FDA Posts Video, Slides: Regulating NGS Cancer Panels, Feb 20, 2016

On February 25, 2016, FDA held a workshop on "Next Generation Sequencing-Based Oncology Panels," agency web page for this meeting, here.  The FDA posted an 8 page discussion paper for the meeting, here.

FDA also compiled the slide decks presented as one 200 page, 8 mb file (here).  The video webcast is archived on line (here).  Update: Unofficial transcript in the cloud, here.

The agency accepted written public comment until March 28, 2016.  The agenda is posted below the break.

CMS Withdraws Poorly Designed Anti PSA Screening Metric

Last fall, this blog and other sources severely criticized a proposed CMS metric against PSA screening ( my November blog here).  Even without taking a stand pro or con PSA screening, the wording and rules for the proposed CMS metric was not even consistent with the CMS NCD for diagnostic use of PSA in cancer management.

On February 26, 2016, the AUA announced CMS had withdrawn from further work on the poorly constructed metric (here).

CMS has other inconsistent coverage rules versus physician performance metrics.  For example, the CMS coverage benefit for colon cancer screening COVERS the Exact Sciences Cologuard test, but it is NOT covered by the CMS metric for physician performance in getting their patients colon cancer screened.   See "Medicare is Inconsistent" heading at this blog entry.

The ACP 86 Page Free Guide to CLIA (For Physicians)

A freebie on the net, American College of Physicians offers an 86 page overview of CLIA, written in 2014.   Details after the break.  Find also some links to CLIA history.

White House One Year Anniversary Summit on Precision Medicine (Feb 25, 2016)

On February 25, the White House streamed live a one year anniversary summit for the Precision Medicine Initiative.   Youtube website here (initially streamed live;  also the archive link.  President enters at 1h50m).

I've provided an open access, 40 page transcript (16,000 words), in the cloud, here.  In addition, I've put the two hour conference in the cloud as a downloadable 160 mb mp3 file, here.

For pre-publicity press on the event at Morning Consult, here.  At Washington Post, here.  At "STAT," here and here.  Fast Company here.  New York Times here.  Beckers Hospital Review here. Genomeweb here.  More after the break.

Peabody et al. (2014): Open Access Paper on Clinical Utility of Molecular Pathology

There are a number of papers on clinical utility, including one by Felix Frueh and myself in 2014 (pubmed here, journal here) which is not open access, although my own explanation of it is (here).   The most comprehensive review article on clinical utility is Parkinson et al., here.

See also the 2014 article, "New Thinking on Clinical Utility: Hard Lessons for Molecular Diagnostics," online at the influential Amer J Managed Care and open access, here.

FDA Invites Payers to the Party: Federal Register Notice

On February 24, 2016, the FDA published a two-page Federal Register notice inviting more commercial payers to participate in helping stakeholders understand the mix of regulatory and payer evidence required for coverage decisions.  The respondents could be payers, or third parties like health technology assessors.  The invitation is specifically from the devices division (not the biopharma divisions).  Details after the break.

High Impact Digital Health: A "Beta" White Paper

This week, I had the chance to Chair a very forward-looking conference held by the New York Venture Capital Association on Digital Health.

To help organize my thoughts, I created a "working version" or "beta version" white paper that extends some of the themes raised in an earlier document, "Digital Health: The Impact on Genomics." (here).    The earlier genomics paper takes a bottom-up construction, starting with about 12 real companies, putting them in categories, and drawing inferences and conclusions about industry trends.   This "beta" white paper on "Path to High Impact" takes the opposite construction, starting with some high level or 20,000 foot conceptions of health care and potential reasons for digital impact or transformation, and working to some rules and applications.

The "beta" white paper on digital health - the path to high impact -  is in the cloud, here.

The NGS MAC and its Molecular Services LCD

Most is written about the MolDX molecular coverage program at CMS, and for several years, the Novitas contractor has had elaborate LCDs for both oncology and non oncology molecular tests.

Don't lose track of the fact that the NY/New England and Upper Midwest IL/MN/WI contractor "NGS" (originally standing for National Government Services) has produced its own elaborate molecular diagnostics LCD.

The LCD was released in draft form last fall.  (Separately, the MAC has an LCD, effective April 1, 2016, for lung cancer genomic profiling, here, L36376.  This attracts a lot of attention as this is the LCD for lung cancer genomic profiling in Massachusetts, where Foundation Medicine is located.) Details follow.

MolDX Updates Tier 2 Fee Schedule

Beginning in 2013, AMA CPT began issuing several hundred codes for specific genes (such as KRAS) as well as "Tier 2" codes which are organized in 9 ascending levels of complexity and which, in total, contain over 500 gene names.

The CMS MolDX program covers a limited number of single genes by name within the Tier 2 codes.  For these, it publishes pricing.   It does not provide one blanket price per Tier 2 level, but prices its gene by name individually.  There is wide variance for the prices of covered genes within each AMA CPT mopath tier.

For 2016, the pricing was updated on the MolDX website (their table online here).  Tables and graphics after the break.

NYC February 23: Digital Health Conference

Tuesday, February 23, I have the pleasure of chairing a panel and other moderator duties at a Digital Health conference in New York City co sponsored by the New York Venture Capital Association and Executive Council.  The meeting runs 1-6 pm at the Microsoft Technology Center and tickets are still available.

Website here or here:  http://www.hbtsummit.com/

The Agenda is online here.  Registration here.

Digital Health and Genomics (Beta White Paper)

This week, I was invited to present on "Digital Health: The Impact on Genomics" at the Confera 12th Annual Economics in Oncology Summit in La Jolla, California.  (Conference website here).

For the February conference, I presented a 20 slide deck, available in the cloud here.  A slightly updated deck was presented at an ASU conference on genomics in April, here.

In parallel, I prepared a "beta" or "draft" white paper (3000 words, 40 citations), also in the cloud, here.

This is a fast moving field; for example, 48 hours before my conference presentation, a company I had not yet heard of, Seven Bridges [Cambridge MA; Feb 16] raised $45M for cloud based oncology bioinformatics analysis (press release here).  Stating:  "Seven Bridges is the biomedical data analysis company accelerating breakthroughs in genomics research for cancer, drug development and precision medicine. The scalable, cloud-based Seven Bridges Platform empowers rapid, collaborative analysis of millions of genomes in concert with other forms of biomedical data." AKA:  Digital health impacts genomics.

Short link: tinyurl.com/Digitalgenomicsbeta

Meaningful Use on the Chopping Block; Draft Senate Bill on EHR Interoperability

Meaningful Use on the Chopping Block
After a record level of EHR lobbying in 4Q2015 (here) on the "meaningful use" policy dictatorship (here), CMS officially stated that Meaningful Use in its current form would probably die off (here). CMS is even starting to opine on where EHR incentives will go next (here).   EHR penalties and bonuses will still be around, because they play a substantial role in the physician payment reform package called MACRA (here).  MACRA will enter CMS rulemaking in Summer 2016 and kicks into gear in 2017.

Senate Draft Bill on Long Awaited Interoperability Goals
Meanwhile, the Senate offered a draft 68 page bill on interoperability standards for EHRs (bill here, article from Health Care Informatics, here.)   See a nine page discussion of the key issues from the College of Healthcare Information Management Executives (CHIME), July 2015, here.

Stakeholders Comment on Senate "Chronic Care" Proposals

Next to universal coverage, getting a grip on costs and quality in chronic care is the holy grail of health reform.  In December 2015, the Senate Financed Committee issued a 30 page white paper "Bipartisan Chronic Care Working Group Public Options Document" with a call for public comments, see the white paper PDF here.

In early February 2016, the committee released an index to the over 300 public comments they had received, online here.

In the cloud, I've uploaded the white paper the index to comments, and a personal selection of about 40 public stakeholder comments culled from the 327 submitted.  For example, I culled the AMA, American Hospital Association, Alzheimer Association, Davita & Fresenius, American Telehealth Association, Advamed, BCBSA, Aetna, and a couple dozen others, for the Zip file.  Here.

Communicating with Payers versus Communicating with the FDA

At the beginning of the year, the FDA released an elaborate new 30-page guidance document for industry, "Best Practices for Communication between IND Sponsors and the FDA during Drug Development" (here).  For open access trade press and blogs, see RAPS here, Weinberg Group here, 505(b) Blog here, and PPDI here.  Comparison to "payers," after the break.

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.