Sunday, October 31, 2021

Very Brief Blog: AMA CPT Publishes Decisions from Sept 2021 Editorial Meeting

The AMA CPT Editorial Panel meets three times a year, and a few weeks later publishes the results of the panel votes on new code proposals.  CPT has posted results of the September 29-30, 2021, meeting.

Find the website here and the September 2021 results here.  I tallied the category "rejected" 9 times, and they category "withdrawn" 20 times.   

For digital health, it was busy, but often with belly-flops..  A code for "digital behavioral therapy management" was withdrawn, and one for "health coaching."  A Category III code for "digital behavioral health interventions" was rejected as was a code for "Digital E&M Services."   A code for virtual reality therapy was withdarwn.

Lab Industry 

In the lab industry, a code for Tier 2 macular degeneration was withdrawn, as was a code for MAAA cutaneous melanoma.  A code for genomic sequencing for bone marrow failure (precursor to some leukemias) was accepted.   A code for genomic panel testing for pharmacogenetics was passed.  

Also in the lab industry, the three mainstay codes for 5-50 tumor gene panels and 50+ tumor gene panels were revised to include methods for either targeted RNA or targeted DNA testing (the current code was for both), while there were some revisions to the preamble text for these tumor gene panels.

Remote Cognitive Behavioral Therapy

AMA CPT now has several codes for remote physiological monitoring and for remote therapeutic monitoring.  They're adding an additional service type under remote therapeutic monitoring, for cognitive behavioral therapy.

Odds and Ends

Odds and ends occur.  A code for +15 minutes added to psychotherapy services, ratified at the February 2021 meeting, was rescinded at the September 2021 meeting.   

Thursday, October 28, 2021

Nothing Says Clickbait Like...

Nothing says clickbait like a mummy in a cute hat - 


Brief Blog; Novitas Finalizes PGx LCD; Tracks Close to MolDx

MolDx and PGx

Over a year ago, the MolDx MAC adopted a broad pharmacogenetics policy that keyed Medicare coverage to current FDA PGx recommendations and current recommendations of the consortium CPIC.

Novitas Follows MolDx

In June 2021, the Novitas and FCSO MACs (which operate in tandem) proposed PGx coverage on generally similar terms to MolDx.

Novitas LCD Finalized

On October 28, 2021, the Novitas/FCSO PGx LCDs were finalized with minimal changes, along with final "billing & coding" articles and responses to public comments.  The new policies are effective December 12.


The policies should be seen in light of the 2019 "Operation Double Helix," which found hundreds of millions of dollars of allegedly improper genetics payments, primarily in the Novitas and FCSO MACs.  

In addition, the policies should be seen in light of a Novitas general genomics coverage and non coverage article released earlier in October -  which I covered in a blog here.  It's A58917.  The Q&A document with this final LCD specifically notes that A58917 is the governing coding article.

Redline of Draft and Final LCD

I did a redline comparison of the draft and final LCDs, which showed few if any really significant changes.  The basic template remains coverage under CPIC and FDA criteria on a rolling basis.  New text requires the ordering physician use the tests in management and be experienced in the use of the genetics tests ordered, a requirement also found in the October general anti-fraud article I just cited (here).

The LCD authors (in the comment Q&A) make clear they prefer any LCD comments to be submitted with full-text articles, not just citation or PMID numbers.  Many groups, from Mayo to CAP/AMP, submitted comments.

The billing article (39pp) includes many pages of tables copied from CPIC/FDA guidelines.


It's really, really, really fast for any MAC on any topic to propose an LCD in June and finalize by October.  LCD finalization usually takes closer to a year, even longer.

Cloud File

I include Cloud Files in a zip file of the draft and final PGx LCD, a redline comparison document, the Q&A PDF and the final Coding and Billing PDF.   Find the Zip file open access here (For the Q&A comments, use file "Landscape.")

I've also posted current versions of all the links here.


The blue states all follow MolDx rules.   The purple states are under Novitas or FCSO (Florida); these two MACs are in a complicated multi entity ownership structure related to Florida BCBS.  The remaining two MACs (upper midwest + northeast) are the National Govt Services or NGS MACs.

The map also makes clear why the MolDx rate always "wins" in the annual gapfill process, where the determinative price is the median price and with 28 states, the MolDx price is always the 25th or median position.

click to enlarge


A number of commenters pointed out that pharmacists or genetic counselors should be able to order PGx testing; Novitas responded that this falls outside current Medicare law and regulations.

I've assumed that FCSO MAC documents released on the same day on the Medicare Coverage Database are in sync with concurrent and identically titled Novitas documents; I haven't checked.

See a subscription article at Genomeweb on 23andMe's acquisition of telemed/pharmacy firm Lemonaid to complement 23andMe's PGx services (here). Also gains capabilities in primary care and disease management.

Wednesday, October 27, 2021

Very Brief Blog: Joe Grogan's Blog on the Need for MCIT

Joe Grogan, one of the leaders in health policy for the Trump White House, is now a policy expert associated with USC and recently published an excellent blog on the need for Medicare coverage of breakthrough devices.   

Below I provide a link to his September 2021 blog, as well as some background.


October 27, 2021, the USC Schaeffer Center for health policy hosted a webinar with Scott Gottlieb, former head of FDA, and Joe Grogan, who headed health policy for the Trump White House.   The webinar mentioned a recent blog by Grogan on the Schaeffer Center website. It's worth reading.  One headline therein:  "CMS's Concerns Used as Justification for Rescinding the Rule are Unfounded."

> > > Find the Grogan blog, dated September 23, 2021, here.

The MCIT Rule

The MCIT rule is "Medicare Coverage for Innovative Technologies," and was finalized by the Trump administration in early January.   It promised 4 years of coverage for any device approved by FDA as a "breakthrough device."  

MCIT was put on hold by the Biden administration in March 2021, and proposed to be permanently canceled in September 2021.  (See the cancellation rule here.  See my blog on the cancellation announcement here.   My short video on the cancellation here.  My later blog, in October, on some of the submitted Public Comments, here.)

Broader Problems with Medical Device Coverage

In the USC webinar on October 27, Grogan also spent substantial time to describing the pain and duration of problems caused by our awkward and slow device coding, coverage, and pricing.   Scott Gottlieb noted that the impetus for MCIT came from FDA leadership, which worked directly with Seema Verma as head of CMS.   Verma, in turn, had to overcome opposition from staff under her in order to get the rule proposed and finalized during Year 4 of the Trump administration.  


There's been legislation introduced in Congress that would reproduce what had been proposed as MCIT - here.   Something like MCIT is also included in possible future legislation called 21st Century Cures 2.0.

See an auto-transcript of the MCIT remarks today, here.

PAIGE AI Webinar Shares More Data on Performance in Prostate Cancer Analysis

PAIGE, developing AI software for pathology, received $100M in funding in early 2021 and FDA de novo clearance for prostate cancer AI in September 2021.  

In this blog, I recap some of the key timepoints, provide links, compare to AI in radiology, and summarize a few remarks on clinical performance from yesterday's PAIGE public webinar.


It was big news in January 2021 when PAIGE landed a $100M Series C funding round (here, here.)  There was even more excitement on September 22, 2021, when PAIGE announced de novo marketing authorization for Paige Prostate "a clinical grade AI solution for prostate cancer detection."   FDA marked the day with a press release (here).  

See trade press at 360Dx here.   See trade press at MobiHealthNews here.


The FDA website provides a special page for de novo designations here, where you can find the Paige Prostate classification order (DEN200080 here).  At some point, this FDA page will also display a link to a detailed clinical trial safety and effectiveness report (typically 20-40 pages).  But the appearance of the safety, effectiveness, and clinical trial report can lag the marketing decision by a few weeks or months.

The new (aka "de novo") classification group is 21 CFR 864.3750, "Software algorithm to assist users in digital pathology."  

Note that the products are intended to "assist users" not "diagnose" the slides.  This is very similar to FDA regulation of AI and machine learning in radiology, where the software is allowed to flag parts of images or to prioritize cases within a queue so that patients with health-critical lesions get their diagnoses before patients with normal scans.  

The Paige Prostate FDA product code is QPN (same title as 364.3750) and is here.  I don't think the regulation for category 864.3750 has been released yet.  FDA assigns numbers in advance of finalizing the public text of the classification.

(In contrast, the paperwork for the 2020 Viz-AI software is complete.  Viz-AI has FDA approved radiology software for its ContaCT product, and you can find the full 18pp safety & effectiveness decision summary online at FDA (DEN 170073). And, the public regulatory classification into which ContaCT falls is for "radiological computer aided triage and notification software."  This was published 4/1/2020 as 21CFR 892.2080 here.    In contrast, for Paige Prostate, neither the FDA Decision Summary nor regulatory classification .3750 are online yet.)

The PAIGE indications use state:

Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. 
After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist. Paige Prostate is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized with Paige FullFocus WSI viewing software. 
Paige Prostate is an adjunctive computer-assisted methodology and its output should not be used as the primary diagnosis. Pathologists should only use Paige Prostate in conjunction with their complete standard of care evaluation of the slide image.


On its website, PAIGE notes that "Paige Prostate has been tested on slides from more than 200 institutions and in multiple peer-reviewed studies," but I didn't easily find a publications list (see [*]).  The FDA S&E data may pop up online and show much of the data prior to some of the the journal publications).

I did have a couple recent prostate AI publications at hand.  Last year, Lancet published a detailed paper by a Swedish group, Strom et al., on "artificial intelligence for diagnosis and grading of prostate cancer in biopsies," here.  See also a Lancet Digital Health paper Pantanowitz et al., "artificial intelligence algorithm for prostate cancer diagnosis on slides," here, reflecting software being commercialized by IBEX.  (And see footnote [*]).

This Week's Webinar

In a public webinar on October 26, PAIGE discussed its journey through the FDA and also discussed some very interesting performance data for its product, describing a key publication as being submitted.   PAIGE described a study with samples from 5 countries, 22 states, and 217 institutions, and review by 16 pathologist (some GU specialists, some generalists).  While the FDA labeling describes the software as flagging either 0 or 1 lesion for further pathologist review, the webinar emphasized that in a protocol, slides could be signed out as no cancer, or as cancer, or as flagged as indeterminate for further review ("deferral," with other pathologists and/or special stains).  False negatives for generalists dropped from 12% to 4% for generalists, and from 9% to 5% for urologic specialists.  This improves the sensitivity of diagnosis (false negatives mean missed cases mean lack of sensitivity.)  However, specificity also improved.  False positives fell from circa 2-3% to circa 1-2% for both generalists and specialists.  

PAIGE summarized that there was an decrease of 24% in "unnecessary deferrals" and an increase of 59% in "necessary deferrals."   An unnecessary deferral would be a slide flagged initially for deferral, but signed out as positive when the pathologist considered both his diagnosis and what was flagged by Paige.   A "necessary" deferral is when a slide was pulled from the "diagnosis benign" queue, and brought into further review that led to a correct cancer diagnosis (for example, with conferral or with immunohistochemistry).   


In the webinar, PAIGE listed key related FDA approvals as the Phillips IntelliSite solution in 4/2017, the Aperio solution in 5/2019, the Sectra pathology module in 4/2020, the Paige FullFocus system in 7/2020, and the Paige Prostate system in 9/2021.   

While AMA CPT and CMS don't have clear payment pathways yet for AI in slide pathology, CMS has provided add-on payments (what are called NTAP) to radiology AI products used as part of inpatient care, with several products approved successively by CMS in August 2020 and then August 2021 in annual inpatient rulemaking.   See my reference above to 21CFR 892.2080.


(*) Some additional publications

Some other interesting publications in the field include:

Mata, 2021, PMID 34597215, on AI assisted diagnosis viewing MRI and biopsy as a collective diagnostic process.

Purysko, 2021, PMID 34597239, Op Ed on the above.

Perincheri, 2021, PMID 33782551, Paige Prostate tested at Yale.

da Silva, 2021, PMID 33904171, "real world application of Paige AI prostate cancer detection."

Raciti, 2021, PMID 32393768, Paige AI system increases detection of prostate cancer.  Writing, "Without Paige Prostate Alpha, pathologists had an average sensitivity of 74% and an average specificity of 97%. With Paige Prostate Alpha, the average sensitivity for pathologists significantly increased to 90% with no statistically significant change in specificity. With Paige Prostate Alpha, pathologists more often correctly classified smaller, lower grade tumors, and spent less time analyzing each WSI."

For an earlier paper on development of the Paige AI system with weakly supervised machine learning, see Campanella, 2019, PMID 31308507.

Though not directly reporting on AI accuracy, an interesting paper is "integrated digital pathology at scale," by Schuffler, 2021, PMID 34260720.  Writing, " We built a vendor-agnostic, integrated viewer for reviewing, annotating, sharing, and quality assurance of digital slides...used by 926 pathologists and researchers evaluating 288,903 slides...An interconnected Honest Broker for Bioinformatics Technology (HoBBIT) to systematically compile and share large scale digital pathology datasets...We highlight major challenges and lessons learned."  (It sounds like Google Earth for pathology.)

Addendum. Although not directly related to PAIGE, another item related to advanced pathology.  See Balaur et al. in Nature, 6 October 2021, "Colorimetric histology using plasmonically active microscope slights," aka, "the slide becomes a sensor."   Nature here.  Trade press here and here.  Youtube here.

Earlier study by Powley on patient derived explants for anti-cancer drug discovery here.

Tuesday, October 26, 2021

Pew Charitable Trust Says More Regulation of LDTs Is Needed, "Growing Risk to Patients"

In a fact sheet and a research report dated October 22, 2021, the Pew Charitable Trust argues that more federal oversight of LDTs is needed.

  • See the fact sheet here.
  • See the full report here.

The authors conclude,

To ensure the public has access to safe, reliable, accurate, and innovative diagnostics, Congress should pass legislation that would increase the transparency of the market and authorize FDA to review them based on their risks to patients.

They note in a summary table:

click to enlarge


See a prior PEW Article, September 22, 2020, on need for risk based regulation of LDTs, here.  See a PEW position piece, labs need stronger FDA oversight, January 11, 2021, here.  See a PEW letter to HHS on April 28, 2021, here and here.

See an article, "Once a cheerleader for latest VALID Act, PEW now has some reservations," behind a subscription wall, at Medtech Insight, August 25, 2021, here.  

See Medtech Insight behind the wall, "VALID Act Introduced for Third Time," 24 June, 2021, here.  See a Medtech Insight article, open access for me today, "Abbott preps for potential VALID Act," Sept 28 2021, Here.

On a separate note, for a Pew Report on how FDA regulates AI, see here.

Monday, October 25, 2021

Tidbits: Webinar on Breakthrough Device Reimbursement; Roche Launches "Foundation Medicine in a Box" (RUO)

Two items noticed in the Monday announcements.

Webinar - There's a webinar on device reimbursement and FDA breakthrough status, Wednesday November 3, 10 PT / 1 ET.   It's  produced by Allison Komiyama of AcKnowledge regulatory consultancy, and Mark Domyahn of JD Lymon Group.   Register here.

Roche launches a (non-FDA-approved) kit "designed to match Foundation Medicine CDx panel content" with 324 genes.  Read the details at Pharma Times, here.

Thursday, October 21, 2021

Novitas Article Attacks Genetics Overspending; Action after "Operation Double Helix"?

Novitas made some updates October 29, 2021, including "Clarifying 81479 text" - see most recent version here.  The minimal update is shown as "Footnote".


It's been two years since the Department of Justice announced what it alleged to be $2B in fraudulent genetic charges, almost entirely in Southern states, in September 2019.  (Here).  This represented the largest scheme in 50 years of Medicare (ibid), and resulted in hundreds of millions of dollars of anomalous payments, substantially shifting Medicare MoPath payments - which had been around $500M - to over $1.5B in a couple years.

I covered this topic in a five-part article series in December 2020 (entry point here).  The anomalies most prominently involved explosive growth in the highest Tier 2 codes (which pay up to $2000 a pop) which were unedited and uncontrolled, especially in the Novitas, Cahaba, and FCSO MACs.  That is, they were "ATM machine" codes.  (When the Palmetto MAC took over the Cahaba states, and applied Palmetto edits, genetic spending there fell precipitously downward).  

You could also see the anomalous pattern in CYP pharmacogenetic codes (separate blog here.)  In 2018, half of national Medicare CYP payments (81225, 81226) went to Georgia alone (!!).  These payments under Cahaba CYP edits (or lack of edits) fell 90% or more when these states switched over to Palmetto (or MolDx) edits.  (ibid).

I've analyzed this situation across 2017, 2018, and 2019.  I've been anxiously waiting for CMS to release state-level data for CY2020 payments, which should occur any week now (late October).   

Meanwhile, I just learned of a new genetics coding article from the Novitas MAC that's intended to ward off the types of payments cited by DOJ when it undertook Operation Double Helix.

click to enlarge

Novitas' Remarkable New Article A58917: Molecular Pathology Coding and Billing

You've got to read this one.  Find it here:

It's effective November 8, 2021.  The article provides history of genetics coding, under "stack codes" for gene amplfication up to 2013, and under gene-specific codes since then.  However, the article asserts, in the last two years "stack coding" has exploded.  

The article puts tight controls on Tier 2 genes (see my series of 5 blogs, cited at the top of this article).  They write that "diseases that manifest severe signs or symptoms in newborns" or "childhood, or that result in early death" are subject to AUTOMATIC DENIALS in the Medicare population.   I've been making exactly that point for over a year now, as loudly as I could.   Tier 2 codes for such rare genes, like those coded under 81408, grew from being almost unknown in Medicare in 2017, to the HIGHEST PAID CODES in Medicare in CY2019.  Astounding.   How could genes that are officially listed as too rare to merit Category I CPT codes, be the very highest paying, most utilized of all codes in all of Medicare?

The new Novitas article also has anti-fraud phrases like stating that past payment for certain codes (because they were unaudited and unedited) in no way implies active endorsement or medical necessity of billing that code.   

Why it's taken 24 months from the original DOJ announcement of Operation Double Helix, to product this article, is beyond me.   It should have taken a week back in 9/2019 (maybe two weeks, for a two-fingered typist). 

Novitas Also Has PGX LCD and Article in Draft Form

The Novitas MAC also has a new PGx LCD (DL39063) and article (DA58801) in draft form from last spring, which could be finalized anytime now.  I haven't studied these with a magnifying glass, but they seem similar to the PGx LCDs used in MOLDX states.

Cloud Zip File

As a convenience to readers, I've put a copy of the Novitas MoPath coding article, and the PGx LCD & Article, in a public access Zip file in the cloud - here.


Update of 81479 text on October 29.

Very Brief Blog: CMS Releases New Report on Innovation Center Plans

There's a running joke that any given pharma is constantly restructuring one more time, and let's add, the CMS Innovation Center (CMMI) is perpetually offering one more new vision of itself. 

Here's the latest.  Download a new 32-page PDF white paper on plans for the Innovation Center in the coming years.

See trade press:

Sorry, but most predictable buzz phrase: "Partnering to Achieve System Transformation."  

For a contrast, see McKinsey's recent report on the excessive $1 trillion we spend a year on administration and policy - here.

For recent reports on CMMI (cited in the new white paper) see MEDPAC 2021 (chapter 2) here and National Academy of Medicine (9pp) here.

MCIT Rule: 115 New October 2021 Comments! Zip File.


click to enlarge

Most CMS rules go through one cycle of comments; the MCIT rule has gone through three, garnering  115 comments in the third cycle just completed. Links provided.  

I have also pulled about a dozen major comments and placed them in a cloud ZIP file for readers.


What Happened?

As shown in the figure above, under the Trump Administration, CMS proposed "Medicare Coverage for Innovative Technologies" in September 2020 (85FR54327).  The final rule was published January 14, 2021, effective March 15, 2021.   It would have provided 4 years of coverage for new FDA cleared or approved "breakthrough devices" without requiring favorable LCDs or NCDs for coverage.

CMS, under the Biden Administration, delayed the rule (with comments opened) on March 17, and delayed it again on May 18.   Finally, on September 15, 2021, CMS proposed a new final rule that would in effect simply revoke the January 2021 final rule, and a third comment period September 15-October 15, 2021.   


See the original January 2021 final rule here - the rule which is currently in place, but suspended until December.  See the September 2021 rule here - the one whose comment period just closed.  See the "unified agenda" showing all the different publications and comment dates, here.  See the comments, 115 of them, for the comment period just closed, here.   

Trade Press

See an October 2021 article in HealthCareDive by Nick Paul Taylor summarizing some of the major comments, such as AdvaMed's and MDMA's (Medical Device Mfgr Assoc).  Here.

Next Steps

The current CMS administration will want to act on this rule and comment cycle by December 2021, when the "delay" of the Trump rule from January 2021 will expire.

To accomplish the MCIT by lawmaking on the Hill rather than by CMS policy action, bills like the "Ensuring Patient Access to Critical Breakthrough Products Act" are being introduced - here.

Zip File

I've made a search through the 115 comments for some names I recognized, and I've placed those comments in a cloud Zip file for readers - here. (4 mb).

Comments I pulled included AAMC, Abbott, ACLA, Advamed, AMP, BIO, C21M, DTA, Masimo, MDMA, Medtronic, Misonix, PCMA, PHRMA, PMC.   With the keywords I used, I didn't find comments from CAP or AMA.

My "Informal" Comment Notes

I'll show you my scratchpad.  I put some very informal personal notes on the comments in a separate webpage here.  These are only informal notes and you should see the full association statements for their positions.


My original September 2020 blog and links on the first Trump version of MCIT is here.  

Some negative Op Eds appeared in December 2020 (and later); December blog here.

See my August 2019 blog on the history of Breakthrough coordination between CMS and FDA, going back to 2016 - here.

It would be helpful if Federal Register and listed the comments by the submitter's organization, but they don't.  When you click to see the 115 comments, all you see is screenfuls of the comment document index numbers, one after another.  (It's even worse when there are 2000 comments).

Wednesday, October 20, 2021

Two Resources on Healthcare's Costly Administrative Burdens in the U.S.

We constantly hear that U.S. healthcare has vastly higher administrative costs than anywhere else. (Here, here.)

Two new resources this week.   

In the first, McKinsey issues a major report (a 70 page report and 8 page summary) on administrative costs and potential solutions.  Hint: The administrative burden is basically $1 Trillion   Over ten years, that's $10 Trillion - triple the notorious current "infrastructure bill."

The McKinsey article is paired with a new, October 20, online companion article at JAMA - here.

Separately, there's an excellent long-format article on skyrocketing administrative costs for providers working with North Carolina Medicaid this year.   See Clarissa Donnelly-DeRoven's article at North Carolina Health News.


If you're enjoying these, try also Cass Sunstein's new September 2021 book, "SLUDGE," about red tape, paperwork, and how sludge stops us all from getting things done.  MIT Press.  At Amazon here.  It's only 168 pages, minimizing the administrative burden of actually reading it.

For a different view of admin burdens and health costs, see Valenti, 2015, here.

Tuesday, October 19, 2021

Very Brief Blog: Scott Gottlieb on Regulatory Policy for Devices; with Joe Grogan; at USC Schaeffer Center for Health Policy Oct 27

On October 27, 2021, see a webinar with Scott Gottlieb discussing regulatory policy at FDA and lessons learned from the COVID epidemic.  He's interviewed along with Joe Grogan, who headed the Domestic Policy Council at the White House.   Moderated by Erin Trish, Co-Director, the USC Schaeffer Center for Health Policy & Economics.

Date and time are 11:00-11:45 Pacific (2:00 eastern), Wednesday October 27. 

Register here:

Friday, October 15, 2021

AMA Announces Review of 4th Quarter PLA Codes

 AMA takes applications for new PLA codes quarterly, and the committee votes on them after a brief period for public comment.   The codes proposals for October 2021 are up for review and the Editorial Panel will vote on them on November 4.


See the AMA home page for PLA codes here, and find "Public Agenda" (the codes) and "Register" (for the meeting.


The agenda notes that if you have interest in commenting on a code, please do so rapidly at the email address on the agenda.  Based on a separately posted calendar here, the "comment request deadline" is October 21 (Thursday), and based on instructions on the agenda form, comments must be turned around in 3 days.  Based on experience, I'd recommend seeing the agenda by Monday October 18 and filing a request by Tuesday October 19.

And What's Up?

There are 27 agenda items.  2 are deletions (2 PLA codes for Biofire panels) and four are edits.  That leaves 21 new PLA applications.  

Medicare Coverage for Nephrosant "QSant" - First Urine-based Kidney Transplant Rejection Test

The MolDx program has granted coverage to the NephroSant "QSant" urine-based test, a multi biomarker test including urine donor organ DNA.   Previous Medicare coverage in this space was attained by the CareDx and Natera tests, which use a blood test to look at donor organ DNA shed into the circulation.  Leaking of donor DNA signals damage to the transplanted organ.   

  • See Nephrosant's website here.
  • See a Genomeweb article (subscription) about the clinical launch earlier in 2021, here.
  • See the company's press release here.
  • For publications, see a 601-patient study, Yang et al., in Science Translational Medicine 2020, here
    • See also a validation study in 223 samples from multiple sites, Nolan et al., J Clin Med 2020, here.  
    • Nolan et al. conclude, "The Q-Score [also] detected subclinical rejection in patients without an elevated serum creatinine level but identified by a protocol biopsy.  This study confirms that QSant is an accurate and quantitative measurement suitable for routine monitoring of renal allograft status."
  • See the MolDx LCD and articles as follows:
    • MolDx LCD DL38671 here.
    • MolDx article for the above, billing instructions, Article A58170, here.
  • Palmetto also runs a website that lists coverage ("yes/no") by lab and test name, here.
    • At that website:
    • The test is listed as Covered, and priced at $2753.
    • This is essentially the same as the CareDx AlloSure test, and the Natera Prospera test, which are $2840.

Two Papers Highlight Amazing Speed of COVID Variant Replacement

From October 4 to October 14, two remarkable papers on COVID sequence epidemiology and the remarkable speed with which one strain replaces another.

The newest paper is Vohringer et al., Nature, on a year's worth of exploding then vanishing strains of COVID in England.   See the open access paper here, see an open access article in Genomeweb here.  See the explosive growth of the "red" then "brown" (delta) strains.

Vohringer, Nature

And from last week, see Tartof et al. reporting first, on vaccine effectiveness, but second, on strain epidemiology, in a Southern California population.   Lancet article by Tartof et al. here.   News report here.  Bar chart on strain replacement below:

Tartof, Lancet

Thursday, October 14, 2021

Very Brief Blog: The somewhat clumsy search for "Future Effective" New Final LCDs

For the last few years, MAC websites have all had a "Medical Policy" section that lets you search for that MAC's proposed but unfinished LCDS, and, for finalized and "future effective" LCDs.   In the past,these links (when they worked correctly) would send a CMS website policy library, AND, to the specified category of result such as "future effective" LCDs.  

Currently, it seems like these MAC links for "future effective" LCDs still send you to the CMS policy database, but just dump you out at at the CMS home screen.  From there, it can be difficult to find "future effective" LCDs.   (I noted this in an earlier blog this week).

Below, some simple documentation of what I'm finding, to help you run your own searches for "future effective" or "in notice" (synonyms) LCDs.


Start here:

If you go to the CMS articles and policies home page search box (above), you can't search directly for "Future Effective" nor "In Notice" LCDs.   (Another issue is why CMS uses different synonyms in different places for the same thing, keyword "future effective" = keyword "in notice.")

If you go to REPORTS, there's report call LOCAL / WHAT's NEW (sounds appropriate) or or local reports for either FINAL LCD or PROPOSED LCD.  However, for me, the WHAT'S NEW search doesn't actually catch all that's new.  And, it also pulls up a ton of articles being updated only because of a single decimal point change in one ICD10 code, and you have to wade through those one click at a time.

Note however the "future effective LCDs," a super important category, are neither "Final" nor "Proposed," so there's no option to go straight to them.   Here are some workarounds.


If you ask for REPORT, Final LCDs, you'll get over 1000, but sort by "Effective date" present to past, then the future effective dates will rise to the top.


If you go to REPORT, Proposed LCDs by Contractor, you get 170 entries sorted by title.  Here, you now see that there's a status drop down box and you can pick "Future Effective" as a status but with the term "IN NOTICE."  However, in what should be a nationwide search, this pulls up only 7 LCDs as "in notice" right now, which seems like it might be an undercount, given the national volume of LCDs proposed (170).   Since they go into "notice" for 6 weeks, and must be finalized in 1 year, at any given time, about 10% of them should be rolling forward into the Notice status (10% of 170 is 17).   


If you go to Final LCDs by Contractor report, you get 1009 LCDs, and a drop down box with the particular option "FUTURE EFFECTIVE."


Proposed LCDs gives you 170 LCDs by "DL" or "Draft" number, and you can search by a drop down for IN NOTICE draft LCDs, meaning finaled, becoming effective.  N=7.

FINAL LCDs gives you 1000 LCDs by "L" or "LCD" number, and you can search by a drop down for FUTURE EFFECTIVE.  N=8, those 7 plus 1.


Local Coverage Report, Proposed, then search status IN NOTICE.  N=7

DL34635 (WPS Botulinum)

DL39051 (WPS, Cosmetic)

DL38737 (Palm, Fracture)

DL39027 (NGS, Resp Panel)

DL38968 (NGS, Thyroid nodule)

DL38902 (Noridian, Wound)

DL38904 (Noridian Wound)

Local Coverage Report, Final, then search status FUTURE EFFECTIVE.  N=8

Here, the LCDs are "L" final plus "future effective", so the numbers change from DL to L in this view.

Same as above plus also an 8th LCD:

     L33802, TENS, CGS & Noridian DME MAC

Brief Blog: NGS MAC to Hold Public Meeting on Tumor Genomic Profiling

The NGS MAC (with 3 upper midwestern states and NY/New England) has traditionally had very low payments per capita for genomic testing, except for two tests controlled by NCDs (Cologuard in Wisconsin and Foundation Medicine F1 in Massachusetts).   They have proposed a new LCD for tumor-based genomic testing, aka comprehensive genomic profiling or CGP.   You may want to track a public comment meeting on this important LCD to be held on October 20, 2021 at 1 ET.


Find the NGS MAC policy page here.

Find the page for pending meetings here.  There's a "registration" link.


Right now, draft (proposed) policies are a little harder to find than they used to be.  MACs used to link to a common CMS database in a way that took readers right to that MAC and its short list of proposed policies.  Now, in my experience, those MAC links just dump the reader off at the home page for CMS policy searches.   And, once you're there, CMS has made it harder to look for the topic "proposed policies" (or, completed-pending-active policies).   I've written to CMS and complained.

The policy in question is DL37810, "Genomic Sequence Analysis Panels for the Treatment of Solid Organ Neoplasms."    

At the CMS search page:

Type in Dl37810.

I get DL37810 at this link:

I had a "brief blog" on the LCD when it was proposed in late September (here).  It guarantees coverage for 5-50 gene tests in lung cancer and colon cancer.  It then has another section that provides coverage for larger tests (e.g. 300 genes) when smaller tests are "insufficient."   The coverage section isn't very clear on when this occurs, and the discussion section discusses numerous policy topics (from racial equity in biomarker testing to using large sequencing bins to report TMB).   

There's also a closing sentence that states, "Given the abundant (if conflicting) literature, and widespread societal support for NGS CGP testing in advanced cancer, National Government Services reservedly deems such testing appropriate for advanced somatic cancers, consistent with CMS NCD 90.2 (1)."  This might be interpreted to mean that CGP testing is covered in patients with advanced cancer (assuming patients meet 3 or 4 rules listed in the NCD), but it's not clear to me if this easily agrees with the phrase that each patient must be tested to whether a 50 gene panel for him/her was "insufficient."  Comments run from 9/30 to 11/13.

News x 2: California Law for Biomarkers; Consensus Terminology for Precision Medicine

Two news items in the field of precision medicine policy this week.

California Law

In California, new law SB535 restricts insurers from using "prior authorization" to restrict the access of cancer patients to oncology biomarkers.  See an open-access article at Genomeweb, here.  The California bill follows earlier (but different) legislation in Illinois and Louisiana.   

Standards in Precision Medicine

After several years of work, Journal of Precision Oncology (sponsored by ASCO) publishes, "Adopting Consensus Terms for Testing in Precision Medicine," by Martin et al.  Many experts and organizations contributed to this consensus, led by Lungevity, a lung cancer foundation.  Find the open access paper here.   See a white paper about the project online here.

Wednesday, October 6, 2021

Very Brief Blog: AMA to Hold Nov 18 "Forum" on CPT Services & Special Topics

 AMA has announced a 7-hour "Feedback Forum" to be held November 18, 2021, on a range of CPT-related topics.  The forum registration is open.

Some of the topics are general, like "Capturing the full value of the CPT eco system."  Others are quite specific, like "Normalizing genetic testing: Coding solutions can improve access."   

Recall that AMA held a public workshop in late July on the topic of genomic coding issues and trends; I haven't seen a public meeting report on that yet.

Tuesday, October 5, 2021

Very Brief Blog: JAMA Under Fire; Health Equity Issue Lacks Black/Latino Lead Authors

In July, I noted a review publication - a white paper - at the AMA about health equity, which was timed close to a JAMA special issue on health equity (here).

September 23, STAT covers that and related topics, see article here.  

The article is headlined, "Health Equity Tourists: White scholars are colonizing research on health disparities," by Usha Lee McFarling.

The author writes:

STAT has documented dozens of cases where white researchers are building on the work of, or picking the brains of, Black and brown researchers without citing them or offering to include them on grants or as co-authors.

A glaring example occurred in August when the Journal of the American Medical Association — a leading medical journal already under fire for how it handles issues of race — published a special themed issue on racial and ethnic health disparities in medicine. Meant to highlight JAMA’s new commitment to health equity, it served up an illustration of the structural racism embedded in academic publishing: Not one of the five research papers published in the issue included a Black lead or corresponding author, and just one lead author was Hispanic.

They add, one study "documenting the lack of Black medical school faculty and led by a white author, reported results similar to findings published 3 years earlier, Black researchers." Elle Lett, the author of the 2018 paper, is quoted as, "“It is troubling that a white man, who has had every privilege conferred on him, is writing a paper about the plight of Black academics.  He is extracting from our pain for his career advancement.”  The author, at Harvard, responded in a message, "It was not my goal to be either colonial or extractive."


Very Brief Blog: Oxford Nanopore IPO Document

This past week, Oxford Nanopore had an IPO on the London Stock Exchange, which attracted numerous press articles.  E.g. The Economist here.   Motley Fool here.  Genomeweb here.  Reuters here.

Being a London IPO, it was a little harder to track down the 285-page prospectus document.  Cloud copy here. *   

Like all IPO documents, there are many listings of risks (we may fail to do X, we may fail to do Y).  Benefits are listed at page 93 forward and include the following:

  • Value proposition in genomics research
    • More than 2100 publications
  • High throughput genomics
  • Value proposition in public health, epidemiology
  • Clinical and translational research
    • Dark genome, immune system genes, large and small scale variation,etc
  • Segments include
    • Oncology, immunoprofiling, infectious disease,  microbiome, food safety
  • Commercial Strategy
    • Discussion follows (p. 98ff).
* (The 9/30 285 page version replaces a 9/9 229 page version that that I noticed here.)

BETOS - Medicare's Data Categories for Clinical Services - Upgraded as BETOS 2.0

How do you categorize HCPCS and CPT codes?   CPT codes in the 80,000's are lab codes; HCPCS codes starting with E are durable medical equipment....   CMS uses a system called Berenson-Eggers Type of Service codes, BETOS.    Dr Berenson is an active policy expert at the Urban Institute (his home page here, Wiki here.)  The original BETOS system was designed in 1998-2000 (here).  

See BETOS at Wikipedia here.  BETOS has seven highest-level categories:  E&M, Procedures, Imaging, Tests, DME, Other, and Exceptions.


CMS has a new home page for the BETOS 2.0 system - here.

The page above includes a link to a 56 page white paper on the new BETOS 2.0 system - here.

There's a separate, 2020, 51-page report on the design of the BETOS 2.0 system online at Urban Institute, here.  

For an example of a recent paper using BETOS codes to track radiology for ten years, here.


The legacy BETOS page was here.

Berenson and Walter Zelman wrote a 1998 book, "The Managed Care Blues and How to Cure Them," still available via a Kindle edition.  Here.

Monday, October 4, 2021

MolDx Z-Identifiers Now Requires by United Healthcare Medicare Advantage Plans

In a separate blog, I noted that MolDx has upgraded and updated its website - here.

Some of the news items are noteworthy.  On the home page, MolDx announces that Z-identifiers (aka Z codes) are going to be required for Medicare Advantage plans going to United Healthcare plans.  (See my April 2021 blog forecasting this, here.)

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On the General FAQs page - here - you'll also find this notice:

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MolDx Launches New Website, Integrates "DEX" Registry Better

Last summer, Palmetto GBA, which runs the MolDx program, took over the DEX registry (Z-code registry).   

This month, they've substantially updated the website with a new design, a more energetic look, and better functionality.

Start here at the website

In the blue boxes at right, if you click DEX REGISTRY, it takes you to the traditional DEX search site (search 14,000 tests).  That's here, but I don't think it's upgraded.

If you click MOLDX PROGRAM, it takes you to this page:

Note that 2 of the green box sequence are the same - Dex Test Registration, Tech Assessment - but General FAQ is replaced by "Coding and Billing Guidelines" in the green box on the right.  On the lower left, there's still a blue box for DEX, but new blue boxes for MAC LOGIN or MOLDX LCDs.  There's also a new "News" feed, this time, featuring a GI molecular test meeting on October 12.

There's a new Tech Assessment Forms inventory, with renamed forms, and a better two-column guide to what is useful, when.

File names have change; some of us (eeek) knew forms with names like "M00151" and "M00116" by heart, but they have new names like GEN-CQ-003 and GEN-PF-001.   "CQ" documents are either checklists or questionnaires ("Are you FDA approved?")   PF forms are "provider forms" (e.g. our limit of detection is .001).  


For a long time, MolDx ran on a mix of policy articles variably on the MolDx website, MAC websites, or the CMS article database.  It looks like policy and billing article links now refer the reader to the central CMS article database.   (Right now, links for "MolDx LCDs" and "MolDx Articles" seem to just dump me out at the general home page for the CMS article search engine.)

For news about Z codes and Medicare Advantage, here.

Sunday, October 3, 2021

Very Very Brief Blog: KHN: Covid Test Costs More Than a Tesla

Over the summer and up to September 25, NYT and others ran several articles on the sporadically very high cost of COVID testing.  Entry point here.

Update worth noting.  September 30, 2021, article by Kaiser Health News (KHN) Aneri Pattani, "A Covid Test Costing More Than a Tesla."  Eeek.

See also links therein to NPR health news.

Friday, October 1, 2021

Very Brief Blog: AMA Posts October 1, 2021, PLA Codes

Every quarter the AMA CPT publishes a new roster of PLA codes.  Here's the list for October 1, 2021:

Code 0090U was revised, say goodby to Code 0208U (deleted), and welcome new codes 0285U-305U, a crop of 21.

Code 0090U is edited as ownership transfers from Myriad Genetics to Castle Biosciences.  0208U was the Afirma Medullary Thyroid Classifier from Veracyte.  

Codes released today will be effective January 1, 2022. 

Gilfillan, Berwick Publish: Medicare Money Machine, "Expose'" of Medicare Advantage

In the form of a deep-dive journalist's expose', health care leaders Richard Gilfillan and Don Berwick publish a two-part series in Health Affairs about what drives the profitability and expansion of Medicare Advantage.  Authors also focus on the new and different dynamics of Direct Contracting, which they view skeptically as well.   (Direct Contracting would essentially simply replace MACs in defined geographic regions.  For example, Novitas might have Texas, but Direct Contractor X could take over all Medicare claims for Houston.)

Find Part 1 here.   Find Part 2 here.


Berwick also had a good article in January 2020 on "Medicare for All" - policy ins and outs.  Here.

Cross reference: NYU's new Master's program in law and healthcare business strategy.

Cross reference:  Follow up article at Bloomberg, here.

Feds Release Another Round of Surprise Billing Regulations

 After discussions of Surprise Billing that came and went during the Trump Administration years, in December 2020 Congress suddenly passed a major Surprise Billing law, to take effective January 1, 2022.  Accordingly, the Administration has been going through several rounds of releasing implementing regulations so the industry can get ready for changing ground-rules between providers and insurers.

An early round of regulations were released July 13 - here.   See my earlier blogs in July here, September here.

  • Now on September 30 there's a another round.  
  • Fact Sheet at CMS here.  Press release here.
  • New regulations, 520pp, here, in inspection copy.  
  • The Fed Reg typeset version will be out on October 7.

The laws put strict limits on the amount of out-of-network billing and sets both what the patient is responsible to pay and what the insurer will pay the provider as the main payment.   Some appeals and negotiations are possible.   

See also a special "No Surprises Act" webpage that's been opened up at, here.

See some early press as follows.   

  • NYT here.
  • Rev Cycle here.
  • MedCity here.
  • Stat here. *Subscription.
  • Fierce Healthcare here.  
  •     (Some further background from Sept. 8 at Fierce, here.)
  • CAP Objects to new rules here.
  • See a rapid publication (promising more) at Health Affairs, here.
  • See Healthcare Dive here ("Docs slam rule").
  • See a more general article in NEJM on "financial informed consent" - here.

As a pathologist, Table 2 caught my eye.  They assert there are 12,640 active pathologists, 44% had out-of-network claims (when serving inpatients).  Of those doctors, 44% of their claims, were out-of-network.  These numbers were net-net higher than any of the other specialties in the table (E.R. med, radiology, anesthesiology, psychiatry, cardiovascular).  Anyway, it's clear why rules and regs around surprise billing are high on the agenda of the pathology associations.
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