High visibility press for the Bioreference 4KScore Test

Prostate cancer is one of the great dilemmas in current medicine.  While prostate cancer is often derided in public policy as an oversampled, overtested, and overtreated disease, nonetheless, it accounts for an astoundingly large proportion of all cancer deaths in men.  This paradox is not discussed prominently enough.   While the largest scale studies show modest population benefits of PSA screening, the real lesson should be that if testing were 25-50% more accurate and therapies were 25-50% more effectively chosen, this issue would be converted from a marginal benefit into a heavily weighted "win" for precision medicine against one of the major killers in cancer.   PSA and its historical performance curve should not be taken as a given, especially in an era of rapidly evolving diagnostics.  Replacing PSA should be taken as a mandate, as an urgent public health issue.  It would be like fixing a play by booting out a crappy actor and replacing him with a good one.

White Paper on Business Challenges for the Advanced LDT Industry

A couple years ago, a friend who works in venture capital asked me, "What are the main hurdles to success for a startup molecular lab?"   This topic is timely given the new burst of enthusiasm and venture funding flowing into LDT and usually Next Gen molecular diagnostics in 2H2015 and early 2016.  Liquid biopsy oncogene panel tests are rising rapidly in prominence and fall into the LDT category for the foreseeable future.

One of the easiest entry points to the topic was writing a white paper on some of the key barriers that are poorly understood outside the field, such as the challenges of a new lab being "out of network" with the health plans of the patients it provides tests for.   This and other distinct business challenges are explained in my white paper, "Evolving Challenges for Value Priced LDTs."

While the body of the white paper remains as written in 2014, the topics are timely.  For example, out of network labs were covered in Dark Daily in December 2015 (here).  However, 2015 topics like PAMA are not covered in this white paper.

The white paper is archived in the cloud and can be downloaded, here.

Is the "70% Rule" for Impact of Lab Tests an Urban Myth???

• For update that actually HAS a 70% data source, see here.

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For years we have heard that "70% of clinical decisions rely on lab tests."  While there is no question that lab tests are very often pivotal to a patient's management, a few years ago Mike Hallworth published a two page article that decimates the evidence base for this quotation.

Hallworth is a clinical biochemist in England; his 2011 paper is open access at Annals of Clinical Biochemistry, here.

MolDX Redesigns Its Website!

For the new year 2016, MolDX launched a complete and modern redesign of its website.  It features a new homepage with a ready list of popular topics.   It also includes a banner, that uses the top of the screen of all topic sections, and allows "one click" return to the "MolDX Hub."

You'll love it.  Here:  (click).

http://www.palmettogba.com/palmetto/moldx.nsf/DocsCatHome/MolDx

Don't forget to like MolDX on Facebook and follow it on Twitter - !

Big Data at JP Morgan (Panel)

At the January 2016 JP Morgan biotech conference, Astellas and Deloitte sponsored an expert panel on where we stand with big data in the life sciences, and where we should be by 2025.   A brief summary is provided, along with a link to more detailed notes.

January 2016: 34th Annual JP Morgan Healthcare Conference

This week, hotels all over San Francisco are sold out as the biopharma, medtech, and investment worlds converge on the JP Morgan Healthcare Conference in San Francisco.   Admission to the halls of the event itself is limited to C-level executives and to credentialed investors.  However, the hotels and restaurants are filled to the rafters with countless additional executives, as well as thousands of attorneys, consultants, and others.  

The conference website is not secret and conference materials are generally posted in the interests of open SEC disclosure of investment information to the public.  While that being true, the public website entrance can be a little bit tricky to call up on Google, it is here;   http://jpmorgan.metameetings.com/confbook/healthcare16/login.php  (here).

FDA Posts Transcripts of November 2016 Next Gen Sequencing Workshops

On November 12, 2015, the FDA held a workshop on analytical performance for next generation sequencing tests.  On the next day, November 13, the FDA followed with a workshop on the use of public databases as reference standards "the clinical relevance of genetic variants."  The FDA has now published transcripts of both conferences.   (Other materials, such as agendas, webcasts, and Powerpoints, are also online at the FDA.)

Medicare Says: Don't Bill Single Gene Codes along with Tumor Gene Panel Codes

Since 1996 Medicare has published "procedure to procedure" edits, which are large excel spreadsheets showing which codes should not be used together, because they are exclusive or because one is encompassed by the other.  For 1/1/2016, Medicare has block used of single gene (and "Tier 2") genomic codes if tumor gene panel codes are used on the same claim.

GAO Draws Attention to Site of Service Payment Disparities and Incentives

The GAO has released a 37 page report on what it views as perverse incentives for hospitals to acquire physician practices and rebrand them as hospital-affiliated outpatient locations.   The report, "Increasing Hospital-Physician Consolidation Highlights the Need for Payment Reform," is online here.  For Medscape's coverage, here.

Pathologist as Movie Star: Concussion (2015)

Rare when a movie stars a pathologist.   

Concussion (2015) tells the story of recent controversies and publications in sports concussion-related encephalopathy through the perspective of Bennet Omalu, a neuropathologist who devoted considerable energies to the definition of chronic traumatic encephalopathy (CTE).

Year End Review: Books of Note & Blog Info

Books of Note

I've posted an annual book review listing, a mix of healthcare policy and books about business disasters and innovation.  Here.  

On a more personal note, I posted an essay about lessons learned in 15 years since finishing an MBA (here) and an essay on the strategy of innovation management (here).

Bloggery

Discoveries in Health Policy hit 59,000 views in December 2015, running about 5000 hits per month. There were about 17,000 hits in year 1 and 42,000 in year 2.  There were 50 blog entries in year 1, and about 150 in year 2.

The vast majority of hits come from Google, but the hits for any given keyword are limited and unpredictable.  (Cologuard seems surprisingly frequent.)  The most popular blogs include the annual CLFS fee schedule releases.  DIHP continues to host the world's longest listing of articles about Theranos (here), which has garnered about 1400 hits in a year.   

Of 20 posts in December, there were 700 hits, with 7 posts having over 40 hits.  The most active post in November, on CMS quality metrics and PSA testing, had 80 hits (here), not counting postings of CMS November fee schedules, which quickly generate over 100 hits.  

My December 23 write-up of favorite and influential books of 2015 had about 60 hits in 48 hours, which I attribute to being kindly cross-listed on my wife's Facebook account.

Quick Links: Out of Network Problems Mount; Special Stains Increasingly Challenged.

Two quick links.

Dark Daily publishes another article in its ongoing series about the weak negotiating position and poor financials for out of network laboratories.  December 21 article here, with multiple links to their previous articles on this topic (when balance billing becomes the entire balance.)

Mick Raich, of Vachette Business Services and Stark Medical Auditing, notes that at Medicare MACs, special stains are increasingly under fire as more MACs adopt a stiffly written LCD originated by the Palmetto MolDX program.  Raich's December 22 essay here.

AMP Responds to the FDA's "20 Case Studies" about Bad LDTs

On November 16, 2015, the House held a hearing on regulation of LDTs, and FDA provided a sometimes poorly written review of 20 inferior or dangerous LDTs as Exhibit 1 (here).

On December 13, 2015, the Association for Molecular Pathology (AMP) released a 15-age response to the FDA's case.  Find it here.  Generally, AMP found that the FDA concerns were overstated (or worse).  In a few cases, such as the Kif6 case study and the OvaSure case study, AMP notes that a modernized CLIA that includes some clinical validity review would have caught any problems and FDA LDT review was not required.

12/21/2015: NYT Discusses New MAAA Diagnostics for Prostate Cancer

Posted online December 21, 2015, the New York Times "Well" (Health) section discusses new diagnostic tools for prostate cancer such as Oncotype DX Prostate.  The full article is here.  The author, Roni Caryn Rabin, discusses pros/cons of the introduction of new tests, with quotations from proponents as well as experts who feel more data is needed.

Update: Wide press in January 2016 on another advanced diagnostic for prostate management, the 4KScore test, see here.

MolDX Updates NGS Coverage; Comes Up With Surprising Definitions

The MolDX program released several coverage and policy updates between December 16 and 18, with some surprises.  The MolDX program uses a distinctive approach to coding, billing, and pricing, which cannot always be predicted by the use of the AMA CPT code book and CMS CLFS price tables alone.