Brief Blog: CMS Posts PPT Template for July 31 New-Code Pricing Meeting

This year, CMS announced earlier in June that a TEMPLATE will be required for POWERPOINT presented at the annual CLFS new code pricing meeting - aka the crosswalk/gapfill meeting.

The CMS CLFS webpage is here.   Toward the bottom, see the Zip file for the Powerpoint Template.  The ZIP file includes both (1) a PPT template and (2) a brief PDF instruction file - for example, don't use color because CMS will be making printouts for itself in B&W.

For some earlier info on the CMS CLFS meetings on July 31 and August 1, here.  More info after the break.

Brief Blog: Diagnostics Patent Law After MYRIAD and MAYO PROMETHEUS

Two Supreme Court diagnostics patent cases from 2012 and 2013 - Mayo v Prometheus and AMP v Myriad - are so prominent they have their own Wikipedia pages (here and here).  Mayo/Prometheus held that algorithms between biology and clinical outcomes might often be "laws of nature" that are outside the scope of patents.  Myriad held that DNA sequences (even with annotation and purpose) are not per se patentable.

Daughter cases predicated on these two pivotal cases continue to roll out.

• See Kevin Noonan's discussion of Cleveland Clinic v True Health Diagnostics (blog here, original case here).   
• Noonan also cites to his April 2016 discussion of another diagnostics case, Genetic Technologies LDT vs Merial LLC (blog here,  original case here.)
• Both cases tend to roll out and extend what isn't patentable by the "law of nature" exclusion subsequent to Mayo/Prometheus and Ariosa/Sequenom (Wikipedia here).

Generally, Noonan was disappointed in the Supreme Court rulings toward invalidating diagnostics patents and he views the rolling extension of these patent denials as unfortunate and perhaps requiring action by the Hill. Noonan writes,

"Unless the Supreme Court sees the error in its ways, or Congress overrules its Mayo/Alice decisions, technology transfer of university inventions will not be to startups and licensees but to copycats and pirates for the foreseeable future."   

Ouch.  See also Noonan's 2016 Nature Reviews Drug Discovery article here.   For an article on trying to improve diagnostics patentability, Morton & Clarke, here.

Thorough Table Comparing ObamaCare, House Bill, Senate Bill

FaegreBD Consulting, where I worked full time in 2015-2016, has prepared a thorough table comparing health benefits under current Obamacare, under the House amendments, and under the Senate amendments.

Timely - a Senate vote is scheduled for Thursday, June 29.  

The FaegreBD Consulting article is here, three-column analysis here (opens PDF).

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 rulemaking, here.
• Trade journal article here.
• The official Federal Register version appeared June 30, here.
• Federal Register, 6/30/2017, 82 FR 30010-30500 (490 pp).
• Comment period runs to August 21, 2017 [60 days].
• For an update on "physician payment reform" in general, in NEJM July 2017, here.

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:

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.
• FDA Documentation under PMA #P160045.
• The the FDA 51-page Safety and Effectiveness review of Oncomine Dx Target Test, here.   
• The 398-page FDA User Guide, here.
• The 6-page physician insert, here.
• The FDA's approval letter here, June 22, 5-page.
• 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.
• Coverage at MedCityNews, here.
• Coverage at WIRED, here.
• At FDA.gov, see the Drug/CDx page here, listing ONcomine Dx Target Test as associated with drug NDAs on four drugs, Tafinlar, Mekinist, Xalkor, Iressa (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.

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.

The April 2017 decision affirms an earlier shorter negative decision in August 2016 (here).

Update: Heartflow won a classification decision in November 2017; here.
___

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.

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.

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).