Saturday, January 31, 2015

New York Times Coverage of the Obama Precision Medicine Initiative

In the State of the Union Speech on January 20, 2015, the President mentioned he would soon unveil an initiative in precision medicine.  The unveiling came on January 30, with both a detailed White House press release and a 20-minute televised speech by Obama.   For more on the Precision Medicine Initiative, see here.

Between January 20 and January 30, there were two interesting pieces in the New York Times, one a news report and the other an Op-Ed.   Discussion below.

Friday, January 30, 2015

White House Details $215M Initiative in Precision Medicine

In the President's State of the Union Speech, January 20, 2015, one sentence referred to a precision medicine initiative:
21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine -- one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes -- and to give all of us access to the personalized information we need to keep ourselves and our families healthier.
On January 30, the White House describes the initiatives tied to this proposal (here).  The President's 20 minute press conference streams on CNN (here).  Some talk highlights here.  Details after the break.

Wednesday, January 28, 2015

Metrics about MOLDX Code Coverage - A Snapshot for January 28, 2015

Recently, I was asked to do an analysis of MolDX coverage by CPT code, and I pulled some of its current data into Excel spreadsheets, available (here; look for small 'down arrow' to download).

Note that MolDX coverage may change at any time, so the cloud spreadsheet just provided represents one day's snapshot of MolDX current coverage and non-coverage webpages.

Details after the break.

Tuesday, January 27, 2015

21st Century Cures: A Health Policy Legislation Smorgasbord

Throughout 2014, the House Energy & Commerce special task force, "21st Century Cures," has held hearings on topics as diverse as orphan drug incentives, telemedicine, and the regulation of LDTs, all tied to the theme of U.S. competitiveness in biomedical innovation.

On January 27, 2015, the committee released an example of draft legislation, covering dozens and dozens of diverse topics, and including more than a few empty "placeholder" sections (such as text affecting FDA regulation of lab-developed tests.)   The website is here; I've uploaded texts like a committee "one pager" and other committee summary documents to the cloud, here.  See an early summary of the 393-page legislative draft (discussion) text at Science, here.  RAPS, the Regulatory Affairs Professionals Society, has a blow by blow discussion online, here.  Their discussion tends to skip over Medicare sections, so I highlight some of those below.  Pink Sheet has a table of explanation of the document, here (subscription).  FaegreBD Consulting discusses where the bill might go, here.

The 21st Century Cures document is not literally a "legislative proposal," but rather a centerpiece to help organize ongoing discussion.  For example, some of the topics may be included just for "airing" and might be very unlikely to be included in final legislation. Modern Healthcare quickly ran a headline, "Dems Balk at Bill" (here).  For the Association of Molecular Pathologists comment, here.

The Senate Finance Committee released a parallel report on medical product innovation on January 29, 2015 (109 pages; SFC website here, 109 page PDF report, here.)  The Senate report is clearly meant to be generally favorable and supportive of the House-side 21CC effort.

Further comments after the break.

Fifty Shades of Blog

At the one year anniversary of this Discoveries in Health Policy blog, there have been 50 postings.  In a year, there were 17,000 page views (about half are real and about half are search engines).  I was tickled that both Nature and the New York times reached out for quotes recently ( New York Times, here.)

Review of most-popular first year entries, after the break.

Friday, January 23, 2015

MOLDX LCD for Comprehensive Genomic Profiling in NSCLC

Palmetto GBA has published a draft LCD to provide coverage for large-scale gene panel tests in non small cell lung cancer.   The LCD is available here at the CMS website.  A public comment period is open from February 10 to March 27, 2015.  Details after the break.

Thursday, January 22, 2015

CMS Announces MEDCAC on Molecular Prognostic Tests - March 24, 2015

CMS has announced a MEDCAC (advisory panel) public meeting on prognostic molecular tests, focused on breast cancer and colorectal cancer molecular tests.   Such meetings often kick off with a technology assessment subcontracted by AHRQ.

Update [March 25]: Early trade press after MedCAC suggests it went exactly as predicted in this blog many weeks ago.  An advance copy of the transcript is available here.

Details after the break...

Tuesday, January 20, 2015

The Backdoor to JP Morgan: Symposia and Presentations On Line.

Every winter, the annual JP Morgan life sciences conference brings Wall Street and the U.S. pharma, biotech, and medtech community to San Francisco for four hectic days.   Admission to the actual conference - which locks down the St Francis Hotel at Union Square - is very strictly controlled.   The conference is for Wall Street and for CEOs/CFOs.

However, under SEC open information laws, most of the conferences stream online, just like quarterly earnings calls.  This isn't much advertised, but it's a public website and this is the link for the 33rd annual conference:

(Registration is free with your email).

There were four keynote events in addition to the dozens of corporate presentations.  Francis Collins, the head of NIH, gave his outlook for genomics and biotech.   There were also three panels featuring national thought leaders on the topics of pricing and value-based genomic tests, next-generation sequencing, and disruptive DHealth technologies.   More details after the break.

Thursday, January 15, 2015

FDA posts Videos, Presentations, From Jan 8-9 LDT Workshop

The FDA has released both two days of video and all publication presentations from the January 8-9, 2015 public workshop on FDA regulatory of laboratory developed tests.

See:  Here.

Agenda and links after the break.  82 presentations were calendared, although a few were withdrawn.

Saturday, January 10, 2015

HHS Says Court Case Fighting the NCD on Amyloid PET Scans Isn't Valid; Defendants Fire Back


  • Three beneficiaries, supported by Lilly, filed for summary judgement against the CMS beta-amyloid NCD in September 2014.
  • CMS filed a lengthy motion to dsmiss in December 2014.
  • The plaintiffs filed a renewed request to invalidate the NCD and enjoin enforcement in January 2015.

Details after the break.

Thursday, January 8, 2015

ACLA Releases New Position Paper against FDA LDT Regulation; AMA Weighs in Too

On January 7, the American Clinical Laboratory Association (ACLA) released a detailed legal white paper on why the FDA does not have the authority to regulate laboratory developed tests.   The press release is here, the legal white paper here.  

ACLA released, on the web here,  its oral comments at the January 8-9,2015 FDA public workshop on LDT regulation.

Last summer, the FDA responded to three Citizen's Petitions for and against FDA LDT regulation, with the petitions and the FDA's responses to each clipped below. 

'06, '08, '13 Petition
7/2014 FDA Response

The subscription website Genomeweb interviews the ACLA legal authors, here, and a counterpoint, here.

  • Also this week, the AMA publicly released its letter to the House "21st Century Cures" group, which requested public feedback on the FDA LDT issue by this week.  
  • AMA document, here.