Monday, June 22, 2026

CMS LCD History: How "CAC" Meetings Evolved (2005, 2015, 2019)

 Medicare's contractor advisory committees have evolved greatly from 2005, to 2015, to the present (2019 forward).   I've put the Medicare LCD Manual from each period into one cloud zip file (here).

I asked Claude Opus to evaluate those three files, and compare CAC meetings under each era.

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From Carrier to Contractor: How Medicare Rebuilt the CAC Between 2004 and 2019

A reading of three Program Integrity Manual layers — and why today's Contractor Advisory Committee looks nothing like the standing state roster of 2005.

If you have ever sat on a Carrier Advisory Committee, the modern CAC can be disorienting. The thing many of us remember from 2005 was a standing roster of specialists — one seat per specialty society, often fifteen or twenty members, meeting quarterly in a hotel conference room, receiving each draft Local Coverage Determination as it went out the door to public comment. The thing we attend in 2026 is something else entirely: a half-dozen experts, frequently national rather than in-state, convened for a single afternoon to work through ten or twelve structured questions about the evidence on a topic that does not yet have a draft LCD attached to it — the whole session recorded and posted as a transcript.

That transformation is fully documented in three sedimentary layers of one manual chapter. Reading them in sequence shows that the change was not a gradual drift. It was a single, discontinuous response to a statute, bolted onto more than a decade of deferred housekeeping.

Read the revision stamps first

The three documents are not freestanding policies. They are the same Program Integrity Manual section at three points in time, and the revision stamps tell most of the story before you read a word of substance.

The 2004 text carries Rev. 63 (01-23-04) and sits in the old PIM numbering as §8.1. The 2015 text is the same manual, renumbered to §13.8.1, but its bones are still Rev. 71 (04-09-04), with the structure-and-process subsection bumped only to Rev. 473 (06-21-13). The 2019 text is a different creature altogether: Rev. 863, issued 02-12-19, effective 10-03-18, implementation January 8, 2019, relocated to §13.2.4.3.

That January 8, 2019 date is the tell. It is the go-live date of CMS's wholesale rewrite of the LCD process, issued under Change Request 10901 to carry out Section 4009 of the 21st Century Cures Act (P.L. 114-255, signed December 13, 2016), codified at Social Security Act §1862(l)(5)(D). So you are really comparing two eras, not three: a carrier-era artifact that barely moved between 2004 and 2015, and a Cures-driven reconstruction in 2019.

Sidebar — The CAC across three manual layers

Feature 2004 (Rev. 63) 2015 (Rev. 71 / 473) 2019 (Rev. 863)
Name Carrier Advisory Committee Carrier Advisory Committee (text still says "Carriers") Contractor Advisory Committee; actor is the MAC
Geography One CAC per state, rigidly One CAC per state, rigidly Per state, per jurisdiction, or multi-jurisdictional / multi-MAC
Membership theory Specialty representation; one seat + alternate per specialty Same Evidence expertise; "more voices" (nurses, epidemiologists, etc.)
Core function Dissemination & liaison; carry drafts to societies Same Review the quality of the evidence
Link to comment clock 45-day clock starts on distribution to the committee Same Severed; comment period is a separate statutory step
Timing vs. draft CAC reviews the draft LCD as released Same May meet before a proposed LCD exists, on the topic's evidence
Cadence ≥ 3 meetings/year, ≤ 4 months apart Same No minimum; MAC sets frequency by LCD volume
Leadership CMD + elected physician co-chair; 2–3 yr tenure Same Co-chair / tenure language dropped; MAC approves members
Transparency Minutes to members & RO; web posting optional Same (+ PSC/GTL overlay) Recorded (audio/video), public, posted as LCD record
Compensation None; voluntary service None None (the one provision carried forward verbatim)

2004–2015: the standing state roster as a representation machine

In the first era the committee is the Carrier Advisory Committee, and almost every structural choice flows from that one word. One CAC per state; where a carrier spanned several states, each state got "a full committee and the opportunity to discuss draft LCDs." The committee was built around specialty representation: one member plus a designated alternate per specialty, with additional specialists pulled in when their expertise was implicated. In practice that produces exactly the body many of us remember — a standing roster running to fifteen or twenty seats, because the design goal was to have the relevant society's voice already in the room for whatever LCD surfaced.

The functional theory was dissemination and liaison, not adjudication of evidence. The "Role of CAC Members" section is explicit: members existed to carry proposed LCDs back out to their state and specialty societies to solicit comment, to carry Medicare program information back in, and to flag inconsistent or conflicting medical-review policy. They were conduits. The contractor medical director co-chaired with one physician elected by the committee, and the co-chairs set the agenda and pushed background material out at least fourteen days ahead.

Two features matter most for understanding what later broke. First, the CAC was wired directly into the comment clock: the 45-day comment period "starts when the proposed LCD is distributed to the committee members," and the co-chairs "present all proposed LCDs to the CAC for discussion." The CAC meeting was the public-facing event for a draft LCD — which is precisely the co-distribution-to-CAC-and-public simultaneity of the 2005 model. Second, the cadence was fixed and frequent: a minimum of three meetings a year, no more than four months apart. That is a standing quarterly body by design, because a standing body is what you need when the committee is the routing point for every draft in the jurisdiction.

What is striking is how little changed by 2015. The Medicare Modernization Act had already replaced carriers with A/B MACs years earlier, yet the 2015 text still says "Carriers shall establish," still says one CAC per state, still prescribes three meetings a year, still triggers the comment clock on distribution to the committee, still names an elected physician co-chair, still suggests two- to three-year tenures. The only real accretion is a maintenance overlay reflecting the program-integrity contractor apparatus — the parenthetical "(for PSCs, the GTL, Co-GTL, and SME)" threaded through the directory, waiver, and recordkeeping provisions — plus the 2013 (Rev. 473) refresh of the structure section. Between 2004 and 2015, CMS updated the plumbing references and left the committee's constitutional theory entirely intact. The 2015 document is a carrier-era document wearing a MAC-era nametag.

2019: the Cures rupture

The 2019 rewrite changes the committee's purpose, not merely its logistics, and nearly everything else follows from that.

Carrier becomes Contractor. The committee is renamed, the actor throughout is "MACs," and the carrier vocabulary is finally retired a decade and a half late.

The geographic unit is loosened. Where the old rule was rigidly one-CAC-per-state, 2019 permits one CAC per state, one per jurisdiction, or a multi-jurisdictional CAC with representation from each state — and CMS's companion LCD Process Q&A confirms that multi-MAC CACs are also on the table. This is the textual hinge that permits the modern reality. Once you may convene a single panel for an eleven-state jurisdiction, the chair of pathology at one academic center and the chair at another become natural picks, because you are no longer staffing for in-state representation. You are staffing for the best available evidence reviewers.

Representation becomes evidence review. This is the conceptual core. The old purpose — a formal mechanism for physicians in the state to be informed of and participate in LCD development, plus a liaison forum — is replaced by a purpose centered on the evidence: members "review the quality of the evidence used in the development of an LCD." CMS said the quiet part plainly in the Q&A: because Cures now requires LCDs to include a summary of the evidence considered and a rationale, the role of CAC members should evolve to reviewing the quality of that evidence instead of only representing a constituency. The 2019 language even imports the deliberative register of the national MEDCAC — advice is "most useful when it results from a process of full scientific inquiry and thoughtful discussion with careful framing of recommendations," and the panel exists to ensure an "unbiased and contemporary consideration of 'state of the art' technology and science." That is consciously MEDCAC-style framing dropped onto a local body.

The comment-clock coupling is severed. Note what disappears: the entire mechanism by which distributing a draft LCD to the committee started the 45-day clock, and the instruction that co-chairs present "all proposed LCDs" to the CAC. This is the most consequential deletion. Cures created, by statute, a separate and mandatory public process — the MAC must post the determination in its entirety, identify where and when it was first made public, and supply a rationale, at least forty-five days before the effective date. Once the open public-comment period and the proposed-LCD posting are independent statutory steps, the CAC no longer needs to be the comment vehicle. It is freed to move upstream: it now convenes around a contemplated topic and its evidence base. The Q&A makes the new optionality explicit — a MAC may host the CAC before posting a proposed LCD, to inform the upfront analysis, or after. That is exactly the shift from the 2005 picture (draft presented to the roster, co-distributed to the public, clock running) to the 2026 picture (a future topic, structured evidence questions, no draft on the table yet).

Transparency is mandated, and it reshapes the format. The 2019 rule requires the MAC to record every CAC meeting — video, audio, or both — and to maintain that recording on the contractor website as part of the LCD record. All CAC meetings are open to the public to attend and observe; only the non-evidence portions (provider practice-trend reporting, fraud-and-abuse discussion) may be closed. The old regime asked only for minutes distributed to members and forwarded to the regional office within ten days, with web posting optional and FOIA-redacted. The published transcript of a modern CAC is the direct artifact of this recording-and-posting mandate, and the structured, ten-to-twelve-question, roughly two-hour format is the natural operational form of "review the quality of the evidence" plus "careful framing of recommendations." It is a local echo of the MEDCAC voting-question script, engineered to produce a clean, citable evidentiary record rather than a roundtable of society liaisons.

The standing body dissolves into an ad hoc panel. Several deletions point the same way. The fixed cadence is gone; the Q&A confirms MACs now set frequency "based on the appropriateness and volume of LCDs requiring CAC input," and a CAC is not required for every LCD. The two- to three-year tenure guidance is gone. The elected physician co-chair structure is gone; member approval now rests simply with the MAC. The dissemination-to-societies role is gone, because the statutory public-comment process now performs that solicitation directly and at scale. The reference to the Practicing Physicians Advisory Council is gone (PPAC itself had been sunset earlier in the decade). The substitution rule tightens and formalizes — a substitute may attend only if the MAC is notified and approves at least one week ahead — which is the housekeeping you would expect once a meeting is a recorded, public event of record. About the only provision carried forward verbatim is the honorarium prohibition: participation remains voluntary, expenses on the member or the society.

The net trajectory — and why 2015 is the instructive case

Put the two eras side by side and the arc is coherent. The carrier-era CAC was a representative standing committee — a per-state roster of society delegates, meeting quarterly, functioning as the routing point and comment trigger for draft LCDs, steered by the contractor medical director and an elected physician. The Cures-era CAC is an evidence-review panel — convened at jurisdictional or multi-jurisdictional scale, often stocked with national figures chosen for expertise rather than in-state constituency, addressing a future topic through structured questions in a recorded, public, transcribed session that becomes part of the LCD record, with the comment period and the proposed-LCD posting hived off into their own statutory channels.

The 2015 document is instructive precisely because it isn't a transition. It shows that as late as 2015 CMS was content to leave the 2004 design frozen, which means the 2019 change was not a slow evolution but a single discontinuous response to a statutory mandate. The "many other ad hoc changes" — the multi-jurisdictional option, the substitution mechanics, the recording medium, the closable fraud-and-abuse portions — are best read as CMS using the Cures rewrite as the occasion to clear a decade of deferred modernization in one transmittal.

One caveat for readers who want to follow the functions rather than the committee: these provisions capture the CAC specifically. The full 2019 Chapter 13 rewrite also created or relocated the informal pre-LCD meeting, the formal open meeting, the new-LCD request process, and the comment-and-response (RTC) machinery. Those companion provisions are what make the upstream repositioning of the CAC coherent. The dissemination and comment functions the CAC used to carry did not vanish in 2019; they were redistributed into a statutory public process that the committee no longer needs to host.

Key documents


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#Alternate

Chat GPT 5.5

Core thesis

The CMS CAC evolved from a standing, state-based professional advisory committee embedded in the draft-LCD comment cycle into a more flexible, evidence-review body that MACs may convene around a topic, often before a proposed LCD is released. In 2004 and still largely in 2015, the CAC was part of the old carrier-era culture: one committee per state, regular meetings, local specialty society representation, minutes, agendas, and draft LCDs distributed to CAC members at the same time the 45-day comment period began. 

By 2019, after 21st Century Cures and CMS’s broader LCD-process revisions, the CAC had become more formalized as a transparency and evidence-review mechanism: open to public observation, recorded, potentially jurisdictional or multi-jurisdictional, and explicitly focused on the quality of evidence rather than simply “local physician input.”

CMS itself described the 2018–2019 Chapter 13 revision as a response to the 21st Century Cures Act, intended to improve transparency in the LCD process. (Centers for Medicare & Medicaid Services)

Sunday, June 21, 2026

Slow LCDs: Some Date Snapshots

We often hear about slow timeliness for LCDs, and outsiders can't always believe the numbers.  ("We can turn in your LCD request by August 1, 2026; contemporary data shows the LCD may be finaled as late as in August, 2032.")   A bill for quicker LCDs, H.R.8500, has been proposed.

Case Study

MolDx received a dossier and coverage request for DCIS breast cancer molecular testing in June, 2020 (here).

MolDx held a streamed, expert advisors meeting on July 15, 2024 (scroll for Stratification in DCIS on this page.)  For two hours, 7 experts addressed 12 structured questions. A 120-page transcript was posted.  (More here, incl. transcript summary.)

The next summer, July 17, 2025, MolDx posted a draft non coverage LCD, DL40142.  After reviewing 57 publications, the LCD concludes:  

"This contractor believes the utility of risk stratification, based on all evidence reviewed, is in the identification of patients who may not derive meaningful benefit from RT aside from individualized risk considerations given current practices and dependence on RT use. At this time, there is no convincing evidence that any test (and their analytes measured) can identify a patient who would not reasonably benefit from RT beyond clinicopathologic factors already demonstrated to risk stratify patients.

A fiinal LCD would be expected sometime in summer 2026.

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I asked Chat GPT for a concise comparison of the transcript and draft LCD.

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The CAC meeting was exploratory, dialogic, and clinically nuanced; the Draft LCD is the same discussion converted into a formal MolDX coverage standard. 

In the CAC, MolDX framed the task as understanding whether DCIS biomarker risk-stratification tests had enough analytical validity, clinical validity, and especially clinical utility to meet Medicare’s “reasonable and necessary” threshold. The experts generally agreed that DCIS is frequently overtreated, that many patients receive radiation therapy for small absolute benefit, and that a test able to identify patients who could safely avoid radiation would have real clinical value. But the meeting also exposed disagreement over what counts as low risk, whether IBTR or invasive recurrence should drive decisions, how much absolute radiation benefit is clinically meaningful, and whether current biomarker tests add enough beyond ordinary clinicopathologic tools.

The Draft LCD adopts much of that CAC logic but resolves the ambiguity -- against present coverage. 

It acknowledges the clinical need and even states confidence that biomarkers may eventually improve DCIS risk stratification. However, it concludes that current tests such as DCISionRT and Oncotype DX DCIS have only limited evidentiary support and have not yet shown, with sufficient validation, that they identify a Medicare-relevant group for whom radiation therapy provides no meaningful benefit. The LCD’s key move is to define “sufficiently low risk” operationally: a group in which the absolute reduction in ipsilateral breast tumor recurrence from radiation is 5% or less. It then requires future tests to complete MolDX technical assessment, be used only in their validated population, and show incremental value over existing clinicopathologic nomograms or risk systems. In short, the CAC supplied the clinical dilemma and evidentiary questions; the Draft LCD turns them into a noncoverage policy with a clear but demanding path to future coverage.

Key source anchors: MolDX’s CAC purpose was to assess evidence, decision-making, and whether tests improve patient outcomes rather than merely change management. The LCD summarizes the CAC as finding clinical need but debate over evidence, endpoints, clinicopathologic comparators, and the 5% absolute-risk-reduction threshold. The LCD’s rationale then concludes that current biomarker evidence is insufficient and must show incremental value over existing tools.


Thursday, June 18, 2026

OIG: Another Workplan, This Time It's Genetic Tests in Part B

 A few days ago we flagged an OIG workplan about pathogen panel coding for > 5 pathogens (think 87798) - here.

OIG has another another molecular pathology workplan - this one focused on genetic tests.

The audit and report is expected to run 2026-2028.  In particular, they will look for differences in payments between MOLDX and Non-MOLDX geographies.

https://oig.hhs.gov/reports/work-plan/browse-work-plan-projects/trends-and-vulnerabilities-in-genetic-tests-covered-under-medicare-part-b/


Medicare Part B spending on genetic tests has been climbing steadily, with 2024 expenditures topping $3.6 billion—a half-billion-dollar increase over the previous year.  

Genetic tests can harness the power of technological advancements to provide Medicare enrollees and their providers with valuable insight into disease risk, prevention, diagnosis, and treatment.

However, the rapid emergence of new tests and the higher average per-test payment amount can also make genetic tests vulnerable to fraud, waste, and abuse.  

Prior work by OIG and its law enforcement partners has identified genetic testing fraud schemes involving deceptive telemarketing campaigns and kickbacks.  This study will examine avenues for strengthening oversight of genetic tests covered under Medicare Part B, including identifying tests that may be vulnerable to fraud, waste, and abuse; assessing trends among laboratory test providers; and examining whether geographic variations exist, particularly between jurisdictions that do and do not participate in the Molecular Diagnostic Services Program.

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"Panels of 5" Project was announced 6/11, this one on genetics, announced on 6/15.

AI Corner: Chat GPT Interprets German-Language Sequencing Policy Documents

This week, Genomeweb has an excellent article about reimbursement and policy changes in German regarding NGS.   The article includes a number of important commentaries from experts. 

As an AI experiment, I was curious how well Chat GPT could read the underlying 8-page and 35-page dense government documents in German, and turn them into an article for English-speaking US readers.  While I can read German, I have not checked the 43 pages of original documents against the Chat GPT output.

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Germany Rewrites Human Genetics Payment:
Broader NGS Recognition, Lower Marginal Reimbursement

BERLIN — Germany’s national physician-fee-setting process has approved a major restructuring of outpatient reimbursement for human genetic in-vitro diagnostics, updating a 2016-era payment framework for next-generation sequencing while adding explicit price cuts, volume degressions, and tighter billing architecture for high-growth genetic testing.

The June 9 decision by the Erweiterter Bewertungsausschuss — the Extended Evaluation Committee that sets the Einheitlicher Bewertungsmaßstab, or EBM, for physicians treating patients in Germany’s statutory health insurance system — takes effect Oct. 1, 2026. For U.S. readers, the EBM is roughly analogous to a national physician fee schedule, but with important differences: it is negotiated between the National Association of Statutory Health Insurance Physicians and the national association of statutory sickness funds, and it operates within Germany’s corporatist, self-governing statutory insurance system rather than through unilateral CMS rulemaking.

CMS Puts HCPCS Modifiers for Local, Metastatic Cancer - On Hold

Last fall, CMS proposed to create two cancer modifiers as two-letter HCPCS codes, for local versus metastatic cancer.  (See my February blog here).

CMS has published its final results based on that December 2025 code cycle, and CMS will NOT procede with the cancer modifiers at this time.

Find the "Final Decisions" PDF here, and see page 144 "Next Generation Sequencing."

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(1)
https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/current-prior-years-level-ii-coding-decisions


(2)

Page 144-145.

CMS Final HCPCS Coding Determination

We appreciate the comments provided in response to CMS’ published preliminary determination. After consideration of the comments we received, CMS is revising its preliminary coding determination. Based on the concerns that were raised by stakeholders, CMS will not be pursuing the implementation of the proposed modifiers at this time.

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Public comment

The Association for Molecular Pathology (AMP) expressed concerns about CMS’ preliminary determination. The primary concern centers on the administrative burden these modifiers would place on laboratories. AMP emphasized that laboratory professionals, while integral to patient care teams, do not directly manage patients or determine cancer staging. These modifiers would require laboratories to obtain and verify detailed staging information. This would be operationally impractical and could delay access to critical genomic information needed for treatment decisions. They stated that these modifiers could provide payers with additional mechanisms to inappropriately delay or deny reimbursement. 

The commenter recommended that CMS delays implementation of these modifiers and clarify that they apply only to somatic testing, not  NGS germline testing, as current coverage policies for germline testing do not restrict coverage based on cancer stage. AMP expressed interest in working with CMS to reopen National Coverage Determination 90.2 to align coverage criteria with current advancements in the field and welcomes further discussion to provide additional technical and clinical insights.


Wednesday, June 17, 2026

Vinay Prasad: HE'S BACK

Before Vinay Prasad, the UCSF oncologist, served as head of CBER at FDA, he was famously outspoken—in blogs, vlogs, podcasts, and peer-reviewed articles.

During his time at FDA, those informal channels went quiet. 

Now that he is out of FDA, he appears to be back at full volume. His YouTube channel, dormant for a year, has posted nine new vlogs in a month, most running 20 to 30 minutes.

https://www.youtube.com/@vprasadmdmph/videos

There's a similar rebound for his blog/substack.  It was silent after May 2026, and beginning June 2, eleven articles.

https://www.drvinayprasad.com/

How did life in Washington change him?   I took his eleven  new articles and his last eleven from Spring 2025 before his hiatus, and asked for an AI comparison.  Embarrassingly, Claude counts "13" new articles; that's not central so I've left as-is.

SUMMARY

The two analyses below ask the same question: what changed when Vinay Prasad returned to public writing after his turbulent year at FDA’s CBER? The first, from Claude, is more quantitative and biographical, tracking article counts, length, citations, profanity, topic mix, and the conspicuous silence around his FDA controversies. The second, from ChatGPT, is more interpretive, arguing that Prasad’s center of gravity shifted from culture-war combat toward clinical epistemology: weak evidence, observational bias, overdiagnosis, medical AI, journals, and institutional incentives. Together, they both conclude that Prasad is out of power, but not out of influence.



Register Now for June 25 HHS Webinar on AI, Policy, and Reimbursement

HHS Webinar June 25: What Did HHS Hear About AI in Clinical Care?

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AI Corner: Chat GPT 5.5
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In December 2025, HHS issued a broad Request for Information asking how the Department should accelerate the adoption and use of artificial intelligence in clinical care. The RFI was only 3 pages, but it was pointed. HHS asked how it should use three big levers — regulation, reimbursement, and research and development — to move AI into clinical care faster, while still addressing safety, privacy, interoperability, and trust.

The RFI was released December 19, 2025, and appeared in the Federal Register shortly afterward (12/23). Comments were due February 23, 2026. 

Now HHS/ONC has scheduled a public webinar to discuss what it heard.

Webinar: Adoption of AI in Clinical Care: Updates from the HHS RFI
Date/time: Thursday, June 25, 2026, 3:00–4:00 pm ET, 12:00-1:00 PT
Registration entry point:
https://healthit.gov/event/adoption-of-ai-in-clinical-care-updates-from-the-hhs-rfi/

Why This RFI Matters

Very Brief Blog: Using AI to FInd Someone's Name

 We live at a time where some people use AI like second nature and some nearly never.

Here's a real life example.  For a moment today I was blocking on the name of Jennifer Leib, a well-known health policy consultant in DC.  Here's my prompt and here's the result.

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PROMPT
There is a woman in washington dc whose training is as a genetic counselor and she runs a small but high quality health policy consulting group. it has a sort of generic name (like "policy innovations"). ???

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RESULT [chat gpt]