Wednesday, March 20, 2019

How CMS Handles the CPT Block-Retrieval and Laser Dissection Codes That Precede Tumor Genomics

This past week, someone asked how the CPT codes for retrieving a paraffin block (88363) and laser dissection of a block (88380) differed, and how Medicare handled them.

It was a more interesting question than I expected.  It's also interesting to compare how Medicare handles 88363 (it pays it) versus another CPT code, 0502T, which is for data preparation and transmission of a cardiac CT scan for advanced digital fraction flow reserve analysis (the Silicon Valley cardiac company HeartFlow; see 0501T-0504T.  More here.)

  • 88363   Examination and selection of retrieved archival (ie, previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis)

This code is billable global-only (not as professional and technical component).  In an independent lab, Medicare pays $24.15.   If the physician doing this is in a facility, Medicare pays him/her $20.54.  The code dates to 2011.  It has a very long RUC rationale (AMA subscription database RBRVS DataManager.)  The RUC surveyed it and noted it had lower value than an intraoperative consult (frozen section).  They ended up with .37 Work RVUs for 17 minutes of not super intense MD time.  There are six minutes for a lab technician, and 6 minutes of capital equipment microscope use for 19 cents.

The code was used 18,494 times in Part B in 2012, rising to 26,343 times in Part B in 2017 (about $600,000).  93% of the time it was billed by a pathologist, but 6% of the time directly by a lab (e.g. the lab's NPI).   62% of locations were hospital, 16% office, 9% independent lab.  The main diagnosis codes were breast (20%), followed by lung, prostate, and colon (at 16%, 10%, 7%). 

The physician personal work vignette is:  After verifying that the patient has tissue samples in the pathology archives, the pathologist reviews the reports and examines the slides and blocks from the relevant specimens to determine which has the richest and most representative area of non-necrotic tumor for KRAS analysis, such to be sent to an appropriate reference testing laboratory.  The service does not include the molecular diagnostic interpretation or microdissection.  The physician (pathologist) will document the review of the pertinent pathology reports and slides and selection of the appropriate material for submission.

There don't seem to be any LCDs or Articles about 88363.

Hospital Outpatient Handling of 88363

88363 has status indicator Q1, and APC placement 5731 ($17).*   Q1 means it is payable unless it is billed together with a status code S, T, V, or X... in which case it is bundled and no separate payment.  I would imagine there could be circumstances where pulling the block was the only service for that patient that day.

Why Did I Bother?  88363 for Pulling Block vs 0502T for Pulling Radiology

The interesting thing is to compare the handling of 88363 to 0502T, the latter for pulling imaging information from an archive and transmitting it.   0502T has status code "N" meaning never paid in the hospital outpatient setting.  It's bundled with any underlying service, even if not on the same claim.  Score in the APC Arena: Pathology 1, Radiology 0.

In Part B, it looks like 0502T is "contractor priced," not Status N, so it could be payable in an independent facility.

  • 88380   Microdissection (ie, sample preparation of microscopically identified target); laser capture

This code can be broken into global, professional, and technical components.  In an independent setting, it pays $136.   For a physician working in an institution, he gets $57.  The code dates to 2015.  It's timed for 33 minutes of physician work.  While under review, the inputs change, rising to as many as 11 slides.  They're cut, but not stained. Technician time is 72 minutes.  Supplies and capital costs are minor (slides, alcohol, microtome).  But a capital equipment Veritas microdissector is $195,000 with a 7 year life, used for 37 minutes for $22.

Don't look for much use of this code.  It had 163 uses in 2017, down from 254 uses in 2014.  That's a paltry total of $23,000.  64% of uses were in an independent laboratory.

The physician personal work vignette is:  A review of a serial slides shows tiny clusters of cancer cells interspersed among numerous lymphocytes. The tumor and normal cells are almost inseparable. All the blank slides are stained with a DNA-compatible stain. The pathologist performs laser capture microdissection of multiple high power fields to obtain an adequate number of cells for DNA sequencing. Typically over 2,000 cells are microdissected for each assay.

  • 88381  Microdissection (ie, sample preparation of microscopically identified target); manual dissection

This code is for manual dissection, e.g. not using a laser.  It actually pays somewhat more, $156.

The work vignette shows that the pathologist circles the tumor and a technologist dissects it:  Following comparison with adjacent stained sections from the same tissue block, areas of adenocarcinoma tumor cells in the background of normal lung cellular parenchyma and inflammation are microscopically identified and marked by the pathologist. The pathologist counts a representative sample of tumor and non-neoplastic cells in the circled area to estimate the proportion of tumor cells in the microdissected area. The tumor cells are manually obtained from all the marked areas for DNA extraction (by the technologist) and analysis for EGFR mutations.

Only 20, not 33, minutes of MD work are used.  But technician work rises to 106 minutes.

For 88381, utilization was 19,222 in CY2017 in Part B.  That's about $3M.  73% of services are in an independent lab, 27% in physician office.

MAC Policy for 88380, 88381

Only one MAC showed up on a keyword based article search, FCSO.  It remarks in LCD L34510:  "Any procedures required prior to cell lysis (e.g., microdissection [CPT codes 88380 and 88381]) should be reported separately and utilization must be clearly supported based on the application and clinical utility. Such claims may be subject to prepayment medical review."

While one could argue a laser isn't always necessary, simply pulling a block and cutting unstained slides in order to do FFPE NGS surely is always necessary, so use of code 88381 should be pretty safe, at least to my reading.

Hospital Outpatient Handling of 88380, 88381

Easy - zilch.  Both 88380, 88381 are bundled services and N = Never paid in hospital outpatient settings (to the hospital's APC).


I've heard a CMS MAC medical director say that he/she didn't usually expect to say the laser dissection code billed (88380) because usually you can just circle the tumor and pick blocks that way for unstained slides for sequencing.   Well, yes, fair enough, but manual dissection actually pays more than laser dissection - $156 (88381) vs $136 (88380), so you are just chasing people away from a $136 code and into a $156 code.

Hospital outpatient summary.   In this article, we've reviewed four codes - 0502T and 88363 for pulling things (imaging and blocks, respectively), and  88380/88381 for dissection.  Of the four codes, only 88363 for "pulling blocks from an archive" has payable status in the APC setting.


Note: This article reflects my best knowledge working from AMA, CMS databases, but you need to make any coding research and decisions for your own lab.

* APC 5731 is "Level 1 Minor Procedures."

Tuesday, March 19, 2019

CMS Releases 2020 Budget Plans (350pp)

With much media pro and con, the President released a CY2020 budget plan a week ago - e.g. comment here, document here.

With less media, HHS has now released an annual CMS budget and strategic plan of 321 pages.  Here.

321 pages

Org Chart; page 4 of 321 pages; click to enlarge
The keynote paragraph is interesting:
This performance budget reflects CMS's vision by investing in our people, processes, structure, and capabilities. The budget will support initiatives to transform Medicare into an affordable, patient-driven program that encourages innovation and competition. The budget supports tools that permit patient control and provider sharing of secure healthcare data, allowing for better coordination of care and less duplication. Additionally, CMS is proposing to further modernize our programs, address the increasing role of technology in seniors' lives, keep their data safe, and upgrade key information technology systems. 
Recall that in early March 2019 CMS hired its first "Chief Healthcare Informatics Officer" - Dr. Mark Roche, formerly of Northwestern University and NIH - here.

Bingo: Recyling the Eternal Reference to Now Ending Pay-and-Chase

They refer to the problem of pay-and-chase (paying for fraud, then chasing it with court cases to get the money back later) on page 2.  And again on page 124.  CMS is always transitioning "away from pay-and-chase."  It's been the same statement every year for decades.

Congressional Requests for Reports

Each summer Congress issues budget documents which include numerous requests for reports.  CMS generally responds in this Spring document.   CMS addresses quite a few of these in responses from page 211 ff.  This can take the form of a call-and-response, as in these examples:
  • Hill: The Committee is concerned about the dramatic increase of pharmacy direct and indirect remuneration [DIR] fees in Medicare Part D, especially the impact of ‘‘pharmacy DIR fees’’ on Medicare Part D beneficiaries who incur high drug costs....
  •     CMS:  In the 2019 Part D proposed rule, published on November 28, 2017, CMS included a Request  for Information (RFI) regarding the application of manufacturer drug rebates and prices concessions to drug prices at the point of sale....On November 30, 2018, CMS published the Modernizing Part D and Medicare Advantage to Lower Drug Prices Proposed Rule....
  • Hill:  Hospital-Acquired Pressure Ulcers - The Committee is aware of recent data from CMS identifying that pressure ulcer discharges have significantly increased...
  •     CMS:  We agree that pressure ulcers are a critical area to address...The Patient Safety 90 Measure...One of the components is pressure ulcer rates...

What's Not There - IPI

One of the highest visibility proposals, in October 2018, was an International Price Indexing Model for Part B drug prices proposed by Pres. Trump in a press conference person at HHS.  (Here).  While this was only a notice that there could be future rulemaking (based on CMMI authorities), essentially a glorified Request for Information, to my eye the IPI idea doesn't even get mentioned anywhere in the 321 pages of CMS proposals and activities.

Very Brief Blog: Robust Range of New Code Proposals for May 2019 CPT Meeting

There are 56 agenda items now released for the May 2019 AMA CPT meeting in Chicago.   (Note that lab codes were released, and had a comment period, a few weeks ago, here.)
  • See the full line-up of agenda items online at AMA, here.   
Comment on Pending CPT Codes

Stakeholders can request the proposal packet from AMA and then submit comments on it, through April 25 (request to review and comment must be made by April 18).  AMA will review that the commenter has a director interest in the application before releasing it for review.

Cornucopia of Code Proposals

56 agenda items cover a lot of ground.  These range from revised chronic care management codes, to "non face to face review of lab tests," to new codes for superficial radiotherapy, to revised codes for percutaneous ventricular assist devices.  A new code is proposed for transrectal prostate ultrasound ablation, and a range of Cat III codes, such as for "digital questionnaires," for "health coaching," "Tai Chi," and "Meditation Stress Reduction."   Revised instructions are proposed for Mod 51 and Bilateral Procedures.

Precision Medicine Consultancy DIACEUTICS Plans $70M IPO

The precision medicine consultancy DIACEUTICS, which raised about $5M last year from WhiteRock Capital, has announced plans for a $70M IPO on the London Stock Exchange.

The firm announced that it believes the addressable market for its consulting services is $2.5B (by 2023).  The business currently has annual revenue circa $15M. 

  • See a 2018 press release on the earlier WhiteRock Capital funding, here.
  • See press releases and trade press about the 2019 IPO here, here, here, here, here.
I've had the chance to present on CMS precision medicine trends at Diaceutics conferences several times.  Diaceutics was founded in 2005 by Peter and Ryan Keeling.

I've understood the firm was founded in Northern Ireland.  Trade press lists its headquarters in Dunkalk, Ireland, north of Dublin and just on the south side of what will soon become an E.U. border after Brexit.   


18 months ago, in November 2017, global consultancy Navigant acquired SF-based precision medicine and pharmacoeconomnics consultancy Quorum Consulting for an undiscovered amount.

Monday, March 18, 2019

Very Brief Blog: PAC CARB Holds Sudden Meeting on Hospital Antibiotic Stewardship

Sepsis and antibiotic resistance are two keynote themes of the current administration, HHS, CDC, FDA.    I had the chance to write a blog collating a lot of recent online resources, here.

New update.  PAC CARB - the President's Advisory Commission on Combating Antibiotic Resistance - has announced a special pop up meeting all about CMS.

  • The special meeting will be April 8, 2019; website here.   

Almost three years ago, CMS proposed that hospitals serving Medicare would have to have formal permanent Antibiotic Stewardship Programs - ASP's.   That rule was never finalized, though, and it will automatically sunset in June 2019.   PAC CARB has heard from some stakeholders that the CMS ASP program should be a national health priority.  On April 8, it will discuss whether to throw PAC CARB's prestige and weight behind a memo to HHS Secretary Alex Azar, which would ask him to require CMS to formalize its ASP policy. 

Very Brief Blog: MEDPAC Proposes Revamp, Simplification of Inpatient Measures

Last week MedPAC released its 530-page annual March Report to Congress and the public on CMS payment policy.    See press release here, full report here.

Let's draw attention to a special chapter proposing to radically simplify Medicare's inpatient hospital metrics

Four programs would be rolled into one.   Unlike MIPS - the physician metric "simplification" that mostly just wrapped a lot of tape around the diverse existing programs - this inpatient program rolls up existing measures, rewards, and penalties, but also proposes a great deal of simplification as well. 

Go straight to the inpatient measures chapter here.    I think this will have a lot of influence because it's so well aligned with what CMS/HHS wants to do anyway.   Recall that CMS spent last April's inpatient rulemaking in throwing overboard a lot of measures and creating few if any new ones.

click to enlarge

Friday, March 15, 2019

Very Very Very Brief Blog: Theranos HBO Documentary Gets Theatrical Run

Very very brief blog...This week, there is a Theranos documentary on ABC and another on HBO.  Here.

The HBO documentary is also getting a theatrical run in Los Angeles.   Typically, a week or two in theaters is the minimum for potential nomination for Academy Awards.

For a discussion in LA Times, here.

HBO Also Books New York Run

INVENTOR opens in New York as well, on Friday March 22 at Cinema Village.

Theranos's Sales Claims vs Public Medicare Data

According to the CMS provider database, Theranos' NPI was 1548546401, and 2014 allowed charges were $17,658.   2015 was $131,540 and 2016 was $0.   (The October 2015 WSj article led pretty quickly to cancelling their CLIA licence.) 

One of the documentaries - either the ABC one or the HBO one - comments that in 2014 or 2015 Theranos' asserted its revenue was "$1 billion."  That total would be very unlikely, if your public Medicare lab revenue was $10,000-$100,000.  And finding your public Medicare revenue doesn't take a Pulitzer level journalist or the world's smartest investor.   Would have been a fine moment if Holmes on stage had been asked how her all-payer lab revenue could be "$1B" if her CMS revenue was $10,000.  See CMS files in Excel, here.

Ironically, the fourth-most common lab payment from CMS to Theranos was "Insertion of needle into vein."  The most common test was chem panel 80053, CBC 85025, and basic lipids 80061, followed by TSH 84443.

Although CMS paid for about 14,000 total tests, none were the herpes test that was the only FDA cleared test on the Edison.

Neither Holmes nor Balwani appeared to be excluded from Medicare as of 3/2019 (here).

THE INVENTOR had a favorable, front-page review on the Los Angeles Times entertainment section for  Friday March 15.    "A Fraudulent Tech Wizard's Fall."  That said, it's playing in one fifty-seat fourplex, and I saw in an audience of 8.

Three Suprisingly Independent Problems at Theranos

What I extracted from the documentaries was that there were three independent problems at Theranos.  (1) The Edison device didn't work.   (2) Separate from that, when they started running an industry platform based CLIA lab for clin chem, they couldn't do it right.   (3) Separate from that, they allegedly claimed to investors their revenue was very high - hundreds of millions or a billion, if I remember correctly from the documentaries and SEC and investor lawsuit news stories - when it wasn't.  Even without the first two problems, that independent third problem would have caught up with them very badly as soon as they required funding with more closely audited financials or an IPO with back-year financials. 

Thursday, March 14, 2019

Very Brief Blog: There are Two (not One) Documentaries about Theranos

See my earlier blog for some links to a podcast documentary, and an HBO documentary, on Theranos.  Here.

New-news.  There is ALSO a second independent TV documentary about Theranos, called THE DROPOUT, which will air on ABC on Friday, March 15.   (The HBO documentary premieres on March 18).   Both the prior podcast documentary and the newly announced documentary are named DROPOUT and related to ABC.

See articles here and here and here about the ABC film DROPOUT.

Billboards for the HBO film INVENTOR have spread around Los Angeles:


There are also still occasional newsbits suggesting a biodrama movie about Elizabeth Holmes is still in preparation.  Hard to be sure.

Wednesday, March 13, 2019

Two (or Seven) Major Anomalies in the CMS NCD for NGS Cancer Tests

A week back, I wrote a white paper on the current brouhaha about a CMS NCD that impacts prior LCDs regarding genetic tests that are used in the management of cancer patients. 

There are a few major anomalies that turned up in my white paper research, which I capture here in two figures.

First, Insertion of Novel Non-Coverage Text

The March 2018 NCD did not contain a full section of non-coverage language that appears in the November 2018 "transmittal" of the decision.

OK, sit back in your chair.  Here's what occurred.

Whereas the NCD coverage of the section is the same, and the LCD coverage section is the same, a new section documents "non-coverage."   I realize that CMS may feel it can impute or imply the non-coverage from the decisional part of the NCD.  However, if the NCD was originally clear and could only be interpreted one way anyway, why add new language?  If the NCD was ambiguous (as many would argue), is it fair to add a one-way interpretation so late?   I and many others have noted that the original NCD contained some crystal clear language that narowed its own scope to the material and rationale discussed and reviewed.  See a sentence stating that the NCD did not extend to all types of NGS testing, but only applied to testing for targeted therapies (e.g. combination diagnostics).*  That was clear enough for me...  Made good sense.

To visualize what happened, see a comparison of the March 2018 version and the November 2018 version, below.  (Click to enlarge; but see white paper for a full-size version).

click to enlarge; see also white paper

Second, Completely Skipping NCD Process Requirements in Statute

You can call this one major anomaly or you can tally about six different missed steps, as shown in the figure below.

Statute has stringent requirements that CMS must present the public with a full rationale for its decision, all data sources, respond to comments, etc. 

As I show below, the NCD doesn't provide any rationale for exclusion (the new interpretation at CMS and MACs) of NGS testing outside targeted therapies.  It doesn't present the public with any such decision resources.  (In fact,  it states explicitly that things such as NCCN germline cancer guideline are out of scope).  There were point blank comments about whether the NCD blocks germline testing, not directly responded to anywhere in the NCD Q&A.

Finally, the key word searches and bibliography excluded germline references.  (In part, if course, the germline medical necessity literature was well-developed under Sanger sequencing, so it isn't fully replicated merely because the lab method switched to NGS.  A BRCA founder mutation like the frameshift mutation 185delAG is the same under any sequencing (or PCR) method.)  In short, there is severe inconsistency between the body of the NCD and the decisional part, and even the Supreme Court reads documents as a whole in order to find a decision that makes sense and avoid conclusions that are absurd.  A final, and conscious, conclusion that PCR or Sanger sequence mutations in the same patient, same time, same purpose, are medically necessary, but an NGS report of that mutation is medically unnecessary - is absurd.  It is like saying that a contract means one thing if written in Arial, but comes to mean the opposite if written in Times Roman.

click to enlarge
The statute 1862(a) shown in the small box, and reflected in the table above, is here:
In making a national coverage determination (as defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure consistent with subsection (l) that the public is afforded notice and opportunity to comment prior to implementation by the Secretary of the determination; meetings of advisory committees with respect to the determination are made on the record; in making the determination, the Secretary has considered applicable information (including clinical experience and medical, technical, and scientific evidence) with respect to the subject matter of the determination; and in the determination, provide a clear statement of the basis for the determination (including responses to comments received from the public), the assumptions underlying that basis, and make available to the public the data considered in making the determination.
These rules were met for tumor testing ("YES") but not for germline testing ("NO!").

CMS might argue that the "decisional" part of the NCD survives point-blank contradictions in the actual reasoning and explanatory section.  But slow down.  There are many examples from CMS itself where regulations per se can only be understood with reference to provided explanatory language or implementation policies.  Also, interpretation should never lead to absurdity when other options are at hand.

What Entities Joined the Sign-On Letter to CMS, re the NGS NCD?

On January 31, 2019, some sixty entities joined a sign-on letter raising concerns that CMS was unexpectedly moving to block all uses of next generation sequencing in inherited cancers, removing coverage provided by local coverage decisions in all states.   The local coverage has been consistent with ASCO, NCCN, and other cancer patient management guidelines.  The coverage was also consistent with clinical practice both in community settings and in academic centers.

  • See story at Genomeweb here, article at STAT here.  
  • See the actual sign on letter here, and press release about it here.

I've attempted to generally categorize the signers, although my listing may not be perfect.  I separate organizations that are primarily patient disease associations at left.  Then, I've listed clinician associations (like ASCO and AMA) outside the lab profession.  Next are direct care entities (e.g. Columbia University).  The two right columns are for associations in the lab industry and its professionals, and finally actual lab entities or industry entities.

click to enlarge
For my white paper on the issue, here.

For an even newer ACLA press release on guideline-based cancer genetics, here.

CMS Tries to Make PAMA Simple: New Educational Materials 1Q2019

CMS has posted several new educational documents to help labs understand whether they will need to report 1H2019 private payer payments, when the reporting period opens in 1Q2020.

See the somewhat cluttered PAMA page at CMS here.  (Enter at your own risk).

See some specific materials from a January 22, 2019 town hall call here.  (Includes deck and a full transcript, and an audio file you can download to replay over and over).

  • See a summary of the rules updated as of February 27, 2019: here.
  • See a 25-page revised information set, also revised February 27, 2019:  here.
  • Finally, completing the February 27, 2019, trifecta, see a 14 page Q&A on PAMA, here.

I am not a card-carrying PAMA expert, but it looks to me like we are switching from essentially no hospital labs reporting in 2017, to large numbers of hospital labs reporting in 2020. 

Why?  In 2017, a hospital lab had to bill Medicare under its own NPI to be a reporting entity.  This was very rare.

Next year, hospital labs have pretty simple standards for becoming a reporting lab.  They have to bill Medicare (at least $1) on a 1450 outpatient form for a Medicare non-patient (meaning the hospital lab is providing tests for other than registered inpatients and outpatients).   Then, based on 1450 forms, the lab has to get more than 50% of its revenues from Medicare Part B (PFS/CLFS).   This either goes to one extreme or the other.  If you view the NPI as the collecting entity, then the hospital NPI probably gets more revenue from the Outpatient APC system on 1450 forms, than it gets from B (CLFS/PFS).   However, if you view the lab as the collecting entity, or you look only at 1450 collections for "non patients," 100% of its revenue will be from CLFS/PFS on its 1450 forms since there is no APC revenue for "non patients."   CMS itself notes that the latter will be the case (page 7 of the Summary document).  Also, CMS notes that it is not all 1450 forms, but 14X 1450 claims (nonpatients) and not 13X 1450 claims (outpatients).

Finally, the entity must get at least $12,500 from the CLFS in the six-month collection window, or about 1,000 $12 lab tests.

Once a hospital lab is reporting, it reports lab test prices for its (non-Medicare) non-patients, see Q&A, Q3.22, Q3.23, Q3.24.   However (!) if the lab does bill on its own NPI (which is rare), and it acquisitions labs from both outpatients and non patients, then it reports both (Q.25).

An interesting note is that hospitals should combine outreach laboratories for calculations, if it has more than one (Q3.8).  For example, if it had two outreach labs that both bill Medicare for $8,000, together they met the $12,500 line.

Not specific to hospitals, CMS confirms that if a lab test is initially paid during the data period (say, $20) and is appealed and paid more after the reporting period (say, $40), then that claim is not reported at all, since the final payment is not within the reporting period.  CMS also reconfirms that unlisted code payments are not reportable. 

Belated Blog: New Path Codes for May 2019 CPT Meeting - Some Interesting Proposals

AMA CPT took code applications in mid-February for its mid-May meeting. 

They very rapidly post the proposed Pathology/Lab codes for public comment.  Unfortunately, that pathology comment period was so rapid it had a deadline of March 8 (for requesting a code packet to comment on) and March 15 (for submitting said comment to AMA). 

This is because lab codes are reviewed by some internal early subcommittees, long before the May meeting.  The regular CPT applications (outside the lab codes) are not even posted yet - they will go up March 16 - and they have a more leisurely comment schedule, to April 26.

With that apology, here is a link to the AMA CPT calendar, and here is a link to the May 9/10 code agenda.   The meeting will be in Chicago.

Most Interesting Proposal

As you read at this PDF link, there is an application, Tab 7, for "non face to face review and MDM (medical decision management) of lab results." 

At first I read this as MTM - medication therapy management - but it's MDM, medical decision management.  However, I suppose MDM includes MTM.

Other Proposals

There are six drug assay applications, mostly monoclonal antibodies (e.g. adalimumab, infliximab).

There are two general cancer codes, one for "genome wide CN SNP array in neoplasia" (Tab 22) and one for "cytogenomic microarray in neoplasia" (Tab 24).  There is a genomic sequencing procedure (aka gene panel aka GSP) application for familial hypercholesterolemia (Tab 25).

There is also a GSP for "Lynch Syndrome," (Tab 26), not sure how that will be different than 81435, existing gene panel for colorectal cancer risk. 

There is a GSP for "solid organ or hematolymphoid neoplasm," not sure how that differs from existing 81445, 81450, 81455.

There are a few MAAA codes, one for a 12-gene breast cancer recurrence score (Tab 28; I am guessing Myriad EndoPredict) and one for prostate cancer metastasis risk (Tab 29).

For a few additional lab codes see PDF linked above. Check the same link after March 17 to see the full code agenda including non-path codes.


For Panel Actions (accept/reject) from Tucson, CPT February 2019, here.

Tuesday, March 12, 2019

Very Brief Blog: My Two Talks at Molecular Med TRICON, SF

This week in San Francisco, I had the chance to give two talks at the 26th annual, 3500-person Molecular Medicine TriConference (web site here).   (The same organizations hosts the large annual Next Gen Dx conference in August in DC, here.)  Links to decks are at bottom of blog.

On Monday, I was on a panel for Personalized Medicine Coalition discussing external constraints on Medicare.  I discussed four.  (1)  CMS doesn't set prices (doesn't encourage or discourage by pricing), but prices are set by PAMA (at least PAMA takes over after an initial period).   (2)  CMS almost never makes lab codes, but follows what the AMA produces.  For better or worse, CMS initially prices all lab codes coming out of the AMA CPT process, whether CMS uses the codes or understands the particular service.   (3)  In the case of a recent NCD for NGS testing, CMS handcuffs its coverage to FDA decisions.   (4) In the case of preventive services, CMS is tied either to those provided by Congress or those endorsed by USPSTF.  USPSTF has a very slow time cycle (up to 5-10 years) and almost never reviews de novo services.  This is an artificial barrier to investment in preventive services technologies.

On Thursday, I give a talk on recent NCDs and LCDs.  For the NCD, I focus on the CMS NCD for NGS tests in cancer patients, and for LCDs, I briefly profile five very recent MolDx LCDs.  I showed that just three companies (FMI, Exact, Guardant) had variance of about $20B in upward marked cap tied in part to NCD/LCD decisions.

I also have a slide showing 2018 review times once an LCD has undergone public comment - how long til the final LCD is released.  (76-250 days).

click to enlarge
  • (1) Short deck on Constraints on Medicare here.
  • (2) Deck on Recent NCDs and LCDs here.
  • (3) Zip file holding six or seven recent proposed "MolDx" LCDs here.

Saturday, March 9, 2019

Brief Blog: McDermott Law Firm: DHealth White Papers, Blog, Podcasts, Book

The law firm McDermott Will & Emery - named 2018 Health Group of the Year by Law360 - has a cornucopia of thought capital offerings in digital health.  They are aggregated here.
  • See blog series Of Digital Interest here.
  • Get access to two white papers here (email registration).
    • One is on data, 18pp; one is on care coordination & reimbursement, 14pp.
  • See the MWE podcast series, Of Digital Interest, at iTunes or other podcast aggregators
  • See their new digital health legal textbook, "The Law of Digital Health," Broccolo & Mazur ($165) at American Health Law Association:
    • Download executive summary here (scroll down to book section; 8pp).
    • Order the full book or ebook from AHLA here.


For a 2019 UK NHS report on digital health, and other links, here.

Thursday, March 7, 2019

CMS Delays "Implementation" of NGS NCD until April 8, 2018

CMS has updated its "implementation date" for the NCD on NGS testing in cancer patients.   The NCD has triggered a lot of confusion regarding its application to germline testing - see the backstory here.

Confusingly, NCDs are "effective" on the day they are published, but contractors develop "implementation" rules and instructions over months - in this case, over a year.  (See here).

The "effective" date remains March 16, 2018, but the brand new "implementation" date is April 8, 2019.

  • See Transmittal 214 here.

CMS also indicates that it knows stakeholders are confused and upset and it is working on the issue.

Tuesday, March 5, 2019

CMS Oncology Genomics NCD - White Paper March 2019

Here, I'm providing by PDF a 25-page white paper on how the March 2018 CMS NCD for Foundation Medicine turned into a wave of concern among oncology stakeholders in early 2019.

Find the white paper in the cloud here.

Update - on March 6, 2019, CMS delayed "implementation" to April 8, 2019, and CMS remarked it is "sensitive" to concerns of stakeholders. Here.

I've clipped the introductory section below the break.

Sunday, March 3, 2019

Very Brief Blog: Michael Cohen and Novartis; Follow Up 2019. Bonus: Theranos.

Recall that one of the earliest news stories about Michael Cohen was his lucrative consulting contract with the CEO of Novartis.   I joked about the statement of work, at $100,000 a month, which is only a few words long - here (July 2018).

John Carroll of Endpoints has some followup in March 2019, based on Cohen's recent House testimony and Q&A.  Here.

Bonus pic:

Theranos and Elizabeth Holmes - now on billboards in Hollywood in LA.   The HBO documentary premieres on March 18.  Here.

Very Brief Blog: Illumina's Podcast Series on Genomics; and Harvard Precision Medicine podcast

For a number of years, Mendelspod has been issuing multiple interviews each month with leaders in genomics and precision medicine.  Website here.

New to me - Illumina has a podcast series also.  See the home page here; at Apple podcast here.  

Recent topics include a review of Genomics 2018 and an interview on precision healthcare in Estonia and an episode on trends in RNA sequencing.

They have an easily scannable homepage.  Episodes are typically 20-25 minutes.

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Harvard Business School runs a podcast series, Cold Call.   On February 28, 2019, they feature precision medicine progress at Intermountain Healthcare.  See the podcast here, with full transcript available.  Get the $8 Harvard Case Study here.


There's also a Harvard business case about Boston Children's molecular spinout Claritas, 2014 but still germane, here.  It shut in 2018.

Saturday, March 2, 2019

Portfolio of New and Recent Resources: Diagnostics in Sepsis

In the past few weeks, I ran across a range of resources on the importance of diagnostics in sepsis (and infection and antibiotics management), linking to some new policy perspectives and trends.  I provide links here.  Call it a portfolio...a cornucopia...a Pandora's box...a weblink compendium of open resources...

Topics Discussed re: Infectious Disease
  • The Importance of Diagnostics - Ginocchio, CAP Today, 2019
  • PAC CARB, 2019
  • 2020-2025: HHS Five Year Plan for CARB
  • Combating Antibiotic Resistance - Spellberg Book, Articles
  • Importance of Diagnostics - UK Report (O'Neill Report)
  • Importance of Diagnostics - US IDSA
  • Economics of Diagnostics - including BARDA
  • CMS Measures
  • JAMA Review of NGS in Microbiology
  • Costs, Causes of Sepsis
  • Zip file in cloud (open access sources)

Update: President's Advisory Council on Combating Antibiotic Resistance - PAC CARB - to hold special session on April 8, 2018, on whether it should throw its weight and prestige behind formally demanding that HHS should require CMS to finalize a postponed measure regarding hospital antibiotic stewardship requirements.  Here.  

Importance of Diagnostics - Ginocchio, CAP Today, 2019

In an article for CAP Today, Christine Ginocchio PhD (who has a long academic CV, currently at Biomerieux) provides an article titled, "No diagnostics, no stopping antibiotic misuse."   See it here.  Diagnostics can't be the poor stepchild of antibiotics & public health innovation.

PAC-CARB, 2019

Which is also a lead-in to the next topic,

Dr Ginocchio is, to the best of my knowledge, the first industry-based panelist at PAC-CARB, the President's Advisory Committee on Combatting Antibiotic Resistant Bacteria.

See the home page for PAC CAB, here.  It's become very active.

To get a feeling of the scope and value of the PAC CARB meetings, see the full agenda and decks for PAC-CARB's most recently meeting (January 30-31, 2019) are all online here.  (The webcast is also archived).   For some excerpts about T2 Diagnostics' presentation at PAC CARB, here.   PAC CARB has a special pop up meeting April 8 re: CMS seemingly dormant plan to require hospitals to have antibiotic stewardship committees, here.

2020-2025: HHS "Five Year Plan for CARB"

HHS is wrapping up its first five-year national plan to combat CARB (2015-2020).

In August 2018, Secretary Azar of HHS tasked PAC CARB with assisting HHS in creating a new five-year plan for CARB.   Here.

See the home page for the 5-year plan, including the original from 2015 and progress reports.  Here.  One of the arms of the five year plan directly involves improving diagnostics. 

See the 3-year interim review, dated October 2018, here.  Medicare watchers will note the CMS-based activities are pretty thin (see more below.)

Combating Antibiotic Resistance - Spellberg's Book and Articles

See Brad Spellberg's excellent nonfiction book on the global threat of antibiotic-resistant bacteria, "Rising Plague" (Prometheus, 2009; paper and ebook).  See his open access article on antibiotic policy dilemmas, Critical Care, 2014, here.

See also Spellberg's excellent open-access article on the difficulties of organizing strategic responses in hospitals, "How to Pitch an Antibiotic Stewardship Program to the Hospital C-Suite," Open Forum Infect Dis 3:ofw210, 2016, here.

(This free article should be required reading for anyone interested in how hospitals function.)

Importance of Diagnostics #1 - UK NHS, O'Neill Report (2015/2016)

UK has run a national "Review on Antimicrobial Resistance," aka the O'Neill Report. AMR home page here.  (This is cited in Ginocchio, above).

For work products, see the 2016 final UK white paper, which has a section on the importance of advancing diagnostics, here.

See also a special O'Neill commission report that is focused directly on rapid diagnostics, here.

Importance of Diagnostics #2 - IDSA (2013-2018)

In 2015, IDSA released an excellent 20 page white paper on the importance of diagnostics, and the role of LDTs in infectious disease.  Here

See also IDSA public policy paper Caliendo et al., "Better Tests, Better Care: Improved Diagnostics for Infectious Diseases," 2013, here.

See their 2018 IDSA guideline on "Utilization of the Microbiology Laboratory," Miller et al., entry point here, hopefully 94 page full document open access here.

IDSA has a home page for diagnostics policy here.  To reflect its policy positions, IDSA has written FDA and Hill to discourage over-regulation of LDT diagnostics which are vital for emerging infectious diseases, here.  IDSA has raised concerns about CMS infectious disease measures, here.

Economics of Developing New Diagnostics

There is a huge national and world literature on the economic challenges of developing new antibiotics, dis-investment by pharma in antibiotics, etc.  But: there are also substantial challenges to launching new diagnostics for infectious disease.  (See here and here and here for just three of countless possible examples.)

BARDA, the biodefense investments agency, has markedly upgraded its investments in infectious diease diagnostics in CY2018.  See website for BARDA/DRIVe investments in sepsis, here.

For an overview of some new BARDA investments, I highly recommend a trade press review article by Roth, HealthLeaders, February 2019, here.   Here, Roth summarizes the last 5-10 significant innovation investments by BARDA in this field.  Their goal is to help overcome market dysfunctions and valley-of-death problems for innovative microbiology diagnostics (and antibiotics).

In October 2018, Nature Reviews Microbiology published a truly superb review of the challenges of infectious disease diagnostics R&D and finance, Van Belkum et al, open access here.  This is the work product of an international team; I wrote about it here

(For a subscription-only article on PAMA and microbiology lab innovation, 360DX interviews Glenn George, here.  For a subscription-only article on how lab directors may skeptically view holistic arguments about test economics, here.)

For a comprehensive 2018 review of new and future antibiotic susceptibility testing systems (ASTs), Puttaswamy et al., open access, here.

FDA:  Antiobiotics, diagnostics, and resistance are FDA agency priorities.  For example, track back to a major address Dr Gottlieb gave at PEW Foundation in September 2018 here.   See also the FDA"s homepage for antibiotic resistance, here.

I highlight just one new item here.  In January 2019, FDA announced new efforts to help ensure that antibiotic susceptibility tests are available for new antibiotics, here and here.

CMS Measures for Infectious Disease Control and Prevention

In 2018, CMS proposed dropping a range of measures related to infectious disease, which stimulated concern in trade journals and public coments of the Association for Professionals in Infection Control.  Trade journal here, APIC letter here.

Dormant Requirement for Hospital ASP.  APIC has also asked CMS to finalize a proposed, but dormant, requirement for Medicare participating hospitals to have formal antibiotic stewardship committees (APIC policy page here with links to multiple letters to CMS, to PAC CARB, etc).   Note also that CMS has at best minimal roles and accomplishments in the 3-year review of the HHS Five Year Plan for CARB - here.

SEP-1.  I've written about CMS's important but controversial hospital quality measure, SEP-1, which is followed by less than half of US hospitals, entry point here.  SEP-1 was criticized in a 2018 article by NIH authors in Annals of Intern Med, Pepper et al., here.  See also a quite critical article by Faust & Weingart, 2017, here.

2019 - JAMA on Next-Gen Sequencing of Pathogens

Open access, review of advances in NGS sequencing and microbiology, by Gwinn et al., a two-page highlights article.  Here.

Coding of sepsis is difficult; CMS discusses this in its annual inpatient rulemaking each year, and there is a nice 6-page white paper from ACDIS (Assoc. Clinical Documentation & Improvement Specialists), here.

Costs and Causes of Sepsis - 2018 and 2019 Reviews

See a 2018 paper by Paoli et al, "Epidemiology and Costs of Sepsis in the United States," open access at Critical Care Medicine 46:1889-97.  Here.

Do see also a 2019 article that sepsis is a leading cause of hospital death, but nonetheless, in some proportion, acknowledge that it overlays other directly impending causes of death (terminal cancer, other terminal diseases).  Trade journal by Cheney, here, original article Rhee et al., here.

Not Cited in This Blog

I'll leave the citations there.  Not discussed - much effort at PEW Foundation, much effort at CDC.

Zip File in Cloud

Everything I've cited that is open access, find in a ZIP file in Cloud, here.  It's roughly 30 PDFs, 30 mb.

Medicare Curiousities: DME MACs to Hold Complex Advisory Board on Tumor Electrical Field Therapy

In typical Contractor Advisory Committees, a MAC (say, Noridian or Novitas) issues several new or revised LCDs, posts them for a public comment meeting, and also holds a session of its Contractor Advisory Committee, typically about 20 physicians of diverse specialties.  (Note: This process is changing per new 2019 instructions from CMS; here.)

For durable medical equipment, CMS divides the U.S. into four districts, which are managed by a total of two special DME MACs.  Their LCDs are always identical.  These MACs issue new LCDs and hold advisory committees quite rarely.

Elaborate DME CAC on NovuCure Tumor Device

However, an elaborate DME MAC advisory committee is coming up soon.  It will be held on the CMS campus in Baltimore, just like NCD MedCACs, and the agenda is quite formal.   In addition, CMS has assembled an advisory board of specialists. 

The topic is NovoCure's electrical field therapy for glioblastoma, which is delivered on an ongoing basis by a portable device.  Novocure (website here) has annual revenue of about $250M and a market cap circa $5B (which has double in the past year; here.)   See recent investor call here, and trade press here, here, here.   Its device is currently not covered by CMS under LCD L34823.

The Device; The Code; The Price

Novocure is headquartered in Jersey (the island, not the state; near Mont St Michel, France).  Its website lists office in Switzerland, Germany, New Hampshire, New York, Japan, and more.

See the FDA paperwork for the device here; P100034.  Per the company's homepage, it provides "a cancer therapy that uses electric fields to disrupt cell division, inhibiting tumor growth." 

The code is  E0766 here.  This is "Electrical stimulation device used for cancer treatment, includes all accessories, any type" and dates to 2014.

The code is not covered (L34823) and being a non covered DME code, it isn't on the current 2019 DME fee schedule at all.

The LCD L34823 is nearly entirely boilerplate.  It has no scientific citations or discussions, and in the middle of it is a single operational sentence that E0766 is not covered by Medicare.  See also A52711 coding article (no meaningful content).

The Upcoming Contractor Advisory Meeting - March 6, 2019 at CMS Auditorium

Novocure issued a press release last October that a DME CAC meeting was pending - here.

The CMS DME MAC webpage for CAC meetings has come to life with five links.   These include a bibliography, an announcement of the panelists, which include Kevin Camphausen MD, Chief, Radiation Oncology, NCI, and Henry Friedman MD, Chief of Neuro-Oncology at Duke, and many more luminaries.

The committee will discuss a series of Key Questions, with ratings 1-5 for response, similar to a CMS MedCAC.  Teleconference and webcast info is provided, and the agenda runs all day, 9-4, similar to an FDA ad board or CMS MedCAC. 

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Resources in the Cloud

I've put all the webpages and resources cited into a Zip file in the cloud.  Here.

Corporate Presentation

See a 52-page January 2019 corporate slide deck here.
Annual reports are interactive online here.


I believe there is no required timeline, after the CAC meeting, for the DME MACs to issue a draft revised LCD.   I also believe that after issuing one, there isn't a timeline for finalizing it, except for a new rule that draft LCDs expire after 1 year.

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image from Google Image Search

Friday, March 1, 2019

Good News: STAT Publishes Article on CMS NGS NCD & Access Issues

In March 2018, CMS released an NCD on next generation sequencing in cancer, and beginning in November 2018, adverse interpretations and conflicts have arisen.   For one quick entry point here.

On March 1, 2019, STAT publishes the first report on the problem outside diagnostics trade journals or association press releases.  It's by genomics expert Roger Klein MD.   

See the article here:

Thursday, February 28, 2019

Very Brief Blog: CMS Announces New Correct Coding Edits Contractor

For years, Medicare has maintained a publicly available system of computerized and manualized edits and coding rules, collectively called the National Correct Coding Initiative.  The rules also apply, by law, to Medicaid (here). 

On February 8, 2019, CMS announced that the NEW contractor for managing the edits is Capitol Bridge LLC, in Virginia.  See CMS announcement below the break; link here.  The consultancy's website is here.  The final cutover date (after a transition period) is March 15, 2019.

The prior contractor was called Correct Coding Solutions LLC, and was headed by Dr. Niles Rosen.

CMS posted some ridiculous new laboratory coding edits in late November 2018, which stakeholders are currently dealing with at the agency level.

Very Brief Blog: Theranos: The Book, The Blog, The TV Shows


Many in the lab industry are familiar with the Theranos saga from numerous news articles and from the 2018 non fiction best seller BAD BLOOD.   Bad Blood was written by WSJ journalist John Carreyou.  Here.


Newly minted: Theranos, the podcast mini-series. It's called THE DROPOUT.   Hosted by Rebecca Jarvis and produced by ABC, the podcast series runs six episodes and and about 4 hours at 45 min per episode.  Find it on iTunes and other podcast aggregaters.  Website here.


Upcoming: the HBO documentary THE INVENTOR.  It premieres March 18.  Website here.  The website includes the video trailer.

For an early review of the documentary, March 8, MedCity, here.

UPDATE 3/14/2019

I just learned that there will ALSO be a Theranos documentary on ABC, 20/20, on Friday, March 15, 2019.   This TV documentary builds on the Podcast documentary "DropOut."   Link here.


Vanity Fair
See a February 2020 update on the last days, and the hereafter, of Theranos, at Vanity Fair, by Nick Bilton (limited open access), here.

Someday: I've heard little about a rumored biopic movie with Jennifer Lawrence, but I haven't seen that it's canceled either.  The Hollywood rumor mill now pegs it for 2020.  Here.

My Chronological Archive of 100's of Web Articles
My 24-month month running archive of Theranos web articles, some dating back to 2004/2006, here.  Most of the links are 2014-2016, spanning the media-fueled rise and fall.


Unrelated to Theranos, but another new example of the long-form miniseries podcast as a type of journalism, see Bag Man, about Nixon's criminal vice president Spiro Agnew, at NBC here.  (At this website, also available as transcripts of the podcasts).

Monday, February 25, 2019

Roche to Buy Spark Therapeutics at Double the Share Price; Medicare Reimbursement $850K/Patient

Roche will acquire Spark Therapeutics, maker of the $850,000 retinal drug Luxturna.   Roche will value the company at about $4.8B, double the market cap of the prior day.

See business news at Bloomberg, Biopharmadive, MedCity.

See my January 16, 2019, article on the details of how CMS prices Luxturna - here.  Hint - it's innocuous-sounding HCPCS code J3398.  Million-dollar drugs get their reimbursement five alphanumeric characters at a time, just like everybody else.

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Some other gene therapy stocks also rose 15-30%, here.

In other news, CMS released a draft national coverage policy for CAR-T biologicals, February 15, here.

For a WSJ article on paying for million-dollar biologicals by installment, re Bluebird Bio, here.

Friday, February 22, 2019

Very Brief Blog: Open for Public Comment, NCQA National Quality Measures

The National Committee for Quality Assurance (NCQA) maintains sets of measures that apply to health plans (HEDIS) and well as other organizations (e.g. Patient Centered Medical Homes.)  As a standards body, NCQA is separate from CMS, which has its own rosters of measures for ACOs, Medicare Advantage plans, etc.

Currently, NCQA is accepting public comment on its measures for Patient Centered Medical Homes (PCMH) through March 4, and on Health Plan Accreditation through March 11.
  • See the NCQA home page here.
  • See the summary of proposed HEDIS changes here. (For instructions, here.)
  • See the web page about each measure vetted for a proposed change, here.
Examples of HEDIS changes include dropping a measure that checks whether arthritis patients are prescribed disease-modifying drugs (DMARDs; rationale, a fair percentage of patients don't need them but they're hard to identify in the measure).   See a 6 page PDF here.

Another measure up for deletion is related to osteoporosis screening, because of "concerns about the validity of capturing the specific evidence-based tests recommended for osteoporosis screening using a survey question."  See a 12 page PDF here.

Among new measures, one is proposed for pharmacotherapy of opioid use disorder (here).
  • This is a typical example of the measure progression.  
    • It's a measure developed by RAND (presumably somebody funded RAND to do so....)
    • It's stewarded by USC.  That means they shepard it through the NQF process.
    • It's approved and archived in a library at NQF as NQF Measure #3175.  Here
  • The measure looks to, "the percentage of adults [diagnosed with OUD] who receive OUD pharmacotherapy and adhere to continuous treatment for at least 180 days, allowing for 7 treatment gap days." 

Digital Measure Strategy

NCQA also has an open docket, based on a 32 page white paper, on how it should approach Digital Health Measures, here.


NCQA also has a 35-page white paper on changes to its range of antibiotics measures, here.

Measure Process Alphabet Soup

Don't confuse NCQA with NQF, the National Qualify Forum, which holds libraries of of hundreds of vetted measures which specific bodies like CMS can bring their shopping cart to.  NQF here

CMS also maintains a complex Measures Management System (MMS) which keeps most aspects of measures development and measures proposal separate from the inpatient and outpatient rulemaking process itself.  (Primarily, just the final adoption of measures goes through notice and comment annual rulemaking).  See the MMS home website at CMS here

  • For example, via MMS, stakeholders can pick a measure already vetted and  archived by NQF in its measures library, and propose it to CMS as a future CMS measure.  
  • Then CMS can cherry-pick from these public MMS proposals to bring a possible measure or two into the spotlight of annual public rulemaking.
  • The measures then support VBP - Value Based Purchasing by CMS, such as bonuses and debits tied to measure performance.
The "Slow as Molasses" Measure (SaM)

Measures work on slow timelines, for example, NCQA/HEDIS is taking comments now on changes in measures proposed for 2021.  CMS also takes comment on measures it plans to implement 2-3 years in the future, in most cases.  And these processes all follow the year-plus process for NQF adoption of a measure after submission, as it moves through committees and comment cycles.