Friday, January 31, 2025

Genomics Listicle: Worthwhile Items Today from Linked In

 A flurry of interesting articles at Linked In today.

### EU AND INNOVATION

The prolific Denis Horgan writes about EU at a "crucial turning point in healthcare innovation."  (And not hard to draw some dotted lines between EU issues and US issues).   

Here.   (He cites to a new EU document.)


### LDT REGULATORY ARTICLE

Frequent Linked-In contributor Shannon Bennett links us to a new (firewall) article on "Regulatory Requirements for Laboratory Developed Tests in the United States," in J Imm Meth, 27 January 2025.  Find it here.  Bennett et al.


### ALL ABOUT THE FDA LDT CASE

Xander van Wijk updates at Linked-In on the FDA LDT case, with numerous links to months of major court filings.  Note the most recent, a court filing that has led to an oral arguments hearing on February 19.   His article here.   (He closes by saying, expect an update on the new adminstration, soon.)


### SURVIVING A MOLDX REVIEW

Becky Winslow of IngeniousRx gives a case study of a genomics lab that failed its MolDx tech assessment and was ready to throw in the towel.  She helped them understand how they could turn-around and succeed with MolDx.   Find the story here.


### CGP WITH WGS VS LARGE PANELS

Svetlana Nikic carefully assesses a new paper comparing WES-WGS (plus transcriptome) in tumors, compared to large panels (e.g. several hundred genes).   Read her assessment here.

See the original papaeer, Kerle et al., in Nature/ Precision Oncology, published January 10.  Looks like open access here. Most authors from Dresden.


## WHY UNDERSTANDING THE NEWS MATTERS

Not from Linked In, but from Bloomberg.  A few weeks ago I noted news about the declining numbers of Wall Street analysts who assess buy/sell news.  (Blog).  

Update - More of the same idea at Bloomberg on January 31 (see Justina Lee.)  Is the market becoming irrational due to the mass investments in (rational) index funds? 

My takeaway is - Given the extra high volatility of Genomics stocks (quick example here), the decline of analysts in general should create even more value in those analysts who DO understand and track (bet on) genomics by using a deep and hard-won understanding of the policy and technology complexities.

###

AI CORNER

Chat GPT 4 reads & summarizes Kerle et al. on WGS in tumors.

TL;DR: Whole Genome vs. Panel Sequencing in Precision Oncology

This study compares whole-exome/whole-genome sequencing (WES/WGS) + transcriptome sequencing (TS) versus broad panel sequencing (Illumina TSO500/TST170) for precision oncology.

  • Key Findings:

    • Therapy Recommendations (TRs): WGS/TS provided slightly more therapy recommendations per patient than panel sequencing.
    • Overlap: ~50% of TRs were identical between WGS/TS and panel sequencing.
    • Advantages of WGS/TS:
      • Captures RNA expression, mutational signatures (e.g., SBS3, HRD scores), and structural alterations not covered by panels.
      • Some actionable fusion genes and copy number variations (CNVs) were missed by the panel.
    • Panel Sequencing Advantages:
      • Faster turnaround, lower cost, and easier logistics (can use FFPE samples).
      • Panel sequencing successfully detected 4/5 pathogenic germline variants, recommending genetic counseling in three cases.
    • Clinical Impact:
      • 10 molecularly informed therapies were implemented, 8 of which were supported by the panel.
      • 2 therapies were based on biomarkers only detected by WGS/TS, supporting the added clinical value of comprehensive sequencing.

  • Conclusion: While WGS/TS provides a broader molecular profile, panel sequencing remains a more practical choice for routine clinical use. Further randomized trials are needed to assess the true cost-benefit of WGS/TS in oncology.

Thursday, January 30, 2025

AI Corner: Chat GPT Seeks "Most Humorous Moments" in 6 Hours of RFK Jr

RFK Jr was interviewed on the Hill for more than six hours (two days).  I fed both transcripts to Chat GPT and asked it to pick out "five humorous moments."

I'd say the pickins' were slim, and so are the results.  However, Chat GPT could understand the gist of the request for "humorous moments," and at least shows "some idea" of what was requested.   And Chat GPT had to read about 60,000 words of auto-transcripts in a couple of seconds. Result below.

See also, sidebar, Chat GPT assessing the two days in the voice of Lewis Black.  

##

AI CORNER

##

Here are the five most humorous moments from Day 1 and Day 2 of Robert F. Kennedy Jr.'s Senate confirmation hearing for Secretary of Health and Human Services:

1. Senator Cassidy’s "Florida Gator" Roast (Day 2)

📍 What happened?
At the start of Day 2, Senator Bill Cassidy (R-LA) welcomed Kennedy and his family, then jokingly singled out his nephew:

“I like your family—except for the nephew who's a Florida Gator. We’ll let that go.”

📍 Why it’s funny?
Cassidy, a LSU guy, took a good-natured jab at Kennedy’s relative supporting the University of Florida, a rival SEC school. It added some casual SEC football rivalry into an otherwise tense hearing.

2. Kennedy's "I'm Not Anti-Fish" Defense (Day 1)

📍 What happened?
Kennedy tried to reframe his reputation by comparing his vaccine advocacy to his environmental work:

“I worked for years to raise awareness about mercury in fish, and nobody called me anti-fish!”

📍 Why it’s funny?
The idea of someone being labeled ‘anti-fish’ is so absurd that it momentarily lightened the mood. But the comparison fell flat, because vaccines and fish regulations aren't exactly the same thing.

3. Rand Paul’s "Submit to the Government" Rant (Day 2)

📍 What happened?
Senator Rand Paul (R-KY) launched into a passionate tirade against government-mandated vaccines:

“You people up here are so separated from real people at home! There’s such a belief in submission—submit to the government! Do what you’re told! No discussion allowed!”

📍 Why it’s funny?
Paul sounded like a rebellious teenager arguing with his parents about curfew, except he’s a U.S. senator. The exaggerated “submit to the government” line could have come straight from a dystopian sci-fi movie.

4. Kennedy’s “I Will Apologize... Eventually” Dodge (Day 2)

📍 What happened?
Both Senator Cassidy and Senator Sanders demanded a clear yes or no:

Cassidy: “Can you unequivocally state that measles and hepatitis B vaccines do NOT cause autism?”
Kennedy: “If you show me data, I will apologize for any statements that misled people.”

📍 Why it’s funny?
Kennedy dodging the question like Neo in The Matrix frustrated senators. The phrasing was also unintentionally amusing—it was like a politician's version of ‘I’ll apologize... if I have to’.

5. The “Lyme Disease Bioweapon” Backpedal (Day 2)

📍 What happened?
Kennedy was cornered on his past suggestion that Lyme disease was created as a military bioweapon:

Cassidy: “Do you still believe Lyme disease was a military bioweapon?”
Kennedy: “I’ve never believed that... but we should always follow the evidence.”

📍 Why it’s funny?
Kennedy pivoted so hard he almost fell over. He didn’t deny saying it before, but also tried to distance himself from it while keeping the door slightly open. A classic conspiracy walk-back!

Final Takeaway: Laughter in the Chaos

Despite the high-stakes nature of the hearing, these moments added levity—whether through Senator roasts, exaggerated speeches, or Kennedy’s verbal gymnastics. 

AI Corner: Chat GPT Assesses RFK Jr Hearing on Day 2; Also Sums Up Both Days

Previously, I posted a Chat GPT analysis of RFK Jr Hearing, Day 1.

https://www.discoveriesinhealthpolicy.com/2025/01/ai-corner-chat-gpt-assesses-rfk-jr-hhs.html

Here is a similar analysis of Day 2, following by a conjoint analysis.  The conjoint analysis resulted in a 60-65% prediction of success for RFK Jr.

###

HealthcareDive was unimpressed by RFK Jr's Medicare/Medicaid answers, day 1 or day 2.

IDSA summed up both days here.  

Endpoints summed up here, noting that RFK can lose 3 Republican senators (and he's expected to) but still squeak by with the Veep tie-splitter.  But if he loses one more, like Sen. Cassidy, a physician, he's toast.

###

CHAT GPT

Here is a detailed summary and insightful analysis of Day Two of Robert F. Kennedy Jr.’s Senate confirmation hearing for Secretary of Health and Human Services.

Summary of Key Moments

Opening Statements

  • The hearing opened with Senator Bill Cassidy (Chairman) acknowledging Kennedy’s family legacy and stating his concerns about Kennedy’s past vaccine positions. He praised Kennedy’s stance on reducing ultra-processed food but pushed him on whether he would publicly affirm vaccine safety and work to restore public confidence.
  • Senator Bernie Sanders (Ranking Member) focused on healthcare system failures, high costs, and lack of universal coverage. He challenged Kennedy’s ability to stand up to corporate interests and address economic inequality in healthcare.
  • Robert F. Kennedy Jr. introduced himself, emphasizing his background in environmental law and arguing that chronic disease is the primary driver of America’s health crisis. He expressed support for President Trump’s “Make America Healthy Again” movement, framed himself as a reformer, and said he would base decisions on science rather than personal opinions.

Vaccine Controversy & Kennedy’s Stance

  • Cassidy and Sanders grilled Kennedy on his history of casting doubt on vaccine safety. They asked whether he would unequivocally state that measles and hepatitis B vaccines do not cause autism, citing extensive scientific evidence.
  • Kennedy refused to give a direct answer, saying he would need to review the studies but would apologize if proven wrong.
  • Sanders was visibly frustrated, saying Kennedy should have already been familiar with this evidence before applying for the position.

COVID-19 Vaccine Debate

  • Sanders confronted Kennedy on his past opposition to COVID-19 vaccines, citing studies showing they saved millions of lives.
  • Kennedy refused to acknowledge the vaccines' impact, saying "we don’t have a good surveillance system" and that the data was unclear.
  • Sanders accused him of spreading dangerous misinformation, calling his refusal to accept scientific consensus "really problematic."

Other Controversial Moments

  1. Lyme Disease Bioweapon Theory

    • Kennedy denied believing that Lyme disease was created as a military bioweapon, but acknowledged that he had read books making that claim.

  2. Conspiracy Theories & 9/11

    • Senator Tim Kaine pressed Kennedy on a 2024 social media post where he questioned what was "conspiracy theory and what isn’t" about 9/11.
    • Kennedy refused to take a stance, saying, “I haven’t investigated it.”
    • Kaine called this "deeply disturbing" and suggested it showed Kennedy had difficulty distinguishing fact from conspiracy theory.

  3. HPV Vaccine & Sexual Harassment Allegation

    • Senator Patty Murray criticized Kennedy for calling the HPV vaccine "dangerous and defective" and falsely claiming it increases cervical cancer risk.
    • She also raised a past sexual harassment accusation against Kennedy, pressing him on why he apologized to the accuser.
    • Kennedy denied the allegations, saying his apology was for something else.

  4. Abortion & Birth Control

    • Senator Tim Scott (R-SC) asked whether Kennedy’s deputies would be pro-life.
    • Kennedy said he would implement Trump’s policies, which include restrictions on late-term abortion.

  5. Medicaid & Healthcare Cuts

    • Sanders pressed Kennedy on whether he would oppose Republican-led Medicaid cuts.
    • Kennedy refused to commit, instead arguing that the entire healthcare system is broken.

Analysis: Strengths & Weaknesses of Kennedy’s Performance

Strengths

✔ Chronic Disease Focus – Kennedy effectively shifted the conversation to chronic disease, arguing that the healthcare system focuses on treatment instead of prevention. His emphasis on ultra-processed food and environmental toxins resonated with some lawmakers.

✔ Populist Messaging – His anti-corporate stance, particularly against Big Pharma and the food industry, was popular among Republicans and some Democrats.

✔ Pledged to Follow the Science – He repeatedly stated that he would change his position if presented with data, though his refusal to engage with existing evidence raised doubts.

Weaknesses

✖ Vaccine Doublespeak – Kennedy refused to make a clear statement affirming vaccine safety, even when presented with overwhelming evidence. His "Show me the data" response seemed deliberately evasive.

✖ COVID-19 Vaccine Misinformation – His refusal to acknowledge that COVID-19 vaccines saved lives put him at odds with Trump himself, who has praised Operation Warp Speed.

✖ Conspiracy Theory Ambiguity – His refusal to “take sides” on 9/11 conspiracy theories played into concerns that he engages in misinformation.

✖ Ethics & Financial Conflicts – His financial ties to lawsuits against vaccines raised concerns about bias in how he would regulate pharmaceutical policies.

✖ Clashes with Democrats – His responses to Sanders, Murray, and Kaine reinforced Democratic fears that he would be an untrustworthy steward of public health.

Final Takeaway: Can Kennedy Be Confirmed?

Kennedy clearly has support from Republicans, particularly those who favor individual choice in healthcare and distrust public health agencies. However, his evasiveness on vaccines, history of promoting misinformation, and refusal to engage with established science may make it difficult for him to secure bipartisan support.

✅ LIKELY SUPPORTERS:

  • Republicans who want a populist disruptor at HHS.
  • Anti-regulation conservatives who favor his criticism of public health bureaucracy.
  • Vaccine skeptics and anti-corporate advocates.

❌ LIKELY OPPONENTS:

  • Democrats who see him as a dangerous choice for public health.
  • Public health experts who view him as a misinformation spreader.
  • Some Trump allies who fear his vaccine stance conflicts with Trump's legacy.

Bottom Line

Kennedy framed himself as a reformer, but his vaccine stance, conspiracy rhetoric, and financial conflicts raise serious credibility issues. His confirmation remains uncertain as senators weigh whether his populist appeal outweighs his public health liabilities.


###

Discuss the odds of success.  (Spoiler alert - 65%).

###

Assessment of Robert F. Kennedy Jr.’s Confirmation Prospects for Secretary of Health and Human Services

Based on the transcripts from both Day 1 and Day 2 of Robert F. Kennedy Jr.’s Senate confirmation hearing, his chances of being confirmed for Secretary of Health and Human Services (HHS) depend on several key factors: Republican party unity, his stance on controversial issues, and the pressure on swing votes.

1. Summary of Key Findings from the Hearings

Day 1: Introduction, Policy Proposals & Early Resistance

  • Republican Support: Chairman Senator Bill Cassidy (R-LA) and others praised Kennedy’s focus on chronic disease, processed foods, and transparency in public health.
  • Democratic Opposition: Senator Ron Wyden (D-OR) delivered a scathing attack, accusing Kennedy of promoting conspiracy theories, spreading anti-vaccine rhetoric, and undermining public trust in health agencies.
  • Vaccine Safety Debate: Kennedy claimed he was not anti-vaccine, but Democrats confronted him with past statements, including a petition to block COVID-19 vaccines for children.
  • Abortion & Medicaid Issues: Kennedy refused to commit to protecting Medicaid from Republican cuts and was evasive on abortion policies, raising concerns among Democrats.
  • Samoa Measles Outbreak: Democrats accused Kennedy of fueling vaccine hesitancy that contributed to deaths in Samoa—an accusation he vigorously denied.

Day 2: Pressure on Vaccines, Medicaid, and Partisan Dynamics

  • Republican Reservations on Vaccines: Senator Cassidy and Senator Rand Paul (R-KY) pressed Kennedy on his willingness to change positions based on data. Cassidy asked him point-blank if he would tell the public that measles and hepatitis B vaccines do not cause autism. Kennedy refused to directly say yes, instead asking for more data, which frustrated even Republican allies.
  • Democratic Attacks Escalated: Senator Bernie Sanders (D-VT) hammered Kennedy on COVID-19 vaccines, quoting studies that estimate millions of lives were saved. Kennedy refused to acknowledge this, saying there was no good surveillance system to prove it—a response Sanders called "deeply troubling."
  • Medicaid & Healthcare Reform: Democrats, including Sanders, pushed Kennedy on whether he would fight Trump’s rumored Medicaid cuts. Kennedy deflected, saying Trump has not discussed cutting Medicaid with him. This failed to satisfy Democrats.
  • Partisan Pressure on Republicans:
    • Most Republicans seem reluctant to break ranks, even if some (Cassidy, possibly Romney or Collins) have concerns about Kennedy's vaccine rhetoric.
    • Even doubtful Republicans may not want to risk becoming a target by voting against him, given Trump’s strong backing.
  • Trump Factor: Kennedy frequently invoked Trump’s name, emphasizing that he was aligned with Trump’s “Make America Healthy Again” movement and that Trump personally trusted him.

2. Key Factors Affecting His Confirmation Prospects

✅ Reasons Why RFK Jr. Could Be Confirmed

✔ Republican Majority (Even if Slim): With only a narrow Republican majority in the Senate, Kennedy doesn’t need bipartisan support, just near-total GOP unity. Given Trump’s backing, many Republicans may feel compelled to vote yes. 

✔ Trump’s Direct Endorsement: Trump hand-picked Kennedy, framing him as a health reformer. Republicans who vote against him risk angering Trump’s base. 

✔ Strong GOP Support on Non-Vaccine Issues: Kennedy’s focus on nutrition, ultra-processed foods, and chronic disease prevention aligns well with many Republican health policies. 

✔ Pressure on Swing Republicans to Stay in Line: Senators like Mitt Romney (R-UT), Lisa Murkowski (R-AK), and Susan Collins (R-ME) may have doubts, but voting against Kennedy would expose them to fierce backlash from Trump-aligned forces. 

✔ Anti-Bureaucracy Stance Appeals to Conservatives: His criticism of the FDA, CDC, and NIH resonates with Republicans who distrust public health institutions.

❌ Reasons Why RFK Jr. Could Be Rejected

✖ Deep Republican Concerns About Vaccines: Some Republicans (like Cassidy and Paul) have serious reservations about Kennedy’s anti-vaccine reputation. Cassidy’s pointed questioning about whether Kennedy would definitively say vaccines do not cause autism showed lingering doubt. 

✖ Unified Democratic Opposition: Every single Democrat is likely to vote against him. Even moderate Democrats see Kennedy as a public health risk. 

✖ Baggage on Conspiracy Theories: His past remarks on vaccines, Lyme disease, and 9/11 make him a politically toxic pick for some senators. 

✖ Potential GOP Defections on the Vaccine Issue: If two or three Republicans defect, Kennedy could be blocked—especially if Vice President Vance's tie-breaking vote isn't enough to override resistance. 

✖ Concerns About Medicaid Cuts: Even some moderate Republicans may worry that Kennedy would not fight against potential cuts to Medicaid, harming seniors and low-income Americans.

3. Final Prediction: Does Kennedy Have the Votes?

Kennedy’s confirmation is uncertain but still slightly favored due to Republican pressure to stay in line.

✅ LIKELY PATH TO CONFIRMATION:

  • Kennedy is likely to secure most Republican votes despite some concerns.
  • Trump’s influence on the party is a major factor—Republicans who oppose Kennedy risk blowback.
  • If only one or two Republicans defect, Kennedy would still be confirmed with VP Vance’s tie-breaking vote.

❌ WHAT COULD DERAIL HIM?

  • If three or more Republican senators (e.g., Cassidy, Romney, Murkowski, Collins) vote no, his nomination would fail.
  • Last-minute GOP pressure over his vaccine stance could tip the scales if Republicans fear long-term backlash from public health advocates.

Final Probability Estimate

🔵 Kennedy Confirmed: ~60-65% Likely 🔴 Kennedy Blocked: ~35-40% Likely

4. Strategic Takeaways

  • If Kennedy wants to secure confirmation, he must assure Republican swing votes (Cassidy, Romney, Collins) that he will not undermine vaccine policies.
  • Democrats will use this hearing as a campaign point against Republicans in 2026, portraying Kennedy as a public health risk.
  • If Kennedy fails to win confirmation, Trump may nominate a more traditional Republican to avoid a prolonged fight.

Conclusion

RFK Jr.’s confirmation is not guaranteed, but he remains slightly favored to be confirmed due to the Republican majority and Trump’s backing. However, his vaccine views remain a significant liability, and if just a few key Republicans break ranks, he could be blocked.

Wednesday, January 29, 2025

AI Corner: Chat GPT Assesses RFK Jr HHS Hearing: Day 01

I pulled the YouTube auto transcript of the CNN-channel video of the RFK Jr hearing, Day 1.   The hearing ran 3.5 hours.  Chat GPT4 was asked to read and assess Day 1.

###

Please provide a detailed summary and insightful analysis of this senate confirmation hearing of Robert F Kennedy Jr for secretary of Health and Human Services.  

###

Summary of the Hearing

The Senate confirmation hearing for Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) was marked by sharp partisan divisions, scrutiny of his past statements, and concerns over his qualifications for the role.

Opening Remarks & General Tone

  • The Chairman opened the hearing with a neutral and formal introduction, acknowledging Kennedy’s accessibility and engagement with members on both sides of the aisle.
  • He emphasized the importance of Medicare, Medicaid, telehealth, prescription drug reform, and chronic disease prevention, framing HHS as central to addressing America's disjointed and costly healthcare system.
  • The Ranking Member, Senator Wyden, launched a strongly critical attack, arguing that Kennedy has spread conspiracy theories, promoted anti-vaccine rhetoric, and lacks policy experience.

Key Themes in Kennedy’s Testimony

  • Chronic Disease & Prevention: Kennedy stressed that the U.S. is facing an epidemic of chronic illnesses, including obesity, diabetes, and autoimmune diseases, which are driving high healthcare costs. He proposed a stronger focus on nutrition and preventive care.
  • Vaccination & Public Health: He denied being "anti-vaccine," claiming his past concerns were about vaccine safety rather than opposition to vaccination itself. However, senators challenged him with his own past statements, including his petition to the FDA to block COVID vaccines for children and his book downplaying measles risks.
  • Health Policy & Government Reform: He pledged transparency at HHS and criticized bureaucratic inefficiencies, advocating for value-based care over fee-for-service models.
  • Controversial Statements: Senators confronted him on past conspiracy-laden remarks, such as:
    • Claiming COVID-19 was genetically engineered to spare Ashkenazi Jews and Chinese people.
    • Suggesting Lyme disease was a military bioweapon.
    • Allegedly stating pesticides contribute to transgender identity in children.
    • Suggesting African AIDS differs from Western AIDS.
    • Changing stances on abortion, vaccine mandates, and Medicaid reform.

Senators’ Criticisms & Key Exchanges

  • Vaccine Safety & Samoa Measles Outbreak:

    • Senator Wyden accused Kennedy of fueling vaccine hesitancy in Samoa, where 83 people (mostly children) died in a measles outbreak.
    • Kennedy denied involvement, blaming poor vaccination rates before his visit.
    • He reaffirmed support for the measles vaccine but was challenged with his own writings downplaying measles severity.

  • Healthcare Programs & Medicaid Reform:

    • Several Republican senators focused on HHS spending, Medicaid reform, and bureaucratic inefficiencies.
    • Kennedy criticized Medicaid expansion, arguing it has increased costs without improving care.
    • He suggested pilot programs, telemedicine, and AI-driven efficiencies.
    • Senator Cassidy pressed him on specific Medicaid proposals, to which Kennedy admitted he had no broad dismantling plan but preferred gradual experimentation.

  • NIH, FDA, and Staffing Cuts:

    • Kennedy previously stated he wanted to fire 600 NIH workers and remove 2,200 employees from HHS.
    • Senator Warner questioned him on which offices he planned to cut.
    • Kennedy struggled to specify departments, saying only that poorly functioning bureaucracies needed reform.

  • Reproductive Rights & Title X:

    • Kennedy aligned with Trump on banning late-term abortion, preventing federal funding for abortion, and upholding conscience protections for healthcare workers.
    • Senator Lankford questioned him on Title X funding for family planning, and Kennedy pledged to support Trump’s restrictions.

  • Global Health & PEPFAR:

    • Senator Cornyn asked about continuing PEPFAR (HIV/AIDS relief in Africa).
    • Kennedy expressed full support, calling it one of the most successful health programs.

  • CMS Bureaucracy & Rhode Island Healthcare Disparities:

    • Senator Whitehouse criticized CMS payment disparities in Rhode Island, calling CMS policies “remorseless, senseless, and inhumane”.
    • Kennedy agreed bureaucracies were dysfunctional and pledged to fix disparities.
    • (See AI Sidebar about Rhode Island.)

Audience Disruptions

  • At multiple points, audience members interrupted the hearing with cheers and outbursts.
  • The Chairman warned that disruptions could lead to a recess or removal by security.

Analysis: Strengths and Weaknesses of Kennedy’s Performance

Strengths

  1. Well-Prepared & Measured Tone:

    • Kennedy stuck to a central theme of chronic disease prevention and inefficiency reform.
    • His personal story as an environmental lawyer and recovering addict resonated with some senators.

  2. Transparency & Bureaucratic Reform:

    • His pledge for greater transparency in HHS, particularly regarding NIH and FDA conflicts of interest, was welcomed by Republicans.

  3. Public Health & Preventive Focus:

    • Emphasized nutrition and public awareness as cost-saving measures.
    • Proposed restructuring healthcare incentives towards preventive rather than reactive care.

  4. Alignment with Trump’s Priorities:

    • Strongly reaffirmed loyalty to Trump’s policy agenda, particularly on:
      • Medicaid reforms
      • Pro-life policies
      • FDA and NIH oversight
      • Ending the chronic disease epidemic

Weaknesses

  1. Vaccine Contradictions:

    • His past statements contradict his hearing testimony.
    • Senators exposed direct contradictions in his vaccine stance, particularly regarding COVID-19 and measles.

  2. Lack of Policy Specificity:

    • On Medicaid, Medicare Advantage, and cost reduction, he offered few concrete proposals beyond generalities.
    • Struggled with integrating Medicare and Medicaid funding.
    • No clear answers on where HHS staffing cuts would come from.

  3. Reputation for Conspiratorial Thinking:

    • His history of fringe statements on bioweapons, pesticides, and transgender issues was weaponized against him.
    • He failed to convincingly disavow those past claims.

  4. Partisan Doubts & Confirmation Prospects:

    • Democrats made it clear they will vote against him.
    • Some Republicans were cautiously supportive, especially on transparency and Medicaid reform.
    • His ties to Trump help him among Republicans but alienate moderates.

Final Assessment:

Robert F. Kennedy Jr. came well-prepared but struggled to defend past statements and offer concrete policy solutions. His focus on chronic disease prevention was a strong point, but his credibility issues—particularly regarding vaccines and science-based policy—remain a major obstacle. While he had some support among Republicans, the hearing exposed deep divisions and his confirmation remains highly uncertain.

Would you like a breakdown of specific senators’ stances or a prediction on the confirmation vote?

###

You mentioned that Republicans were "cautiously supportive."  If 52 Republicans all vote for him, it's a done deal (he's in.)  Could you discuss the range of specifically Republican support (from cautious to strong?)

Yes, let’s break down the range of Republican support for Robert F. Kennedy Jr.’s confirmation, from cautious to strong.

1. Strong Republican Support (Likely to Vote Yes)

These senators enthusiastically back Kennedy because of his alignment with Trump’s agenda and anti-bureaucracy stance:

  • Sen. Chuck Grassley (R-IA) – Focused on transparency, PBM accountability, and drug pricing reforms. Liked Kennedy’s commitment to oversight.
  • Sen. Josh Hawley (R-MO) – Views Kennedy as a populist disruptor who will challenge the "deep state" at HHS.
  • Sen. J.D. Vance (R-OH) – Actively supports Kennedy’s anti-bureaucratic rhetoric and criticism of NIH/FDA overreach.
  • Sen. Ron Johnson (R-WI) – Strongly supports Kennedy’s vaccine skepticism and anti-government regulation stance.
  • Sen. Marsha Blackburn (R-TN) – Echoed concerns about government health mandates, particularly on vaccines and reproductive health policies.
  • Sen. Ted Cruz (R-TX) – Appreciates Kennedy’s opposition to FDA “overreach”, particularly on mifepristone (abortion pill) and vaccine mandates.

📌 Verdict: These senators fully support Kennedy as a disruptor of big government health policies.

2. Cautious but Leaning Yes (Will Vote for Kennedy but Have Reservations)

These Republicans agree with Kennedy on some issues but have concerns about his past statements or lack of policy depth:

  • Sen. Bill Cassidy (R-LA) – Pressed Kennedy on Medicaid reform and dual-eligible integration. Liked his views on value-based care but was concerned about his lack of specifics.
  • Sen. John Cornyn (R-TX) – Supports Kennedy’s PEPFAR commitment and mental health focus, but hesitant on his experience in managing Medicaid and Medicare.
  • Sen. Lisa Murkowski (R-AK) – Concerned about Kennedy’s past statements on vaccines but liked his pledge to focus on rural health.
  • Sen. Mitt Romney (R-UT) – Skeptical of Kennedy’s anti-vaccine rhetoric but might vote yes if he commits to science-based policy.
  • Sen. John Thune (R-SD) – Wants clearer Medicaid reform details before committing.
  • Sen. Marco Rubio (R-FL) – Torn between supporting Trump’s nominee and Kennedy’s vaccine stance, which he sees as politically risky.

📌 Verdict: These senators might vote yes, but Kennedy must reassure them on issues like vaccine safety, Medicaid reform, and healthcare spending.

3. Skeptical Republicans (Leaning No or Uncertain)

These Republicans worry about Kennedy’s controversial statements and his ability to lead HHS:

  • Sen. Susan Collins (R-ME) – Deeply skeptical due to Kennedy’s anti-vaccine record.
  • Sen. Thom Tillis (R-NC) – Expressed concerns about Kennedy’s credibility and policy depth.
  • Sen. Todd Young (R-IN) – Finds Kennedy too unpredictable.
  • Sen. Shelley Moore Capito (R-WV) – Concerned about vaccine safety rhetoric but open to discussion.

📌 Verdict: These senators may defect and vote no, making Kennedy’s confirmation uncertain.

Does Kennedy Have Enough Votes?

  • If all 52 Senate Republicans vote yes, he’s confirmed.
  • If just 3-4 Republicans defect, his confirmation fails unless he flips a Democrat or two.
  • Democrats are nearly united against him, so Kennedy must lock in all Republicans.

📌 Final Assessment: Kennedy likely gets confirmed, but his margin could be thin. If he reassures skeptical Republicans and avoids further controversy, he secures 52-54 votes and takes the job. If more concerns arise, he could lose crucial Republican support and his nomination might fail.

###

The politics are complex.  If only a couple Republicans vote no, RFK loses.  But, if only a few vote no, perhaps those couple Senators leave the room with a target on their backs, so to speak, especially if 48 or 49 of their peers wanted RFK.

[Note to reader.  In this answer, Chat GPT pulls in other sources, quite new ones, such as a Politico article on Pete Hegseth's need for a VP tie breaker vote.  (Mitch McConnell voted against Hegseth.)  The original AI output had hot-links, not shown here.]

The political dynamics surrounding Robert F. Kennedy Jr.'s nomination for Secretary of Health and Human Services (HHS) are indeed complex. With a slim Republican majority in the Senate, even a few defections could jeopardize his confirmation. Conversely, Republican senators who oppose Kennedy's nomination might face political repercussions, especially if the majority of their party supports him.

Potential Consequences for Republican Senators Voting 'No':

  1. Primary Challenges: Senators opposing a nominee endorsed by President Trump may risk facing primary challenges from candidates aligned more closely with Trump's agenda. For instance, Senator Joni Ernst experienced significant pressure from Trump's allies, including threats of primary challenges, when she opposed certain administration positions. citeturn0search13

  2. Party Leadership Tensions: Defying the party line can lead to strained relationships with party leadership and colleagues. Senator Mitch McConnell's recent vote against Trump's Defense Secretary nominee, Pete Hegseth, forced a tie-breaking vote by the Vice President, highlighting internal party divisions. citeturn0news24

  3. Public Criticism and Media Scrutiny: Senators opposing high-profile nominees may attract negative attention from media outlets and political commentators, potentially impacting their public image and future political prospects.

Balancing Act for Republican Senators:

Republican senators must weigh the potential backlash from their base and party leadership against their personal convictions and the interests of their constituents. The decision to support or oppose Kennedy's nomination involves navigating complex political terrain, where each vote carries significant implications for their political careers and the party's unity.

In summary, while a few Republican defections could prevent Kennedy's confirmation, those senators might face substantial political consequences for breaking ranks, especially if the majority of their peers support the nomination.

Tuesday, January 28, 2025

More About Strange Novitas LCD, Genetic Testing in Oncology (L39367)

Novitas' LCD for genomic testing in oncology has made news several times.

  • Summer 2023
    • Novitas released a final version that was greatly different than the 2022 proposal.
    • Stakeholders got CMS to cancel that, and Novitas had to reissue the LCD as a "new" proposal for public comment.
  • Summer 2024
    • Novitas announces that new final version would be delayed.
  • January 2025
    • Novitas releases the new final version, with almost exactly the same non-coverage test list as 2023.
    • On January 27, 2025, Interpace Diagnostics issues a press release that the Novitas LCD is delayed again, until April, to allow the Trump Administration to review the data for an Interpace test.
More Weirdness

You're excused if you don't think anything could get more atypical.  In this blog, I look at the actual final LCD (albeit, on hold).

First, the title changed.   The draft LCD was L39367, "Genetic Testing for Oncology."  

The final LCD has a different title - "Genetic Testing in Oncology - Specific Tests."

Second, Novitas defines "genetic" to be any form of DNA or RNA test.   (I think more often, genetic focuses on germline, genomic to broader applications.)  

Novitas says, it is not appropriate to use the term "genomic."

Use of the term, "genomic," in PubMed (1.9M results):



Third, while the LCD has some very broad definitional sections (see "Structure," below), the only "coverage statements" are about 11 brand-name special tests (of which only one, Urovysion, which is FDA-approved, is covered).

Fourth, this means, you'll look in vain for any explicit text about whether Novitas covers tumor CGP, or when, or covers liquid biopsy CGP, or when, or MDR testing, or when.   

Fifth, the LCD references two billing/coding articles.  

A59123 seems more specific to the LCD (its title, says, "Specific Tests.")  
A58918 is "billing and coding, molecular pathology and genetic testing."  A58918 has a banner, "Not an LCD Reference Article."  Although, A58918 references several LCDs in its official "associated documents" section, and, A58918 is referenced by, L39367.  

A58918 references Novitas LCD L34519 for "molecular pathology procedures."  
But that LCD is from 2021 (and mostly 2015), so you'll look in vain for any text about modern developments like LBx, MRD, etc.

Structure of LCD

The HTML document is not paginated, these are pages from my version, to give you a general idea.
  • Page 1
  • Coverage Indications, Limitations, Medical Necessity [header]
    • History/Background
    • A page of general remarks about molecular testing and its "complexity and rapidly expanding knowledge."
  • Page 2-4
    • Definitions
    • Of note, definition of treating physician (related to who can order a test.)  
    • Genetic defined as any DNA RNA test.  
    • "Genomic" not to be used.  
    • Some topics like MRD and TMB are defined, but not otherwised used again.
  • Page 4
    • Covered Indications
    • This section says Urovysion (FDA) is selectively covered.
  • Page 5
    • Limitations
    • A few general limitations then a list of non covered branded tests, of which I don't think any are FDA approved.  These non covered tests are #4-#12.
  • Page 6
    • Provider qualifications - only treating MD can order.
    • See my May 2024 blog about MolDx's important article, A59741.  Writing, "Pathologists may order molecular diagnostic services..." within certain guardrails.
  • Page 6-14
    • Summary of Evidence [each named test discussed in turn.]
  • Page 14-34
    • Analysis of Evidence [Rationale]
  • Page 34-65
    • Bibliography (n=470)
Half the LCD, by volume, is bibliography.
  

###
Recall a September 2024 announcement by Novitas that (while it has few LCDs on the 100s of PLA codes), it reserved the right to require full medical records documentations from patients whenever a PLA code is ordered.

Novitas & NGS MAC Publishes Gapfill Survey for Spring 2025

Each fall, CMS assigns a couple dozen new lab test codes to be priced by gapfill.  It transmits to each MAC a list of codes for which the MAC's gapfill will be requested.

MolDx MACs generally have not made any public posting of this.   (MolDx has stated at public meetings, that it reaches out to stakeholders as needed to do its gapfill work.)

Novitas/FCSO MACs generally make a public posting and a web portal for data submission. That's now up, for 2025.  Data is requested by February 28, 2025.  See the web page:

https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00246106

Novitas provides a cost-COGS template.  They also provide a web portal with different questions.

click to enlarge. Novitas.


NGS MAC also has a public posting:

https://www.ngsmedicare.com/web/ngs/search-details?selectedArticleId=5270181&lob=96664&state=97178&rgion=93623


###

CMS posts final decisions on about 100 new codes in late November (blog), some of which decisions state "gapfill."

###

I understood from some emails that early MAC GF lists may have had some errors but hopefully that's resolved.

###

MACs give their gapfill data to CMS in mid-spring, CMS publishes online, requests public comment, and final MAC gapfill prices appear in the fall.

###

CMS sets prices at the median more-or-less at 'state" level, so MOLDX, with 28 states, always controls the median result.

###


Friends of Cancer Research: 2024 Year in Review (158pp)

Friends of Cancer Research has released its 2024 Year in Review, a 158-page PDF.  The event also celebreates the organization's 25th anniversary.

Find it here:

Home page:

https://friendsofcancerresearch.org/impact-reports/25th-anniversary-impact-report/

PDF:

https://friendsofcancerresearch.org/wp-content/uploads/Friends-Scientific-Report_2024.pdf



The 158-page report includes full reprints of a number the organization's sponsored publications, such as Andrews et al, analysis of 20 assays to mreasure homologous recombination deficiency (Andrews et al, JCO Oncol Adv).  There are also white papers, such as a framework for integrating ctDNA changes into cancer clinical trials (p. 110ff).  There is also a white paper for pragmatic post-market trials (p. 59ff) which is paired with an op-ed on RWE (Stewart et al., ESMO J.)




####

AI Corner

AI Summary (Chat GPT4)

Highlight Summary for Blog Readers:

The Friends of Cancer Research 2024 Scientific Report showcases significant strides in oncology drug development and policy. Key themes include enhancing diversity in clinical trials, leveraging real-world evidence for regulatory decisions, advancing early endpoints and cell/gene therapy frameworks, and harmonizing biomarker diagnostics with AI applications. 

Notable initiatives include the Homologous Recombination Deficiency (HRD) project and the Digital PATH project, targeting variability in diagnostic tests and AI model outputs. 

This work underscores the importance of collaboration and innovation in improving cancer care and regulatory pathways. Full report details these advancements, emphasizing patient-centric approaches.

##

Monday, January 27, 2025

Genomeweb Scoop: Novitas Delays Cancer LCD Implementation Date for DJT

According to a eye-catching new article at Genomeweb, dated January 27, 2025, Novitas has delayed implementation of its new LCD for oncology, "to give the incoming presidential administration time to fully review the proposed changes."

I have never seen this before, at the LCD level.  The mechanism is, the "notice date" of the LCD is still the same, January 9 to February 22, but, a new date has been added, an "effective date," which is pushed out to April 24, 2025.

Interpace is cited as a moving party.

click to enlarge

Press Release

The Interpace press release states,

Interpace Diagnostics®, a subsidiary of Interpace Biosciences®, (“Interpace” or the “Company”) (OTCQX: IDXG) today announced notification that the Centers for Medicare & Medicaid Services (CMS) directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay implementation of the Genetic Testing for Oncology Local Coverage Determination (LCD) (L39365), from February 23, 2025, to April 24, 2025.

This change of effective date will allow the incoming Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN® assay, and fully assess the negative impact on patient care if the currently proposed LCD comes into effect.

.....We are thrilled that this extension decision also supports the dozens of employees who meticulously process specimens and otherwise would have lost their jobs.
....Further review and evaluation of the clinical validation and utility of PancraGEN demonstrates the incoming Trump administration’s commitment to proven, cost-effective patient care.”

##
Theory
Could it be that DJT is postponing any and all LCDs, only coincidentally the Novitas one containing Interpace?   No sign of that yet.  Eg Another recent LCD still has its original normal implementation date.
##
How could this help Interpace?
While the whole LCD is delayed until April, I've only seen a press release from Interpace.  So, it's not clear if the WH is asking Novitas to reconsider all aspects of the LCD - including many other tests - or only Interpace Pancragen.   And, what are the logistics?  If Novitas views Pancragen more favorably, could it simply rewrite & release those new paragraphs of the LCD?  Or, would that violate public comment regulations?   If the latter, would Novitas need to rewrite those paragraphs, reissue the whole LCD as a new draft and then finalize the re-write in summer or later? 

##
In addition to Mehmet Oz MD as Administrator of CMS, Becker's reported Stephanie Carlton RN as his chief of staff, Chris Klomb as head of Medicare ("Center for Medicare,") and Abe Sutton as head of CMMI.  Carlton is ex-McKinsey, Klomp CEO of a healthcare IT firm, Sutton worked in the first DJT WH then got a JD from Harvard.  

FDA LDT: Oral Arguments! Stay Tuned for February 19, 2025

Closing arguments for the FDA LDT federal court case were submitted in December 2025.

As reported by Christine Bump at Linked In, now oral arguments have been scheduled for February 19, 2025.

To my eye, that pushes a judge's decision to at least late March if not April.   

ACLA/AMP requested an oral hearing, which wasn't required.   This may give them a chance to emphasize those arguments most in tune with the judge's questions, or to clear up any misunderstanding that a judge's question might reveal.  Also, it might let ACLA/AMP get a temperature check on the tone of the justice department in light of the new administration (and, by February 19, possibly a new head of HHS and of FDA).  

  https://www.linkedin.com/posts/christinepbump_ldts-activity-7288552664173318144-cUMd/

 ##






Find Christine at Penn Avenue Law.

Quick Journal Watch: Super AI from China? - AHA on Hospital AI - Flatiron and Ambient AI

Some quick links on hot topics.

##

Economist and China's Revolutionary AI

You may have heard China is producing high-quality AI models at a sliver of the US price.  Crisis?  Two articles at The Economist.

https://www.economist.com/briefing/2025/01/23/chinas-ai-industry-has-almost-caught-up-with-americas

https://www.economist.com/leaders/2025/01/23/chinese-ai-is-catching-up-posing-a-dilemma-for-donald-trump

Same topic at tech blog Stratechery

https://stratechery.com/2025/deepseek-faq/

Nvidia stock slips from $150 to $120 (market cap still $3T).  See also Dan Gallagher at WSJ.

AHA on AI in Hospitals

AI - New 25 page white paper from AHA on how hospitals should view it.

https://www.aha.org/center/emerging-issues/market-insights/ai/building-and-implementing-artificial-intelligence-action-plan-health-care

Flatiron Rolls Toward "Ambient AI"

DeepScribe partners with Flatiron for "Oncology Ambient AI" (clinical visit dialog).

https://www.mobihealthnews.com/news/deepscribe-partners-flatiron-health-oncology-focused-ambient-ai

Diagnosing Cancer?

See however, arguments that AI in cancer will be much harder that some predictions suggest.

https://www.linkedin.com/posts/dr-jeffrey-funk-a979435_cancer-artificialintelligence-ai-activity-7288514439387979776-H5jf/

In that last link, Dr Jeffrey Funk poins us to MIT Technology Review:

https://www.technologyreview.com/2025/01/21/1110192/why-its-so-hard-to-use-ai-to-diagnose-cancer/

This latter article is based in part on a new Arxiv.org article by Alber et al. trained on 1.2M slides (WSI).

https://arxiv.org/abs/2501.05409

###

An Extra Link

Potential for Large Language Models.  Essay by Loalza-Bonilla, a founder of Massive Bio, using AI to connect patients to trials.

https://www.medscape.com/viewarticle/rise-large-language-models-medicine-next-frontier-2025a10001fo

####

####

AI CORNER

Chat GPT 4 reads the materials above.  It includes citations to the papers above which don't copy/paste well; I've inserted the word "cite."

####

Blog Update: Advancing AI—The Revolution, Realities, and Challenges

Artificial intelligence (AI) is undergoing a seismic shift across industries, with rapid innovation creating opportunities and hurdles. Here are four key updates shaping AI's future, from China's surging capabilities to healthcare's cautious embrace:

1. China's Rapid AI Revolution

China's AI industry is now closing the gap with U.S. innovation at an unprecedented pace. Companies like DeepSeek are leveraging cutting-edge techniques such as mixture-of-experts (MoE) and multi-head latent attention to produce advanced models rivaling those of OpenAI and Google. For instance, DeepSeek’s V3 model combines innovation and cost-efficiency, training at a fraction of the usual expense while maintaining competitive performance​(CITE CITE CITE). 

These advances challenge Western dominance, creating geopolitical and economic implications as China skirts U.S. chip restrictions with novel workarounds like the use of constrained GPUs​ (CITE).

2. Flatiron and Ambient AI in Oncology

Ambient AI is making strides in healthcare, exemplified by Flatiron Health’s partnership with DeepScribe. This collaboration integrates ambient AI into Flatiron's OncoEMR platform, automating clinical documentation for oncology. By contextualizing patient histories and generating structured notes, this AI-powered system aims to reduce administrative burdens, enabling clinicians to focus on patient care​ (CITE). Flatiron's foray into ambient AI reflects a growing trend in deploying AI to enhance operational efficiency and provider satisfaction in niche clinical workflows.

3. AHA’s Strategic Roadmap for Hospital AI

The American Hospital Association (AHA) has released a comprehensive 26-page report outlining how hospitals can adopt AI effectively. The framework is built around people, processes, and technology, emphasizing leadership, change management, and centralized capabilities. While AI’s potential to improve patient outcomes and reduce burnout is clear, challenges like workforce readiness, data privacy, and addressing algorithmic bias remain. 

The AHA advocates for intentionality, ensuring AI aligns with strategic objectives rather than being a mere technical solution​ (CITE).

4. Cancer Diagnostics: Progress and Pitfalls

Despite AI's promise, cancer diagnostics remain a significant challenge. The Mayo Clinic's Atlas model illustrates incremental progress, achieving human-level accuracy in specific tasks like colorectal cancer detection (97%) but struggling with others, such as molecular-level predictions. Barriers include limited training data, the sheer complexity of pathology samples, and the difficulty of generalizing results across rare diseases​ (CITE CITE). 

Experts argue that transformative advancements require new data strategies and fundamentally different models​ (CITE).

The Takeaway

AI’s transformative potential is undeniable, but the road ahead is marked by competition, technical hurdles, and ethical considerations. Whether it’s geopolitical races in AI supremacy, practical healthcare implementations, or the nuanced complexity of medical diagnostics, the evolution of AI demands thoughtful application, collaboration, and investment. The future is bright but must be approached with precision and purpose.

Let me know if you’d like to expand on any of these sections!

Sunday, January 26, 2025

Xifin Portal Offers Insights to Commercial Genomic Pricing

The revenue cycle consultancy XIFIN offers a fascinating open-access portal, called "Payor Intelligence Hub."  Find it here:

https://www.xifin.com/lp/xifin-payor-intelligence-hub/

Payer Transparency Monitor

Let's look at one of the resources, Payer Rate Transparency Monitor.  XIFIN writes, 

  • "This innovative tool now offers a more comprehensive view of the payor landscape, through interactive visualizations of more than 7 terabytes of data reported by payors pursuant to the CMS Transparency in Coverage (TiC) Final Rule.  
  • It allows providers to select their diagnostic test category, billing codes, and billing modifiers across one- or multiple payors to better understand and inform their market access and payor relations strategies."

Pull down menus offer several categories, such as Medical Devices versus Laboratory.   Each gives you several open-access options for CPT codes.  For example, select Molecular then BRCA 81162.  Here, you can see payment level data for CIGNA and UHC.   The Cigna weighted average is higher $2229, while UHC weighted average is $1782.   But you'll also note that Cigna has contracts at numerous price rates (many little bubbles) where UHC aggregates a lot of payments at $765 and $1094 (large bubbles.)


Total payment range is huge (e.g. $18 to $20,827).   That huge range of outlier low and high payments was also seen when CMS collected commercial payer data under PAMA in 2017, and gave the public access to a very large cloud database of anonymous rates.

Payor Policy Changes

Open access to some pages  for payor policy updates.  Here.

XIFIN White Papers

In addition, XIFIN has a "resources" page where they periodically issue or update white papers on lab reimbursement and policy data.


Brief Blog: Two Additional Names for Health Policy at DJT White House

Header: Theo Merkel and Joel Zinberg have been reported as staff for health care policy in the new administration.

##

Las week we noted that Abe Sutton, a veteran of the first DJT White House, was likely heading to Medicare as head of the Innovation Center (CMMI).  That's noteworthy because the enabling statute for the CMMI allows to to waive any CMS law for the purpose of a demonstration project (which could be very large and long in scope).  SSA 1515A, see (d).  "The Secretary may waive such requirements of titles XI and XVIII...as may be necessary solely for purposes of carrying out this section..." [*]

Now, via Linked In, two more names are reported, this time for the new DJT White House.  See a press release on January 22 from Paragon Health Institute, see also a blog by Brian Blase, a comment by Joe Grogan, and a subscription health article by Amy Lotven at Inside Health Policy.  

  • Theo Merkel - 
    • Special Assistant, Domestic Policy Council (DPC)
  • Dr Joel Zinberg -
    • Special Assistant, National Economic Council (NEC).

Merkel and Zinberg "will be responsible for coordinating health policy across the executive branch."

##

Merkel has experience as an assistant on the Hill, Special Assistant WH 2019-2020, at Manhattan Institute, and as Director for Private Health Reform at Paragon Health.  See an article by Merkel comparing Medicaid expansion and employer insurance, 9/2024, here.

Dr Zinberg, and MD/JD, served previously as "General Counsel and Senior Economist" at Counceil of Economic Advisors in the DJT WH.  He's been a clinical professor of surgery at Mt Sinai (NYC) and a lecturer in law at Columbia University.  He's been Visiting Scholar at American Enterprise Institute, and "Director of Public Health" at Paragon Health.  MD Columbia; JD Yale.



##

[*]

Nerd note.  CMS has long held extensive waiver authority for Medicaid (Title XIX, 19) under SSA Section 1115, enabling states to test innovative healthcare approaches. In 2010, the ACA introduced SSA Section 1115A, granting new waiver authority for Medicare (Title XVIII, 18).  ACA also includes SSA 1332 state plan waivers for Obamacare exchanges. Sidebar table.

##

Acting head of FDA - Sara Brenner.  Acting HHS Secretary- Dr Dorothy Fink.


Friday, January 24, 2025

Going Boldly Where MolDX Has Never Gone Before: DEX Contains LCD Links!

The unique MOLDX program, which sets molecular policy and pricing for about 29 states nationwide, offers an online database (not mirrored at CMS) which shows coverage status of many tests.  They now have unveiled a data window that shows you the relevant Medicare coverage article or LCD for each test.

See the result below: Click to enlarge


Up at the very tippy-top you can see this is the Diagnostics Exchange Registry with Bruce Quinn signed in.  The name of the test is Signatera/CRC/MIBC.   Our database location - in bars near the top - is Catalog/ All Lab Tests/ Keyword Signatera/ Signatera Single Plasma Test / and so on.

The test is then described in three or four sentences. ("This test combines...")

We see the local price (under code 81479 and a Z code) is $2098.45.   NEWLY, we see a box for MCD, Medicare Coverage Database, where the field is "A58476".   Though it's not hotlinked, you can search A58476 at the CMS Medicare Coverage Database.     

At far bottom, we see for plan type = MOLDX, the text is covered.    

WHAT YOU CAN'T DO YET

You can't click on an LCD - such as for minimal residual disease - and see all the tests available under the LCD.

YOU MIGHT STILL BE PUZZLED

In the example above, you can read the long test name, plus the several sentence test description, and refer back to the LCD, and still have a hard time integrating it all together as to for what patient, under what conditions, this test is covered for, or at exactly what timepoint interval, etc.   

ANOTHER THING  YOU CAN DO NOW

If you have the tab catalog horizontal location-bar near the top chosen for "Catalog Overview" and "All Lab Tests," you can see a left side set of choice boxes for general types of tests, which then display in the body of the form.   Click to enlarge:


MolDx might be able to use this html framework for interface except in a new version where instead of test types, the left-side pull down would be an LCD list.   





Thursday, January 23, 2025

Brief Blog: Natera Signatera Price Changes: CMS Fee Schedule ($3500, $2919, $3920)

Header: CMS has raised the fee schedule price of the Natera Signatera test, a minimal residual disease (MDR) detection test.  But not without some hiccups.

##

The Natera Signatera code is 0340U.  CMS priced it at $3500 (list price) through an ADLT pricing decision in July 2021, valid until March 2022.   

In the initial version of the CY2025 fee schedule, released a few days after January 1, 2025, CMS lowered the stated price for 0340U down to $2919. [*]

However, in a revision dated January 10, 2025, without further comment, CMS raised the price of 0340U up to $3920.   

click to enlarge

###
#####
#######

Most ADLT codes do not change year to year.   This suggests a balance of pricing power between ADLT labs and payers.  (But some reports on industry genetic test reimbursement are grim - here.)  

On the other hand, Natera's price rose notably, from $3500 to $3920, suggesting negotiating strength.

###

Dedicated readers of the 2000-row CMS CLFS will recognize the interim price, $2919, as the price of 81455, tumor panel, 51 or more genes.

###

[*] I believe if you dig hard enough, there's some location in early January where Natera mentions publicly it had been mis-priced by error, which CMS promised to correct.  It might have been a passing remark in JP Morgan Q&A.

###

ADLT means Advanced Diagnostic Laborotory Test.  Qualifying tests are paid 9 months at "list price" and then annually on "median market price."  Table here.   The ADLT table above, plus annual CLFS tables for all the ADLT codes, show that the prices of ADLTs are quite stable year-to-year (but see Castle's test 0108U rising from $2350 to $4950).

###

###

Besides this single Signatera code - The MolDx DEX REGISTRY website has elaborate code combinations, e.g. "plasma series," etc, for Signatera MRD testing.  Here.




Wednesday, January 22, 2025

"News Outside the Bubble" - Nature Reviews on Clinical MRD Use Cases

If you mostly attend Precision Medicine conferences, the speed of adoption of new genomic technologies like minimal residual disease (MRD) seems breathtaking and probably every talk is positive.

If you go to another sphere, like radiology, they'll be talking about innovative new imaging biomarkers, important new AI imaging algorithms, and the speed of advance of THAT field.  

If you look at current reviews articles from sources like ASCO and Nature Reviews, you'll get a vibe that's more circumspect that the precision medicine attendees, and that's a third forum that's worth paying attention to.   

See a new review article for January 2025 at Nature Reviews Clinical Oncology, Normanno et al., which takes a comprehensive view of MRD in lung cancer.

Betteridge's Law says if a title has a question mark, the answer is "no."

And indeed, amidst a thorough review of the field, these authors summarize, 

Owing to the limited number of patients enrolled and the different technologies used for ctDNA testing in most of the clinical studies performed thus far, their results are not sufficient to currently support the routine clinical use of ctDNA monitoring in patients with early stage or locally advanced NSCLC. 

Therefore, we discuss the need for interventional studies to provide evidence for implementing ctDNA testing in this setting.

With this review in mind, we can look back at Decibio's recent update about payer coverage for use cases for MRD in oncology (here.) On the one hand, coverage for MRD has expanded.  But on the other hand, MRD seems to be mostly MolDx and a still-easily-countable handful of tests and indications.  Over at AMA, there's no general CPT code for MRD.  And the CMS NCD for NGS in cancer, NCD 90.2,  seems to create a barrier, if anything, by its emphasis on one-time testing for NGS (not serial monitoring).  And it's five years old.

##

I was reminded of the Natera JP Morgan deck, presented January 15, 2025.  One of the slides highlights a trial in CRC, "CALGB/SWOG 80702," which is a big randomized RCT with 1,011 patients, all getting Signatera (bespoke MRD) testing.   While the direct outcome will have some value (use of celecoxib, an NSAID), the overall picture of the 1000 CRC patients and their clinical pathways with their Signatera results, will provide a lot of data for MRD itself.   My reading would be that Natera wants to invest to maintain a lead in large-scale trials and outcome data for MRD.  

###

See a quote from a Genomeweb article about a Br Ca trial ZEST using Signatera in 1,000 patients. There, Turner of Royal Marsden remarks, 

  • "We've shown here that ctDNA can pick up nearly all of the people who are going to relapse, but we don't really know yet how to use that information to guide therapy and whether identifying it early can improve outcomes," Turner said. "At the moment, if you do one of these tests, and you find ctDNA, but you can't see anything on the scan, we don't actually know how to use that information to treat those people."
  • A positive ctDNA test when there is no evidence of radiological progression can be difficult for patients to understand, too, but lessons from trials like ZEST are helping the field better understand how to use ctDNA testing in precision oncology. "We're on the way to identifying the clinical situations where, hopefully, we can use these tests to improve outcomes in the future," Turner said.  
###

In January 2025 remarks on ASCO GI, financial analyst Dan Leonard of UBS remarked that an ASCO panel on MRD in CRC reported mixed opinions.

###
Also "news outside the bubble" - Tibau et al 2024 in JAMA Oncol claiming only 24% of new cancer CDx had significant value.

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