Friday, May 27, 2022

The AMA Updates to Tumor Coding: Now Released by CMS; and PGX Coding

Update: AMA is holding June/July/August workgroups on future changes to tumor coding - here.


On May 26, 2022, CMS released an upcoding code list (i.e. meeting agenda) for the annual lab meeting in which new codes are priced.  Details here.

Several quarters ago, AMA CPT announced they had updated the codes for tumor gene panel testing, and now, those codes are published by CMS as part of the new code pricing process.  (The codes will also be released by AMA itself in September for the 2023 year code book).

Basically, there have been three codes for cancer genomic testing.  81445 was for 5-50 genes in solid cancers, 81450 for 5-50 genes in hematopoietic cancers, and code 81455 for more than 50 genes in any type of cancer.   CMS data for 81455 has always been pretty squirrelly because some such genomic tests have proprietary codes (e.g. 0037U, Foundation Medicine), and the MolDx program has never recognized 81455 as a payable code, so at MolDx, large tumor gene panels have always been coded as 81479, thwarting efforts to understand their volume and rate of change.

Basically, all three codes morph into code pairs, including the base code revised (81455) and probably added new adjacent codes (e.g. 81456) which will represent RNA only analysis.


81445 previously stated,

Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed.

81445 is now revised as:

  • Targeted genomic sequence analysis panel, solid organ neoplasm, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed; DNA analysis or combined DNA and RNA analysis.

Basically, this is pretty trivial wordsmithing, from an early statement "DNA analysis and RNA analysis if performed" to a closing statement "DNA analysis or combined DNA and RNA analysis."   While AMA may have seen a syntactic preference here, it's hard to see it is a difference that makes a difference.

What's new are the new RNA specific codes, one for each of the existing base codes 81445, 81450, 81455.

Here are the changes as I read them:

81445 Solid cancer 5-50 genes
    No change except rephrasing the options of (DNA) only or joint (DNA & RNA) analysis
    New code option 814X1 for RNA analysis only

81450  Heme cancer 5-50 genes
    New code option 814X2 for RNA analysis only

81455  Solid cancer or heme cancer, 51 or greater genes
    New code option 814X3 for RNA analysis only

Given the "14 day rule" at Medicare, it seems that if you do DNA-RNA analysis on Day 1, you get a code that is the same (or a trivial adjustment) to the existing codes 81445, 81450, 81455.   However, if you do an RNA analysis alone AFTER day 14, then it would be code-able as one of the new RNA only codes (X1, X2, or X3).

PGX / Pharmacogenomics Coding

Also of interest in genomics, there's one other genomic sequencing procedure new code, which is 8X000, drug metabolism (pharmacogenetics), at least 6 genes, including CYP2C19, 2D6, and 2D6 dup/del analysis.

Code 0X47U, psychiatry, 15 genes, is not listed with a brand name on the CMS worksheet, but matches Myriad Genesight, based on the public PLA code agenda for April 2014 released by AMA in mid-April.  Both codes 8X000 and 0X47U will be up for pricing decisions at the summer lab meeting.

"Equity" as a PubMed Term: 10X since 2017

 Healthcare articles including the term EQUITY are far more common than they used to be, but how much?  I ran a PubMed search for "equity" as a simple single-word term.   Usage rose from about 1,000 in 2012 to over 12,000 in 2021.  For 2022, I assumed one-third of a year (Jan-Apr) and multiple by 3.

Search was done here.  Graphic below.

MolDx Coverage Article for BRCA (81162) Scheduled for Retirement; New Article Deletes 81162

One of the largest codes in the Medicare system for genetics/genomics is BRCA 1&2 testing, code 81162.  The highest paid codes have been 81479, $290M, 81528, Cologuard $210M, 81408 Tier 2 $207M, and then BRCA 1&2 81162 at $85M for 46,788 services in CY2020.

Currently, MolDx covers BRCA testing (81162) under billing and coding article A56854 (here).

81162 is prominently listed at the top of this article's covered codes (for LCD L36082).   However, A56854 is listed for FUTURE RETIREMENT on July 3.  

So what happens next?  

The replacement LCD appears to be L38966 and billing article A58652.  (For full links see my prior blog on this new LCD and article here.)  This billing article, which goes into effect on July 3, has conspicuously deleted BRCA 1&2 81162 ($1824) from the public list of codes covered under the policy, but it does include BRCA 84132 ($679).

I wondered if perhaps BRCA 81162 was absent because it is not "a panel" but codes like BRCA familial variant ARE in the covered codes list, and that certainly isn't a panel.


In Medicare Part B 2020 data, there were 45,000 Medicare uses of 81162 for $80M and there were only 10,000 Medicare uses of 81432 for only $8M.

May 26: Update on VALID Proposed Legislation, 433pp.

In a May 17, 2022, blog, I noted that Senators Murray and Burr had released a "discussion draft" of new VALID legislation, giving the FDA new authorities over LDTs.

Updated versions are available.  For discussion, see the May 17 blog.  The legislation is 433 pages.,%202022%20--%20TAM22997.pdf

ACLA public comments (probably on the earlier draft) here:

CMS Expands Annual Lab Meeting New Codes to 105

 On May 10, I noted that CMS had released about 70 codes for the upcoming summer annual lab meeting (ALM) - see here.

On May 26, CMS updated the list to 105 topics.   This includes codes passed at the early May 2022 CPT meeting.   For details about the process, see the prior blog (May 10).

Here is the updated 105 topic list, as a cloud zip file, labeled as a May 26 update:

Using a sort/search button, 13 of the codes are new 80,000-series lab codes.  6 are individual microbiology codes, 6 are genomic procedures, including re-writes of the tumor gene panels (81445, 81455) hinging on DNA vs RNA vs both analyses and some other text updates.

I tally 72 PLA codes.  I tally 19 reconsideration codes (normally is 2-3).

Thursday, May 26, 2022

MolDx Releases 3 Major LCDs After a Year's Review

The MolDx program issued a number of LCDs for review in May 2021, and on May 19, 2022, three were released in final form.  This set of LCDs will be effective July 2, 2022.

The three topics are:

  • MOLDX: Melanoma Risk Stratification Molecular Testing - L37725 here.
  • MOLDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer - L38985 here.
  • MOLDX: LDTs for Inherited Cancer Syndromes in Patients with Cancer - L38966 here.
LCD numbers vary in different MolDx jurisdictions (e.g. Noridian).   For each of the above LCDs, you must also scroll to the bottom of the LCD to find the associated billing & coding article.   In addition, each LCD links to a Q&A from the public comment period.   

I've put all the LCDs, the associated billing and Q&A articles, and also a Word REDLINE of the final version, in a cloud zip file.  Find it here:

Some highlights of the LCDs:

L37725 Melanoma Stratification

This LCD is several years old, focused on a Castle melanoma test for risk for lymph node biopsy.  It was released in May 2021 with an unusual paragraph highlighting some debates in the dermatology literature about the use cases for this testing, and a solicitation of public comment.   The final LCD had no significant changes, but includes a 57 page public Q&A document.   The LCD is an umbrella that can cover similar tests, such as the Skyline Merlin test. (Which is covered, at $3200, in the separate DEX registry here.)

The LCD is 14 pages long with 49 references.  A redline version shows several paragraphs added to the discussion but few other changes.

L38985 Prostate Stratification

This LCD is 12 pages with 63 references, and the public Q&A document is 23 pages.  The LCD lists two use cases, to inform the decision to biopsy at all (e.g. what to do with a PSA of 5) and tests that are performed when a prostate biopsy is negative but there is a high suspicion of a false negative.   

Note what is not included.  The Opko 4KScore test fits the first use case (the PSA of 5) but it's not a molecular test, so it doesn't fall under MolDx.   Veracyte/Decipher and Oncotype Prostate and other tests are used after a cancerous biopsy (or resection), and therefore are downstream of the use cases covered by this LCD.  There are 11 rules (e.g. "test is ordered by...a urologist or oncologist.")

The billing article A58700 lists two tests "which are performed in the post biopsy setting," a urine test Progensa and the Confirm MDx FFPE test.

A redline review shows that this was the most-extensively-altered LCD between draft and final.
L38966 Cancer Hereditary Genetics 

This LCD is only 7 pages long but has 43 references.  Much of the decisional material is delegated to the billing article (A58652 17pp).   The Q&A A59058 ran 24 pages long.

Historically Medicare has basically covered risk testing as BRCA testing (and related genes) after a diagnosis of cancer with increased family risk, or Lynch syndrome testing in colorectal cancer patients.  This foundational or umbrella LCD is pretty generic - patients must have "a cancer diagnosis, a clinical indication for testing, a risk factor for germline inherited cancer," and "not tested for the same content."  MolDx lists the required variants to test in associated online forms (see the MolDx website tech assessment template section) and "the test has well established guideline based evidence."  This allows a lot of opportunity for expansion as guidelines change.

Hereditary cancer genetics falls under some controls added in 2019 to NCD 90.2, NGS cancer tests (whether of tumor or germline).

The structure of the billing article is simple, listing a single block of pertinent codes (e.g. the codes for HBOC like 81432 and the codes for LYNCH like 81435) and then listing a very long range of cancer ICD10 codes.   

Note that while the LCD points to "well established guidelines" neither the LCD nor the billing article enumerates any particular objective risk factors that have always been found in BRCA LCDs, such as a particular constellation of risk factors, number of relatives with which cancer, etc, which would allow BRCA coverage.   In contrast, the prostate LCD lists 11 highly granular and meticulously redlined and specific rules for test coverage, about as perplexing to work through as as crossword puzzle.  Turn to BRCA and Lynch testing, and the rules evaporate in this version of a BRCA/Lynch LCD except for a call out to "well established guidelines."   

Nerd Note

The LCD for hereditary cancer syndromes requires a personal history of cancer and LCDs usually pair that with a family history of cancer.   To my eye, a very close reading of NCD 90.2 does not require a family history of cancer, since the named and allowable risk factors cited in the NCD can be as generic as "aging" instead of as particular as a "high family incidence."

In principal, you might think the LCD would apply coverage to any type of inherited disorder with strong guidelines (e.g. why not cardiology genes ) but note that the title of the LCD is for cancer syndromes only.

Wednesday, May 18, 2022

CMS Releases Proposed Gapfill Prices for 2022; Comment Period 60 Days

Gapfill Proposals Released

Every summer, CMS reviews new lab codes and prices them by an existing price ("crosswalk") or a de novo price ("gapfill.")   MACs reviewed codes sent to gapfill last fall, this past spring.   Now, on May 11, 2022, CMS has released the "proposed prices."   CMS takes comment for 60 days, which it will share with the MACs.    Finally, CMS will release final prices around September.   This triggers a final appeal period which occurs between the lab and CMS lab price staff.

Now you know everything I know.

Where to Find It

Here's the webpage for lab information at CMS:

Here's the link to the Gapfill Prices, which are an Excel inside a Zip.

Comments may be submitted to by by July 11, 2022.


There are 36 codes in the gapfill process.  CMS calculates the pricing based on the 57 zones of the Clin Lab Fee Schedule, which date back to old geographic regions in 1984 that don't really exist anymore.  CMS calculates the final price as the "median" of the 57, or the 28th price from low to high.  MolDx has more than 28 zones, so the uniform MolDx price will always be the median, regardless of minority MACs propose.

The second tab of the spreadsheet is "rationale."

Two prices are near the top of the historical range (0267U $6739 and 0265U $5475.)  These are PRAXIS WGS plus optical genome analysis, and PRAXIS WGS alone.   After that, 4 prices are between $1000 and $1500 and five prices are between $2200 and $3200.


The NGS MAC appears to always agree with the MolDx MACs.   I tested this by subtracting the CT price from the CA price and this always equaled zero.

As a crude measure of how much the MACs agree or disagree with each other, which means how much the Novitas-FCSO MACs disagree with (MOLDX + NGS MAC), I did the following.  For each row, I calculated the standard deviation and then the standard deviation as a percent of the median (the proposed price).

Using this "percentilized SD," for 13 codes the variation was >25%, for 5 codes >40%.   These high variation codes were 0272U (65%), 0274U (54%), 81560, 0018M, 0257U (all 42%.)  code 0272U was $608 in the MolDx MACs (controlling the median) but over twice as high at $1511 at the Novitas MAC.  

Gapfillology in the Cloud

I've posted an open access copy of my gapfill math in the cloud here. Note there are several tabs.

Tuesday, May 17, 2022

Senators Murray and Burr release new FDA legislation, including FDA regulation

Update:  On May 26, updated versions of the VALID LEGISLATION and ONE PAGER were released.,%202022%20--%20TAM22997.pdf

ACLA public comments (probably on the earlier draft) here:

On May 17, 2022, Sens. Murray and Burr released draft legislation for FDA changes, including LDT regulation.



See early coverage at Genomeweb here.  Back in March 2022, Genomeweb ran a subscription review of issues and debates in this area, here.

Submit feedback til May 22, 2022.  (See contact info at bottom of press release below).


May 17, 2022



Anali Alegria: 202-224-5398 (Murray)

Caitlin Carroll: 202-228-1616 (Burr)



Senators Murray, Burr Release Legislation to Support FDA Programs to Lower Costs and Spur Innovation


Bipartisan user fee package ensures FDA has the resources it needs to do its work, includes new oversight of cosmetics and dietary supplements, modernizes diagnostic test regulation, reauthorizes important programs for medical product development, and more


Murray: “Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important.”


Burr: “This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products.”


Washington, D.C. – Today, Senate Health, Education, Labor and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC), released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act—legislation reauthorizing the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements. The legislation also includes provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products to benefit Americans.


“Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important. This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day,” said Senator Murray,  “I’m also laser-focused on lowering drug prices, and that’s why this legislation increases competition by helping cheaper generic and biosimilar drugs get to market and ensuring drug approvals are always driven by what is best for patients and families—not pharmaceutical companies’ bottom lines. I look forward to working with Senator Burr and my colleagues to strengthen this legislation further and get it passed into law.”


“The COVID-19 pandemic demonstrated the critical partnership of the FDA and private sector in bringing a range of tests, treatments, and vaccines to Americans in record time,” said Senator Burr. “As we transition into a new normal, it’s essential that the agency use the same urgency to bring life-saving treatments and cures to Americans suffering from other devastating diseases, like cancer or Alzheimer’s. This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products. It also includes key measurements to ensure the agency meets its commitments and modernizes our diagnostic testing framework to bring certainty to test developers and give Americans confidence in their health care decisions. I look forward to working with my colleagues as we finalize this significant bill to ensure it not only reflects the best deal for Americans, but also holds the FDA accountable to its performance commitments for years to come.”


The Senators developed the discussion draft following hearings with FDA officials and stakeholders last month, and plan to introduce and mark up a final version of the legislation in the coming weeks.


In addition to reauthorizing the FDA’s user fee agreements—and ensuring that the FDA can continue its critical work approving prescription drug, generic drug, biosimilar, and medical devices and fostering innovation—the discussion draft of FDASLA also includes steps to:

  • Strengthen oversight of cosmetics and dietary supplements;
  • Improve regulation of diagnostic tests—including COVID tests;
  • Bring more competition to the market to lower drug prices;
  • Increase safe disposal of opioids and other drugs with serious risks;
  • Modernize the data that can be used to support medical product development, including alternatives to animal studies;
  • Expand the successful hiring authorities authorized by the 21st Century Cures Act and require a Strategic Workforce Plan to help strengthen FDA’s workforce; and,
  • Ensure FDA is transparent and accountable for the user fees it collects from industry.

Feedback on the discussion draft should be submitted to by May 22, 2022.  


Section-by-Section of FDASLA Discussion Draft HERE.

Full text of FDASLA HERE.


Sunday, May 15, 2022

Very Brief Blog: MolDx Updates Billing Article for Pathogen-Testing Policy

On May 1, 2022, we noted some updates and delays regarding the MolDx pathogen testing policy - here.

Now MolDx has issued more updates to the MolDx pathogen testing "billing article," or A58710.  These are the "R2" or second round of revisions, and will be effective May 17.

Find the updated A58710 here:

The revision notice is 535 words long.   The billing article being amended is about 11,500 words long (including tables of IC10 codes).   For comparison, the US Constitution is 4400 words long.

I've put a cloud copy of the newest May 17 version (R2) over the original version (which I'm calling R0) - here.

Take a deep breath, and these are the revisions in this release:

Thursday, May 12, 2022

Brief Blog: Noridian Proposes to Delete Former MolDx LCD (4KScore); Palmetto Issues Update of Same

Noridian proposes a draft LCD for Opko 4KScore, seemingly only for the purpose of deleting the LCD.  Last month, Palmetto MolDx reviewed and reissued the same LCD with typos corrected.   Note that MolDx has generally been removing the word "MolDx" from the title of LCDs that are proteomic rather than DNA/RNA, to indicate the LCD is now excluded from the MolDx scope of work and the LCD may or may not be deleted in the future.


Since 2016, Palmetto MolDx has had a non-coverage policy for the Opko 4KScore test (L36763, here.)   This has always been an unusual policy, since the 4KScore test is a sole-source test billed to the Novitas MAC from New Jersey, and the Novitas MAC covers 4KScore.   See L37792.   In 2020, 4KScore code 81539 had 12,734 uses paying $9.7M in Medicare Part B.  

Palmetto: Revise.  Noridian: Nix.

Here's a little oddity.  Currently, in the Medicare Coverage Database, the Palmetto LCD L36763 for the 4KScore test is listed as newly revised, with Revision 8 described as a revised title, bibliography format changes, and typos corrected.   OK.   Here.   I don't recall seeing it listed as "draft under revision," so maybe typos can be corrected without public comment.

But there is a version of the same LCD proposed as "DL37120," a draft LCD, on the Noridian website.   Here, the LCD is presented with the comment, "This LCD is being retired because this lab or test is no longer available and Noridian does not anticipate any claims for this service."   This isn't exactly correct, the test is very available, but not in Noridian's territory, so it's true, Noridian won't see any claims. [*]  The CMS database website lists this LCD version as "draft in comment" April 28 to June 11, but the D-LCD itself doesn't list any comment period nor does it list a public comment meeting.    

Before procedural revisions in 2019, attributed to "21st Century Cures Act," LCDs could be expanded at any time (without notice) and deleted at any time (without notice).  This Noridian maneuver suggests that an LCD deletion gets a comment period for 45 days.


81539, 4KScore, is $760.  This is a common price for specialty tests, the price for 81539 plus (0005U, 0011M, 0012M, 0013M, 0021U, 0089U, 0113U, 0203U).  

I think that 81539,  4KScore, was the originally priced test at $760, so all the others are "crosswalked" to it, but I haven't confirmed that.   


Nerd note: 30% Rule 

There is an exceptional case where Noridian might see an 81539 claim: if a lab gets an order for the test in a Noridian state, and sends it out as a reference test to Opko, in which case either lab can bill the test (as long as only one does), or, the Opko lab actually has to bill the test if the referring lab (that got the specimen) sends out more than 30% of its tests annually.  This is the Medicare rule about the 30% line and lab-to-lab billing.   It's a statutory rule to avoid the creation of shell labs that only bill tests that are actually performed in other wet labs, the latter of which would be evading the visibility of direct Medicare billing. But, if a lab gets an order for 10 tests, and sends out just 1, it can still bill for all 10 tests.


Generally, the 4 MolDx MACs have had uniform LCDs.   The fact that a service wasn't offered in some states (e.g. not offered in CGS MAC or WPS MAC) hasn't been a factor in whether the LCD would be issued across all MolDx MACs.   Here, Noridian proposes to delete an LCD because it doesn't expect claims, but if that were the general rule and applied uniformly at MolDx, a number of MolDx LCDs could be deleted in places like Iowa (the WPS MAC).

Guidelines for Prostate Genomics

Although not directly tied to 4KScore (which is used for "biopsy decision management," not active cancer management), the AUA recently updated its guideline for genomic (RNA expression) tests in prostate cancer management - here.

Opko History

Opko acquired BioReference Laboratories in 2015 for around $1.5B. The genetic division, GeneDx, was sold to SEMA4 in early 2022 for around $650M.   At $9.7M revenue (Part B) in 2020, 4KScore (Part B) was 0.7% of OPKO's $1.4B in revenue.

OPKO stock peaked at $17 in 2015, currently $2.85.  

SEMA4 stock peaked at $20 in December 2020, currently $1.66. 

Tuesday, May 10, 2022

FDA Approves CSF Alzheimer Test. "14 Day Rule" Rears Its Head.

On May 5, 2022, we had an article in ONCLIVE on testing challenges in cancer patients (here), and on May 4, FDA announces approval of the second-ever biomarker test for Alzheimer's disease, a CSF test (here, here).  

What connects these?   Remarkably, the "14 day rule" for Medicare hospital inpatient and outpatient services.

The 14 Day Rule

The 14 Day Rule is actually an interaction between two different regulations.  All hospital inpatient biopsies and tests are bundled to the DRG, unless ordered 14 days after discharge.  All hospital outpatient biopsies and tests are also bundled to the hospital outpatient payment, per regulation 42 CFR 419.2(b)(17), unless there is an exception.  Exceptions are created not at 419.2, but at an entirely different regulation, 42 CFR 414.510, the date of service rule.  The main exception is for human DNA-RNA tests.    

Tests on biospecimens that are not hospital-related (from physician office or a lab draw center) are always paid fee for service and not bundled.


The ONCLIVE article discusses the 14 day rule as a barrier for cancer testing.  This is especially true for inpatient biopsies (such as tissue from a lung lobectomy, or a colectomy, or nephrectomy).  Payment for genomics may be delayed more than 14 days - for example, 5 days while the patient recovers in the hospital, plus 14 days after discharge, = 19 days, and that's for ordering the test, allow more time for running the test and delivering it.  

For a hospital outpatient biopsy (e.g. melanoma tissue), for most cancer tests the DNA-RNA rule applies and the biopsy can now be tested and paid separately right away.  

CSF - Alzheimer Proteomics Test

The Alzheimer CSF test also bumps up into this rule, as I read it.  

The Fujirebio "Lumipulse" Alzheimer test is a proteomic test, an ABeta 42/40 ratio, so it's not a DNA-RNA test.  The main CSF lumbar puncture code is 62270, which ran about 80,000 services per year 2015-2019 (pre COVID).   But, 44% of these tests are inpatient, and 35% are E.R. and another 10% are hospital outpatient.  (That tallies about 90%).   For proteomic tests, all of these hospital-associated CSF biospecimens collide with the 14 day rule.   Only 10% of the 80,000 tests, or 8000 tests, were in a physician office which doesn't collide with the 14 day rule, and where the test can be billed immediately.

To my knowledge, there isn't yet a specific CPT code for "amyloid biomarker lab test," nor a PLA code for this test. 



In 2020, coding was changed.  62270 continues, but over half of services now bill under the new code 62328, which is lumbar puncture including imaging guidance.  The coding complexifies, but the 14 day rule applies the same.


The Fujirebio test had Breakthrough review at FDA, granted in February 2019.


Per FDA, "97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan."  Detailed FDA summary-of-effectiveness usually appears weeks or even a few months after approval (clearance).  This product went through De Novo review.

ADLT Not Possible

The test isn't eligible for ADLT status, since it's not a sole source test.  Even if it got ADLT status as an FDA-cleared test, FDA-cleared ADLTs don't get exemption from 14 day rule, only MAAA-type ADLTs (see 414.510).   

Amyvid PET History

FDA previously approved the Lilly Amyvid PET Amyloid biomarker (and later several other brands) in 2012 (and as a PMA approval as a drug), but CMS has "non-covered" it since 2013.  (There's are some paid claims for approved clinical studies - here.) 


So in summary, if you have Alzheimer's disease, you can't get a PET scan, you can't get an amyloid drug (Aduhelm), and it's darn hard to get a proteomic CSF test due to bundling.

I mentioned effects of this type of bundling on innovation in a recent article.   This aspect of bundling is usually left out of articles on bundling (JAMA 2022 here).

Very Brief Blog: CMS Posts CLFS Update, New Codes, Reprises PAMA Years

CMS issues the Clin Lab Fee Schedule (CLFS) update for July 1, 2022, with cover date May 4, 2022.

CMS adds 9 new PLA Codes for July 1, 0323U-0331U.  These are codes that were announced by AMA CPT on about April 1.   (CMS also mentions deletions of 0139U, 0168U).  Note that the newest batch of PLA codes are voted on this week at AMA CPT and will be released by AMA on July 1, but, will probably also be released by CMS by early June to be part of the June annual pricing meeting.    

CMS also reprises info on PAMA timelines.

The next data reporting will be 1Q2023, reporting claims data from 1H2019.  This will result in a new fee schedule CY2024 2025 2026.   Labs will report 2025 data in 2026 to make a new three year fee schedule CY2027 2028 2029.

CMS notes there is 0 price reduction in 2021 2022, and a max price reduction per year of 15% in CY2023-2024-2025.   

After that (e.g. 2026 or for the new years 27-28-29) there is no annual cap on the price reduction, it is based only on survey data with an immediate price reset.  

Monday, May 9, 2022

Has the Famous "HHS Directory" Suddenly Dropped Email for Staff?

Update May 11.

Yes, HHS dropped emails from the cross-HHS directory (FDA, NIH, CMS, etc).  Reported on this blog May 9, and confirmed by POLITICO on May 11.

Original May 9 Blog Follows

For at least 15 years, there's been an HHS Online Directory of all staff (HHS, CMS, FDA, etc), providing name, agency, department, phone, and email.   

Someone asked me for staff emails just a few days ago, and I looked the person up, got their email, but also provided the main directory link.

As of this morning, May 9, 2022, the directory is returning only name, agency, and department.  No actual contact information!  New to me.

There are a lot of implications.  

  • Recently, a FOIA request from me to a MAC was badly mishandled.  (Helpfully to itself, the MAC provided no appeals contacts or information in its reply).   I can no longer look up the next-level-up FOIA person at CMS to address the error.
  • Academics at universities will find it much harder to reach their colleagues at NIH.
  • What if you have an issue for a mid-level person at CMS?  You can no longer access their email or any other contact info.  Are you supposed to send your correction or issue to the head of the agency (Chiquita Brooks-LaSure) and hope it gets filtered down through multiple departments and divisions to the person you know is supposed to handle it?



HHS DIRECTORY was not the only place to get government staff emails, but it was a very convenient one.   Here are some examples.

FDA - FDA lists lots of management email contacts, such as here at the CDRH (devices) website:

CMS - CMS regularly lists some staff emails, for example, every MAC instruction or transmittal is public and has staff contact emails for that particular document.   CMS publishes elaborate annual rulemaking in numerous areas (hospital outpatient, hospital inpatient, etc) and each one lists 20 or more staff contacts & emails for each subsection.  

NIH - I would think academics at universities would regularly want to get in touch with their comrades at NIH.  HHS DIRECTORY was one stop shopping for those emails.   Usually you can get university emails from the university directories, but now it's gotten harder to find an NIH faculty email.   

Tuesday, May 3, 2022

CMS Renews MAC Awards for NGS MAC and for FCSO MAC

In December 2021, CMS renewed the contract for the NGS MAC for "Jurisdiction K," New York and New England.  This MAC, which is related to Anthem, also has a midwestern MAC with MN, WI, IL aka J6.

On May 1, 2022, CMS renewed the contract for FCSO MAC for "Jurisdiction N," which is Florida and Puerto Rico.  Like the Novitas MAC, FCSO MAC is related to Florida BCBS.  In the last couple years, to my observation, Novitas MAC and FCSO MAC have had more policies in closer (or identical) alignment, which wasn't always the case.

See the MAC page at CMS here:

In older news, Novitas was re-awarded JL in July 2021, and back in 2020, Noridian was re-awarded JE, and NGS MAC was re-awarded J6.

National Quality Forum Dismisses "SEP-1" Appeal Process

In this blog, I covered trade journal articles and NQF website announcements regarding the five year review, and an appeal from IDSA and others, regarding the SEP-1 quality measure (NQF 500).

Original blog and links here, March 8, 2022.  See March 2022 MedPageToday here.

On April 29, 2022, SEPSIS ALLIANCE issued a press release that NQF had dismissed the appeal of IDSA and other organizations.  If I read this correctly the Sepsis Alliance announcement on April 29 matched the closing date on the NQF website of an appeal-triggered comment period.

See: Medpage Today, May 2022 here.

See:  NQF Press Release, May 2022 here.

The SEPSIS ALLIANCE statement is here:

APRIL 29, 2022

Sepsis Alliance commends the National Quality Forum (NQF) Appeals Board for dismissing the submitted appeal of NQF #0500: The Severe Sepsis and Septic Shock Early Management Bundle, also known as “SEP-1.”  Since its initial endorsement by NQF, SEP-1 has been saving lives and limbs, in large part due to its evidence-based focus on timely recognition and early therapeutic intervention. Because SEP-1 offers a standardized process for every patient with sepsis or suspected sepsis, it encourages closing gaps in sepsis outcomes across race, socioeconomic status, geography, and insurance type, and it supports hospital leadership in retaining focus on the possibility of sepsis in every case. Today’s decision by the Appeals Board will keep sepsis—the leading cost of care and cause of death in U.S. hospitals—at the forefront of clinical discourse, where it belongs. 

We thank NQF for its work making evidence-based determinations to improve care quality for all patients, and we support the ongoing efforts to modify SEP-1 in response to updated evidence. 

There is certainly still work to be done. We will continue to pursue quality improvement initiatives that benefit sepsis patients, as well as better public and provider sepsis education and policy solutions. Today’s decision paves the way for continued improvement. 

Monday, May 2, 2022

FDA Posts Draft Guidance: ctDNA in Clinical Cancer Trials

In January 2020, FDA released final guidance on use of minimal residual disease tests in clinical trials for hematologic malignancies (MRD; here).

Fast forward to May 2022.  FDA releases a draft guidance for use of circulating tumor DNA (ctDNA) in clinical trials for solid cancers.  11 pages, find it here.   The LCD covers three use cases, ctDNA for patient selection, ctDNA for patient enrichment, and ctDNA as a measure of response.   They note (page 8) that tests might be bespoke (tumor-informed such as post tumor exome sequencing) or tumor-naive.  They note that tumor naive panels could like at epigenomic methylation or fragmentomics.

The Federal Register comment period notice will be in the Fed Reg on May 3.  Here.  The comment period will run 60 days (about July 1).

Draft Guidance

MIni Update: CMS Provides Partial New Codes List for Summer Lab Pricing Meeting

 In mid-April, CMS announced dates for its June and July clinical lab fee schedule public meetings for pricing new codes.  Here:

On that page, they have posted a first-draft agenda for the meeting (see Zip file for Excel spreadsheet):

The current version of the Excel code agenda list has 70 items, nearly all PLA codes.  I assume they will update with the several regular 80,000-series new codes before long.   Also, in recent years, CMS has also updated the list circa June 1 to include codes ratified at the mid-May AMA CPT meeting.  

Items 39-58 are reconsideration codes, almost 20, instead of the usual two or three.  While the majority of all codes are PLA codes, nearly all the reconsideration codes are 80,000-series codes.

Sunday, May 1, 2022

Very Brief Blog: MolDx Delays Infectious Disease Panel LCD, Issues "FAQ"

This was published May 1, see another update May 15.

In early March 2022, MolDx released a wide-ranging new LCD for infectious disease molecular testing, and a week later, released a technology assessment template for it (here).  Thetech assessment template is in a different, and to my eye, more helpful format than they'd used previously.  (Helpful, but also, pretty long and detailed).  

On April 22, MolDx announced a delay in the implementation of the LCD, to May 17.  Here, and screen shot below.

MolDx also released an FAQ, web page here, PDF here.  Cloud copy here.