Wednesday, August 24, 2016

CMS to Hold PAMA Lab Advisory Panel on ADLTs: Public Meeting September 12, 2016

CMS has announced it will hold a PAMA Advisory Panel on two topics on September 12, 2016.

The morning topic will be "Automated Test Panels under PAMA."  The afternoon topic will be the "Advanced Diagnostic Laboratory Test (ADLT) Application Process."

The sessions are open to the public but advance registration is required.   As of August 24, I heard a comment that registration had temporarily been listed as "closed" but in error.  As of August 24, it shows 220 spaces available.  CMS states that registration will close when the advance registration process is full, or, seating will close on September 2, whichever comes first.  Public comments must also be submitted by September 2.

The Online Agenda is available as a PDF file, here.
The meeting webpage and registration and other are available at CMS's website, here.

CMS web page (harvested August 24) is clipped below the break.

Monday, August 8, 2016

AACR/FDA Public Meeting on Liquid Biopsy Policy: Slides & Transcripts!

AACR hosted an all-day public meeting on Liquid Biopsy policy in July 2016, in collaboration with FDA.   Good example of a co-branded public/private partnership.

AACR has now posted both slides (355 pages of slides) and a complete transcript from the workshop.   Find everything here.


Sunday, August 7, 2016

The BMS/Opdivo Market Crash in Context: Personalized Medicine, Pathology, and Big Numbers

The big news of the month in biotech will probably remain BMS's striking stock price crash after announcing the failure of Opdivo in a first-line lung cancer trial.

As Fortune writes, "BMS shed about 16% of its market value Friday after a clinical trial failure."  Here.   At FiercePharma, "The news swept away $25B in market value."  Here.  Matthew Herper at Forbes picked up on the important personalized medicine angle, here, and this blog will nerd-dive that, further below.

What happened in brief after the break, and why pathology, test standards, and personalized medicine play a very big role.


Thursday, August 4, 2016

BIO360 - An interesting genomics aggregator website

A friend tipped me off to 360BIO today.  I may have seen it sometime, in the past, but lost track of it. 360BIO looks like primarily an aggregator of open access content - such as press releases and journal abstracts - but it does so in a dynamic and valuable style.

Worth checking out.

360BIO - Here.  Sections include Algorithms, Biomarkers, Genomics, Grants, Finance (VC), Regulatory, and Products.

Two other favorite highlights websites are DIVE BIOPHARMA for biotech news and DIVE HEALTHCARE for payer industry news.  If you add to those two, a touchdown at 360BIO every few days to scan for genomics trade & publication news, you've got pretty broad coverage of what's going on.




CMS Posts Code List for Labs Reporting under PAMA

On August 4, 2016, CMS updated its web page for PAMA lab price reporting.  It's HERE.

Labs doing more than $12,500 in Medicare  revenue in 1H2016 must report all payments by private payers for all lab tests on a list.  That list includes the regular CLFS prices, as well as those codes that are under contractor pricing (and possibly gapfilling) during 1H2016.  Details after the break.

The Sole Developer Clause in PAMA: How Bad Is It?

One of the most complex and interesting documents in the history of CMS laboratory policy is the final rulemaking to implement Section 2016 of PAMA (Clinical Lab Fee Schedule Policy Reform).

Most readers have heard of PAMA and several excellent ten page summaries are available (see a listing of some links, here).

One of the quirkiest parts of the is the CMS intepretation that the test must be developed and furnished by one laboratory.   (CMS does allow the "laboratory" so defined to have more than one CLIA lab.)

CMS explained on page 41,060 sole developer is treated strictly and if the development is 20% at an academic center and 80% at an independent laboratory, then neither one can claim to be the sole developer, and, lacking a sole developer, the test cannot be an ADLT.  More detail after the break. And I've quoted CMS below, so you can have a crack at parsing its language for yourself.

Wednesday, August 3, 2016

Early Press on Theranos' Talk at AACC 2016 (Links)

For eighteen months, I've run a nearly weekly update on Theranos article, steadily listing news items both favorable and critical across the march of time; here.  There are about 450 newspaper and trade journal links.  This blog entry has had about 3000 hits.

Early reaction to CEO Elizabeth Holmes' presentation at the American Association for Clinical Chemistry (AACC) in Philadelphia this week has trended negative, as shown below.  (Links after the break.)

Youtube Archive (90 minutes): AACC, Youtube, here.




Myriad to Acquire Assurex: Pharmacogenetics for Psychiatry

In a vote of confidence for the value of pharmacogenetic testing to improve clinical outcomes in psychiatry, Myriad Genetics will acquire Assurex Health for $225 in upfront payments (with potential milesteon payments of up to $185M).  See a news article here.  Details after the break.

AMA Meetings re: PAMA New Coding Policies; August 10 Call; August 12 Workgroup Deadline.

One of the more complex parts of PAMA, the Medicare changes for laboratory policy, is a new code set for proprietary tests and FDA approved tests.   CMS has offered to create any necessary codes with quarterly G codes - if AMA CPT codes don't exist for the test in question.   Meanwhile, AMA is working hard to have a quarterly code generation process up in running.  The AMA coding system will be part of CPT but the program name is "PLA - Proprietary Lab Analyes."

August 10 (Deadline August 8)
AMA is setting up an informational call on the PLA plan.  To join the call on Wednesday August 10 at 7 pm CT (8 ET, 5 PT), check out the information on this AMA webpage, here.   Sign up for the teleconference before August 8.

August 12
AMA is setting up a multi stakeholder policy workgroup for the PLA coding system.  Join the committee - they are taking applications for committee membership through Friday August 12.  See the full information at the AMA webpage here.  Be part of PLA-TAG - the Proprietary Laboratory Analyses Technical Advisory Group.   (Hopefully there will be baseball caps and T-shirts in addition to the workgroup conference calls.)






Press Release: New Two-Day Forum on Payers, Liquid Biopsy, Clinical Genomics (November 2-3, 2016)

The Green Park Collaborative (GPC) will host a Genomics Technology Policy Forum in Baltimore on November 2-3.  The conference topics will span health systems and genomics, liquid biopsy, and the emerging field of "panomics."   Panelists will span the range - from NCI to NantHealth to CMS.  The press release is copied after the break.



Tuesday, August 2, 2016

Foundation Medicine Announces FDA/CMS Parallel Review; Pathway to PAMA ADLT?

On August 2, 2016, Foundation Medicine (FMI) announced it was part of a Parallel Review program with FDA and CMS.   The FDA pathway will be "Expedited Access Pathway" for "breakthrough devices."  Press release clipped at bottom.  FMI's FDA/CMS project, coverage at Genomeweb, here; Fierce Biotech, here.  For additional coverage of FMI's quarterly investor call, here.  More details after the break.


NCCN Policy Summit in Washington: Biosimilars & Molecular Testing (September 16, 2016)

On Friday, September 16, 2016, NCCN hosts a national policy summit on Biosimilars at the National Press Club in Washington.

After a presentation on Clinical Implications of of Biosimilars and Molecular Testing in Oncology by Sean Tunis, Center for Medical Technology Policy, I will be presenting on Regulatory Aspects of the same topics.  The Summit runs from 8:30 to 3:00.

The full website is here.




Precision Medicine in Barcelona: September 14-15, 2016

International Molecular Diagnostics Congress, 2016 
Unlocking Personalized Medicine through Molecular Diagnostics:

Genetic InsidER organizes the first congress focused on capturing the real value of diagnostics the 14-15 of September in Barcelona. The conference website is here.  Join me there !

Personalized Medicine remains an area of huge opportunities and promise for diagnostics companies, but capturing the real value will require a disruption of the current reimbursement and delivery model. To enhance your fair share of value in this huge market Genetic InsidER organizes the first congress fully dedicated to this goal.

Captura2

See full details after the break.

Friday, July 29, 2016

RockHealth's Report on Digital Biomarkers in Healthcare

RockHealth is a San Francisco based organization that funds and supports innovative ventures in digital health.  (For their portfolio of 60 funded and/or affiliated company, see here.)

RockHealth has released an online essay that provides an overview of digital biomarkers in healthcare.  (For the full report, $99, click their "Download Report" button.)

Thursday, July 28, 2016

FDA Panel Supports Landmark CGM Indication for Insulin Management; Medicare Needs to Change

For years, Medicare has held a bizarre position that continuous glucose meters (CGM) are not covered because they are "precautionary" medical devices.  For recent examples of how administrative judges have treated this policy posture harshly, see here.

Meanwhile, the industry took a big step forward on July 21, 2016, when the FDA's clinical chemistry advisory panel voted to support a new indication for the Dexcom CGM, one that directly points to its use in insulin dosing.

Hopefully, this is a stage that will leading directly to FDA approval of this indication -- and long overdue fixes at CMS.