Discoveries in Health Policy

Two Articles on the Medicare CRUSh Anti-fraud Effort

2026-04-26T10:58:00.000-07:00

Much has been written about CRUSH in the past month, here are two more.American Journal of Managed Care covers Medicare fraud hearings. From Giuliana Grossi, April 24.https://www.ajmc.com/view/-fraud-pays-congressional-hearing-exposes-deep-cracks-in-medicare-s-defensesSee also an essay at the consultancy ADVI, Stacey Gilbert, March 17.https://advi.com/insight/

Six Powerful Ways AI Helped Me Understand AMA CPT AI Policy (Appendix S)

2026-04-24T12:02:00.000-07:00

How AI Has Greatly Helped Me Understand AMA CPT “APPENDIX S” For AI For over a year, AMA has been working on a heavy overhaul of its Appendix S, coding and classification policy for software-intensive services like AI. At many points, the journey has been a confusing one, trending toward better revisions even as the revisions have come to occupy most of the original

Chat GPT Assessing an Important Court Case for Labs on Medical Necessity

2026-04-23T08:42:00.000-07:00

For years, labs have had variable success during audits (or during prior authorization), depending on how much original physician-side chart documentation must be procured by a lab. Notably, MolDx published an article that a physician's order (often with ICD10 codes, etc) is an integral and valid part of the medical records as a whole. A59798. My blog here.A recent

Amazing: AI Can CLean-Up the "APPENDIX S" AI Policy for AMA CPT Meeting

2026-04-23T08:19:00.000-07:00

Several years ago, AMA CPT introduced "Appendix S," a policy statement about language and coding for software-intensive services. From May 2025 to the upcoming May 2026 CPT meeting, AMA has released multiple very extensive revisions of "Appendix S," one of which will probably be voted on, at the May 1 Boston AMA CPT meeting. See a 2021 Linked In announcement here. See a 2022

CMS Announces "RAPID" Coverage for Breakthrough Devices - More to Follow

2026-04-23T07:35:00.000-07:00

CMS Announces RAPID Pathway for Breakthrough Devices; "Cuts Red Tape"On April 23, CMS issued a press release annoucing a new CMS-FDA collaboration for Breakthrough Devices, called the RAPID Pathway. The pathway will RAPIDly see the release of a proposed NCD, for 30 days comment, concurrent with FDA approval. CMS will "pause" the TCET NCD-CED pathway ("Transitional

Connecting the Dots is Fun: From FOCR Webinar to WSJ FDA Article

2026-04-22T10:10:00.000-07:00

It’s always interesting when policy dots connect across events that at first seem unrelated. A few weeks ago, Friends of Cancer Research (FOCR) held a webinar on its workstream addressing new horizons in external control arm (ECA) studies—that is, the broader problem of how regulators and clinicians should interpret evidence from single-arm trials. My April 13 blog provides a fuller report

United Health Group, $3 Billion Bet on AI (see Stat Plus)

2026-04-21T19:06:00.000-07:00

On April 6, Casey Ross of STAT PLUS published a deep-dive aritcle on United Healthcare's massive investments in AI.See the subscription article here:https://www.statnews.com/2026/04/06/unitedhealth-group-massive-artificial-intelligence-push-patient-implications/I don't want to infringe on his article, so here are just a couple highlights.###This is not “AI in health care” in the abstract;

Roche/FMI to Acquire SAGA: See the Chat GPT Research Memo [AMAZING]

2026-04-21T18:50:00.000-07:00

In April 2026, Roche announced that, via FMI, it would aquire SAGA Diagnostics, a Swedish MRD company that got MolDx coverage in 2025.I put Chat GPT into its "Deep Research" mode and it spent about an hour checking hundreds of links and then writing a single, 13-page, 3400-word memo on SAGA, including a number of original figures. This is what's called "agentic" research mode - Chat GPT

Humor: How Hospitals Handle CMS 14 Day Rule

2026-04-20T10:45:00.000-07:00

The CMS 14-day rule for "date of service" has different versions for inpatients and outpatients, and for human molecular tests versus other molecular tests. It's often a source of confusion (look for some publications on this, in the next year).Here's a Chat GPT illustration of how hospital billing staff deal with the 14 Day Rule.

The Future Decade in Sequencing: Learning from Past Decades?

2026-04-19T16:22:00.000-07:00

I was given a questionairre on the future of clinical sequencing in the next decade - whether FFPE, or MRD LBx, and so on. Of course, any projections ten years ahead are tricky. What might we have predicted in 2000, or 2010, and how would reality have looked by comparison?Three clinical landmarks in genomics might be introduction of the Oncotype Dx test around 2005, the

Get Them Here: Detailed Notes on the April 16 CMS Webinar on PAMA Reporting

2026-04-16T13:14:00.000-07:00

On April 16, 2026, CMS provided a one hour webinar on PAMA lab price data reporting, which runs May June July, 2026.CMS PAMA PageCMS stated it would soon post the video on its PAMA resources page.https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/clfs-pama-reporting-resourcesFind the CMS VideoScroll down on this page to see April 16 video at CMS:https://

Some Thoughts on the Revisions to AMA Appendix S for Software-Intensive Services

2026-04-16T10:45:00.000-07:00

Header - For a year, AMA has circulated larger and larger revisions of Appendix S, its position on software-intensive services. Here, I argue not for or against specific redlines (which may be copyright or confidential) but rather I discuss some general principles.###In 2023, the AMA added an “Appendix S” to the AMA CPT procedures and codes handbook. Appendix S does not

CMS Inpatient Proposed Rule: Canning the Fast Track to NTAP (!)

2026-04-15T13:18:00.000-07:00

In 2020, the first Trump adminstrationi proposed fast track routes to Inpatient NTAP (new technology add on payment) and fast track to coverage for breakthrough devices (under MCIT). MCIT was replaced, under Biden, with TCET, an inferior plan.Now, the Trump administration itself threatens to nix the fast track methods to NTAP. See AI discussion below.Find the CMS source material

CMS Releases Inpatient Proposed Rule

2026-04-14T15:31:00.000-07:00

CMS has released the Inpatient Proposed Rule. Find it here:https://www.federalregister.gov/documents/2026/04/14/2026-07203/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-andIt's in Fed Reg, April 14, 2026, 91:19312 (576pp). 16 mb.Note: This downloads for me in a locked copy I can't annotate. However, you can "extract all

AMA Releases the Biggest Batch of PLA Applicants Ever

2026-04-14T11:34:00.000-07:00

Just two weeks ago, AMA released 29 new and finalized PLA codes, April 1 (here).Here's the PLA home page:https://www.ama-assn.org/practice-management/cpt/cpt-pla-codesAccording to the calendar there, AMA releases draft codes April 14, wants feedback by April 21, and will finalize by April 21. The codes are then voted on by the Editorial Panel regular spring meeting (April 30-May 1).Here is

Friends of Cancer Research: 3-Hr Webinar on "External Control Arms"

2026-04-13T08:49:00.000-07:00

When you have a one-arm trial, you need a comparison group - the general problem presented by "External Control Arms."Catch up with the newest thinking via a 3-arm webinar hosted by Friends of Cancer Research (streamed live on April 7, 2026).Find it on YouTube here:https://www.youtube.com/watch?v=fh7y3J2xyYYFind the project home page at FoCR here:https://friendsofcancerresearch.org/eca/

House Hearing on Medicare Fraud: Comparison to CMS CRUSH Proposal

2026-04-12T17:19:00.000-07:00

CMS released its CRUSH anti-fraud proposals around February 26. At the beginning of the month, February 3, the House Energy & Commerce Committee held a 3 hour hearing on healthcare fraud. Find it here:https://energycommerce.house.gov/events/oversight-and-investigations-common-schemes-real-harm-examining-fraud-in-medicare-and-medicaidI asked Chat GPT to compare the contents

College of American Pathologists, CRUSH & Genomics Fraud; Doesn't Like National MolDx

2026-04-12T16:59:00.000-07:00

Since comments closed on March 31, I've highlighted several groups that commented, such as ACLA and the BCBS Association. Both supported "nationalization" of MolDx, a topic on which HHS was seeking input. (ACLA had some guardrails, though).College of American Pathologists (CAP) posted its comments, 7 pages long. A substantial proportion of the comment recounts problems

Tamara Syrek Jensen - The Medtech Strategist Interview

2026-04-09T17:42:00.000-07:00

Medtech Strategist has released an interesting podcast interview. Learn about Tamara Syrek Jensen's career at CMS, much of it in the Coverage Group, and the insights she brings to clients today as a Principal of Rubrum Advising.(Note, she seems to say a couple times, CMS is where I am; but it's clear she was out-of-government at this interview and working with Lee Fleisher at Rubrum

CMS Webinar on PAMA Lab Data Submissions: Video April 16,

2026-04-09T13:47:00.000-07:00

Here's new from CMS about PAMA sales price reporting, due at CMS in May-June-July 2026.The live webinar is sold out, but hopefully they will post archive video.It was sold out but they opened a larger channel.###CMS press release:Clinical Diagnostic Laboratories: Get Ready to Report Starting May 1Are you an independent laboratory, physician office laboratory, or hospital outreach laboratory that

Phillips et al in SCIENCE: Diagnostics and Policies for Value

2026-04-09T12:59:00.000-07:00

In the April 9, 2026, issue of SCIENCE, see an article by Phillips, Horn, & Califf on the value of diagnostics and good diagnostics policy. It's titled:Diagnostics investments and disease burdenRegulatory and payment policies could facilitate investment and innovation in diagnosticsFind it here - (firewalled).Find a detailed UCSF press release here.Here's the abstract:Screening

CMS "CRUSH" Comments Website is Flaky

2026-04-07T16:46:00.000-07:00

Update - The website is still flaky, but a bit more on that. If you search for ACLA, you will in fact pull up 1 thing, the ACLA comment. This has many mentions of "MolDx" but if you search "MolDx" you will not get ACLA. Also, when I searched on "Blue Cross Blue Shield" I got a comment about MolDx being related to BCBS South Carolina, but I didn't get the big 54 page BCBS

Released:; Chaihorsky et al., A New White Paper on the "Laboratory 2.0" Vision

2026-04-07T13:27:00.000-07:00

At Linked In, see a new 16-page paper about the vision for "Clinical Laboratory 2.0," by Chaihorsky, Van Ness, Cooper, and Shotorbani. Authors are from the consultancy Alva10, Wuscott LLC, and the Project Santa Fe Foundation.Link here.Abstract,Clinical laboratories are facing significant economic pressure as the Protecting Access to Medicare Act (PAMA) driven reimbursement cuts erode

Chat GPT Can Now Write 20-page Reports with 30 Citations ("Deep Research")

2026-04-07T12:35:00.000-07:00

My subscription version of Chat GPT ($20/mo) recently got a new function called "Deep Research" (an option on the left-hand menu.)This week, I asked it to write a report on value-based cancer care, what has held back the field, and whether new kinds of metrics (maybe using AI) could have a big impact.Chat GPT thought for 45 minutes, and wrote a report (17-page PDF) with some 30 specific footnotes

Blue Cross to CMS: Nationalize MolDx Now!

2026-04-07T12:20:00.000-07:00

This winter, CMS proposed a wide anti-fraud initiative called CRUSH, taking comments until March 30. Two targets were (1) genomics fraud and (2) DME fraud. In an earlier blog, I covered the ACLA comment, includings their remarks on MolDx.At least 17 of the public comments involved MolDx. This includes the 50-page BCBS comment, which supports the proposed