Book review and comment: The Remedy (Robert Koch, Arthur Conan Doyle, and Pasteur)

The Remedy, by Thomas Goetz.   An offbeat view of history that brings together Robert Koch, Conan Doyle, Pasteur, and the quest to understand tuberculosis in the 1890s.  For my review, click the link below the picture.

California Clinical Lab Association Protests CMS Authority for LCDs

The California Clinical Laboratory Association (CCLA) has filed a lawsuit in federal court in Washington, DC, challenging authority of CMS to delegate coverage decisions down to the authority of its local claims-processing contractors, or Medicare Administrative Contractors (MACs).    The CCLA press release is here, their law firm's announcement here, and the initial court filing, which is publicly available, is 77 pages long and can be found here.

As stated by the CCLA, key features of the complaint include:

• Congress has unlawfully delegated regulatory power to the MACs;
• MACs have implemented Medicare policy without following required federal rulemaking requirements;
• MACs have developed LCDs based on criteria they are not permitted to consider;
• HHS has eliminated any meaningful opportunity for laboratories to administratively appeal the application of LCDs and has not established a required mediation process;
• HHS has not developed an effective plan to evaluate the appropriateness of adopting new LCDs nationally, as noted recently by the Office of Inspector General.

FDA Announces Another Workshop on Next-Gen Sequencing - September 24-25, 2014

The FDA has just announced another workshop on policy for next-generation sequencing.  (See the meeting announcement here.)  According to the announcement, two-day event will focus on:

Establishing protocols for ensuring the safety and quality of next-generation sequencing (NGS)-related information without sacrificing scientific merit or interfering with innovative processes.

The purpose of the workshop is to engage NGS stakeholders in a forum to discuss the current use of the technology and the development of data standards of NGS-related information.


This is the third or fourth FDA event on Next Generation Sequencing.   The FDA held a one-day discusssion on June 23, 2011 (see the agenda and powerpoint presentations here  and an official meeting summary here).  In early 2014, the FDA also held a meeting on NGS for micriobiology (here).  And there was a considerable flurry in the press when the FDA began approving NGS platforms later in 2014 (typical press here and here, and a joint NIH/FDA article in the New England Journal of Medicine here.)

Last January, the Center for Medical Technology Policy in Baltimore announced the launch of a year-long effort to study guidelines for NGS clinical utility evidence (press release here; news at the proprietary website Genomeweb, here).  The "paradigm shift" for integrating NGS into clinical testing in oncology was also a topic this month at the American Associatoin for Cancer Research (AACR) meeting in San Diego (also from Genomeweb, here).

April Medicare Reform and the Tangent that Impacts Pathology Tests

April's Medicare bill, most simply described as "The 2014 SGR Bill," is formally named the Protecting Access to Medicare Act of 2014 (PAMA).  Its main function lies in a short initial section that delays for another year the physician pay cuts related to the longstanding Sustainable Growth Rate rule.  

The lab industry is aware that there was also a substantial section changing the way clinical laboratory tests will be paid in the future, at market-based rates, which has been widely discussed (e.g. by my firm and at Dark Daily.)   However, there is ALSO a section which gives the Medicare agency a much more free hand in setting the rates paid for pathology tests, such as flow cytometry, in situ hybridization, and immunohistochemistry.   For more detail, click to continue.

Structured Risk Benefit and the Elucidation of Uncertainty

The Long Struggle to Clarity on Risk/Benefit Decisions

The FDA and international regulators have long struggled with how to assess risk/benefit issues.   For example, in 2007 the FDA's Robert Temple wrote a thoughtful essay on the disadvantages or difficulties of quantitative risk benefit analysis (article online; pubmed), in response to an article promoting the quantitative risk/benefit approach by Hughes et al.

23andMe is Alive and Well in the Media This Spring

In a well known story, the Yahoo-backed direct-to-consumer genetics company 23andMe was on a roll last fall - capped with the appearance of its CEO, Anne Wojcicki on the cover of Fast Company magazine.  Almost simultaneously, the FDA announced that the company would need to stop offering its product to consumers, on the basis that it was not an approved medical test, and that some of its information (for example, very partial results on the BRCA gene) could have greater harms than benefits.

(See the New York Times story, where Duke professor Misha Angrist said at least some of the FDA's claims were "borderline absurd."  While in contrast, a Forbes columnist called 23andMe's tactics "the dumbest regulatory strategy" he'd ever heard of.)

FDASIA Report on Healthcare Software Regulation Released - April 2014

"FDASIA" was the 2013 round of new funding for the FDA.   One of its mandates was the the FDA collaborate in a multi-stakeholder effort to develop best practices for the regulation of software in healthcare - whether electronic health records, software inside medical devices, decision-assistance software, or mobile apps.   This is an area where Congressional voices have weighed in, coalitions have struck position, and relatively little concrete action has occurred - yet.

The report, released in early April 2014, is relevant to stakeholders in a whole host of fields, from telemedicine to new horizons in healthcare self-help apps.

On our Foley Hoag website, see our full review of the new 2014 consensus report: go to our  full website here.   We also provide the text as a 4-page PDF.

An Important New Blog has Appeared!

There are a lot of good blogs available...I track a couple dozen, and least lightly, via the web app FEEDLY, have a few real favorites, and there are probably other good ones I'm not aware of.

Louis Jacques MD, who until early 2014 held the very important position of head of the Coverage and Analysis Group at the Medicare agency, is now a national-class blogger with a steady stream of new ideas.   In March 2014, he stepped down from his agency position to join the health policy consulting group ADVI.

Dr. Jacques' blog is called Healthcare Insighter and is worth tracking.

Are Health Technology Assessments Good or Evil or is this the Wrong Question?

Often the perspective from industry on health technology assessments is that they are more-or-less evil (on a scale of good to evil).   I was surprised by the high quality, assemblage of facts, and overall astute viewpoint provided by a new 30 page white paper that can be downloaded from The Economist on value based healthcare and its implications for the global drug industry.   (Free with registration).

The Go-To Article on Everything that's been Written on Clinical Utility

In the past decade, much has been written about how to define, assess, or benchmark the clinical utility of clinical laboratory tests, like genetic tests.   Clinical utility, as a term, is most familiar in the triad of terms, "analytical validity, clinical validity, clinical utility" which describes three aspects of the information that pertains to diagnostic tests.   Analytical validity means what goes on inside the test tube - we can measure "X" within 2%; and test to test, the precision is plus-minus 1%.  Clinical validity means that "X" correlates with something clinical; for example, high glucose correlates with having diabetes, and in cancer, elevated expression of certain genes correlates with more aggressive tumors.   Clinical utility means that there is clinical value in using the test; something about the test helps us in a credible way with diagnosis or patient management.

Parkinson et al. knock the ball out of the park

A recent issue of the journal Clinical Cancer Research provides a detailed 18 page review of the literature on clinical utility of diagnostic lab tests, written by David Parkinson and 13 coauthors who are a who's who of top names in the laboratory and evidence based medicine fields.   The article is a keynote within a special issue of Clinical Cancer Research devoted to the rapidly growing role of diagnostic tests in the management of cancer.

Can OMHA do math? Do they want to?

OMHA stands for the Office of Medicare Hearings and Appeals.   Generally, if you appeal a denied Medicare claim, seek reversal of an audit, or appeal a provider enrollment denial, you will end up here, before an administrative law judge.

OMHA is not in good shape.  Because of the booming business in Medicare audits over the last several years, the case load for this department has grown enormously, but its professional staff has only grown very slowing.   How bad is it?   A few months ago, the head of OMHA (Nancy Griswold)announced a moratorium on new cases for two years into the future (!).   (For a blog explaining this, click here.)

The Vague Advisory Panel for New Clinical Lab Tests

 Much attention has been aroused by the major reform of clinical lab test pricing in the Medicare system which occurred on April 1, 2014 (no joke) when President Obama's signature met the Protecting Access to Medicare Act (PAMA).  One of the major sections of the bill shifts the Clinical Laboratory Fee Schedule - how Medicare pays for clinical chemistry and genetic tests - to peg all the federal prices to market-average prices, beginning in 2017.   (For details, see our Foley Hoag summary of the CLFS provisions).  The bill also gives CMS a free hand in resetting the prices of all physician services, including pathology tests - more about that later.

As regards laboratory test payments, the PAMA reforms were generally well accepted by two of the largest trade organizations, ACLA and Advamed, but it has also been portrayed in the trade press as a mix of good news and bad news.