Discoveries in Health Policy

tag:blogger.com,1999:blog-83343212718272177592026-07-31T14:54:25.877-07:00Discoveries in Health PolicyIdeas for or from an evolving healthcare systemBrucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comBlogger3448125tag:blogger.com,1999:blog-8334321271827217759.post-26172005144855819932026-07-31T10:03:02.844-07:002026-07-31T14:54:25.877-07:00Major News: FDA Posts Its 28pp Review of ArteraAI - Breast Cancer Computational Pathology

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-52402333267715457372026-07-30T08:22:26.242-07:002026-07-30T08:24:55.803-07:00AI Guest Author: AI Researches, Writes, White Paper on the "87798" Story at Medicare

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-39518850428178985262026-07-29T08:47:39.557-07:002026-07-30T10:27:23.866-07:00Very Brief Blog: New Book Coming: Pixels and Precision Pathology

 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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-2202079651996413072026-07-28T13:31:43.849-07:002026-07-29T08:28:40.930-07:00AI Corner: AI Counts New Diagnostic LCDs, Timelines

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-4218078619984414972026-07-28T11:00:08.201-07:002026-07-29T10:49:13.578-07:00Nerd Note: How CMS Handles Initial OPPS Pricing of the Newest Cat III Codes

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-29254043550232006192026-07-28T09:39:10.454-07:002026-07-28T10:03:05.135-07:00AMA Releases Cat III Codes; CMS Prices New Digital Pathology Cat III Codes

 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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-53600039836011767432026-07-27T09:19:47.503-07:002026-07-27T09:24:57.391-07:00Excellent Movie May Contain Medicare Policy Error

 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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-7637908100999033532026-07-27T09:03:47.394-07:002026-07-27T09:03:47.395-07:00Two Articles by Lennerz: (1) Fixing European IVD Regs, (2) Flexible & Agile Regulation

 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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-36140404927429884242026-07-26T20:32:11.523-07:002026-07-27T09:04:12.463-07:00WSJ Opinion Piece: "Trump's Plan to Reform the AMA"

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-44246384377006263192026-07-26T12:29:13.132-07:002026-07-26T12:42:56.940-07:00Very Brief Blog: Hospital Charges In Real Life: $15,417 for $446

 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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-81339132844124403292026-07-24T11:38:35.435-07:002026-07-24T11:39:33.944-07:00How I Use AI: What Percent of CRC Stool-test Orders Get Done? What Percent of Positives Get Colonoscopy?

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

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-13879884307945319682026-07-23T15:32:23.488-07:002026-07-23T15:32:23.488-07:00More CMS Legal Cases: LCD Challenges

 Header: A dissatisfied beneficiary can appeal his denied claim, OR, challenge the offending NCD or LCD as a whole. Let's see what's current on the CMS website.##AI CORNER##Medicare beneficiaries may challenge an LCD as unreasonable under 42 C.F.R. Part 426, but the process is obscure and procedurally demanding. Fifteen recent DAB cases show an active yet largely unsuccessful docket: all

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-87843068582012670382026-07-23T14:38:40.498-07:002026-07-23T14:42:06.338-07:00MolDx in Court: Scanning CMS and Federal Cases for "MolDx"

 I'm such a CMS nerd that every year or two I used to scan the CMS Office of Hearings and Appeals (OMHA) for interesting cases.  (Back-when, there were some gems involving HeartFlow).I'm not sure if OMHA still posts as many cases.  But I asked Chat GPT to search CMS and the web for legal cases involving MolDx.  I show the results below.##AI Corner##The publicly available 

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-54914049300661799442026-07-23T14:12:11.321-07:002026-07-23T14:12:11.321-07:00From NGS MAC to WELLPOINT FEDERAL

I mentioned several weeks ago that the NGS MAC (New England, New York, and MN-WI-IL) had begun referring to itself as WELLPOINT FEDERAL.  (While using "elevance" emails.)WELLPOINT FEDERAL is now showing up on CMS.gov websites, as below.Earlier:https://www.discoveriesinhealthpolicy.com/2026/06/the-mystery-of-wellpoint-federal-aka.html

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-45085242312737284772026-07-23T13:52:55.830-07:002026-07-23T15:10:13.224-07:00CMS and Software-Intensive Lab Services: The Third Rail is "How to Enroll" after Coding and Payment

In both its OPPS proposed rules, and its PFS or Part B proposed rules, CMS has proposed to drop AI-based or software-intensive lab diagnostic tests from the Clinical Laboratory Fee Schedule.  CMS says these services are not "CLIA tests" and do not require CLIA lab status.   In both rules, CMS preserves coding and payment pathways.  In OPPS, coding is the same, payment is

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-71999182294115513712026-07-22T10:23:44.501-07:002026-07-22T10:25:27.879-07:00Very Brief Blog: FDA Guidance on Payor Communications

Here's one for your horizon scan.  FDA has posted draft guidance updating its policies for communications with payors, such as HEOR information.Here's my understanding.  FDA already had a guidance that covered marketed product (drug or device) communications with payors about 'health economics' that was not misleading.  Recall that the starting point for FDA-regulated

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-46047034478604962622026-07-21T16:33:06.867-07:002026-07-21T16:56:05.965-07:00Here's the AI White Paper on Paying for AI...Articles from STAT and PETERSON

Do payers pay for AI?   Or do they assume AI-mediated savings, and deflation of prices?  Is one clinical area totally different from another in terms of AI financing and strategies?STAT just ran a three-part series on AI and reimbursement, with Medicare and other use cases.  Peterson Institute just released a 15pp on AI financing in healthcare.  And there are collateral

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-66164234639490844952026-07-20T19:29:45.004-07:002026-07-20T19:36:23.244-07:00AI Guest Author: A Detailed White Paper about Payors and Genomics 2017-2026

Header: An AI-generated 20-page white paper that surveys a decade of articles about payors and genomics.  Here's another adventure in current AI thinking and writing.  Chat GPT 5.6 surveyed 15 papers on payors and genomics, and for contrast, it also read 5 papers on payors and other medical industries. The report provides a general overview and key conclusions.  Trends

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-41052282101511428872026-07-20T12:20:13.278-07:002026-07-20T12:32:46.158-07:00The LabCorp $14M Fine on Tox Testing (Humor)

 You're probably seen press releases about the recent LabCorp $14M DOJ fine related to urine tox testing.There are some sources that go into numbing detail about the coding situations and the coding definitions and overlap.  First link is DOJ press release; second link is 11p court document.https://www.justice.gov/opa/pr/labcorp-agrees-pay-145m-resolve-false-claims-act-allegationshttps:

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-5994570269013592882026-07-20T11:58:24.445-07:002026-07-23T12:38:17.195-07:00How I Use AI: "Ten Papers on Barriers to Molecular Test Adoption"

Header: For some questions, AI can search Google or AI can search PubMed more efficiently than I can.Today I asked Chat GPT to search PubMed and bring back ten papers on barriers to adoption of molecular tests in oncology.  I named some categories like slow adoption of LBx for driver genes [CDx], the slow adoption of Oncotype Dx or similar tests.  Pro's and Con'sUpsides - The AI

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-7994229719334834212026-07-19T11:33:32.919-07:002026-07-31T10:26:01.646-07:00AI Guest Author: Review of H&E AI Breast Cancer Prognosis, versus Standard Methods (21-gene)

Update:  See the FDA's 28-page review of the Artera AI breast cancer H&E prognostic test, here.####I have seen a scattering of articles that study whether AI interpretations of H&E slides can mirror the prognostic value of molecular tests.   The linked PDF white paper is entirely machine generated.Here were the steps:I asked it to seek literature on the topic from PubMed.It

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-21415183675059182092026-07-19T10:42:35.612-07:002026-07-21T09:52:36.426-07:00AI Can Do More Than You Think: Downloading the PDFs & Busywork

UPDATE.  I did have one day of success asking Chat GPT in "LLM" mode to download PDF papers and give me a Zip file.  But it took a long time (?hour).   I couldn't make it repeat this successfully on other projects.BUT...I understand you can do this reliably if you learn how to use full-strength agentic mode where it "takes over" your desktop browser etc.  I don't know

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-68320301307455512012026-07-19T10:09:21.181-07:002026-07-19T10:10:35.487-07:00AMA CPT: Call for Comments on September 2026 New Codes; also AI in Code Change Application

 AMA has a webpage for the September 17-19 Editorial Panel meeting in Minneapolis.  There are limited in person seats; first come first served; but unlimited virtual participation.  It's at the Hyatt Regency.https://www.ama-assn.org/membership/events/cpt-editorial-panel-meetingThe public agenda for all codes is now available.  Comment for lab codes is already closed (to allow

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-60513005664975101502026-07-16T20:32:58.013-07:002026-07-20T16:24:09.297-07:00Assessing the New MolDx LCD for Transplant Rejection; And Our First LCD Report from Agentic Instructions

Header: MolDx releases a long-awaited LCD on transplant rejection testing.  See L40140. Clear improvements in coverage and some explanations.  The actual coverage rules could still be improved for clarity.  For this blog, this is the first time a report has been entirerly self-generated by AI.  There were 9 steps for creating a report, for example, #10 create a 500-word

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-70634019698639564082026-07-16T10:15:46.106-07:002026-07-20T10:29:21.715-07:00Tying Together: Five Policy Events Rapidly Circle Around Digital Pathology!

Header: In the last couple months, five separate and active policy events circle around digital pathology.DP Policy Event 1:  CAT III WSI Codes Not on CLFS (June 10)DP Policy Event 2:  Congr. Dunn Released "Enhance CLIA Bill" (H.R. 8890, w/ Dig Path) (June 12)DP Policy Event 3:  OPPS Rule Pushes DP Off CLFS, Onto APC System (July 2)DP Policy Event 4:  PFS Rule Knocks DP &

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com