CMS Lab Pricing Public Meetings: June 24, 2019 (Public), July 22-23 (Advisory Panel)

CMS has published, in the Federal Register, advance notice of its annual summer meeting for the pricing of new laboratory CPT codes.   The public meetings will be Monday, June 24, 2019.  The Advisory Panel will be Monday-Tuesday, July 22-23.

Here are the key dates in full:

• Circa May 20, 2019, CMS releases agenda 30 days in advance of meeting (list of all codes)
• June 10, 2019, Presentations due
• Same date for public registration for non-presenters
• June 24, 2019 (Monday), Public Meeting at CMS, Baltimore
• Location: CMS Main Auditorium
• July 8, 2019, Comments within 2 weeks of public meeting
• July 22, 23, 2019, Advisory Panel on Clinical Lab Tests
• July 1, 2019, deadline to register to attend Advisory Panel
• Early September - Proposed Prices
• Early October - Deadline for comment on proposed prices
• November - Final Fee Schedule for CY2020
• 60 Days after Final Fee Schedule, deadline to submit "reconsideration"
• Reconsideration simply brings the code back for the July 2020 meeting

See the CLFS Public meeting announcement > here.  See the July Advisory Panel announcement > here.

Track further announcements at the CLFS public meeting webpage here, and the Advisory Panel homepage here.

Foreign Nationals

Not always clear in these announcements, if you are a foreign national, you must reach out to CMS much farther in advance and provide additional materials.  Otherwise, you'll be stopped at the front gate ... even though CMS has otherwise accepted your online registration.  I've seen it happen.

CMS Preferences (Stated August 2018)

Last year, in program materials released in August, CMS announced that in general, it preferred single crosswalks and not stacked crosswalks, and crosswalks x1 in preference to fractional crosswalks (e.g. x1.5 or x2.5).   These are not absolute rules, but now they are stated CMS preferences.  Codes that can't be easily crosswalked under these preferences are more likely to be turfed to the MAC gapfill process which spans the following calendar year.

PLA Codes

On March 21, 2019, AMA updated its PLA code list (here).  I believe last year's meetings included all PLA codes released to AMA's website up to June 1, and this new meeting will cover all PLA codes released between August 31, 2018 and June 1, 2019.   (For the latter codes, the submission deadline is April 3, and the finalization will be at the May 8-9 CPT meeting).  Roughly, this is PLA codes 0062U to 0104U (42 codes), plus let's guess another 20-30 codes for May 2019.  That means there will be 60, 70, or more PLA codes in the June 2019 summer meeting, plus the dozen or more "regular" CPT lab codes generated this year.   

PLA codes become active for use up to several quarters before their CMS pricing cycle.  In contrast, regular lab and other CPT codes generally aren't active for use at all, until after the CMS pricing cycle completes.  

An Additional Date to Watch!

Since pricing arguments and powerpoints are due by June 10, applicants should get started on that process by early May, understanding the rules, picking crosswalks or arguments, considering alternatives.  If you want to consult with stakeholder groups (like lab associations) for advice, you should have draft materials written by the beginning of May.  

MolDx Releases New LCDs, May 2019

MolDx has released a host of new LCDs, to be discussed at a May 6, 2019 open meeting (for the Palmetto MAC).   The LCDs will, over a future period of weeks, be introduced in each of the several MACs around the U.S. who participate in MolDx consensus policies.  For Palmetto itself, the 45-day comment periods run May 6-June 20.  May 6 is a public comment meeting in Columbia, SC.

See All LCDs in ZIP File in Cloud:  HERE

DL38043:  G360 Liquid Biopsy in Solid Tumors

Re-release of Guardant G360 LCD but now expanded from lung cancer to broader coverage in solid tumors, with notes the test use must ALSO be consistent with the CMS NCD 90.2 for use of NGS tests in advanced cancers.

DL38045: General LCD for NGS in Solid Tumors
This is a general LCD about next gen sequencing in cancer regarding when it will be viewed as compliant, or non-compliant, with NGS NCD 90.2, as well as local implementation rules.  This particular policy is stated to be only concerning solid tumors, not hematologic cancers, ctDNA, or germline testing.   It doesn't say those other areas are outside the NCD, it simply says they are outside this particular LCD's discussion of the NCD. 

LDT NGS tumor panels are covered *after* completing a MolDx technical assessment (the LCD refers to the MolDx website for details).  For example, if I read this correctly, the Sloan Kettering IMPACT gene panel test under MolDx would have the same coverage as the FMI F1 CDx test under the FDA-approval-oriented parallel review NCD.  Assuming only that IMPACT or a similar test passed the in-house tech assessment by the MolDx team.  I believe that the LCD won't list test names, but that a MolDx article would need to list test names so that Medicare Advantage plans could implement corresponding coverage.    

The only CPT code listed for NGS testing is 81479, not 81445/81455. 

DL38047: General LCD for NGS in Myeloid Cancers
This is a general LCD about the use of NGS LDT tests (non-FDA-approved tests) for actual or suspected myeloid malignancies.  This appears to be a "class" LCD, provided general rules, but requiring that any particular test ALSO successfully pass a MolDx test specific technology assessment.  

Leukemias had some difficulty under the CMS NCD which allowed payment only for advanced cancers that must be "recurrent, refractor, relapsed, or stage 3/4."   To resolve this, the LCD explicitly declares AML, MDS, MPN as "refractory or metastatic cancers" by definition.  Gene panel testing is also covered where a myeloid malignancy is "suspected," with cytopenia over six months and "other possible causes have been reasonably excluded."

DL38041: Natera Prospera Test for dd-cfDNA in Renal Rejection

Provides coverage for the Natera Prospera test for donor-derived cell free DNA (dd-cfDNA) in management of renal graft rejection.

Noridian LCD L37358 covers the CareDx AlloSure test for cfDNA.

DL38039:  TruGraf Gene Expression for Renal Rejection

Provides coverage for the TruGraf Blood Gene Expression Test (Transplant Genomics, Inc), which uses gene expression to identify renal graft rejection. (Last year, MolDx covered a different type of renal rejection test, from CareDx, which picks up donor graft DNA in patient blood).

DL38029, DL38035: Decipher Prostate - Intermediate Risk

Decipher Biopsy Prostate Classifier to be covered for men with intermediate risk disease.  This helps determine next clinical steps after an intermediate-risk biopsy.

Assay covered with separate criteria in two separate LCDs (!) - one for patients with "unfavorable" versus one for patients with "favorable" intermediate-risk biopsy.

DL38051: DermTech Pigmented Lesion Assay PLA

The DermTech Pigmented Lesion Assay (PLA) assess RNA expression in patient skin for atypical lesions to determine the need for a melanoma biopsy in a atypical lesion.

DL38037: InterAct Drug Interaction

Although not billed as a "MolDx" LCD, an interesting additional LCD does NOT provide coverage for separately coded and billed drug interaction testing.  See on the InterACT Rx software system which is paired with a blood assay for interacting (including non-Rx) substances.  See Aegis website here.

That totals nine different new LCDs.

Notes

Coverage of the Guardant LCD at Genomeweb, here.  The NCD provides LBx coverage for patients with a solid tumor which could require a drug with a genetic biomarker on the G360 panel.  Note, though, that larotrectinib is approved in any solid cancer with an NTRK mutation.

For a recent blog on the overall structure and clarity of MolDx LCDs, here.

One thing I noted in that blog, is fixed already.   I was concerned that MolDx LCDs ended, as required by CMS, with an "Analysis of Evidence" but previously MolDx limited this to a few words, like "Quality Moderate, Weight Low."  Nothing else.  That's not "analysis."  

These new LCDs now end with a one or two paragraph analytic discussion of the quality and meaning of the evidence vis-a-vis the coverage decision.  I think this is a big improvement.  My only remaining wish is that they'd provide a short description of what the heck they mean by their three terms, "Quality, Weight, Strength" and how each term specifically differs from another.  When can evidence have "high weight, low strength" for example.

LCDs Timed with PLA Codes

Two LCDs are timed with new April 2019 AMA PLA codes.  These are PLA Pigmented Lesion Assay, Dermtech (PLA 0089U), and MyPath Melanoma, Myriad (PLA0090U).


Formatting of Indication: One Place or Two?

In DL38029, DL38035, Decipher Prostate Biopsy Assay,  the LCDs open with a short description of general coverage (e.g. "to inform  treatment decisions...for men with unfavorable intermediate risk prostate cancer."   Detailed coverage criteria with multiple bullet points and "AND" logic statements appear at the end of the LCD body.

In contrast, the DL38051 PLA melanoma assay has a brief coverage description at the beginning immediately followed immediately by detailed coverage criteria.

LCD Data

The LCDs average 11 pages (included coding lists or boilerplate) and 23 citations, citation range 7-39.

Three Renal Transplant Tests - Indications

The two new, and one prior, molecular renal graft tests are compared in the table below:

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Administrative Details: Open Meeting, Columbia, May 6

(Read the fine print at bottom of LCDs.)

1965, Meet 2025: Medicare Launches AI Challenge for $1.6M

You've been waiting since November 2018 (here).  The Innovation Center, or CMMI, at CMS wants to support new ways through which AI can improve the quality of healthcare.

See the "AI Health Outcomes Challenge Homepage" here.  It's in partnership with the Laura and John Arnold Foundation and the American Academy of Family Physicians (CMS contributes $1M and the other two, together, $600,000).

Here's what CMS says:

CMS is calling on developers from all industries to create new predictive AI applications to help providers participating in CMS Innovation Center models to deliver better care and make quality measures more impactful. 

"The Artificial Intelligence Health Outcomes Challenge is a three stage competition that will begin with the Launch Stage, in which participants will submit an application at ai.cms.gov," officials explain. "Up to 20 participants will be selected to participate in Stage 1 of the Challenge. We anticipate that more information about Stage 1 and Stage 2 will be announced later this year." 

As much as $1.65 million in total awarded to participants during Stage 1 and Stage 2.
"If selected for Stage 1, participants will develop algorithms that predict health outcomes from Medicare fee-for-service data, and strategies and methodologies to explain the artificial intelligence-driven predictions to frontline clinicians and physicians while building trust in the data," according to CMS. "Participants in Stages 1 and 2 of the competition will use Medicare claims data sets provided by CMS to develop their algorithms and solutions."

• See the full 11-page notice online here.  Entries are due June 18.
• See coverage at Healthcare IT News here, Fierce Healthcare here, HealthLeaders here.  

In the past day, the Trump Administration has announced that it would not fight a lawsuit (running in Texas and higher courts) that would wipe out the whole Affordable Care Act, including the CMS Innovation Center which runs the AI Challenge.  CMMI was created by Section 3021 of the ACA.

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In 2016, the Arnold Foundation awarded $7M to four groups working on drug price policy, including one to Peter Bach of Memorial Sloan Kettering - here.

For an article on more mundane uses of AI, such as matching Medicaid-eligible patients to their Medicare Advantage plans, here.

The UK also has been issuing upbeat reports about how AI and DHealth can improve the NHS - entry point here.

For a June 2019 conference on AI and healthcare in Boston, here.

For a March 2019 PWC report on digital health, pharma, and FDA, here.

HHS FY2020 Plan Mentions CMS Parallel Review, CMS Payment for Breakthrough Devices

A couple weeks ago, the Trump Administration released the President's overall budget for FY2020.  A few days ago, CMS released its 350-page budget and strategic plan for FY2020. 

Now, the other shoe, or the third shoe, has dropped, which is the 162-page HHS budget and strategic plan for FY2020.

There are three interesting references to Medicare policy, on page 84.

Strengthen the Parallel Review Process to Streamline Medicare Coverage
The Parallel Review program is a collaborative effort between the Food and Drug Administration (FDA) and CMS that is intended to reduce the time between FDA approval of a drug or device and Medicare coverage of that item. This proposal strengthens the existing parallel review process to improve device manufacturer participation and increase transparency.

    Takeaway: It's not clear exactly what this would look like.  CMS has issued Parallel Review NCDs twice, for Exact Sciences Cologuard in 2014 and for Foundation Medicine F1 CDx in 2018.   In speaking to ACLA's annual meeting on March 26, CMS coverage director Tamara Syrek Jensen didn't add any color to this HHS remark.   She noted that there is more happening under the umbrella of Parallel Review than just the two NCDs the public has seen.

    Debbie Downer:  Since CMS can't release in advance the date or content of its decisions, and, it already is in extensive Q&A dialog with Parallel Review participants, it's unclear what the "increased transparency" would be.


Improve Clarity and Transparency around Medicare Coverage Process
Some stakeholders find the process and standards for the Medicare coverage determination process lack clarity. This proposal requires CMS to issue additional guidance around the Medicare coverage process, including sub-regulatory guidance on the evidence standards that CMS utilizes in assessing coverage and the process to appeal coverage determinations, in an effort to improve clarity around Medicare coverage.

    Takeaway:  I have worked on many coverage issues for 15 years, and it's hard to give general rules for "what justifies coverage."   The situations, alternatives, comparators, vary greatly from one scenario to another.   Very, very few coverage decisions are NCDs, so this would mostly apply to LCDs.   CMS markedly updated the LCD process in October 2018, with changes rolling out now in 2019.   
     * I reviewed a group of very recent MolDx LCDs, and found the coverage analysis and clarity was quite high.  Here.
    * But right now, a device can have FDA Breakthrough Status, rigorous CMS Inpatient New Tech approval for added payment for confirmed new benefit, and still not get LCD coverage.  That's just insane.
    * As far as NCDs, I reviewed the quite recent NCD production process for the Foundation Medicine NCD, and found it was just pretty awful (white paper here, some other notes here.)

   Debbie Downer:  This HHS paragraph might refer mostly to the LCD improved processes already released a few months ago.


Improve Medicare Beneficiary Access to Breakthrough Devices
There is currently no expedited pathway for Medicare beneficiaries to access innovative devices that have received FDA breakthrough designation. This proposal provides Medicare coverage of devices approved through the Breakthrough Device Program for beneficiaries participating in clinical trials for up to four years from the date of FDA approval.

    Takeaway:  While legislation was floated in 2018 to improve CMS coverage of "breakthrough devices," there's also potential regulation lodged in 2018 with OMB (here), and a history on this topic dating back a full two years with monikers like EXCITE and PACER (here, here).  

    Debbie Downer:  The quote here is about coverage of approved Breakthrough Devices just for patients "in clinical trials."  Really?  Medicare normally already covers many devices in clinical trials anyway, with or without the breakthrough status (webpage here).  

CMS Announces It Will Soon Issue "Reopening" of Next-Gen NCD

In March 2018, CMS released the final version of its National Coverage Determination (NCD) for the Foundation Medicine F1 CDx FDA-approved test and similar FDA-approved tumor gene panel tests. 

From November 2018-February 2019, an unexpected series of events began with a CMS transmittal of the NCD that inserted a new text sections which raised alarm that the NCD will be interpreted to block NGS-method (but not other methods) of BRCA and other germline testing.  This would apply to all Medicare patients, regardless of age.   For a protest letter signed by about 60 clinical organizations in January 2019, here.

Reopening Announced on March 26

• On March 26, 2019, at the American Clinical Laboratory Association, the director of the CMS Coverage Group, Tamara Syrek Jensen, announced that CMS plans to "reopen" the NCD within weeks. 

What Does This Mean?

CMS New Action #1
In my understanding, CMS could issue a revised NCD directly, allowing 30 days of public comment before finalization.   For example, CMS could redline the text to confirm the overriding effect of existing sentences "buried" in the NCD's body that state it applies only to tumor testing, not germline testing.

CMS New Action #2
Alternatively, and I believe more likely, CMS could simply issue a statement that the NCD is being "reopened," much like a request for information. 

Through this "reopening," CMS could request public comment on the best ways to modify the existing NCD.   Such a comment period would run for 30 days, after which, in some period of weeks or longer, CMS could issue a proposed NCD, take another 30 days of comment, then finalize it.

Bizarre Situation 

CMS is unlikely to make any "retroactive" changes to the NCD, which by law is effective the date is was released one year ago. 

If the NCD is interpreted to "ban" NGS BRCA or other NGS testing in stage 1-2 cancer patients, then potentially CMS could seek recoupments.  But given the messy situation, it's unlikely that CMS itself would try this. 

Some other entity could seek recoupments (such as a for-profit Recovery Audit Contractor or for-profit qui tam case).  In my personal opinion this would likely fail sooner or later, as the NCD contains clear, mutually contradictory statements about its own scope.    Like Schroedinger's Cat, the NCD taken as a whole currently blocks and allows germline testing by NGS at the same time. 

For a detailed white paper on the saga since 2017, see here.

For the white paper, a chart that compares how CMS met statutory NCD requirements for analysis and justification of its position on tumor testing versus the failure to meet any of these requirements regarding germline testing:

Should Evaluation of Psychiatric PGx Focus on the "Red Drug Patients?" (Yes.)

Both in the US and Europe, there has been a marked uptick in the interest in pharmacogenetics in the past five years. 

Benchmarks include the growth of the CPIC - Clinical Pharmacogenetics Implementation Consortium, and a range of research and investments over the past several years by NIH-IGNITE (Implementing Genomics in Practice). 

There is an increasing consensus that implementation science is key, such as providing integrated PGx data in electronic health records, coordinated with pharmacies/pharmacists, and providing the right tools for the physician at point of care and across a health system.  This is equally discussed in the U.S. and in Europe (see e.g. Blagec et al. 2018, open access, here.)  I discussed this emerging consensus around implementation and patient selection in a white paper for Thermo Fisher in mid 2018 (here).

One of the most discussed RCTs in pharmacogenomics, certainly in the financial community, is the Greden et al. "GUIDED" trial, using the Myriad GeneSight test and supported by Myriad.  (Not open access, but here.)   This study - Genomics Used to Improve Depression Decisions - compared treatment as usual (TAU) to a pharmacogenomics-guided intervention where physicians could utilize information from a PGx test panel.    In the text arm, using PGx, response and remission rates were improved, but another metric, mean symptoms, did not (p=.10).   Assessment were performed at weeks 4, 8, 12, and 24 (1, 2, 3, 6 months).  The final per-protocol cohort was 1398 patients (717 in TAU, 681 with PGx). 

Higher-Risk Patients

One of the emerging concepts in PGx trials is to use higher-risk patients.

Here, in GUIDED, patients had "treatment resistant depression," failing at least one medication in the current episode of care.  Other research, not specific to depression, also looks to flag high-risk patients for preemptive pharmacogenomic testing (e.g. see the firm YouScript, here, which can screen population health system records for patients at highest risk of PGx-mediated adverse effects). 

Largest Impact Seen on "Red Drug" Patients

Although not a primary endpoint, Myriad has pointed out that the largest impact on health outcomes was in a population created not by the a priori entrance criteria (TAU), but by the gateway test itself.  This is the population of patients who are currently on a "red" or "not-recommended" drug.   In these patients, the point of testing would be to convert them to a higher-chance response on a "green" or "recommended" drug. 

In an online presentation, Myriad emphasizes this data analysis (here).   Basically, this sorts out 30% of patients who are already on GeneSight "Green" medications and have no significant expected GeneSight benefit.*  When you do this, you get larger impacts on the 70% of remaining patients, which you would expect, and all the p-values are below 0.05:

You Would Expect GeneSight's Result, And Its Absence Would Be Worrisome

Note that you would expect the GeneSight data to show larger favorable impact by removing the "already genetically appropriate" group of 30%.   Meaning, if this did NOT happen - if the clinical benefit occurred but it was somehow exactly level between green-drug and red-drug patients - it would be pretty worrisome that green/red identifications were actually irrelevant.  You might worry it was a non specific placebo effect, for example.  That doesn't happen, the "red-drug" patients get bigger effects and the green-drug patients don't. 

Expect Test Impacts to Be Positive and Real...but Finite

Impacts of PGx testing may be real, useful, but modest per 100 patients.  For example, if 11/100 patients remit in the control group, and 18/100 in the test group, that is 8/100 who benefit.   Discussion can shift not to "whether" there is an impact, but whether that is or is not "enough" to merit testing.   Generally, one background fact is that a PGx test has a pretty low risk profile, making it easier for the clinical risk/benefit to be positive.   And usually one in ten effects are impactful on practice; if one drug benefits 30 patients per 100 and another 40 per 100, the second drug will be favored, while the net impact is 1 patient per 10.  For example, if you run a Herceptin test and 2 patients in 10 are test-positive, the 2 get the drug, and one of them lives a year longer, that is a one-year benefit for 1 patient of 10 originally tested.  (See also Marquart, Chen, Prasad, 2018, here.)


Fitting PGx To Other Accepted Principles in Precision Medicine Analysis

To me, this could have been a study design in itself. 

The whole era of precision medicine, since Herceptin, has been to look at the impact of a precision medicine intervention in a defined subgroup.  This is how we evaluated Herceptin - see the book Her2, by Robert Bazell, 1998.   About 20% of cases are her-2-neu positive.  We then look at the impact of Herceptin on these 20% of patients; we don't dilute the impact across the 80% of patients who are test-negative and don't get the intervention.

For example, in a 2012 Cochrane review, Herceptin-treatment women (within 3 years) were about 40% less likely to have cancer recurrence and about 40% less likely to die.

If you diluted that effect over all women who "got the Her2neu test," the 80% who don't test positive and don't get drug, the effect would be diluted down by about 80% (e.g. 10% net effect included negative patients) and might not be statistically significant at all.   Nobody suggests running the analysis this way - nor for EGFR in lung cancer, for ALK in lung cancer, and so on.   There are some reasons for looking at the whole population - for example, the Her2neu, EGFR, and ALK tests are run on the whole population and contribute to population costs (you have to run five $150 Her2neu tests, on five patients, to find one positive patient, so the test cost per positive patient is $750, not $150).  And you can ask whether there are adverse impacts on women who test negative (usually that is a minor consideration, and applies to other tests, like estrogen receptor).

Consistent Impact for Sicker and/or "Red Drug" Patients

Gregen et al 2019 is not the only study with this type of finding.  In a large, 700-patient RCT that also looked a treatment-resistant patients, the difference in test performance was higher in the "severe depression" patients (although also significant in the moderate/severe cohort).  See Bradley et al, 2018 (open access, here) :

Bradley et al. 2018

Results also trend higher in a group not previously on a green drug, and trend higher in a decade-by decade age analysis within the cohort (about 15% were >65). 

Another RCT, with 150 patients randomized, was similarly favorable for panel PGx use in difficult patients, Singh et al., 2015.  Open access here.  It was discussed favorably in a 2018 review (see Zeier et al., below).

Can We Reduce the Boil On This?

Focusing on the population  who actually qualify for a test-directed intervention would reduce the temperature of current debates on psychiatric pharmacogenetics.   In the past year, FDA opined the subject in a confusing way, and JAMA carried a negative-toned news article.   There was a fairly balanced review in the APA journal, by Zeier, Nemeroff and colleagues (article here, APA trade press here).   Zeier has a publication date of September, but was E-pub in April.   Unfortunately, while creating a document for the APA position, due to timing,  Zeier et al were not able to review either the 700-patient RCT by Bradley et al. nor the 1400-patient RCT by Gregen et al. 

While these were appearing, there was what I read as a somewhat "just throw anything at the wall" op ed in JAMA.   To me, many of the concerns therein about internal controls and validity are resolved by the precision-medicine-paradigm of analysis looking at more severe patients or the "non green drug" patients, the same way we assess the value of other precision medicine tests. 

There is a famous quotation to the effect, "Statistics is common sense applied to numbers."   It seems like common sense not to dilute the impacts of a Herceptin intervention on the 80% of patients who test away from that intervention and don't get it.  By the same token, in these several psychiatric PGx trials, the actionable intervention is shifting from a red to a green drug, and "already-on-green-drug patients" just don't receive that intervention. 





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*To my eye, at most there would be a slight benefit in that the "green drug" ill patients might be switched to another green drug while avoiding a "red" drug.

Have MolDx LCDs Gotten Better? A Look At Some Recent Ones

Summary:  I reviewed a set of recent LCDs from MolDx.   The overall quality of the writing and scientific review has gotten quite good.   The LCDs are detailed, typically over 3500 words, with over 25 citations.  There are elaborate objective tables summarizing test performance and clinical data.  It's a lot of work to produce a pipeline of documents of this quality on a wide range of clinical topics.

Update: See also a post on 8 even newer MolDx LCDs, March 28, 2019, here.

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In business school, there is a of emphasis on "learning curves" - factories become more efficient with time, have fewer defects, or at least they should.  This is familiar to anyone with healthcare training - for example, surgeons get faster and better with fewer adverse events with experience.  This is especially prominent with the most complex tasks like robotic surgery.

Is this true for payers as well?

I have tracked pretty much every MolDx LCD since the program's inception, around 2012, and  I lectured on the most recent "block" of LCDs recently at a conference in SF.  (Here).  I'll summarize in this post, but the take-lesson is that yes, MolDx LCDs have gotten impressively well written.  

Part of this is learning curve, and part may be driven by recent legislation and by changes in CMS guidance.   CMS also provides in-service training to medical directors on LCD writing.    

The 21st Century Cures Act of December 2016 required more clarity in LCDs, which I discussed in a blog in November 2017.  Here.  At that time, I already showed a NGS MAC LCD which was characteristic of the improvement evidence discussions.    

More recently, in October 2018, CMS released more widespread changes in the LCD process which we are all still getting used to in CY2019.  Here.   Some of these are good, some may have unintended adverse effects.   Interestingly, some of the manualized changes in LCDs in October 2018, emerging from CMS, captured ideas floated earlier in legislation (not passed) by CAP and others, here.   

LCDs Selected for Review

These have been selected from Noridian's recently posted draft or newly finalized LCDs; here.  I've also put the PDFs in a zip file in the cloud, here.

Basic Statistics

I looked at six recently proposed LCDs.   The average word count is 3636, and the average number of citations 26.8:

3700 words is pretty long.  I wrote a big white paper (27pp, 7500 words) on the history of the CMS NGS NCD, and it was only about twice as long as some of these single-topic LCDs. 

Coverage or Non-Coverage?

All are basically coverage LCDs.  This is because MolDx jurisdictions have a master overlying LCD that says molecular tests are not covered until they are covered by MolDx (L35160, here).   So things that were proposed to MolDx, but not covered, may not get their own LCD.   

MolDx can and does issue specific non-coverage LCDs.   They recently issued an LCD retracting coverage of the CardioDx Corus CAD test, here, which by dollar volume had been amongst the largest proprietary tests paid by Medicare.  That was case where early Medicare coverage was not followed by much private payer coverage.

Overview of the Recent LCDs

Here are some summaries of the LCD features.  Whenever I am asked, "What is the evidence level for an LCD?" or "How many papers  do you need for an LCD?" I tend to roll my eyes, because almost every LCD presents some unique twists or features that are unique to its decision process.  I try to highlight a few of those below.  The opinions are entirely my own.

Structure of LCDs

The LCDs have a systematic structure, usually with a short coverage decision at the top (for patients with symptoms X, Y but not Z, etc.)

This is followed by an introduction summarizing the disease state, and then a detailed summary of the evidence.  

Summary of the evidence forms the body of the LCD, and for diagnostic tests includes both elaborate tables of test performance ("accuracy, PPV, NPV, FP, FN," etc) and tables summarizing the clinical validity or clinical utility studies reviewed in the text.  (E.g. "RCT, 125 patients, +3 months survival, P=0.01").  The overall approach gives an impression of thoroughness and accuracy. 

Professional guidelines are cited and summarized.  A closing section provides criteria for coverage (or non-coverage).   

The MolDx LCDs close with an extremely brief section called, "Analysis."   "Analysis" provides three words, Quality, Strength, and Weight, with a modifier for each (e.g. Quality:Moderate, Strength: Moderate, Weight: Moderate.")   CMS requires the LCD to include "Analysis" but I don't think CMS specifies the form.   This is the only part I would criticize.  (For more detail, see footnote.*) 

Update: New LCDs released by MolDx on March 28 still have the cryptic "Analysis" words like "Strength vs Weight" but now, they ALSO have a several paragraph analysis summary, that weighs the evidence strategically vis-a-vis the particular coverage decision. Good.

Veracyte Envisia Test for Idiopathic Pulmonary Fibrosis (L37891)

This is a test that helps resolve the diagnosis of idiopathic pulmonary fibrosis (IPF) in cases where a prior high resolution CT scan was non-diagnostic.  Unlike many of these LCDs, the coverage rules section is fairly long.  However, it follows a simple principle: If the CT is definitive for IPF, or unlikely for IPF, do not use the molecular test.  Only use the test when the CT is probable but indeterminate for IPF.  Guidelines and rules for this call, are provided.   Overall, the LCD flow and text are very clear. 

This is one of several LCDs in this short set they resolve an ambiguous situation.   Since the situation is ambiguous, it depends on the call of the reader of the high resolution CT scan.  It would be difficult for Medicare to audit such a call, without bringing in an equally qualified specialty radiologist (pretty thin on the ground at CMS or OIG), and having a copy of the original scan.  

Inivata InvisionFirst (LBx) (DL37899)

This is a gene panel liquid biopsy test for patients with advanced lung cancer.  Coverage is closely defined, for advanced lung cancer at progression, or advanced lung cancer where a tissue biopsy has failed or is not medically feasable for the patient.   The coverage maps closely to that provided in July 2018 for the Guardant G360 test.   The use of liquid biopsy in lung cancer has been increasingly recommended, with a number of high profile publications in recent months.   (Guardant, publicly held, has a market cap in the $7B range.)   

Coverage in some cases hinges on whether the treating clinicians view the tumor location and patient status as viable for biopsy.   The LCD also deals with cancer patients getting an NGS test, so it falls under the domain of the recent CMS NGS for uses of NGS in cancer.   Audit would involve determining whether Medicare's auditing physician also viewed the anatomy and patient as indicating a difficult to biopsy case.   

Myriad MyPath Melanoma (DL37881)

This LCD was recently finalized exactly as proposed.   This test is used on paraffin block biopsy tissue after a board-certified dermatopathologist has determined that the specimen is melanocytic, but equivocal for cancer, AND, the patient would otherwise have further surgery (surgical lesion wide excision or sentinel node surgery).   

Once again, as mentioned Veracyte Invisia, this LCD involves a human decision that a diagnostic test is ambiguous.  Here, it is a glass slide reading of the biopsy that is uncertain, and could only be audited by another board-certified dermatopathologist looking through the original glass slides and special stains of a case one-by-one, a difficult task.

Decipher For Prostate/Biopsy (DL37820), Biotheranostics BCI Expansion (DL37824)

Both of these involve expansion in coverage of a test.   Both are MAAA-type tests which are gene expression profiles of the likely aggressiveness of a cancer and the need for further intervention.   The Decipher test had originally been approved for use post-prostatectomy, to assess need for additional surgery; here, it is approved for use in decision-making on biopsy.   The BCI test is a breast cancer gene expression test, which also received an expanded indication for a larger population of women who are post-lumpectomy and making therapy intervention decisions such as regarding adjuvant chemotherapy.   

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*
Footnote.

Usually, health technology assessments (including CMS NCDs) discuss the evidence first (1) objectively ("summary of evidence") and then (2) more qualitatively, meaning they turn to discussing in paragraph form the pro's and con's or biases ("Analysis").  

At MolDx currently, "Analysis" means these pop-up two-word phrases like "Quality:Moderate" which are terse and not very enlightening.  None of the three categories (Quality, Strength, Weight) are defined, nor the possible modifiers to each.  For example, what would be a "High Quality" body of evidence that is "Low Strength"?  Or how would you arrive at a body of evidence having"High Weight" but "Low Quality?"  We don't know.  

Very Brief Blog: Looking Up Providers Excluded from Medicare

Someone asked me which, if any, persons involved in Theranos had been excluded from participation in Medicare and Medicaid.   I don't know of any; I think exclusion usually follows a criminal conviction, and there are elaborate regulations for that.  (But see footnote*).  The statute is at SSA 1128, here.  See also 42 CFR 1003, revised 2016, here.  Mandatory exclusions include conviction for health care fraud.  Elective exclusions include loss of professional license related to professional performance or "financial integrity."

The good news is, HHS OIG makes it very easy to find exclusions.  There's a special webpage here.  There is a list of excluded individuals and entities (LEIE) which is a 70,000 line Excel file, here.  See also an online searchable database here.

Skimming the alphabetized LEIE spreadsheet from top down, there are 9 excluded persons at "accounting firms," and 90 excluded acupuncturists.

There are 108 excluded dental practices, followed by names of 1198 excluded dentists.   There are 613 excluded DME supply companies, and so on.  There are only about 45 excluded clinical laboratories or named employees of clinical laboratories.

You can also be excluded even if you are not a clinical provider like a doctor or nurse.  For example, there are ten excluded lawyers.   Persons excluded can't own or manage a business that serves Medicare or Medicaid. 

There are about 330 excluded "recipient/beneficiary" persons, followed by almost 200 persons excluded as "recruiters, cappers."

40 persons in the list of 70,000 are based in Abilene, Texas, and 146 reside in Des Moines, Iowa.  The rate is 2X higher in Des Moines (1 per 1500 residents vs 1 per 3000 in Abilene).  Glendale, CA falls in between (1 per 1750).

I don't think they cull the list for decedents, there are 138 persons listed with birthdates before 2019/03/22, so, more than 100 years old.   About 1000 names are persons born during the 1920s, the pending centenarians, including a podiatrist in Ohio and a pharmacist in St Louis.   The oldest physician listed was born in 1924 (103), the youngest 1987 (30).   There are 20 persons born in 1997, 1998, 1999.

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Note that in the database some physicians are listed as "Medical Practice, MD" and others as "Physician (MD/DO)."

Statistically, about 190 should share anyone's birthday (70,000/365); 5 share my exact birthdate.

One elective reason for exclusion is "claims for excessive charges or unnecessary services;" SSA 1128(b)(6).

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Owners of Theranos do not yet appear on the OIG Exclusion website.  However, they were excluded from: "participating in the operation of, or profit from, a laboratory for two years" beginning July 2016, the apparently expiring July 2018.  Here, final page, page 33.  This was a specific line-item exclusion but not a general exclusion from all services under CMS.

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 for pulling a block (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 (via 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).  (Added:  2018 Part B use was 29,011 times for $637,509).  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 (so only $20.54 was paid), 16% office, 9% independent lab (where $24.15 is paid) .  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 [e.g.] 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 APC/OPPS

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 a Block vs 0502T for Pulling Radiology Case

The interesting thing is to compare the handling of 88363 to 0502T, the latter for pulling imaging information from an archive and transmitting it to an outside analysis center.   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 Outpatient APC Arena: Pathologists 1, Radiologists 0.

In Part B, it looks like 0502T is "contractor priced," not Status N, so it could be payable in an independent facility.  The code is too new to have any publicly released data on utilization (on claims paid).

• 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, is 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 now the technician work rises to 106 minutes from 72 minutes in 88380.

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, the work of 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).  Whereas 88363, pulling a paraffin block, is $17 for the hospital to usually send the block to an outside reference lab, 88380/81 for laser dissection are presumably paired to local services for which the hospital gets paid (e.g. 81445, DNA sequencing of 5-50 tumor genes, etc).

Anecdote

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.

   0502T - Radiology data pull and send - no APC payment.
   88363 - Pull slides from archive - APC 5731 for $17 (but can get bundled to certain other procedures if on the same day)
   88380 - Laser microdissection - no APC payment
   88381 - Manual microdissection - no APC payment

Part B Utilization Summary (2017)

  0502T - Radiology data pull; No data available yet.
  88363 - Pull slides from archive - ~26,000 uses for $600,000.
  88380 - Laser microdissection -  ~160 uses for $23,000.
  88381 - Manual microdissection - ~19,000 uses for $3M.
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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.

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* APC 5731 is "Level 1 Minor Procedures."

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," "Yoga," 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.   

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

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 meeting is about whether PAC CARB should formally petition HHS to finalize CMS's 2016 proposal to require hospitals to have antibiotic stewardship committees.  If this 2016 proposal is not finalized by June, it will expire.

• The special meeting will be Monday, April 8, 2019; website > here.  
• See links on website for registration, Federal Register notice, draft agenda, proposed Letter to HHS.
• The virtual meeting is short, 12:00-1:15 eastern.
• Public comments are due April 2 midnight, no more than one page (see Fed Reg notice at link above).

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.  For this meeting, on April 8, PAC CARB 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

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. 

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:

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

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!").

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*
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.