Discoveries in Health Policy

tag:blogger.com,1999:blog-83343212718272177592026-06-18T18:33:37.596-07:00Discoveries in Health PolicyIdeas for or from an evolving healthcare systemBrucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comBlogger3381125tag:blogger.com,1999:blog-8334321271827217759.post-9881830488529102822026-06-18T13:33:28.529-07:002026-06-18T14:15:33.555-07:00OIG: Another Workplan, This Time It's Genetic Tests in Part B

 A few days ago we flagged an OIG workplan about pathogen panel coding for > 5 pathogens (think 87798) - here.OIG has another another molecular pathology workplan - this one focused on genetic tests.The audit and report is expected to run 2026-2028.  In particular, they will look for differences in payments between MOLDX and Non-MOLDX geographies.https://oig.hhs.gov/reports/work-plan

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-15333965841326698362026-06-18T12:37:12.904-07:002026-06-18T12:57:57.843-07:00AI Corner: Chat GPT Interprets German-Language Sequencing Policy Documents

This week, Genomeweb has an excellent article about reimbursement and policy changes in German regarding NGS.   The article includes a number of important commentaries from experts. As an AI experiment, I was curious how well Chat GPT could read the underlying 8-page and 35-page dense government documents in German, and turn them into an article for English-speaking US readers.&

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-17126294785750730442026-06-18T11:53:23.639-07:002026-06-18T12:17:06.210-07:00CMS Puts HCPCS Modifiers for Local, Metastatic Cancer - On Hold

Last fall, CMS proposed to create two cancer modifiers as two-letter HCPCS codes, for local versus metastatic cancer.  (See my February blog here).CMS has published its final results based on that December 2025 code cycle, and CMS will NOT procede with the cancer modifiers at this time.Find the "Final Decisions" PDF here, and see page 144 "Next Generation Sequencing."#### (1)https://

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-41920469562690247112026-06-17T21:33:22.975-07:002026-06-17T22:53:44.198-07:00Vinay Prasad: HE'S BACK

Before Vinay Prasad, the UCSF oncologist, served as head of CBER at FDA, he was famously outspoken—in blogs, vlogs, podcasts, and peer-reviewed articles.During his time at FDA, those informal channels went quiet. Now that he is out of FDA, he appears to be back at full volume. His YouTube channel, dormant for a year, has posted nine new vlogs in a month, most running 20 to 30 minutes.https:/

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-50938159440637129812026-06-17T20:33:33.612-07:002026-06-18T09:16:24.416-07:00Register Now for June 25 HHS Webinar on AI, Policy, and Reimbursement

HHS Webinar June 25: What Did HHS Hear About AI in Clinical Care?##AI Corner: Chat GPT 5.5##In December 2025, HHS issued a broad Request for Information asking how the Department should accelerate the adoption and use of artificial intelligence in clinical care. The RFI was only 3 pages, but it was pointed. HHS asked how it should use three big levers — regulation, reimbursement, and research and

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-7606997558903408122026-06-17T20:14:51.130-07:002026-06-17T20:14:51.131-07:00Very Brief Blog: Using AI to FInd Someone's Name

 We live at a time where some people use AI like second nature and some nearly never.Here's a real life example.  For a moment today I was blocking on the name of Jennifer Leib, a well-known health policy consultant in DC.  Here's my prompt and here's the result.###PROMPTThere is a woman in washington dc whose training is as a genetic counselor and she runs a small but high quality

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-13839952177268773292026-06-16T13:56:20.119-07:002026-06-16T13:56:20.119-07:00Breaking News: Noridian to Hold Meeting on Neurodegenerative Diagnostic Lab Tests

There's been a boom in more accurate lab tests in neurodegenerative disease - both Alzheimer's and Parkinson's - and quite a few CPT codes in this space.   But it's been "crickets" in terms of Medicare coverage policies.Details are pending, but the Noridian MAC plans an advisor workshop (a "CAC") on the topic on August 20, 2026.    Potentially that could precede an LCD a few

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-77496948937948745392026-06-16T10:30:53.404-07:002026-06-18T13:34:35.182-07:0087798: OIG Going After Use of "Panels" Larger than 5 Assays

Update: See also a project on genetic tests, here.##The MolDx program, and perhaps others, have LCDs making it difficult (not impossible) to bill for covered pathogen panels of >5 pathogens.   That is, the code(s) for 3-5 pathogens are easily payable, a code for 6-11 pathogens is much more tightly controlled.However, implementation of a 5-analyte cap was weak when faced with high

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-30954589428245571632026-06-15T14:05:10.899-07:002026-06-16T11:53:56.824-07:00Nerd Note: What's Up with Medicaid Waivers, Statute 1115, New Neutrality Rule (1115(g))

I've been perpetually confused by SSA 1115 Medicaid waivers, and SSA 1115A which creates the CMMI, Center for Medicare Innovation.  New press from CMS (here, here) and others (here) made me stop and figure it out.In a nutshell...Section 1115 dates to the 1960s and allows Medicaid program waivers, which usually originate in a State and are brought up to CMS for approval.  

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-72269287323669745202026-06-14T21:19:13.306-07:002026-06-18T09:24:57.863-07:00Sidebar: Urologist Billing of 87798

The 30 MolDx states have LCDs that generally, make it hard to bill for panels of  >5  pathogens (with some rules and exceptions), and that, generally, make it hard to bill for urine pathogens using large molecular panels.CMS recently released CY2024 national Part B payments for 87798, "other pathogen, amplified probe."  Of around $450M in payments, about 90% went to labs

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-22231726971036966302026-06-14T20:54:57.891-07:002026-06-15T10:38:08.437-07:00Medicare Labs Intensely Billing 87798: Comparing Novitas/Texas and Noridian/California

See a June 2026 article on sentencing of a Burbank lab fraud case in the tens of millions of dollars.  And now in 2026, we're hearing about rising denials on code 87798.  From Policies to Coverage to Coding to PaymentLet's look at Medicare local policies for pathogen panels.  First, the MolDx system, like Noridian, has a quite strict LCD about pathogen panels, generally

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-9903872341927266692026-06-14T19:56:05.892-07:002026-06-15T10:39:26.726-07:00CMS Creates New "Office of Health Technology & Health Technology Products" - Led by Amy Gleason

 It's a quiet Thursday, you're reading the new issue of Federal Register, not to much too see, turn the page, turn the page again...And suddenly, HHS announces the creation of a new office at CMS, the "Office of Health Technology & Products," the OHTP.  See the presentation at 91 Fed Reg 35478-35482 Find it here:https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11743.pdfSee

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-45231053257680872842026-06-12T21:40:48.167-07:002026-06-12T22:06:54.008-07:00The Fascinating Context: Florida's Dr. Dunn, HR 8500 (LCDs), HR8890 (CLIA)

 [AI Corner, Chat GPT]See also: Blog on HR 8500, LCD Reform, here    Cosponsor: Barragan (D-CA), Tenney (R-NY)See also: Blog on HR 8890, CLIA Reform, here   Cosponsor: N.A. (6/12/2026)##HEADERRetiring Florida Congressman Neal Dunn, M.D., has introduced two surprisingly substantive diagnostics bills: H.R. 8500 to discipline Medicare LCD timing and transparency, and H.R.

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-22632778300532494562026-06-12T16:04:02.994-07:002026-06-13T08:13:24.400-07:00Digital Pathology at CMS: Annual Lab Meeting Postpones It, But CLIA Reform Would Boost It

 If you follow digital pathology (whole slide imaging) at CMS, you'll know that Medicare placed around ten WSI tests on the Clinical Laboratory Fee Schedule through 2004.  Then, AMA CPT stopped making new PLA codes for WSI.  Then, beginning in February 2026, AMA CPT has created at least four new Category III codes for WSI tests.  (AMA will release the full text on July 1,

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-63405196164179108602026-06-12T15:27:28.536-07:002026-06-18T12:21:15.092-07:00Congress Releases Full Text of 45-page CLIA Reform Bill

In May 2026, Congressman Dunn of Florida issued a press release about a new Enhance CLIA bill (here), and there was a policy article from the McDonald Hopkins law firm, Campbell et al. (here).  Around June 11, a full version of the 45-page legislation has been posted.  Find it here:https://www.congress.gov/119/bills/hr8890/BILLS-119hr8890ih.pdfTrack updates to HR 8890 here.It's

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-91696151737323119362026-06-12T14:56:40.071-07:002026-06-12T15:02:09.506-07:00HHS OIG Releases Legal Viewpoint on MCED Supplemental Testing

 A favorite question the last five or ten years - if CMS pays you for one test (let's say CRC screening) can the lab provide an additional report (let's say kidney cancer screening)?   Does it imply Anti Kickback Statute concerns?See an article on June 10, 2026, at National Law Review, that OIG's viewpoint is favorable with terms and conditions.https://natlawreview.com/article/

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-38917382644331703312026-06-12T11:14:40.749-07:002026-06-12T11:14:40.749-07:00AI Guest Report: Claude Opus Reviews Annual Lab Meeting (June 10, 2026)

On June 10, 2026, CMS held its all-day Annual Lab Meeting for public comment on correct pricing of over 100 new lab test codes.Claude Opus 4.8 studied the 5-hour transcript, the agenda (of 47 presenters), and the code list (about 110 code descriptors).   It then produced a nine-page meeting report.Find the report here:https://drive.google.com/file/d/1-On-eq4I_bsBB24ydul6XyDoJnv46VTz/

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-82131534968195008932026-06-10T05:34:59.145-07:002026-06-10T05:47:12.591-07:00AI Guest Column 02: Does Medicare Still Use COBOL? A Book Chapter by Claude Opus 4.8

A previous blog entry provided a book chapter, written by Chat GPT, on Medicare claims processing software ("Is it really still in COBOL?")Here is a second book chapter, by Claude Opus 4.8, which was given the earlier Chat GPT book chapter and asked to start again, and push it further in a new draft.Offered as an example of current AI-managed writing products; not verified.###Version 2, this time

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-508471319346557132026-06-10T05:16:28.444-07:002026-06-10T05:47:22.413-07:00AI Guest Column 01: Does Medicare Still Use COBOL? A Book Chapter by Chat GPT

AI CORNER:  Written by Chat GPT.One of a series.  Offered as an example of current AI-managed writing products; not verified.See also: A second version, alternatively created by Claude Opus 4.8, here.##Medicare’s Hidden InfrastructureJune 10, 2026 / Chat GPTThis chapter explains the hidden technological infrastructure underlying Medicare fee-for-service claims processing, including the

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-52431099921454422382026-06-09T22:22:46.596-07:002026-06-10T05:47:50.799-07:00AI Guest Column: Oz and Mulligan on Saving Healthcare Costs

 AI CORNER: Chat GPTTwo Senior CMS Officials on "Saving Costs" - June 2026MedCityNews, June 9, 2026 (Katie Adams): CMS Dr. Oz on Making Healthcare Affordablehttps://medcitynews.com/2026/06/dr-oz-cms-healthcare-affordability/MedCityNews, June 8, 2026 (Katie Adams): Casey Mulligan on Healthcare Cost Incentiveshttps://medcitynews.com/2026/06/hhs-affordability-healthcare-costs/##For experts,

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-38537132492695918062026-06-09T12:07:49.854-07:002026-06-12T08:51:21.539-07:00CMMI ACCESS Program: Can Well-Intentioned Goals Conceal Adverse Incentives?

Header:  CMMI produces a JAMA Op Ed on its "ACCESS" technology and chronic care program.  I used an AI-generated essay to explain, then critique the program in some detail._______This week, JAMA publishes an important paper from CMMI, which appeared online May 11.  See:Outcome-Aligned Payments for Technology-Enabled Care—A New CMS Approach to Paying for Chronic Disease Care in

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-45537091813831766962026-06-09T06:07:30.607-07:002026-06-09T06:57:20.977-07:00AI Attempts to Classify 100 New PLA Codes (Gets Migraine)

I asked Claude Opus and Chat GPT to make a classification system for the 102 PLA codes being considered for this summer's Annual Lab Meeting, which will price the 102 tests by the crosswalk or gapfill methods between now and November.I noted that one approach is repeated binary decisions (human vs microbial; then microbial as pathogen panels vs other; and so on), but I emphasized that other

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-28688124698536653212026-06-08T11:02:00.105-07:002026-06-08T11:02:00.105-07:00News Summary: WaPo: HHS Wants to Bring Physicians and AI Together

 On June 4, 2026, Washington Post has a lead aritlce, "Push to bring AI doctors into American medicine," by Elizabeth Dwoskin.___Chat GPT summarizes;The Washington Post article is worth reading because it shows how quickly AI medicine is moving from speculative futurism into federal and state policy. The main story is not just that chatbots may help patients, but that some officials and

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-16431183223246392762026-06-07T19:59:36.015-07:002026-06-08T10:08:34.389-07:00AMA's New Digital Pathology Codes in "Category III": What If They're Not on the CLFS?

Key Lesson:In 2026, AMA CPT began assigning whole-slide-imaging digital pathology codes to Category III, rather than the PLA pathway used for earlier WSI codes. That matters because PLA lab codes can move onto the Clinical Laboratory Fee Schedule and be priced by crosswalk or gapfill, while Category III codes are usually not nationally priced by CMS. If software-intensive WSI services

Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comtag:blogger.com,1999:blog-8334321271827217759.post-12084623444244913432026-06-06T16:15:57.928-07:002026-06-06T16:19:32.050-07:00How You Get CMS to Liberalize a Burdensome Rule (Case Study: Physical Therapy Orders)

Why You May Care... Many stakeholders approach CMS each year with a request to liberalize one or another rule - be it an administrative policy, an NCD, or some other problem.   While the example below is not related to molecular laboratories (my main readers), the example DOES show how multiple stakeholders coordinated - and over several years - to get  a meaningful policy

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