago, CMS announced it would nix the TCET program for rapid NCDs with Coverage with Evidence Development. And replace it with RAPID. However, details only appeared late Friday, August 7, in the Federal Register."Regulatory Alignment for Predictable and Immediate Device" RAPID coverage pathway.Find it here:https://www.federalregister.gov/public-inspection/

AI Analyzes Lab Pricing Recommendations from Medicare's Expert Panel

2026-08-07T11:36:33.503-07:00

A prior blog conveyed the availabililty of the CMS lab pricing panel decisions - here. This blog dives into the analysis. (Put on your nerd hat and thick glasses!)##Part 1. What This Project DoesEach summer, CMS convenes its Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, a federal advisory committee—often simply called the CDLT Panel—to review the roughly 100 new or

Very Brief Blog; CMS Releases Lab Expert Panel Pricing of New Tests

2026-08-07T08:36:12.140-07:00

On July 14, 2026, CMS hosted its expert advisory panel, which votes on crosswalk or gapfill for about 100 new lab codes.CMS has now released the voting data. Next step, CMS will release its proposed prices for public comment in 1H September.Website here:https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panelClick on "Panel

AI Guest Author: On David Clark's Essays on the NHS Digital Pathology Investment

2026-08-07T06:31:12.863-07:00

[Chat GPT August 2026]##British pathologist David Clark is an expert on digital pathology & real-world integrations. Below, Chat GPT writes a detailed commentary on his four recent articles on NHS and its digital pathology investment tactics.David Clark - Nottingham - hematopathologist - Nottingham NHS Trusthttps://www.linkedin.com/in/david-clark-61a79a23b/He's written a

Clinical Behavior in Genomics: New Paper on Reflex Tests for Genomic Biomarkers

2026-08-06T10:51:49.196-07:00

An important new paper is just released, and open access. See Pineualt et al., on protocols and barriers regarding reflex testing for gene panels in non small cell lung cancer (NSCLC). Find it here:https://pubmed.ncbi.nlm.nih.gov/42467547/i've linked via PubMed which gives you, at bottom, a useful list of related papers.##AI CORNER##What Happens After the Guideline? Achieving

Very Brief Blog: CMS "Rapid Benefit Categories" for HCPCS Codes

2026-08-06T07:45:52.358-07:00

Several years ago, CMS announced a process where it would codify something it was already doing - making benefit category decisions for new HCPCS code applications. That is, CMS already for years would deny a new HCPCS applicant on the grounds it was "not a benefit category" - "Thanks, CMS." And if it gave you a code, it usually meant, they believed it did fit some benefit

CMS Proposes to Pull WSI Tests Off the CLFS—Entering Topsy-Turvy Land?

2026-08-04T11:33:10.984-07:00

In both the summer proposed hospital outpatient policies and the proposed physician payment policies, CMS proposed taking software-intensive whole-slide imaging (WSI) tests off the Clinical Laboratory Fee Schedule (CLFS).Forget the current payment amounts for a moment. CMS proposes that, under Part B, WSI tests would be contractor-priced—eek! In the hospital outpatient setting, where contractor

CLIA, and Computational Pathology on H&E: The Dog that Didn't Bark?

2026-08-04T11:19:45.528-07:00

There's a Sherlock Holmes story where a dog barked at every stranger. Since the murder was committed on a night the dog didn't bark, Holmes concluded the murderer was someone known to the household.Here, I'm putting together some puzzle pieces from recent CMS (and FDA) decisions.Background FactsIn July proposed rulemaking, CMS proposed to take existing whole slide imaging codes,

CMS Denial Rates for PLA Codes

2026-08-03T11:24:16.565-07:00

CMS has a terrific database where you can see all codes (services) paid for any US laboratory. Find it here.CMS also has a database for all CPT codes paid to Part B providers and labs, along with denial rates. These tables are national, and are not provider specific. But, if the code is a sole-lab PLA code, it's almost the same as provider specific. Database here.I

AI Guest Author: New 20-page AI White Paper on Medicare vs Commercial Coverage for Genomics

2026-08-02T07:20:11.282-07:00

It's become almost a cliche' in the past decade that for many tests, Medicare coverage will occur ahead of most commercial insurance coverage. Or, in clinical areas like minimal residual disease (MRD) or comprehensive genomic profiling (CGP; CMS NCD 90.2), Medicare coverage will be broader.This 15-page white paper was written entirely by Chat GPT, which was given only a few

Linked In Deep Dive: Daniel G's Writings on Where MRD Is Going

2026-08-02T00:17:07.176-07:00

Daniel G. and the Rise of the LinkedIn Topic Expert in MRDhttps://www.linkedin.com/in/daniel-giner/This blog written by Chat GPT 5.6._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _LinkedIn has developed its own class of expert: the experienced industry participant who chooses a relatively narrow field, follows it almost continuously, and publishes enough commentary that readers begin to rely on

Big News: The FIND RCT Study in Colorectal Cancer: Integrating ctDNA and Imaging Management (Mo et al.)

2026-08-01T16:04:52.026-07:00

SUMMARY:The randomized phase III FIND trial integrated serial ctDNA methylation testing with protocol-driven CT imaging after colorectal cancer surgery. ctDNA-guided surveillance detected recurrence a median 3.9 months earlier and doubled curative-intent treatment among patients who relapsed (48.1% versus 23.6%). The study moves MRD beyond prognosis toward actionable surveillance, although

Linked In Deep Dive: Josh Bowerman's Articles on Genomics Industry Dynamics

2026-08-01T15:11:00.958-07:00

Josh Bowerman Maps the Rapidly Changing World of Clinical Genomics[This blog written by Chat GPT 5.6]Josh Bowerman has developed a distinctive body of commentary on clinical genomics, particularly oncology diagnostics, liquid biopsy, early cancer detection, comprehensive genomic profiling, and minimal residual disease. His articles are brief, visually polished, and generally published on LinkedIn

LinkedIn Deep Dive: Jack Kohler's Work on Interpreting Clinical Trials for Commercial

2026-08-01T14:49:47.746-07:00

Reading the Clinical Paper Commercially: Jack Kohler’s Methods to Bridge from Evidence to StrategyThe essay below is written by Chat GPT 5.6 after reading Kohler's web articles. He's focused on biopharma, where one main pivotal trial usually is hugely influential in FDA decisions as well as coverage. In diagnostics, VERY often, at least tests in novel areas, a whole sequence of

Major News: FDA Posts Its 28pp Review of ArteraAI - Breast Cancer Computational Pathology

2026-07-31T10:03:02.844-07:00

In May 2026, ArteraAI got FDA clearance for its computational pathology test for breast cancer. FDA can take "weeks to months" to post its 20- to 30-page review packet - and the breast cancer review is now public.Artera AI Breast Cancer (NEW)See the K254114 product home page here;https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254115See the FDA's 28-page 510(k) review

AI Guest Author: AI Researches, Writes, White Paper on the "87798" Story at Medicare

2026-07-30T08:22:26.242-07:00

A once-obscure CPT code, 87798, PCR for "other organism," exploded in usage to become the highest-paid molecular code in 2014. During 2016, OIG reports have appeared and Medicare MACs rapidly began to slash payments for 87798. See a representative Linked In article, here.As an experiment in AI writing - I briefly asked Chat GPT 5.6 to research 87798 at Linked In at elsewhere, get

Very Brief Blog: New Book Coming: Pixels and Precision Pathology

2026-07-29T08:47:39.557-07:00

It's not out yet, but I'm seeing publicity for a new book on computational pathology, "Precision Pathology: From Pixels to Predictions." Springer, here. The Amazon page says it ships November 4, 2026, here.See LinkedIn for one of the coauthors, Dr. Gu of Pittsburgh, here.If that's of interest, you may also like Rajni Toppo's essay, Human vs. Machine Judgment in

AI Corner: AI Counts New Diagnostic LCDs, Timelines

2026-07-28T13:31:43.849-07:00

I was interested in how many LCDs the different MACs produce for lab diagnostics (MolDx, Novitas, Wellpoint Federal [former NGS MAC].)To my surprise, Chat GPT was able to follow instructions, search the CMS database for different parameters, and produce clean tables as output. It could also volunteer insights along the way.You can see my long dialog with Chat GPT in a PDF, and also get

Nerd Note: How CMS Handles Initial OPPS Pricing of the Newest Cat III Codes

2026-07-28T11:00:08.201-07:00

In the previous blog, I noted that CMS provides proposed OPPS/APC prices of Cat III codes that won't be effective for six months...and that don't even have public final code numbers. (The same blog shows a comment letter from Valar that includes both the placeholder codes and real codes side-by-side).This is a Chat GPT explanation of how that particular bit of CMS magic works.###CMS Prices

AMA Releases Cat III Codes; CMS Prices New Digital Pathology Cat III Codes

2026-07-28T09:39:10.454-07:00

A lot of action on the digital pathology front.#1AMA RELEASES Dig Path CODESAfter the equivalent of a moratorium on new digital pathology codes, AMA began adding some to the Category III code set at February 2026 and May 2026 CPT meetings. Those codes, while not active until January 2027, were published by AMA CPT on July 10.Find the AMA home page for Cat III here. Jump

Excellent Movie May Contain Medicare Policy Error

2026-07-27T09:19:47.503-07:00

I live in Hollywood; I love movies. I've worked on CMS policy for twenty years; I love CMS policy.Here's a potential glitch where the two coincide.One of the top-rate films of the last couple months is TUNER, which covers romance, classical music, and ruthless dangerous criminals in one package. Plus it's set in NYC and contains several scenes in the modern underground 600-seat

Two Articles by Lennerz: (1) Fixing European IVD Regs, (2) Flexible & Agile Regulation

2026-07-27T09:03:47.394-07:00

One of the most reliably interesting voices on Linked In is Joe Lennerz, successively of Harvard, Boston Gene, and now Natera. Find his home page here, his Linked In postings here.In the last few days he's co-authored several important publications. Kahles et al. appears in Health Policy & Technology, covers major problems arising from recent changes to IVR regulations

WSJ Opinion Piece: "Trump's Plan to Reform the AMA"

2026-07-26T20:32:11.523-07:00

On July 14, the Washington Post had a scoop as the physician payment rule was released: it would contain an abrasive RFI going after AMA for its payment institutions, the CPT and the RUC. (Here, here.)The WSJ had to take a time-out, but today we get a viewpoint (in WSJ) on Trump/RFK/AMA, and written by Kurt Miceli as an opinion piece. Dr . Miceli is chief medical officer at the

Very Brief Blog: Hospital Charges In Real Life: $15,417 for $446

2026-07-26T12:29:13.132-07:00

I had an MRI in June at a nearby hospital outpatient center. When I log onto Medicare.gov/my/claims, I see the MRI code the hospital charged against, and the charge; $15,417.Medicare allowed $446.50, and Medicare Part B paid 80%, leaving $89.30 to my BCBS Medigap plan. (Separate paperwork from them shows they paid the $89.30; I owed $0.)So the hospital charge-to-fee

How I Use AI: What Percent of CRC Stool-test Orders Get Done? What Percent of Positives Get Colonoscopy?

2026-07-24T11:38:35.435-07:00

Header: Chat GPT rapidly answers general medical questions, here, slippage in colon cancer screening.##We had a screening colonoscopy in the family recently and I wondered:1) Of stool tests ordered, what percent get completed (e.g. mailed back)?2) Of positive stool tests, what percent get the indicated colonoscopy?Below is the direct output from Chat GPT. I'm not taking it as gospel