FDA announces two-day public LDT Regulation meeting, January 8-9, 2015.

On November 24, 2014, the Federal Register published the FDA's announcement of a two-day public workshop on January 8-9, 2015, on its proposal to regulate laboratory developed tests.   The meeting announcement is available here.  The workshop will be held at the Natcher Center at the NIH.

UPDATE:

The FDA posted transcripts webcasts  after the meeting, here.

The rest of the original blog continues...

Registration is first come first serve until December 12, 2014, at 4 pm, but may sell out earlier.  The FDA may "limit the participants from each organization."   A streaming webcast is expected to be available.

Oral presentations must be requested by December 12, and winners will be selected by December 17.  Presentation materials would be due by January 6, 2015.

Comments may be submitted before or after the meeting, up until February 2, 2015.

The meeting announcement is four pages long and contains additional commentary on the FDA's plans and goals.

Medicare Finalizes an Updated "Coverage with Evidence Development" Guidance

In 2006, Medicare released its first guidance document for Coverage with Evidence Development.  In 2012, CMS released a draft update of its guidance (for a discussion from 2013, see here).

On November 20, 2014, CMS finalized its updated guidance document.   The full CMS text is online, here.  CMS also published a public "summary of comments received" document, available here.

Analysis to follow.

For those with subscription access, the Gray Sheet trade press coverage is here.

Medicare MolDX Program Issues "Molecular Test Panel Alert"

On Friday, November 14, Medicare's program for molecular test coding, pricing, and coverage - MolDX - issued an "Alert" for molecular test coding when a laboratory performs a "set of medical tests composed of individual laboratory tests" that is completed "on a single sample."  Labs performing such tests should start to register such tests as panels beginning on Monday, November 17, 2014, to obtain a "unique MolDX identifier" for each panel.

Effective in six weeks, January 1, 2015, MolDX will "reject tests" submitted with a single biomarker CPT code for each biomarker.

Full text after the break.

FDA Law Blog: Summary of November 6 CDC-FDA meeting on LDT regulation

At the FDA Law Blog, Jamie K. Wolszon & Jeffrey N. Gibbs of Hyman Phelps provided an extended summary of the November 6 FDA-CDC public workshop on the FDA's plan to regulate laboratory developed tests.  Their report is here.  "OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTs."

For those with access, Genomeweb provided a detailed report previewing the Association for Molecular Pathology "Visit the Hill" day this week, focusing on the AMP's position on LDT regulation....here.  Turna Ray writes:  "Following Republican Election Gain, Detractors of FDA Lab Test Regulation Seize Chance for Support."

CMS Releases Proposed NCD for Lung Cancer Screening

On November 10, 2014, CMS released a proposed NCD that covers annual low-dose CT lung cancer screening for beneficiaries with a long smoking history.

For detailed coverage of the public advisory panel held at CMS last spring, see here.

The topic was controversial because the screening test received a "B" rating earlier from the USPSTF, and the Affordable Care Act requires coverage for individuals with commercial health insurance.   Medicare law allows coverage under Medicare, but requires a separate review and National Coverage Determination, the process that is underway.

In my reading, the topic was controversial because while the pivotal trial was very, very large (about 50,000 patients), the absolute survival benefit was very small (about 0.4%), suggesting that if implementation was a little bit less effective than the trial, there wouldn' t be a benefit.  This is almost always the case with very large trials; if you study an anti-platelet drug in 30,000 patients, it's because the benefit of the drug is likely in the 1% range.

CMS proposes to require that all beneficiaries covered for low dose CT screening have a standardized, multi-faceted training and awareness counseling session, and that each eligible center must participate in a nationwide Medicare registry.  

The national coverage decision is online here.   Coverage at the radiology/imaging industry website AuntMinnie is here (free registration required).  New England Journal ran an article on cost-effectiveness a few weeks ago, here.  JAMA Internal Medicine ran recent articles on the topic, here ("Overdiagnosis in CT screening") and here ("CT Screening, How strong is the evidence?")  JAMA Internal Medicine is edited by Dr. Rita Redberg (here) who also is chairperson of the federal advisory committee MedCAC (here).

Coverage at NY Times here; at Medscape here.  At "Radiology Business," here.

A blog at Health Affairs by Dora Hughes MD, here.

Some interesting parallels between this NCD and some recent LCDs on molecular diagnostics will be discussed in a future post.

CMS Rulemaking for CY2015 Released: Outpatient and Physician Settings

On Friday evening, October 31, CMS released its final policies and spreadsheets for CY2015 for both the physician fee schedule (here) and the hospital outpatient service (here).  The full set of PFS files is here and the full set of outpatient data files is here.

The final typeset versions of the rules will appear in the Federal Register in about two weeks.