Wednesday, June 30, 2021

Very Brief Blog: Medicare Updates Its "COVID SNAPSHOT" Public Data

Medicare periodically updates its 15- to 20-page PDF of data around COVID.   Much of it is normalized to cases per 100K based on race, Dual-Beneficiary status, and geography.   A new file has been released based on data through April 24, as received by May 21:

The death rate among all hospitalized Medicare COVID patients was 17%. 


On a separate note, I stumbled across some data where I live, Los Angeles County, that current COVID cases (including Delta) are enormously concentrated in a few cities out on the northern, high-desert, rim of LA County.  Notes here.   As has been true throughout the pandemic, cases are very sparse in upscale areas of LA County like Santa Monica.   (Palmdale, two weeks, 209 cases; Santa Monica, two weeks, 16.)

Tuesday, June 29, 2021

Very Brief Blog: Is United Healthcare's Policy Listing a Great Source for MolDx Policies?

A few months ago, Xifin published a blog that United Healthcare would begin using MolDx Z-codes (here), presumably through a licensed arrangement.   (United had announced a separate, non-Z-code test registry last summer - here).   I was googling for any updates to the MolDx/UHC relationship, and I hit a number of articles bringing UHC and MolDx together.   (I didn't any updates, besides that Xifin article, on Moldx and UHC).

UHC Provides Long Tables of Hyperlinked MolDx Articles

UHC has a 21-page document and a 52-page document that, in general, provide hotlinked libraries of related MolDx policies, for example, the policies published under separate index numbers by Palmetto, Noridian, WPS, and CGS.   

  • See UHC Genetic Testing here.
  • See UHC Molecular Pathology here.
For example, for blood group molecular typing, the Genetic Testing article gives you a nice row with the Palmetto, Noridian, CGS, and WPS articles on that topic nicely in a row.  (Noridian usually has 2 article numbers, one for CA/HI/NV and one for the Mountain states).  In those cases where there is a related LCD from the non-MolDx MACs, they will also be listed.  

Handy to know, and especially handy the codes are all hyperlinked.

You'll notice some quirks where Noridian has coverage documents on the same topic but they are LCDs in other MolDx MACs and a long "article" with the same text in the Noridian MAC.   (My insight, as far as I have one, here.)


Very Brief Blog: CMS Prices Cat III Codes for OPPS (Outpatient) Setting, July 2021

 I don't always mention, but CMS issues frequent updates to hospital outpatient coding and pricing, as new codes are creating.  Sometimes these are worth tracking.  For example, CMS may place new CPT codes, especially new Category III CPT codes by crosswalking them to outpatient pricing tiers ("APC" pricing), well ahead of the time CMS Part B assigns conventional RVUs.

For example, in CR12316 here, CMS provides rapid APC pricing for Cat III codes 0640T-0670T.   Sometimes MACs find and use this APC pricing as an index towards their local pricing of Cat III codes.

Very Brief Blog: FDA Posts Still More Aduhelm Documents

 A week ago, FDA posted some internal review documents on the home page for aducanumab (Aduhelm).   At that time there were three; now there are a total of six.   

These include the full-length review of clinical pharmacology and of statistics.  (Pretty long versions were presented at the November 2020 Ad Comm meeting; but these are the "full, final" versions as of June 2021.)

Article at Endpoints here.  The FDA home page for ADU is here.  

The released FDA documents are these:

 FDA Application Review Files

Monday, June 28, 2021

HHS: July 19: Meeting on "Implications Posed by Aducanumab" for Alzheimer's; PLUS "Closed-Door" Meeting at Duke

Update - A rough computer generated transcript is in the cloud, here.


HHS First Meeting on Aduhelm  - July 19, 2021

The Department of Health and Human Services has a longstanding Advisory Council on Alzheimer's Research, Care, and Services.

The Council will meet to discuss "the implications and opportunities presented by the approval of aducanumab [Aduhelm] on July 19, 2021.   A very brief meeting announcement has been posted in the Federal Register.

  • See the home page for the Council here.
  • See the agenda page for all meetings, here.
  • The last meeting was on May 5, 2021 here.
  • See the placeholder webpage for the new July 19 meeting here.
  • See the Federal Register webpage for the meeting announcement, here.
  • The prepublication PDF is here, the Federal Register paginated announcement is to appear June 29.
The meeting will be held on July 19, 2021 from 12:30pm to 4:30pm EST.  The meeting will be virtual, streaming live at  Public comments will be allowed (2 minutes) from 4 to 4:30 pm.  Register to comment by emailing  Please submit your written copy of oral comments by July 20.   Alternatively, submit written comments only to the same email.

As stated above, the only remark on Aduhelm is a brief phrase, "the implications and opportunities presented by the approval of aducanumab" will be considered.

"Duke to host private meeting with payers and biopharma on how to pay for Alzheimer's drugs"

Separately, Endpoints reports that "at the request of the FDA" the Duke-Margolis Center for Health Policy will hold a "closed door meeting" to discuss "to convene public and private payers, clinicians, academics, patient groups, and industry" to discuss "coverage and evidence challenges" for A-beta drugs as a class.   It's unusual for FDA to go very far in convening meetings on "coverage" and they usually take themselves to be their own gold standard for "evidence."  Article here.

Saturday, June 26, 2021

Very Brief Blog: Reducing Hereditary Cancer Act Introduced by Congr. Wasserman-Schultz

One of the major quirks of Medicare policy is that the agency feels it can pay for hereditary cancer risk testing only if a patient has already been diagnosed with cancer.   For example, a woman who is a Medicare beneficiary with three close relatives with breast cancer does not qualify for BRCA testing, but a woman with three close relatives with breast cancer can be tested after SHE personally develops breast cancer.   

This is unique to Medicare; woman in commercial health plans would qualify for BRCA testing based on USPSTF and HHS guidelines for implementing required preventive services.

  • On June 23, 2021, legislation to correct this was introduced into Congress by Representative Wasserman-Schultz of Florida.   It's bill HR 4110 in the current 117th Congress.   Read it here.  
    • Note: I've posted the link; the legislation text wasn't visible online yet as of June 26.
  • Press release, dateline June 23, at Wasserman-Schultz website here.
  • See discussion at the website of FORCE, Facing Our Risk of Cancer Empowered - here.  
  • The Medicare benefit would be linked to major clinical guidelines, such as NCCN.


There are two arguments in play more generally in this area.   

One argument today is that persons with high familial risk should have testing (as per USTPF for example) for management of their risk, their schedule of colonoscopy or mammography, etc.   This management should be able to commence before a personal history of cancer.

A different argument, and it's separate, is when, whom, what to test after a diagnosis of cancer.  There have been multiple large studies (here) that after a diagnosis or breast or colon cancer, the risk of finding actionable genetics is just not much different with or without a high family history of cancer.  Therefore, the argument goes, it would be more rationale to predicate this testing on the patient's personal history of cancer, even if a family history is not present in the available data.   


And yet another twist in the field is that in some cancers, like colorectal cancer, testing of the cancer may include mismatch repair genes (MMR genes) which cause microsatellite instability (MSI) which is medically necessary testing for some types of treatment selection.   

The MMR/MSI findings may be of germline or somatic origin, but are used to guide present therapy choices, so hereditary risk is not invoked as "the" reason for testing the same hereditary risk genes.   Another way of reaching the same point is to argue that germline testing (including hereditary oncogenes) is necessary to properly interpret the results and actions following comprehensive genomic profiling (CGP) of the tumor tissue.


Readers may have notice that a woman who is 64 with three breast cancer relatives is covered for BRCA testing now, per national preventive benefits under the ACA and USPSTF, and should get it now, because she won't be covered when she turns 65 next year and flips into Medicare coverage.


I've summarized what I think I understand, below.  


A:  Medicare covers genetic risk screening for patients with a personal history of cancer AND a family risk history.

B:  USPSTF/ACA covers women without breast cancer but with a high risk family history, for BRCA testing (here). This applies to commercial insurance under the ACA but doesn't apply to Medicare.

C:  FORCE bill, newly proposed, provides CMS hereditary gene coverage based on preventive guidelines, e.g. NCCN.

D:  Some currently argue that patients with cancer, but with or without a family history on the record, all have enough genetic risk to justify genetic testing.  Data for genetic findings "in guidelines" and "outside" guidelines justify this.   In fact, it's become dated to refer to this testing as "outside guidelines" in that at least one major guideline already now includes women with breast cancer with or without family history (here, here).

E:  Some argue for population-wide screening of certain risk genes, e.g. BRCA, regardless of family history or personal cancer history.

click to enlarge

Unofficial PDF Transcript of June 24, 2021 CMS Annual Lab Meeting (Pricing New Lab Tests)

On June 24, 2021, CMS held an all-day public comment meeting on the pricing of some 100 new lab test codes for 2022.  

  • Find a unique unofficial transcript of the publicly streamed meeting - 
    • 89 pp.
  • Find the CMS home page for the meeting day, here.
  • CMS will host an expert panel on the same topic, July 28-29, find it here.

Friday, June 25, 2021

Very Brief Blog: BMJ Publishes Data on US Life Expectancy, COVID, Race

There is endless data on the impact of COVID on minority and economically disadvantaged groups in the US; I put up one blog showing data from CMS's own public website (December 2020; here).

See a June 24, 2021 paper in BMJ on the impact of COVID on life expectancy on US populations.  

A key graphic shows -3.88YR life expectancy loss for Hispanics and a -3.25YR life expectancy loss for African Americans, comparing 2020 to historical data for 2018.  (The US average life expectancy loss was -1.9YR.)  BMJ op ed here.

Although Google serves up some news hits for this story, it seemed fairly thin (an ABC News article here.)

Thursday, June 24, 2021

Very Brief Blog: The Washington Post's Correlation of Vax Rate and Covid Cases

On June 14, 2021, the WaPo ran an article headlined, "Coronavirus infections are dropping where people are vaccinated, rising where they are not," here.  

Is that true overall, and statistically significant?  Yes.  Figure here:

Cases tend toward upper left, lower right

States tend to map out toward the upper left and lower right, following the commonsense rule, more vax, less COVID.   

However, there's also a lot of noise; OK and TN share weak Vax rates with WY and NV, but the OK and TN have much lower COVID incidence. (The Y-axis is cases per 100K per day, the range currently around 1 to 10).

Update: New York Times Data

I was looking at today's NYT online data of similar rates, and put them into Excel for the 50 states and DC and PR.   I got a simple Excel correlation of -0.5 (negative zero point five), which is surely statistically significant but still leaves a broad "cloud" of data points.  See the screen shot below.  

States with a favorable case rate of 1 or 2 can come in anywhere from 35% to 65% vaccinated.  Some states with well above average vaccination rates (OR, WA around 55%) come in far above average in cases (at 6).  

Excel; Cloud link

Last Fall's Peak and Plummet in Dakotas

I remember being struck by COVID data last fall of a colossal rise in case rates in the Dakotas, followed by a rapid drop (around Oct/Nov), despite a reluctance to change most local laws.   And then California had a skyrocketing rate last December/January, still rising well into January, despite a new and severe lockdown starting in mid-November (you literally couldn't sit by yourself outside a Starbucks, let alone inside, and masking in our big wide-open city parks was essentially 100%).   

We Went Through Drastic Differences in School Rules

I saw a chart very recently that 30-40% of U.S. kids remained in school this school year just ended (I believe mostly in Southern states) all year, whereas schools around Los Angeles where I live were locked out from March 2020 right through til May/June this year.  Very different norms from place to place. 

Covid in the Air: Breathing vs Talking vs Singing

There was a very interesting paper by Bazant and Bush in PNAS this spring suggesting that breathing transmits very little COVID, much higher with speaking, and much much higher with singing (or, of course, coughing - here; graphic below).   Essayist Holman Jenkins remarked in WSJ, "in a state that weeks ago successfully vaccinated its 50-plus population, I saw an elderly couple driving alone in their car masked up like they were venturing into a Yunnan bat cave."  (NPR on bat caves last week.)  He was making the point we badly need better COVID public education; I'm often left wondering that doesn't fully sink in how much we probably still don't know.

Bazant 2021; Singing (top), quiet breathing (bottom)

Will Different Covid Rates Impact Behavior, Or Will We Just Live With Them?

If we develop a situation with high Delta Covid rates in low-vax regions, will that spur behavior change?   The final real-world proof?   It's not clear what will happen, or, how we'll react.   Scott Gottlieb argues June 27 that we may see harsh pockets of Delta outbreaks in low-vaccinated areas (here).   That's both possible and may be likely, but I'd just say, we don't know for sure.   If that happens, what will  happen next?  Will it be the smoking gun that causes behavior change?   Again, maybe or maybe not.   Witness that we roll on for decades with lung cancer rates 3-4X higher in some states than others, for example.  We just live with that.  Could we see the same for Covid, with some sharply identified areas just rolling on with low vax and high Delta?   Maybe, but my main point is, it's hard to know.   

Lung cancer deaths: From 15 in Utah to 80 in WV


This chart was designed to show the reader the rise in school attendance in the second half of the year (blue line). But living in a near-zero-school state, I was struck to be reminded by the "yellow line" that 30-40% of kids nationally were always in school this academic year - here.

Local to Los Angeles County, where I live, we have a current epidemic that is far, far higher in several northern cities, Santa Clarita, Palmdale, Lancaster.  For example, Palmdale had 209 cases the past 2 weeks, whereas Santa Monica and Pacific Palisades, upscale Westside neighborhoods with roughly similar population, had only 16 cases.  I made notes and some graphics here.

Very Brief Blog: VALID Act for Regulating LDTs Is Re-Introduced

In May, Rand Paul re-introduced his VITAL Act, which builds a wall around the FDA preventing it from regulating LDTs.  AMP, Association of Pathology Chairs, and others voiced support - here.

On June 24, 2021, Burr, Bennet, DeGette, and Bucshon, representing both House and Senate and Republicans and Democrats, re-introduced the VALID Act, which would reform FDA regulation of both IVD's and LDTs to a considerable extent, while introducing risk-based FDA oversight of LDTs.

  • Find the press release here.
  • Find the plain-English six-age summary here.
  • Find the legislative language here.
    • The full act weighs in at 245 pages, 46,000 words.
    • The 2020 version S3404 was only 38,000 words.
I had a chance to be a coauthor of a paper on budgetary impacts of the VALID act, under several different implementation assumptions - Huang et al., here.

Trade journal Healthcare Dive, here.


Redline?  How'd they get from 38,000 words to 46,000 words

I attempted to use MS Word to make a "redline" of the March 2020 version of VALID - as S.3404 - and the June 2021 release, provided in the Congressional weblink above.  The result is pretty clumsy, but if of interest, I've put in the cloud here.  I haven't made sense of it, but I did see the topline result that the S3404 March 2020 version was 38,000 words, and the new online version is 46,000 words, so something clearly was going on.

Tuesday, June 22, 2021

Very Brief Blog: FDA Releases 100 pp of Memos on Aduhelm, the New Alzheimer Drug

 When the monoclonal biological ADUHELM got accelerated approval on June 7, 2021, I provided a set of links to the higher than typical number of documents the FDA released - original blog here.

Two weeks later, on June 22, the FDA released an additional 100 pages, in 3 PDFs, of memos, data analyses, and rationales for the approval.   Stories on this topic ran in Stat and Reuters, but it was hard to find the original links. I've added the new documents as an update to the June 7 blog and I'm also posting the links here.


  • On June 22, 2021, FDA released one 80-page PDF and two shorter PDFs about the ADU review process at FDA.  
  • Stories highlighted this at Stat and Reuters, and USNews, but didn't link to the documents.  
  • Find the new documents at the FDA home page for ADU, in the lower right, under "FDA Application Review Files."

WSJ here.  Fierce Biotech here.

Two senators have called for a hearing about Aduhelm, here.  Hill letters circulating here.

June 22, 2021: House Legislators Offer Plans for "21st Century Cures, 2.0"

In the waning December days of the Obama administration, House and Senate passed "21st Century Cures," a set of FDA modernizations (and a few CMS updates) that garnered wide praise.

On June 22, 2021, see a press release and online documents that describe a wide-ranging "21st Century Cures 2.0."  

Press here.  It's sponsored by Rep. Degette (D-CO) and Rep. Upton (R-MI).  (See also some earlier points and themees in a April 2020 webpage on 21CC, here.) 

There's more stuff.  There is a concept document for a $6B translational research and innovation agency to be called ARPA - find that by Francis Collins et al. at Science.

A 120-page version of draft legislation is here.  

A four-page highlights reel is here.


Please send feedback/comments to by July 16. 

I've produced a separate nerdy blog, sort of a sidebar or text box, which some readers might find of interest, comparing prior breakthrough bill HR5333, the CMS MCIT regulation, and the new 21CC proposal.  Find that sidebar here.

Return of the MCIT: Requires Close Reading, Though

Section 307 sort of recreates the MCIT (Medicare Coverage for Innovative Technologies) rule that was finalized by the Trump Administration and critiqued and put on hold by the Biden administration.  However, Section 307 is quite long and takes a number of new twists not found in the MCIT rulemaking, so it will take a while to fully digest this.  (For example, there's a section that deals with new FDA breakthrough devices that are not already in any existing Medicare benefit category - wow. And a section alludes to a breakthrough lab test being paid higher than the regular crosswalk amount, but it's vague what that higher amount would be.  See some nerd notes in a side bar here.)    

Do read this with the knowledge that the proposal is only draft legislation, for comment and suggestions.   

The bill also incorporates, potentially, the PASTEUR legislation for novel antibiotics.

Below, I've done a direct copy of the sponsors' own bullet-point highlights of 21CC 2.0:

  • Improve how Medicare covers innovative new health care technologies, making them more available to those who need them.
  • Increase diversity in clinical trials to ensure new drugs and treatments are both safe and effective for a greater majority of patients throughout the country.
  • Require FDA to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches.
  • Provide training and educational programs for caregivers – many of whom are often family members with no prior health care experience – to help improve the quality of care patients are provided at home, between clinical visits.
  • Provide patients greater access to more health information to improve their understanding of the illness they face and make them a more integral part of the decision-making process when assessing which course of treatment is best for them.
  • Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.

New York Times Article on ADUHELM Costs is Leaky

At the New Yorker, the diligence of its fact checking has been legendary for decades (article here).

That sort of fact-checking is dead as a doornail at New York Times nowadays (a literary reference that can itself be fact-checked to page 1 of Dickens' "A Christmas Carol.")

In a New York Times headline on June 22, "New Drug Could Cost the Government as Much as It Spends on NASA," there are a number of leaky places.  It's not a toss-off piece, the authors including one of the NYT main health journalists, Margot Sanger-Katz.    But the citation trail doesn't hold up very well.

History of Ridiculous Medicare Projections

New drugs and technologies have often triggered hysterical cost projections for the Medicare program.

  • When the prostate cancer drug Provenge (sipuleucil) was approved by FDA in 2010, there was an outcry that its vast expenses would topple the Medicare program, given the prevalence of well over 1M men with prostate cancer.  
    • In fact,  Provenge sales were never surprisingly and the developer (not the Medicare program) went bankrupt.  Provenge sales ran around $200M per year, 2011-2013.
  • When heart transplants began to become practical in the 1980s, there was a groundswell of federal concern that costs would skyrocket and rapidly overwhelm the Medicare program.  (I wrote about the history in 2015 here).  
    • Never happened.  Didn't even get close.[*]
Paper Trail for NYT Figures

Today, NYT proposed $6-29B in new costs per year for Aduhelm.   The key reference is here: "Analysts expect that Medicare and its enrollees, who pay a share of their prescription drug costs, will spend $5.8 billion to $29 billion on the drug in a single year."  There are multiple references to "analysts" and the high estimate is hyperlinked to a Kaiser paper here.   

The Kaiser webpage is supported by the Arnold Foundation, which is notoriously anti-drug-cost.   Although this is given as the source of the headline high-estimate for the NYT, the Kaiser essay doesn't claim to have any actual data or serious data- and modeling-based projections of costs.  Kaiser simply remarks that "if 1Medicare beneficiaries receive Aduhelm, spending on Aduhelm would exceed $57B in a year."  

Well, yes.  If 1M people get a drug at $56K per year, that is $56B.   That's not a projection, it's basic arithmetic.  Kaiser then hyperlinks the 1M patient count as being "on the low end of Biogen's expectations."  Well, they say "it MAY be on the low end of Biogen's expectations."  That's a red flag; the 1M number is either on the low end of Biogen's expectation, or it isn't.   

Following the Kaiser hyperlink takes you to an online Biogen deck deck, specifically, dropping yo at page 26.  All that Biogen says on this page is that 1-2M patients have mild dementia, and there may be gradual uptake of patients (prescriptions), and modest revenue in 2021 may ramping up to "multi billion dollar opportunity" over several years.   

Did you see $56B?  I didn't.  Did you see that "$56B is at the low end?"  No.   The next page in the Biogen deck doesn't have any dollar expectations either, stating generally that "site infrastructure continues to scale" and "revenue [ramps] beginning in 2022."  Another page, page 30, says that Biogen expects "modest revenue" from Aduhelm in 2022, ramping thereafter.  Nowhere does Biogen say that $56 is "on the low end of its expections."  It doesn't even get near such a statement.


Net net, NYT attributes its high numbers to Kaiser, and Kaiser simply spitballs that 1M patients would be $56B costs, and then Kaiser attributes and hyperlinks the projections to a Biogen deck that says nothing of the sort at all.


[*] Back of envelope, we have about 3000 heart transplants per year, and even at $2M each, that would be $6B or 0.15% of a $3.8T health budget.  

Sunday, June 20, 2021

New Progress for VITAL Act: AMP, Endorsements

May 2021: We've been hearing about a new era in laboratory test regulation since 2010, with multiple episodes (in one episode, FDA was going to take on national LDT regulation unilaterally).   

The VALID Act amounts to reform of both packaged kit (IVD) test regulation and risk-based regulation of what have traditionally been LDTs.  It was introduced in the prior Congress (March 2020; from 2020 see trade journal here, here, law firm Mintz Levin here; response of ACLA here).  Favorable stance toward VALID from the Pew Foundation in January 2021, here.

Meanwhile, the smaller and feistier VITAL Act, from Sen. Rand Paul, would prohibit FDA regulation of LDTs.   There's a pop-up of news on that front in May 2021.

VITAL 2021; AMP Support

VITAL is re-introduced in May 2021 - ClinicalOmics here, MedTechDive here.

May 18, 2021

See also something I missed a few weeks ago - on May 18, 2021, both AMP and the Association of Pathology Chairs (APC) weighed in with a press release supporting VITAL and urging its passage.  "The VITAL Act of 2021 would enhance transparency, preserve innovation, and ensure widespread patient access to essential medical services."  See 2-page PDF here.

Support for Rand Paul's VITAL Act, Keeping FDA Away from LDTs

Back to the Larger VALID Act Proposal

AdvaMed and others support the VALID Act.  CAP noted its 2020 version was better than prior versions, with less overlap of FDA and CLIA.  (Both quoted in LabPulse, 2030, here.)   But AACC was quite opposed; quoting LabPulse, "The American Association for Clinical Chemistry (AACC) believes the VALID Act "introduces new and redundant regulatory hurdles" for labs for many diseases and conditions that are not public health emergencies, according to a March 6 [2020] press statement.  The AACC sees the VALID Act as imposing new and duplicative regulations on labs, as well as "cost-prohibitive" user fees for labs that develop tests for nonemergency applications."  

May 21, 2021

On May 21, 2021, ACLA sent a detailed 3-page letter to Secr Becerra on HHS LDT policy - here. It's worth reading; it emphasizes the role of LDTs in the COVID response, and that FDA on its own doesn't have authority to regulate LDTs.  Beyond that, ACLA generally supports legislative improvements to be worked out among the stakeholders, and ACLA mentions VALID by name, but not VITAL.

Economics of VALID

Last month I had the chance to be a middle author on a paper on the costs of VALID under alternate scenarios; Hsiao et al., J Clin Oncol Oncology Practice, here.

The FDA's big push to regulate LDTs came under the Obama administration, 2008-2016, while the FDA's disputed regulation of Covid LDT tests came under the Trump administration, which had quashed the FDA 2014-2016 effort.  Now under Biden, clearly the different stakeholders are lining up in the ring and expecting new discussions and potentially, new actions.

June 24, 2024

The VALID Act is re-introduced for the new 2021-2022 term - here.

Friday, June 18, 2021

Very Brief Blog: CMS Posts Agenda (Speakers) for June 24, 2021, Lab Meeting

On June 1, I noted that CMS had updated its list of codes for the annual lab pricing meeting on June 24, 2021 - here.  The agenda is about 95 codes long.  Comments were due the first week of June.

CMS has also posted the agenda, i.e. the order of speakers or associations, for the meeting.  Find it here.'

The full CMS webpage, with numerous links that it may update from time to time, is here.

CMS Sepsis Measure SEP-1: Under Summer Review at the NQF

The CMS SEP-1 measure is under review at National Qualify Forum this summer, with open comment periods and with committee meetings scheduled.   This blog provides some links and resources for the reader.

To cut to the chase, the public NQF agenda weblink is here:

Measures 101: Hospital Quality Measures

The US has a complicated system for quality measures.  Any one can develop a quality measure, but it's usually groups like medical specialty associations.   Then, they are reviewed by the National Quality Forum, and if reviewed favorably (by an academic committee), they are incorporated in a library of measures at NQF.   Health plans (including Medicare) can then cherry pick their most valued measures and use them in the payor-provider relationship.   Technically, Medicare can make up its own measures, but Congress instructs Medicare to use publicly validated and curated measures whenever feasible, to help be sure that the provider measurements used by Kentucky Medicaid, Florida BCBS, Medicare, and Cigna might all be the same, drawn from a common library.

CMS SEP-1 Measure (NQF 0500 Measure)

One somewhat controversial measure is CMS measure "SEP-1," also known as NQF Measure 0500.   It's one of the only chart-based hospital measures still used by CMS.  Sepsis early management and rapid intervention is enormously important, while specifics of SEP-1 have been criticized by some major bodies (like the infectious disease association, IDSA).    In early comments to NQF, the AMA recommended that SEP-1 not be continued in its present form.  

SEP-1 (0500) is unusual in that it is curated by Henry Ford Hospital, not by a body like IDSA, AMA, etc.   I'm not sure what it means, but Henry Ford Hospital itself receives a low ranking on SEP-1 performance.  (My original blog here; I saw the same data recently and it only changes incrementally.  Currently HFH is at 41%, national average 60%, scale to 100%.) 

A simple search of SEP-1 as a title word in PubMed lists about 35 titles (simple list here).  As a chart-based measure, the accuracy (or consistency) of measurement has been critiqued, with a low correlation value (kappa between two raters, only .4) (here).  Barbash et al. 2021 found low impact of SEP-1 implementation in one health system (here.)   IDSA's position paper on SEP-1 improvements is here.  See a pair of 2021 Op Ed's, by Harvard's Jeremy Faust here and Harvard's Michael Klompas here.

Important organizations like Sepsis Alliance are urging the re-endorsement of SEP-1 and providing detailed rationales, here.  They provide a range of impressive educational materials about sepsis (here).

NQF Agenda Pages for SEP-1 Review

NQF last reviewed SEP-1 in 2017, where it "passed" (remains in the library) but the votes on different aspects of SEP-1 were heavily split.

See the Summer 2021 NQF agenda pages here:

On this home page, see measure under review 0500, Severe sepsis and septic shock.  The current status (2017) is "endorsed."  There is a Zip file on this home page with several documents, a few from 2017, others from 2021.   

But see also:  The tabs at the top, which link to Events and additional Materials.   Spring 2021 measures will be discussed at an Event on June 24 (also June 25).  Comments are open here, until September 9.  There will be a "post comment web meeting" on 13 October.  SEP-1 (0500) is filed under Patient Safety measures, so the Patient Safety committee will be in charge of discussion and voting.

I don't have an opinion here, but it seems to me the committee may want to focus not so much on the original trials 10+ years ago, which have a substantial secondary "critique" and "pro/con" literature, but on the years of implementation data that SEP-1 has an active hospital measure.  


For a 2020 blog on Congressional report language regarding SEP-1, here.

Thursday, June 17, 2021

Preparing for MolDx Tech Assessment: Pre-Analytical Validity & Transport

Labs are sometimes surprised by the depth and detail of technical documents required by MolDx, the special Medicare lab policy program that is active in 28 states and 4 MACs.   One area that can generate questions from MolDx is sample handling.  

One easy entry point is a new review article by Pierre & Wiencek (at Vanderbilt) in the AACC's publication Clinical Laboratory News.  Find it here.

While you're there, you might enjoy an adjacent article on "beyond COVID testing," on uses of equipment and skills now that we've passed the COVID peak.  Here.

Tuesday, June 15, 2021

MedPAC Releases June Report to Congress; Chapter on PAMA, Lab Pricing

In December 2019 - pre COVID - Congress passed a law that included a delay of the CMS PAMA lab pricing process, while asking the advisory body MEDPAC to look into Medicare's implementation of PAMA law.   MEDPAC flagged some of its early PAMA findings in a PowerPoint presentation to its advisory committee this past April 2.

The MEDPAC PAMA report was due by June 2021, and it's out.  It's part of a bundle of different reports and topics, totaling 403 pp, 40 pp of which are about PAMA and lab pricing.

  • See the full report (403pp) here.  
    • It's a big locked PDF, so you can't note or highlight.  
    • I've put an editable PDF of Chapter 9, the PAMA report, in the cloud, here.
    • You can also get MEDPAC's locked version of Chapter 9 here.
MEDPAC reports that:
  • CMS markedly undersampled hospital and physician labs.
  • CMS and physician labs both were paid substantially more for lab tests than independent labs.
  • If CMS sampled all labs, PAMA prices would rise, but not drastically, since independent labs are such a large market and the median price is fairly robust to sampling changes.
  • MEDPAC is concerned that some innovative high cost labs may have high pricing power with commercial payers.
  • MEDPAC considers possible survey-based methods, based on work by RTI consultancy. [*] 

To my eye, MEDPAC understates the fact that a huge part of the growth of "expensive tests" in 2018, 2019, was due to what the DOJ has alleged are fraudulent claims under Operation Double Helix, which DOJ says tallied $2B in charges, thus swamping out the normal industry for genomic tests.

MEDPAC inserts several pages on the profitability of COVID tests for large suppliers.

Taken as a whole, the 403-page report covers many topics and is summarized in a MEDPAC press release, here.

In its April committee presentation, MEDPAC staff suggested that CMS or Congress consider banning telemedicine genetic test orders.  It was also mentioned in a different context, the March report on telehealth.   That isn't mentioned in the June report today.


[*] MEDPAC states in Chapter 9 p.315 that the full RTI report is on the MEDPAC master website, but I didn't find it yet.

Friday, June 11, 2021

Medicare's Somewhat Confusing Path to Liquid Biopsy Coverage: A Brief Recap

There's a huge amount of news every week about liquid biopsy in cancer management - even more this week, with the bonanza of reports at ASCO.  Here, here.

Medicare's coverage is a little confusing, so I'll briefly recap here.

National Coverage

CDx and Hereditary Risk (FDA).  Medicare has a national coverage decision NCD 90.2 governing the use of FDA approved or cleared NGS tests in cancer - both companion diagnostic tests and hereditary risk management.   This NCD covers the use of NGS tests as companion diagnostic, among them CDx liquid biopsy tests, on a rolling basis as they are approved by FDA.  

Currently the FDA CDx liquid biopsy tests covered under NCD 90.2 are the Foundation and the Guardant PMA LBx NGS tests.   The FMI test is 0239U, the Guardant test 0242U.

Screening for CRC.  Separately, CMS has a national coverage decision for liquid biopsy screening tests for colorectal cancer, IF they meet sensitivity and specificity standards already set by CMS.    Several such tests for CRC screening will likely be approved by FDA in the next several years, and in essence, the CMS NCD coverage is "pre written" or "pre fab" awaiting them.  See the CRC NCD, 210.3, version 6.  See an implementation guide from CMS, here, here.

Local Coverage

MolDx: CRC Management.  In 2019, MolDx promulgated an LCD covering the use of the Natera Signatera test in colorectal cancer management.   This was proposed as DL38290, with Signatera as the name-brand test in the LCD title. It was finalized as L38290, which removed "Signatera" from the LCD title, and focuses on the Signatera test but is not specific to that test alone.  The original proposal is still online here.  The final version is here.    This is MolDx's current active LBx MRD coverage.

L38290 or an identical version with a different code number is active at three different MolDx MACs - WPS, CGS, Palmetto.   Quirkily, and in contrast, the fourth MAC, the one Natera actually bills to, Noridian, covers the test by an "article" that recapitulates the text of the MolDx LCD used elsewhere.  See article A58449.

MolDx: Pan-Cancer Management.  Since last August, MolDx has a new and broader liquid biopsy LCD under review, DL38779.   This will (A) have coverage for most all kinds of cancers (both solid tumors and hematopoietic cancers) and (B) cover two major intended uses, recurrence monitoring (such as after colectomy) and determining therapy response.  It should be finalized by August 2021.  See the "four-square" table immediately below.


click to enlarge
Pricing for MRD/LBx

Palmetto MolDx run a branded website that is separate from the main MAC website, the Diagnostics Exchange.   Here you can often find locally-set test pricing information. 

For Natera, there are three pricing levels for different configurations of Signatera.  
    • $5897
  • EXOME TEST AND PLASMA TEST (no remark on bundle, so presume 1 exome, 1 design, 1 plasma test)
    • $3878
    • $3177
    • (Patient has a previous exome test from somewhere used to design the bundle 4 test plasma test)
Running the Numbers

If you assume the values of the different components are linear  you can impute or interpolate internal values.

The MolDx public prices and descriptors translate into a table without using any new math:

From the table above, it looks like the exome is valued at $2720.   This is because exome and four plasma tests (top row) are $5897, but the four tests without the exome (bottom row) are $3177.   We can illustrate it like this:

In the box above, note from the bottom row that 4 plasma tests w/o any exome test are $3,177.  This suggests a price per test of $794.

Moving on, now let's look at the other white box.  The exome and four tests is $5897 (top row), but the exome and 1 test is $3878 (second row.)  This suggests the value of the 2nd/3rd/4th test might be $2019.   We can illustrate it like this:

So - if the MolDx pricing was linear, and we don't know that - we would end up with this table:

We know that the $2,019 represents 3 tests, so if we divide by three we get $673.

There's just one box we haven't addressed.   If we assume the first column is valued at $2720, and the third column is valued at $2019, and all three columns add up to $5897, then the middle column - what we're calling "first plasma test" - can be gapfilled at $1158 ($5897-$2019-$2720 = $1158).  Shown next:

Again, and I got a couple calls and emails, this is only doing the third-grade arithmetic with the information that we read about different test versions and different prices that MolDx has posted publicly.  MolDx gives you a price for exome and four tests; and a price for exome and one test; and a price for four tests, but no exome.   That gives you the rows and columns of the table.  Arithmetic gives you the numbers shown, but it doesn't guarantee the MolDx pricing ever thought about it this way.


For a large new paper on CRC MRD, see Chen et al. 2021 (here).

Thursday, June 10, 2021

CMS to Hold Town Hall June 16, 2021, on RVU System Reform

Update.  I wasn't able to attend but a colleague sent me a link to a 148-page RVU report from RAND that is currently uploaded at CMS.   Here.

This goes into much more detail than the 13-page white paper from RAND that I had linked in my original blog, below, on this topic.  One theme I picked up in the 148-page version, they note (15) that attributing "practice expenses" has become far more difficult as practices consolidate into large multi-tiered corporate entities.   The original "practice expense" input (like doctor hiring nurse time and paying rent) was designed to match up best to a Dr. Welby-type solo practice office.  


I'm very pleased when CMS holds a town hall on an important policy topic.  I recall they held a full-day town hall on CMS and opioid abuse issues, several years ago, and the range of stakeholder engagement and quality input was very high (August 2018, here.)  I've often felt that CMS should hold a similar robust town hall on how we should be approaching sepsis quality measures and how we can build on what worked and didn't work in past efforts.

CMS will hold a town hall, spearheaded by RAND, on Wednesday, June 16, 2021, from 1-4 pm ET.  The topic of updating and revising the RVU system.

They write, "CMS hasn’t changed the data and methodology for practice expense payments under the Medicare Physician Fee Schedule for over a decade. The RAND Corporation is researching approaches to collect new data, along with potential changes to the current allocation system for us."

They add three goals, (1) how to collect new data going forward, (2) how to manage data by specialty (including when costs are similar or dissimilar), and (3) how to refine the current rate-setting system.

  • The news and events webpage is here, scroll down for "Town Hall - June 16".
    • There's another entry point here.
  • You'll find a separate registration page link (here).
  • There's a 13 page agenda online here.  The agenda is like a white paper on the current RVU system.  See also 39 pages of presentation slides here.  The slides appear to closely track the document.
    • I've put an archival copy of the PDF agenda and slides in a cloud file; see links at bottom of blog.
    • There's an email box to submit comments until June 14.
  • CMS will take later comments as well, until June 23.  Base your comments on the 13 page agenda.
If you like RVUs, you'll love the deeply researched, 300 page, 2016 book on the topic by Prof.  Miriam Laugesen of Columbia University.  Find "Fixing Medical Prices" here.

See The Video!

I've done a 3-minute video about the workshop - here.



Cloud copy of PDF agenda: 

Copy of slides:

See a February 2021 Radiology article about AI in radiology codes,

See CR12071, December 2020, where the closing paragraphs discuss aligning old rules to new AI technologies.

ADUHELM and Apo E4: The Other Biomarker?

This week, the FDA approved aducanumab (ADUHELM), a monoclonal antibody which is the first drug approved by the FDA for its ability to reduce plaque burden in Alzheimer's Disease (this and other biomarker-based approvals are generally "accelerated approvals.")  Find a range of links here.

The labeling is very broad - "indicated for the treatment of Alzheimer's disease" without explicit biomarker, age, or severity classifications.  Since all ADUHELM clinical study patients were PET-scan positive for beta-amyloid, insurers might require that for drug therapy.   Alternatively, there is a CSF amyloid test under FDA review (press releases from Fujirebio), although there's no mention of that in the FDA labeling.

There's one other biomarker that has garnered less media this week - Apo E4.   ADU studies consistently found that patients who were ApoE4-positive, a minority of the natural population, were twice as likely to develop ARIA (drug-induced brain changes.).   And in some of the studies, ApoE4-status was used to set initial dose of drug for safety reasons.   

Generally, Medicare contractors have a block against testing ApoE4 status,[*] and the usage in the Medicare population has been very low [**].   I haven't seen any discussion of whether ApoE4 status will be considered a standard of care for an Alzheimer evaluation when ADUHELM therapy is one of the central considerations.

Most private payers block ApoE4 payments, according to an April 2021 study of payer policies here.

* Copy of ApoE article here.   ApoE genetics and CSF Tau studies are mentioned in labeling; FDA is known to be reviewing some CSF AMY tests.

** ApoE4 (2*, 3*, 4*) is a Tier 2 code (81401) suggesting it is so low in clinical frequency that it has never been elevate to a Tier 1 code.