Quinn: Speaking at Diagnostics Reimbursement Course, SF, Feb 19

I'm pleased to participate in a Short Course on Diagnostics Reimbursement held in parallel with the giant annual Molecular Med TriCon in San Francisco.

The Short Course, "Coverage and Reimbursement for Advanced Diagnostics," will be 2-5 pm on Sunday, February 19, in San Francisco.  The TriCon conference is a large, international gathering and runs February 19-24.

The short course agenda is here (or below the break).   The main conference webpage is here.  The course is organized by Katherine Tynan of TynanDX Consulting.

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The Downing Report, 2017: Innovation at HHS

Gregory Downing, Executive Director for Innovation at HHS, which an early proponent of of precision medicine in the mid-2000s at HHS, researching and calling for more coordination among NIH, CMS, FDA, and other parts of HHS and the government.  Since then, he has had a broader mandate for HHS innovation initiatives.

On January 15, 2017, Downing released a 63-page Innovation Report, along with a blog that frames its genesis and purpose.

Downing's blog entry is here.
The 63-page PDF report is online here.

The report has six sections:

1. Innovation and Entrepreneurship in the US HHS
2. Innovation Management Theory in Government Practice
3. Design, Management, Evolution of HHS Innovation Program
4. Innovation and Entrepreneurship in State and City Governments
5. Models of Sustaining Innovation in Large Private Sector Organizations
6. Strategies for the Future

As an Appendix, there are a couple dozen references cited (including books by Harvard's Clayton Christensen) and several dozen interviewees are listed.

Barack Obama Writes NEJM Article on ACA Repeal

On January 26, 2017, Barack Obama published an article NEJM on current approaches to ACA Repeal.   He views repeal, without replacement, as a bad idea.   The article is online here.

Gulfo and Soon-Shiong Continue to Circulate as Trump Allies

Additional news stories this week on a fourth candidate for head of FDA, Dr. James Gulfo.

Prior potential nominees for FDA have included Republican speechwriter and investor Jim O'Neill, young biotech founder Balaji Srinivasan PhD, and well-respected physician-policy expert Dr. Scott Gottlieb.

In addition, in a speech on January 31, President Trump focused attention not only on pharma prices, but on (A) speeding approval "instead of waiting for many many years" and (B) access for the terminally ill, usually viewed as "right to try" laws (here).  Trump also stated that "We have a fantastic person that I think I'll be naming fairly soon who's gonna streamline the FDA and you're gonna get your products either approved or not approved, but it's gonna be a quick process."  See here.

Dr. Joseph Gulfo

The week of January 23, new attention has focused on Dr. Joseph Gulfo.  For a full listing of his credentials, see his impressive Linked-In page, here.

Gulfo trained in oncology, worked in CROs and biotech startups, and had his longest career segment as CEO of Mela Sciences, which developed the Melafind device for augmented accuracy in selecting atypical moles for biopsy.  Melafind had a difficult multi-year course at the FDA, which Gulfo detailed in his book, Innovation Breakdown (2014).  At Amazon, here.  Book website, here.  A 2011 6-page white paper at the Progressive Policy Institute (here) gives a summary of the FDA's delays and policy issues on Gulfo's product Melafind.

Gulfo, an MD/MBA, has also written a general book on leadership and management (here).

Gulfo is a strong proponent of approvals based on intermediate endpoints, including biomarkers.  More about Gulfo and his book, after the break.

New News on Dr. Soon-Shiong

On January 24, the subscription health news website STAT ran an article that Dr. Patrick Soon-Shiong, who's been shortlisted by NIH watchers as a  potential head of NIH, could also appear in the Trump administration in a novel role.  The role could be closer to health innovation czar, rather than an existing title like Surgeon General, Head of CMS, Head of NIH, etc.  The subscription article is here with a follow-on the next day here.  Aggregated news sources suggest that Soon-Shiong has met at least three times with Trump, one shortly after the election and twice during January.

Soon-Shiong is a very, very strong proponent of molecular medicine, precision medicine, and Cancer Moonshot.  For additional speculation on the health czar role, Managed Care, here; LA Biz, here.

Update: On February 5, a New York Times article by Katie Thomas surveyed the FDA candidate field, dealing at most length with Jim O'Neill, suggesting the Times viewed him as a leading candidate worthy of comment.   O'Neill and Scott Gottlieb declined to comment to the Times.  Gulfo commented at some length.  Times article here.  More on Gulfo after the break.

Ex-CMS Administrator Slavitt to "Stay in Washington, Broker Deal"

Andrew Slavitt, the outgoing acting administrator of CMS, previously worked as a senior executive at Optum.   He announced this week he won't be going back to Optum or United Healthcare, at least for now.  He will be staying in Washington to "help broker a deal" on Fixing Obamacare.

Story and interview at Politico, here.

Update: In March 2017, Slavitt announced plans to join the Bipartisan Policy Center (here).

FDA Publishes Guidance: Manufacturer Communications with Payers

On January 18, 2017, the FDA released a 20 page Draft Guidance on:  Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities.

The document is in the form of a Q&A and the FDA will accept comment for 60 days, until about March 15, 2017.  The FDA PDF is here.  The matching comment website is here.

Outgoing Commissioner's Califf's remarks on the document release, one of his last acts in office, is here.

A blog by Amy Dow of Epstein Becker Green is here at NLR; one at RAPS here.

For a detailed blow-by-blow analysis by Tufts policy guru Peter Neumann, see Health Affairs, February 2017, here.

In Amy Dow's brief summary:

FDA states that it will not object to manufacturers providing payors with “unbiased, factual, accurate and non-misleading” information regarding investigational drugs and medical devices, provided that those communications include a clear statement of the investigational status of the product and that its safety and effectiveness have not been established, along with information regarding the stage of product development of the product. 

Information that may be provided by manufacturers in accordance with FDA’s recommendations in the draft guidance includes information about the product such as its drug class or design, the indication sought and the patient population under investigation, a factual presentation of the results of clinical and pre-clinical studies without any conclusions regarding the product’s safety and effectiveness, the anticipated timeline for FDA approval, product pricing information, and anticipated marketing strategies and product-related programs and services, such as patient assistance programs.

More details and links after the break.

National Law Review on "Trump's FDA" - Cites Gottlieb 19 times

The influential journal National Law Review ran an article on January 20, "How Will Trump Change the FDA," focusing almost entirely on Dr. Scott Gottlieb's positions (here).

Despite the generic headline, the article cites Gottlieb by name 19 times.

At the NIH, Francis Collins is remaining as chief for the time being, and possibly long term.  At the FDA, on January 17 a final decision was announced that recently confirmed Administrator Califf was definitely out, putting the FDA's leadership firmly in play for the new administration.

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The National Law Review article was authored by Foley & Lardner attorneys Simon Elliott & Courtenay Brinckerhoff.

The Executive Order on Obamacare (January 20, 2017) (Full Text)

On his first day in office, President Trump issued an Executive Order asking the branches of government to do the maximum possible, within the law, to take actions to minimize "the economic and regulatory burdens of the ACA."   The order requires compliance with the Administrative Procedures Act, which generally means that implementation created by agency rulemaking and regulations needs to be rescinded by another round of rulemaking.

The order applies to "all agencies and authorities" and is targeted to those parts of the act that impose economic burdens on states or individuals, providers, payers, or medical manufacturers.

Health order:  Coverage at New York Times, here.  At WSJ, here.  CNN, here.   Forbes, here.  For a rapid post by the prolific Timothy Jost at Health Affairs, here.   NBC highlights "five provisions that could change right away" (here) while The Hill advises that "Hill waits for word from Trump" on what to do next (here).  For discussion by policy expert Nicholas Bagley, here.  For an assessment of the executive order as "very confusing," Vox, here.

General Regulatory Freeze: The White House also issued a freeze on the issuance of any regulations except those required by emergencies (here; at Politico, here.)

Full text after the break.

FDA Writes Very Rapid Report on Drugs that Crashed in Phase III - AKA Why We Need FDA

Since mid November, some of the possible candidates for head of FDA have been long time advocates of a more libertarian stance, "let the market decide," not the FDA.

FDA has just released a detailed and granular 44 page white paper on "22 Case Studies" where drugs worked in Phase 2 but crashed in Phase 3.   That is, FDA argues that rigorous and closely reviewed Phase 3 trials, before market release, kept once-promising drugs from hurting patients through premature access.

The FDA white paper is here.   Coverage at John Carroll's ENDPOINTS is here.

As Carroll notes, the commissioner won't be Califf, as he steps down today.  In contrast, NIH chief Francis Collins remains in place, as least for the near term.

Califf's departure was finalized a few days ago (here, here).

Brief Blog: Nice Idea, But No Takers (CPT 46762 Deleted)

Apparently it was a good idea in theory, but had few takers.

The AMA CPT agenda for February 2017 is out, and Agenda Tab 13 is:
[details after the break]

Brief Blog: Digital Genomics, SAP CoSponsors Precision Medicine Webinar with ASCO

Continuing the them of digital genomics, in February 2017 the interntional enterprise software company SAP will co-sponsor a two part course/webinar with ASCO on precision medicine in oncology.

For an article about the project at Forbes, here.  The course is in a MOOC series branded as OpenSAP.   See more about the course content and registration, here.   It runs February 14-March 15, 2017.

The specific course sounds interesting, and will highlight Big Data and ASCO's CacerLINQ program.
However, it is also part of an emerging advanced software layer in the genomics industry, with other examples being as diverse as IBM Watson's recently announced collaboration with Quest and genomics software/service companies including (e.g.) Syapse, MolecularHealth, Farsight, GenomOncology, MolecularMatch, NofOne, Cellworks, DNA Nexus, Pierian, Translational Software, YouScript, DarwinHealth, and others.

For an archived February 2016 white paper on the advent of "digital genomics industry,"  here.

Brief Blog: Conway = CMS Acting Administrator; New Medicare Law re Appeals, Precedents

Three items of CMS news:

• Slavitt Steps Down
• Conway, Bassano Step Up
• Making Appeals Decisions Precedent-Setting

Slavitt Steps Down
Acting Administrator Andy Slavitt stepped down from his leadership roll at CMS, and leaves behind a blog describing his experiences, here.  Slavitt, a Harvard MBA, and previously worked at McKinsey and as an EVP at Optum.   He gave a 3300-word fireside chat at January's JP Morgan conference in San Francisco (here), which streamed publicly on the JPM website.

Conway, Bassano Step Up
Patrick Conway, currently head of CMMI and also Chief Medical Officer, will act as Acting Administrator until the Senate confirms a Trump Administration appointee (or until a different Acting Administrator is named.)   Amy Bassano will be Acting Director of CMMI.  Some on the Hill have proposed discontinuing CMMI has part of Obamacare repeal (eg here.)

Making Appeals Decisions Precedent-Setting
In other news, CMS has published regulations allowing it to make certain decisions of the Medicare Appeals Council "precedential," meaning they can be more rapidly and easily enforced when similar cases arise in the appeals process.   Lawmaking at 82 FR 4974 (January 17, 2017) is here.  (The 167-page rule has other parts, such as revising the Part D appeals process.)

• The regulations attempt to deal with the colossal delays and backlogs in the appeals process.   See e.g. here.  
• A December blog at this website, here.
• Trade journal article here . 
• Precedential rulings means that a favorable one should be repeated consistently in future hearings on the same topic.  But if an unfavorable one becomes precedential, it may be more difficult to return to the judges with new arguments leading to a favorable decision in future similar cases.

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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.