MolDx Deletes Codes from Its LCD Scope: Retreats from Proteomics

Summary.  Since about 2012, the MolDx program has operating under a master LCD called "Molecular Diagnostic Tests."  One function of the LCD was to allow MolDx to treat certain tests that were not yet reviewed or covered, as "non-covered."   The LCD quirkily defined "molecular diagnostic tests" as assays of DNA, RNA, proteins, or metabolites.  We just discovered newly-released edit changes. MolDx appears to be walking back from asserting coverage or control of proteomic/metabolomic testing.

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Medicare's documentation cited at links throughout this article, but also available in a cloud zip file here.

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MolDx dates back to 2011/2012 (white paper here, ACLA letter here) and operates under a "master LCD" that defines its scope, and a couple dozen individual LCDs for specific tests or clinical use cases.  

The Master LCD, or MDT LCD, is here (L35025) and the associated coding and billing article is here (A56853).

Molecular diagnostic tests are defined in the LCD as being, "any test that involves the detection or identification of nucleic acid(s) (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or may not include multiple components. A MDT may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation." (quote-unquote).   

MolDx has a number of LCDs on proteomic MAAA tests (e.g. Biodesix XL2, L37031, here).  Others are covered by articles (e.g. Palmetto article on Myriad Vectra, A53110 here).

What's New: Test Types Abruptly Deleted from Master MolDx LCD

Here's what's new.  Go to the master coding article for MolDx tests, A56853 (here).  Scroll down to Revision History.  In Revision R7, released February 5, 2021, but effective January 1, we count that 32 specific test codes are DELETED from control by the LCD.   (MolDx also deletes several unlisted codes, e.g. 84999).  

It looks like proteomic and metabolomic codes, which had previously been actively listed (hence requiring active deletion) are being deleted.  See table:

Click to enlarge / Deleted from Control of Master LCD for MolDx

Some Quirks We've Found

MoLDx is an important but quirky program, and I've counted 4 quirks triggered by the article updates.

1. Mismatch of LCD Text and Its Coding Article

The LCD text defines Molecular Diagnostic Tests as including DNA, RNA, proteomics, or metabolomics, but the corresponding article exempts all but DNA and RNA tests from its domain. So the LCD and coding article seem out of sync.

2. Palmetto Rules, Out of Sync with Other MACs in MolDx Program

The corresponding Noridian LCD/Article (L35160, A57526) haven't been revised for a year, so they are currently out of sync with the Palmetto MolDx documents.

3. MolDx Palmetto "DEX" Website Lists Tests as "Non-covered by MolDx" that MolDx Defines as Outside Its Scope

I realize that's a mouthful.  

MolDx appears to be defining non-DNA, non-RNA tests as outside of its scope.  OK.

However, if you go to the official Palmetto- and MolDx-branded and Medicare-branded Diagnostics Exchange website, it's clear that some of the tests deleted from scope above, are concurrently listed as "non covered by Medicare Palmetto MolDx" on the DEX website.  

Potentially, Medicare  Advantage plans could view the Palmetto- and MolDx- and Medicare-branded DEX website as a coverage decision source, see a test there being directly named as non-covered by MolDx Medicare, and non-cover it under Medicare Advantage.   This seems hard to square with the test being outside MolDx Medicare scope of review per A56853.  (For example, ineligible for a MolDx LCD to reverse the MolDx non coverage.)  I'm not sure what next steps for such a company would be.  Let's say they have code 80101, and it's a proteomic MAAA test, and it's deleted from eligibility for review by Palmetto-Medicare-MolDx, but it's listed on DEX as non-covered by Palmetto-Medicare-MolDx.  Seems like that would be a Catch-22 which could annoy someone significantly.  

Below is an actual example of a test that is publicly listed by "Palmetto MolDx Medicare" as not covered, on the DEX website, but the very same test is also excluded from the MolDx scope and tech assessment and LCD review process by "Palmetto MolDx Medicare."  Ouch.  

4. Article Appears to Define MolDx Scope, but Variance Occurs

Article A56853 says that its code lists define the codes that apply under MolDx ("This addition and deletion is due to coding that is applicable to the MolDX program," quote-unquote.) 

However, MolDx has recent and active LCDs in infectious disease (e.g. LCD L37315 governing code 87631 per article A57340), and has even held a 2021 advisory panel on infectious disease (here). But, like proteomic codes, DNA RNA infectious disease tests appear to not be codes that MolDx views as active under MolDx per the MDT LCD and its code-list article.

I think at the end of the day, MolDx is helping us understand that it focuses on DNA RNA tests, while reserving the right to contribute its staff expertise to other MACs in the MolDx consortium on other types of tests.   

Very Brief Blog: Medicare Advantage Proportion by State

Kaiser Family Foundation (KFF) runs a detailed website of CMS data, one aspect of which is Proportion by State in Medicare Advantage.   The website is here.  They provide a lookup table by year, the most recent year is 2018.  Overall Medicare Advantage was 34%, but was ~40% or higher in 8 states.  The peak state was 56% in Minnesota.  Florida, California, and New York all clock in around 40%.

Overall, in round numbers, about 1 in 5 Americans is over 65 and in Medicare.

GEO Model Would Chip Further at FFS Population

I find this next topic quite confusing, but Medicare has proposed a GEO demo model that would seemingly sweep up fee for service beneficiaries in selected zones and put them in a sort of Medicare Advantage plan (Commonwealth Fund here).   

The GEO contractor for those zip codes would pay claims but could also impose medical management rules, have preferred provider networks with better copays, etc.   CMS web page here with new header commenting "GEO is under review" (e.g. from Biden administration).  Fact sheet here.  Dark Daily report here.  Article "CMS pushes pause" here.

Tempest in a Teacup: AHIP vs MEDPAC on Med Adv Spending

On February 26, 2021, AHIP released an online article criticizing MedPAC numbers showing high Medicare Advantage spending - here.   A few days later, on March 3, MedPAC responding with a counter-article, here.

Very Brief Blog: AMA Posts New Lab Code Proposals for May 2021 CPT Meeting

Every four months, AMA CPT holds an editorial panel meeting, and posts lab codes about 60 days in advance.  (Other codes are posted about 45 days in advance).

At the AMA website, here's how you find the lab test code agenda:

• The main homepage for editorial panel postings is here.
• AKA "About CPT Editorial Panel."
• Scroll down this page, to find the recently-created posting for May 2021 meeting.
• In the future, you'll scroll down this same page to find the future creations for the October 2021 meeting, the February 2022 meeting, and so on.
• Find the May 2021 Editorial Panel homepage here.
• Note that there is a link for free Registration (Don't wait to the last minute, registration will close).
• Under AGENDA, find the lab codes public agenda.  AMA PDF cloud link here.

You can receive a summary of a particular lab CPT application, if you are a concerned stakeholder.  This is defined by AMA review, but it excludes e.g. consultants who are just curious about the code proposal.  See instructions on the PDF, including how to request a proposal by email and the requirement you explain your rationale for a request.  This moves fast - you must request a proposal (on which to comment) by March 15, and must submit a comment by March 22.   AMA would provide you with a structured comment template.

This cycle is the last cycle of new codes that will enter the CMS crosswalk/gapfill meeting in June 2021 and will be published in the AMA CPT annual book January 2022.

Code proposals for May 2021 include:

• Hydroxychloroquine drug assay
• Pancreatic elastase test, quantitative
• Mitochondrial antibody
• Voltage gated calcium channel antibody
• Actin smooth muscle antibody
• Antineutrophil ctoplasmic antibody
• Blood culture, PCR multiplex panel, 26 or greater targets
• Note: The code reference was initially mislabeled, AMA updated as 87X00..
• Review 81228/81229 cytogenomics codes to better fit any future parent/child codes
• Genomic sequencing procedure (GSP) for bone marrow failure (814XX)
• Admin MAA A for renal allograft failure (CD154 memory cells)
• Pedigree analysis for genetic risk (96X41, a 9---- series code, not 8--- series lab code)
• Cytogenomic constitutional array by low pass NGS sequencing, 812X0

Regarding cytogenomic NGS sequencing.  In its recent going-public materials (page 23), Sema4 described clinical exome sequencing PLUS low pass NGS cytogenomic structure ("low pass genome") as a core test.   In addition, labs like Mayo, NY Genome Center and Perkin Elmer have gotten PLA codes for low-pass NGS cytogenomics (0012U, 0156U, 0209U), but there is no comparable non-branded CPT code.  

I noted this in a recent white paper about genomics and PLA codes (here). See e.g. Chau et al., 2020, Human Genetics 139:1403 (here), Chaubey et al. J Molec Dx 22:823 (here).  I discuss these further in a later blog - here.

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Why are Lab codes posted earlier than other codes?

Lab codes are reviewed by at least one if not two workgroups AHEAD of the committee-of-the-whole meeting on May 6-8.   

Molecular codes are reviewed by a mopath workgroup (called MPAG) and then those codes and all lab codes are reviewed by the multi-stakeholder group Pathology Coding Caucus, convened by CAP and including members like AdvamedDx and ACLA, industry groups which do not otherwise have a seat at the table of the AMA's CPT.

Registering for the Meeting

From the May 2021 home page, there is a link to register.  This will trigger some follow up AMA DocuSign confidentiality documents then the AMA will send you a Zoom link for the May 6-8 meeting.

Next AMA CPT Meeting

The next CPT code application due date is June 30, for the September 30-Oct 2 CPT meeting.  Around 15-20 days after June 30, e.g. June 15-20, starting checking the About CPT home page for the creation of a new AMA webpage for the September 2021 meeting.  You may have to scroll downward a full screen or two.  When that September 2021 webpage is created, it will start containing links to preview the code agendas.  (See a screenshot of this process, here.)

Very Brief Blog: Health Affairs Reports on "The COVID 19 INNOVATION SYSTEM"

Journal club - the new issue of Health Affairs includes a 10-page review article by Bhaven Sampat (Columbia) and Kenneth Shadlen (London School of Economics) on the "COVID 19 INNOVATION SYSTEM."

Find it here.  Looks like open-access.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic response brought forth major changes in innovation policy. This article takes stock of the key features of the COVID-19 innovation system—the network of public and private actors influencing the development and diffusion of technologies to combat the pandemic. 

Before the pandemic, biomedical research and development policy consisted largely of “push” funding from the public sector in support of basic research and “pull” incentives from patents to motivate private companies to invest in clinical trials and develop drugs and vaccines. 

In contrast, during the pandemic, public funding shifted its focus to late-stage product development and manufacturing. Procurement agreements with governments replaced traditional pull incentives from patents for the major private companies. Nonpatent barriers to competition may also have incentivized innovation. 

The challenges to ensuring diffusion [of innovation] have gained in prominence during the pandemic, though it is unclear what role patents will play in pricing and access. Some aspects of this approach to biomedical innovation may be unique to crises, but others could provide lessons for policy beyond the pandemic.

Very Brief Blog: CMS Issues Guidance on Commercial Payer COVID Test Payments

 As highlighted in a March 1, 2021 article in HealthCareDive by Nick Taylor, CMS has finally issued a major guidance on how and when private health plans must pay for COVID testing at commercial laboratories.

• See the HealthCareDive article here.
• MedCityNews here.
• 360Dx here.
• See the 11-page CMS document here, issued February 26.
• CMS also issued a press release here.
• ACLA praised the document here.
• But on Feb 22, ACLA had been very annoyed at the confusion in recent policy (here).
• See Biden's January 21 executive order about a COVID pandemic testing board here.

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Of separate interest, see an article in medCityNews on the high barriers created by prior authorization - here.

Very Brief Blog: LA Times Shows Mismatch Between COVID Cases, Vaccinations

In an article February 24, 2021, Los Angeles Times shows a striking mismatch between zip codes rated for vaccination rates and COVID burden.   Below, red arrows highlight Santa Monica, with very high vaccination rates and very low COVID history, and South Central LA, with a completely opposite pattern.  

click to enlarge

Other articles discussed issuance of "vaccine access codes" specially targeted for new distribution sites opening in low-income areas, but "vaccine tourists" from wealthy zip codes show up with the codes (here, here).  

For an update on this topic also from LA Times on Feb 28, here.

Very Brief Blog: Liz Fowler Tapped to Head Center for Innovation at CMS

As first noted in Politico here, and presented in Fierce Healthcare here, Biden has picked Liz Fowler to head the Center for Innovation (aka CMMI) at CMS.

The Fierce Healthcare article is worth reading and gives a good background on both Fowler and CMMI.  Fowler work in the 00's for Max Baucus in the Senate, and was an advisor to the Obama administration.  Most recently she's been at both Johnson & Johnson and the Commonwealth Fund.

CMMI originated in Section 1115 of the Affordable Care Act, to run "demo projects."  Due to a quirk in the law, there is no limit on the size and duration of "demo projects" or their scope, as they can alter any aspect of CMS law "for the duration of the demo."   For example, the Trump proposal to up-end existing law about drug pricing for injectable (Part B) drugs, pegging prices instead to European prices, was a to be a decade-long nationwide "demo project" (sic).  That is on hold due to court actions (here) and its CMS webpage says it won't be implemented without new rounds of notice and comment rulemaking (here).  There was actually legislation proposed in early 2020 to reign in CMMI by restricting its demo's to be less than unlimited scope and duration.    (Here, here).

See her December 2020 blog on whether the puzzling, Trump-proposed "Medicare Geographic Care Model" is a good idea - if I understand it correctly, essentially depositing Medicare FFS beneficiaries in some zip codes into capitated-budget, Medicare Advantage plans.  Her blog.  See an article on Geographic Model at the trade journal Dark Report on Feb 12, here.

On March 1, CMS posted a notice on the CMS webpage for Direct Contracting GEO model, that the model was being "reviewed" - here.   Beth Mantz-Steindecker, of Washington Analysis group, noted that this was not unexpected as the complex model has competing stakeholders vying for the final position of the Biden administration.  She wrote that, "patient groups complained about the Geo design’s lack of beneficiary choice and potential confusion among beneficiaries given involvement of insurers and repeatedly asked the Biden administration to re-examine, if not halt, this demo."

Very Brief Blog: Many Hospitals Still Struggle with Margins, Cash

In the first two COVID months, we heard how hospital revenues often plummeted and the situation was described as dire.   

For an update to February 2021, see a report from Kaufman Hall on hospital finances and margins.   

• See a trade journal summary at HealthCareDive here, 
• See an update by a different HCD journalist on Feb 25, here.
• See the original 30 page PDF online here.

The authors summarize, "The median hospital operating margin was down 46.1% compared to January 2020, and down 34.1% when CARES Act funding is factored in. Smaller hospitals tended to experience smaller drops than larger institutions.  Adjusted discharges were down 17.6%."

Kaufman Hall provides consulting services (strategic, financial) for institutions including healthcare and education.

Very Brief Blog: WSJ Features COVID Sequencing Variants

In a lead article released February 22, 2022, Wall Street Journal features COVID sequencing, and notes that some COVID PCR tests that already exist pick up some sequences in COVID - e.g. render a positive - while not seeing the important mutation that underlies the U.K. Variant.   Brianna Abbott writes,

The highly transmissible Covid-19 virus variant that first emerged in the U.K. can partially evade a commonly used coronavirus test. Some health authorities are using that fact to their advantage.  

As more-transmissible variants emerge as a concern in the fight against the virus, the vast majority of Covid-19 diagnostic tests haven’t been affected. But for a handful, including one from diagnostics giant Thermo Fisher Scientific Inc., TMO -2.25% a section of the test can’t pick up on variants including the U.K. variant that have a specific mutation, the company, laboratories and health officials who have processed its tests said. 

Yet the other parts of the tests still work. So if a test comes up positive for Covid-19 but that portion of the test fails, that could indicate that the samples contain the U.K. variant. Some laboratories are exploiting the bug to more quickly find cases that might be caused by the fast-spreading variant.

• See the full WSJ here.
• See Thermo Fisher's educational page on COVID testing, here.

Some Related Links

WSJ also cites HELIX tests.   COVID SEQ tests with EUA include Helix here, which uses several PCR amplicons detected via NGS reads.  Guardant also has an EUA COVID-SEQ test (N1 gene, P gene), here.   Illumina has a sequence-reporting 98-target COVID SEQ test, EUA here.   

Biden Administration is expected to inject up to $1.6B more funds into COVID testing and sequencing, here.

 

Very Very Brief Blog: Most Unusual Map: COVID in Iowa (Feb 2021)

 Writing as a native Iowan, the most unusual COVID map I've seen all year (new cases):

HARPA: Proposing a Multi-Billion Dollar Applied Medical Research Agency

You may start hearing about the abbreviation HARPA - modeled on DARPA, a "HARPA" would be a large-scale national research agency modeled on applied healthcare research.  The idea is that this big middle area of healthcare is missing out in our current mix of (A) NIH funding, on the one hand, and (B) industrial for-profit funding, on the other.   You'll also see the abbreviation ARPA-H, modeled on ARPA-E, the existing federal energy research agency.

See an article appearing February 12, 2021, in Fast Company online - here.   The summary is, "The Biden administration is contemplating creating a research agency to help fund breakthroughs that aren’t economically viable for big health and pharmaceutical companies. Meet HARPA."  Potentially, tens of billions could flow through "HARPA" as part of Biden's plan to spend as much as $300B on federal research during his administration.

One of the advocates is Mike Stebbins, formerly on the White House Office of Science and Technology Policy (OSTP).  "Innovations in biomedical research are right now largely funded by the private sector or through organizations like the NIH...The problem is you’ve only got a $40 billion budget for the NIH annually, and they fund very little in the way of research on products.”

For back story, see a August 2019 article in WaPo here.  See advocacy on the topic from the Wright Foundation, here, with a 30-minute video and special website here.

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Readers interested in this topic might also enjoy a recent blog on a USC white paper on amped-up federal health technology assessment - here.

A side note, last fall CMS opened a special office to deal with problems and dilemmas in technology coding and pricing in healthcare - under Jason Bennett, here.  I see situations all the time when useful products fall aside from VC's (and aren't funded by NIH) because of illogic, biases, and gaps in the reimbursement system we have now.

Biden Nominates CMS Administrator; MolDx Gets Add'l Medical Director

Brooks-LaSure Nominee for CMS Administrator

On February 17, 2021, it was widely reported that the Biden administration will nominate Chiquita Brooks-LaSure to lead CMS, overseeing the Medicare and Medicaid programs.  See Fierce Healthcare here.  She's worked successively at OMB, on the House Ways and Means Committee, and at HHS during the implementation of the Affordable Care Act.  Most recently, she was a managing direct at Manatt in its consulting and policy group.  She holds a BA from Princeton and an MPP from Georgetown - bio here.

See a follow up article on Brooks-LaSure here.

• Separately, hearings for Xavier Becerra as Secretary of HHS have been scheduled for February 23 (HELP) and February 24 (Finance).

Charnot-Katsikas Joins MolDx as Medical Director

According to Linked In, in December 2020, Dr. Angella Charnot-Katsikas joined MolDx as a medical director.   See Linked In here, U Chicago website here (here).   See the full listing of Palmetto medical directors here.

As of 2/2021, she had 24 publications based on a PubMed search (here).  At Chicago, she served as Assistant Professor and Assistant Director of the Clinical Microbiology and Immunology Laboratories.   She holds a BS from University of Chicago and her MD from Rush.

Brooks-LaSure; Charnot-Katsikas

FDA Publishes Position Paper on Regulation, COVID, in NEJM

FDA has regularly been using forums like Health Affairs and NEJM to share its positioning on diagnostics regulation, especially under the umbrella of COVID.   On February 13, 2021, they posted an article on FDA regulation of COVID serology, but with numerous side comments reflecting goals of FDA leadership for national diagnostics policy.

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On September 2, 2020, I published a blog on recent announcements from FDA (August 18) and HHS (August 19) offering conflicting views on the FDA regulation of diagnostics.  That September 2 blog is updated, to include a September 9 FDA article in NEJM, and a September 15 backstory in Politico.

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On February 13, 2021, FDA's Jeff Shuren (head, devices) and Tim Stenzel (head, diagnostics) offer an NEJM op ed focused on the year's history of FDA regulation of COVID serology.  Here.  (Update: Paginated at 384:592-4, here.)    I would argue it's not just about "COVID serology," however, as the Op Ed has a range of opinions and goals about how diagnostics should be regulated and "lessons learned" the FDA intends to apply moving forward.   For example, there is a lot of emphasis on national planning and central coordination, something the Trump administration had been repeatedly criticized about.   My reading is that the FDA team is saying, if you want more national planning and coordination, we're here and ready to roll.  

USC Health Policy Center Posts White Paper on Health Tech Assessment

USC has an active health policy center (website here) and has just released a white paper on the state of health technology assessment (HTA) in the US.

• See the press release and summary here.
• See the 11-page white paper here.
• See an essay about the project by health expert Jason Shafrin, online here.

Quoting from Shafrin's  summary, the USC white paper has six recommendations - 

1. Continue to encourage private HTA [BQ: e.g. Evidence Street, Hayes, others]
2. Establish a nationally funded Institute for HTA, I-HTA
3. Include economic evaluations in the reports
4. Include new and old devices, both specific tech's and "health policy interventions"
5. Allow stakeholder engagement
6. Have US policies that encourage such HTAs to "impact" policy-making

The new USC paper was issued February 9, by Lakdawalla et al.  

There's more history on the same topic at USC.  See a February 2020 USC policy center article here, which itself included a 45-page 2019 USC white paper on the history of US HTA, here.

There's also an updated, 72-page "Office of Technology Assessment" white paper produced as recently as April 2020 by the Congressional Research Service - find it here.  

Journal articles.  You can also find an open-access 28-page 2014 academic article by Wong at Biotechnology Law Report on the history of HTA in the US, here.   See also a 53-page academic article on "the role of the federal government in comparative effectiveness research," in Annals of Health Law in 2012 by Francis, here, open access here.  Even further back, see a 2003 open access article by Stevens et al. at J Public Health, 2003 (here).

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There's a wealth of information on efforts toward HTA harmonization in Europe; for one entry point, see a 2018 white paper here.

White Paper on PLA Codes: Statistics, Trends, Impact on Genomics Coding

What does "PLA" stand for?  (Proprietary Laboratory Analyses codes.)  How are they impacting the coding for genomic tests?

When was the first PLA code created?   How many are there now?   How many are for human genomics, as opposed to drug tox testing or microbiology?   How often are they crosswalked?  How often are they gapfilled?   What is the timeline for getting one?    

For answers, see a new white paper, "US Reimbursement of Genome Wide Sequencing: A Coding and Pricing Perspective."

• Find the white paper here.

It's PLA-ology!

For example, of 212 PLA codes created as of July 2020, 165 were for human tests, and 47 were for non-human tests (either drugs or pathogens).  Of the 165 human tests, 46 were MAAA tests and 119 were non-MAA A tests.  13 PLA codes were exomic or genomic (including whole transcriptome and joint germline/tumor analyses).  

click to enlarge

Turning from test type to pricing method, of 123 codes in the CMS pricing process by last summer, 63 had been crosswalked, and 24 gapfilled, with 36 more in the active gapfill process.  Only a few PLA codes were priced at CMS by the "ADLT" process (Advanced Diagnostic Laboratory Test pricing rules.)

click to enlarge

The white paper compares existing CPT Category I genomic codes with the growing library of PLA codes.  The paper closes with a "case study" of a real-life lab getting a PLA code and seeing it through the pricing process, and a discussion of some issues and predictions for the future.

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Editorial content and data analysis and any errors are the sole responsibility of Bruce Quinn Associates LLC.  We thank Illumina for support of the research work for this study.

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One thing I didn't mention in the white paper.  Every PLA code gets a short clinical and technical description in each year's edition of AMA CPT CHANGES.  You can buy these as paper books or eBooks (see AMA CPT website or Amazon), and you buy buy them as part of a (fairly expensive) subscription to Optum Encoder Pro plus an add-on Total-CPT services package.