Friday, May 28, 2021

Very Brief Blog: ACLA Files New Appeal in Ongoing 2017 PAMA Case

ACLA's case against CMS's implementation of PAMA lab pricing law enters another round.   In a press release on May 28, 2021, ACLA announced that it was responding to another setback, on March 31, in federal court, by filing an appeal.

See the ACLA press release here.  See an updated FAQ here.

And if you want to really delve into the situation, see the litigation timeline here (with numerous document links.). See the most recent March 2021 dismissal, PDF, 11pp, here.

Originally, ACLA protested CMS's implementation of PAMA, focusing on under-counting of hospitals and their lab test prices.  In the first round at District Court, case was denied since the CMS lab fee schedules are outside judicial review.  Federal Court determined that the case could and should be reviewed, and remanded back to the same district court.   Now, after 18 months, District Court has re-reviewed it, but dismissed as "moot."  

District Court notes that CMS revised its regulations in 2018, to include far more hospital labs and claims.  Therefore, the judge surmises, the only live issue is whether the 2016-2017 price setting was wrong, resulting in under-pricing 2018-2021, with the potential for enhanced payments (restitution) for these recent past years.   HHS argues that no refunds or bonus payments would be possible, and therefore no material event remains at issue in the case (it is all moot).   The judge concurred that it could not order new payments for past years, but in the new documents, ACLA strenuously disagrees.

Wednesday, May 26, 2021

Very Brief Blog: CMS Publishes MAC Proposed Gapfill Rates for CY2021

CMS has some 50 codes in the CY2021 gapfill process.  These are codes, new in CY2020, that CMS could not price by its crosswalk method.  Therefore, CMS asks its MACs to submit their prices for the tests, now in CY2021.  CMS will take the median for setting its national fee schedule in 2022 and future years.

See the CMS lab website here:

And look for the file:  2021 CLFS Gapfill Preliminary Determinations (ZIP).

Regarding comments, CMS states,

  • Interim Medicare Administrative Contractor/Preliminary Gapfill payment recommendations have been posted below. We invite comments through July 26, 2021. Please submit comments to


Highest prices range up to $5475 and $5225 for 0212U and 0214U.   These are the Genomic Unity Whole Genome from Variantyx, and the Exome Plus test from Variantyx.   (For 2014U, the company asked for a code stack of 20+ codes over $10,000; MAC prices they got are pretty close to the off-the-shelf genome price for 81425.)

There are two codes priced in the $3000 range and 5 codes priced in the $2000 range.   

Several COVID tests are being priced by the gapfill method, including U0002 at $51 (regular COVID PCR) and U0003/U0004 at $75.   $75 is the CMS administrative price for high-throughput COVID, and the MACs are proposing just the same price.   The CMS administrative price would rule while during the public health emergency, and the gapfill price will replace the administrative price after the public health emergency.

MAC Variance

CMS picks the median price of the MACs, which for this purpose is set by states rather than MAC contractors.   All the MOLDX states always match, and they add up to more than half the states, so the median is set by whatever MOLDX picks.

That said, I did a very crude test by taking the 57 columns of the spreadsheet and calculating the SD and the proportional SD (SD/Median).   

  • For 25 codes, half the codes, the proportionate SD was less than 10%, so all the MACs basically agreed.   
  • For six codes, the SD divided by median (proportionate SD) was > 50% and up to 200%.[*] 
    • The far right of the graphic below. 
    • The largest variance was 0209U, PerkinElmer, cytogenomics of whole genome, NGS, which got pricing ranging from $787 to $5031 (whew, that's six-to-one.)  A fairly similar code, 0156U (NYGC whole genome cytogenomics), came in at a $1364 median but some MACs as low as $597.  

Errors Possible!

I discovered at least one code where the CMS median is clearly wrong.   At least in version 1, Code 0156U has median listed as $1364, but 80% of the states (prices) are clearly $597, so the median should be $597.   Odd.  This was the only line of the May 26 V1 with an incorrect median, and it was corrected on May 27 in a V2 spreadsheet.


Regulations and CMS policy require the MACs to submit a "rationale" but these are generally so bland as to be meaningless.  They appear on a separate tab.  In row after row, the price rationales are "price determined by 42 CFR 414 Section G" (the whole PAMA section in its entirety) or "research of tests and comparison to similar tests."  Some answers are more specific.  


Distinctive Code - AI Analysis of H&E Breast Cancer Slides

Code 0220U is for the PreciseDX test or test system, which images H&E breast cancer slides, adds AI analysis, and predicts which are very likely to have a low score on an Oncotype Dx test.  See press here, see company here.  It was priced very close to $706 by all MACs.

See earlier codes for cytology, screening by automated system, 88174/75, and 88361, IHC (including staining), computer-assisted.  


NGS MAC Departs from MOLDX Price, Twice

Comparing the columns for CT and KY, the NGS MAC matched the MOLDX MACs in all but two codes, the differences being,  0016M (a MAAA where NGS MAC is $700 high) and 0175U (a PGx where NGS MAC is $440 low.)  


There was no correlation between price (higher rank on the vertical axis) and the degree of MAC variance (farther right on horizontal access).  Arguably the higher-tier prices have less variance (clustering in upper left), but it could be chance (r = negative .3).

Yes, I know that if the SD is bigger than the median, the data is not gaussian, not parametric, and technically an SD is not valid.  A better non-parametric measure would be the high MAC price over the low MAC price ratio.  This goes from 1.0 to 6.5, but half the cases are less than about 1.1 or 1.2.


Very Brief Blog: FDA Publishes Article, Report on "South Korea's COVID Diagnostics"

FDA has published a 20-page report, summarized in a Health Affairs article, on South Korea's response to COVID from the perspective of diagnostic testing.  The article is authored by the FDA's director for all medical devices, Jeff Shuren, and the director for diagnostics, Tim Stenzel.

  • See the Health Affairs article here.
  • See the FDA webpage for the report here.
  • See the FDA PDF here.
Key points include:
  • History of Korean investments and public-private partnerships
  • Supporting financial risk for test manufacturers
  • Tests were validated in central locations sponsored by the K-CDC
  • A national testing strategy was rolled out (plan)
  • Networks of testing sites developed (bricks and mortar)
  • The quarantine violation rate for positive individuals is estimated to be very very low.

Very Brief Blog: Amazon Offers Big Healthcare Conference (May 27, 2021)

See a large-scale, multi-track virtual conference from Amazon Web Services, themes Healthcare and Life Sciences, May 27, 2021.  The multi-track conference is packed into 3 hours (8-11 PT, 11-2 ET).

It looks like you register with a name and a password and you get a website that has a few live events and mostly a large number of "on demand" videotaped talks.  (See bottom figure).

Keynotes specific to personalized health include Wilson To PhD, Worldwide Head of Healthcare, AWS; Josh Ofman MD, Chief Medical Officer, GRAIL, and Alisha Alaimo, President, US Organization, Biogen.

Tracks include:

  • Payor and Provider
  • HealthTech
  • Genomics Track
  • Biopharma
I've clipped the Genomics Track information below.

Genomics track keynote
Brian Donnelly - Genomics business lead
The importance of data standardization and interoperability in the age of cloud genomics
Peter Goodhand - CEO
Bringing enterprise scale and security to genomics on the AWS Cloud
Susan Tousi - CPO
Using machine learning to bridge NGS limitations in infectious disease
Arne Materna, PhD - CEO
Ares Genetics
Genomics England, accelerating COVID-19 research in the cloud
Pete Sinden - CIO
Genomics England (GEL)
LATTICE™ – accelerating personalized medicine with multi-omics technology
Tom Schoenherr - CCO
Konica Minolta Precision Medicine (KMPM)
Scaling machine learning to uncover the genome’s role in complex diseases
Denis Bauer, PhD - Group Lead
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
How the Broad Institute powers globally impactful science with open genomics data
Grace Tiao - Associate Director, Computational Genomics
The Broad Institute
Serratus: exploring the planetary virome to uncover novel coronaviruses
Artem Babaian, PhD - Computational Biologist
University of British Colombia Cancer
The Technology behind the UK Biobank research analysis platform
George Asimenos, PhD - CTO
Powering the single cell “resolution revolution” on AWS
Niranjan Vissa - Director, Software Engineering
Mission Bio
Mid-pass whole genome sequencing enables biomedical genetic studies of diverse populations
Anne-Katrin Emde, PhD - Associate Director of Bioinformatics
Variant Bio

Monday, May 24, 2021

Very Brief Blog: Kaiser Colored Map of Medicare Advantage, by State

 Here's a figure I haven't seen before.  We know that Medicare Advantage membership rates are rising steadily, but how much does it vary by state?  A lot, and Kaiser Family Foundation (KFF) gives us a color map, dated 1/2021.  Find it here:

note that the low-enrollment color, orange, 11-20%, covers a very small part of the population. (Sorry, North Dakota...)

LA Times on Covid and T-Cells; NYT on Vaccinated People w/o Antibodies; Adaptive Commercializes TCR Test

Flurry of T-cell news and interesting the level of science facts that general readers need to keep up with to understand emerging COVID news in major newspapers.   

LA Times on T-Cells

In the LA Times, Berkeley's Marc Hellerstein publishes a long piece on the role of T-cells in the COVID immune response.   See the LA Times piece here, and a Fall 2020 Berkeley interview with Hellerstein here.   The article is complimented by a 30-minute video interview with Hellerstein and Prof. Otto Yang of UCLA - here.   The interview is led by Dr. Patrick Soon-Shiong, who is both CEO of NantHealth and owner of the LA Times.

NYT on Immunocomprise and Vaccination

Concurrently, NYT runs an essay by Prof. Candida Moss (University of Birmingham) discusses her life as a transplant recipient, fully vaccinated, but without detectable anti-COVID antibodies.   Here.

Adaptive Biotechnologies Commercializes T-Detect COVID Test

In the last several months, Adaptive Technologies has commercialized an NGS-based blood test that reports both natural and vaccinated response to COVID by T-cell DNA analysis.   See the FDA press release here, the FDA EUA document here, the lab test's website here.

I ordered T-Detect on March 22, and elected to try the at-home mobile blood draw, which came on March 30.  (In between there was an order by PWNHealth, recently acquired by Everywell).  The test report was issued by email on April 7 - and was positive, as expected, since I was fully vaccinated by March 30.

There have been several molecular tests that really caught my attention.  One was the Genomic Health Oncotype Dx test in the 1995 era - because it could predict clinical outcomes based only on RNA extracted from an otherwise obscure paraffin block.  Another was the PathWorks tumor of unknown origin test a few years later - identifying the likely tissue of origin of an unknown cancer by RNA expression and no other clinical or pathological information.   

Here, the T-Detect test seems remarkable because the human body is able to produce millions of T-cell receptors, and making the link from the raw DNA sequence alone, and no clinical information, to the biological immune response is a new and remarkable thing.   

Very Brief Blog: ASHG Releases 96-Page Report on Economics of Human Genomics

American Society of Human Genetics (ASHG) has released a 96-page report on "The Economic Impact and Functional Applications of Human Genetics and Genomics."  

  • See the PDF online here.  
  • See early coverage at Genomeweb here.

The report was supported by TEConomy Partners.   As Genomeweb summarizes: "Areas of impact include minable big data, with the assembly of exabytes of genomic information available for analysis to provide insights into genome structure and function and the association of gene variants with human diseases and health disorders; the identification of disease predisposition through carrier testing, pre- and postnatal testing, and child and adult testing; and the diagnosis of both rare and common disorders."

Friday, May 21, 2021

MOLDX: New LCDs and LCD Proposals - May 2021

CMS runs a database of national and local coverage decisions, which includes a "What's New" weekly update report for LCDs and Articles from MACs.   This website lists both newly completed LCDs and newly proposed ones.  Here.

I noted a flurry of MOLDX activity.  Note that MolDx LCDs and articles appear at four different MACs (Palmetto, Noridian, CGS, WPS) and each has its own timing.   For example, at one MAC a proposed LCD might appear two weeks later, so at that MAC its comment period runs two weeks later as well.

Here's a What's New listing, and I also put all the items into one Zip file in the cloud here.

  • DL37725 - Melanoma Risk Stratification Molecular Testing.
  • DL38966 - NGS LDTs for Inherited Cancer Syndromes.
  • DL38988 - Multiplex NAAT Panels for Infectious Disease Testing
  • DL38985 - Biomarkers to Risk-Stratify Patients for Prostate Cancer
  • L38671 - Molecular Testing for Organ Allograft Rejection
    • Here.
    • A58170, Billing and Coding for same, here.\
    • Existing Allosure LCD L38255 has simultaneously been scheduled for Retirement on 6/5/2021.  Here.
  • L38645 - Phenotypic Biomarkers for Circulating Tumor Cells
    • Here.
    • A58185, Billing and Coding for same, here.
    • A58782, Response to Comments for same, here.

General Comment

Overall, these policies represent umbrella policies (sometimes called foundational LCDs) that outline general criteria for a class of coverage.   

Tech Assessments Move from LCD Body to Private Documents.  Previous LCDs provided detailed tech assessments of particular tests, so you could tell (for example) exactly what the MolDx review required in domains like sensitivity, specificity, PPV, limit of detection, and so on..   Notably, now those evaluations go inside of internal technology assessments and are not publicly visible in the LCD body, or elsewhere.  

Covered Tests May or May Not be Named in Billing Article.  In addition, covered tests may appear in the billing article, or may not appear there.   (The billing article may only say that covered tests not otherwise named, should be submitted as 81479 unlisted code + Z code).  The point is: This makes it difficult for Medicare patients, their physicians, or other labs to know which tests are in fact covered, or, based on what performance.

If Covered Tests Aren't Named, and, TA is Not Published, The, How the Heck Do You Show You Are Equivalent to Covered Tests?   For a new entrant, difficult to know what the acceptable technical criteria for the covered tests for that LCD were, criteria that shall be met or exceeded, if the covered test is not named in the coding article and if its TA performance is private, not in the body of the LCD as before.   In order to write a dossier showing a new test is similar to a covered test.   Showing an incoming new test is similar to a prior covered test is the whole point (the raison d'etre) of these policies. 

Unlisted Codes - Limited Value for Public Health Researchers. 
While unlisted code use + Z codes are a key feature of MolDx claims processing, this does make it difficult for public health stakeholders and researchers to know year by year what tests for what purposes are being covered by Medicare; all the claims for different disorders and conditions aggregate under payments for code 81479.  Among many others, groups that use CPT utilization to understand Medicare trends include Katherine Phillips' group at UCSF (e.g. here) or Peter Neumann's group at Tufts (e.g. here).  You can count, study, and assess which Medicare patients got a tumor panel test if coded as 81455 or a PLA code, but not when coded as 8179 unlisted code.   (Unlisted codes also circumvent the PAMA rate setting process entirely.)

In More Detail

Please note, I am only summarizing highlights of coverage here and readers must see the full LCD (or draft LCD) for details.  TA = Tech Assessment (elaborate paperwork and spreadsheets submitted to MolDx).  

DL37725- Melanoma Risk Stratification
   The patient has a personal history of melanoma, AND T1b/T1a, AND evaluated for therapy, AND non-metastatic, AND has >5% chance of coming to sentinel node biopsy, AND as a tumor consistent with requirements for a particular test.   The test must be evaluated by technical assessment (TA) to have utility beyond conventional risk factors and performance similar or better than covered similar tests.

DL38966 - NGS Tests for Inherited Cancer

Note that this is an NCD, 90.2, that covers FDA approved NGS tests for both advanced cancer tumor testing and FDA approved NGS tests for inherited risk testing.   If not FDA approved, such tests fall  under LCDs.

Test is covered if it has completed a TA, and has the "minimum genes or variants" for its intended use and clinical decision making.  Genes and variants will change with evolving literature.  Remarks on non-duplicative germline testing.  Do not use NGS panel to confirm a variant that can be confirmed with a specific test.  Legacy tests not covered by TA yet must have TA by the effective date of this policy (likely 6-12 months in the future, it is a new draft policy).

This is actually a pretty radically different (postmodernist?) approach to an LCD.   At both Medicare and commercial payers, including current MolDx, there are careful lists of rules for when BRCA testing is covered (maybe 6-10 rules), when Lynch testing is covered, and so on.  Here, there is just an umbrella statement that for whatever diseases at risk, appropriate testing or panels are covered, having completed a TA.   

One point I am sure to hear from lab clients is, this sort of floating general statement without any specific facts is very hard for Medicare Advantages plans to implement, as they work to conform to regulations requiring MA plans to match Medicare coverage rules.   

It's also impossible for physicians and patients to read the LCD, as written, and know which genes are covered for which patients.   Or for public health experts to compare published policies of different payers and compare them in a table to this one.
Quite similarly, Novitas recently released a draft LCD that infectious disease panels are covered 'when they are timely and likely to influence care" - full stop.  Again, very hard as a rule that Medicare Advantage plans must copy and audit to. (DL38916).  And hard for labs to educate physicians in advance what is covered or not covered by their MAC.

DL38988 - NAAT Panels for Infectious Disease

Note that MolDx held an advisory public meeting on this topic in January 2021.

The critiera for this LCD are much longer than other LCDs and the full text should be read.  In addition to the link above for DL38988, I've cut and pasted the current draft text in a separate blog here.  Panels > 5 are covered in certain circumstances.   This LCD will replace current and quite narrow LCDs for respiratory and GI testing which have been protested by groups like IDSA and AMP.

DL39095 = Risk Stratification of Possible Prostate Cancer Patients

MolDx had previously had a number of separate LCDs for tests to handle ambiguous PSA levels and, if possible, avoid biopsy.  This consolidates coverage, when finalized in the future.  This only attempts to stratify patients who are being considered for a biopsy in the future.  Tests include 4KSCORE, ExoDX, EPI, and others.

Separately from this, MolDx also covers molecular tests to determine, post biopsy, if a prostatectomy is better than watchful waiting.


L38671 - Molecular Testing for Allograft Rejection

Covers both circulating DNA tests (e.g. Allosure) and expression tests to determine management of transplant patients.  "Intended use of the test must be: To assist in the evaluation of adequacy of immunosuppression, wherein a non-invasive or minimally invasive test can be used in lieu of a tissue biopsy..."

This umbrella policy will supercede L38255, Allosure and Equivalent Tests, which is being retired shortly, here.  CareDx was up 3% in morning trading (market cap +$115M), perhaps on information that the new replacement LCD held no surprises when finally published.  NASDAQ as a whole was up only +0.2%.

L38645 - Biomarkers in CTCs

Covers e.g. Her2 testing in CTCs rather than biopsy.  See Comments document; there were a large number of supportive comments.  Covered tests include Biocept HER2 and androgen receptor ARV7 tests (coding article A58185).

At a recent California Clinical Lab Association meeting, MolDx leadership noted that in the future, they planned to issue technical assessment templates specific to each foundational LCD, when required.  For example, if there is an future LCD for "ABC" clinical category, they will issue an excel spreadsheet or similar templates for how to submit a technical assessment of your test in ABC clinical category.  This should speed the review process and increase the uniformity of decisions.

Tuesday, May 18, 2021

CMS Retracts Plan to Cut Billable Code List for Cancer Tests; More on the Back-Story

On May 17, 2021, CMS announced it was ending its plan to cut a large number of currently payable ICD-10 codes used in breast cancer, lung cancer, and other major cancers (effective July 1).   

The proposal will be put on hold for a year for further study.

We provide links to all the key documents,  and give you some further back story.  This blog includes:

  1) What happened

  2) More on CMS ICD-10 guidance for cancer coding

  3) A CMS May 2021 proposal affecting ICD-10 coding for DRGs

See our original May 5 blog on the topic here and a 6-minute video version here.


Details after the break.

Monday, May 17, 2021

Michael Lewis' New Book on COVID Pandemic: He Thinks We Dropped the Ball on Sequencing

This month, book reviews and media tours for noted author Michael Lewis for his new book on the pandemic, PREMONITION.   He starts with ten years related to the background for pandemic preparedness and then on the first half-year of the actual Covid pandemic.   

Lewis builds his story around three iconoclastic experts who were both ahead of the curve and played genuine rolls in the actual response.   To my surprise, one of his major focus points was the missed role of advanced sequencing and how the US fell far behind some other advanced countries in the use of sequencing to understand and then fight the virus.

Lewis focuses on Dr. Charity Dean, a public health officer in California; Dr. Carter Mecher, a creative senior physician at the VA who was on federal pandemic committees; and Prof. Joseph DeRisi, a molecular biologist at UCSF.   DeRisi is profiled in NYT in June.

California's Near-Success Experience with Widespread Sequencing (Summer 2020; Failed)

For molecular biologists, Lewis focuses on ReRisi's record of creativity and adventure in microbiology, and later, Lewis focuses on the fact that California was close to launching a major sequencing program by the summer of 2020.  

Lewis gives us the build-up to that pivotal moment, including direct meetings with Governor Newsom, and then says the plan simply got lodged in some burocratic rabbit hole or another at that time (p. 276-77).   Lewis also gives a good deal of air time to the Chan-Zuckerman Biohub and its efforts to boost the early use of sequencing for public health purposes.  


Lewis gets to the next-gen sequencing and public health story on page 277 of a 300-page book, so it's the natural order of things that few of those who buy the book will get that far.


Looking back I see I blogged on this theme on March 1, 2020 and on March 28 and especially May 11.  It seemed obvious that fingerprinting the virus - which had hundreds of subclinical mutation variants - and really sophisticated use of big data could have helped make up for our deficits in contact tracing or rapid identification.  Lewis gives examples, like identifying workplace infections with disparate mutation fingerprints proving that the infections were not occurring in that workplace but elsewhere in the community.  (See similarly a Genomeweb article on May 15 last year.)


On May 20, PREMONITION was #4 on the Amazon sales list, #6 on the NYT sales list.


I haven't seen it yet, but there is a second May 2021 book on the pandemic, by writer Nina Burleigh, called Virus: Vaccinations, CDC, and the Hijacking of America's Response to the Pandemic.   Here.


Saturday, May 15, 2021

Very Brief Video: What's Happening to the MCIT Rule - Medicare's Breakthrough Device Policy

 On May 14, 2021, CMS put the MCIT rule - Medicare Coverage for Innovative Technology - on a new seven-month delay until December 2021.

I've posted a 3-minute video that gives you the story:

For more text, citations, and links, see my blog on the topic here:

Friday, May 14, 2021

CMS Again Delays "Breakthrough Rule" - MCIT - This Time Until December 15, 2021

On Friday afternoon, May 14, 2021, CMS released a decision to delay the MCIT rule until December 15.   

The agency provided several pages of discussion of pro's and con's regarding MCIT, based on public comment solicited March 15-April 15.   

The rule, finalized in January, promised to provide four years of Medicare coverage for FDA-cleared or -approved "breakthrough" devices.

All CMS is legally doing is delaying the rule in the form it was written this past January.  Since CMS also seems to foresee multiple problems with the existing rule, it's very unlikely (or I'd say impossible) that CMS will simply implement the existing, suspended rule, but on December 15.  Rather, sometime on or before December 15 CMS may revisit with "new rules."

Read the CMS announcement here:

See my 4 minute video on the story, here:

See my Friday morning update, written before the delay was published that afternoon, but including some recent news article links:

May 14 Update: CMS Coverage, Breakthrough Devices: DELAYED TIL DECEMBER 15 2021


On Friday afternoon, May 14, 2021, 

CMS released a decision to delay the MCIT rule until December 15.   

The agency provided several pages of discussion of pro's and con's regarding MCIT, based on public comment solicited March 15-April 15.   

All CMS is legally doing is delaying the rule in the form it was written in January.  Since CMS also seems to foresee multiple problems with the existing rule, it's very unlikely (or impossible) that CMS will simply implement the existing, suspended rule on December 15.  Sometime on or before December 15 CMS may revisit with "new rules."

Read the CMS announcement here.

See my 3 minute video here.

Trade press at Healthcare Dive, May 17, here.  MedCity News here.


Below, blog as written on Friday morning, May 14.


Last August, the Trump administration proposed a requirement that Medicare cover any new FDA breakthrough pathway device for four years.  The rule was finalized in mid January, but in mid March, the Biden administration put it on a 60 day hold for further review, and potentially, new decision-making.  See here.  CMS opened a new comment period that ran from March 15 to April 15.

The 60-day hold is about up today.  Look for further news from the Biden administration, possibly at the end of Friday May 14 (after 4 pm ET) or Monday May 17.

News Items

  • While you're waiting, check out an article at MedTechDive by Nick Paul Taylor as experts prognosticate what will happen.  Here.
  • See a (subscription) report that 37 legislators asked CMS to move forward and create MCIT coverage - here.  
    • See open access coverage on the legislators' letter to CMS, here.
  • See an article in Forbes urging adoption here.
  • See an article in Med Tech Dive about Advamed's push for approval here.


On May 10, and regarding a different CMS topic, the Biden CMS showed it is capability of turning on a dime and reversing even pretty major Trump CMS decisions.   Under the prior administration, and only last summer, CMS announced it was ditching longstanding complex charge-based rules to set the relative values of hospital DRGs.  Instead, as early as 2024, CMS would use relative DRGs related to commercial payer rates.   That was a BIG change.   

Nope, that was then, this is now.  See 86 Fed Reg 25527, May 10.   "After further consideration of the many contract arrangements hospitals use to negotiate rates with Medicare Advantage payors, we are proposing to repeal...the market based DRG relative weight methodology."  Presto - done.  Adding,  "Comments received...provided questions and requested we delay or repeal the policy."  

Net-net, the massive DRG policy change barely took one blandly worded column of the Federal Register to reverse.   

On May 13, Medtronic presented this slide to CMS in a meeting about finalizing the MCIT rule.

See 97 comments on the March 2021 Biden revision, here.

Thursday, May 13, 2021

CMS Announces Dates for Summer New Lab Code Pricing Meetings (June 24, July 28-29)

Each summer, CMS holds two meetings to collect information on how to price new laboratory test codes for the coming calendar year (here, 2022).

Here are the links, and I've put the key documents in one ZIP file in the cloud as well.

  • CMS webpage for the public comment summer meeting here.
    • CMS Federal Register announcement of the June 24, 2021 public meeting here.
    • Publication May 3, 2021, 86 Fed Reg 23886-9 (4pp)
    • Comments due to CMS by June 3; registration required.
    • CMS comments that registration is first-come first served.
    • CMS Excel file of CPT codes to be considered here.
    • Note that the Zip file may be updated and the link changed.
    • See CMS webpage for newer links.
    • >> One of my clients and I found a substantial typo in our code name, so don't assume correct CMS transcription.
  • CMS webpage for the advisory panel meeting here.
    • CMS Federal Register announcement for the July 28-29 meeting, here.
    • Publication May 3, 2021, 86 Fed Reg 23885-6 (2pp).
    • The public doesn't submit comments, but can watch the panel.
  • My own ZIP file (one stop shopping) of the key documents as of May 13, cloud, here.
What Are The Codes?

As of now, CMS posts 53 codes, of which 6 are reconsiderations, and 47 are new.  

27 of the 47 new codes are PLA codes.

Note that CMS is likely to add PLA codes coming out of the April-May AMA CPT cycle, as well as new Category I codes coming out of the May 7-8 AMA CPT meeting.   In past years, CMS has always quickly added the May AMA CPT codes to the June pricing meeting.   CMS is supposed to publish the final agenda for the June meeting 30 days in advance, e.g. by May 25.  Check for updates.

COVID Codes In Play

Ten new COVID codes are up for pricing discussion, including 4 category I COVID codes.   

Note that some major COVID codes are currently in the CY2021 gapfill process.  CMS will post the MAC gapfill prices for these COVID codes sometime between May and August for 60 days public comment.  

Wednesday, May 12, 2021

Very Brief Blog: CARIS Raises $830M In One Funding Round

This is a record or near-record for a single round of funding in genomics.   On May 11, 2021, it was announced that CARIS, a genomics and diagnostics lab with its main facilities in Arizona, raised $830M for growth capital.  Investors included Sixth Street, Silver Lake, Fidelity, and a number of others.

  • See press release here.
  • WSJ here.
  • Fierce Biotech here.
  • Genomeweb here.
  • Biospace here.
  • Endpoints, here, notes the net valuation at $8B.
  •    That's about the same as the recent $8B valuation of GRAIL.
  •     For comparison, Guardant has a market cap of $11B and Exact Sciences $16B and Myriad $2B. 

See the Caris home page here.  Headline - "Molecular Science Meets Artificial Intelligence."

Caris had previously raised $310M in financing during 2020.

Quoting from Endpoints, "The company says their platform allows doctors to assess all 22,000 genes in both DNA and RNA to do so, utilizing whole exome sequencing, whole transcriptome sequencing and protein analysis in addition to its AI models."

Caris has a PLA code 0211U priced at about $7500 in Fall 2020, by CMS, by adding multiple crosswalk codes (specifically, 0019U+0036U).  Once FDA-approved, the code would be covered under NCD 090.2 for FDA NGS tests used in cancer.  FDA issued Breakthrough Status to the Caris review in 5/2019 here.  Caris reported submitting two PMA device submissions to FDA in 4/2020 here.


In other news today, Bluestar Genomics, a San Diego-based startup developed NGS and epigenomics-based approaches to cancer detection, raised $70M in Series C funding.  Here

Tuesday, May 11, 2021

Very Brief Blog: Full Roster of Palmetto GBA Medical Directors

 I was looking up a Palmetto GBA medical director this week, and I landed on a Palmetto web page that lists all 

I'm pretty sure I've never seen a MAC that had such completely listed along with short biographies.  Nice feature.  Here's the March 1, 2021, version.

Dr, Harry Feliciano; Dr. Leland Garrett; Dr. Gabriel Bien-Willner; Dr. Miguel Brito; Dr, Judith Volkar; Dr. Shane Mull; Dr. Jason Stroud; Dr. Lisa Banker; Dr. Maria Lenaz; Dr. Angella Charnot-Katsikas.

Separately, CMS updates a director of CMD names and emails from time to time; here.


Who are the medical directors 

for Palmetto GBA?


Harry Feliciano, M.D., MPH, 
is Palmetto GBA's Senior Medical Director accountable for all coverage policy activities at Palmetto GBA. Dr. Feliciano is also the lead Contractor Medical Director for home health and hospice coverage policy. His specialties are internal medicine, geriatrics, preventive medicine and public health. Dr. Feliciano brings to Palmetto GBA an intense interest in implementing new approaches to improving provider-payer communications and performance based on the principles of Lean Six Sigma.
(continues after the break)

Very Brief Blog: New Article on Preventive Care

See a new deep-dive article, as well as a summary blog, on preventive care and how we should think about it.

The authors are impressive - the article author, Joseph Newhouse, is a senior professor at Harvard.  The blog author, Jason Shafrin, is a well-known health economics expert in his own right.  Homepage for the blog is here.

  • Overview of the Newhouse article, by Shafrin - at Healthcare Economist - here.
  • Original article by Newhouse - at Journal of Economic Perspectives - here.  

Newhouse, Joseph P. 2021. 

"An Ounce of Prevention." 

Journal of Economic Perspectives, 35 (2): 101-18.


I look at prevention through an economic lens and make three main points. First, those advocating preventive measures are often asked how much money a given measure saves. This question is misguided. Rather, preventive measures can be thought of as insurance, with a certain cost in the present that may or may not pay off in the future. In fact, although most medical preventive measures improve expected health, they do not save money. Various lifestyle and early childhood interventions, however, may both save money and improve health. Second, preventive measures, including medical and lifestyle measures, are heterogeneous in their value, both across measures and within measure, across individuals. As a result, generalizations in everyday discourse about the value of prevention can be overly broad. Third, health insurance coverage for medical preventive measures should generally be more extensive than coverage for the treatment of a medical condition, though full coverage of preventive services is not necessarily optimal.


A few other recent articles on prevention that might be of interest.

Liran et al. 2020 ask if selection affects screening outcome studies, Amer Econ Rev, here.

Testy round of articles on mammograms starting with article and op ed (here, here) in JAMA Intern Med 3/2021, and rebuttal in radiology trade journal here.

Article by Ofman of GRAIL on value of multi-cancer screening tests, AJMC, 2021, here.

Monday, May 10, 2021

Brief Blog: CMS Releases Inpatient Rule, Says Nothing About SEP-1 Despite Controversy

I posted some earlier remarks on the recent release of Medicare's FY2022 inpatient proposed rule, which is open for comment until June 28, 2021.  For example, I discussed the multiple AI software devices being discussed for inpatient new tech add-on payments.

On May 10, CMS officially published the Federal Register version - hereComments to June 28.

In other news, the NTAP section runs about 200 of the 700 pages (25203-25395, PDF 134-326). Turning to SEP1.

Nothing About SEP-1

Nothing about CMS's increasingly debate-ridden SEP-1 measure.  

The proposed rule just says that SEP-1 is officially slated to remain in place for FY2023 (p. 25583), FY2024 (p. 25584), FY2025 (p. 25586), FY2026 (p. 25587).  They say this by listing the name of the measure in the tables for each year.

In mid-2020, IDSA sharply criticized SEP-1 and officially called for changes in the measure.   Herehere.  See also an Op Ed by Rhee, "Time to Improve Sep-1," here.

In April 2021, see a major negative paper by Barbash et al. with Op Ed by Klompas.  Herehere.  (For much additional literature, see the bibliographies of these two items.)  Klompas notes that one of the key things we need is better diagnostics.

In May 2021, see a brand guidance article by Yealy et al. (representing the Emergency Medicine specialty) and a boldly argued Op Ed by Harvard's Jeremey Faust (herehere).  

Faust notes the emerging body of negative publications about CMS SEP-1 may make it nearly impossible for NQF to re-affirm this measure when it comes up for review and vote this year.  He also notes that even Congress has weighed in on the SEP-1 issue and asked CMS to act (here, p. 144).


In March 2021, NQF Measures Applications Partnership reviewed a proposed episode-based economics measure for sepsis hospital care (for which physicians would be rated), here.  NQF MAP recommended against this.

Friday, May 7, 2021

Very Brief Blog: Two State Bills Address Payers and Cancer Genomics

I can't speak to the odds of passage, but bills in the California and Louisiana state senates address genomics testing in cancer patients.

The bills are subject to amendment on a rolling basis, but I'll give key points of today's versions, here.  I provide links to the legislative websites.


SB 535 - Prior Auth re: Cancer Biomarker Testing

A health plan "shall be deemed to provide coverage of all generally medically accepted cancer screening tests."

After January 1, 2022, a plan shall not apply prior authorization to: biomarker for a patient with advanced or metastatic cancer, or biomarker testing for progression of such patients.

A biomarker test is a DNA or RNA alteration in order to guide patient treatment.  The bill has two nearly duplicate sections (which amend different underlying insurance laws), and both say that "biomarker" does not apply to biomarker testing that is not for an FDA-approved therapy.


SB-84 - Cancer Genomics

Any health plan in Louisiana "shall include coverage" for genetic or molecular testing for cancer including but not limited to tumor mutations, NGS, hereditary genetic testing, PGx testing, whole exome/genome, and biomarker testing.

Coverage is subject to applicable evidence-based-medicine criteria.

("Biomarker" is defined broadly). 

Wednesday, May 5, 2021

CMS Proposes to Delete Coverage of Codes that Drive Care for Lung and Breast Cancer Patients






From time to time, a CMS regulatory change produces unintended consequences much larger than expected.  Unless a recent announcement is adapted to make more sense, we’ll have one of those big events on July 1, 2022.


In addition to this blog, I've posted a four minute video explaining what is happening VIDEO HERE.


Coverage for Lung and Breast Cancer Patients Will be Slashed 

In a nutshell, CMS controls a patient's eligibility for genomic testing in advanced cancer when FDA-approved tests are used.   Some tests are covered for specific cancers (like lung cancer or colon cancer), and other tests are covered for any solid organ cancer (e.g. excluding leukemias and lymphomas).   CMS has official instructions on how to code – see document SE1518.   

In sharp contrast to the coding instructions provided in SE1518, which require providers to code ICD-10 decimal points only to the level of information available, CMS proposes to delete coverage nearly anywhere that any kind of unspecified term is found - for example, breast cancer, of left breast, and now status post mastectomy - but, quadrant not specified.

These instructions for code deletion contradict not only SE1518, but code lists used by Medicare's own MACs, by private payers, and CMS coding instructions for hospital and hospice care.

Patients Get Denial Notices, Too

Numerous stakeholders are becoming aware of the pending problem - and hope that CMS will delay the instructions to allow administrative review.   The denials triggered by these edits won't just affect labs.  Patients - or if the patient has died, families - will get the Medicare "explanation of benefit" denials that CMS under Biden has newly, and administratively, reclassified care for the patient's metastatic cancer as not medically necessary.  

Deeper Dive - What's Happening 

ICD-10 Rules - From CMS Itself

With that background, let's look at what CMS instructions for coding are.  I'm going to quote them at length; skip downward once you get the idea.  From SE1518:

Sign/symptom and unspecified codes have acceptable, even necessary, uses. While you should report specific diagnosis codes when they are supported by the available medical record documentation and clinical knowledge of the patient’s health condition, in some instances signs/symptoms or unspecified codes are the best choice to accurately reflect the health care encounter. 

You should code each health care encounter to the level of certainty known for that encounter. If a definitive diagnosis has not been established by the end of the encounter, it is appropriate to report codes for sign(s) and/or symptom(s) in lieu of a definitive diagnosis.

When sufficient clinical information is not known or available about a particular health condition to assign a more specific code, it is acceptable to report the appropriate unspecified code.  

You should report unspecified codes when such codes most accurately reflect what is known about the patient’s condition…[do not] select a specific code that is not supported by the available medical record documentation, or conduct unnecessary tests to determine a more specific code.  

The level of specificity of the [disease] code will not change the coverage and payment of most services.

  • Got it?
SE1518 text is matched in the 2021 version of the CMS official ICD10 coding guideline (120pp) - Section I.B.18 - here.  It's also found in sources like the 2021 AHA ICD10 Coding Guide (700pp).

ICD-10 Coding: Lung Cancer
Let's look at coding for lung cancer.  It's anatomically complicated because of the multiple lobes and bronchi.  Similarly, breast cancer coding is complicated, because if the detail is known, you can code to a nodule in any of the 8 quadrants in the two breasts, even if the past is years post mastecomy.

Coding guides developed by certified coders follow conventions and list code levels as "billable" or "non-billable" (here).

As  you open the coding trees and reveal the decimal points, more and more billable codes appear:

The ICD10 principle is that the terms are categories (not billable "codes") if there is an additional digit available.  You need to know the table structure to read if a term is a "category/subcategory" or "code."  For example, Z10.1 is a code if there are no five-digit codes starting Z10.1.   As soon as ICD10 creates Z10.10 and Z10.11, then Z10.1 is itself no longer a code, rather, it is now a category that olds the billable codes Z010.10 + Z10.11.   But the key fact is that when higher levels of specifity are provided, they are not required.  Webbed fingers, left hand, and webbed fingers, right hand, are billable codes, but webbed fingers, hand not specified, is also a billable code if that is the status of the medical record available.  AHA Handbook for ICD10 notes that in some cases, information relevant to early encounters (e.g. needle biopsy of left upper outer breast contract) is no longer relevant (e.g. patient is status post metastectomy of left breast with mets to liver [breast quadrant not specified].)  AHA, 2021, p.38.

The Transmittal

In Transmittal 12124 (zip file therein, here), CMS proposed to delete normally payable cancer codes, codes payable for years under the NCD, if they contain the word "unspecified," even it's buried deep in the diagnosis tree, out in the decimal points that have no impact on care or drug choices.

This makes no sense.  

The codes are listed as payable under standard ICD10 coding conventions, as noted earlier.  The cancer patient's cancer isn't unspecified - it's lung cancer.  The lobe isn't specified - it's upper lobe, for example.   Only a decimal point nuance (position five or six in the code structure) is left flexible.  Details that were not available to the billing laboratory, and which have no impact whatever on coverage (under the rules of the NCD), nor FDA test approval, nor FDA drug approval, nor the oncologist's therapy choice.  

The deletions violate clear instructions in SE1518 - code to the level of detail available.  If the lab has lung cancer, lower lobe, right, they code to that.  If they have lung cancer lower lobe, side not stated [in the lab's document] - they code to that.

Hospital, Hospice, Private Payers, and More

AND - The widely-used codes being deleted on July 1 appear in carefully maintained hospital DRG coding rules at CMS - hereAND - They show up in coding instructions for hospice care - here.  AND - They show up in Blue Cross cancer policies - hereAND -  They show up in United Healthcare policies - here.  And they show up in CMS MAC coverage policies, and so on.

What Should Happen

The transmittal should be delayed or deferred for further study, pending further review - a common mechanism for this type of problem at CMS.   Alternatively, the instructions could be rescinded retroactively in August or so - withdrawal of a transmittal isn't rare, but in this case, the problem can still be avoided.