Saturday, June 24, 2017

Brief Blog: Comparing Oncotype DX and Veracyte Afirma Adoption Curves

Veracyte is a publicly held, advanced diagnostics laboratory based in the SF area.   It has annual sales of about $65M and a market cap of about $275M.  In their current investor decks, they show the adoption curve of the Veracyte AFIRMA test with US payers (click to enlarge):


It's none too different in terms of pace and progress from a chart published in 2010 by Health Advances documenting the payer adoption curve of the Genomic Health Oncotype DX [Breast] test:


Both charts run 6 years, Oncotype from 2004 to 2010, Veracyte AFIRMA from 2011-2017.

Brief Blog: MIPS/MACRA Rulemaking for 2018 Published; Rapid Coordination of Doctor Metrics & Patient Benefits

CMS released CY2018 MIPS/MACRA rulemaking on June 20, 2018.

  • CMS press release, here.   
  • CMS 26 page summary of 1054-page rulemaking, here.
  • Trade journal article here.
  • The early release 1054-page typescript rule ("public inspection version") is here.   
    • The official Federal Register typeset version will appear June 30.
  • Comment period runs to August 21, 2017 [60 days].
CMS Proposes Simultaneous Prevention Benefit (DPP) and Matching Metrics to Encourage Physician Awareness

Brief Blog: Use of KRAS Testing (CPT 81275) and EGFR Testing (81235) in Medicare Part B CY2015

In June 2017, Medicare released Part B payment data by CPT code and provider name.  The code is in an easily filtered, sorted, and downloadable database online (here).  Here we look at payments for 81275 (KRAS) and 81235 (EGFR).  Details and charts after the break.

Brief Blog: MolDx Updates NGS and Unlisted Code Guidelines (M00127, V3, June 21, 2017)

For a couple years, MolDX has required multiple genes performed as an ad hoc panel to be billed with 81479, the molecular unlisted code, rather than stacking individual CPT codes.   (The latter appears to be the instruction of the AMA CPT, as in AMA CPT Assistant August 2016.)

One of the pivotal MolDX guidance documents, M00130 V2, February 2016, appears to be no longer active on the MolDX website, although some other MolDX documents still refer to it.  Some of the same information is now in M00127, V3 which was updated on June 21, 2017.

M00127 V3 is online at Palmetto here.  I've also cut-pasted below the break.  A cloud archive of M00127 V3 is online here.

The instructions carve out NGS use of sequencing towards unlisted code billing (81479), although some AMA instructions in the CPT handbook state that genomic sequencing procedures are agnostic to method unless otherwise stated.   According to 2015 CMS data, about 99% of the use of 81479 in Medicare Part B was via the several MolDX policy MACs.

Brief Blog: Genetic Testing Best Practices Summit, Chicago July 24-25 2017

Healthcare Education Associations is is sponsoring a Genetic Testing Best Practices Summit in Chicago, July 24-25, 2017.    Topics range from clinical and ethical considerations with secondary findings to payer acceptance of gene panel testing and coding/reimbursement issues.  Many of the speakers are from leading academic medical centers.

Press release here.   HEA website here.  Conference web site here (if this doesn't work, google conference title.)


From Press Release:

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.  
    • A subscription deep-dive article at Genomeweb followed, here.

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.  The product will be rolled out at a number of major US reference labs beginning in July.

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.

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.

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.

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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.   More after the break.

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.

Brief Blog: Omada Health Raises $50M, Led by Cigna

Omada Health, a leading provider of virtually delivered disease prevention programs, announced a new funding round of $50M on June 14, 2017.  For details, here.   


DPP Programs Validated Internationally
Type 2 diabetes is becoming one of the largest drivers of healthcare costs.   International studies have shown that intensive behavioral modification programs addressed to persons who do not have T2D, but are at elevated risk, have a material impact on better health.   In addition, the CDC has developed a certification program for diabetes prevention program (DPP) providers (here).

Medicare Roles Out New Preventive Services Benefit: DPP
Medicare - the Center for Medicare and Medicaid Innovation - ran a large-scale pilot program and found that DPP's were cost saving in the Medicare population (peer reviewed publication here).  CMS will roll out DPPs as a new Medicare preventive benefit in 2018, and plans to include both "brick and mortar" and virtual providers, since both have been proven similarly effective, including in the Medicare population (report of publication, here).  For CMS updates and more CMS links, see the CMMI DPP website, here.

Omada Health
For its home page, here.   For current news articles on Omada, here.  For an undated, but detailed, interview with founder Sean Duffy, here.  See also an announcement of a three-way partnership between Omada, AMA, and Intermountain Health in 2016, here.

Through 9/2015, Omada had previously raised at least $77M (here).  Besides Cigna, investers include Norwest, Humana and Providence, Oak and Oxeon,

Reimbursement Processes
AMA has been in the process of creating Category III codes for both "brick and mortar" and virtually delivered DPP services.   For more details of the Medicare program being planned for CY2018, see Medicare's Part B annual public rulemaking, which will be published in the Federal Register circa July 1.  CMS plans to create a new provider category specific to DPP which will be cross-linked to CDC DPP provider certification.

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image from Omada's press release website.


Monday, June 12, 2017

Brief Blog: AMP/CAP Comment on MolDX LCDs for Gene Panel Testing of CRC, Melanoma, Ovarian

For a couple years, MolDX has provided coverage of comprehensive gene panel (CGP) testing in lung cancer, but with fairly stringent technical standards.  In December, they announced coverage would be broadened by 3 new LCDs in new topic areas - CGP for colorectal cancer, for metastatic melanoma, and for ovarian cancer.   (Article here).

In March 2017, CAP/AMP sent joint comment letters to MolDX and posted them publicly.  In general, they feel that MolDX sets arcane and inappropriately high technical requirements for coverage tests.   They assert that very, very few US labs could meet the closely fitted technical requirements found in the LCDs.   They are concerned that NY State approval is required even for labs and patients in Midwestern or West Coast states.  More after the break.

Brief Blog; Digital Genomics Panel at Precision Medicine Leaders Summit (San Diego, August 23, 2017)

This year the second annual Precision Medicine Leaders Summit will be held in San Diego, August 21-24, at the Hilton Bayfront next to the Convention Center and Gaslamp District.

I have the privilege of chairing a panel on Digital Genomics - focusing on companies that that focus all their services on data interpretation and clinical utility after the sequencing is complete.      We're still developing the full panel for this panel (we do know the date and time - August 23 at 4 pm).  See the full conference website is here and the agenda page is here.




Brief Blog: ACLA Continues to Weigh In on PAMA Policy with House and CMS

In June, ACLA continues to weigh in on how CMS implements PAMA Section 216, repricing of national Medicare lab fee schedules based on market price surveys.

ACLA and other stakeholders have raised concerns that CMS is using methodology that will result in incorrect and excessively low repricing.
  • ACLA's June 1 letter to the House Ways & Means committee is online here.
  • ACLA's June 7 letter to Seema Verma, administrator of CMS, is online here.
The House letter has a range of topics - bad execution of PAMA law at CMS; illogical gapfill/crosswalk amounts for obscure rationales; and need to nix the 14 day rule.

The Verma letter asks that PAMA be delayed, and rapid interim final rulemaking should require hospital outreach labs to be part of PAMA, giving them November-January to report.  ACLA anticipates that PAMA repricing could be implemented (with extra hospital lab data) by 7/2018, and the next cycle of data collection should be pushed from 2020 to 2021.


For a March 2017 press release providing an overview of the issues facing ACLA and other lab gruops, here.  A March letter to HHS leader Tom Price was signed by ACLA, AdvaMed, CAP, and other groups (here).

One Washington Hillwatcher noted that academic medical centers, in general, do not like DAIA.

Friday, June 9, 2017

Brief Blog: The Crazy Complicated World of MIPS-MACRA Measures

Update - 2018 MACRA rulemaking was published on June 21, 2017, here.  Trade article here.  26 page summary of 1074 page rule, here.

_______________

Just yesterday I was talking to a European consultant colleague about helping a European company understand how its innovative product might be affected by U.S. MIPS/MACRA measures.   (Answering that question is a substantial deep dive research project, including explaining in clear terms to foreigners what Medicare is and what MIPS/MACRA is, let alone drilling down into a specific subject area and then building out a corporate strategy and then executing it.)

In my inbox today, CMS is holding an annual call for MIPS/MACRA measures, which is open til June 30.   See that and more below after the break.

Monday, June 5, 2017

Trump Administration Should Keep Releasing Annual Part B Medicare Billing Data; Vivid Example (Allergy Skin Testing)

UPDATE: CY2015 DATA RELEASED BY CMS ON JUNE 15, 2017.  HERE.  

Original Article June 5:

Beginning several years ago, after HHS lost lawsuits regarding whether physician billing records to Medicare were private or subject to FOIA, CMS began releasing annual physician and other part B provider billing records online.

Records are available for CY2012, CY2013, CY2014, at this website; click Interactive Dataset.  The full dataset is 2 GB (too large for Excel) but there is a web interface from which you can select and filter data and download it.  For example, all Part B providers of allergy skin testing (95004) make about a 1MB file.  (To use the database yourself, see my instructions here.)

CMS had been releasing annual data after about 16 months, e.g. CY2014 data in April 2016.   CY2015 data has not been released.  Possibly, because physician groups have protested data release, the Trump administration will stop voluntarily releasing data.  (If so, I believe parties could still get the 2 GB file via FOIA).

A Case Study With One HCPCS Code

The data is a valuable tool against abuse.   For example, for a client, I pulled the 4,114 Part B providers who were paid for skin testing 95004 in 2014.  2,307 were allergists.  88 were nurse practitioners, and so on.

What's of interest is your ability to further sort the data.  The facts are pretty shocking.  The highest paid provider for allergy skin testing garnered $1.2M from Medicare - for 95004 alone.  He was paid about $1,500 per patient - at $7 each, that's 180 daily skin tests per patient.  (This was in New York.)   Of the 15 busiest annual providers of 95004 nationwide, by dollars per year (for all patients), only one was an allergist.  All were paid over $200,000 per year by Medicare for allergy testing.  Most of these high billers were in New York or Texas.

About 30 providers were paid by Medicare over $700 dollars per year per Medicare patient, most with over 100 skin tests per patient - on average.   All but 5 of the top 33 providers with that billing pattern were allergists.  Of the top per-patient billers, most were in California.

About 570 of the 4100 providers billed, on average, more than 70 services per patient.    (Several LCDs and BCBS sources cite a maximum of 70 tests per patient, though others have lower suggested limits).  These providers grossed $20M for 95004 out of the $58M total paid for 95004.  In sum, about 33% of Medicare payments went to providers who were billing at above-guideline intensities, sometimes far above guidelines.  







LESSON

CMS should keep releasing Part B data, and public sources should study it to identify the biggest overspending problems in Medicare and keep the executive branch on its toes.  Stay on the lookout for whether CMS releases 2015 data by June or July of 2017.

This column previously discussed the equally or even more wacky world of Medicare BRCA gene test pricing (here), also using only publicly available CMS data.

___

Data for 95024, intradermal skin tests, look very similar to the graph above for 95003.

Allergists billed 55%  ($32M) of 95004 billings.  Allergists billed 50 services per patient, on average, SD 19.  32 allergists billed over 100 services per patient (> 2 SD high).  Non allergists had the same average and SD: 52 average, SD 17.

As George Orwell wrote, "To see what is in front of one's nose needs a constant struggle," but the online CMS database is a big help.



Friday, June 2, 2017

United Healthcare May Be Widening "Pre Auth" for Genomic Tests

United Healthcare posts a provider bulletin online each month, and the June 2017 issue has a page describing upgrades and extensions to genomic test pre-authorization requirements.  The PDF is here; the genetic preauthorization policy page is on page 17.  The article adds, "Details will be published in a future bulletin."

Waves of tighter genetic test payment controls have been rolling through the payer industry.  For example, Medicare genomic test payments actually fell from 2014 to 2015, due to tighter controls on CYP (pharmacogenetic) testing that cut out several hundred million dollars of services.  

A mini-industry of standalone companies exist to help payers mediate and control payments to laboratories (BeaconLBS; Anthem AIM; Avalon; Concert Genetics; Evicore; and others.)  These are often called LBM - laboratory benefit managers - in analogy to PBMs, pharmacy benefit managers.





Wednesday, May 31, 2017

Brief Blog: The Nit-Picky World of CMS Policy Gems

While we hurtle forward in Washington with health insurance reforms, CMS continues to put out little policy corrections on a daily basis.   These are called "Transmittals" - they have a special webpage and there are several hundred per year (here).

  • PLA Codes.  In R3783CP, CMS updates some details of hospital outpatient claims processing and includes use of the brand-new AMA CPT "PLA" section of codes, which AMA will produce quarterly.  Here.  (There's a policy mistake in it; here.)
  • HIV Screening.  Based on a USPSTF recommendation, Medicare covers HIV screening tests under one set of conditions between ages 18-65 and another set below 18 or over 65.  
    • Medicare has 4M beneficiaries below age 65.   
    • There are also a set of special rules and specific codes for pregnant Medicare beneficiaries.  
    • Here
  • Oncology Care Model - Includes Cancer Patients Who Need Hospital Care ("Somebody tell the computer.")  With much fanfare, CMS created a monthly special payment for cancer care called the "Oncology Care Model" or OCM.  It was discovered that payments were blocked if a claim for the monthly support was submitted on a day when the patient was in hospital.  CMS fixes this.  Here.
  • Mysteries of Drug Q Codes.  CMS normally produces new drug codes on a January 1 basis, based on a year long review process for applications submitted the prior January.   However, it sometimes pulls drugs into rapid code production, called "Q" codes, which are issued quarterly and help the claims processing work until the next January cycle.  When and how CMS decides to upgrade a drug to a rapid temporary Q code is an enigma to me.  
    • The drug ustekinumab (Stelara, for psoriasis, iv) gets a Q code right now.  Few other drugs do, they have to wait til January.  Here.
    • There is also the mysterious creation of two codes for hydroxyprogesterone caproate, available as Makena, under an orphan drug license that may expire in early 2018. One of the codes is specific to "Makena."  For articles, here and here.  Issues on orphan pricing of Makena and accusations of price gouging date at least to 2011 (here).
  • CGM.  In a big breakthrough for diabetes patients, CMS finally approved coverage of continuous glucose monitors earlier in 2017.   This requires codes.  Here come the codes (here).  They are a rarely use class of codes,  "K" codes, which are "temporary DME codes."   
  • PILD.  Since 2014, CMS has not covered lumbar spinal stenosis surgery if done by the percutaneous image guided technique (PILD).  After two CED trials, CMS reviewed the topic and decided to wait for more CED trials.  Sounds like the goalposts are not clear.  NCD here, transmittal here.
    • Note that open and endoscopic lumbar surgeries are covered without further controls; it is only image-guided lumbar surgery that is restricted.  
    • This is a variant from most CMS surgical coverage, which is agnostic to method.  For example, there was never any NCD on the topic of robotic prostate surgery as a technique nor on any other robotically-mediated surgeries.   



CMS Incorporating Use of AMA CPT "PLA" Codes on a Rolling Basis

PAMA law, passed in 2014, requires CMS to create codes for new "advanced diagnostic laboratory tests" (ADLTs) as well as any new FDA cleared or approved tests (FDACOATs) that request a code.

While CMS could create these with the G code system, AMA has initiated rapidly quarterly creation of "PLA" codes based on a simple abbreviated application form.  The abbreviation stands for AMA "Proprietary Laboratory Analysis" codes.

The PLA code system will allow a wider set of tests to be coded than the PAMA requirement, as PLA includes ADLTs, additional sole source tests that don't meet the fine points of ADLT rules, as well as  FDA cleared or approved tests.   I wasn't sure how readily CMS would adopt the PLA code system - especially when PLA codes were created for things that wouldn't have gotten ADLT codes under PAMA.  Verbally, I had heard someone remark that he had heard that someone had said CMS would be using all the PLA codes.

However, solid evidence in a new hospital outpatient policy transmittal suggests that CMS will be adopting all the PLA codes as they come out, on a rolling basis.   Transmittal "R3783CP" includes classification of the two newest PLA codes, 0004U and 0005U.   (For hospital policy purposes, 0004U is separately payable and 0005U is bundled to hospital outpatient services.)

CMS notes that its policy cycles do not necessarily match the AMA CPT PLA publication cycles.  For example, these two codes will be added to the July 2017 editor but with effective dates retrograde to May 1.   These are code files only; CMS coverage and payment would be determined separately.

The CMS publication is here.
The AMA website for PLA codes is here.
The current list of PLA codes is here.
Image, click to enlarge:


This could mean that PLA codes will be put in the annual CMS July crosswalk/gapfill cycle.  The agenda for this year's crosswalk/gapfill cycle has not been announced as of May 31.  Administrative MAAA codes have been incorporated in crosswalk/gapfill meetings as they appeared.

Tuesday, May 30, 2017

Brief Blog: Simple Way to Organize a Brainstorming Meeting

Brainstorming meetings have their advantages, but can be too disorganized in the pursuit of "blue sky" ideas.   In an SF meeting last week, we used this simple motife to structure what was basically a one hour, three-person brainstorming whiteboard session on a topic that held a lot of uncertainties.

Here's the picture:


Brief Blog: Hidden Gems from the SEC Blasczak Insider Document: How Wheels Turn at CMS

Last week, news broke that the long-simmering story about insider information leaks had reached public filing of an SEC legal document (news links here, SEC document online here.)

One interesting aspect is to actually read the SEC 51-page filing.   Business journalists picked up on the lurid details - how one individual was allegedly dangling future benefits in front of a CMS employee, and embarrassing turns of speech clipped out of emails from 2013 and 2014.

But policy watchers can also read the SEC document for some interesting insights into how the wheels turn at CMS.   For example, in January, I was describing to a client how, if you want to affect June 30 annual rulemaking, you need to back up to publications or communications in January, February and March, because issues at the agency will converge towards final meetings and decisions in April if possible for writing, editing, and troubleshooting sessions in May and final vetting underway by early June.  

The SEC documents contain stories that mirror that timeline - for example, there are emails traded about policy meetings in March and April, and the crafting of CMS debriefing and decision decks on that timeline, all in preparation for rulemaking that must be released around June 30 after vetting by higher levels at CMS and legal counsel and the Office of Management and Budget.

Brief Blog: Incredible Concert Genetics Reports on Genomics Industry and BRCA Industry

Concert Genetics (formerly NextDxGx) is a company that provides services to health plans nationally to help them manage genetic testing.  Home page here.

A Wall Street report on the genomics industry this week cites several deep-dive PDF-format studies available from Concert Genetics (download with simple email registration).

These include:
  • "The Current Landscape of Genetic Testing" - 20 pp, here.
  • "A Guide to BRCA Testing for Health Plans" - 12 pp, here.
  • "Critical Steps to Realizing the Potential of Personalized Medicine" - 24 pp, here.
Many interesting graphics, charts, and tables.



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For a publicly available checklist of process management for an out of network molecular lab, see here.
Publicly available sources suggest Concerto (NextGxDx) has raised about $10M in venture capital, here.


Monday, May 29, 2017

Brief Blog: Unique Scott Gottlieb House Hearing Transcript / May 24, 2017

On Thursday, May 25, 2017, FDA Commissioner Scott Gottlieb testified before the House Committee on Appropriations.    The House webpage is here (includes Youtube archive of the hearing).   Gottlieb's six page prepared testimony is here.

FOR A UNIQUE TRANSCRIPT OF THE HEARING, CLICK HERE.
  • Coverage at Endpoints, here.
  • WSJ here and here.
  • Bloomberg here.  
    • This article by Max Nisen pivots off Gottlieb's testimony, but mostly covers drug pricing trends in general.  Several interesting charts.
  • Coverage at RAPS, here.



Friday, May 26, 2017

Brief Blog: Breaking The Box in Genomic Research Paradigms: DecipherGRID

An article in this week's New England Journal, written by an international consortium (here), focuses on the global data for widespread data sharing in genomic cancer research.   They summarize the needs and goals, as reflected in programs like Cancer Moonshot.  

An innovative approach to shared genomic research resources appeared as Zhao et al. earlier this month in JAMA Oncology (here).    The authors took the concepts of luminal and basal gene expression or differentiation - as long used in breast cancer - and applied it to prostate cancer, with significant results.  (These panel-based classifications may prove clinically impactful for prognosis-dependent management and in predicting responsiveness to androgen deprivation drugs.)

However, a very interesting aspect is how they did it: with large gene-chip archives of data developed by San Diego's commercial firm GenomeDx through the DecipherGRID program.

GenomeDx has commercialized a prognostic prostate cancer test which has Medicare coverage.  In addition, GenomeDX uses a methodology which has also archived genomic data on 46,000 coding and non coding genes through array technology - the DecipherGRID program (homepage here.)  Researcher can collaboratively test hypotheses on the data - and many dozens of publications have already appeared.

Additional coverage of the Zhao et al. paper at Genomeweb here., and Genomeweb coverage on the DecipherGRID program here.

DecipherGRID data archives have also contributed to a major article on prostate cancer radiation sensitivity (research in Lancet Oncology here, press here.)




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For an article on coverage issues for prostate gene panel tests, see Managed Care, May 2017, here.  For example, a couple years after launch, the Myriad Prolaris test conducted for prognostic classification on biopsy tissue received relatively narrow coverage from Medicare MolDx (October, 2014; here);  which was expanded considerably over 18 months later (May 2017; here).

Thursday, May 25, 2017

SF's Genome Medical Raises $12M for Telemedicine Genetic Counseling

One of the challenges with the rapid growth of genetic testing is the shortage of genetic counselors.  Genome Medical, a San Francisco start up, aims to address this by rapid development of high-quality telemedicine services.

The startup has raised $12M in recent months from major investors such as Illumina Ventures, Canaan Partners, and others.   The company is founded by Randy Scott (previously involved in founding both Genomic Health and Invitae, which have a combined market cap of $1.3B), Lisa Alderson, and Harvard Medical School geneticist Dr. Robert Green.
  • CNBC story, here.
  • Genomeweb, here (brief).  Genomeweb subscription deep dive, here.
  • Genome Medical website, here.
In January 2017, Invitae acquired the patient-centered data information company AltaVoice (here).  Invitae also has collaborations centered around the Illumina spinout Helix (here) and Invitae announced a new exome service in March 2017 (here).   (Illumina has a current market cap of $25B).


Legal Case Filed Against Market-Moving CMS Information Leaks - Blaszczak et al.

According to multiple news reports on May 24, SEC has filed against an insider-trading scheme driven by CMS information leaks to a consultant for hedge funds.   The alleged actions in the case date back to 2012/2013.
  • The 51-page complaint, SEC vs Blaszczak et al., is online at SEC.gov, here.
    • SEC press release, here.
  • New York Times, here.
  • Reuters, here.
  • Bloomberg, here.
  • Deep dive at MedCityNews, here.

Public information on the case is not new, with news stories dating at least to October 2014 (WSJ 2014 here.  Reuters 2014 here.)  According to MedCity News, one individual, Fogel, has pled guilty and is cooperating with prosecutors.

Sound bite from Bloomberg:
     A wide-ranging U.S. probe into under-the-radar information links between Washington and Wall Street snared three hedge fund executives, a D.C. consultant and a government employee, who are accused of profiting off inside information about changes in health-care regulations.
     The prosecution takes aim at the political intelligence industry in Washington, in which consultants -- often former government employees themselves -- nurture ex-colleagues for information about potentially market-moving decisions, and relay that to hedge fund traders and others in exchange for lucrative consulting fees.
     That’s what prosecutors in Manhattan accused three partners at Deerfield Management, a Centers for Medicare and Medicaid Services employee and David Blaszczak, a former CMS worker with his own D.C. consulting firm, of doing.
Linked-In for Blaszczak here.

Tuesday, May 23, 2017

Landmark FDA Approval Based on Tumor Gene, Not Tissue Type (Mismatch Repair, Keytruda)

In a landmark FDA approval, Keytruda has been approved based on expression of a mismatch repair gene, rather than on a tissue type such as colon cancer or lung cancer.    For additional coverage, see MedCityNews, here.  FDA press release here.  Reuters here, MedPageToday here.   Forbes here.  Genomeweb here.

Four weeks ago, this blog emphasized the growing buzz around total mutational burden, or TMB, which is often triggered by defective DNA repair in cancers (here).

In February 2017, Genomeweb reported that Personal Genome Diagnostics (PGDx) in Baltimore had landed an NIH grant to develop a TMB test on circulating tumor DNA.

An excerpt from MedCity News below:

   Colon, pancreatic, stomach, or ovarian cancer; it increasingly shouldn’t matter. In an era of precision medicine, the treatment approach should reflect the genetic makeup of the person’s tumor and the presence or absence of key biomarkers.
   That ethos was set in stone on Tuesday, with the landmark FDA approval of Merck’s checkpoint inhibitor, Keytruda (pembrolizumab), for patients with solid tumors that express so-called mismatched repair genes.
   In a statement, FDA noted the historic nature of its decision. “This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.”
The approval is an accelerated approval, meaning that it can be subject to eventual re-review on the basis of required additional studies.

Monday, May 22, 2017

Trade Press Summary: Color Genomics Pivots Towards Payers

A detailed subscription-only article at Genomeweb on May 22 discusses Color Genomics' new strategy to begin directly contracting with, and billing, major payers (here).  Color provides a 30-gene test that brings together genes for risks associated with eight common cancers (breast, prostate, etc).  The test's price point has been $249.  Genomeweb also has a short public-access summary, here.

The company raised a new funding round of $45M last September (here, here.)
  • For an open access trade journal on new-news regarding Color and payers, see MedCityNews, here.
  • For an open-access publication on its test in Breast Cancer Research and Treatment (dated June 2017), here.
  • For a 6-page white paper on its test on the company's own website, here.
  • The company made a switch among founders between Chairman and CEO in December, here.
  • For a look-back on the company's history by SF Biz Journal, here.
  • For a trade journal review of three companies (Grail, Twist, Color), see here.
  • For a commercial market report on the growing global predictive testing marketplace, here.
  • For an article on another innovator in the space, see MedCityNews on TrueHealth, here.

Chief Medical Officer Jill Hagenkord MD has worked successively at Complete Genomics, Invitae, UCSF, 23andMe, and Color (here).  More after the break.

Thursday, May 18, 2017

MolDX Issues Draft LCD: Covers Liquid Biopsy in Selected Lung Cancer Patients (Guardant360 Coverage)

On May 18, 2017, the MolDX program released a draft LCD that would provide coverage under several special conditions for a gene panel somatic mutation liquid biopsy test in lung cancer.

The LCD is online at CMS here or in the cloud here.


The proposed policy provides coverage in circumstances when an invasive biopsy is medically contraindicated or quantity-of-tissue failed to be sufficient for necessary genomic profiling.  The LCD cites 2017 NCCN guidelines that when tissue biopsy is unenviable, plasma genomic profiling should be considered.  The comment period runs from June 5 to July 20.

Guardant Health has had several successful funding rounds, totalling $550M, according to Forbes, here.  Its liquid biopsy test has also been recently approved by the New York Clinical Lab Evaluation Program (here).

See also a general article about liquid biopsy in Genetic Engineering News, here. Coverage of the new LCD at Genomeweb, here.  Press release here.  More after the break.

Wednesday, May 17, 2017

Brief Blog: Humor: "Clone Wars" As a Metaphor in Oncology

Someone recently pointed me to an article on "Clone Wars" in oncology and the genomic evolution of tumors.

The term has some history.  That are about ten hits on PubMed specific to "Clone Wars" in oncology, and they date back to 2006.   A search for oncology + cancer + "clone wars" on Google pulls up additional hits, such as a 2013 webpage at MD Anderson (here), and a deck by ASU's George Poste (here).

For the most prominent recent article, see Beltran's article The Clone Wars in Science Translation Medicine in February 2017 (here).   For an open access example, see Worsley et al. 2016 (here).

More examples after the break.

Brief Blog: Real World Evidence: An Emerging Mini Industry

The term real world evidence, supplemented by the term pragmatic trials, has been around for some years, but remains on an upswing.  Pubmed gives over 400 hits for "real world evidence," including a dozen articles currently "in press" (as of May 2017) in Journal of Clinical Epidemiology (here).  "Pragmatic trials" has 350 hits.

The specialists at EyeForPharma recently held a conference on RWE in Amsterdam in April 2017 and provide a long synopsis online, here (archive here).  The April 2017 agenda is still online, here.

They've also set up a webpage for a forthcoming November 2017 Philadelphia conference, here.




Saturday, May 13, 2017

Brief Blog: CMS Posts All Agenda Files for May-June HCPCS Meetings

CMS has posted all files for its May 16-17-18 and June 7-8 HCPCS code application meetings.   By law, CMS must post agendas for all applications, explaining the applicant's position, the CMS response, hold a public meeting, and post a final decision in the fall with response to comments.

The May 16-17-18 meetings are on drugs; the June 7-8 meetings are on DME and related supplies and equipment.   Generally, applications for major intravenous or physician-administered drugs zip right through.  Everything else has a low chance of being accepted (maybe 5%?)   For example, Medtronic applied for new coding for its 670G artificial pancreas, a widely praised achievement, but CMS turns down its application for a new code.   (Medtronic and stakeholders can attend the meeting and try to convince CMS otherwise.)

Links to the meeting registration (closed for May events; open til about May 20-24 for June events) are posted here:  https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html  

The events will be webcast live (exciting!!) - see links at page above.

Agenda items as PDF files are listed here for each of the five days, or in one zip file in the cloud here.

Drug and biologicals have 15, 13, and 11 agenda items (May 16-18), and DME and supplies have 17 and 18 agenda items (June 6-8), or  74 HCPCS agenda items in total. Some represent clusters of several related code items.

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Update: Meeting Videos have been posted by CMS for DMEPOS (and other sessions).
DMEPOS, June 7, AM, here.
DMEPOS, June 7, PM, here.
DMEPOS, June 8, AM, here.