My talk at California Society of Pathologists

On December 5, I had the chance to give a short talk as part of a panel on changes in payer policy and how they are impacting practicing pathologists.  The location was the nationally popular winter California Society of Pathologists meeting, which gives both Californians and pathologists from cold wintry states a December trip to San Francisco for CME credits.   The final program is available here.

I was pinch hitting for a senior Medicare speaker, but did my best both to talk about what is going on at Medicare vis-a-vis pathology and to convey how the field, profession, or industry (take your pick) looks from the viewpoint of a Medicare policymaker.  My deck for the presentation is available in the cloud, here.

My key points were...

•  Federal policy changes for pathology are legion

•  Local changes to pathology policy

•  MolDX Program

–MolDX LCDs

•  How pathology looks to policymakers

•  Can changes be more selective?

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.

My Talk at Harvard

On Friday, October 17, I had the opportunity to give a talk on genomic medicine policy in the U.S. at Harvard (Brigham & Women's Genomic Medicine seminar series.)   The deck I presented is here.(Click on the small black down arrow to download).

While the slides are meant to be spoken to and not just read, my "Prolog" is that in a traditional business, you design a product and use sales and marketing to transfer it to customers, and if they like it and want it, you get return on investment.   In healthcare, and especially in molecular diagnostics, there are many diverse policy headwinds that make this process more complex and circuitous.

The rest of the deck talks about the transition from molecular stack codes to today's CPT coding and pricing and future PAMA market-based pricing.

I give some examples of potentially shifting business models - while also noting that one man's barriers to innovation are another's protections against excess cost and overutilization.   As an example, should out-of-network payment policies for startup labs become onerous enough, there will be more incentive to create on site hospital-based delivery systems, because the hospital is (almost) always in network for its own patients.  My point from an MBA perspective is that this "policy based" market force (starve out-of-network labs) may intersect and synergize with new technologic capabilities (e.g., FDA's approval of Prosigna.)

Along the way, I cite the excellent Harvard Business School case study from 2013 by Robert Higgins on Claritas Genomics (here).  The last few slides discuss approaches to clinical utility that my coauthor Felix Frueh and I have worked on (here).

CMS Releases Prices for New CPT CLFS Codes - Gene Panels Get Gapfill

On October 9, 2014, CMS released its pricing decisions for all new CPT laboratory codes that will be active in 2015.

It finalized its proposed in on November 25, 2014.

The CY2015 Excel spreadsheet fee scheduled, released about January 1, 2015, is at the CMS website, here.  (See: 15CLAB.zip).

* Drug testing codes - use by Medicare is deferred, as is pricing by Medicare.
* Genomic tests - gapfilled.
* Exact Sciences ColoGuard - $502.

UPDATE:
Codes were finalized by CMS as proposed.  Final CMS positions are posted here.  

Note that for specific drug tests, CMS produced some two dozen new G-codes to use, replicating 2014 CPT codes, instead of using new 2015 CPT codes. 

Details after the break.

FDA and LDT’s: Should it be "Guidance" or "Regulation"?

Since a public meeting in 2010, the FDA has been discussing its plans to bring laboratory tests at local hospitals and laboratories under its scope of regulation.   This activity escalated quickly with the release of a planned regulatory framework to Congress on July 31, 2014, and the official release of the same documents on October 3, 2014, kicking off a 120 day public comment period (here).

On September 9 (here), the House Ways & Means committee held a hearing on the proposed new scope of FDA activities.  In that hearing, some lawmakers and public stakeholders repeatedly suggested that the FDA should undertake these activities only after formal federal notice & comment rulemaking.   But Dr. Shuren of the FDA repeatedly emphasized that the FDA had solid legal grounds allowing it to regulate laboratory developed tests by issuing and finalizing a “guidance document.”  

What would really be gained by the rulemaking process?   

1. For one thing, for regulations proposed that would have a greater than $100M economic impact, a formal budgetary analysis must be made by the agency and reviewed by the Office of Management and Budget.   
2. For another, new regulations (law made by an agency and codified in the Code of Federal Regulations) would be proposed, open to comment, and then finalized verbatim and rarely changed.  
3. Finally, policies that are related to, but not literally laid down in the C.F.R. regulation would also be presented  and generally followed by the agency until changed through another round of agency proposal and public comment.  

We discuss the FDA LDT proposals from this perspective after the break, borrowing some analogies from CMS regulations and policy and from the FDA formal rulemaking for Analyte Specific Reagents (ASRs) in 1996.

A Critical Look at "Choosing Wisely" - But it's not Today's NEJM.

Update 10/2017:
  Health Affairs "festival" on Choosing Wisely held in DC, here.
  Example of later quantitative health services article by Colla (2017), here.
  3 October 2017 Articles in Health Affairs here, here, here.


On October 2, 2014, the New England Journal published an article on reducing low value healthcare, one of the approaches being the Choosing Wisely campaign.

Unfortunately, the author did not have the time and space to cite another New England Journal article on Choosing Wisely - one that I read with enthusiastic agreement, because that earlier article encapsulated what I'd been telling colleagues and friends for a couple years as I've read press about Choosing Wisely.  The earlier article is open access and worth looking up.

FDA Releases Official Draft Guidance for LDTs; 120 Day Comment Period

On September 30, 2014, the FDA officially released its two major guidance documents on LDT regulation: The first guidance covers a framework for FDA review, for risk classification and for proposed LDT safe harbors such as unmet needs.   The second guidance covers "reporting" for LDTs as medical devices, i.e. adverse event reporting.

The guidances were released to Congress on July 30, 2014, under a legislative requirement that Congress be given 60 days notice before the "official" release and comment period.  Which starts now.

The documents are dated October 3, 2014, so the 120 day comment period will extend until about January 1, 2015.

FDA Draft Guidance for the LDT Regulatory Framework, here.
FDA Draft Guidacne for LDT Adverse Event Reporting, here.

Federal Register notice of the release and comment period - for Framework, here; for Reporting, here.

The FDA commented it made no changes to July documents, except in the definition of combination diagnostic and in the exact grammar for "traditional LDTs" composed of components legally marketed for clinical LDT use (e.g. ASRs).  They clarify that they are proposing special allowances when LDTs are made from components marketed legally ^for clinical test use.  RUOs are marketed legally, but not marketed legally ^for clinical test use.

IOM Publishes Ebook: Characterizing the Uncertainty of Risks and Benefits.

A fundamental problem shared by both regulatory agencies like the FDA and payers like CMS is assessing the level of net benefit for a new product or service.  

Much has been written over the last twenty years about quantitative (e.g. turnkey) assessment of risk and benefit, but it is very difficult to do so.  In clinical trials, the benefit is usually a fixed statistical endpoint - survival was increased by 4 months plus or minus one month, or strokes per year were reduced by 20% plus or minus 3 percent.  On the other hand, "risks" or adverse events are ungainly, random, unpredictable events of all kinds differing widely in impact and frequency.   It would be easy if we could say, the benefit is "ten plus minus two" and the risk is "negative five, plus minus one" so that the net benefit is favorable, in this case, about plus five with a modest standard deviation and certainly greater than zero.  Comparing risks and benefits is never easy largely because "benefits" are well trained animals in a tight box, and "risks" are an ungainly wild menagerie.

Although the terminology may vary, the same issues face payers and regulators, with the payers typically adding more concerns about comparative effectiveness, overutilization, and external validity (will it work outside the trial).  In a word, payers see or infer much bigger "error bars" that the original trialist and statistician.

Given the difficulty in adding and subtracting risk and benefits against each other, a core problem is uncertainty.  This year, the FDA and Institute of Medicine held two full day public workshops specifically tied to "uncertainty" in risk-benefit decisions.  (See my April 2014 blog, here.)   IOM has now released a 123 page ebook for free download, here.

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.