Brief Blog: California Medicare - Noridian's LCD Open Meeting February 8

The MOLDX program released a "bonanza" of molecular LCDs in late December.

These are cross-listed as Noridian Jurisdiction E LCDs.  Their next public comment meeting on new LCDs is February 8, at the LAX Marriott.   Noridian requires registration two weeks in advance (circa Feb 24).

At the Noridian Jurisdiction E website, here, click Policies, and then Open Public Meeting (should be here).

Agenda after the break.

Brief Blog: Medicare Continually Expands Exclusion Authority

Medicare (via internal reviews and/or via OIG actions) has increasing authority for long-term exclusion of providers from the program.  I ran a blog on one expansion of exclusion authority in February 2015 (here).  That allowed "revocation of Medicare billing privileges" if the entity "has a pattern of submitting claims that fail to meet Medicare requirements."  This is of interest because of trade journal reports that as many as 75% of genetic/genomic claims may go unpaid, across Medicare and private payers.  Sounds like that could be "a pattern of claims that fail."[*]

More news.  On January 11, OIG published enhanced regulations expanding its exclusion authority in cases where providers are not compliant with or obstruct audits.

• Article at Fierce Healthcare, here.
• Article at McKnights, here.
• The OIG's new 19 page rule, 82 FR 4100, here.
• A lengthy table listing all of OIG's statutory authorities for exclusion, here.
• This lists 24 legal rationales for exclusion, organized in 4 categories.
• See also the OIG's public 7-page memo on exclusion authority and discretion under SSA 1128(b)(7).

This is also an example of the broad reach of the ACA and the impacts of "repealing Obamacare," as these far-afield regulations over at the OIG stem, in part, from a few phrases originally embedded in ACA lawmaking

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[*]  See also an article in the January 9, 2017 Dark Report about the CGS MAC, after a ZPIC review, reclaiming all $27M it had paid a genomics lab over 3 years.
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Exclusion for "excessive claims...or unnecessary services" is found at 42 CFR 1001.701. Note that via new lawmaking, this will be updated with new text in February 2017.

Results May Differ, Even in Evidence-Based Medicine (Two New Examples)

One of the hallmarks of Evidence Based Medicine is the standardization of evidence review, with the aim of providing a more objective process likely to lead to the same results in different hands.

But it's not always the case.   Two examples in the last few weeks are a differing assessment of breast cancer prognostics from a major HTA agency, and a differing assessment of diabetes prevention testing between the USPSTF and an evidence review in the BMJ.  Discussion after the break.

Google Meets New Yorker: Both Argue for Innovation in Primary Care

In the press this week, Silicon Valley alumni of Google and Uber have claimed to create a new-generation doctor's office that will have a transformative effect on office visits.   The service is premiering under the brand, "Forward."

See coverage at Business Insider, here. and at DiveHealthcare, here.  At TechCrunch, here.  (A critical article about Forward appeared at MedCityNews, here.)

More after the break.

The Most Coherent Republican Health Plan Yet (Health Affairs, 1/18/2017)

Many have commented that six years after the passage of the Affordable Care Act, Republicans have not had a fully vetted and effective plan for replacement.

(For example, health spending accounts are hard to imagine over $3000-5000, and 80% of US healthcare is spent by people with very high costs, far above that range, so HSAs only control spending incrementally, and only within a cost segment that totals 20% of the spend. So you might save 30% of 20% of the total costs or 7%.)

A lengthy blog-format article appears in Health Affairs authored by  Congressman Pete Sessions (R-TX), Senator Bill Cassidy (R-LA) and consultant John Goodman.  Details after the break.

FDA Provides White Paper On Its Deferred LDT Regulation Agenda

From 2010-2016, the FDA active promoted an evolving plan to regulate LDTs nationally.   In 2014, it released a detailed roadmap for LDT regulation, for public comment.   Shortly after the election, November 18, FDA announced it was deferring its LDT regulation plan.

Exactly 8 Friday's later, FDA released a 12-page lookback and review of its LDT regulation effort.

• For the FDA document, here.  
• For a review online at RAPs, here.
• Coverage at Genomeweb (subscription), here.

The document is styled as a "discussion paper" and likely captures some of the learnings and changes in plan that occurred inside the FDA between the 2014 draft guidance and the writing of a final guidance that has been deep-sixed.

CMS Innovation Center (CMMI) Issues 3rd Annual Report to Congress

The CMS Innovation Center (CMMI) issued its third annual report to Congress, evaluating the past year in 103 pages.

The index for the dozens of CMMI reports is here; the January 2017 Report to Congress is here.

I've clipped the Table of Contents after the break.

CMS Abruptly Reverses Longstanding Non-Coverage of Continuous Glucose Monitors

For years, through obscure program remarks or local contractor articles, CMS has declined to cover continous glucose monitors (CGMs).   In the last year, administrative law judges had begun to overturn and simply ridicule CMS's position.

On January 13, CMS used a rarely-invoked administrative procedure to overturn its past decisions, and allow coverage of certain CGM's.   As a result, Dexcom's market value popped upward by 25%, about $1.5B, in minutes.

Earlier this year, I covered and posted an obscure Departmental Appeals Board ruling that was probably pivotal in collapsing the logical structure of the agency's objections to coverage (here).  In January 2017, a favorable RCT appeared in NEJM, along with an op ed (here, here).

The new change is decisive and appears in the form of an Administrator's Ruling, rather than an NCD, LCD, or other program instruction.   In addition, the sixteen-page Ruling is essentially a mini-course in the legal and policy mechanisms of DME decisions (here).  

The ruling holds that CGM, when FDA-labeled for insulin dosing based on their readouts, are DME.   They meet and exceed the hurdle that they are primarily for a medical use.   Unfortunately, in the last sentences of the decision, the ruling holds that CGM that guide necessary glucose testing, but are not themselves FDA-labeled for dosing decisions, are not DME.  I think this closing sentence, not justified by the prior dozen pages of text and reasoning, is in error and is capricious, because it is unjustified in the body of the document.

The ruling determines that the Dexcom G5 "is DME," but leaves it to coverage decisions in LCDs or NCDs to confirm that it is medically necessary DME.

More after the break.

Candidates for Head of NIH and Head of FDA

The current head of NIH, Francis Collins, has been widely popular and many are advocating that he be kept in position under the Trump administration.

However, other names are being floated as head of NIH.   On January 13, 2017, Nature's headline is:  "Surprising contenders emerge for NIH's Trump Chief;" see the online article here.

More after the break, including coverage of FDA candidates.

Harvard's Fifth Annual Health Policy: Year in Review (January 23, 2017)

This year, the multi-stakeholder Health Law: Year in Preview/Review will be held on Monday< January 23, at Harvard Law School.  Seating is limited but registration is free.

The event website is here.  Videos from last year's event are posted online there. The January 2017 agenda is clipped below the break.

The event is hosted by

• The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
• Harvard Health Publications/Harvard Medical School
• Health Affairs
• The Hastings Center
• PORTAL (Program on Regulation, Therapeutics, Law at Brigham & Women's)
• Center for Bioethics at Harvard Medical School.

Genomeweb Publishes 2016 Year in Review Article

The trade journal and information hub Genomeweb has published its annual Genomics Year in Review for CY2016 - online here [subscription].

The 2600-word article discusses the boom in immunotherapy diagnostics, including the new role for immunohistochemistry there, the freeze on the FDA's regulation of LDTs, the continued chance that IVD diagnostics will be undercut by LDTs even though there were more pharma-diagnostic joint development programs last year than ever.   The FDA is showing more flexibility in approving NGS diagnostics than ever, with more coming this year (such as oncology gene panel tests by FMI, Illumina, Thermo Fisher).   Reimbursement remains an issue, although December brought a significant expansion in covered tumor profiling by the MolDX program at Medicare.

Tracking JP Morgan Life Sciences Conference: Key Links

The week of January 9, the 35th annual JP Morgan Life Sciences conference is being held in San Francisco (trade press here at Business Insider)..  While access to the meeting is tightly locked down, many of the presentations will be available as streaming audio, variably for weeks or months.

You can get to the Log In page here:
http://jpmorgan.metameetings.com/confbook/healthcare17/login.php

After the simple login (name, email, hit return) you have access to live and archived webcasts and as well the full four-day agenda.  Some 400 companies (public and pre-public) will deliver presentations to 4000 investors.  Once you have logged on, on your device, this link takes you to the presentations agenda and archives to streaming or audio files.

JP Morgan Panels - about a half dozen, from "the future of diagnostics" to Joe Biden Fireside Chat, to Greg Simon of Cancer Moonshot - are also archived for streaming.

JP Morgan Research Reports - Once you're logged on, click Research Reports for some major deep dives, like a 157pp report on the global diagnostics and genomic tools industry.

Craig Venters Steps Down as CEO of Human Longevity Inc (HLI)

On the afternoon of January 4, news broke that in a few days Craig Venter will step down as CEO of Human Longevity.  Article at MedCityNews, here.

The new CEO will be Cynthia Collins, from GE Healthcare.  Collins hold a BS in microbiology and an MBA from University of Chicago; she's worked successively at Abbott, Baxter, Sequoia Pharmaceuticals, Beckman Coulter, GenVec, and GE Healthcare for IVD research and applied markets.

Venter is one of the most accomplished and well-known living biologists.  HLI completed $220M in Series B fundraising in April 2016.   On a personal note, my career in consulting began in October 2001, when Accenture assigned me (as a physician with a fresh MBA) to a strategy team working at Venter's company Celera in Maryland.   Fifteen years later, I'm still doing strategy consulting in genomics!

Very Advanced Bioinformatics as the Next-Next Generation in Precision Oncology

Next generation sequencing has always required very sophisticated assembly and bioinformatics, just to produce sequence sense out of the sequencing technology processes.  Advanced software also goes far in predictive variant calls (for one example and citations, see Lai et al., 2016).

For December 2016, the journal Genome Medicine has published a special open access collection discussing the forefronts of precision cancer medicine (here).  What struck me is that most of the articles feature an extremely bioinformatics-intensive component, such as predictive cellular modeling in silico.   This goes far beyond sequencing 50, or 500 genes, and noting that the ALK mutation is associated with a clinical crizotinib response and the EGFR mutation with a clinical erlotinib response.  Rather, the complexity of the genome is leveraged through analytics that a human couldn't see by reviewing a gene-drug table or by just digitizing it into a pathology report.

The new horizons may also create new policy and regulatory challenges.  (Is a genomic test incorporating remotely leased or operated SAAS software still an "LDT" for the FDA?   Is this "medical software" vended across state lines?  How would you know if something went wrong?  What does a career laboratorian CLIA inspector inspect? And to be viable over the long run, is the development and management of such software supposed to fit within a lab's falling fee schedule payments for genomics?)

The open access articles in the special collection are accessible at Genome Medicine, here.  I've clipped abstracts of articles illustrating the informatics theme after the break.

Second Annual Book List: Books from 2016

See my second annual "Book List," here.