Thursday, June 22, 2017

Landmark FDA Approval of NGS Gene Panel Test - Thermo Fisher WIns PMA Race

Thermo Fisher announced on June 22, 2017, that the FDA had approved a 23-gene version of its Oncomine NGS oncogene panel test for lung cancer targets.  See the press release here.

See the product website here - the Oncomine DX Target Test.

See initial coverage at Genomeweb, here.   Genomeweb notes that the test can run on as little as 10 ng of DNA.

Still in the FDA pipeline are tumor oncogene panel tests developed by Illumina and Foundation Medicine.

The cited Thermo Fisher press release is quoted below the break.

Wednesday, June 21, 2017

Panel June 21 at BIO Conference: Federal Regulatory Perspectives on Genomics

On Thursday, June 21, at the International Biotechnology conference (BIO) in San Diego, I'm on a panel.   Speakers are Brian Carey (Foley Hoag LLP), Christopher Hall (President, Veracyte), Dan Todd (Todd Strategies LLC) and myself.

If of interest, my deck is in the cloud here.  

The talk outlined in the deck will review the FDA "bombshell regulation" effort of 2014, its fizzle-out after the Trump election, and the rebirth of legislative alternatives (e.g. the DAIA bill in 2017).   I also discuss "FDA Lite" regulation of some genetic tests and the slow breakaway from the one-drug, one-gene, one-test paradigm.   Regarding payers, I discuss that CMS Parallel Review still has very few examples after five years, while local CED or "CDD" is a quirky saga.  In other coverage trends, there will be a short update on PAMA and a discussion of how payers are adapting to gene panels and how the "Laboratory Benefit Management" industry may emerge more rapidly than some think.

Brief Blog: Medicare Payments for Pathology Slide Consultations in CY2015

Medicare recently released a database of all provider payments by CPT code in CY2015, here.

Pathology Slide Consultation Codes
Code 88321 pays about $90 for review of slides prepared elsewhere.  There were 181,427 services totalling $17,043,561 in allowed charges.   88325 is for "comprehensive" review (e.g. with medical records or imaging), paying about $180.  There were 8,224 services totalling $1,513,496 in allowed charges.  These are from summary 2015 data of all Part B services.

The provider payment database is just a bit different as it excludes providers with <10 services per CPT code.  Here, in this database, I tally $17,037,639 services for 88321+88325.   The top 10 providers were 19% of payments and the top 15 were 22% of payments.

Academic Institutions 
The top provider was Johns Hopkins ($690,728).  The third top was UCSF Dermatology ($555,931).  The sixth top was Washington University ($186,959) - showing that the dollars drop off pretty fast.

Not Academic Institutions
The second top provider was a medical corporation in California, enrolled as a clinical lab, $621,878.  The fourth and fifth top were individual doctor names, enrolled as dermatologists, one in Colorado, one in California, receiving $315,802 and $248,187, respectively.  The seventh-top provider was a California dermatologist.  Three of the top 7 providers were dermatology practitioners or groups.  According to AMA RUC online data, only 8% of all 88321 billings were from dermatology, but if they bill, they can be very active.

The AMA RUC database, which is copyrighted, provides a very lengthy RUC panel discussion and rationalization for payments on 88321, describing it as part of a 2016 CMS screen for high cost services > $10M.

The RUC states in part, and I hope this is a fair use short extract, "The RUC reviewed the survey results from 52 pathologists and recommends the following physician time components: pre-service time of 0 minute, intra-service time of 50 minutes and immediate post-service time of 0 minute. The RUC reviewed the survey respondents’ estimated work values and agreed that the specialties’ recommendation to maintain the current work value of 1.63 is appropriate for this service. The RUC compared the service to key reference service CPT code 88307, Level V - Surgical pathology, gross and microscopic examination."  Accordingly, the database physician time assessment for 88321 is 50 minutes.  (88325 is valued for 90 minutes).  This suggests dermatologists billing 1000-2500 service units spent 833-2,083 hours per year doing consult slides, or 3 hrs to 8.5 hrs per each M-F workday.  (A standard work-year of 50 weeks x 40 hours is 2000 hours).  This would be a record of only their Medicare Part B practice.   In some cases, what appears as single physician billing might be rolled up from several in a group practice, I think.

Tidbit. Each single immunohistochemistry slide is valued by the RUC at 25 minutes (CPT 88342; same for 88341 for 2nd and add'l slides), suggesting each tray of 10 such slides requires almost 5 hours to sign out.

Flurry of Progress forHeartflow, But Medicare Coverage Lags Private Payers

Heartflow is a Bay Area company that has raised over $200M to create and commercialize sophisticated software that assays dynamic cardiac flow built on existing imaging technologies.   For an early, deep-dive article from 2011, see here.  For a more recent article, here.

This summer, Heartflow announces favorable assessment from BCBS Evidence Street (the successor to BCBS TEC).   See news here, here, here.   Heartflow has just completed some big hires, including former J&J Chairman William Weldon as Chairman of Heartflow's board, and experienced senior executive Michael Buck as EVP and Chief Commercial Officer.

Medicare Coverage?

The web also has some clues to the status of Medicare coverage.   An online reimbursement states that coverage is subject to LCDs and no LCDs have been announced (here; on web 6/21/2017).

A new layer was added in April 2017.  An online decision by the Departmental Appeals Board, a judicial panel at CMS, found that that Heartflow was appropriately denied enrollment in Medicare as an Independent Diagnostic Testing Facility (IDTF), and stating further that the MAC had determined "the service...was not reimbursable" (see the 25 page CMS judicial position here).
CMS argues the added software diagnostic service and novel report were bundled in prior payment for cardiac imaging test "and interpretation."  CMS maintained this, so far, despite arguments that the underlying imaging was purely spatial and anatomical while the new report was novel information about functional cardiac flow.   CMS argued that if the single Heartflow service was foreseen as not-billable, there was no need to enroll the company in Medicare. 
CMS precedents seem to fall on both sides.  In some cases in imaging, CMS has indeed made payment for additional diagnostic interpretation when clearly represented by CPT codes; see special codes for 3D rendering interpretation and mapping of CT and MRI exams.  See a 2016 story about older supplemental rendering code 76375 being replaced recently by '376 and '377.


A substantial part of the 25-page judicial decision is devoted to matters of due process, miswritten deadlines, etc.

Brief Blog: A Prototype View of the Digital Genomics Industry

Over the past year, there is increasing consideration of a "digital genomics" industry, which I've sketched in a prototype map below.

Full discussion after the break.

Tuesday, June 20, 2017

Brief Blog: Does MOLDX Manage 87% of US Medicare Molecular Pathology?

A few days ago, CMS released provider-specific and CPT-code payment files for CY2015.   See the initial blog here, which includes a targeted analysis of Medicare spending via unlisted code 81479 (here).    Later, we provided a brief overview of Medicare spending by several key categories (here).

Today's analysis sorts each state by Medicare mopath spending (codes 812xx 813xx 814xx 815xx) - and then aggregates states by MAC and by whether the MAC is part of MolDx.

If our analysis is correct, 87% percent of US Part B MoPath codes pass through MolDX states and policies.   

Most of this is via Noridian, with the lead states of California and Utah.  See the following table; click to enlarge:

We also provide data sorted by state for the top 21 states, which cover 99% of payments (click to enlarge):

For MolDX, in round numbers, of $480M total:  there's almost $275M in California, another $50M in Utah and almost $25M in Ohio.  Then add in $35M for Hawaii and Washington State.   That sews it up.

The excel spreadsheet is in the cloud, here.  In the cloud, see several tabs at the bottom of the webpage and see the local-download arrow at the top right.

Disclaimer.  These calculations included quite a bit of sorting and filtering and block-addition by hand; it's correct to the best of my knowledge.

Sunday, June 18, 2017

Brief Blog: Meeker Internet Trends 2017 Report: Emphasis on Healthcare

For some years, Mary Meeker of Kleiner Perkins has released an elaborate annual internet trends report.

The report for 2017 was released at the end of May:

  • See CNBC coverage here.  
  • Download the 355-page report here (free registration required).
Pages 288-319 cover digital health.  Noah Knauf, who joined Kleiner in 2016, is listed as lead author for the health chapter (here, here).

Friday, June 16, 2017

Brief Blog: CMS Molecular Payment Data CY2015

As noted in earlier blogs, CMS posts Part B data by provider name and CPT code for 2012, 2013, 2014, 2015.  The data can be displayed in a web interface that is very easy to sort and then download filtered data in Excel.

Although I'd usually post the Excel file in the cloud for you, it feels awkward to do so, because even though the data is publicly available, it contains hundreds of physician names, addresses, and NPI numbers.  However, you can easily find the data yourself or download it yourself [*].

  • You get a file of several hundred KB and about 2,000 lines by filtering the total database for codes beginning in 812, 813, 814, 815.  (If you're really brave, filter for 8nnnn - all lab and pathology codes - and you'll get a 100 mb dataset of 850,000 lines which does still open in Excel for me on a laptop, albeit slowly.)
  Quick View of 2015 MoPath Data
Biggest CPT Code by Provider
The highest claim line was $57M to Genomic Health for Oncotype DX.

Lines Required to Reach 50% of Payments
The second highest was $32M to Ambry Genetics for "unlisted code."  Just 12 claim lines out of 2000 total claim lines reached $240M or 50% of all payments for the year.

$1M or Higher
62 claim lines were at least $1M or higher (78% of all payments).  An earlier blog noted that 1/3 of all payments went through the unlisted code 81479, and 99% of that fell in MolDX states.

Click to enlarge:

More after the break.

Brief Blog: FDA Burst of Activity on Digital Health Regulation vs Innovation

On June 15, 2017, FDA Commissioner Dr. Scott Gottlieb issued a blog on the FDA's plans for a new Digital Health Innovation Plan.  It sounds like the plan will consolidate several years of planning on regulation of apps and digital health software, some legislative changes in 21st Century Cures, and Dr. Gottlieb's vision toward this kind of agency problem-solving.
  • The June 15 Gottlieb blog is here.
  • Coverage at Biopharma Dive here.
  • Coverage at MedCityNews here.
  • Coverage at MobiHealthNews, here.
  • In addition, MedCityNews on "avoiding legal misteps" in digital health, here; see also here.
  • In addition, a May 2017 article in WIRED on the same topic, here.  Interview with Bakun Patel, "associate center director for digital health."  For another current WIRED article on mobile health apps, here.
  • FDALawBlog on 21st Century Cures legislation and its effect on healthcare software regulation, here, here.
  • In past months, the Clinical Decision Support (CDS) Coalition proposed its own draft validation guidelines (absent clear guidance form FDA; here) and filed a Citizens Petition urging guidance to be released from FDA (here).

As quoted in WIRED: "As Patel, now the associate center director for digital health at FDA, was digging through the guidance’s 1,400 comments, he had a lightbulb moment. “We’ve been trying to translate the current regulation paradigm for digital,” he says. “But what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.”

Gottlieb writes that he wants to continue to rapidly clarify what is NOT regulated by the FDA, and to introduce innovative and rapid processes for things that ARE regulated (third party reviewers, exemptions from review for minor updates.)

Brief Blog: CMS Posts Comprehensive Part B Provider Data Set for CY2015; 81479 Case Study

On June 15, CMS posted the fourth annual comprehensive data set of claims and payments to Part B providers.  See the home page for the annual data sets here and the 2015 data set here.

As described here in a recent blog, the data can be downloaded as very large 2 GB files incompatible with Excel and requiring database management software.  However, CMS also provides an extremely user-friendly online data screening and sorting webpage.   For a discussion of the value of the dataset (using 2014 data), here.  For my brief overview of how to use the dataset step-by-step, here.

For example, in one second, you can find that 22 entities billed CMS in 2015 for 81211 - BRCA sequencing - with from 11 to 13,717 claims paid per entity.[*]   In a minute or two, one could track 81211 payments (or any other code of interest) for any or all providers sequentially in each year from 2012 to 2015.

For an example of dataset use, see below the break.

Thursday, June 15, 2017

Brief Blog: MEDPAC releases annual report to Congress

MEDPAC is a standing federal body that issues reports to Congress on Medicare policy, and holds five or six public meetings a year on Medicare policy topics.

The June 2017 annual report is released today and weighs in at the usual 350 pages.  Here.

Topics include bundled payments for post-hospitalization care, Part B drug payment issues (e.g. physician office drugs like chemotherapy), use of "premium support" in Medicare, an alternative to current Medicare Advantage, the MIPS/MACRA metrics program, pharma/medtech payments to teaching hospitals, and an "overview of the device industry."

MEDPAC is harsh on the new MIPS metrics system, saying it will not help patients chose better physicians, help physicians improve outcomes, or shift CMS meaningfully toward better value for outcomes.   (But, the massive MIPS buro-juggernaut chugs on, here).

The medtech device chapter highlights Medicare's new-inpatient-technology add on payments, of which only 19 of 53 applications have been approved in 15 years, with only about $200M of add-on payments.
(For perspective, note that Medicare Part A is some $300B a year - that's over $3T in 15 years.  And the $200M allowed over 15 years was budget-neutral, by skimming a minute percentage off all other Part A payments - the $300B a year -  to create $10M or $20M a year in Add-On special payments).
DME medtech is mentioned, along with competitive bidding.  But the high disincentives to innovation by making new HCPCS DME codes virtually unobtainable is not mentioned.

CMS CLFS: Public Pricing Meeting July 31, PAMA Advisory Board August 1

CMS has announced the dates of the annual summer Clinical Laboratory Fee Schedule pricing meeting, as well as the PAMA Laboratory Advisory Panel Meeting.   Historically, these meetings have been held in mid-July, but this summer they fall on Monday July 31 and Tuesday August 1, respectively.

The CMS lab public meeting page will be updated soon (it's here).   You can already see the advance posting of the Federal Register notices online as follows:
  • CLFS Pricing Meeting ("Crosswalk/Gapfill Meeting"), here - July 31.
    • Agenda for the Pricing Meeting, here.
    • The agenda is 8 pages long, 31 regular Tier 1 codes, 1 GSP code, 4 MAAA codes, 4 immunology/microbiology codes (including Zika IgM),  and 16 PLA codes.
  • CLFS PAMA Lab Policy Advisory Panel Meeeting, here - August 1.
CMS requires registration in advance; instructions to follow.  Registration will open on June 19 and close on July 14.

Details after the break.

Wednesday, June 14, 2017

Brief Blog: The Elaborate Websites of Academic Spin-off Laboratories - And What It Means

Academic outreach laboratories - both general reference labs and for genomics - are increasingly either "bought out" by big national labs or spin off as entities that are independent enough for direct investment and funding.

Recent spinouts include OMNISEQ (from Roswell Park Cancer Center), SEMA4 (from Mt Sinai in NYC), and NAVICAN (from Intermoutain.)   An early example of a spinout was CLARITAS GENOMICS, from Boston Children's Hospital.  Claritas was the subject of a Harvard business school case study (here).

SEMA4 has upped the game for website design.

SEMA4 has a very elaborately coded website with active interacting serial feeds from Instagram, Facebook, Twitter, and more.   It will be "a partnership of scientists, doctors, engineers and genetic counselors dedicated to empowering healthier living through data."   See the website here.

NAVICAN (which raised $15M on June 1, 2017) promises to "bridge the gap between testing and treatment, because all cancer patients deserve access to the best care."  The Navican Theramap process bridges from sample acquisition, to sequencing, to bioinformatics, to molecular tumor board, to chemotherapy access (trials, payers), to the cancer patient's clinical follow-through.   See the website here.

While OMNISEQ's home page is only middle-elaborate, it gets bonus points for the somewhat dizzying perpetual background video.  They also have a very busy, separately branded and located website with similar infinite-loop video background for its specialty service, Immune Report Card or IRC - here.  

The Point Is...

The main point is not the visual complexity of the websites, but the far-reaching horizons that NAVICAN and SEMA4 envision for their services.   

It's wrong to characterize them as "spin out labs" - at least in the stated vision, they are hoping to create offerings that are both broad and longitudinal in their integrated services for patients.   Lab 2.0 - or maybe they hope to be Lab 3.0 - will be something different than "a lab," in this vision.


Although it's not a clean fit to this theme, because it's not an academic spinout, Fabric Genomics (formerly Omicia) has a comprehensive website that describes systematic advanced bioinformatics offerings that will fit you whether you are (a) a clinical lab, or (b) a health system, or (c) a nation running national population-health genomic programs.   The next step, I guess, would be (d) providing healthcare on other planets.

For two more academic spinouts, see from Wash U, Pierian Diagnostics, and see also from Columbia University, Darwin Health.  

For an interesting use of a subtly moving and morphing background to a website, see the consultancy Decibio, here.

Brief Blog: Stanford Big Data Conference: Now Streaming Online

On May 24-25 2017, Stanford held its annual two-day conference on biomedical applications of Big Data.

Watch it all at home at 2 am!   After a holding period, conference presentations now stream online, here.

(The main conference homepage is here.  The 2017 agenda page is here.)

(In related news, on June 13, 2017, it was announced that the director of the Stanford Center for Digital Health had departed for Apple - Dr. Sumbal Desai - news here.  Her Linked-In, here.)

Brief Blog: Detailed Conference Notes on PMWC East (May 2017)

This is the twelfth year of the Personalized Medicine World Congress, traditionally held in Silicon Valley in February and attracting very large audiences.   This May 2017, PMWC held an East Coast conference, for which detailed conference notes are provided online, here.

One of the highlights was an in-depth presentation by NIH leader Francis Collins on the Precision Medicine Initiative ...aka "All of Me"... large population sequencing program.

NIH websites here and here.   Dr. Collin's 23 page deck in the cloud, here.

The PMWC main website is here.  PMWC was founded by Tal Bejar (here).  A few additional screen shots after the break.