CMS Public Lab Meeting Monday June 25, 2018; Advisory Panel Webinar-Only, July 16-17

UPDATED: FINAL AGENDA HAS 100 CODES; SEE UPDATE MAY 25 HERE.
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Each summer, CMS convenes an annual public comment meeting for its pricing of new laboratory codes (e.g. codes that will be active in January, 2019). 

Public Comment Meeting Monday June 25

This year CMS holds its annual public meeting on Monday, June 25, 2018, at the CMS headquarters in Baltimore. 

Registration for in person attendance begins April 4 at CMS via its CLFS webpages.

Stakeholders must submit their presentations by June 11, 2018.   Written comments will be accepted until July 9, 2018. 

CMS publishes the code list for the public meeting at least 30 days in advance.  This means the code release date May 25 will be at least 2 weeks before the presentations-due date June 11.

Advisory Panel Meets Later, And Only By Webinar

CMS also will convene its Clinical Diagnostic Test Advisory Panel, but only by webinar.   The panel teleconference/webinar will be accessible to the public on Monday/Tuesday, July 16/17, 2018.

Get the Documentation:

The Federal Register notice for the June 25 meeting is here.

The Federal Register notice for the July 16-17 advisory panel webinar is here.

Read Carefully:  CMS Proposes One-Slide Per CPT Code Per Stakeholder !

In past years, CMS issued instructions in text on what they needed for pricing: the purpose of the test, clinical population, use, cost and charge information (especially for, but not only for, gapfill).   In 2017 they handed out a 5-slide model deck with "test purpose and method," "cost/charge" data, "recommendation."  This year, they issued a one page PDF instruction for how to build your one slide per test, which should look about like this:

Brief Blog: Some Nerdy Aspects of the Lab Gapfill Process

For many years, CMS has used either a "crosswalk" or "gapfill" process to assign prices for new laboratory tests.   This process is still used for new laboratory tests, up until the time the next triennial PAMA pricing exercise occurs.   Right now, in spring 2018, about 19 codes are in the active gapfill process.  Around April/May, CMS will post MAC proposed gapfill prices and trigger a 60 day comment period.  (Sounds like you could base an office lottery on the CMS date).   Final MAC gapfill prices will be posted in September.

For the first time, MACs will be required to display a "rationale" for their gapfill decisions.  Also for the first time, MolDX will have a majority of price proposals, thus controlling the "median" MAC proposed price.

Details follow. 
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Recent Gapfill Activity
2015:  About 30 codes being gapfilled; least half got no price.
2016:  About 16 codes being gapfilled, mostly MAAAs; all were priced.
2017:  No gapfill activity this year.
2018:  About 19 codes being gapfilled.  First year requiring "rationales." 


The Gapfill Process in Regulation
The gapfill process was formalized in regulation by CMS in 2007 due to a Congressional request (the 2003 Medicare Modernization Act, Section 942; see 42 CFR 414.508).  PAMA also puts gapfill rules in regulation, although in a somewhat patchy way.   PAMA (c)(2) describes the information that gapfill should concern, but as far as I can see, PAMA doesn't give CMS any stated way of handling the gapfill information (e.g. calculating medians of MACs).   Regulation at 414.508 says CMS will set prices at "the median of contractor specific amounts."

2018: Using MACs rather than CLFS Zones for the Median Price
In recent years, rather than setting payment at the median of "contractor" amounts, CMS set gapfill prices at the median of the 57 CLFS zones. 

Now, in 2018, CMS has no more CLFS zones, so presumably CMS will set gapfill prices at the "median of contractors" rather than the median of states or zones. 

2018:  MOLDX Owns the Median
MOLDX controls 7 MAC jurisdictions (Noridian x 2, WPS x 2, CGS x 1, Palmetto x2) and there are only 5 other MAC jurisdictions (Novitas x 2, NGS x 2, FCSO), so MOLDX will control the median.

(Alternatively, if you counted MACs only once, it would be 4:3, and MOLDX would also control that method.)

2018: Gapfill and MAC Rationales
In final PAMA rulemaking of June 23, 2016, CMS stated that it would require MACs to provide a "rationale" for gapfill decisions (p. 41086).  There were no codes being gapfilled in CY2017, but presumably now in CY2018 MACs will be required to provide a "rationale" for their gapfill decisions.  The "rationales" for CMS crosswalk prices can be pretty scanty, so don't expect too much from this new requirement for gapfill rationales.

2018:  Crosswalk to "an" appropriate code or "the" most appropriate code?
Whereas regulation 414.508 specifies that crosswalk is to "an appropriate test," statute 1834A(c)(1) requires that CMS crosswalk to "the most appropriate test."   Arguably the statute sets a higher bar for what is an acceptable crosswalk than the regulation.  Often, two or three crosswalks are being debated and have different pro's and con's, and CMS could easily say it had chosen "an" appropriate code among its choices, which was all it had to do.   Proving you have chosen "an" appropriate code rather than "the" most appropriate code....key policy point, or angels dancing on the head of a pin?

Codes in Play for Gapfill during CY2018

Blog deleted.

This blog contained incorrect information and was deleted.

See updated blog

http://www.discoveriesinhealthpolicy.com/2018/03/brief-blog-cms-public-lab-meeting.html 

Very Brief Blog; CMS Appoints Ombudsman for Pharma/Tech Industry, per 21CC

As required by the December 2016 21st Century Cures law, CMS has appointed an ombudsman for "pharmaceutical and technology" e.g. industry, issues.   Section 4011 of 21CC (here) required CMS to appoint an "ombudsman" for complaints, grievances, and requests for "pharmaceutical, biotechnology, medical device or diagnostic products" for which coverage is sought, with respect to "coverage, coding, or payment" concerns.  

The appointment may be from February 2018.   See the Ombudsman webpage for full contact info, here.  The Ombudsman is James Bailey, who is also found on the Ombudsman section of the webpage for Hearings and Inquiries, here.

From the CMS ombudsman page:

We are pleased to announce that James Bailey is currently serving as the new Medicare Pharmaceutical and Technology Ombudsman, a role that was established by the 21st Century Cures Act to help support customer service and innovation in the Medicare program. This Ombudsman will receive, and look into, concerns and questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers and other stakeholders regarding Medicare coverage, coding, and payment for products already covered or for which coverage is being sought.   The Medicare Pharmaceutical and Technology Ombudsman will collaborate closely with our other Medicare program ombudspersons in the CMS Offices of Hearings and Inquiries.

In addition to helping stakeholders navigate the Medicare Program, James is also interested in hearing about their experiences and sharing this information with CMS policy makers as appropriate, helping to promote transparency and predictability.
The Ombudsman does not duplicate or replace existing processes such as grievance procedures, appeals, judicial hearings, or other formal avenues stakeholders may access. However, the Ombudsman may look into how procedures were followed in these processes, and bring to the attention of policy makers any feedback regarding what works well and opportunities for improvement. This Ombudsman cannot advocate for new coverage, coding or payment within the Medicare Program, but can facilitate information exchange.

Very Brief Blog: CAP TODAY publishes article on the puzzling 14 day rule

Anne Paxton, one of the lead journalist for CAP TODAY, has published an article on CMS's confusing 14 day rule and its recent changes.  See online open access, here.

The Intro?  "For labs navigating the new billing regulations, some forecasters are predicting confused seas ahead.  “We’ve been reaching out to a number of our customers who I know will be affected by this and saying ‘What’s your take?’ and together just putting our heads around what it really means. But there is still quite a bit of confusion out there,” says Kurt Matthes, vice president, reengineering and service, at revenue cycle management software provider Telcor.

See the full article at CAP TODAY.   They write that "CMS opted against exempting ADLT tests because they are FDA cleared or approved, genomic sequencing procedures..." [sic]  CMS did state that in final November rulemaking, but it sounded goofy then and that doesn't seem to be how CMS is implementing the rule. In the most recent implementation instructions, GSP and genomic PLA tests are categorized in the way that leads to exemption from the 14 day rule.  CMS put up a website for date of service lab policy on February 27, no doubt after the CAP TODAY article had gone to press.

Very Brief Blog: Health Affairs Blog Critiques the CMS NCD on Genomic Tests in Cancer

On March 22, 2018, an open access blog in Health Affairs, by Gail Javitt and Robert Wanerman of the Epstein Becker Green law firm, critiques the recent final CMS NCD for use of next generation sequencing in cancer.  Find the blog here.

While praising some aspects of the NCD, the authors refer to a "regulatory disconnect" and devotes some attention to the different treatment of FDA certified companion diagnostics and 510(k) NGS tests that are required to show high accuracy.   Since the tests authorized by CMS may release large numbers of off-label gene reports for off-label drugs, as I read it, the authors think that CMS missed an opportunity by not including a "more flexible and less burdensome" level of CED.

See also a critique that preceded the final NCD.  On November 30, Rebecca Eisenberg of U Michigan, authoring a SCIENCE Op Ed with Nobel laureate Harold Varmus, praised the use of CED with cancer genomics and was cleared prepped to be released with the NCD (here, here).  On January 10, Eisenberg submitted comment to CMS that the NCD "undermined the benefits of important steps [take by] the FDA."   Eisenberg noted that

"The MSK-IMPACT test uses nearly identical methods to analyze the genes categorized as critical components of companion diagnostics in the F1CDx test. Both tests provide very similar or identical information about variants in very similar sets of genes, with similar implications for clinical care. The MSK-IMPACT test has some notable advantages, including more rigorous validation of the existence of somatic mutations because both tumor and germ line DNA are analyzed. Both tests have been used in tens of thousands of patients and validated by stringent criteria, such as those of the NYSDOH."

Very Brief Blog: CMS Releases Instructions and Calendar for "ADLT" Lab Tests

The PAMA legislation of 2014 created a new category of test, Advanced Diagnostic Laboratory Tests, with special initial and annual payment rules.   Test must be sole source tests, either of the MAAA type (Type A) or the FDA-approved sole-source type (Type B) (42 CFR 414.502).

Somewhat belatedly, on March 23, 2018, CMS released application forms, quarterly calendars, and additional guidance for becoming a MAAA.   Find the CMS webpage HERE.

CMS provides a 17 page application form and a 30 page guidance document.  Half the guidance document is about price reporting (applicable periods, TINs, special cases, etc.)

CMS is planning to enforce a rule (not found in the PAMA law) that the test must provide "new clinical diagnostic information not available from any other test or combination of tests."  The applicant writes this justification itself, and it's not obvious how CMS staff would search the market for tests not named by the applicant (this might take a lot of content knowledge about the industry, available tests, and clinical care pathways), but they will use the Advisory Panel on Clinical Diagnostic Laboratory Tests to assist them (guidance document, page 8).  They don't mention an appeal process yet.

• The "originality clause."  I never thought this whole "originality clause business" was applicable, since it's not in statute, and even more, the statute explicitly contemplates ADLTs that are 510(k) tests, thus, have a close predicate and often the same intended use.
• It's unclear exactly how CMS will apply these originality concepts (e.g. for competing breast or prostate cancer MAAAs) or if a test would cease to be an ADLT in the future if a too-close competitor appeared.   
• CMS seems to box itself off unnecessarily from value-based purchasing.  
• For example, if a test replicates a prior ADLT MAAA, but is performed twice as fast at half the cost, it might not be able to be an ADLT because it didn't have a "unique" clinical purpose.
• Would the FMI F1 test be "original" enough?   Both the FDA approval and the CMS coverage focuses laserlike on its CDx tests, but exactly those F1 CDx tests are generally available from "one or more other tests on the market."  
• OK, this is a trick question, because this is a PMA/510k category ADLT ("criterion B ADLT").   
• Some tests may be both a Criterion A ADLT (it's a unique MAAA) and a Criterion B ADLT (it's a sole source MAAA that is FDA approved).  It may be better to apply for ADLT for this test as a "Type B ADLT" because it avoids any review under the originality clause.
• If you upgrade your test (from a 50 gene to a 51 gene MAAA) to your reboot the ADLT periods by becoming a "new" MAAA ADLT?  
• If you're an LDT, how do you define and revise your "claim?"  Isn't partly it up to you?  The FDA and CLIA aren't writing your "Claim" for you like the FDA does for reviewed products with formal FDA labeling.
• The "Licensing clause?"  What Licensing clause?  
• In final PAMA rulemaking, June 23, 2016, CMS said that a university that licensed-out IP for a test could not be the test developer, but also, that  a lab that licensed-in IP for the test could not have been the sole developer, either, and neither could be an allowable "successor laboratory."   Since almost all tests license some IP from somewhere, this seemed tortuous.   
• See and read: 81 FR 41060, column 1, June 23, 2016.
• Gratefully, CMS has chosen to simple drop any explicit reference to this perplexing part of the original rulemaking.  
• However the paperwork does refer to "the lab that DESIGNS" the test in a few places, not just the lab that solely provides the test.

CMS will process applications quickly, e.g. accepted during January, reviewed during February, applicant notified during March, and code and payment active April 1.

Tests must show they have been "covered by Medicare Part B."  This is probably a good thing, because it means early policy benefits won't expire while the newly launched test is just awaiting coverage.

CMS webpage here.

Once tests have coverage, they can apply for ADLT.  ADLT law gives them "market list price" payment for 9 months, then payment at an annually surveyed market median price.   (This latter survey median price is similar to the triennial survey price for regular lab tests).   

Often lab tests (like other health services) have list prices that float substantially above actual prices, e.g. $4000 list, but real world discounted $2200 average price from payers.   

If the gap between the initial "list" payments and the later "average" payment is large (130%), CMS can recoup the difference.  It's not hard for CMS to do this, it's common; MAC just sets up a debit against future payments.   Labs would be incented (in their first nine months) to accept high payments but appeal low payments to ensure only high payments are logged for CMS price setting review.  This pushes the lower priced claims like a bolus into the next fiscal period, but the first fiscal period is weighted most heavily due to the clawback rule.  Want to see in real numbers?   I show an example where a lab gets $21M instead of $13M (net of clawbacks) in years 1 and 2 together, here.

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See also Medlearn Article SE1619, 2017, which provides general guidance on CLFS PAMA reporting.

Very Brief Blog: The Bonanza of Palmetto MolDX LCDs for Public Comment

In October, Palmetto GBA, which originates all the MolDx LCDs, won a contract to manage three additional states (Jurisdiction J, KY AL GA).   My understanding is that Palmetto "froze" all pending draft LCDs so they could be re-released for public comment in JJ, since they will eventually apply there.

A batch of 24 LCDs (most of them being re-released in comment for the benefit of JJ stakeholders) are open for discussion at March 26 and 29 public meetings. 

Homepages for the two meetings are here.  You can click through to to LCD lists.  I've also clipped the LCD list below the break.

Columbia SC March 26
https://www.palmettogba.com/event/pgbaevent.nsf/EventDetails.xsp?EventID=AVQSK98322

Nashville TN March 29
https://www.palmettogba.com/event/pgbaevent.nsf/EventDetails.xsp?EventID=AVQSUB7560

Very Brief Blog: Standardizing European Health Technology Assessment (HTA)

In the US, health technology assessment can be a nightmare for innovators due to the highly fragmented healthcare system (Medicare National, Medicare Regional, 50 Medicaid states, countless private payers).

In Europe, there have been efforts to harmonize HTA across countries.  A news article says its far from clear how much progress there is.

• See PharmaForum here.  
• See also a dedicated webpage for European Union policy and legislative proposals here.  
• The Euro HTA legislative program dates to at least 2016 and released proposals in January 2018 for potential action in 2019 and later implementation.
• Nonlegislative efforts at harmonization and collaboration among Euro countries dates back longer. See  https://www.eunethta.eu/

A Flow Chart for Medicare's Final NCD for NGS Testing in Cancer

Here's my best version of a flow chart for Medicare's March 16, 2018, Final NCD for NGS Testing in Advanced Cancer. 

click to enlarge

Note that patients with non-advanced cancer have:

• no NGS testing (neither NCD nor LCD) or 
• alternatively can get LCD testing if the test is a "non-targeted-therapy test" (e.g. minimal residual disease tests), and this difference:
• depending on a sentence on page 4 about the scope of the NCD.

In this sentence, CMS writes that the NCD applies only to NGS tests to choose targeted therapies or assign patients to targeted therapy trials. 

The LCD pathway is not specific for indication, though it is specific for advanced cancer and 1 use of a test.

The green boxes show the route to guaranteed NCD coverage:  NGS technology & patient has advanced cancer & test is FDA companion diagnostic & patient's cancer is on-label for test & patient has not had this test for this cancer before.

For my long article on implications of the NCD, see here.

Very Brief Blog: New Book on Personalized Medicine: Kristin Poithier of EY

Kristin Pothier, who was a partner at consultancy Health Advances and now is Global Head of Life Sciences Strategy at EY, has published a new book on precision medicine.  Titled "Personalizing Precision Medicine: Global Voyage from Vision to Reality," it was released by Wiley in October. Amazon webpage here.

The publisher notes, Pothier "reviews the full continuum of personalizing precision medicine, including diagnostics, therapeutics, big data, supportive care, regulation, and reimbursement and innovation in precision medicine worldwide."

Other recent titles have been, "Genomics and Personalized Medicine: What Everyone Needs to Know" (Michael Snyder, Oxford, 2016, Amazon) and "The Personalized Medicine Revolution" (Pieter Cullis, Greystone, 2015, Amazon) and "Genomic and Precision Medicine, 3rd Edition" (Ginsburg & Willard, Academic Press, 2016, Amazon) and "Precision Medicine: Guide to Genomics in Clinical Practice" (McCarthy & Mendelsohn, McGraw-Hill, 2017, Amazon.)

Also of interest, recent books that look at digital health, data, and precision medicine together.  These include "Moneyball Medicine," by Glorikian & Branca (2017), "Fourth Wave" by Paul Sonnier (2017), and "Realizing the Promise of Precision Medicine: Patient Data, Mobile Technology, Consumer Engagement," Cerrato & Halamka (2017). 

Very Brief Blog: New York Times Runs Long Article on FDA-approved Digital Therapeutic Apps

• Update: There was also a detailed article on the topic in Boston STAT on March 13 here.

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It's likely a firewall article, but NYT runs a detailed article on the growth of the field of FDA-approved digital therapeutics. 

For example, one featured app is the ReSET app, prescription-only, which was authorized by the FDA last fall as the first app for improving outcomes in addiction treatment programs when used in conjunction with or added to outpatient standard of care. 

The article discusses pro's, con's, and policy issues from a range of perspectives.

click to enlarge

CMS PUBLISHES FINAL NCD FOR NGS TESTING IN CANCER

Note:  This article has been revised several times on a rolling basis as the implications of the NCD have become more clear.

CMS released the final NCD for NGS testing in cancer.
Online at CMS here.
Also a PDF cloud copy here.

CMS also issued a press release here.

Coverage at Genomeweb here. Genomeweb follow up here.  MedCityNews here.  Forbes here. Reuters here.  Wired here.  Medscape here.  Targeted Oncology here.  Regulatory Focus/RAPS, here.

My best current effort at a comprehensive logic flow chart for the NCD is here.

The NCD provides a great measure of forward-looking certainty for investors and developers, because "Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met." [from press release]

Highlights as discussed further below:

• Difference #1:  All FDA CDx at Parity.  Approved and Cleared FDA CDx are treated at parity.  (But there are almost no "cleared" CDx.)
• Difference #2:  MSK IMPACT loses its CED based coverage.  The Draft had clear coverage (though with CED) for tests like 510(k) MSKCC IMPACT.  No such coverage for MSK IMPACT in the final.
• Difference #3:  FDA CDx tests + disease type.  CMS looks to tests BOTH being cleared/approved as IVD, AND as companion diagnostic, AND with an indication in each patient's cancer (e.g. "lung cancer.")
• Difference #4:  LBx LDTs better off.  There was essentially no coverage for advanced LDT liquid biopsy panel tests as they awaited FDA approval; now they can be covered by LCDs.
• Difference #5:  Nix Huge National CED Program. The Draft proposed a massive national CED program; there's no CED at all in the final.
• Difference #6:  LCD Coverage Not Killed.  There was no LCD coverage under the Draft, it was voided.  Now, LCDs can cover NGS tests with some stipulations.
• Side Issue #1:  Safe Harbor for Germline Risk Tests.  Germline tests with NGS (such as Lynch panel or BRCA-related panel) seem exempt from the NCD due to a sentence on page 4.
• Side Issue #2:  Some "Excess coverage" scenarios.  NCD could lead to "excessive coverage" in some possible scenarios.
• Side Issue #3: Paradoxically discourage migration to NGS?  Since the NCD controls NGS methodology so closely, it could discourage migration of some tests to NGS platforms, since they'd require revisions to the NCD even if PMA approved but outside the NCD rules.  Labs can do Sanger and PCR to their heart's content since the NCD doesn't touch them.
• Side Issue #4:  Oncologist must order.  CMS clarifies that while Medicare allows pathologists to order some tests themsleves ("a stain needed to complete a case"), only treating physicians can order NGS tests.
• Side Issue #5:  What about FDA and 510(k) CDx?  FDA has cracked the door open for 510(k) "companion diagnostics" with a 12/2017 BCR ABL test; can this be a wider door for developers?
• Medicare Nerd Points include that: (A) there's no clue how MACs will handle the potential opening up of off label gene results and off label drug options with tens of thousands of imminent, real-world patients.  (B) LDTs might dodge the "one test per patient" rule by having a 300-gene test, a 305-gene test, a 310-gene test.   (C) CMS covers a 400-gene panel, based on its CDx indications, even if only one gene was CDx-relevant to a patient's cancer, and that gene is already known to be positive or negative.  

Differences from the draft include:

• (Difference One)  Approved and Cleared (meaning PMA and 510k) tests treated at parity - but only for patients that have a "companion diagnostic" indication.  And so far, FDA has almost never granted the "companion diagnostic" status to a 510(k) test.
• Is this sharp difference between 99% accurate tests a good policy idea?
• Both PMA and 510(k) classes of tests might be, for example, 99% accurate (Kim et al 2018; or Shin eta la. 2017; or Strom et al. 2015), run on essentially similar platforms and chemistry, and thus produce nearly identical reports on the same tumor.  Diagnostic lab tests measure things, which is different than a therapeutic device or drug.  They don't measure or cause outcomes; they measure things.
• PMA tests are always validated on "clinical data."   FDA allows either (1) de novo clinical studies, or (2) briding studies aka concordance studies in paraffin blocks on a lab bench to an existing test.  Most of the FMI genes were PMA approved via concordance [bridging] studies in about 200 paraffin blocks (here)...e.g. these are benchtop analytical accuracy studies.  Accuracy studies are equally available to 510(k) tests.
• 510(k) tests require at a minimum "paper dossiers" collating clinical trial data, guidelines, and I suppose FDA labeling in order to list gene test results as clinically validated.   (This is tier 2 of the FDA's "food pyramid" of precision medicine test results).   However, at least one 510(k) test for BCR-ABL includes some clinical studies in its paperwork, meriting classification as a companion diagnostic.  
• For a short deck on the FDA's PMA and 510(k) CDx approaches, see here.
• FDA's approach to giving out test indications is evolving.  
• FDA's historic approvals of single-gene tests (like cobas BRAF) were for one drug based on one clinical trial of one gene.  
• But when the FMI test was validated against one BRAF diagnostic that was validated for one drug, to my eye FMI gets on label indications for all BRAF drugs.  See here.  
• This indicates FDA is shifting to test accuracy, not one-by-one pairings of genes with different drugs, for indications.  
• FDA's own paperwork reviewing the FMI test (58pp) and the MSK test (57pp) show extremely high NGS read accuracy for both tests.  I'm a board certified pathologist; if both tests are 99%+ accurate at reading sequences from paraffin blocks, then their reports are the same, and what's left to debate?
• The FDA required studies showing that the FMI test is >90% concordant with prior PMA single gene tests.  See online.
• The FDA required studies showing that the MSK test is extremely reliable and accurate for sequencing, and its reported genes are clinically valid based on literature (including FDA labeling).   See online.
• Nutshell:  Private payer policies and MAC LCDs may not see as much difference as CMS does between accurately-measured gene reports and accurately-measured gene reports labeled as CDx. 
• But wait! There's more.
• (Difference Two)   The draft had CED-based NCD coverage for MSK IMPACT.  The final has no automatic coverage for MSK IMPACT (since it's not released as a CDx so-labeled by FDA).   
• FDA allows 510(k) gene panel tests based on accuracy + clinical literature.  That's the road IMPACT took.   However, and experts tell me this is new, FDA has also begun clearly 510(k) tests if they have high accuracy + some clinical study data.  See the December 2017 approval of the MolecularMD BCR-ABL test, which is a 510(k) test supplemented with a few pages of clinical data. It's K173492.
• FLAG.  Don't try to interpret the NCD without referring back and forth to the FDA Companion Diagnostics Page.   
• See Medicare Nerd Question 1, below.
• (Difference Three) For NGS, companion diagnostic tests, CMS looks to the test being cleared or approved as a companion diagnostic, "AND," the patient for whom the test is ordered must have an on-label indication (e.g. "lung cancer.)   
• This means the NCD covers the Thermo Fisher Oncomine test for lung cancer; the FMI F1 test for lung cancer, colon cancer, and a few others.  
• However, my reading is that CMS only looks to the test labeling ("lung cancer.")  So such a test is usable in all advanced lung cancer patients, even if a particular on label drug has narrower labeling (like only "second line lung cancer patients that have failed cisplatin.")   
• (Difference Four) Liquid Biopsy Tests.
• The draft had no coverage for LDT gene panel LBx tests.
• In the final, prior to FDA approval,  NGS LBx panels can be covered under MAC review.
• As they become available, FDA authorized "CDx" NGS panel liquid biopsy tests will be covered under the same conditions as other NGS tests.   
• CMS states later in the NCD discussion that it doesn't distinguish NGS tests by sample type. 
• Note that FDA defines the recently created NYS/510(k) accelerated pathway as being for tissue tests, not LBx tests.
• (Difference Five) There's no "Coverage with Evidence Development" / CED. Period.  
• Pretty massive CED had been in the draft.
• (Difference Six) LDT NGS tests can get MAC LCD coverage.  
• Local MACs aren't obligated to cover them, however.
• This LCD escape clause isn't a free ride.  
• (A) NGS LDTs that are in the 28 MolDX states get extremely close technical review which can take hundreds of pages and months of time.
• (B) Other MACs have been pretty frugal about covering gene panel tests at the LCD level.
• When a test like FMI CDx is used "off-label," for example in kidney cancer, it can be covered by this local LCD option.
• If I were MSK IMPACT, I'd quickly publish a study that I matched with FMI F1 99% of the time, if I could, and bring that to MACs.
• There's one restriction, the NGS test must be used in a patient with advanced cancer, even under the LCD pathway.

A few interesting side issues include:

• (Side Issue One) Germline NGS tests are "OK" - when you read the fine print!
• The full NCD needs to be read, not just the coverage section.
• First, be aware that today, all states cover LCD based NGS testing for germline cancer risk in patients with personal history of breast cancer and personal history of colon cancer.  
• But, the opening section of the NCD warns that it allows NGS testing by NCD or LCD "only" for patients with is advanced cancer.
• However:  In the body of the NCD we read:
• "We do note this decision is not applicable to all diagnostic laboratory tests using NGS, but rather to a unique diagnostic laboratory test that uses NGS for patients with cancer to manage the patient’s cancer by identifying either targeted therapies with known efficacy or in some cases, eligibility for a cancer clinical trial."   
• Since BRCA panels and Lynch panels aren't for "targeted therapies" they seem to be exempt from review under the NCD.  Assuming the sentence I've just quoted is operative and interpreted the same way by CMS and MACs. 
• Bad drafting!  I would have put this clause in the opening sentences and not buried in the 60 page text. The sentence appears on page 4 of my PDF version.

click to enlarge (p4 of 60p NCD)

• (Side Issue Two)  Could the NCD lead to "Excess Coverage?" 
• Serial testing by different tests?  The NCD seems to cover multiple serial, different FDA reviewed tests, without much restraint, as long as the same one isn't used twice.
• This is easier for LDTs, which could make a 350 gene version, a 351-gene version, a 352-gene version.
• CDx Tests Covered Even If CDx Genes are "known positive" or "known negative."  For example, the multi-thousand dollar FMI F1 CDx test is covered in melanoma, even though it only has one approved gene in melanoma (BRAF).  Even if a patient's cancer is already known to be BRAF positive or negative, CMS seems to cover the FMI test.  This undercut the high importance given by CMS to pivotal on label CDx results as a justification for testing.
• No "value based purchasing" - everything is equally covered..  For example, if Test A has three genes in lung cancer, each at 10% frequency, and a Test B has one gene in lung cancer, at 1/1000 frequency, both are covered.  It's hardly "value based purchasing..."
• No limits on block age.   From time to time, a patient relapses after 5-10 years.  The NCD has no restrictions on age of blocks.  CMS probably assumes clinicians will use common sense.
• Duplicate testing.  Medicare's Correct Coding pathology manual has the commonsense policy that CMS won't pay for testing the same analyte twice.  So if you run the FMI panel, you probably shouldn't later run individual ALK, EGFR, etc., tests.  However, if you run the single gene tests first, the NCD does protect payment for the FMI test, as far as I read it.  (I'm not saying I'd actually try this.)
• The MSI elephant in the room.   Keytruda is approved for all advanced cancers, so an NGS test with MSI at the "FDA Compansion Diagnostic" indication level  would be covered for all advanced cancers.    
• However, the test would have to be "approved or cleared as a companion diagnostic for MSI."  
• The Medicare-covered population would probably be "all advanced cancers" if the MSI test is so approved, because Medicare doesn't plan to read through to the actual more restrictive Keytruda drug labeling (advanced cancers that have failed lines of therapy and have no options).  
• (Side Issue Three)  Discourage migration to NGS platforms for non advanced cancers?
• The NCD certainly encourages migration of tests onto FDA/NGS platforms if they are tests for therapies in advanced cancers.  If you move your Sanger or PCR test for advanced cancer to an NGS platform (and it's an FDA companion Dx) it's auto-covered by the NCD.
• But, the final could discourage migration of diverse tests to NGS platforms for indications for non advanced cancers, since they can't be covered, since cancer is non advanced and it's a test that employs or deploys NGS.   
• For example, if the Oncotype test for non metastatic breast cancer migrated from PCR to NGS, it would become non-covered, which is weird.  It would fail twice under the NCD: it would be for non advanced cancer, and, it would fail to be a companion diagnostic.
• Mitigation 1:  This may be muted by the text in the body that says it applies the NCD only to tests intended "to identify targeted therapies."
• Mitigation 2:  I suspect as soon as someone actually had in hand a real FDA approved NGS test for non advanced cancer, CMS would revise the NCD.
• Mitigation 3:  The LCD section is not restricted to any particular indication for NGS testing.   But it is restricted to advanced cancers X 1 use per test.
• (Side Issue Four)  Tests must be ordered by treating physician and that is not a pathologist.  
• See Q&A discussion inside NCD.  Normally tests must be ordered by "treating physician."  There's a longstanding CMS exemption for a pathologist to order a test in order to complete a report (CMS BPM Ch15:80.6.5).   CMS says don't use the exemption here.   Ordering a $4000 test to complete a tumor report seemed like a stretch; CMS confirms it's a no-go.
• (Side Issue Five)  Creates a very high incentive to make 510(k) type "Companion Diagnostics."   Even an FDA expert I talked to thought that the "companion diagnostic" label was available only to PMA tests.  PMA devices involve high regulatory costs, fees, annual reports, etc.   With the coverage guarantee from CMS applying to either 510(k) or PMA CDx, developers will be looking closely at how the MolecularMD test got CDx indication on a 510(k) platform in December.   
• This is another flag to how fast the FDA is changing the options.  
• In June 2017, the Thermo Fisher Oncomine test was approved for 3 CDx genes, and only allowed to report 20 additional genes most closely tied to lung cancer.  
• In November 2017, FMI is allowed to report a larger handful of CDx benes, but throw in 350 extra genes of highly variable clinical utility.   
• Then in December 2017, a BCR-ABL test gets CDx status on the less costly, less regulated 510(k) policy platform.

The NCD is 62,000 words long and prints, for me, at 60 pages.

Here's my graphic of current FDA approaches to CDx labeling.  Full deck here.

click to enlarge

Medicare Nerd Points

Medicare Nerd Question 1.

Are 510(k) tests really not covered at all?

This one is a doozy.

"Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met."

Wait for the rest of CMS's requirements.  The test must be cleared as a companion diagnostic AND have an indication for THAT patient's cancer (e.g. lung cancer).

PMA approved tests are approved "as a companion diagnostic" but 510(k) tests are very rarely "cleared as an in vitro companion diagnostic."  See the FDA's list of "companion diagnostic" tests here.  It lists drugs (NDA/BLA) and then tests (PMA) although the page title says "cleared or approved as CDx" so it is possible for a 510(k) to be a CDx.  One isolated example being MolecularMD BCR-ABL K173492 - the test is a Class II 510(k) clearance but the validation included two explicit clinical studies, which is why it ranks on the FDA CDx webpage.

The labeling for FMI CDx F1 clearly states it is approved as a companion diagnostic for a limited table of genes and drugs (this table doesn't currently include F1's MSI or TMB signatures and certanly doesn't include all the hundreds of genes).

The FDA CDx home page indicates that the pathway may be PMA, 510(k), or Humanitarian Device, but virtually all of the CDx's are PMA.

CMS will depend on the FDA CDx table.   This rolls up older PMA CDx whether or not FDA in older times used the term "CDx" as prominently or consistently in labeling.  PMA CDx are important to list, since you can get a new PMA test by matching the performance of an existing PMA test. 

Another FDA source of information is their "food pyramid" and attending text about CDx claims that FDA published in NOvember.  To be a CDx, you must have Analytical validity + direct correlation with clinical trial OR concordance in paraffin blocks to a prior CDx test. 

510(k) tests can now be released that report gene panels for cancers, where to  clinically significant mutations, you can have high analytical accuracy, no clinical studies, but compile the relevant clinical literature.   See here. 

Let me use an example.  So one test, you measure ALK fusion 99% accurately and also show it matches at least 90% of the time to a prior PMA ALK test which correlated with clinical results of Xalkori.   In this box, you'll find the FMI F1 CDx PMA test.  The next test, you measure ALK fusion 99% accurately and know that correlates with clinical results of Xalkori based on this PMA labeling and an NEJM article.  In this box, you'll find the MSKCC IMPACT test. 

Medicare Nerd Point 1.  

Advanced Cancer versus the Diversity of Cancer

NGS tests[for therapeutics] can be covered in advanced cancer, but never covered in non advanced cancers.

• Is glioblastoma an "advanced cancer?" by CMS's specific definition?   It's not usually recurrent (it doesn't go away) and it's not metastatic and not usually referred to as Stage III or IV (which varies by cancer but for most solid cancers is based on anatomy and distant metasasis.)  
• Is leukemia an "advanced cancer?"  It's not always "recurrent" and isn't commonly called "metastatic" (leukemia cells aren't found in places foreign to white blood cells, and who hears, see the patient in room 209 with metastatic leukemia?)   There are "staging" systems which really look like "cell classification" systems in which CMS can't find a way to describe any advanced stages and terms like "III" and "IV" aren't used - here.

Medicare Nerd  Point 2. 

On label versus Compendium cancers.

Based on a long history of policymaking, CMS generally covers FDA-labeled and Compendium-endorsed drugs at parity.   However, the NCD is specific to FDA labeling for the test and its drugs. The NCD has no entry point for compendium endorsed drugs, except for the LCD clause at the bottom of the coverage section.

Medicare Nerd Point 3.

Time Needed for Real-World Implementation of the NCD.

NCD's are legally binding on the day they are issued.  However, MACs usually only implement them per CMS coding and implementation instructions that may appear months, even a year, later.   With an NCD of this immediate impact on hundreds of thousands of patients, let's see what happens.

Medicare Nerd Point 4.

How Will CMS Handle "Medicare Advantage" Financials?

Medicare Advantage Plans must cover what is covered by CMS.   However, there is a concept where some large NCDs or other abrupt coverage expansions are not the financial obligation of MA plans for the first year or two.   It remains to be seen if CMS rules this NCD is an immediate coverage and cost expansion for MA plans, or, if it will use the option to run NCD-based claims through regular Part B for the first year or two for MA plan patients.

Another aspect of the NCD is that Medicare Advantage plans seem obligated to cover all PMA approved gene panel tests even if they would rather contract and discount with a few preferred venders or based on the MA plan's assessment of test quality and usefulness.  Again, the NCD doesn't include "value based purchasing."

Conclusion

Medicare Nerd Questions remind me of another project I am working on this year.

In sepsis policy, CMS has a 2015 metric called SEP-1 which requires several steps to be executed within 3-6 hours of diagnosing sepsis.  The key bullets are very brief.  However, CMS has released a 150 page rulebook for implementing this metric, and many implementation issues are still contentious.  (How do you define the minute when sepsis is diagnosed?  If antibiotics must be administered, which drugs count?  All these issues lead to pages of discussion and terrorizes providers.)   Similarly, the coverage section of the NGS NCD is short, but implementation across a wide range of cancers, drugs, labeling variations, and constantly updated FDA tests and indications will require a rulebook.   (Similarly, the CED proposal in the November proposed NGS NCD was short to write and read, but would have been very complex to implement, and as originally written led to some nonsensical implications.)



___________________________

CMS NCD Final Coverage Text:

A.  Coverage

The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

Patient has:

• either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
• either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and
• decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

The diagnostic laboratory test using NGS must have:

• FDA approval or clearance as a companion in vitro diagnostic; and
• an FDA approved or cleared indication for use in that patient’s cancer; and
• results provided to the treating physician for management of the patient using a report template to specify treatment options.

B.  Other

Medicare Administrative Contractors (MACs) may determine coverage of other Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a treating physician and the patient has:

• either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
• either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and
• decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

___

Endnotes.

Endnote One.
Volumes of Data on Test Results Will Have No Tracking

While this effort is closed for now, the testing will generate volumes of genomic data on Medicare patients and will lead to large amounts of drug administration whose outcomes aren't well enough tracked.   See a current March 2018 article in JAMA by Feero, tied to a March 16 National Academies publication on learning healthcare systems in genomics. 

I've argued that if you had test, cancer, test results, and Part B and D drug records, it would be enormously important, directionally correct real world evidence.  The only part CMS is missing is the tests.  Such data would start to enormously improve the work of tumors boards and provide return for CMS's now-finalized billion dollar investment in tumor gene panels; see Patel et al. 2018 and see Perera-Bel et al. 2018.  While groups like TAPUR move in this direction, and Syapse facilities sharing among users, and the FMI-Roche-Flatiron provides a giant-size proprietary footprint in this region, CMS/HHS should be doing something, because important issues like racial health disparities in genomic data are involved (see here, and see also the NAS report).

Endnote Two.
How Will MACs Handle New Opportunities for Off Label Drugs?

Some have argued that the broad sequencing will release a lot of data to clinicians of Medicare patients regardless of whether local MACs or Medicare Advantage will cover off-label drugs, the net risk-benefit of off-label drugs, etc.   CMS sidestepped a Q&A question on this issue by treating it as primarily one of speculative emotional stress rather than speculative medical risk/benefit.  For a paper on potential emotional stress, see JAMA Oncol 2017 here. 

Endnote Three:  
Why Use a $100 Test If Medicare Covers a $4000 Test?

Regarding the possibility that patients will get a $4000 NGS MSI test (on a panel) when they only "need" a regular $100 MSI test, CMS stated that cost considerations were out of scope of their review.

THERANOS: SEC Action; See CMS Theranos Payments Here.

On March 14, 2018, the SEC issued a press release with the title: "Theranos, CEO Holms, and Former President Balwani Charged with Massive Fraud." 

The 24-page SEC PDF against Holmes is online at SEC here.    Less-noted is the 23-age SEC complaint against Balwani - which describes him as Holmes' one-time boyfriend; here.

Coverage today, including open access coverage, is widespread.  See e.g. WSJ, Bloomberg, Forbes.  NYT article, NYT OpEd.  Political view at Vox.   Update; May 2018 coverage of the boyfriend, WSJ, here.

The decline of Theranos is usually traced to an October 2015 expose' by WSJ's John Carreyou (for the story on the story, here).  And in April 2016, David Boies was still telling NYT that he and the board have complete faith in the CEO.  But by April or May 2016, Medicare data would have been published showing they had only $15,000 in Medicare billings in 2014, although they confirmed to investors that in 2014 they had $100M in revenue.   See below.

Background

I kept an online running inventory of web articles about Theranos from December 2014 to December 2016, totaling about 500 links.   Here.

The case has two aspects: (1) overstatements of the success of the Edison point-of-care platform, and (2) overstatements about actual revenue.   This second story is much newer and is my focus here.

Using SEC filings, WSJ shows charts of $600M investor cash raised by 2014.  WSJ asserts that Theranos stated revenue of $108M in 2014 versus $100,000 actual:

SEC filing 3/14/2018

Discrepancies between lab revenue claimed versus actual would have materialized annually from Medicare public access records.  I've put Theranos Medicare payments in the cloud for CY2014 and CY2015, but these are just pulls from the open access CMS dataset.

• From this data, for Theranos billing under NPI 158-854-6401, CY2014 payments from Medicare Part B were $15,311.  
• Blood draw was billed for 574 unique Medicare patients.   
• Theranos billed the US Medicare program for less than 50 cases of most lab tests it billed.  (Generally, it charged CMS the CMS fee schedule amount).
• CY2015 payments, from the same data for same NPI, were $128,804.
• Very few beneficiaries had more than 1 lab test per type of test.  E.g. "1" of test X and "1"  of test Y per year.

Since Medicare revenue is usually 1/4 or 1/3 or more of lab revenue for tests (here), it would be hard to extrapolate from these public numbers ($15K or $100K) to income of $100M.   If what Theranos was asserting to investors for clinical revenue was far different than actual, the gap would have declared itself at regular annual intervals in public CMS data.   The train wreck would be fast and there would be nowhere to hide.

If Theranos stated to investors in early 2015 its 2014 lab revenue was $100M, what did they expect the reaction to be in May 2016 when data was public that its Medicare 2014 lab revenue was $15,000?

This financial issue would have come out and been the same story, even if the Edison lab machine had worked perfectly.  Even if John Carreyou had never heard of them.  It's remarkable.  It's not just a "misleading story" like convincing yourself the Edison is better that it is, or holding a delusional belief it is getting better faster than it is.  The financial statements can't be classed as wishful or misguided; they were like jumping off a building without a parachute. 

CY2015 Part B to Theranos.  Click to enlarge.

___

BuzzFeed has an interesting approach, mining public "Glassdoor Reviews" comments by employees about life at Theranos, here.   For Buzzfeed's take on 7 biggest lies, here.

SEC case; a key financials page: click to enlarge.

SEC financials.  Click to enlarge.

 ___
Regarding tests per patient.  For 85025, CBC, Theranos did about 1.05 tests per patient.  Quest did 1.6, with some Quest centers doing >2 per patient (same database; data not shown).
___
On a personal note, as an MBA working with larger and smaller startups, I'm still amazed they could raise >$500M while the CEO owned half of the company but controlled 99% of the voting stock, and the board members were 85 year olds who knew nothing about healthcare or technology, rather than voting investors.  It's an overused word, but it is - amazing.

Very Brief Blog: President's Cancer Panel Releases Report on Cancer Therapy, Prices

The President's Cancer Panel serves NCI and was created by the National Cancer Act of 1971.*  New news: The panel has now issued a report on "Promoting Value, Affordability, and Innovation in Cancer Drug Treatment."

The 70-page report is online here.   Trade press at  BioPharmaDive here.

The report focuses on cancer drug prices and the rising number of therapies that are priced >$100,000 per year.   From several word searches, although focused on current cancer policy, the report has virtually no discussion of genetics, genomics, precision medicine, or diagnostic testing.   (The word "test" only occurs in contexts like "testing new payment models.") 

Right to Try

In other news today, Right to Try legislation failed to reach a 2/3 majority vote in the House, falling 7 votes short.   Right to Try is "access to experimental options for life threatening illnesses when patients have run out of options."  It was supported by most Republicans and by the President per his State of the Union speech.  US regulators were generally not in favor, pointing out there are already "compassionate use" frameworks that are similar to the right-to-try concept, but follow trackable channels.  In October 2017, FDA commissioner Gottlieb "raised concerns" about the bill, as did Deputy Commissioner Rachel Sherman and CBER director Peter Marks.   I've borrowed from a trade article here.

Stem Cell Therapies & FDA

Stem cell therapies have, in some cases, been relatively unregulated as "practice of medicine," hence the billboards and odd clinics and claims we see in California.  FDA has vowed to crack down on that.  In a new article in NEJM, FDA outlines its path for regulation and approval of stem cell therapy products.  Trade press here.  The article cites to four recent FDA guidance documents.  The article states:

Such an approach is just one example of how the FDA is taking an original policy approach to the regulation of a highly innovative field, one in which our traditional approach to regulation may not be as efficient or effective as in more mature fields. 

As part of its efforts in the area of regenerative medicine, the FDA is also encouraging investigators who are involved in innovative product development to engage in dialogue with the agency early on in the process, including through informational meetings, before more formal discussions are held about submitting an application for an investigational new drug.... Our aim is to refashion our traditional tools for regulation to meet the challenges and opportunities presented by such highly innovative products as cell-based regenerative medicine.

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Richard Rettig's 1977 book on the National Cancer Act of 1971:  "Cancer Crusade," Princeton.  Legislative history was a carnival and the history traced back a decade.

Genetics Company Receives OIG Subpoena March 12; Updates March 13

From Genomeweb open access:

OIG Subpoenas Myriad Genetics for Hereditary Cancer Billing Documents in Investigation

Mar 12, 2018

| 

staff reporter

NEW YORK (GenomeWeb) – Myriad Genetics recently received a subpoena from the US Department of Health and Human Services, Office of Inspector General, related to "an investigation into possible false or otherwise improper claims submitted for payment under Medicare and Medicaid," the company said in a regulatory document.

According to a Form 8-K filed on Monday by the company with the US Securities and Exchange Commission, the OIG subpoenaed Myriad for documents related to its billing of government-funded healthcare programs for its hereditary cancer tests. The subpoena covers a period starting Jan. 1, 2014, through the date when the subpoena was issued. Myriad launched its 25-gene myRisk Hereditary Cancer test in September 2013.

Myriad said in the SEC document that it is cooperating with the government’s request and responding to the subpoena. At this time, no claims have been made against Myriad.

___

Myriad payments from Medicare are open public record, but Medicaid payments are not.  CY2014 CMS payments are here, CY2015 CMS payments are here.   CY2016 CMS payments have been released by state; they will be released about May/June 2018 by lab or doctor.

2014 click to enlarge

2015 click to enlarge

Cloud spreadsheets here 2014 and here 2015.

I've previously noted (October 2017) that there seems to be a 2015-2017 edit blocking use of 81211-81213 together unless a special medical circumstance dictates that use of a -59 modifier is appropriate.  CMS reiterated the same 81211/81213 edit in December 2017 for CY2018, here.  As a retired former medical director, and consultant giving advice to other labs about how CCI edits work and are enforced, I was puzzled how Noridian was handling the intersection of the 81211/81213 payments in light of the CCI edit; see Noridian's response here.  CMS guidance on when - and when not - to use Modifier 59, here.  Article by OIG authors on Modifier 59, here.

MYGN Update (3/13)

In a commentary at a Cowen and Company conference, early on March 13, 2018, [audio archived in cloud], CEO Mark Capone briefly commented on the subpoena, noting that Medicare was only 7% of Myriad revenue and that doctors typically currently order Integrated BRACAnalysis and MyRisk, the former of which is processed in a Sanger laboratory and with a large DupDel platform BART, and the latter in a separate NGS laboratory.  MyRisk was undergoing MAC contractor review and finds substantial mutations not found in BRCA analysis alone.   Currently billing is via 81162.

AMA Update (Posted 3/13)

Details of a February 9-10 AMA CPT meeting are confidential to participants and observers of the meeting.  However, AMA posts a brief public notice of the results on its website.  Revisions to the BRCA code set were determined and would normally appear in the 2019 code book.  In its public notice, AMA refers to "deletion of 81211, 81213, 81214."

Myriad Stock Down on March 13, 2018

In morning trading on March 13, 2018, MYGN was down about 10%, from about $33 to about $29.   Recent peaks include $43 on October 1, 2015 and $37 on January 1, 2018; recent troughs include $16 on January 1, 2016.

2014-2015-2016 BRCA Payments by CMS: Data Tables.

Tables of 2014-2015-2016 BRCA payments by state and lab here, with links to all data sources.