CDC Atlanta Forum on FDA LDT Regulation Announced: For November 4-5, 2014.

The CDC has announced a three-agency forum on FDA LDT regulation, to be held in Atlanta November 4-5.  (FDA LDT regulation is only part of the agenda.)

The CDC writes (federal website here, my cloud archive here):

MATTERS FOR DISCUSSION: 

• The agenda will include agency updates from CDC, CMS, and FDA. 
• Presentations and discussions will include the FDA Draft Guidance on Laboratory Developed Tests.

The CDC's published post-meeting notes are clipped further below.

House Energy & Commerce Holds Hearings on FDA LDT Proposal [September 9, 2014]

On September 9, 2014, the House Energy & Commerce committee held a hearing through which a range of stakeholders could discuss the FDA's recent proposal to regulate laboratory developed tests.   The six speakers included Jeffrey Shuren, MD JD, the head of the Center for Devices at the FDA, followed by a series of public stakeholders:  Christopher Newton-Cheh of MGH, representing the American Heart Association; Andrew Fish, representing AdvaMed Diagnostics; Alan Mertz, representing the Americal Clinical Laboratory Association (ACLA), Charles Sawyers MD, recent president of the American Association of Cancer Research, and Kathleen Wilsey PhD, co-founder of the Coalition for 21st Century Medicine.

This newly arising topic has been integrated into a months-long series of hearings by the "21st Century Cures Initiative" in the House:  here.

Two Publications: A New PMC Policy White Paper, and a New Paper on Clinical Utility

This summer, I've been fortunate to have a hand in two publications.   I had a major writing role in the Personalized Medicine Coalition's policy paper on diagnostics reimbursement.   The final paper, I should add, is a PMC work product, and many shared in the final comments and editing.  It's on the PMC website, HERE.

With co-author Felix Frueh PhD, in August 2014, we've been able to publish a "New View of Clinical Utility" - our attempt to help out an area that's been contentious for a long time.  Available online HERE.   More on clinical utility after the break.

FDA RELEASES ITS PLAN TO ENTER THE DOMAIN OF LDT REGULATION

On July 31, 2014, the FDA released an armful of documents announcing its extensive plans to regulate laboratory developed tests (LDTs).

Update: The FDA's draft guidance was officially released for 120 days of public comment on October 3, 2014 (here).  The official comment period documents are virtually unchanged from the July early release versions.

In this post, we review the major documents released and briefly summarize the back story, which dates to the 1990s.   We discuss some lower-visibility aspects of the documents that may have significant strategic implications.   We note that while the FDA has played its cards with a big splash, the proposal is massive and would be colossal to implement in its full fledged form – as well as raising substantially higher regulatory barriers to daily medical lab operations than in other advanced countries such as Canada, England, and the European community.   The plans might be backed down to something more akin to the New York State special test-by-test approvals that many labs already navigate, but only time will tell.

[Updates through August 6]
[For my summary of September 9, 2014 Hill hearings on FDA-LDTs, see my later blog, here.]

Government Responds to CCLA Lawsuit about LCDs; CCLA Responds to Gov't; Govt files its reply

[Updated for all three July, 2014 documents]
[Updated 8/27/2014:  Judges schedule oral argument for December.]
[Updated 2/3/2015:  Orals arguments were heard in DC on February 2.]

Last spring, the California Clinical Laboratory Association filed a court case against the federal Department of Health and Human Services asserting that Local Coverage Determinations were unconstitutional.   This was announced with a public press release, covered in the trade press, and I provided a short blog and a link to the original CCLA filing here [April 18, 2014].

In early July, the government responded with a 32-page motion to dismiss on several grounds.   This is typically the first move when you sue the government – I worked as a Medicare medical director in the previous decade (the 00’s) and lawsuits against us were quickly transformed into motion-to-dismiss cases.  In mid July, the CCLA, through its attorneys, responded to the motion to dismiss  and finally, at the end of July, the government responded to that CCLA filing as well. Finally, in late August, judges scheduled oral arguments in the case for December, 2014.

Medicare MOLDX Program Posts Guidance Documents, New Coverage-With-Evidence LCD

Since 2012, Medicare has supported a distinctive local contractor-based coverage and coding program called MOLDX.   The program was originally created by the Palmetto GBA program for us in Jurisdiction 1 - California, Hawaii, Nevada - from 2012 to 2013.  Palmetto GBA now also operates the program in its "home states" of SC, NC, VA and WV, and the program are also valid for labs in the new Jurisdiction E (CA, HI, NV) -- states where the laboratory's claims are actually processed by the Noridian contractor (here).

In June 2014, the MOLDX program (which has its own website, here) published several guidance documents for labs submitting new-test dossiers and publications for coverage decisions.

In addition, the MOLDX program published an innovative draft LCD (DL35368) providing coverage for the MDxHealth test ConfirmMDX.   ConfirmDX helps rules out the need for repeat biopsies in cases of potential prostate cancer.

Links and more after the break.

Judges Reject Decades-Old Medicare Ban on Transgender Surgery

On May 30 and 31st, the media buzzed with reports that judges at Medicare had suddenly thrown out the longstanding federal ban on payment for transgender surgery.  For examples, see the CNN report, here, and USAToday's coverage, here.

I won't talk about the important social and societal issues, but if you would like more information on how the wheels turned, how the rules and procedures played out within the Medicare agency, and links to hard-to-find key documents, see more after the break.

* UPDATE: CMS RELEASES NEW NCD; JUNE 2016; HERE.

Using the Giant Medicare Physician Data Database

In April 2014, after years of legal efforts by multiple parties, including the Wall Street Journal, CMS released nearly 2 GB and some 10 million lines of physician data.   Both the Wall Street Journal and New York Times provide simple consumer friendly websites where you can look up a single doctor by name and zip code and see his Medicare billings for calendar year 2012.

Although it took most of a day, I was able to use the database for some client projects and I've made a Powerpoint deck and online 20 minute video that explains how the database(s) can be used. Details after the break.

An Online Video Course on Clarifying Discussions of Clinical Utility

This course summarizes PowerPoint seminars I've given in the first half of 2014 at several conferences and workshops.   Our peer-reviewed publication on the framework, Frueh & Quinn, 2014, appeared in July 2014, see here.

The thesis is that current simple frameworks for assessing diagnostic tests - like "analytical validity, clinical validity, clinical utility" are "real" in that they certainly do reflect actual different aspects of the test, but those six words are not modular enough to guide assessment.   That is, one has to bring a lot of content knowledge to those several words to do a technology assessment based on them.

Videos and PowerPoint downloads are available after the break.

Wednesday May 14: Washington Panel on Lab Markets after PAMA

PAMA is the acronym for the bundle of changes to Medicare policy that become law on April 1, 2014.  Most prominently, it deferred the physician pay SGR cut for a year.

Our firm, Foley Hoag, has a webpage describing the major impacts of PAMA on the diagnostics industry, here.

Details about the Webinar and conference we hosted on May 14, 2014, are stored after the break.

Lung Cancer Screening: CMS Advisory Panels Splits 180 degrees from USPSTF

Update: Proposed CMS Decision released, November 10, 2014:  See here.
___________________

Last winter, the United States Public Services Task Force (USPSTF) issued a Grade B recommendation that low dose CT scans provide a health benefit in the age 50-80 population, who have > 30 pack years of smoking and who currently smoke or quit less than 15 years ago (see report here.)   Under the Affordable Care Act, commercial insurers will be required to offer this benefit, without copays, in a year or two.

In February, Medicare opened a decision analysis on whether to add this benefit to the Medicare program.  Medicare has undertaken this process and concurred with the USPSTF recommendation in numerous NCDs since 2010.   On April 30, Medicare held a public panel - a MedCAC advisory board - to discuss the low dose CT screening benefit for Medicare patients.   The Medicare panelist gave strikingly low votes that they had confidence the benefits would exceed the risks and uncertainties in the Medicare population.

My detailed notes on the meeting can be downloaded from online here. [50 pages including key figures presented, websites, and footnotes for most of the articles cited by speakers.  At the link, see the upper left arrow for 'download.']

(Update 9/24/2014: The CMS transcript of the full session, word for word, is now online here.)

For a brief trade journal review, the MedPageToday summary is here.   The Lung Cancer Alliance immediately expressed its "deep disappointment" with the panel's vote.

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.