Tuesday, January 27, 2026

Medicare Nerd: Medicare's Confusing Double-Track for Medicare Advantage Policy 2027

On January 26/27, 2026, the big news was that CMS has announced there is virtually no change in rates for Medicare Advantage in CY 2027.  They issued a press release, FAQ sheet, and a 160-page policy document.  Reader here for Reuters. Or see picture for the main takeaway:


But wait a second -  back on November 28, 2026, they issued a 137-page Proposed Rule for Medicare Advantage in 2027.  

How to do the policy making processes differ?

I asked Chat GPT.

###   SUMMARY OF THE TWO DOCUMENTS

  • CMS released two different CY 2027 “Part C & D” documents, but they serve separate legal functions — one changes program rules, the other updates payment mechanics.
  • The November 2025 Federal Register Proposed Rule (CMS-4212-P) is formal regulation. It amends the Code of Federal Regulations and covers policy areas such as Star Ratings methodology, marketing and TPMO oversight, enrollment processes, SNP policies, and Part D benefit redesign. This rule determines what Medicare Advantage and Part D plans must do operationally. It will later become a Final Rule. 
  • The January 26, 2026 Advance Notice is not a regulation. It is an annual payment methodology notice required by statute. It updates MA benchmarks, growth rates, risk adjustment models (CMS-HCC and RxHCC), normalization factors, coding intensity adjustments, and Part D benefit parameters. It determines how CMS calculates plan payments, and becomes the April Rate Announcement, not a Final Rule.

###

###  LINKS

Fed Reg November 2025 here.
Advanced notice 160pp January 2026 here.  Fact sheet here.  January 2026 press release here.

###

###

You are absolutely justified in being confused — CMS uses two totally different legal pipelines that both talk about “Part C & D changes for 2027,” but they do different jobs.

Here’s the clean mental model.


🧠 You are looking at two separate rulemaking universes

November 28, 2025 documentJanuary 26, 2026 document
Federal Register Proposed Rule (137 pages)Advance Notice (160 pages)
Docket: CMS-4212-PNot a FR rule — payment notice under SSA §1853
Amends regulations (42 CFR Parts 422 & 423)Updates payment formulas, rates, and risk models
Becomes a Final Rule laterBecomes the Rate Announcement (April 2026)
Legal authority: APA rulemakingLegal authority: MA rate-setting statute
Changes program rulesChanges how plans get paid

📘 1. The NOVEMBER rule = PROGRAM POLICY RULE

This is a classic CMS regulation. It changes the rules of the game.

It covers things like:

  • Part D benefit redesign codification (IRA changes)

  • Star Ratings methodology changes

  • Marketing / TPMO oversight

  • Enrollment rules

  • SNP policy

  • MLR / reporting ideas

  • Network adequacy process changes

It literally amends the CFR.
This is about what plans must do.

Source: The November rule states it revises “Part C and Part D regulations” and includes policy areas like Star Ratings, marketing, enrollment, and drug coverage.

2025 CMS 1128 90FR54894 137p Pr…

👉 Outcome: Final Rule later in 2026.


💰 2. The JANUARY document = PAYMENT & RISK ADJUSTMENT NOTICE

This one is not a regulation. It does not amend the CFR.

It exists because the Medicare statute requires CMS to annually publish:

  • MA growth rates

  • Benchmarks

  • Risk adjustment model updates (CMS-HCC, RxHCC)

  • Coding intensity adjustment

  • Normalization factors

  • Part D benefit parameters

  • Payment methodology details

It is explicitly called:

“Advance Notice of Methodological Changes for CY 2027 MA Capitation Rates and Part C and Part D Payment Policies”

2026 CMS 0126 Part C D 2027 Pro…

This is about how CMS calculates plan payments, not beneficiary rules.

👉 Outcome: Becomes the Rate Announcement (April 6, 2026), not a Final Rule.


🔑 The Key Distinction

TopicLives in November Rule?Lives in January Notice?
Marketing restrictions
TPMO oversight
SNP eligibility policy
Part D benefit structure (legal codification)
MA benchmark math
Risk adjustment model calibration
Coding pattern adjustment
Star Ratings payment impact✖ (policy only)
Part D risk model updates

🎯 Why CMS does this (historical reason)

Medicare Advantage has two separate legal mechanisms:

A. Program rules

Made through APA rulemaking → CFR changes
(That’s your November document)

B. Payment formulas

Made through annual rate notice → Actuarial / statutory process
(That’s your January document)

This split goes back to the Medicare Modernization Act (2003) and earlier managed care law. MA payment is treated like insurance rate-setting, not standard rulemaking.


⚠️ Why it feels overlapping

Both documents mention:

  • Star Ratings

  • Part D

  • Risk adjustment

  • “Part C and D policies”

But:

November = WHAT the program requires
January = HOW CMS calculates money

Example:

November rule: May change Star Ratings measure set.
January notice: Applies Star Ratings to determine bonus percentages in benchmarks.

Different step in pipeline.


🧭 Think of it like this

StageDocument
Rules of footballNovember Proposed Rule
How the referee calculates the scoreJanuary Advance Notice

📌 Final takeaway

You are not seeing two competing proposed rules.

You are seeing:

1️⃣ Policy rulemaking (regulations)

2025 CMS 1128 90FR54894 137p Pr…


2️⃣ Annual payment methodology notice (actuarial rate process)

2026 CMS 0126 Part C D 2027 Pro…

They run in parallel every year and converge when plans bid.


If you’d like, next I can:

A) Map how a single issue (like Star Ratings) flows through BOTH pipelines
B) Show which parts of the January notice plans actually care about most
C) Explain how Part D IRA changes appear in each document

Your confusion = totally rational. CMS’s architecture is… vintage 1997 managed care law meets modern Medicare.


#######

Biden year 4 Med Adv policymaking had many pages about insuring coverage parity, e.g. validity of LCDs in Part C.   Trump Admin went radio silent.  No change, I assume?

####

Short answer: No — neither document meaningfully addresses traditional coverage policy (NCDs, benefit categories, Part A/B service definitions, or Part C “same benefit” scope issues).

You’re picking up on a real shift.


📘 November Proposed Rule (CMS-4212-P)

This rule is about MA/Part D program operations, not Medicare coverage law. Its focus areas are:

  • Part D benefit redesign mechanics

  • Star Ratings methodology

  • Marketing / TPMO oversight

  • Enrollment and SNP policy

  • Reporting, MLR, network adequacy processes

It amends 42 CFR 422 & 423, but does not reopen:

  • National Coverage Determinations (NCDs)

  • “Reasonable and necessary” standards

  • Part A vs Part B benefit definitions

  • MA “uniformity” or “same benefit as FFS” doctrine in any substantive way

Even the IRA Part D sections are benefit design financing, not coverage scope.
Source: The rule’s purpose is described as revising MA and Part D regulations on Star Ratings, marketing, enrollment, drug benefit structure, etc. — not coverage policy.


💰 January Advance Notice

This one is even further removed. It is a payment mechanics document:

  • Benchmarks

  • Growth rates

  • Risk adjustment models

  • Coding intensity adjustment

  • Part D bid parameters

It explicitly describes itself as updating capitation rates and risk models, not benefits.

No discussion of:

  • Coverage standards

  • Clinical benefit categories

  • Concordance with FFS NCDs

  • Scope of Part A/B services


🎯 What’s changed vs prior CMS eras

You’re right — prior administrations (especially 2021–2024) used MA rulemaking to discuss:

  • Guardrails around MA “reinterpretation” of coverage

  • FFS-equivalence expectations

  • Clinical evidence standards

  • Prior auth alignment

That language is largely absent here. The focus is:

Program integrity, payment calibration, and administrative simplification
not
Clinical coverage policy


🧭 Bottom line

TopicNovember RuleJanuary Notice
NCDs
Part A/B benefit definitions
“Reasonable and necessary”
MA must mirror FFS benefitsOnly background law, not policy
Coverage expansions or restrictions

These documents operate in the MA/Part D administrative and financial domain, not the Medicare coverage doctrine domain.

Your observation = correct: coverage policy discussion has moved offstage in these CY 2027 materials.

Decibio: "Clinical" Increasingly Dominates "Tools"

Stephane Budel and DeciBio post a four-page summary of some of their recent research on the moving l ine between tools and clinical diagnostics.  Find their post and PDF here.

Writing,

Life sciences research tools (LSRT) companies are pivoting hard toward clinical and translational value pools:

- Illumina: ~60% of consumables now clinical...

- 10x Genomics: launching a CLIA lab...

- [more examples]

Adding, “clinicalization” requires a significant business model transformation. Reimbursement, quality systems, go-to-market, partnerships… it all changes...



Payor-Owned Primary Care is still Miniscule

We hear about big payors like Optum buying up primary care practices - but how big is that, really?

See remarks at Linked In by Brian Miller - here - and see a new paper in Health Affairs Scholar by Adler et al. here.


Here's Brian's summary:

Ironically this paper shows that Optum is not a competitive concern in primary care markets:

-Payers own 4% and Optum owns 2.71% of all primary care practices

-Optum max market share 35% in 3 counties

-There are over 3,200 counties

Sunday, January 25, 2026

"Value Based Payment & Manage Care Won't Solve USA Affordability Crisis"

It seems obvious to me that "value based care" and "managed care" won't solve the US outlier position for healthcare costs.   But we've got a headline article in Health Affairs that makes the point.

See January 23, 2026:

Value-Based Payment And Managed Care Will Not Solve The Affordability Crisis

Ryan, Rooke-Ley, Berenson (Brown Univ. & Urban Institute)

https://www.healthaffairs.org/content/forefront/value-based-payment-and-managed-care-not-solve-affordability-crisis

Among the unsurprising data shown here, Bond and colleagues in 2025 JAMA found that ACOs saved $300/pt after six years.  Ryan et al. point out that in the target year, 2019, that was $500M savings compared to $800B spending - a small fraction of 1%.   Open access and good reading.

The authors give some airtime to concerns that technology drives healthcare costs.  We could go vastly farther in encouraging technologies that save healthcare costs,  instead of making them almost impossible to adopt.  

(For one promising example see PaigePredict here. I'm not promoting this particular example, but rather, it stands-in for a whole class of beyond-the-horizon breakthrough efficient technologies that deserve attention, also here.)

___

I find this unsurprising.  If you go to capitated managed care, there are immediately huge incentives to "under-provide."  If you call it 'value based payment," you are either selectively a trivial number of healthcare parameters (maybe 15, like flu shots, and heart failure readmission rates, and A1C), or to really track health care "value," you'd have an inordinately complex parameter system that doesn't exist.
___

The article doesn't have an abstract but here's a 200 word summary [Chat GPT 5.2]:

Policymakers keep backing value-based payment (VBP) as the fix for U.S. health care costs, shifting from fee-for-service to risk contracts like ACOs and Medicare Advantage. 

But decades of experience show minimal or no real savings. Even the most optimistic recent ACO studies suggest Medicare savings of only 0.06–0.13%, and those estimates are likely inflated by patient selection and diagnostic upcoding, not true efficiency. Meanwhile, CMS bonus payments and gaming may mean net losses.

Claims that VBP indirectly slowed national spending growth (“spillovers”) don’t hold up. The U.S. slowdown began before the ACA and occurred across OECD countries with very different payment systems. The more plausible driver was a temporary lull in diffusion of expensive medical technologies, not payment reform.

Conceptually, VBP targets the wrong problem. U.S. costs are not mainly due to excess use of routine services; compared to peers, Americans often use fewer hospital days and doctor visits. The real drivers are

  • high unit prices, 
  • adoption of costly new technologies, and 
  • administrative overhead
ACOs can’t control hospital pricing or tech adoption, and only capture a fraction of savings they generate.

Bottom line: VBP outsources cost control to intermediaries while leaving the core pricing and coverage decisions untouched—so it can’t solve long-term cost growth.


Thursday, January 22, 2026

Two MACs Block Coverage of AI in Radiology; Should Pathology Be Concerned?

Header: More MACs Block Medicare Coverage of Advanced Imaging in Radiology.

##

I've often mentioned that experts interested in the growth of AI in pathology should look to advances in AI in radiology for signposts.   See for example a 2022 blog on the topic here.  (Also here). This may be even more important now, as AMA is advancing ideas originally thought up in the context of radiology, to apply to both radiology and pathology, which alarms me.  2026 blog here.

The CGS MAC brought out and finalizing, and the NGS MAC has just proposed, an LCD that doesn't pay for any kind of advancd diagnostic algorithms in MRI.   Amazingly, the CGS MAC LCD got ZERO comments.

The LCDs are titled, "Automated Detection and Quantification of Brain MRIs."

  • The CGS MAC LCD DL40224 was proposed with comment period in October.
    • To my great surprise, it got no comments - A60362.
    • Finalized here.
  • Now it's proposed newly for the NGS MAC region - as DL40332.  Comment to March 8, 2026.
The gist of it is,

The use of AI augmented technology does not eliminate the need for appropriate reader training, and the results are not intended to be used independently of physician interpretation. National Government Services does not consider automated detection and quantification of brain MRI imaging to be reasonable and necessary.

Investigations have explored the potential of automated quantification technology for the evaluation of ARIA, MS, TBI, epilepsy, brain tumors, and other neurologic conditions. However, progress has been limited by the lack of established measurement standards and insufficient access to large, diverse datasets for training these tools....Without standardized data, it is difficult to determine whether subtle changes reflect true pathology or normal variation. At this time, there is insufficient evidence of clinical utility or validity, and use of this technology is considered investigational and therefore not covered. National Government Services will continue to monitor the evolving research related to these devices.



Wednesday, January 21, 2026

Blocked from Regulating LDTs, FDA Still Fights "Collection Devices"

Continuing a saga that goes back 20 years, FDA goes after some companies not for their in-house LDTs, but for their collection kits shipped through the mails. (See a 2013 warning letter from FDA to 23andMe disallowing a non-approved saliva collection device.)   (See a 2025 warning letter from FDA to DRG instruments that a saliva collection device was sold RUO, but with text referring to its "patient samples.")

According to a new item at 360DX, the FDA recently issued warning letters to:

  • Genovate
  • Germaphobix
  • ProDx Health
  • Genetrace.  Online FDA warning letter January 2026 here.
FDA's attention was especially high because direct to consumer marketing is involved. Actions could include "seizure, injunction, monetary penalties."

FDA noted that there are FDA-approved collection devices available (e.g. FDA protecting the market of companies that had invested in FDA approval.)




What's New at NEJM? (1) Kadakia 2026 New Tech Coverage by Law; (2) Kang 2025 Reviewing CMS NGS Denials

My eye tagged a new article in NEJM about Congress granting coverage privilege to a class of interventions, like those which have FDA breakthrough status.  That's Kadakia et al. 2026.  

But I'll devote 3/4 of this blog to discussing their citation #2, Kang et al., 2025, on CMS NGS claim denials.   

 Along the way, I noticed several interesting recent titles which I'll highlight in fine print:

Tuesday, January 20, 2026

AMA Considers Over 50 PLA Codes This Quarter

 Typically, a PLA code quarterly agenda involves about 20-25 codes.

This quarter, I count 53 codes that are either new or in revision.   There are another five or so that are being deleted.

The codes were released around January 13 (sorry I didn't post) and the PLA committee is meeting and voting today, January 20.   The 50-some codes will appear as a "consent calendar" or "single vote" at the AMA CPT meeting in Palm Springs, February 5-6, 2026.

PLA page here

https://www.ama-assn.org/practice-management/cpt/cpt-pla-codes

Agenda, 8 page PDF, here:

https://www.ama-assn.org/system/files/february-2026-pla-public-agenda.pdf

Back up here.



Thursday, January 15, 2026

AI at Work: Can AI Look Up Recent Genomic Industry Funding Events? (Yes)

 AI resources like Chat GPT get better and better at scouring the internet.   

Can it find molecular diagnostics funding events?   In the last month or two, I had noticed the SPAC for Freenome; the Series B for Mercy BioAnalytics; the Series B for Precede Biosciences.   

I asked Chat GPT if it could find those and any others from November 1 to January 13.

Old Regulations, New Tests: Classic OIG Lessons Illuminate Today’s Genomics

Today we ask how large gene-panel lab runs fit to "what's ordered, medically necessary, and billed."  Surprise - The OIG was there in 1997-1998.

And, today we ask about pathologist orders to complete a case - such as in this MolDx article.  In 2007-2008, OIG was already there, with concepts like the in-office exception and its guardrails.  

See the two-part essay below for both topics.  

  • Disclaimer - Of course, AI can list and compare ideas and link them; can entertain; for real opinions, see a compliance attorney.

Wednesday, January 14, 2026

CMS Cloud Database: Part B Code Utilization for 2024

Header:  CMS releases physician-CPT Code summary data for 2024 in January 2026.

###
CMS has released a cloud database of procedure code utilization for CY2024.  

Note, this is a summary by CPT code.   

Wait for mid-2026 to see the gigabyte database for 2024 that shows CPT code utilization broken down at the level of each physician or lab.


Find it here:

Note, you can also get summary data for 2024 in download-able EXCEL files rather than cloud data.

 


Tuesday, January 13, 2026

Freenome Announces Big Collaboration with NVIDIA, Cancer Detection AI

On January 12, 2026, Freenome announced an expansion of its successful collaboration with NVIDIA, bringing artificial intelligence to early cancer detection.

See the press release here.  See the Freenome Linked In posting, where you can track real-time comments and feedback.  

Freenome was featured in NVIDIA's "Healthcare Diagnostics Industry Brief" a couple months back - here.  See the 9 page PDF white paper here. [Highlights from Freenome, Natera, Guardant, Sofia, 

###

AI writes in brief:

  • Freenome announced a major expansion of its AI partnership with NVIDIA to speed up and improve the accuracy of its blood-based multi-cancer screening tests, using GPU-accelerated deep learning to analyze cfDNA, methylation, RNA, and protein signals at massive scale. 
  • The collaboration will support both Freenome’s proprietary fragment-level deep learning models and a new open-source cfDNA methylation foundation model, as the company prepares for FDA review of its first colorectal cancer test and multiple new launches in 2026.
##
See a January 2025 announcement of Mayo-NVIDIA collaboration on digital patholog - here.  See follow-up about Mayo-NVIDIA in July 2025 here and August 2025 here.

Venture Capital in Genomics: Precede Biosciences Secures $83M in Total Financing

Boston-based Precede Biosciences announced on January 12 that it had received $83.5 in financing, arriving as $63.5M in Series B equity, push $20M in a strategic, non-dilutive credit facility.

See the company's press release here. And see the posting from the CEO, Rehan Verjee, at Linked In here.


Here's an AI summary:

Precede Biosciences is a Boston-based molecular pathology and precision medicine startup focused on decoding detailed disease biology from a simple blood test using its comprehensive epigenomic liquid biopsy platform, which profiles circulating chromatin and the DNA methylome to reveal dynamic gene and pathway activity in diseased tissues from just 1 mL of plasma. 

The company’s R&D goals center on enabling high-resolution insights into transcriptional biology to inform drug development, characterize response and resistance mechanisms, and ultimately develop minimally invasive blood-based diagnostics that could guide clinical decision-making and replace some tissue biopsies. Its platform is already being used in research settings and presented at major scientific meetings for applications in cancer and precision medicine.

Founded in 2021, Precede [had previously] raised roughly $57 million in venture and private equity funding from top investors including 5AM Ventures, Lilly Asia Ventures, Illumina Ventures, and others, supporting both platform scale-up and translational efforts. 

The company’s CEO and co-founder, Rehan Verjee, brings strong life-science leadership experience from his prior executive roles in biopharmaceutical strategy and commercial operations, including serving on the Healthcare Executive Committee at Merck KGaA and as President of EMD Serono, where he helped guide business and product strategy—experience that positions him well to drive Precede’s growth at the intersection of innovative diagnostics and precision oncology.

###
Another Boston-based molecular pathology firm, Mercy BioAnalytics, raised $59M in Series B financing in September 2025.  Focus is early cancer detection.  

###
California-based Freenome announced in December a pending SPAC transaction which will raise over $300M in 1H2026.   Here.  See a January 12, 2026 announcement of a new collaboration between Freenome and Nvidia for deep learning approaches to cancer detection. Here.
 




Big Pharma Buys Modella AI: Now Part of Astrazeneca

In Tuesday's business news, January 13, Astrazeneca announces it is acquiring Modella AI.

Here's some background (Chat GPT 5) about Modella:

  • Modella AI is a Boston-based biomedical artificial intelligence company focused on transforming medical imaging, diagnostic workflows, and therapeutic discovery through advanced AI models. 
  • Emerging from academic research at institutions like Harvard Medical School and Mass General Brigham, Modella AI came out of stealth with multimodal foundation models and generative AI “co-pilots”—tools that combine visual pathology data with clinical context to support tasks like disease detection, report summarization, and prognosis prediction for clinicians and researchers. 
  • Its flagship offerings (such as PathChat and Judith) are designed to augment pathologists’ capabilities by automating routine analysis and enabling rich, AI-assisted interpretation of complex biomedical data. 
  • Modella positions itself at the intersection of AI research, clinical workflows, and diagnostics, partnering with healthcare and laboratory platforms to integrate its technology and improve efficiency and accuracy in pathology and oncology research workflows.
Here are some news sources:  Reuters here.  Modella press release here.   Here is the Modella AI page at Linked In, where you can track real-time comments about the acquisition (here).

The news in brief:

  • AstraZeneca has acquired Modella AI, a Boston-based biomedical AI company, deepening a collaboration that began with a multi-year partnership in July 2025. The goal is to integrate Modella’s multimodal foundation models and AI agents directly into AstraZeneca’s global oncology R&D organization to accelerate clinical development, improve biomarker discovery, and support more data-driven decision-making across AstraZeneca’s cancer pipeline.
  • Modella’s technology sits at the intersection of pathology, clinical data, and generative AI, allowing it to analyze and integrate complex datasets from slides, patients, and trials. By being acquired rather than merely partnered, Modella’s AI platform will now be embedded inside AstraZeneca’s internal research ecosystem, enabling automation, consistency, and scalability across oncology workflows—from discovery through clinical trials. 
  • Both companies emphasized that the combination is designed to turn advanced AI methods into real-world impact for cancer patients, though financial terms of the deal were not disclosed.

More about AZ

Astrazeneca is staking out a leadership role in applied AI in biopharma.   Here's the AZ webpage on computational pathology and its unique system, called QCS, which is being used in FDA-track drug trials for biomarkers like TROP2.  A Roche-Ventana TROP2 IVD has won FDA breakthrough status in 2025 - here, here, here.

###
FDA, Drugs, Digital Pathology
PATHAI has FDA-endorsed digital pathology assays to be used in liver (MASH) drug trials - here.

###
Ventana RUO?
I saw an announcement in the past month that Roche/Ventana would release an RUO QCS TROP2 biomarker for research; I couldn't find it this morning (in fact, my January 9 bookmark from LinkedIn had become a dead link).  Expect more on that later.





HUMOR ESSAY: VC's Invest in New AI Built Entirely From COBOL

From time to time I post a HUMOR essay, entirely separate from my day job.

On a podcast, I heard remarks about the 1950s programming language COBOL, and I wondered, could you build a Large Language Model out of COBOL?

_______

* So, I asked Chat GPT to write a two-page business plan for a novel "AI" based entirely on COBOL. And ask for $100M Series A. 

And then...

* It's assigned to a young VC associate to write-up - and he's heard his VC Partner likes the idea, so he has to evaluate it cautiously,

And then...

* The company comes back two years later, now ready for a $1 Billion Series B.

____

In the blog, that Series B $1B essay is followed by a "serious" one, where Chat GPT discusses why you don't want to build your new LLM out of COBOL.

____

Find these humor essays here:

https://bqwebpage.blogspot.com/2026/01/ai-humor-investing-in-new-llm-based-on.html

_____