Friday, February 25, 2022

Very Brief Blog: Public Citizen Critiques 21st Century Cures 2022; Dislikes MCIT Provision

MCIT was the 2020 plan to provide Medicare coverage for 4 years for FDA breakthrough devices.  It's been tabled, but CMS is looking at alternative approaches to easier and accelerated coverage, see their town hall February 17 (here).   In the last few weeks, I've started think that MCIT was more brilliant than it seemed, and most of the criticisms would be self-mitigating.  I wrote a blog about the status quo, MCIT, and CED, here.  I opened the possibility that the benefits, including indirect ones such as redirectly investment funds to important breakthrough technologies, may outweigh any issues.

The group PUBLIC CITIZEN has issued an 8-page letter to Nancy Pelosi, listing all the parts of "21st Century Cures" or H.R. 6000, that it doesn't like.   New story here.  Letter online here.  Things it doesn't like include Section 105 for antibiotics innovations (aka Pasteur Act), and Section 404, which would reboot MCIT by legislative action.    

Very Brief Blog: Vinay Prasad's Two Articles on the Parachute Metaphor

We've all heard the parachute metaphor (you don't do RCTs to learn the value of parachutes).   The classic source is Smith and Pell, 2003 BMJ here.  That article will soon celebrate its 20th anniversary.  Many later authors have joined the theme;  e.g. Yeh BMJ 2018 - here.

There are two Vinay Prasad articles on the topic.

For the most recent, see:

The use and meaning of the parachute metaphor in biomedicine: a citation analysis of a systematic review and a randomized trial of the parachute for freefall (2022)

Find this online here ($70; Xu and Prasad) and his current Twitter discussion here.

But there's also a 2018 open access article coauthored by Prasad on the same theme in CMAJ Open:

Most medical practices are not parachutes: a citation analysis of practices felt by biomedical authors to be analogous to parachutes (2018)

Find this here (Open; Hayes, Kaestner, Mailankody, Prasad) and 2020 Twitter here.

The $70 article: Is it worthwhile?   I used the US value of $100,000 per QALY.  That is, if reading the article (or not reading it) was worth a life-year, I'd be willing to pay $100,000 (or alternatively, trade a life-year) to read the article.  $70 is 1/1428th of $100,000.   Therefore, based on its $70 price, the article should be worth 1/1428th of a QALY life-year, or about 1/4 day, or 6 hours.  

Unsplash, Kamil Pietrrzak. Sienna Wall

Very Brief Blog: NHGRI Two Day Workshop on Genomics Equity

On April 6-7, 2022, NHGRI will host a two-day virtual workshop on genomics & health equity.

Find more information here:

Very Brief Blog: Texas Surprise Billing Case; Actual Ruling Here

This week, numerous news sources covered a Texas court ruling against part of the Surprise Billing Act regarding the arbitration of what fees an insurer pays to an out of network provider.   The judge ruled in favor the Texas Medical Association and found that part of the rapidly-issued CMS regulations, which specify the exact price-setting pathway, were out of step with the law they were trying to implement.

Most of the articles didn't cite the judge's ruling.  I found one that did (31pp).

See "EMS1" website and the article by Rachel Engel here.   See the ruling at its cloud link here.

I think that surprise billing laws are important for the reference lab industry to track because they can affect the complex balance of different considerations for in-network contracting and out-of-network lab billing (at least in contexts where the surprise rules come into force).  For example, there are also unexpected take-home lessons for telemedicine that consults into ER or hospital settings (e.g. here).

Thursday, February 24, 2022

Debate Over FDA and LDTs Heats Up Again

The longstanding debate about FDA regulation about lab developed tests rears its head again in February 2022.   After a New York Times report that was negative about NIPT (and, I think, pretty misleading), 100 legislators wrote the FDA this month asking for FDA to take action on LDTs.   FDA has responded already, that it would be happy to, given better legislation.   

See the full story and numerous hyperlinks in an open-access article released on February 24, 2022, by Michael Mezher at REGULATORY FOCUS.

See also a story on this week's Friends of Cancer Research meeting, where FOCR released a white paper on faster approval of rare biomarkers.  At the same FOCR meeting, drop-in speakers Repr. Bucshon and DeGette championed their regulatory bill, which is called VALID. 

Monday, February 21, 2022

Very Brief Blog: AMA Releases Covid Genotyping Code

On February 21, 2022, AMA CPT announced they were releasing a new COVID lab test code. This is an area of CPT that's been largely dormant since Fall 2020, despite the enormous uptake of COVID testing of  multiple types.

The new code is announced on the CPT COVID webpage here, and found on the PDF here (at page 9).

The code is:

87913, infectious agent genotype analysis by nucleic acid (DNA or RNA), SARS-CoV-2 (COVID-19), mutation identification in targeted regions.

CMS Pricing?

In the past, CMS has rapidly developed local MAC pricing for new COVID lab codes, ensured that all MACs will pay the same local price, and then published that price.    The codes also come into the subsequent annual summer crosswalk/gapfill process, where they've been generally gapfilled at the same price that was initially set.   We'll see what happens with 87913.



Sunday, February 20, 2022

Revisiting MCIT with Numbers: MCIT Could Triple the Value of MedTech Investments?

Top Line

In this blog, I take a quantitative look at the medtech investment game theory, under Medicare coverage as "status quo," MCIT, and CED.   The model predicts that product value is almost 4X higher under the MCIT paradigm as the CED paradigm.

The CED paradigm is worse than the status quo even when the Medicare status quo takes 2 years with a 50% failure rate, but the CED path has a 90% success rate.  The simple Excel is here.


As everyone in the medtech industry knows, the Trump Administration created "MCIT," Medicare Coverage for Innovative Technologies, which promised 4 years of immediate coverage for all FDA breakthrough devices.  The Biden administration canceled it, but is holding "listening sessions" on future ideas for accelerated coverage.  

Listening Session

The first 90 minute listening session was February 17, with 700 listeners and 20 speakers.  (See a preview blog by me here, my 3 minute video recap here, and an unofficial transcript here).

No Quantitative Rationales Offered!

None of the speakers gave anything approaching a valuation argument for MCIT, versus the status quo, or MCIT, versus "CED" alternatives.   At least one speaker warned the FDA "Breakthrough" bar was too low a bar.   (See FDA webpage for breakthrough device policy, here.)   

I was reminded of an excellent podcast sponsored by USC last fall, where Trump administration policymakers Scott Gottlieb and Joe Grogan talked about the rationale for MCIT (podcast here or here, see also a Grogan op ed here).  They emphasized that the MCIT was intended to boost investment in promising medtech, at little or no cost to the government.   If devices failed "breakthrough" approval, they would never reach Medicare, if they were successful Medicare would cover them anyway, just not as promptly.  

Listening to the 90 minutes of discussion on February 17, and looking back the Gottlieb/Grogan talk, I test-drove some investment models with the status quo, with MCIT, and with the alternative CED.   In a model where an investor would be willing to invest $7M today in the status quo, he should be willing to invest $18M (2.5X) under MCIT.  This means, for example, if the product clinical trials cost $10M, they'd be canceled under the status quo, but green-lighted under MCIT.   On the other hand, in the same model CED was value-destroying (from $7M to $5M), even when you belieeve that CED raises the chance of Medicare coverage from 50% to 90%.   

The models below are intended to be for discussion only; one could easily use different models, discount rates, and different decision thresholds.  However, I provide a model for at least thinking about the status quo, MCIT, and CED in a quantitative way.


In the status quo, the product spends 2 years in clinical trials, 1 year in FDA review, and then 2 years in CMS review.  There's pilot data enough to merit Breakthrough status.  Pivotal clinic trials will begin now if funding is raised.  

Assumptions.  FDA review has a 50% chance of success (an innovative product with meaningful science risk.)  CMS review also has a 50% chance of success in 2 years.  (This is an out of the box product, like the HeartFlow FFR test, or Procept Aquablation surgery, innovations that can easily sink > 2 years in an uncertain CMS review).  Discount rate is 10%.   The investor will invest up to half the current discounted risk-adjusted value of the future product.   We use a terminal value for free cash flow of $100M occurring right after CMS approval.  (We imagine this reflects $20M free cash flow on $100M of sales per year for five years, but the details are irrelevant since we are only using the $100M value).

So by agreement we are assuming the successful product is worth the value $100M in 2027.  CMS has 50% approval ($50M), and track back two years to the FDA approval you have $40M.  FDA approval is 50%, you you have $20M, and track back three years to today, the discounted NPV today is $14.8M.   Remember, I have many choices and will only invest if I expect a return, so I'll invest up to $7.4M.  This means if the clinical trials cost $6M, I'm funding them, and if the clinical trials cost $15M, I'll pass and kill this project.

(For the layout in Excel, see "STATUS QUO" figure at bottom).


I'm using the same future value of the project at $100M, upon CMS approval.  However, CMS approval is 100% and occurs immediately upon FDA approval, so I can skip two years of discounting because there's no CMS review.  I still have 50% chance of FDA success, 3 years in the future at a 10% discount rate.  Now today's value of this product idea is $36M, which means I'm happy to invest up to $18M.   If the clinical trials will cost $15M, this project is greenlighted and the product will be created (allowing for science risk).   The NPV has been raised from $15M to $36M, almost 2.5X, which means the investment merited, though smaller than the NPV, is also raised greatly.

(For the layout in Excel, see "MCIT" figure at bottom.)


This really fizzles.  We have the same initial three years of development and FDA review, with success at 50% with the FDA.   However, now we go into 2 years of negotiation for an NCD and CED, and we'll assume the chance of CMS success rises from 50% to 90%.   However, at that point, we get three years of CED which I assume has 10% of product sales and 0 profit (due to the small scale and trial costs).   Then in year 4 and 5 (after CMS approval and CED starts) we're back in the normal revenue model of  $100M sales, $20M profit in years 4,5 after CMS approval.  I add in a 3-year discount because now revenue starts in Year 4 after CED approval rather than Year 1 (0.9^3 = .72).  

Now the NPV has fallen to $7.8M, which means investors will not want to invest more than $3.9M.  Less than in the base case and only about 20% of the MCIT value (8/36).  But remember, it's not just that developers make less money, it's that many projects will fall below the "red line" and fail to get funded at all; the innovative medtech products won't exist, or, won't have the chance to be studied and brought to the FDA.

(For the layout in Excel, see chart "CED MODEL" figure at bottom.)

Conclusions and Considerations

So in these simple models, MCIT triples the value of a risky med tech product.  One of the best ways to think of this is that many more products would achieve VC funding, and in the interests of the VCs, under MCIT.

It's important to understand the difference between the regulatory effect of MCIT and the policy goal of MCIT.  The "effect" is to start Medicare coverage on FDA approval.   But the "policy goal" is to spur and encourage investment the day after FDA issues breakthrough coverage (as in these models).  To accomplish that, it's critical to make the promised coverage independent of future events during or after development (though as I'm about to show, problems are self-limiting).   

But doesn't MCIT provide "too low a bar" for CMS coverage?   I'd argue this risk is far overweighted and largely self-fixing.  

  • If the product is promising after Phase I trials, and gets breakthrough status, that's far from approval.  Some products won't get funded further, or will have unexpected poor results.   Some won't pass FDA approval, and CMS automatically doesn't have to worry about them.   
  • Other products will pass FDA, but have marginal improvements at best.  I argue this usually takes care of itself.  For example, ten years ago, CMS covered Provenge under an NCD, and on-label, yet the tens of thousands of patients and billions of costs never materialized.  (The product peaked at $300M per year, divided by $100K is about 3,000 patients, then downward).   
  • On the other hand, if the product is really good and a big improvement, then it will move into standard of care and CMS would pay for it anyway, it just moves faster with MCIT.   

Overall, I came out of this modeling experienced much more impress with the potential social and economic value of MCIT than I had been before.  

For quotes from Grogan-Gottlieb interview, here.  The MCIT was dead simple (get BT status, finish trials, get approval, get 4 years coverage, it stops).  This simplicity was a feature, not a bug, when you understand it was intended to spur investment on the day after BT status and innovation quality was approved, such as based on Phase 1 trials.

The Three Models (Click to Enlarge)

Status Quo




Two interesting books on innovation in healthcare:
Burns, LB.  Business of healthcare innovation.
Burns, L.B.  US Healthcare ecosystem: Payers, providers, producers.

Thursday, February 10, 2022

Brief Blog: NGS MAC Releases New Final LCD for Genomics of Tumors

In September 2021, the NGS MAC published a draft LCD that revised its coverage of solid tumor genomics.

On February 10, 2022, the LCD has been released in its final version.  This triggers 45 days public notice before it becomes an effective or active version.

Find the final LCD L37810 here.   Near the bottom, it contains links to its draft version, to a billing article, and to a Q&A on public comments received.  The Q&A document has 10 points and summarizes the incoming comment and the MAC's reply effectively and concisely.

Redline for Changes

I've also taken the body of the LCD as a text document, and done a redline comparison between the September draft and the February final.  Changes are limited.   

One change is that that the original draft proposed that the original  proposal covered CGP (comprehensive testing) only "when a more limited panel of 5-50 genes is insufficient" without further definition.   This could have led to a lot of confusion during chart-by-chart audits of whether 5-50 gene tested had been ordered and proved insufficient (possibly inserting a turnaround time of a week or two besides.)   

TMB is a reason for ordering CGP (because it requires a lot of sequenced DNA) but the LCD remarks that "current evidence fails to support the use of TMB as a biomarker for ICI treatment of all tumor types" and "limitations to precision medicine's impact, involving the widespread assumption of clinical utility of wholesale [CGP] testing, is coming under new scrutiny [FN 31-34]." (See also, recently, Andre' and colleagues.)

The final language allows CGP as necessary under basically the same conditions in the Cancer NGS NCD 90.2, that is, (1) the patient has advanced cancer, (2) has not been tested with CGP for the same content, and (3) decides to seek further treatment.  

The test biomarkers must cover genes listed for FDA approved therapies, and points to the NCCN biomarkers compendium.   

Notably, tests must be FDA approved or cleared.  Or alternatively, the test must have published analytical validity evidence, OR, the test must be certified by a party such as New York State CLEP. 

  • This is not so different that the molecular testing standard in the 28 MOLDX states, which require a MolDx tech assessment review that is pretty exhaustive has many elements of a NYS CLEP review.  And similarly to this LCD pointing to NCCN Biomarkers Guide, the MolDx program regularly updates tables of requirements for genes in tumor panels (for a type of tumor) and genes in hereditary panels.
  • But also note, the LCD promises coverage if the genomic test is FDA approved or cleared. If it's FDA approved (as a CDx) then it falls under the domain of CMS NCD 90.2 and wouldn't really fall under this LCD at all.  

To save  you clicking and searching, I've put all the PDF documents plus the redline into a cloud zip file here.

The NGS MAC LCD is effective in New York/Connecticut and New England, as well as MN, WI, IL.


The LCD was turned around quickly, with a comment period September 30 to November 13, and a publication (notice period) on February 10 (4 months 10 days).   Novitas recently produced a rapid pharmacogenetics LCD, L39063, comment June 10-July 24, released (noticed period) on October 28 (4 months 18 days).  

Wednesday, February 9, 2022

Very Brief Blog: NCI Planning Potential Large Trial in MCED - Multi Cancer Early Detection

On February 3,  2022, I noted that the Biden Moonshot for cancer cures specifically called out MCED as an important area - Multi Cancer Early Detection - here.

Hat's off to the incredible researchers at the healthcare equity research firm Nephron, which uncovered a little-discussed RFI from the NCI in January.   

It's called, "Seeking Input from Multi-Cancer Early Detection Test Developers on Readiness for Participation in an NCI-Sponsored Clinical Utility Randomized Controlled Screening Trial."

See the full RFI information here:

Note that there are several related NCI announcements, highlighted in this announcement, such as 22-010 for biorepositories for MCED and 22-011 on technology for MCED.

Tuesday, February 8, 2022

Notice of Updated Blog: The 2022 Gapfill Process

I wrote a detailed blog on the 2022 CMS lab test gapfill pricing process, which involves 36 codes this spring.  

There have been a number of updates in the last few days.   Rather than have inconsistent articles a few days apart, I have brought the original posting up to date. 

Find it here:

Eric Lander Resigns: Head of Office of Science & Technology Policy at White House

On February 8, 2022, Eric Lander would have been a star presenter at a hearing at House Energy & Commerce about ARPA-H (my blog and links here). Lander is described as Biden's top science advisor. Wikipedia here.

At 9 pm the evening before, stories began running that Lander has resigned in the wake of allegations of abuse and harassment.  

See Politico here.  See Stat here.

Lander holds a PhD in mathematics (1980) but is best known for his work as a geneticist.

Monday, February 7, 2022

Biden Moonshot Report Promotes Germline Testing in Cancer Patients

On February 3, I highlighted the press materials and reports associated with rebooting the "Cancer Moonshot" program.  This program got $1.8B in 2016, as part of 21st Century Cures, and this 7-year funding runs out in 2023.

Another important section to highlight is the emphasis on germline testing (along with somatic tumor testing) in cancer patients.   See PDF page 47 and numbered page 27 in the report, online here.  The report encourages use of paired germline-somatic testing.   By coincidence, this was also a topic at last week's AMA CPT meeting.   

The report authors write,

The time of a cancer diagnosis is an opportunity to determine whether patients carry inherited, or germline, mutations that increase risk of other cancers. Many cancer patients have their tumors sequenced to inform cancer treatment planning, including potential use of precision therapies that target specific mutations. 

Performing germline genetic testing for hereditary cancer predisposition genes in concert with tumor sequencing can provide additional information on genetic risk with implications for the patient’s treatment and future cancer screening and surveillance. Studies of germline genetic testing in cancer patients have documented clinically actionable fndings that were missed by tumor sequencing.

Results of germline genetic testing also have implications for family members. If a cancer patient is found to harbor a cancer-associated germline variant, cascade testing of family members can help identify other carriers. This may lead to increased screening adherence, enhanced screening, or other risk-reducing interventions.

The Panel supports assessment of eligibility for germline genetic testing for all people diagnosed with cancer. If variants of concern are identified, cascade testing of family members should be offered. 

Citations include Samadder, JAMA Onc 2021 (PMID 33126242, and Lincoln, JAMA Netw Open, 2021 (PMID 33026450).   In the latter study, using Invitae data, 2,000 patients were studied, all with tumor testing and germline testing, and 30% had pathological germline variants, many of which were missed by tumor-only sequencing.

First Coast, Novitas, NGS MACs All Publish Their Gapfill Process

On January 25, 2022, I published a blog that the ever-confusing gapfill season for lab codes is underway at CMS and its MACs.  Here.   By February 8, a lot more information has been posted.  

The 2022 Gapfill Codes are  81349, 81560, 86408, 86409, 86413, 87426, 87811, 0018M, 0224U, 0226U, 0228U, 0245U, 0248U, 0249U, 0252U, 0253U, 0254U, 0255U, 0256U, 0257U, 0260U, 0262U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U.  I count 36.  MACs collect information now, submit to CMS in mid spring.  CMS publishes MAC prices, and takes public comment.  Having considered public comment, MACs resubmit final prices to CMS in August.  The prices last for several years, until the next PAMA cycle.  

NGS & Novitas/FSCO

In the last few days, NGS MACs and Novitas/First Coast MACs have published articles and provide channels and due dates for submitting Gapfill lnformation.

NGS MACs ask for basic gapfill information in your own format, and submit by email by March 15.    

The Novitas/FCSO MACs provide a cloud data template and offer some special detailed questions about costs, overhead costs, etc.   The Novitas/FCSO MACs have a due date of February 27/28. 

Gapfill in the MolDx System   

The MolDx MACs (Palmetto, Noridian, WPS, CGS) operate differently.   

They do not have a public article nor due date about the current national gapfill process.   MolDx management will reach out proactively to a stakeholder (or plural) whom it believes appropriate to file a gapfill comment.   Alone of the various MACs, MolDx does not publicize its due date on the website, which tends to make clients nervous that a due date might have been yesterday.   

  • If you are a stakeholder that needs to comment, and to MolDx, I would suggest reaching out to MolDx management (and by mid February) by email to see what your options are and learn what the nonpublished due date is.  
  • MolDx prices are critically important, since CMS sets the code price to a national "median" and the "median" is always controlled by the MOLDX block of MACs. 


Click to Enlarge


Here is are the article links for First Coast and for Novitas.  Each contains a link to a cloud entry form.

Here is the article link for NGS MAC:


Nerd Notes

Nearly all the Category I codes under gapfill are COVID codes.  81439 is low pass NGS cytogenomics, and 81560 is a T-cell transplant test as a MAAA.   I assume the COVID codes just missed the June 2020 pricing meeting, so they came to the June 2021 pricing meeting, and thus the Spring 2022 gapfill work.

Notably, the several MACs take different approaches to gathering information.  A number have public articles, deadlines, and specific request methods (in the case of Novitas/FCSO).  And that's what I had assumed the rule or instruction was.  But in contrast, the MolDx MACs do not open any public article or website, but reach out to relevant entities for each code.   As I noted above, this makes me edgy I might miss some unclear deadline and get in hot water for having missed it.  

Nothing in the program manuals or regulations appear to push either way; CMS only asks MACs to price all the codes by April 1 and to use the decades-old suggested familiar information (charges, resources, etc, 42 CFR 414.508).   Unlike an LCD proposal, which has comment period rules, I findno CMS statement towards the MACs in the vein of first quarter public comment (or making it easy for the public).  Lacking such a command, MACs are still free to post websites, portals, deadlines, and so on, and publicize them.  Certainly, I've always said and continue to say, if you're a lab test in gapfill, for gosh sakes, stay ahead of the ball and at every MAC. 

It seemed weird to me (the Novitas approach seems the most natural to me) but think of Gapfill pricing like LCDs.  MACs can reach out for advice to make proposed LCDs, but nothing is really required.  After they do post a proposed LCD, though, there is a very well structured open public comment process.

So, CMS never refers to "public comment" now, in the initial development period for gapfill.  BUT, once CMS posts the MAC proposals (hopefully in May, but sometimes weirdly late), CMS then does host a true public comment period with comment instructions, and a comment mechanism, and public due dates.   


I've included the text cut and pasted the NOVITAS template below the break.  For the most current version, see the links just above.


Sunday, February 6, 2022

Brief Blog: House E&C Hearing: "ARPA-H, Frontier of Health Research;" Eric Lander

On February 8, 2022, at 1030 ET, the House Energy & Commerce committee will hold a hearing on "ARPA-H, Next Frontier of Biomedical Research." 

  • The meeting may include discussion of new news stories about harassment and employee abuse by lead speaker Eric Lander (Endpoints here, Politico here).  New York Post provides a press conference video clip here.

ARPA-H is a plan for a multi-billion dollar translational research agency modeled on DARPA (defense research agency) and building on successes such as Operation Warp Speed and BARDA's funding successes both before COVID and in the COVID epidemic.  ARPA H has a placeholder webpage at NIH here.  Although it's only a proposed agency, it already has a year's worth of press releases and news events to peruse.  See proposed legislation from Repr. Anna Eshoo in September 2021 - Bill HR 5585 here, and press release here.  See an interview with Eshoo - Feb 3 at STAT - noting that "ARPA H won't be part of NIH."  Here.

Find the live stream here:

See a six page memo from Chairman Pallone to the committee here:

Speakers to include Eric Lander (WH Office of Science & Technology Policy), plus Keith Yamamoto PhD, UCSF; Ester Krofah, Faster Cures; Geoffrey Shiu Fei Ling, Hopkins Neurology, Adm. Brett Giroir, former Asst Secr. of Health; and Brian James Miller, Hopkins Medicine.  As of February 6, it looks like testimony for each is already on line.


NATURE had a summer 2021 on "the rise of ARPA-Everything" here.   D-ARPA is the Defense Advanced Projects Research Agency, apparently the abbreviation H-ARPA (HARPA) (sic) was nixed at some point in favor of ARPA-H.  

Thursday, February 3, 2022

Medicare Will Figure Out How to Cover OTC COVID Tests in "Medicare"

In recent weeks, the Biden administration has worked hard to provide free COVID testing widely, especially home COVID tests.   However, they left Medicare out of this, possibly because Medicare generally doesn't cover OTC items and Medicare usually requires a physician's order for drugs, DME, or tests.  

CMS announced on February 3, 2022, that they will be working quickly on a mechanism for DTC COVID tests right inside the Medicare program.

Press release after the break. It includes a link at the end to a PDF, but the PDF just says that CMS will work out the policy ins-and-outs soon.   Basically, it says, "Stay Tuned" at the level of a press release.  

"Starting in early spring, people with Medicare will be able to go to an eligible pharmacies and other entities that are participating in this initiative to receive over-the-counter COVID-19 tests for free through their Medicare part B coverage. More information about eligible pharmacies and other entities that are participating in this initiative will be available in the early spring. Once the initiative is up and running, CMS will encourage beneficiaries to ask their local pharmacy or current health care provider whether they are participating in this initiative."

CMS Updates Pathways to Diverse Kinds of Data Files

 CMS periodically updates pathways and webpages for its provider data files.   On February 3, 2022, CMS announced they had updated a lot of data files to CY2020.   They have also migrated data from "" (a main tab on the home page) to, the new entry point.

See a home page for CMS program statistics here:

This enters you into 3 main fields of Medicare enrollment, providers, and utilization/payment.  Generally, you get to links that pop you into where you get more granular choices.  

There are still some important databases that are hard to find in a logical way and I usually get there by Google.   The most important is the huge annual database with every physician (and lab) and every CPT code paid.  It's here.  

CMS Begins Promoting Discussions on "Transitional Coverage for Emerging Technologies"

 According to CMS, they've begun promoting town halls in February and March that will discuss, "Transitional Coverage for Emerging Technologies."  (?"TCET")Early in January, this was reported a rulemaking in progress (see blog January 7, 2022.)  This could be, in effect, a replacement or reboot for the canceled plan for MCIT, "Medicare Coverage for Innovative Technologies."  The MCIT would have provided 4 years of coverage for FDA-endorsed Breakthrough Devices.   A program similar to MCIT has been included within drafts of a new, 2022-vintage "21st Century Cures" bill that is in progress.

CMS has promised to produce a new version of a breakthrough device program in CY2022 (see for example Modern Healthcare, 12/2021).

According to staff at the office of communications, CMS will hold teleconferences on February 17 and March 31 on the topic.   Look for further social media from CMS on the topic.  Details below the break.

See a two minute video version of this blog:


Revisiting Medicare's Bizarre Construction of Date of Service Rules for Proteomic MAAA Tests

For a few years, this has been the status quo for Medicare bundling of tests based on blood or tissue samples taken in the hospital outpatient environment (both hospital outpatient medical clinics and hospital outpatient surgical centers.)  The rules are at 42 CFR 414.510.

All laboratory and pathology tests are bundled to the underlying procedure or office visit, EXCEPT for MOLECULAR PATHOLOGY tests.  

In practice, CMS defines molecular pathology tests as human DNA/RNA and marks these with a payable indicator in the outpatient fee schedule.  Payable tests are paid by the lab that performs them (whether hospital or reference lab.)   

Then, CMS adds a couple more exceptions (see 414.510).   Payable are ADLT tests of type 1, which are ADLT tests because they are covered MAAA tests that have applied to be ADLT tests.   Most of these are DNA/RNA tests anyway, but if it's a MAAA ADLT it doesn't have to be DNA/RNA.   

And payable also are "proteomic MAAA tests for cancer."  This latter was added on December 29, 2020 (see 85 Fed Reg 86251ff).  My marked-up cloud copy is here.  CMS opens the discussion noting it had considered this issue in 2019 policymaking and was now revisiting it in 2020.  

Here's where it gets even quirkier, for two reasons.

Category I Rule.  

CMS said that the proteomic MAAA tests for cancer, of which it tallied about six, had to be Category I CPT Codes (classified by AMA CPT as MAAA tests) and not PLA codes.  

CMS held firm on this, despite multiple complaints.   Possibly, AMA or CAP or others should complain this is weird and unfair discrimination against PLA codes.  At some points, in fact, AMA has said that "once a PLA code, always a PLA code" so some tests wouldn't be eligible to graduate from PLA status to 815nn MAAA code status. (fn1)

One Non-Cancer MAAA Test Slips In!  

Then, CMS did something really odd.  While the regulation is for "protein based MAAA tests for cancer," CMS also included a single protein based MAAA test for rheumatoid arthritis, CPT 81490.  Don't get me wrong, I'm happy this test got included, payable rather than bundled, but it's pretty darn weird it's included under a regulation written explicitly for protein based MAAA tests "for cancer" quote-unquote.     

Back to the Future?  

CMS says its intention in the whole Date of Service policy domain is to bundle "common or routine laboratory tests that would otherwise be packaged into OPPS payment."  (p. 86254)  My sense is there will increasingly be non-common and non-common advanced proteomic, functional cell culture, or other tests that will originate in the hospital specialty clinic setting.  


At one point CPT took the position that once a PLA code, always a PLA code, never elevating such a code to CPT Category I. I'm not positive if this is still the 2022 position.

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Biden Cancer Moonshot Specifically Calls Out "Multi Cancer Screening Tests"

Plenty of press yesterday on the White House announcement it was rebooting the Cancer Moonshot program with new goals.

White House talking points here.

Genomeweb here.  Seea lso an NCI RFI on this topic here.

The White House talking points particularly call out Multi Cancer Screening, such as Grail, Thrive, Delfi, and others are developing.


  • Federal agencies, led by the NCI, will develop a focused program to expeditiously study and evaluate multicancer detection tests, like we did for COVID-19 diagnostics, which could help detect cancers when there may be more effective treatment options.
  • This may be a bit of a boost for multi cancer screening legislation (e.g. HR 1946, S 1873, press here.)  See also a report from ITI Foundation here.

Also on the side of screening, the President's Cancer Panel released a detailed report on the status quo for US cancer screening on its own website, here:

(Look in the upper right for the button, "Download full report.")  This is an 84-page PDF.  

They also seem to annotate some priority for stool-based FIT-DNA tests (ColoGuard) as an alternative to "colonoscopy first" screening (p. 21).