Lilly and Anthem: New Drugs, New Ways to Pay for Them

We hear much about a brave new world where providers and payers will have to collaborate toward common goals.  Lilly and Anthem have released two white papers, and a Health Affairs blog, talking about exactly that.

Medicare Memo re Drug Pricing - Withdrawn from its Website

If you google terms like Medicare and drug pricing or price negotiation, there are a flurry of daily hits, from Congressional hearings to New York Times op-eds to fiery statements from presidential candidates.

In the last few days, the healthcare trade press has reported that CMS released a transmittal that seemed to be preliminary to local demonstrations for drug payment reform.  Then CMS pulled the transmittal, a representative saying it had been "premature."  Links after the break.

Genomeweb: Long Article on FDA LDT Reform (Non Subscription)

The genomics trade journal website Genomeweb provides both subscription and non subscription material.  On February 4, 2016, they published a long article by Turna Ray on next steps for the FDA LDT guidance, whether and how it will be finalized.   It's a 1600 word update on the topic.  Here.

The article also includes a 10 page online PDF which compares a range of different proposals and positions on the LDT reform topic (here).

CMS Medlearn Webinar: 2016 Quality Programs

CMS runs a number of very active webinar series, such as Medlearn Connects (here) and an eHealth focused series (here).

This month, CMS held a webinar with a 76 slide deck about 2016 provider quality programs, including an overview of the complex changes caused by MACRA, the 2015 "SGR Fix" that also revamps the quality measure system.  See the 76 slide CMS deck in the cloud, here.  Or just study the key takeaways in the picture below:

DC Court Address Massive ALJ Backlog; Current Remedies Fall Grossly Short

Dani Kass reports in the subscription service LAW360 that the DC Circuit court has "jurisdiction to order HHS to cut down a massive backlog of disputed Medicare claims."  See the judicial decision online here.

According to Kass, the circuit court refers to an "exponentially increasing backlog" and that HHS receives "a year's worth of cases every two months or less."  The current case decision follows hearings in November 2015 (here).

I pointed out that this was obvious and inevitable two years ago on this blog, and that the then-contemporary government math statements wouldn't make sense, even to a seventh grader.

Quinn's April 2014 blog predicting this, here.

Exact Science's Cologuard; Payers; Lawsuits; Colon Screening Policies

Exact Sciences markets the FDA-approved colon cancer screening test based on stool DNA analysis.  It is endorsed by the American Cancer Society (ACS) guidelines and by a Medicare NCD.  However, for many health plans, it is not a required benefit, as it is not endorsed by the US Public Services Task Force.  Based on several recent news stories, the manufacturer sues Humana, on the basis that Kentucky law (and some other states) use ACS guidelines as a state-based standard of coverage.

Cardiac Device Gets "Substantial Benefit" from CMS, But MACs Block Coverage of Claims

CardioMEMS is a sophisticated heart failure monitoring device which won the rarely awarded endorsement of "substantial clinical benefit" from the CMS DRG system.  However, some MACs have declined to cover the device.

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.