Thursday, May 8, 2025

Thermo Fisher Ebook on Clinically Relevant Genomic Testing (24pp)

 Thermo Fisher has issued a number of white papers on genomics recently.   Here's one titled, "Expert Interviews - Revolutionize Patient Care through Clinically Relevant Molecular Testing."

You can download it directly from this Linked In page.  Click to 'enlarge' the article display box, then see a 'download' error at top right.

https://www.linkedin.com/posts/thermo-fisher-scientific_clinically-relevant-molecular-diagnostic-activity-7204931874492706816-KmSK


AI CORNER
Here's a Chat GPT summary:

In this expert-driven primer on clinically relevant molecular testing, leaders in molecular pathology and clinical microbiology weigh in on the expanding role of PCR-based diagnostics in infectious disease and pharmacogenomics. The publication underscores that while analytic and clinical validity are foundational, it is clinical utility—the test’s ability to guide meaningful treatment decisions—that ultimately determines value in modern lab medicine. 

Syndromic panels, especially for infectious diseases like pneumonia, gastrointestinal infections, and STIs, are highlighted as transformative tools due to their speed, sensitivity, and multiplexing capabilities, though experts caution that panels must be tailored by patient population and setting. Cost-effectiveness and stewardship remain pivotal themes throughout. Experts such as Joseph Yao, MD, and Stella Antonara, PhD, emphasize the need for partnerships between laboratorians and clinicians to identify the most appropriate use cases, avoid overtesting, and guide payer policies. 

Meanwhile, pharmacogenomics is positioned as a rising frontier: Sherin Shaaban, MD, PhD, explains how COVID-era lab infrastructure and advances in high-throughput platforms are accelerating PGx adoption, despite persistent barriers like clinician education and data interpretation challenges. 

Across all interviews, the core message is clear: molecular testing is no longer just about lab innovation—it’s about targeted, collaborative implementation that improves outcomes, controls costs, and redefines diagnostic strategy in precision medicine.

Tuesday, May 6, 2025

FDA Seats Dr Vinay Prasad as Head of Biologics, Vaccines

 


HHS has chosen Dr Vinay Prasad, a UCSF-based oncologist, as head of CBER - the biologics and vaccines division.  The former head was Dr. Peter Marks.  The FDA's commissioner, Marty Makary, announced Prasad's appointment in an email to staff.

https://www.cnn.com/2025/05/06/health/fda-vinay-prasad-vaccines

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-names-agency-critic-vinay-prasad-top-vaccine-official-2025-05-06/

CNN writes, Prasad "became a harsh critic of the government’s response and its vaccine policies during the Covid-19 pandemic."  

Reuters writes, "In a note to clients, RBC Capital Markets analyst Brian Abrahams called Prasad an "anti-establishment physician" who has been vocal on a broad range of matters, "including COVID-19, oncology studies, and randomized clinical trial designs in general."

###

Asked for a neutral capsule bio, Chat GPT offered this:

Dr. Vinay Prasad, MD, MPH, is a hematologist-oncologist and professor at the University of California, San Francisco, where he leads research on cancer drugs, clinical trials, and health policy. He has authored over 500 academic articles and two books—Ending Medical Reversal and Malignant—and is known for his critical stance on aspects of medical evidence and regulatory practices. In May 2025, Dr. Prasad was appointed director of the FDA’s Center for Biologics Evaluation and Research (CBER), a role overseeing vaccines and biologic therapies.
His selection marks a departure from tradition, as the position is typically held by career FDA scientists. Dr. Prasad has previously expressed skepticism about accelerated drug approvals and COVID-19 vaccine mandates for young people, positions that have drawn both support and criticism. His appointment has been met with concern from some public health experts and has coincided with a drop in biotech stock prices, reflecting uncertainty about the FDA’s future regulatory approach under his leadership. 


Sunday, May 4, 2025

Natera Data, DEFINE HT Trial: Donor DNA Testing Can Outperform Cardiac Biopsy

For several years, both CareDx and Natera have offered transplant patients the chance to detect organ rejection earlier, by quantifying the release of donor DNA from damaged graft cells.

See news on the DEFINE-HT trial (Natera), presented an an international transplant meeting this past week.  Natera's share price is up from about $40 to $160 over 18 months.

  • See press release here.
  • See clinicaltrials.gov here.
  • See subscription article at 360Dx here.

AI Corner:

See an AI Summary of the press release:

In the prospective, multicenter DEFINE-HT study, Natera’s Prospera™ Heart test with Donor Quantity Score (DQS) demonstrated a strong correlation between elevated donor-derived cell-free DNA (dd-cfDNA) levels and adverse clinical outcomes in heart transplant patients.  Outcomes included treated rejection, graft dysfunction, re-transplantation, and death at one year.

Among over 1,100 samples analyzed, patients with elevated dd-cfDNA had a 2.6-fold higher risk of adverse outcomes (p=0.0299), and dd-cfDNA levels were three times more predictive of graft dysfunction than endomyocardial biopsy (EMB). Prospera with DQS outperformed donor fraction alone and offers a noninvasive, SNP-based assay with potential to replace EMB in surveillance, pending results from the ongoing ACES-EMB trial.

MolDx Recruiting Add'l Medical Director

 See a post by Dr. Gabriel Bien-Willner of MolDx, on Linked-In.  MolDx recruits an additional medical director. It has an open-listing date up until May 9, 2025.

https://www.linkedin.com/posts/gabriel-bien-willner-52a332117_palmetto-gba-is-hiring-another-medical-director-activity-7324463803578863617-GyWY/

Find the full job description here:

https://ourhrconnect.wd5.myworkdayjobs.com/PalmettoGBA/job/WH-South-Carolina/Clinical-Genetics-Director_R1044299-2

They write:

Position Purpose: 

The Clinical Genetics Director is involved in all aspects of the Molecular Diagnostic Program (MoIDX) and DEX application and services operations, and serves as an internal subject matter expert, applying medical knowledge to advise decision makers in support of Palmetto GBA’s mission to create payor controls for molecular diagnostic testing that improve access to critical services and reduce payor and provider abrasion. Responsible for policy and procedure generation, technical assessment reviews, review and approval of documentation and reports. Serves as an ambassador for comprehensive genomic and molecular profiling through education and research efforts within and external to MoIDX. Reviews current literature and formulates policy and direction for MoIDX and DEX. Serves as the subject matter expert (SME) in germline or infectious disease testing for MoIDX and DEX.

To Qualify for This Position, You'll Need the Following: 

  • Required Education: PhD in genetics or related field; OR Medical Doctor (MD) with current active medical license, without restriction.
  • Required Work Experience: 5 years experience in molecular laboratory testing, with 3 years experience in laboratory management. Experience may be concurrent.
  • SEE ADDL BULLETS at website.

Thursday, May 1, 2025

MolDx Medical Director Dr. Charnot-Katsikas: Hear the Podcast

Dr. Angella Charnot-Katsikas has been a medical director with Palmtto/MolDx since December 2020. Dr. Charnot-Katsikas is featured on the first episode of a new series over at Precision Medicine Podcast, led by Karan Cushman.     

It's Episode 66 of the Precision Medicine Podcast - and kicks off their Series 6.  Find the webpage for this edition here.  It's sponsored by Trapelo Health.   (When the episode is ready, find the transcript library here.)   

###
And below, an AI auto summary of the podcast transcript.
###

Podcast Summary: “Bringing Precision Medicine to Everyone” (Episode 66)

Host: Karan Cushman for Trapelo
Guests: Dr. Kashyap Patel (Community Oncologist, No One Left Alone)
Dr. Angella Charnot-Katsikas (Molecular Pathologist, Palmetto GBA)

Overview:
This inaugural episode of a new series on the Precision Medicine Podcast centers on a pressing issue: how to close the access gap in precision oncology—especially for patients in community and rural settings. Although precision medicine is now the standard of care in oncology guidelines, uptake remains uneven. The episode brings together two perspectives—clinical and payer—to discuss solutions that move beyond innovation to implementation.

Key Themes:

  • Real-world barriers to access:
    Dr. Patel emphasizes that lack of provider awareness, financial constraints, and restrictive payer policies still prevent many patients from receiving appropriate biomarker testing and targeted therapies—even in major academic centers.

  • Underutilization of biomarker testing:
    Dr. Charnot-Katsikas highlights not only delays in results and treatment initiation but also underuse of existing guidelines and failure to act on results when tests are ordered.

  • Calls to action:

    • Expand education efforts to include pathologists, surgeons, and all care team members.

    • Address "two-week rule" constraints in DRG billing that disincentivize timely biomarker add-ons.

    • Leverage platforms like Trapelo to streamline decision support and align test selection with payer policy in real-time.

    • Promote team-based care and frequent tumor boards to ensure rapid, informed clinical decisions.

  • Equity in practice:
    Dr. Patel shares moving patient success stories, including one involving international molecular profiling that led to life-saving targeted therapy. His nonprofit, No One Left Alone, demonstrates a localized, replicable model for delivering precision care and support services (e.g., transportation, food, housing).

Takeaway:
Precision oncology cannot fulfill its promise without structural reform in access, education, and workflow integration. The podcast sets the stage for a solution-oriented series aimed at ensuring every patient, regardless of geography or socioeconomic status, receives guideline-based molecular testing and appropriate therapy.

Monday, April 28, 2025

Stat Plus Runs Detailed Profile of Chris Klomp, New Head, Center for Medicare

 

Kudos to Mario Aguilar, journalist at STAT PLUS, for his very detailed profile of Chris Klomp, the new head of the Center for Medicare.

##

When thinking of CMS, in the lab industry we think about NCDs and we think about the Clinical Laboratory Fee Schedule.   

  • The NCD group is part of the Office of Clinical Standards and Quality, where the Coverage and Analysis ("NCD") group report to the CMS Chief Medical Office.   
  • For the CLFS - and all sorts of fee schedules and operational rules - pivot to the Center for Medicare.   

Chris Klomp replaced the prior Center for Medicare chief, Meena Seshamani, on April 21, 2025.

##

Per the STAT PLUS article, Klomp was CEO of health IT company "Collective Medical," which raised $50M before its exit by acquisition.   (He thereafter had engagements such as board seats for Maven Clinic and Nomi Health.)  

Per STAT, Klomp's former associates and other experts say he has big plans for his role, both on the Medicare Advantage side and on the fee for service side.   As head of Center for Medicare, he will report to Dr. Oz, who is head of CMS as a whole.

##

I've asked Chat GPT for a paragraph of two on Klomp.

Chris Klomp has recently been appointed as the Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare & Medicaid Services (CMS), reporting directly to Administrator Dr. Mehmet Oz. In this role, Klomp oversees the Medicare program, which provides health coverage to approximately 68 million Americans and manages an annual budget of around $1 trillion.​

Prior to his CMS appointment, Klomp was the CEO of Collective Medical, a healthcare technology company focused on real-time care coordination, which was acquired by PointClickCare in 2020 . He also served as a senior advisor at PointClickCare and he has held board positions at organizations such as Nomi Health, Maven Clinic, and InnovaCare Health. 

Background.  Klomp's background includes experience in private equity at Bain Capital and consulting at Bain & Company. He holds a BA in Economics and English from Brigham Young University and an MBA from Stanford Graduate School of Business, where he was an Arjay Miller Scholar .​

Chat GPT summarizes several public sources in the business press as: 

Chris Klomp brings a leadership style deeply rooted in data-driven innovation and a commitment to improving care for vulnerable populations. As the former CEO of Collective Medical, he emphasized the importance of real-time care coordination to enhance patient outcomes. His approach at Collective Medical focused on integrating data to close information gaps across the healthcare continuum, particularly benefiting high-risk patients.  Given his background, Klomp may aim to modernize the program through better data sharing and technological advancements.


##

A sidebar to the Stat article cites CBO data that Medicare is now solvent to 2052

 

CMS Releases 2025 Gapfill Prices for Comment; MAC Pricing Ratios

Header - CMS has released gapfill proposed prices for about 34 codes.   These are codes that failed to be priced in Fall 2024 by crosswalk, so they are transferred to the MACs for pricing during 2025.  Comment will be open for 60 days (June 28).  

The Monday April 28 version had typos; the Tuesday April 29 version corrects them, according to a CMS email.

##

Find it here:

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings

On this webpage, scroll down to "Meeting Notice, Agenda, Other Materials" and then scroll down to "CLFS Gapfill Determinations" and then find "CY2025 preliminary Determinations."

Typos

These have been corrected as of 04/29, per CMS email.

A Couple Views

Some of the prices were not too surprising.  

  • For example, 0485U, the CARIS ASSURE test which includes CHIP testing of WBCs, has a MolDx price of $3649, the range for complex LBX comprehensive tests.   
    • However, it might also suggest there's not too much financial bonus for adding workflow for CHIP testing, something that may be increasingly important (Caris/Magee 2025).  
    • Prices are subject to revision in September after the comment period.   
  • 0426U, an ultra-rapid genome for pediatric cases, comes in at $7582, the value CMS has used before for a regular rapid genome (0094U).
Better Formatting

CMS formatted the spreadsheet with full code names next to the code number, which is helpful.  On the other hand, the spreadsheet is "locked," so you have to copy paste into a new Excel to manipulate it.

Rationales

Tab 2 is "rationales."  For every code, Novitas has the same rationale (that it used a combination of reference data to price).   

All the other columns of rationales are the same, for each row, but vary, between rows.  These appear to be MolDx rationales, which were copied (like MolDx prices) by NGS MAC.  These MolDx rationales used a total of 14 nonidentical rationales, although some were very similar to one another.

Differences Among MACs

The MolDx price is always the same for its participating MACs and drives the CMS Median.

NGS MAC prices (e.g. New York State) always match the MolDx price (as do its rationales).   

Novitas/FCSO prices do not usually match MolDx, but are usually within a low multiple.   Sometimes the multiple is 2.2X (0486U) 3X (0440U) or as high as 11X (0441U).  Rarely the Novitas price is half the MolDx price (0498U, 0501U).   

I've uploaded an Excel to Google Docs open access, which shows the ratios of MAC pricing to one another line by line.  Here
Screen shot of cloud excel of MAC ratios

##
Epignostix (0020M) issued a press release that it received a preliminary GF recommendation.  This was $2500; the test uses extensive methylation analysis to match a tumor subclass.

##
Five Category I codes for neuro tests (e.g. beta amyloid) had a range of just $77-93.  If I recall correctly, CMS had initially proposed crosswalk to the generic immunoassay code, probably around $20.

Friday, April 25, 2025

NYTimes Says: New England Journal Gets "Vague Threatening" Prosecutor Letter

 On April 25, 2025, New York Times reported that New England Journal of Medicine received a letter described in the article as "vaguely threatening" - from a federal prosecutor.

https://www.nytimes.com/2025/04/25/health/nejm-prosecutor-letter.html


The news may have been first reported by Stat Plus:

https://www.statnews.com/2025/04/23/new-england-journal-of-medicine-us-attorney-letter-scientific-journals/

###

I made the point in March, that nearly every Op Ed in places like JAMA, NEJM, Annals of Internal Medicine,since November, has been negative about the administration (and by extension, the majority party on the Hill.)   Concurrently, AMA has gotten nowhere in its battle against the most dramatic price cut ever in physician Medicare pay levels (see hte same blog).   It seemed to me there was a dotted line between publishing 20 negative JAMA op eds in a row against Republicans, and then, surprise, AMA lobbyists get a cold shoulder on the Hill when they come asking for a pay raise to Republicans.   

 

Thursday, April 24, 2025

Novitas LCD for Oncology - Specific Tests - Is Finally "FINALED"

Completeing a several-year saga, the Novitas LCD for oncology testing "specific tests" is finally "finalized" - and effective as of today, April 24, 2025.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39365&ver=131&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=noticeStart&bc=11

The take-home lesson is, it took Novitas three years (spring 2022-spring 2025, about 36 months) to non-cover several LDT tests, which could have been done, A to Z, in about six months.

Interpace to nix its Pancragen testing now.

#####

The LCD was released in January 2025 as "final,' but put "on hold" for the "Trump Administration to review" according to a press release by one company involved.

The LCD was started as a proposal in 2022, finalized in 2023.  But CMS put the radically-changed LCD on hold, and it entered a new comment period in summer 2023.   That versiin should have been "finalized" in summer 2024, but Novitas issued a delay notice.   One source commented that besides the LCD appeals, court actions had been filed along the way.

##

The LCD has some quirks.  First, it states that the term "genomic" shall not be used, because it is too confusing.  It uses the word "genetic" to describe any kind of DNA-RNA test.   

The LCD was proposed as a broad LCD with many topics, and extensive references to outside sources (like NCCN) for coverage and non-coverage.   The final LCD is vastly restricted in scope and basically reviews about 7 named proprietary (branded) tests, many of which you've likely never heard of, and almost none of which are covered.  (The scope was narrowed by excluding some tests initially reviewed negatively, but not finalized because they weren't offered by labs in the Novitas region).

The authors write, for example, "Based on these factors, there is insufficient evidence to determine the clinical utility for DecisionDx-SCC."  (This test appears to be non-covered also under MolDx LCD L39583.)  However, the corresponding code is listed as an ADLT status (0315U) by CMS, part of which status requires a determination of coverage.


###

UROVYSION (FDA FISH test) - Covered as listed.

NOT COVERED

  • CxBladder
  • Thyroseq CRC
  • Pancragen
  • Decision Dx SCC Castle
  • Colvera
  • PancreaSEQ


Tuesday, April 22, 2025

CMS Asks for Ways to Simplify Its Regulations

 This week, CMS releases a remarkable 3-page document requesting suggestions how Medicare can "unlease prosperity" by de-regulating its overburdened providers.

Throwing the 14-day rule overboard without a life jacket, comes to mind.   

Find the document at this link.  Suggestions until June 10, 2025.   AI discussion includes 14-day-rule and, at bottom, long needed revisions to oncology NCD 90.2.

https://www.cms.gov/files/document/unleashing-prosperity-through-deregulation-medicare-program-request-information.pdf

Consider in context of HHS's announced reorg and simplification of the entire HHS hierarchy of agencides, while downsizing from ~80,000 to ~60,000 staff.   Here.

Decisions on regulatory reform in areas like prior auth or 14 day rule will bubble up to Chris Klomp, the new head of Center for Medicare (here).

Though not specific to this RFI, see OMB on rules for deregulation here.

###

AI CORNER

###

For readers in medtech policy (and genomics) study this RFI and explain what it means, how likely it is to effect change, and what should stakeholders suggest.   What nuances will make the suggests rise up in the mass of responses this will generate.   For the lab industry, what should they suggest?   I can think of 14 day rule, or some bizarrely complicated and confusing LCD instructions.   Another simplification would be making the MolDx program national, allowing labs to submit claims under one clear rule set.    Have at it.  Thanks.

##

This new CMS Request for Information (RFI)—titled Unleashing Prosperity Through Deregulation of the Medicare Program—is a wide-open invitation for stakeholders to recommend simplifications, eliminations, or automations of Medicare regulatory requirements, under the banner of Executive Order 14192, which mandates that for every new rule issued, 10 older regulations must be repealed.

Below is an analysis tailored to medtech policy professionals, especially those in genomics, diagnostics, and lab services:


⚙️ What the RFI Means

CMS is:

  • Soliciting specific feedback on which regulations, guidance documents, forms, or processes are excessive, duplicative, or burdensome.

  • Looking to identify regulatory redundancies, documentation overload, and non-value-added compliance burdens—especially those that could be removed without affecting patient safety.

  • Triggered by a White House executive order, the RFI has political urgency and real potential to shape upcoming deregulatory policy shifts, especially if CMS receives clear, well-documented feedback.


📈 Likelihood of Affecting Change

Moderate to high—if responses are:

  • Specific (e.g., cite exact forms, LCDs, or regulatory language),

  • Replicable across multiple stakeholders (e.g., same complaint from 50 labs = strong signal),

  • Politically consistent with the deregulation agenda (e.g., cost-saving without new federal spending),

  • Tied to economic productivity (especially if tied to ROI, job creation, or innovation).

Stakeholders that submit data-backed, shovel-ready, or easily implementable proposals will rise above the crowd.


🧬 For Genomics and Lab Industry: What Should You Recommend?

Here are high-value lab-related suggestions CMS should hear:


1. 📆 Fix or Eliminate the 14-Day Rule

  • Problem: The 14-day rule (aka DOS rule) limits labs from billing Medicare for tests ordered within 14 days of a hospital discharge.

  • Burden: Creates billing chaos, stifles access to complex molecular tests, delays care, and generates huge denial rates and appeals.

  • Solution: Repeal it or standardize Date of Service as Date of Sample Collection, as long as patient is not inpatient at time of test.


2. 🧾 Simplify or Standardize LCDs Across MACs

  • Problem: Labs must navigate wildly divergent LCD policies and molecular edit rules depending on the MAC region (e.g., Palmetto vs. Noridian).

  • Burden: National labs must maintain dozens of billing workflows and software updates per state.

  • Solution: Nationalize MolDx or implement a “National Genomics Policy Repository” across all MACs for identical tests.

  • Alternative: Create a CMS Molecular Policy Hub as a single source of truth for LCDs, billing edits, coverage criteria.


3. 🔁 Simplify the ‘Partial Reporting’ Dilemma

  • Problem: LCDs often deny payment if a test panel can’t fully report all biomarkers due to specimen quality or assay thresholds.

  • Burden: Labs are penalized for partial yet clinically valuable results.

  • Solution: Clarify that partial results meeting analytical validity still count as ‘reportable’ and are reimbursable.


4. 🧮 Remove Redundant Prior Auth/Documentation Layers

  • Problem: MACs and contractors often demand clinical records already used by ordering physicians or require labs to become compliance police.

  • Burden: Labs must chase down EHR data, wasting time and risking HIPAA compliance.

  • Solution: Permit attestation by the ordering physician and eliminate duplicative documentation demands when the same info is already in the EHR or certified ordering platform.


5. 📊 Simplify Reporting Burdens for Lab Test Utilization

  • Problem: Some MACs require labs to report utilization or test-specific data beyond CLFS rules.

  • Burden: Adds layers of custom Excel or manual tracking.

  • Solution: Centralize all reporting in PECOS or PAMA frameworks, and eliminate redundant field-level reporting.


🧠 How to Make Your Comments Stand Out

  1. Use CMS language:

    • Quote the RFI back to them (e.g., "This policy introduces duplicative burden under the administrative section of 42 CFR...").

    • Mention CMS form numbers or OMB numbers if possible.

  2. Provide real-world case studies:

    • A claim denied due to LCD ambiguity.

    • A lab that lost millions due to DOS rule denials.

    • Delays in patient care due to MolDx inconsistency.

  3. Bring allies:

    • A coordinated comment from 5+ stakeholders carries 10x more weight than a single comment.

  4. Use economic framing:

    • “This policy costs us $400,000 per year to administer. Removing it would allow us to hire 3 FTEs or invest in expanded testing.”

  5. Connect to care improvement:

    • “This change would speed up cancer diagnosis by 5 days and reduce unneeded procedures.”


🔚 TL;DR Summary

This RFI is a real opportunity for labs, genomics innovators, and medtech stakeholders to suggest clear, impactful deregulation. CMS seeks concrete proposals to reduce burdens—especially around documentation, duplicative regulations, and administrative inefficiencies.

Your response should focus on:

  • 14-day rule repeal

  • Nationalization or simplification of MolDx

  • LCD interpretation consistency

  • Simplified reporting + data integrity

  • Economic and care-quality framing

Would you like help drafting a comment for submission? Or want this as a slide deck summary for internal review?


###
They could also simplify NCD 90.2, which targets advanced cancer patients for 1 NGS test, when today they may need multiple, including serial testings that illudidate checkpoint inhibitor response.

##

Great addition—and spot on for this RFI.

Let’s unpack that for strategic effect, and shape it into a targeted recommendation CMS could take seriously, especially if submitted by stakeholders in oncology, genomics, or molecular diagnostics.


🎯 Specific Suggestion for RFI: Simplify and Modernize NCD 90.2

Current Problem

  • NCD 90.2 restricts coverage to a single FDA-approved or FDA-cleared NGS test for advanced cancer, at initial diagnosis.

  • This excludes serial testing, resistance profiling, and longitudinal monitoring, even when:

    • New tissue is sampled (e.g. progression biopsy),

    • Liquid biopsy is needed due to inaccessible tissue,

    • Tumor biology evolves (e.g. loss of PD-L1, new MET/ALK fusions),

    • Treatment hinges on current biomarker status (e.g. MSI, TMB, ctDNA, emerging markers).


📉 Why It's a Problem

  • Clinically outdated: Oncology practice has shifted toward iterative, longitudinal testing, especially in immuno-oncology and targeted therapy.

  • Restricts patient care: Prevents coverage of essential tests that inform:

    • Checkpoint inhibitor response (e.g., blood-based TMB),

    • Therapy resistance (e.g., EGFR T790M),

    • MRD monitoring or recurrence detection via ctDNA.

  • Misaligned with FDA science: FDA has cleared multiple tests for different settings (e.g., Guardant360 for monitoring and profiling), yet Medicare will pay only once under this NCD.


🔧 Proposed Fix for CMS (in line with EO 14192)

Revise NCD 90.2 to allow coverage of additional FDA-approved NGS tests when clinically indicated, such as:

  • A different specimen (liquid vs. tissue),

  • A different clinical timepoint (e.g. progression),

  • A different clinical objective (e.g., MRD, immunotherapy biomarker testing),

  • A new cancer diagnosis (e.g., multiple primaries).

Alternatively:

Convert NCD 90.2 into a “baseline” national policy and delegate additional NGS uses to MAC discretion (LCDs or claim-by-claim medical review), as CMS does for nearly every other diagnostic test.


🧠 Policy Leverage Points

  • NCD 90.2 is ripe for amendment: It hasn’t been revised since 2020 and is misaligned with real-world cancer care in 2025.

  • Lung cancer care in particular now often requires 2+ NGS tests during a patient's disease course (initial tumor test, repeat biopsy, plasma test).

  • MolDx and MACs already approve many NGS uses under LCDs—allowing local flexibility in place of a rigid national barrier is logical and deregulatory.


✍️ How to Make This Suggestion Stand Out

  • Pair with clinical use case examples:

    • “At our cancer center, 35% of advanced NSCLC patients need a second NGS test within 9 months of diagnosis.”

  • Highlight FDA test availability:

    • “CMS is blocking access to tests already cleared by FDA for monitoring or serial profiling.”

  • Frame as deregulatory + pro-innovation:

    • “CMS could deregulate by delegating these additional test uses to MACs, rather than enforcing a one-size-fits-all policy.”

  • Avoid suggesting costly new benefits—instead, argue this is a modernization and alignment, not an expansion.


Would you like this packaged as a short written comment for CMS submission or added into a stakeholder briefing deck or memo? I can help with either.

YES

📝 CMS Comment for RFI Submission

Topic: Modernizing NCD 90.2 and Other Regulatory Burdens in Genomic Testing

To CMS,

Thank you for the opportunity to provide input on regulatory simplification under Executive Order 14192.

As a stakeholder in precision medicine and genomic diagnostics, I urge CMS to consider the following reforms that would meaningfully reduce burden and improve care:

  1. Revise NCD 90.2 to reflect current oncology practice.
    The current policy restricts Medicare coverage to a single FDA-approved NGS test for advanced cancer at the time of initial diagnosis. This is no longer sufficient. Patients frequently require multiple rounds of testing—including liquid biopsies, resistance profiling, and monitoring of response to immunotherapies. These are all uses supported by FDA-cleared tests and clinical guidelines.
    We recommend allowing additional NGS testing in the following scenarios:

    • New specimens (e.g., progression biopsy, liquid biopsy)

    • New clinical indications (e.g., immunotherapy response)

    • Longitudinal monitoring (e.g., ctDNA or MRD)

    • Diagnosis of a new primary cancer

  2. Simplify the 14-Day Rule (Date of Service regulation).
    The current DOS rule prevents labs from billing for tests ordered within 14 days of hospital discharge, even when the lab performed testing post-discharge. This policy causes confusion and delays. CMS should consider repealing or modernizing this rule, setting DOS as the date of specimen collection unless the patient is currently an inpatient.

  3. Create a national framework for MolDx policies.
    Today, LCDs and billing edits for molecular tests vary across MACs. This creates confusion, denials, and inefficiencies for national labs. CMS should unify coverage policies for molecular diagnostics across jurisdictions or centralize the MolDx program nationally.

These changes would reduce administrative complexity, align policy with science, and ensure Medicare beneficiaries have access to state-of-the-art genomic testing throughout their care journey.

Respectfully,
[Your Name / Organization (optional)]


📄 Stakeholder Briefing Memo: 

RFI on Medicare Deregulation (April 2025)

Subject: CMS Request for Information – Strategic Opportunities for Regulatory Reform in Genomics and Lab Services

Deadline to Comment: June 10, 2025


🔍 Background

CMS has issued an open Request for Information (RFI) to identify regulations that may be repealed or simplified under Executive Order 14192, which mandates the repeal of 10 regulations for every new one issued. This is a rare opportunity to help shape Medicare policy—especially for high-impact sectors like precision oncology, genomics, and laboratory testing.


🎯 Key Issues for Genomic and Lab Stakeholders

1. NCD 90.2 – One-Time NGS Limit for Advanced Cancer

  • Problem: Current policy allows only one FDA-approved NGS test per advanced cancer diagnosis.

  • Real-world gap: Patients may require serial tests to monitor progression, identify resistance mutations, or evaluate checkpoint inhibitor response.

  • Ask: Revise NCD 90.2 to allow multiple NGS tests under defined clinical criteria (e.g., new tissue, different modality, new indication).

2. 14-Day Rule (Date of Service Regulation)

  • Problem: Prevents hospital-initiated tests from being billed post-discharge, even when the lab performs and reports after discharge.

  • Burden: Causes confusion, denials, and billing errors.

  • Ask: Repeal or modernize the DOS rule, using the specimen collection date when the patient is no longer inpatient.

3. Inconsistent LCDs and MolDx Rules

  • Problem: Labs must comply with dozens of conflicting LCDs and MAC edit rules depending on location.

  • Solution: Nationalize the MolDx program or standardize molecular billing policies to reduce complexity.

4. Denials for 'Partial Reports'

  • Problem: Labs may receive denials if even one biomarker in a multi-marker panel cannot be reported (e.g., low DNA yield).

  • Ask: Permit reimbursement for partially reportable tests when clinical value is preserved.


🧭 Strategy for Engagement

  • Coordinate multi-party submissions (e.g., labs, clinicians, payors).

  • Use real-world cases and economic framing (e.g., cost of denials, delay to treatment).

  • Suggest devolution of rigid NCDs to MAC discretion, aligning with EO goals to streamline burdens.


Monday, April 21, 2025

AI Corner: AI Reviews the Transcript in the Supreme Court USPSTF Case (Braidwood)

 

AI SUMMARY:

SCOTUS Takes Up Braidwood v. Becerra: Will the Preventive Care Mandate Survive?

On April 21, 2025, the Supreme Court heard oral arguments in Braidwood v. Becerra, a pivotal case challenging the Affordable Care Act’s requirement that private insurers cover preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) without cost-sharing. At stake is whether the USPSTF’s role violates the Constitution’s Appointments Clause, potentially unraveling a core part of the ACA’s preventive coverage framework. Below is an in-depth breakdown of the oral arguments, key constitutional questions, and a prediction on how the Court may rule.

###

AI DISCUSSION

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Here is a summary and legal analysis of the April 21, 2025 Supreme Court oral arguments in Braidwood Management v. Becerra, as requested—tailored for an audience of health policy attorneys.


Case Overview

At issue is whether Section 2713 of the Affordable Care Act (ACA), which mandates that private insurers cover services recommended by the U.S. Preventive Services Task Force (USPSTF) without cost-sharing, violates the Appointments Clause of the Constitution. The key constitutional question: Are USPSTF members valid "officers of the United States," and if so, are they properly appointed and supervised under Article II?


Petitioners’ Argument (Government / HHS)

Hashim Mooppan, representing the government, defended the ACA’s reliance on USPSTF recommendations as constitutionally sound because:

  • USPSTF members are inferior officers, not principal officers.

  • The Secretary of HHS has adequate supervisory control, notably:

    • At-will removal power (critical in prior SCOTUS decisions like Free Enterprise Fund and Edmond).

    • Rulemaking authority over the effective timing of USPSTF recommendations.

    • Power to require pre-approval of Task Force recommendations under the agency’s rulemaking authority (e.g., under §300gg–92).

  • The term “independent”, used in ACA statute 299b-4(a)(6), refers to independent scientific judgment—not immunity from oversight or removal.

Constitutional avoidance was heavily invoked: the Court should interpret “independence” in a way that avoids finding the statute unconstitutional.


Respondents’ Argument (Braidwood / Religious Employer)

Jonathan Mitchell, arguing for Braidwood, countered:

  • USPSTF members issue binding mandates that immediately affect national insurance coverage and must be treated as principal officers.

  • These officers lack presidential appointment and Senate confirmation, in violation of Article II.

  • There is insufficient supervision: the Secretary of HHS cannot direct USPSTF recommendations, only remove members after the fact.

  • The statute’s use of “independent” implies the Task Force was designed to be free from political oversight, bolstering the separation from executive control.

  • The ACA grants USPSTF powers akin to legislating policy, which is impermissible for a body that is neither elected nor appointed via constitutional channels.


Key Moments in the Argument

  • Justice Gorsuch and Justice Barrett pushed hard on the issue of who actually appoints USPSTF members—Secretary or Director of AHRQ—and whether the Reorganization Act truly transfers appointment power to the Secretary.

  • Justice Alito expressed skepticism that someone removable at-will could meaningfully be called “independent.”

  • Justice Jackson emphasized the presumption of at-will removal unless a statute says otherwise, seeming to support the government’s reading.

  • Chief Justice Roberts and Justice Kavanaugh were visibly concerned about the statutory mechanism that allows USPSTF recommendations to bind the public while only being “reviewable” via back-end removal or timing delays.


Legal Stakes

The case tests the validity of insurance mandates across millions of health plans, potentially stripping cost-free coverage from services like PrEP (HIV prevention), cancer screenings, and immunizations if the statutory structure collapses.

It also has broader implications:

  • Could restrict Congress's use of external expert panels as reference points in legislation.

  • Could heighten scrutiny on similar panels like ACIP (immunization) and HRSA (women’s and children’s health).


Prediction

While difficult to call definitively, the majority may lean toward a compromise that preserves the ACA mandate but narrows the interpretation of “independent” and requires stronger oversight protocols from HHS.

Several justices (Roberts, Jackson, Kagan, Sotomayor) appear open to a functional supervision test, wherein the Secretary's ability to delay, veto, or remove USPSTF members suffices to satisfy Article II.

However, Justices Gorsuch, Alito, and Barrett may vote to strike down the mandate or require USPSTF members to be presidentially appointed and Senate-confirmed—or recommend severance of the USPSTF coverage linkage altogether.

My AI prediction: 6-3 or 5-4 to uphold the ACA structure, relying on constitutional avoidance and finding sufficient supervision by the Secretary under the Reorganization Act and statutory rulemaking authority.


 Were there any humorous moments?

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Yes, there were a couple of light, even humorous moments during the April 21, 2025 oral argument in Braidwood v. Becerra. Here are two literal excerpts from the transcript that captured those lighter tones:


1. Justice Gorsuch, with classic dry delivery:

“I understand you think it's easy. Counsel always thinks it's easy.”
(p. 12)

This came after government attorney Hashim Mooppan insisted that determining the Secretary’s appointment authority was straightforward. Gorsuch gently pushed back, highlighting that what seems “easy” to counsel may not be so in court.


2. Shared laughter over Collins precedent:

JUSTICE ALITO: “Well, maybe that's a little bit unfair. But, I mean — maybe I was wrong in Collins. But explain to me —”
(Laughter.)
(p. 16)

Here, Alito jokingly undercut his own prior opinion in Collins, provoking audible laughter in the courtroom. It was a rare moment of self-deprecation and levity amid otherwise weighty constitutional debate.


These moments won’t rival a comedy club, but for Supreme Court oral argument, they definitely count as whimsical highlights.



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You write that SCOTUS may "preserve the ACA mandate" but "require stronger oversight from HHS."   But SCOTUS has to render a decision now, how can that include an "if" clause such as "if" HHS makes satisfactory future protocols for oversight?

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Great and very sharp point.

You're right—the Supreme Court must rule on the constitutionality of the statute as it stands, not on contingent future actions. The Court cannot condition its decision on HHS implementing better oversight protocols later, because:

  • It’s not a legislative body and doesn’t issue advisory opinions.

  • It cannot defer constitutional validity to hypothetical future agency conduct.

  • It must decide whether the current statutory framework meets Article II requirements.

So when I wrote that SCOTUS may preserve the ACA mandate but require stronger oversight from HHS, the more accurate formulation is this:

SCOTUS may uphold the ACA mandate by ruling that, under current law, the Secretary of HHS already has constitutionally sufficient oversight powers—such as at-will removal, rulemaking control, and power to delay or block USPSTF recommendations.

The Justices probing the removal and appointment structure (especially Gorsuch, Barrett, and Kavanaugh) seemed to suggest they could accept the status quo if they interpret the statute as already granting the Secretary these powers. That’s not a request for new oversight, but a narrowing or clarifying statutory construction to avoid striking down the mandate.

So the “if” is really in the Court’s interpretive reasoning:

If we read the statute to grant HHS sufficient supervision, then it’s constitutional.

This would likely be framed as a constitutional-avoidance holding: the Court would interpret the statute in a way that avoids a separation-of-powers violation, even if the statute’s language about “independence” is awkward.

Let me know if you want help rephrasing that section of your blog or opinion memo.


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Fun Fact (BQ).  The parties from Braidwood originally asked to be exempted from a few benefits for religious reasons, and, the Texas judge granted them that (religious exemption) which hasn't been challenged in court and they still have it.   (What does that mean?  Does their BCBS plan subtract 1/1000 or 1/5000 of their monthly cost?)  

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Original prompt (BQ): CHAT GPT 4o

On April 21, 2025, SCOTUS heard oral arguments in the BRAIDWOOD case.  At issue is the validity of the ACA statute that requires private insurers to cover (and without copay) services endorsed by the USPSTF.   Is the USPSTF a legally possible reference body for such insurance mandates.   Attached is the transcript of the oral argument.   Read the transcript, describe and discuss for an audience of health policy attorneys.   Include your prediction of the outcome of the case.

Friday, April 18, 2025

CMS Announces Summer 2025 Lab Pricing Meetings (June 27; July 23-24)

CMS has announced plans for this summer's new lab test pricing meetings.  The public comment meeting will be June 27, 2025, 10am-4pm ET.  It will  be a hybrid meeting (in person + zoom).  

The complementary Expert Advisors panel will meet in hybrid fashion on July 23-24, 10am-4pm ET.  (They move fast and likely finish early).  

See Fed Reg here:

https://www.federalregister.gov/public-inspection/2025-06756/hearings-meetings-proceedings-etc-medicare-program-new-and-reconsidered-clinical-diagnostic

and here:

https://www.federalregister.gov/public-inspection/2025-06758/hearings-meetings-proceedings-etc-medicare-program-medicare-advisory-panel-on-clinical-diagnostic

Also track the meeting announcement section on this CMS webpage [may be updated slower]:

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings

And the expert advisors web page (see "Meetings")

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel

Notes

  • See registration dates in the notices (for the public meeting, register May 1 -29; submit presentations by May 29).
  • Historically, even ten years ago, anyone wanting to enter CMS and is NOT a US national had special elaborate weeks-in-advance procedures.  FYI only.
  • I had noted that HHS instructed agencies to minimize public comment wherever possible, and, the PAMA act for lab pricing only requires CMS to "consult" an expert panel, not specifically to hold a public meeting. 
    • It's nice to see the public meeting is planned as in the past.
  • For this national meeting, thanks to CMS for starting at 10 ET / 7 PT rather than 8 ET which is 5am PT.
  • Check CMS for updated PPT templates.



Thursday, April 17, 2025

GeneDx Buys Fabric Genomics for at Least $33M

On February 16, 2025, GeneDx announced it was acquiring Fabric Genomics, an advanced clinical bioinformatics company, for at least $33M.   The valuation may go as high as $51M with benchmarks.

See news at:


I can't speak to the total capital previously invested in Fabric, but a valuation of $51M for a clinical bioinformatics company is notable.   (Publicly held SOPHiA has a market cap of $180M).

The acquisition will support GeneDx clinical services in areas like urgent NICU genomics, newborn screening, and international expansion.  GeneDx has a market cap around $2.7B.  Yahoo Finance lists the 52-week trading range as $9-$115.   

**
AI CORNER
**
Chat GPT gives a concise summary of Fabric Genomics.  (Provided as-is.)
___

Fabric Genomics, founded in 2009 and headquartered in Oakland, California, is a clinical bioinformatics company specializing in AI-driven genomic analysis and interpretation. Its platform enables rapid and accurate analysis of whole genomes, exomes, and gene panels, facilitating clinical decision support for applications such as rare disease diagnosis, hereditary risk screening, and oncology.

GEM and ACE

The company's technology, including tools like GEM and ACE, integrates deep genetic, phenotypic, and clinical data to prioritize disease-causing variants, achieving diagnostic yields up to 50% —which is significantly higher than the industry average. 

Clientele

Fabric Genomics serves a global clientele, including children's hospitals, hospital systems, commercial labs, and national genome initiatives, and has been instrumental in projects like the UK's 100,000 Genomes Project. 

Thesis

By leveraging explainable AI and scalable cloud-based solutions, Fabric Genomics has streamlined genomic workflows, reducing clinical review times and enhancing the scalability of genetic testing programs.


##

Compare to SOPHiA?

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(Provided as-is.)

Fabric Genomics and SOPHiA GENETICS are both leaders in clinical genomics informatics, but they differ in scope, platform strategy, and business model.

Fabric Genomics

  • Focus: Primarily on rare disease diagnostics, neonatal ICU, hereditary risk, and whole genome/exome analysis.

  • Strength: AI-driven variant prioritization and clinical decision support, especially through its tools like GEM and ACE, known for explainability and high diagnostic yields.

  • Clients: Pediatric hospitals, academic medical centers, and national genome projects (e.g., UK 100,000 Genomes).

  • Business Model: Licensing cloud-based software for use in hospital labs and reference labs—platform-as-a-service for in-house clinical interpretation.

  • Scale: More niche and focused, with a leaner commercial footprint than SOPHiA.

SOPHiA GENETICS

  • Focus: Broader, covering oncology, inherited disorders, and infectious disease, with a strong presence in tumor profiling.

  • Strength: Cloud-native platform called the SOPHiA DDM™ (Data-Driven Medicine) platform, integrating genomics, radiomics, and clinical data into multimodal analysis.

  • Clients: Large hospital systems globally, including in Europe, Middle East, and the U.S., with over 800 customers.

  • Business Model: Software-as-a-service (SaaS) model—customers upload NGS data to SOPHiA’s cloud platform, which returns interpreted results.

  • Scale: Publicly traded (Nasdaq: SOPH), larger in revenue and global footprint, with strong oncology and pharma partnerships.

Key Differences

  • SOPHiA is a much larger, publicly traded firm with extensive oncology capabilities and pharma collaborations.

  • Fabric is smaller and focused more on rare diseases and deep AI-assisted variant interpretation, especially for high-throughput genomic programs.

In short: Fabric Genomics excels in deep clinical AI for rare disease diagnostics, while SOPHiA GENETICS offers a broader multimodal analytics platform with strong global and oncology reach.

Natera and BillionToOne Win MolDx Coverage

As many readers know, MolDx issues "foundational" or very broad LCDs, and MolDx controls actual coverage and indications by later technological reviews which occur on a test-by-test (company-by-company) basis.

Updated coverage may appear in billing articles attached to LCDs.  But MolDx has notified the public a couple years ago that updates may appear, NOT in such LCD/billing articles, but in its separate "DEX REGISTRY" online database.  (Here, 5/12/23 & here.)

Often, the first notification is not there, at MolDx, but in press releases.  Here are two new examples. 

NATERA - LUNG CANCER MRD COVERAGE

On February 25, 2025, Natera issued a press release that its ctDNA test, Signatera, had garnered coverage from MolDx for surveillance for relapse or recurrence in Stage 1-2-3 lung cancer.  Find it here:

https://www.natera.com/company/news/natera-announces-medicare-coverage-of-signatera-for-surveillance-in-lung-cancer/

Natera's announcement includes citations to 3 supporting publications, the largest study with 108 patients and 378 plasma timepoints (of which 10% or about 10 with recurrent disease, which is usually the "N" that drives the study size).

MolDx also covers MRD-type testing for relapse/response decisions in immune checkpoint therapies.  See a new review on that space, Vega et al.

BILLION TO ONE - LBx CGP

On April 16, 2025, BillionToOne announced Medicare (MolDx) coverage for its Northstar Select test, which is a liquid biopsy CGP test for actionable tumor genes.  It is an 84-gene test, including 19 copy number amlifications and 9 fusions.  It is covered for all advanced stage solid tumors.   Find it here:

https://www.prnewswire.com/news-releases/billiontoone-announces-medicare-coverage-for-northstar-select-302430353.html


From MedTechDive: Update on FDA LDT

The district court decision on the FDA LDT case came out several weeks ago, with a flurry of rapid news and opinion.   

Now that people have had time to reflect, on April 16, MedTechDive revisits the topic. Read a number of updated interviews with experts.  Find it here:

https://www.medtechdive.com/news/lab-developed-tests-what-now-analysis/745464/


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Separately, see a deep dive subscription article by Adam Bonislawski at 360Dx, which is also an updated on FDA-LDT and new expert opinions.

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Re MedTech Dive - I'd mention two things - 

  • The FDA (the DOJ) has 60 days to file a "notice" of appeal.
    • If they do that, it's just one sentence, and keeps the case alive for possible, further, later motions.  
    • So if the filing doesn't occur, the case is dead.
    • BUT, if it DOES get filed, I wouldn't give that filing too much weight.  It could be a bookmark in a book nobody picks up again.
  • Let's give a little attention to what didn't happen - the FDA and HHS didn't make a peep of complaint about the decision.  
    • They could have, if they had wanted to.  Just sayin'.




Separately - Rubrum Advising's Nancy Stade has a rather complex discussion of the LDT ruling and related regulatory law concepts - here.  (See Stade's school of thought about "LDT" and with an asterisk - "LDT * " - which I don't fully understand.)