Friday, June 30, 2023

AMA Releases New Category III Codes: Numerous Codes for Digital Pathology

SHORT READ:  July 2023, AMA releases even more digital pathology codes, expanding from those released January 2023.  


In 2022, effective 1/1/2023, AMA created about a dozen Category III codes for digital pathology.  CMS has said "nope" to paying for them in the hospital outpatient setting, where a lot of biopsies originate.  See here.

On June 30, 2023, AMA released all the new Category III codes effective January 1, 2024, and it again includes a lengthy roster of digital pathology codes.  There are also revisions to the existing January 2023 codes.

At a glance, the codes run from 0827T to 0856T or about 30 codes. 

Read and review them all here:

A screen shot with a peek at the new text is here, click to enlarge.

I believe CMS will discuss the codes from January 2023 in the imminent summer rulemaking (OPPS and/or PFS) and will post valuations for these late-breaking newest codes in the November 2023 final OPPS rulemaking.

TCET: Follow up from STAT PLUS (June 30, 2023), Genomeweb (July 13, 2023)

Short Take:  STAT PLUS publishes a bigger, more detailed article on TCET, with interviews.


On June 22, 2023, CMS released its long-awaited "Transitional Coverage" or TCET rules.  My lengthy original blog here.  

I posted an update on June 28, covering an additional TCET document, which is about new rules for "coverage with evidence development."  Here.

On June 30, Lizzy Lawrence at STAT published a deep-dive subscription article including interviews with multiple stakeholders.  Find it here.

Find July follow up at Genomeweb, here.



  • STAT: See prior articles from 2022 where STAT looks at BT Devices as a whole, here, in a lengthy and detailed piece of journalism.  It notes that early BT approvals ran 70% and when the program became more popular they fell to 40%.
  • STAT: See a very useful a STAT "BT Tracker" here.   
  • FDA: doesn't list devices "inside" the BT program (consistent with never discussing products under review), but FDA does publish those devices which have exited the BT program with approvals - here.  (Currently about 60 of these).  FDA also publishes bar charts of BT status granted per year and a chart parsing them by medical device area (e.g. "cardiology.")   


The Feeble Status of Parallel Review - 2 for 96

The STAT article cites an FDA Q&A about the feeble status of Parallel Review.  It states, "there have been 96 formal requests to participate - two devices have completed Parallel Review.   Cologuard 2014, FMI 2017."  Here.   Let me add, I've known companies that outreached to FDA re Parallel Review and got a curt "Nope!" email response quickly.  I'm not sure if FDA logs those as "formal requests."  So the attempts at P.R. might be much higher than what FDA logged as 96 formal requests.   

Thursday, June 29, 2023

MolDx Finalizes Bladder Cancer Biomarker LCD L38576

MolDx has finalized a bladder cancer biomarker LCD ("Prognostic and Predictive Classifiers" that it proposed in July 2022.  The LCD will be effective August 5, 2023.

The LCD was "MAC initiated."

  • As a MolDx LCD, the LCD covers only DNA/RNA biomarkers.   (In this application, other types of biomarkers may ahve the same indications, but are NOT covered in this LCD).
  • The LCD was "MAC initiated" per its Tracking Sheet.
  • See the draft LCD here. DL38576.
  • See the final LCD here.  L38576.
  • See the "responses to comments" here. A59408.
  • See the Billing Article here
  • The LCD is about 2000 words (w/ Bibliography).  See a draft to final "redline" here.
    • The revisions are minor.
    • Text asking the lab to notify "indications" to the physician, is revised.
    • If NGS is used, conditions in NCD 90.2 must be fulfilled ("advanced cancer," etc.)
    • While several test brands are "covered," only 1 may be used  prior to therapy unless the 2nd is different genomic content and medically necessary in addition to the first.
    • The LCD adds a statement that NCCN "recommends molecular/genomic testing for Stages IVA, IVB," and "possibly IIIB."  
    • In addition the the guidance to Stage IV, the NCCN also is quoted as, "recommends that molecular testing be conducted early."
  • The billing article includes codes 81445 (5-50 genes in tumor), 0016M ("Decipher Bladder", a gene expression test), and 81479 (other genomic test).
Other Topics

  • LCDs vs Articles?
    • A current lengthy article at Genomeweb has multiple stakeholders discussing the ground between LCDs and Articles (here).  
    • Here, similarly, the LCD gives generalistic statements in its concluding section ("Numerous prior Medicare decisions consider the Fryback and Thornbury evidence hierarchy...For patients with bladder cancer, an array of treatment possibilities exist...Diagnostic tests are expected to change physician management."  
    • From these "concluding statements," MolDx discerns, crafts and periodically updates a billing article that covers and non covers various tests without further public discussion or public comment on their evidence.  
  • CGP? 
    • This LCD discusses CGP (Ross et al. 2016, 295 genes, 90% of cases actionable), and the LCD cites CGP genes like PIK3CA and ERBB2 and FGFR2.  
    • But bladder cancer CGP is also covered under rules found in the LCD for Comprehensive Genomic Profiling (e.g. L38158).   
    • And an FDA-approved bladder cancer test like Foundation Medicine would be covered not under this LCD, but under  rules at NCD 90.2, leading the reader to a third overlapping CMS document. 
  • Recurrence? 
    • MolDx has a different LCD (see A58376) that covers the Signatera bladder cancer recurrence test.
  • Other "biomarkers"?  
    • This LCD discusses "prognostic predictive" bladder cancer biomarkers but as a MolDx branded LCD, it covers only DNA/RNA testing.  
      • Some similar recurrence or prognostic indications are covered in an independent document at Noridian, See L36680 "Bladder tumor biomarkers" which certainly sounds by its title like an overlapping LCD.  
      • Unless you're up on your "MolDxology" and understand the quarter to quarter negotiations between Noridian and MolDx, you might not understand the different territory of the two bladder cancer biomarker LCDs and co-existing sets of rules, L38576/L36680.  Neither bladder cancer biomarker LCD points the reader to the other, as if they exist in unrelated universes.
  • Use of NCCN.
    • Recently, Novitas published an oncology NCD that relies heavily on external references sources like NCCN.   (See my blog here, but I understand there's a lot of stormy stakeholder pushback.)   MolDx also points heavily to external guidance in its pharmacogenetics LCD and its hereditary germline cancer syndrome LCD.  Here, for the bladder cancer LCD, in the Q&A A59408, MolDx makes this comment re NCCN.
      • While we acknowledge the NCCN Biomarker Compendium and find it a great resource the MolDx program performs an independent technical assessment to determine Analytical validity, Clinical validity and Clinical utility. 
      • We use the published literature and review it to determine the above criteria and do not rely exclusively on one source.
    • In contrast, the MolDx LCD L39017 inherited cancer syndrome LCD adopts this coverage rule, "The test includes the genetic content with definitive or well established guidelines."

Wednesday, June 28, 2023

MolDx 90 Minute Webinar on Z Codes - Via Dark Daily

On Thursday, June 29, 2023, MOLDX will present a 90 minute public webinar on Z codes.  It's hosted at DARK DAILY and sponsored by XIFIN.

While this may be too late for many to calendar and attend, I am guessing it will probably be available as video archive.  (See the link below for a robust number of good past webinars with on-demand streaming).

The Dark Dailiy webinar home page is here;

Here's the info and registration page for MolDx Z Codes:

MolDx Finalizes Castle Melanoma LCD (L39389)

In an October 2022 blog, I noted that MolDx had issued a proposed revision to a melanoma gene expression test (GEP) LCD - here.

As of June 22, 2023, MolDx has issued a final version of the LCD.  No changes are listed in the change management section.  In the Q&A article, responses to comments, the main focus appears to be on maintaining that a GEP test on an uncertain melanoma lesion can only be ordered by a dermatopathologist.

Find the final LCD here, L39389, effective August 6, 2023.  The "Changes" section suggests none, and I did a redline of the proposed and final, and found none.  The billing article covers 0090U and 0314U.  0090U is Mypath Melanoma, which I think originated at Myriad, and 0314U is DecisionDx Melanoma.

The 2022 proposal is still online, here:

The responses to comments article, A59412, is online here:


There are numerous lengthy comment letters, all of which are answers in the format of "Response #1."

Response #1 is 650 words.

The comments in total, tally about 14,000 words.

Here, for the blog, I offered my condensed version of Response #1.  See the full article A59412 for the full MolDx text, and 4 citations.

Response Summarized:

The comment to which MolDx responds addresses the issue of allowing physicians other than dermatopathologists to order molecular assays for diagnosing cutaneous melanoma. The commenters argued for this change based on reasons such as improving access to care and simplifying practice workflows. However, the response notes that there is no supporting evidence from medical literature for this routine practice. The draft policy explicitly emphasizes the importance of subspecialty training and experience in dermatopathology for accurate diagnosis and clinical management of challenging melanocytic lesions.

The response cites studies that highlight the need for a second opinion from trained dermatopathologists in complex melanoma cases, as well as the benefits of diagnostic accuracy and reproducibility among board-certified or fellowship-trained dermatopathologists. Referring ambiguous cases for expert review and further diagnostic testing is considered standard practice, providing patients with the most accurate final diagnosis. This process does not require the patient to make an appointment or travel, as only the specimens/slides are sent to the expert dermatopathologist. [BQ - or possibly digital pathology.]

The response also clarifies that the current policy is not a departure from previous requirements but has slightly expanded the scope to include board-eligible dermatopathologists. The retention of the requirement for trained dermatopathologists to order molecular tests is justified based on the reasons stated, ensuring accurate diagnosis in challenging melanocytic neoplasms.

Billing Article

A59163, here:


Note that this LCD is for "difficult case" diagnostics.  MolDx has a separate LCD for "risk stratification" whichm aims to assist with decisions like invasive lymph node dissection. Here.

FDA Announces: Regulations about LDT's are Coming Very Soon

In a dry and brief federal regulations announcement, FDA has formally announced that it plans to issue regulations about LDTs, lab developed tests, very soon.   

Expect proposed regulations by August 2023.

Read more about it at

HHS/FDARIN: 0910-AI85Publication ID: Spring 2023 
Title: ●Medical Devices; Laboratory Developed Tests 

This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

In the Trump era there were HHS  memos that FDA could not regulate LDTs; see Topic #1 at a 2021 blog and see "ZIP" file there.

Hey, CMS Released 5, not 4, TCET Documents! See #5, "Guidance for CED Decisions."

 In my lengthy June 22 blog on CMS releasing "TCET," I had four documents.

  1. TCET proposal in Federal Register
  2. CMS fact sheet summarizing it
  3. Chief Medical Officer's blog on TCET goals
  4. CMS NCD Evidence Review Guidance (General)
Well, there's a FIFTH document, which is a 14 page guide to CMS use of Coverage with Evidence Development.  It has its own web page and its own comment cycle.

How to Find CED Guidance, and Evidence Guidance

Here's the home page for NCD guidance documents:

One new entry is "[PROPOSED] CMS National Coverage Analysis Evidence Review."   The other is "[PROPOSED] Coverage with Evidence Development."   Note that new documents for comment are the first entries on this page since 2006.

Comments til August 21, 2023.

Find the CED GUIDE here:
Comments also til August 21, 2023.

CED Sometimes Criticized

CED has been criticized as often not finished or not effective.  For an academic report, see Zeitler 2022.  See also my citations to Grogan and Peschin on CED - here.  Famously, in January 2021, the Trump-era general counsel of HHS Mr Charrow, wrote a memo that CED was not legal - see the section on "statutory basis of CED" in the new CED document.  (See it as Topic #2 at this blog and seek "cloud copy.")

CED is 4600 words.  Here's an AI summary.

The policy topic of CED receives a new proposed guidance document on Coverage with Evidence Development (CED) in medical policy. It begins with an introduction and background, highlighting the statutory basis and the need for transparent evidence development. The principles governing the application of CED are outlined, emphasizing its role in expanding access to medical technologies and addressing evidence deficiencies. The document presents clinical study standards for CED under Section 1862(a)(1)(E), focusing on study design, population inclusion, data quality, reporting, and governance. The importance of control groups and blinding in CED studies is discussed, along with the process of ending CED and ensuring transparency. The document concludes with a revision history.
  • Purpose: The document aims to address the factors considered in making national coverage determinations (NCDs) using the CED paradigm to provide a predictable and transparent evidence development framework.

  • Statutory Basis: Sections 1862(a)(1)(A) and 1862(a)(1)(E) of the Social Security Act form the basis for CED, allowing Medicare payment for items and services that are reasonable and necessary for research conducted under Section 1142 of the Act.

  • Principles of CED: CED NCDs occur within a transparent coverage determination process, expand access to medical technologies, and require evidence generation to address specific evidentiary deficiencies.

  • Clinical Study Standards: CED studies should be conducted by qualified sponsors/investigators with a written plan, addressing study protocol, milestones, study context, design, population, subgroup analyses, care setting, health outcomes, success criteria, data quality, construct validity, sensitivity analyses, reporting, sharing, governance, and legal requirements.

  • Importance of Control Groups and Blinding: Blinding in randomized controlled trials reduces bias, and control groups are crucial for assessing treatment effectiveness and minimizing confounding factors.

  • Fit-for-Purpose Study Designs: CED studies should be designed appropriately to answer specific CED questions, using randomized controlled trials or advanced observational designs with appropriate controls to minimize bias and confounding.

  • Ending CED: CED requirements should be time-limited to facilitate the timely generation of sufficient evidence. Interim analyses and publication of results should inform coverage decisions, and the completion of CED cycles can be triggered by CMS reconsideration or a planned re-examination of evidence.

  • Transparency of CED: The NCD process is transparent, allowing public comment and participation. Reporting study results and registration with enhances accountability, public access to information, and better-informed decision-making.

  • Revision History: The guidance document was first published in 2006 and revised in 2014.

  • Impact: The proposed guidance aims to enhance the evidence development framework, expedite beneficiary access to new technologies, ensure patient safeguards, and support manufacturers in generating evidence for Medicare coverage.

Tuesday, June 27, 2023

Very Brief Blog: TCET Coverage Policy Now Published in Fed Reg

On June 22, CMS released TCET breakthrough device coverage policy, with a primary document and several supplements.

The primary document is now typeset and officially published in the Federal Register.  It's 88 FR 41633-44, officially dated June 27.  Comment is open til August 28,  5 pm ET.

New Study Advocates Pathologists and Genomic Test Orders; But Medicare Law Makes Barrier

SHORT FORM:  A new paper on precision oncology in the community proposes pathologists should order tumor testing.   However, they don't mention CMS regulatory barriers.


On June 20, Precision Medicine Online has a deep dive article by Alison Kanski, discussing an important new study of precision oncology in practice.  

  • Find the subscription article here.
  • Find the original study here.
    • Implementation Science Communications, Ellis et al.
    • "Determinants of targeted cancer therapy use in community oncology practice."

The study carefully process-mapped 11 cancer care delivery teams via interviews with 24 providers, including oncologists, pathologists, and other staff.   The paper takes something of a sociology/anthropology view of roles, processes, conventions, etc.  Their main conclusion is reflected in the abstract:

A key determinant of molecular testing was role alignment. The dominant expectation for oncologists to order and interpret genomic tests is at odds with their role as treatment decision-makers’ and pathologists’ typical role to stage tumors. Programs in which pathologists considered genomic test ordering as part of their staging responsibilities reported high and timely testing rates. 

Essentially, cancer tumor panels would get ordered more timely and more consistently if this was in the hands of the pathologist who is signing out the case, and not an oncologist who is also occupied with caring for the patient and dealing with the clinical challenges of the advanced cancer.

But CMS Regulations Disagree

As many who work with Medicare policy know, CMS regulations require the test be ordered by the physician who is treating the patient and managing him/her.   The regulation is found at 42 CFR 410.32.

  • Diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. 
  • Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary 

There are some limited abilities for a pathologist or radiologist to correct or finish a clinician's order (Benefit Policy Manual 15:80.6.4).  They haven't been extended as for as, say, a Foundation Medicine or Oncotype test.   OIG carefully reviewed non-treating-physician orders for genomic tests in a new fraud report regarding 81408, so it's certainly a live area of policy (here). The point is also emphasized in a current Novitas LCD for oncology genomic tests.\

CMS Legal Barrier Not Mentioned in Ellis Paper

The Ellis et al. paper talks about the improvements that would result from pathologist test ordering, but no one is quoted as being familiar with the current legal barriers that would have to be moved.

The paper includes an elaborate process map (Fig 2):

click to enlarge

They use a method called Rummler Brache process mapping from the consultancy of the same name.

Separate, but related, see a different Genomeweb article on cancer centers & genomic testing, by Caroline Hopkins, here.

Very Brief Blog: News Source / Evaluate VANTAGE

I see a lot of trade journal websites but this one is new to me.  There's a consultancy EVALUATE, which publishes extensive news items.

Here's a 2022 review of the lab company FREENOME, including an elaborate table of contenders in the LBx space.  Here's a June 2023 review of trends in the CAR-T space.  Here's a long listing of topics from ASCO 2023, which seem to be all open access as far as I've checked.  Here's an open access report (with email registration) on biotech dealmaking in 1H2023.  Here's their home page for medtech industry.

April 2023 story on Quest, Haystack, and the MRD space, by Elizabeth Cairns - here.

Very Brief Blog: Registration for September 21-23 AMA CPT Open

 Registration (free) is open now for AMA CPT's September meeting in New Orleans.  Be there or be square, September 21-23, 2023.

Find the registration link here.  The emeting will also be webcast.

CPT applications were due a few weeks ago.   Lab codes are posted early, seeking public comment before subcommittee meetings start.  See lab codes June 29.   Other CPT codes will post for comment July 14.

On a separate but parallel calendar, PLA codes are due in July 6, 2023 and will be posted for comment about July 14.  (The comment period is only a few days).   

lab equipment, bourbon street, AI

Saturday, June 24, 2023

And Then A Miracle Occurs: Veracyte Test 0261U Doubles in Price after Castle Test 0108U Becomes ADLT


Code 0261U was crosswalked to code 0108U when the latter was priced $2350.  Under ADLT rules, 0108U doubled in price to $4950, and so did 0261U.


I'm frequently asked about artificial intelligence and CMS coding - including lab coding.  While many battles are being waged over the CMS valuation  of AI and Machine Learning, a few proprietary lab tests have terms like these in their titles, and are priced through the mechanics of lab test policy.

One of the first to be so priced was code 0108U.   Later, another test, 0261U, was crosswalked to that price.  So far, easy to understand.

Later, code 0108U became an ADLT test - an Advanced Diagnostic Laboratory Test priced under special rules, for three quarters at list price and then, based on its median payor price as reported to CMS.

Under the median price process, 0108U shot up from $2350 to $4950.   And miraculously, code 0261U, which is crosswalked to the price (current price) of 0108U, also doubled in price to $4950.

That's the main story.  Nerdy details below.



Go way back to the June 2019 CLFS meeting, and you'll find a presentation for Cernostics for its "Tissue Cypher" Barrett's esophagus test.   It was sent to the Gapfill process, which in 2020 resulted in a price of $2513.

0108U [Tissue Cypher, Cernostics] Gastroenterology (Barrett’s esophagus), whole slide–digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 protein biomarkers (p16, AMACR, p53, CD68, COX-2, CD45RO, HIF1a, HER-2, K20) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer. 

That would seem to be the end of that.

Then, as I noted in a November 2021 blog, new code 0261U was crosswalked by CMS to the 0108U price.  Blog here.

0261U ["Immunoscore," HalioDx] Oncology (colorectal cancer), image analysis with artificial intelligence assessment of 4 histologic and immunohistochemical features (CD3 and CD8 within tumor-stroma border and tumor core), tissue, reported as immune response and recurrence-risk score.

But Wait, There's More

CMS has created a total of 13 "ADLT" tests, presented on a CMS spreadsheet here:

As you can see, the 0108U test (now owned by Castle Bioscience) became an ADLT test in 4/2022 and got a new price, $2350.   This is actually a bit lower than the $2513 price from its crosswalk.  ADLT initial price is meticulously defined by CMS as the lowest price available to to the public on the first day the test was offered to the public.  We can infer, whenever that day was back in 2018 or 2019, its list price was $2350 not $2513.

That list price held from April 1, 2022, for three quarters - until the end of 2022.  Then, by the PAMA regulations, 0108U is assigned a new price, which is the median price of private insurer payments during the three quarters just mentioned.   THAT price was apparently $4950, so the new price is $4950 in CY2023 now.

And that's where the surprise comes from.  The world may have long forgotten that 0261U was crosswalked to the price of 0108U, but CMS computers know that.  And the price of 0261U was therefore upped to $4950.   If look at the current Clin Lab Fee Schedule for Spring 2023, you'll find the current prices of both 0108U and 0261U are $4950.


How long will this price last?  

There's one answer for 0108U and a different answer for 0261U.

Castle would report its ADLT data for 1H2023 (now) to CMS in 1Q2024, and that will set a new price for CY2025 for 0108U.

The next PAMA reporting period for 0261U would reset its OWN price (no longer crosswalked) based on price data from 1H2019.  But 0261U was only first active in Fall 2021, so it won't be part of the PAMA reporting in 1Q2024 based on data from 1H2019.   Therefore, my guess is, 0261U will remain yoked to 0108U until 0261U gets is own (every-three-year) PAMA reporting.   That is scheduled to be 0261U reporting its 1H2025 paymens to CMS in 1Q2026 for a price in 1/1/2027.  Unless 0261U becomes an ADLT on its own.  


AMA Use of "AI"

Note that 0108U describes its method as computer-assisted immunohistochem (plus algorithm) whereas 0261U includes the term "artificial intelligence."  I've heard at AMA meetings that since around 2022 they are avoiding adding the term AI to future coding.   


Ancient 0108U History.  

Four years ago, in June 2019, according to a file copy I have, Cernostics asked CMS to CW 0108U to 81538, which is the Biodesix Veristrat test.  That test was the second of all ADLT tests, from 2018.   81538 current price is $2871, as an ADLT since 2018, and unchanged for several years.  

Veracyte acquired HaldioDx in June 2021.  Veracyte announced in September 2022 it was discontinuing production of Immunoscore CRC test.

Castle acquired Cernostics in October 2021.   0108U became an ADLT in April 2022.

See MOLDX policies for Barrett tests here.

In CY2021, Pt B national utilization data, 0108U paid Part B claims were 18 claims, pmt $45,000.

0261U claims were not shown.


At the June 21, 2023 CLFS new code pricing meeting, Artera asked CMS to crosswalk its new code, 0376U, to one-half the price of 0261U (which in turn, is crosswalked to 0108U).  

0376U code text is, "Oncology (prostate cancer), image analysis of at least 128 histologic features and clinical factors, prognostic algorithm determining the risk of distant metastases, and prostate cancer specific mortality, includes predictive algorithm to androgen deprivationtherapy response, if appropriate." 


Friday, June 23, 2023


New news.  I've reported in great detail for several full years on the massive and insane spending on Tier 2 codes at Novitas and FCSO MACs, the only MACs that pay in any real amounts for the high level Tier 2 codes like 81408.  I've called 81408 the "fraudomatic' code," with hundreds and hundreds of millions of dollars in visible payments in CMS database.   This extends from 2018 to 2021, at the least.

81408 fraud is different than, say, wheelchair fraud.  A given beneficiary, or 50 of them, MIGHT need electric wheelchairs.  But no elderly Medicare beneficiary has ever never 2 each of all 9 Tier 2 codes, on one day.  Codes, for example, for genes that cause epilepsy in babies.  The gusher of colossal funds wastage continued rampant, despite my public blogs, several major public trade journal articles, also here, and multiple DOJ prosecuted cases.   And it was hardly rocket science to avoid this billion dollars wasted: NGS MACs and MolDx MACs were able to avoid the problem easily and completely.  

Here at last is the scathing OIG report.

Novitas' new LCD for oncology allows a range of payable circumstances of 81408 (incuding at least one for pediatric disease), so fraudulent providers could happily comply and submit claims that were autopaid, unless stopped for records, something Novitas hasn't done in the past.

Similarly, CMS responded (page 19) they would try to audit some sample claims to see if the claims were payable.  Ahh, nice.  Everyone knows the claims are literally impossible.  CMS was part of the worst of the problem, deliberately and officially setting the payable limit for $2000 81408 claims at 2 per day.  Had it been set at 1 per day (like all other genetic tests), a half-billion dollars would have been saved.  

The report focuses laser like on 81408, not emphasizing the key feature, that if a lab billed 81408, and usually billed a stack of ALL THE TIER 2 CODES, in nearly every case.  This enormously adds a greater level of lunacy to an already preposterous claim (for 81408 itself). 

It also adds to the financial damage.  If the labs billing $888M of 81408 were looked at fully, they also billed around another $400M on top of that for other nonsensical Tier 2 codes.

CMS notes that it informed its contractors of problems with 81408, but the fact it took two MACs (not named, but OBVIOUSLY Novitas and FCSO) several years to stop a billion dollars in blatant erroneous payments, is appalling.

Despite this years of awareness, CMS left the "medically unlikely edit" for tests per day for 81408 at "2" not "1" like most all other genetic codes.  Had CMS taken a few seconds to set the test-per-day edit at "1", $500M would have been saved.  I guess no one in Baltimore had the necessary 30 seconds to do so.   

CMS periodically talks about its bold and advanced anti-fraud efforts, e.g. artificial intelligence, but this billiion dollar fraud could be detected by a ten year old with five minutes' training.  

The OIG report has interesting studies of the "ordering providers" who generally had no relationship with the tested patients (duh, surprise).  But it's also noted that one such provide referred to 28 labs (?!?).   It's also noted that several of the biggest ordering providers were already guilty of fraud charges by the time of the report.

It's not possible to easily look up the ordering providers, but the names of labs paid for 81408 and other high tier 2 codes are easily searched in a few seconds on a CMS database.

OIG notes that the labs could remit overpayments voluntarily.  Surprise, honey, how much of this money is already in the Cayman Islands or Macedonia?

OIG notes multiple times that the payments were absurd on their face (e.g. opinions of doctors regarding these codes, like Joubert syndrome.)   I can't tell why this couldn't have been given to recovery audit contractors in 2018, if MACs were too busy, which would have wholly prevented the over-billion-dollar loss.  

Very Brief Blog: AAN Resubmits Complaint about Amyloid Drugs NCD

With the initial accelerated approval of an Alzheimer's amyloid drug CMS wrote a controversial NCD that it wouldn't cover it (outside a phase 4 RCT).   In early 2023, American Academy of Neurology and other stakeholders asked CMS to revisit that, and it said "nope."

Less well known, on June 12, 2023, AAN again asked CMS to reconsider the NCD.  As far as I know, there's no reply yet.  Here's the nine-page, June 12, AAN letter to CMS.

Tidbit - the letter is addressed to Ms. Syrek-Jensen as head of Coverage; she's now moved to a different position in the CMS quality and coverage division.

This week, CMS announced that it would require a bare-bones clinical registry (with fields like doctor name, patient name, and drug name) via a portal it will open as soon as Leqembi gets FDA full approval (any day now).  I wrote two brief blogs about the registry announcement.

Blog #1 - Amyloid tests in the registry.
Blog #2 - Data in the registry.

CMS Outlines Alzheimer Drug Registries; Blog #2: What's in the Registry?

Blog #2 - What's In the Registry?

CMS famously is requiring some level of registries - maybe Registry Lite - for all patients who imminently will start getting the new FDA-approved Alzheimer beta amyloid drugs.

CMS has released template information for the registries.  Specific registries will have their own management and focus and will be set up in the near future.

Information here and here.  

See Blog #1 about the amyloid tests in it - here.

See a rapid report on the clinical aspects of the registry, Tunis & Neumann, Health Affairs here.  Endpoints here.  Genomeweb here.


Blog #2 - The Registry is a Mere Shell?

CMS has made big political waves by insisted that the amyloid drugs are NOT covered under the "accelerated approval" state, and even when fully approved, will NOT be covered outside of some kind of clinical study aka registry.   See American Academic of Neurology here.

CMS has now issued an overview of Registry Lite, see links above.

Does the registry really make sense?  In its effort to keep the registry "lite," CMS is mostly asking for information it already has.   It asks for the physician's name, NPI, address, the patient's identifiers, which drug the patient is on.  Well, those are fields in the claim form the doctor submits anyway.  

Does the doctor's office submit those fields at 11:00 am via the CMS billing process, and then log on to a separate website at 11:15, and type the same information manually into a registry portal?  Is this the monumental advance?   

  • It reminds me of nothing so much as being in a 2023 doctor's office and asked to fill out three paper forms by hand, AND each one requiring handwriting out my name, birthday, address and zip code anew.

The minimalistic registry has a few other fields, like uploading information about cognitive tests, but the NCD doesn't specifically require any so the result of that endeavor may often be minimal.

Emperor and No Clothes?

If you do two things - if you carefully READ the "minimal registry" announcement, and if you also THINK about it - it doesn't seem like much at all is happening.

This is before even considering that the clinical registry has no control group, and the drug effects are subtle and require elaborate tests to verify, acting against any value at all in the area of clinical effectiveness, the area CMS was by far the most interested in.   So they had a goal - more knowledge about clinical effectiveness - and they can up with a method - this Registry Lite - that takes them nowhere towards the goal.

To the extent they wanted as a second goal to track side effects - like hospitalization for stroke - they could do that themselves based on the patient's AMY drug claims and the patient's hospital stroke admissions - without any value in retyping the CMS drug claims and retyping the CMS hospital admissions claims into a CMS portal.

CMS's Own Words

In its new guidance document for CED (in the TCET context) CMS refers to this description of CED studies:

Postmarket study proposals, particularly those that rely on real world data, have the  potential to generate evidence that complements tightly controlled premarket traditional clinical trials by demonstrating external validity.  Nonetheless, manufacturers should be aware that these studies require considerable planning in data validation, linkage, and transformation; specification of the study protocol; data analysis; and reporting.  The study design, patient inclusion criteria, primary and secondary endpoints, treatment setting, analytic approaches, timing of outcome assessment, and data sources should be fully pre-specified in the submitted protocol.  When writing [these CED protocols], manufacturers should propose clinically meaningful benchmarks for each study outcome and provide supporting evidence. 

In contrast the map they've just published defining their NCD Alzheimer real world CED, meet none of these requirements !!!

Similarly, the Alzheimer CED rules seem to bear no relationship to nearly simultaneous CED guidance just published by CMS in tandem with the TCET release - here.

In some ways the requirements mimic a vintage document that was never used, called "coverage with appropriateness determation" which was "a type of CED" in 2006.  I.e., the patient is [x] amyloid positive and [c] not on anticoagulants.

Thursday, June 22, 2023

CMS Outlines Alzheimer Drug Registries; Blog #1: Require Amyloid Tests - But Which and What Price?

 CMS famously is requiring some level of registries - maybe Registry Lite - for all patients who imminently will start getting the new FDA-approved Alzheimer beta amyloid drugs.

CMS has released template information for the registries.  Specific registries will have their own management and focus and will be set up in the near future.

Information here and here.  See Blog #2 about the registry itself here.

The information or minimum data set will include among other things, the patient's diagnosis (mild MCI or mild Alzheimer), plus the prescription of any antiplatelet drugs, plus the results of an amyloid PET scan, or CSF test, or "other amyloid test."

What does this mean?   

PET tests will have FDA approved tracers, like Lilly's Amyvid and others.  There's an approved FDA CSF test (Fujirebio), which is in the current coding & pricing process at CMS.   What what about non-FDA tests?  Or blood tests?   There may be good ones, or over-hyped bad ones.   Do MACs have to cover all of them?   Could a MAC limit to FDA-approved tests?   When you consider an instruction like this, and the wild west of sometimes scuzzy LDTs, you have to wonder about implementation.

Possibly, it simply means that the registry will require the physician to report which amyloid test the patient has had, and how to get it, or who pays for it, or whether one is available, is up to other parts of CMS, not the registry managers.

TCET: CMS Posts Detailed Plan for TCET, Transitional Coverage for Emerging Technologies

The mini recap: Trump administration created MCIT, mandatory coverage for break through devices for four years.  Biden administration killed it but promised a "TCET" or a "Transitional Coverage for Emerging Technologies."  The TCET proposal is now out for public comment.

  • Coverage at Healthleaders here. At STAT, here.  Medical Design, here.  See a follow-on story June 30 at STAT here.
  • Congress introduces legislation, 3/2023, for simple, four-yearMedicare coverage of BT devices [aka MCIT reborn], here (text at HR 1691).

Where is the TCET Document?

Comment runs 60 days, 5 pm August 28.  See first link above for comment link.  The policy runs 11,000 words.  88 Fed Reg 41633-44.  (Tuesday, June 27, 2023).

Don't miss the Press Release/Fact Sheet

It's 2000 words.

Don't miss the Chief Medical Officer's Blog, Either

It's 900 words.

Don't Miss the Agency’s New Evidence Review Guidance Document

It's 3000 words.

Total, all 4: 17,000 words.  As an audiobook, they would together play about 2 hours.

What's the Main Point?

No new regulations are proposed.  The TCET is just a change in process or promised timelines.  Nothing yesterday prevented them from meeting with a company before its FDA approval and rolling out a CED NCD in a few months.  

There's a premarket "nomination" and FDA-CMS review phase, which sounds like the parallel review idea from ten years ago that was used about as often as a solar eclipse.  There will be a  2-5 year period of "transitional coverage" under an NCD, with information updates to CMS.  CMS then could have the simple familiar options (wait for it) of #1 more CED, or #2 non coverage, or #3 coverage under  NCD, or #4 coverage under LCDs.  

click to enlarge

The press release/fact sheet has all most readers will want to know.

The guidance barely mentions diagnostics, except a brief remark that IF there are any diagnostic tests with breakthrough status, THEN, it expects mostly diagnostics will continue to be review by MACs not CMS…not TCET.  The refer to "specialized contractors" but I think they mean "specialized contractor" singular, i.e. MolDx.   (For more on CMS and lab LCDs see PAMA rulemaking at 81 FR 41088).

CMS expects TCET to apply to up to five (5) BT devices per year, and CMS will rely on an evidence contractor to outsource some of the workload.

CHAT GPT Weighs In

I "interviewed" ChatGPT4 about the materials.  I'm printing the answers below, because they match my understanding of the facts.

Summary of the Six Parts of the TCET in Federal Register:

The 11,000 word document was given to ChatGPT in 2000 word parts.

Part 1: This part introduces the Centers for Medicare & Medicaid Services (CMS) and the purpose of the document. It explains the need for a new pathway called the "Transitional Coverage for Emerging Technologies" (TCET) pathway, which aims to provide Medicare coverage for breakthrough medical devices that have the potential to significantly improve patient outcomes. The key objective is to expedite coverage decisions for these devices while generating additional evidence to support long-term coverage determinations.

Part 2: Part 2 describes the criteria for a medical device to be eligible for the TCET pathway. It outlines the characteristics that define a breakthrough device, including FDA Breakthrough Device Designation, providing evidence of substantial clinical improvement over existing technologies, and addressing an unmet medical need. The document also emphasizes the importance of the manufacturer's commitment to collecting additional evidence through post-market studies.

Part 3: This section explains the process of nomination for the TCET pathway. It describes how manufacturers can submit nominations and the required information, including device details, evidence supporting its breakthrough status, and a comprehensive plan for evidence development. The document emphasizes the importance of clear and concise communication between the manufacturer and CMS throughout the nomination process.

Part 4: Part 4 focuses on the steps involved after a nomination is submitted. It highlights the need for manufacturers to promptly submit nominations to facilitate alignment among CMS benefit category determination, coverage, coding, and payment considerations. It provides guidance on how manufacturers can submit nominations and the information required to support their nomination. It also encourages manufacturers to provide additional specific information to facilitate benefit category and coding determinations.

Part 5: This part delves into the review and coverage process under the TCET pathway. It outlines the timeline for reviewing nominations, conducting evidence previews, and developing evidence development plans (EDPs). It emphasizes the importance of stakeholder input, particularly from specialty societies and patient advocacy organizations, in shaping coverage policies. The document also discusses the duration of transitional coverage under the TCET pathway and the transition to post-TCET coverage.

Part 6: The final part of the document highlights the roles of different participants in the TCET pathway, including manufacturers, CMS, FDA, and the Agency for Healthcare Research and Quality (AHRQ). It mentions the availability of other expedited coverage mechanisms like Parallel Review and emphasizes the need to prioritize innovative medical devices with the potential to benefit Medicare beneficiaries. The document also mentions the exemption of information collection requirements under the Paperwork Reduction Act and addresses the response to public comments.

Overall, these six parts provide a comprehensive overview of the TCET pathway, its purpose, eligibility criteria, nomination process, review and coverage process, stakeholder involvement, and the roles of various entities involved.

 How does the new process handle breakthrough devices?   


Yes, the new process outlined in the document specifically addresses the handling of breakthrough devices. It is a program for such devices. 

Breakthrough devices are the focus of the Transitional Coverage for Emerging Technologies (TCET) pathway. The document states that only breakthrough devices, as designated by the FDA, are eligible for consideration under the TCET pathway.

The criteria for a breakthrough device are described. FDA follows regulations to determine there is evidence demonstrating substantial clinical improvement over existing technologies [this might be phase 1 or phase 2 evidence], and addressing an unmet medical need. Devices meeting these criteria are considered breakthrough devices and are eligible for nomination under the TCET pathway.

CMS explains the process of nomination for the TCET pathway, emphasizing that manufacturers can submit nominations for breakthrough devices. The manufacturers are required to provide comprehensive information about the device, evidence supporting its breakthrough status, and a detailed plan for evidence development.

Throughout the document, there is an emphasis on the importance of manufacturers committing to collecting additional evidence through post-market studies. The TCET pathway aims to provide expedited coverage for breakthrough devices while generating additional evidence to support long-term coverage determinations. This highlights the recognition of the unique potential of breakthrough devices to significantly improve patient outcomes and the need to streamline their coverage and evidence development process.

CMS has previously had a process called "PARALLEL REVIEW" where the company, FDA, and CMS met in advance of a CMS policy decision, and a CMS policy decision was crafted for quick release timed with the FDA approval.   That was touted as a big deal 10 years ago, but have almost never been used.   How is this new program different?   

How do we know it isn't the familiar unsuccessful Parallel Review program with a new hat?


The new TCET pathway mentioned in the document shares some similarities with the previous Parallel Review program, but also introduces significant differences. Here are the key distinctions between the two programs:

Focus: The Parallel Review program focused on the concurrent review of both FDA approval and CMS coverage determination, aiming for synchronized decision-making. In contrast, the TCET pathway primarily focuses on rapidly defining post-market evidence development for breakthrough devices, to facilitate coverage under the Medicare program.

Timing: The Parallel Review program involved simultaneous review and decision-making.  The TCET pathway allows for earlier engagement between CMS and manufacturers, beginning with the nomination stage before FDA market authorization. But much of the TCET also occurs in the months immediately following FDA approval.  The TCET pathway prioritizes upfront planning and then ongoing collaboration for evidence development, rather than a simultaneous decision-making process and only before FDA approval.

Evidence Development: The TCET pathway places a significant emphasis on evidence development during the post-market phase. It requires manufacturers to submit a detailed Evidence Development Plan (EDP) outlining how they will collect additional evidence to address any existing evidence gaps. The EDP must be approved by CMS and the Agency for Healthcare Research and Quality (AHRQ). The TCET pathway recognizes the need for generating real-world evidence and addressing uncertainties surrounding breakthrough devices.

Coverage Timing: The TCET pathway acknowledges the time-sensitive nature of coverage decisions and aims to provide coverage under Medicare within 6 months after FDA market authorization. This timeline sets a goal for faster coverage compared to the traditional NCD process.

While the previous Parallel Review program had limited utilization, the TCET pathway introduces a new approach that aligns with the need for evidence development and timely coverage determination for breakthrough devices. The TCET pathway's primary focus on evidence generation, early engagement, and post-market studies distinguishes it from the earlier Parallel Review program.


How will they handle bandwidth under TCET?   

The CMS NCD process is known for being slow and having very little bandwidth per year.   


The document acknowledges the resource constraints and limited bandwidth of CMS in handling coverage determinations. To address this concern, the TCET pathway aims to prioritize innovative medical devices that have the potential to benefit a significant number of individuals with Medicare. The document indicates that CMS anticipates accepting up to five TCET candidates annually due to resource constraints, but those five will be devices impacting the most Medicare beneficiaries.

CMS plans that some workload can be outsourced to contractors.

By focusing on breakthrough devices and implementing a streamlined evidence development process, the TCET pathway intends to expedite coverage decisions. The goal is to finalize the Evidence Development Plan (EDP) approximately 90 business days after FDA market authorization, and the overall timeline for providing coverage under the TCET pathway is intended to be shorter than the traditional National Coverage Determination (NCD) process.

While the document does not provide specific details on how CMS will manage the bandwidth, it acknowledges the need for efficiency and timely decision-making. By prioritizing candidates with the potential for broader impact and leveraging the EDP for evidence generation, the TCET pathway aims to optimize resources and streamline the coverage process for breakthrough devices while choosing devices that benefit the most patients.

The program seems to hinge on "CED" which is Coverage with Evidence Development.  CMS pays for Product X, but only in a clinical trial defined and judged by CMS.   

Some academic papers (see one at ZEITLER) have said that CED clinical trials are often unfinished, never start, fade away, and have rarely been known as impactful respected clinical trials with important results. Will CED under TCET be any better?   And why?


The TCET pathway does incorporate the concept of Coverage with Evidence Development (CED) to generate additional evidence for breakthrough devices. There have been concerns about the effectiveness and impact of CED clinical trials in the past, and, the document does not explicitly address whether CED under TCET will be any better. However, the TCET pathway introduces several elements that aim to enhance the quality and relevance of evidence generated through CED.

Firstly, the TCET pathway emphasizes the importance of collaboration between CMS, the manufacturer, and other stakeholders such as the FDA and AHRQ (Agency for Healthcare Research and Quality). This collaborative approach aims to ensure that the evidence development process is well-designed, scientifically rigorous, and aligned with the needs of Medicare beneficiaries.

Secondly, the document highlights the significance of pre-specifying study protocols, including patient inclusion criteria, endpoints, treatment settings, and analytic approaches. This emphasis on clear protocol specification aims to enhance the transparency and robustness of CED studies conducted under the TCET pathway. [BQ: However, CMS concurrently released its CED plan for early Alzheimer's disease, and that CED plan meets few of the aspirational goals just mentioned.]

The TCET document encourages manufacturers to propose clinically meaningful benchmarks for each study outcome and provide supporting evidence. This suggests a focus on defining meaningful endpoints and ensuring that the generated evidence is relevant and impactful.

While the document does not guarantee that CED under the TCET pathway will be inherently better, it does reflect CMS's intention [aspiration] to improve the evidence development process and address some of the limitations associated with previous CED initiatives. By involving multiple stakeholders, emphasizing rigorous study design, and promoting meaningful endpoints, the TCET pathway seeks to enhance the credibility and impact of evidence generated through CED.

Some have accused CMS of exaggerating that its CED just implements studies of the AHRQ.  Critics have said this is not true, that AHRQ has virtually no involvement with the CMS CED. [See footnote.*]   

What does the new document say about AHRQ involvement in TCET and its CED.


The document acknowledges the involvement of the Agency for Healthcare Research and Quality (AHRQ) in the TCET pathway and its collaboration with CMS. It states that AHRQ will review all Coverage with Evidence Development (CED) National Coverage Determinations (NCDs) established under section 1862(a)(1)(E) of the Act, which includes the TCET pathway.

According to the document, AHRQ will collaborate with CMS in evaluating the Evidence Preview and Evidence Development Plan (EDP) for each TCET candidate. The approvals for these documents will be a joint CMS-AHRQ decision, indicating AHRQ's active participation in the TCET process.

Furthermore, the document highlights that AHRQ will continue to review all CED NCDs consistent with current practice. It implies that AHRQ's involvement in the TCET pathway aligns with its role in reviewing and providing input on CED studies.

While the document does not provide extensive details on the specific nature and extent of AHRQ's involvement in TCET and its CED, it does confirm that AHRQ is a partner with CMS throughout the development and approval of the Evidence Preview and EDP.

What is the stance of CMS to breakthrough devices?   

The Trump administration thought they were great.  The Biden administration seemed to think in 2021 that Breakthrough Device was a not-very-meaningful designation.  Can we glean how much they weight the value of Breakthrough Device here?


The document does not explicitly state the stance of CMS towards breakthrough devices. However, it provides the TCET pathway as an expedited coverage option specifically designed for breakthrough devices. This suggests that CMS recognizes the potential value and importance of breakthrough devices in delivering improved outcomes to the Medicare population.

The TCET pathway aims to provide time-limited coverage for breakthrough devices that do not yet meet the reasonable and necessary standard for coverage under section 1862(a)(1)(A) of the Act. It emphasizes the need for further evidence development through the CMS and AHRQ-approved Evidence Development Plan (EDP). This indicates that CMS acknowledges the importance of generating additional evidence to support coverage decisions for breakthrough devices.

While the document does not explicitly weigh the value of breakthrough devices, the establishment of this new dedicated pathway and the emphasis on evidence development suggest that CMS recognizes the significance of these devices and their potential benefits for Medicare beneficiaries.


Chat GPT Summarizes the Press Release 

The press release highlights the main points of the new TCET pathway for Medicare coverage of breakthrough devices. Here are the key takeaways:

  1. The TCET pathway aims to provide timely and predictable access to new medical technologies for Medicare beneficiaries while maintaining safeguards and promoting innovation.
  2. It utilizes the existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage for certain FDA-designated Breakthrough Devices.
  3. The TCET pathway includes an evidence development framework that allows manufacturers to address evidence gaps through fit-for-purpose studies, including the use of real-world data.
  4. CMS collaborated with the Agency for Healthcare Research and Quality (AHRQ) to develop a comprehensive approach that incorporates greater flexibility into the proposed CED paradigm and allows for fit-for-purpose study designs.
  5. The TCET pathway involves an Evidence Preview, which is a focused literature review to assess the available evidence and identify any evidence gaps. It provides transparency and informs coverage decisions.
  6. Manufacturers develop an Evidence Development Plan (EDP) to address evidence gaps identified in the Evidence Preview. CMS and AHRQ evaluate the EDP for scientific integrity and relevance to the Medicare population.
  7. The TCET pathway is specifically applicable to FDA-designated Breakthrough Devices within a Medicare benefit category that are not already covered under an existing NCD or excluded by law or regulation.
  8. CMS will consider nominations from manufacturers interested in participating in the TCET pathway, and the nomination process involves meetings with CMS and FDA to discuss the technology and review timing.
  9. The duration of coverage under the TCET pathway is tied to the CMS- and AHRQ-approved EDP, typically lasting for three to five years to generate evidence and address evidence gaps.
  10. There will be a transition to post-TCET coverage, where CMS will conduct an updated evidence review and consider whether to continue coverage, require further evidence development, issue a non-coverage decision, or delegate coverage decisions to Medicare Administrative Contractors (MACs).

CMS is seeking public comment on whether similar devices to the Breakthrough Device should be subject to separate coverage conditions or follow the same requirements, including proposing an EDP.


Summary of the Blog of the Chief Medical Officer

The blog post by the Chief Medical Officer provides an overview of the proposed Transitional Coverage for Emerging Technologies (TCET) pathway and the revamped evidence development framework introduced by CMS. Here are the main points:

  1. The TCET pathway is a voluntary program designed to expedite Medicare coverage for certain FDA-designated Breakthrough Devices. It aims to provide an efficient, predictable, and transparent coverage review process while ensuring robust safeguards for Medicare beneficiaries.
  2. The TCET pathway utilizes national coverage determination (NCD) and coverage with evidence development (CED) processes to accelerate Medicare coverage for Breakthrough Devices. It includes a pre-market evaluation of potential benefits and harms of technologies and identifies any evidence gaps.
  3. The pathway allows manufacturers to address evidence gaps through fit-for-purpose studies, where the study design, analysis plan, and data are appropriate for answering specific research questions. Fit-for-purpose studies may leverage existing real-world data, making them more convenient for manufacturers.
  4. CMS may conduct an early evidence review called the Evidence Preview before FDA marketing authorization. This review helps determine the best available coverage pathways based on the strength of the evidence.
  5. CMS engages with manufacturers to discuss evidence gaps and potential study designs that can address them. Manufacturers can propose an Evidence Development Plan (EDP), which is developed in collaboration with CMS and considers both CMS evidence development and FDA post-market requirements.
  6. The goal is to finalize a TCET National Coverage Determination (NCD) within six months after FDA market authorization. Coverage under the TCET NCD will continue only as long as necessary to generate timely evidence for informed decision-making and establish long-term Medicare coverage.
  7. CMS sought extensive feedback from stakeholders during the development of the TCET pathway and evidence development framework. The partnership with the Agency for Healthcare Research and Quality (AHRQ) contributed to incorporating greater flexibility and fit-for-purpose study designs.
  8. CMS has issued proposed criteria, updated guidance documents, and published a series of guidance documents reviewing health outcomes and their meaningful differences within priority therapeutic areas. The public will have an opportunity to provide comments on these documents.

The blog emphasizes CMS's commitment to promoting access to emerging medical technologies while upholding rigorous evidence standards and ensuring the health and well-being of Medicare beneficiaries.


CHATGPT Reads the Evidence Guidance Document - A Rulebook for Readoing Evidence for NCD Authors

The Evidence Guide outlines the methodological principles and criteria used by the Centers for Medicare & Medicaid Services (CMS) when evaluating clinical evidence to make national coverage determinations (NCDs) regarding the reasonable and necessary coverage of medical items and services. The guide aims to provide a framework for assessing the quality, applicability, and strength of evidence to ensure that coverage decisions are based on reliable and relevant information.

The guide emphasizes several key rules and considerations:

Methodological Principles: CMS takes into account various methodological aspects when reviewing clinical evidence, such as randomization, contemporaneous control groups, prospective studies, sample sizes, masking, and thorough documentation. The goal is to minimize bias and ensure internal validity in the study designs.

Review of Individual Studies: CMS evaluates the quality and relevance of individual studies, considering factors like risk of bias, precision of estimates, consistency in the direction of findings, and applicability/external validity. These criteria help determine the confidence and generalizability of study results.

Strength of Evidence Assessment: CMS assesses the strength of evidence across multiple dimensions, including study design, conduct, and outcomes important to patients. The guide highlights the importance of clinically meaningful and durable benefits, while considering the balance between harms and benefits. Case series and case reports are generally assigned lower evidentiary value.

The goal of the Evidence Guide is to promote a comprehensive and transparent evaluation of evidence, ensuring that CMS coverage decisions are based on rigorous and reliable information. By providing clarity on the factors considered and the evaluation process, the guide aims to support predictable and consistent coverage determinations.

It is important to be aware of the Evidence Guide because it outlines the criteria and standards used by CMS to assess the evidence supporting Medicare coverage decisions. Understanding these guidelines can help stakeholders, including healthcare providers, manufacturers, and researchers, align their evidence development strategies and submissions with CMS requirements. Being familiar with the guide can facilitate meaningful engagement in the coverage determination process and ensure that Medicare beneficiaries have access to high-quality and evidence-based medical interventions and services.

10 pp

Error in TCET Guide

CMS makes an error in the TCET proposal which I've seen it makes before, that BT Device applies to only one unique product [sic].  In fact, FDA issues BT Device Status (a review channel) to every applicable device up until one is approved for market.  For examle, similar devices A,B,C, may be granted BT status in January, February, March, and they all still  are "breakthrough devices" if they are successively approved in July, August, September.   More than one device in a category is allowed (for example, comparable liquid biopsy tests from both Guardant and FMI recently approved as BT devices by FDA).


* A general counsel of HHS under Trump wrote a memo that CMS's engagement with AHRQ was so think as to not support this leg of the legal standing the statuted required for CED.  See more on GC Charrow's AHRQ legal memo and also several relevant links, in my blog here.


A proprietary source, Washington Analysis, headlined that the TCET "underwhelms," which I concur with.