Saturday, September 24, 2016

House Hearing on CMMI: Website, PDFs, and (Unique) Transcript

On September 7, 2016, the House Committee on Budget under Chairman Price held a nearly three hour hearing on the Center for Medicare and Medicaid Innovation.

The government's website is here.  The following speakers testified (PDFs online) and there was spirited debate.
  • Chairman Price
  • Mark Hadley, Deputy Director, OMB
  • Joseph Antos PhD, American Enterprise Institute
  • Ted Okon, Community Oncology Alliance
  • Mark Madden MD, OrthoVirginia
  • Topher Spiro, VP, Center for American Progress

Video streams online at the House website.  The House website provides no transcript, but I provide one for you on this blog: here.

For one zip file containing the various PDFs, some additional letters from stakeholders, and the transcript, click here.  (To download look for "down" arrow.)

Friday, September 23, 2016

Medicare's Use of MoPath CPT Codes in CY2014

Earlier this year, CMS released CY2014 data on the use of all CPT codes in Medicare Part B (here).  This data includes extensive provider look-up tables.   (The actual CPT code aggregated data is similar to that released in 11/2015 for CY2014, but the full data sets are more comprehensive by state, or by lab, or by physician, etc.   The full dataset is 1.9GB and needs to be handled by special database software, but the data is open access).

In an excel spreadsheet in the cloud, I've pulled the molecular pathology codes.  They are sorted three ways:  (1) by volume of services per code, (2) by dollars paid by Medicare per code, and (3) a separate table only for Tier 2 codes.   In the cloud, here.  (Download by clicking the small down arrow, upper right in most views).

For screen shots, see larger view by clicking on the images below.
  • By volume, the Tier 2 code 81401 leads, with 422,556 services, while seven codes had >200,000 services and then the usage dropped suddenly to <60,000.  80% of codes had less than 10,000 uses by CMS, half had less than 1000 uses by CMS.  One-third of the codes shown were paid by CMS at least once, but less than 100 times.
  • By dollars, in 2014, two Cyp genes led in Medicare payments, with $273M in total payments or about 50% of all CMS molecular payments.   75% of codes listed had 2% of CMS dollar payments.
  • Among Tier 2 codes, 81401/Level 2, dwarfs all other Tier 2 codes, with about 80% of Tier 2 utilization and $46M paid or about $110 per CMS claim.  Only 2 providers submitted any Level 3 codes, with a total of just 17 tests paid and grand total of $4,700.

(More after the break).

Wednesday, September 21, 2016

The Awesome Complexity of Billing US Payers for Genomics:

I'm giving two talks in Europe this fall on the complexities of the US policy frameworks for genomics laboratories, one issue being the complexities of billing US payers.

It's a commonplace that US administrative costs soar above the costs of other countries; see for example here and here and here.   This complexity may be at its worst, a perfect storm, for genomics laboratories.   For "efficiency," US healthcare ranks at the bottom of 11 developed nations.

While their goal is laudable - to help labs understand and cope with the US system as-is - a new article by Lennerz et al. of MGH shows how awful the system is in excruciating, academically documented detail.   See "Healthcare Infrastructure for Financially Sustainable Clinical Genomics," here (not open access).

It remains unfortunate that an otherwise meticulous AMP-funded documentation of NGS lab costs, published in May 2016, left out overhead and administration costs because they seemed too difficult or variable to calculate precisely (Sabatini et al., open access, here).   Medicare pegs gapfill genomics prices to the numbers they see ("$592.45"), and the colossal costs that tower over Lennerz' work are absent in the cost tabulation of Sabatini et al.

It's a terrible gap, because in general, Medicare does indeed pay for overhead costs, in hospital inpatient, outpatient, physician fee schedule, and other systems.  Even the most efficient large labs, like Quest and Labcorp, have overhead costs that are about equal dollar for dollar to "costs of goods sold," the costs documented by Sabatini et al.  It's probably worse than that for genomic tests, as presented but not dollarized by Lennerz et al.

Are FDA, Medicare, and Moonshot Converging on Cancer Testing? ...Medicare?!

Putting together precision medicine policy milestones of the past year, it looks like Medicare is becoming closely aligned with goals of the FDA, the Precision Medicine Initiative, and Cancer Moonshot.

One of the cardinal goals of the Precision Medicine Initiative and especially the Cancer Moonshot headed by Joe Biden are to break down information silos and creative public databases on cancer genomics.
In June 2016, Foundation Medicine announced it was supporting Cancer Moonshot by "contributed 18,000 genomic profiles from our FoundationCORE knowledgebase to the NCI Genomic Data Commons Portal (GDC)" (here).  
The FDA is producing groundbreaking guidance documents about the FDA validation of genomic tests based on public curated databases.  A harbinger was the approval of a genomic cystic fibrosis test based on a public variant database.  This approach is full steam forward; see a recent guidance document from the FDA on the calibration and regulatory use of variant databases, here.

Medicare has a roughly 25-state unified policy system called MolDX in which local coverage determinations most often originate in the "Palmetto" Medicare contractor jurisdiction and propagate to other multi state jurisdictions.  In September 2016, the Palmetto MAC proposed a new local coverage policy for genomic testing in lung cancer which mandates extensive public data deposition in elaborately defined public access variant databases.    The local decision specifically cites the goals of Cancer Moonshot as being concordant with Medicare's view of eligible open access public genomic databases.  Specifications of an eligible database are listed below the break.  For a deeper dive, see here.

Tuesday, September 20, 2016

Senate Posts Video, Testimony on Precision Medicine and FDA/LDT; With Transcript !!

On September 20, 2016, the Senate HELP committee held a hearing on precision medicine and regulation.  Topics included FDA regulation of LDTs.

For an unofficial transcript in the cloud, click HERE.  

Testimony was provided by David Klimstra, Dept. Pathology, Memorial Sloan Kettering; Brad Spring, BD Life Sciences; Jeff Allan, Friends of Cancer Research; and Karen Kaul, Pathology, University of Chicago.

See files and video online here.

Coverage at Genomeweb, here.

Magnum Opus on State of Precision Medicine (Ashley in Nature Rev Genet, 9/2016)

Euan Ashley of Stanford has produced a "magnum opus" on the state of precision medicine, published in Nature Reviews Genetics in September 2016.

The 16 page article has some 140 references.  For a 45-minute Youtube talk by the author, filmed earlier in 2016, see here.

Ashley, EA (2016).  Towards Precision Medicine.  Nature Reviews Genetics 17:507-22.  doi:10.1038/nrg.2016.86  

Monday, September 19, 2016

Health Affairs New Blog Series: Drugs and Medical Innovation

There is an ancient Greek saying, "Those whom the gods would destroy, they first [drive mad]."  My variant is, "Those whom the gods would destroy, they first make talk about value-based pricing."

A few months ago, I wrote about a particularly creative and multi dimensional blog published at Health Affairs by Dana Goldman and colleagues at Precision for Medicine (blog here; Goldman is also a professor at USC.)  

So I was happy to see Goldman and company feature additional work at Health Affairs and in the open access format.  Health Affairs will have a new blog series, "Drugs and Medical Innovation" (introduction essay here.)  It's supported by the "Innovation and Value Initiative," here, a pretty elaborate website itself.  (Initial funding of I.V.I. is from Precision Medicine Group.)

From the Drugs and Medical Innovation homepage at Health Affairs, here.   An introductory essay by Goldman et al. is "Rapid biomedical innovation calls for similar innovation in pricing and value measurement" - yes!   Nicholas Timmins responds that value assessment may not be that far off and in need of repair; here.  [Timmins just wrote a book about NICE; here.]

Although not squarely in the same series, within the week Health Affairs also published a blog by Berenson et al., "Refining the framework for payment reform," and one by Lee et al., "The politics of Medicare and drug-price negotiation."  


What Health Policy Can Learn from Public Transit

For some years I've made the observation - from my view as a health MBA rather than a health MPH - that most American health econonics focuses on the big picture from a public health policy perspective ("We spend $3T on healthcare, but should spend $2T") and not the actual cash flows and economic strategies and as a result, policy responses often don't match problems.  The problem and the response sail past each other at a ninety degree angle, without touching.

Through a chain of coincidences, I ran across a fascinating book on public transit that I would daringly propose should be required reading in health programs.   The book is "Human Transit: How Clearer Thinking about Public Transit Can Enrich Our Communities and Our Lives" (2011; at Amazon; ebook, paperback, or hardcover.)   More on the chain of coincidences and the book's author, see footnote. [*]

Health Wonk Treat: History of NICE in the UK (open access; 200 pp)

For real health wonks who love to track the history and trends in policy assessment - see a nearly 200 page, open access book called, "A Terrible Beauty: A Short History of NICE," the National Institute for Health and Care Excellence in the U.K.   Get it as a PDF book, here.

For an essay at the UK philanthropy Kings Fund, on the book, see here.

The authors are Nicholas Timmins, Sir Michael Rawlins, and John Appleby.  Timmins writes and blogs at Health Affairs (here, here, here) and is an editor at Financial Times (here).  Rawlins, who I had the chance to share a panel with once, was the long time head of NICE and wrote an agile and entertaining book about health tech assessments, Therapeutics, Evidence, and Decision Making 2011, here.  See also Rawlins' deft analysis and prose in his 2008 Harvey Oration, 54pp, here.


NCCN to hold "Value Tools for Patients in Cancer Care" - December 9, 2016

NCCN has announced a national "Patient Advocacy Summit" entitled "Value Tools for Patients in Cancer Care."  The workshop, to be held at the National Press Club on December 9, 2016, has free registration.   A flyer for the meeting is here.

Register at  

Additional Background

NCCN previously held a summit on "Value, Access, Cost of Cancer Care" in New York on September 11, 2015 - here.

Value frameworks are plentiful - from ICER in Boston; from Sloan-Kettering (Drug Abacus, here), from ASCO, and elsewhere.  See the ASCO Value Framework here.   See also the organization and trade journal, Association for Value Based Cancer Care, here.  For an article in The Oncologist, May 2016, see here.   For an article at AJMC, here; for a review at the ZS pharma consultancy, here; for an article in Nature Reviews Drug Discovery, here.

On September 15, Washington lawmakers introduced a bill "that would require drug makers to justify their pricing and provide a breakdown of their costs before raising prices...more than 10%;" here, here, here.

Friday, September 16, 2016

Deck: A Birds Eye View of US Diagnostics Markets for Europeans

On Wednesday, September 14, 2016, I had the chance to present at the Genetic Insider conference in Barcelona, "International Molecular Diagnostics Conference."

My topic was an overview of the US diagnostics marketplace for European companies and investors.

The 40-slide deck is online here.  

The conference website is/was here.

Deck: NCCN Symposium / New Trends in Biosimilars and in Diagnostics

On September16, 2016, at an all-day NCCN symposium, I had the privilege of providing a keynote address on regulatory aspects and new trends in (a) biosimilars and in (b) molecular diagnostics.

The 40-slide deck is in the cloud here.    The NCCN workshop, held in Washington at the National Press Club, has its own webpage here.

Shortly after the meeting, the FDA made its third biosimilar, a copy of Enbrel (etanercept) called Erelzi (etanercept-szzs).   Note that biosimilars have both a proprietary name (Erelzi) and a common name with a nonsense four letter extension (in this case, -szzs).  The FDA plans to hold one biosimilar advisory committee per reference biologic (here).  From a July adcomm, one more biosmiilar approval is pending in the near future, a Humira biosimilar to be made by Amgen.


On Thursday, September 15, 2016, MOLDX posted a revised LCD for broad gene panel testing in lung cancer.  

Note: This post was expanded on September 19, after a rapid post on September 16.

The LCD is online here.    A PDF version in the cloud, here.

A longer list of registry requirements has been written into the revised LCD.  However, coverage has been significantly expanded.  The LCD allows first line use of genomic panels for testing and is no longer predicated on only light or non smoking lung cancer patients.

Comments are open until November 28, 2016.  Details after the break, including a redline comparison of the existing LCD and the new proposal, then a comparison of the old and new registry rules, a clipping of the body of the LCD, and finally some quotations from CMS policy on CED/CDD in LCDs.

Wednesday, September 14, 2016

Update: Informal/Unofficial transcripts of the 9/12/2016 PAMA workshop

A blog from earlier this week has been updated with informal/unofficial transcripts of the 9/12/2016 PAMA workshop.   See the earlier blog with update, CMS and Youtube links, here.  

Or, to go straight to the cloud, the morning chemistry panel transcript is here, the afternoon ADLT transcript is here.  Note that the transcript refers to working positions under discussion; see those PDF documents here and here.

Tuesday, September 13, 2016

LCD Case Study: Deep Dive on Veracyte PERCEPTA LCD

On September 8, 2016, the MolDX program published a draft LCD for coverage of the Veracyte PERCEPTA test, which provides a molecular risk stratification of patients who have a suspicious lung nodule and an ambiguous bronchoscopy study (here).   A deep dive analysis of the LCD follows.