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.)

click to enlarge

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

click to enlarge

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.