Brief Blog: Trump Considers Libertarian FDA Commissioner?

STAT offers this news article on December 7, 2016:

President-elect Donald Trump is weighing naming as Food and Drug Administration commissioner a staunch libertarian who has called for eliminating the agency’s mandate to determine whether new medicines are effective before approving them for sale. 

“Let people start using them, at their own risk,” the candidate, Jim O’Neill, said in a 2014 speech to a biotech group.

STAT's article online here.  Others hope that current Commissioner Califf, recently confirmed by a Republican congress, may stay on.

Discovery and Profitability in Molecular Diagnostics: Patents vs Time Constants of R&D

Recently, Genomeweb ran two articles on patents and molecular diagnostics.   The first article, on November 15, covered discussions at the annual AMP meeting.  Roger Klein MD JD, of Case Western, debated with Timothy Stenzel, COO of Invivoscribe.   In a second article, December 5, the rate of patent applications was assessed by Duke's Arti Rai and Santa Clara University's Colleen Chien.  Rai and Chien studied 27,000 patent applications from 2002 to 2014.  The data was presented at a Utah conference and is not yet published.  (For an earlier Rai publication, here.)

Patents provide a barrier to entry, which can encourage investment by allowing a window of protected time for investment recoupment.   This could be more important in situations where there is a large upfront investment required, but a relatively low ongoing marginal cost, and, where the product could otherwise be easily observed and replicated.

We can draw a line between these articles and a December 8 article, also in Genomeweb, that Interpace Diagnostics (Parsippany, NJ) has obtained coverage for 200M patients, including major payers like Aetna and Medicare and some BCBS plans for its ThyraMir thyroid nodule classifier test.  According to the article, " Molecular testing using ThyGenX and ThyraMir has been shown to reduce the rate of unnecessary surgeries in indeterminate cases."   More after the break.

15 FDA Authors on Real World Evidence: NJEM December 2016

With the passage of 21st Century Cures on the Hill (by huge margins), and the likely signing by President Obama, we'll hear more about Real World Evidence.   

While there's been alarmist talk that 21CC will foist poorly validated trials with RWE onto the American health system, all that 21CC does is require the FDA to "look at" RWE and set up some guidance documents if it can.

To get a view on what the FDA leadership really thinks about RWE, see an article in New England Journal of Medicine by Sherman et al., including leadershp such as Jeff Shuren, Robert Temple, Janet Woodcock, and the administrator, Robert Califf.   The article is open access, here.  

The following week, FDA authors Califf et al. wrote a companion NEJM piece but focused on big data, coordination, and the learning healthcare system.

Brief Blog: Trump, Interviewed in TIME, Vows to Take On US Drug Prices

In an interview released on December 7, 2016, PEOTUS Trump vowed to cut drug prices in the US.

• For the interview at TIME magazine, here.
• For a summary focused on drug pricing remarks, also at TIME, here.
• For coverage at Bloomberg. here.
• For a regularly updated Bloomberg page on Drug Prices: Costs & Outrage, here.
• Provides multiple links for further reading and resources.
• For John Carroll's rapid blog on the topic at Endpoints, here.

Genetics Testing Company FULGENT; IPO, S-1, Investor Call

Numerous public (INVITAE) and non public (COUNSYL, AMBRY) companies are growing in the genetic testing space.   Business deals are announced regularly (GOODSTART will be offered through a new alliance with Roche's NIPT laboratory Ariosa.)

Fulgent Genetics is a Los Angeles-area genetics laboratory which moved rapidly from its founding in 2013 to its IPO on September 29 (here), which raised $50M.  It has a market cap of $170M as of early December.

Fulgent provides broad-spectrum genetic testing services.   It had 2014 revenue of $1.3M and 2015 revenue of $9.5M.   It had a net loss in 2015 of $5M from continuing operations, most of which would be represented by a reported $4.3M in R&D.

• Yahoo Finance Home Page, here.
• Company website, here.
• 500 page S-1 filing document, here.
• November 7, 2016, investor call transcript, here.   

GRAIL Announces Plans for "Circulating Cell Free Genome Atlas"

On December 1, 2016, GRAIL, a life sciences company created in large part by Illumina, announced the "CCGA" - the Circulating Cell-free Genome Atlas.

• The full press release is here or here.
• Webpage at ClinicalTrials.gov, here.
• Subscription coverage and interviews at Genomeweb, here.
• See the company's website at GrailBio.com.

The observational study aims to enroll 10,000 subjects between August 2016 and August 2022, but with "primary" completion date by September 2017 (ClinicalTrials.gov).  7000 patients will have diagnosed cancers and 3000 will be in the non-cancer arm.

The project has some similarities to the NIH-sponsored Cancer Genome Atlas (TCGA, here) but transfers the genomics from solid tumor tissue to circulating DNA in blood.

Besides Illumina, other investors include ARCH Ventures, Jeff Bezos, Bill Gates, GV (Google Ventures), and Sutter Hill Ventures.

Brief Blog: Keeping Up with the MED-C Cancer Genomics Registry

MED-C was initially established almost two years ago (here).

MED-C took on renewed importance when MOLDX issued a revised lung cancer gene panel LCD in September 2016.  In return for greater coverage, labs are to follow new, expanded and detailed requirements for patient  genomic and clinical outcome data which is to be contributed to a public non profit registry that must meet an extensive list of requirements (here).

To help you keep up with MED-C, here are some key links.

• MED-C organization website, here.   
• Press release on the recently expanded MED-C expert panel, here.
• Press release on MED-C's IRB approval, here.
• ClinicalTrials.gov page for the MED-C registry (NCT02900248), here.

• MED-C announces "Biomedical Data Commons," or "BDC," here.
• 23-page deck about MED-C, by MED-C, here.
• March 2016 article in NATURE about pragmatic registries, including TAPUR and MED-C, here.

Brief Blog: NPR Forecasts "Uncertain Future" for CMMI

On November 30, 2016, NPR ran an article with the title, "Obamacare's Test Kitchen for Payment Experiments Faces an Uncertain Future."   For the full NPR article, here.

The center has been controversial because of its authority to conduct demonstration project that waive any applicable Medicare law.  Some have argument that this is an unconstitutional delegation of authority from Congress to an agency.   Others have raised concerns that a "demonstration project" is not defined and could be of nearly unlimited scope and duration.  On September 29l, 2016, several dozen members of Congress wrote the current (outgoing) head of CMS that they had serious concerns about the behavior of CMMI (here).

See also a November 2016 21-page white paper from the Healthcare Leadership Council on "Accountable Innovation: Reforms to Strengthen and Sustain the CMMI."   White paper here.   With HLC funding, the white paper was created by the consultancy Xcenda, a division of AmerisourceBergen.

CMS Posts CY2017 CLFS File (November 29, 2016)

UPDATE:  AS OF DECEMBER 13, THE CY2017 CLFS FILE (posted Nov. 29) IS OFF THE CMS WEBSITE.  PROBABLY CMS DISCOVERED MINOR ERRORS.

___
Original November 29 article follows.


CMS has, in recent days, released final Gapfill/Crosswalk decisions for the year, and published the results of the MAC gapfill process as well, which included some favorable appeals that raised prices finalized by MACs earlier this fall.  (Story at Genomeweb, November 22, here.)

Today, November 29, CMS posted the full A to Z CLFS fee schedule for 2017.

• The file is available at CMS, here.

Below are genetic tests > $1000 and those genetic tests - mostly Genomic Sequencing Procedures (Panels) not priced by CMS. (Click to enlarge).

Seema Verma, Indiana Health Policy Expert, to Head CMS under Trump

Seema Verma, a health policy expert and health strategy consultant running her own firm in Indiana, has been announced as the next leader of CMS.  Verma's selection brings the agency one of the first administrators with extensive Medicaid experience, and an individual who is a national authority on the use of states as models for managed care innovation.

• News story at Politico, 11/29/2016, here.
• Coverage at STAT here.  NPR here.   Healthcare Informatics here and also here.  Health Affairs here.
• The Indiana Star has reposted and updated its 2014 profile of Verma and her achievements, here.
• Her Linked In Profile is here.  Her Wikipedia page here.
• For a August 29, 2016 blog at Health Affairs on Medicaid reform by Verma, see here.

• Her consulting firm's website, SVC Inc., is here.

The likelihood of major Medicare legislation has been debated into early December in different forums; Paul Ryan wants to move [60 Minutes], but the Senate may be reluctant [Politico].  WSJ writes, "Dems gearing up for Medicare fight," here.

Tevi Troy: Democratic Politicians Can Spread Plenty of Fake News, Too

Tevi Troy: Dems and Fake News

A well-known Republican health policy expert wrote a few years ago that misleading and damaging rhetoric is not limited to any one shrill stakeholder group, or to the current waves of disinformation and "fake news." 

In his book "US Health Policy: An Insider's Perspective"  Republican health expert Tevi Troy argues that in various instances, Democrats wrongly smeared various Republicans as "wanting to kill Medicare" or "destroy Medicare" by print or commercials in the past decade.  In some cases, these contributed to the politician's political demise.  

Troy is CEO of the American Health Policy Institute.  The 2014 book, "US Health Policy: An Insider's Perspective," is a collection of his journal articles and op-eds.

In addition to serving in a senior HHS position in the Bush II administration, Troy has written a number of books on history and policy, such as "Intellectuals and the American Presidency" and "Shall We Wake the President?  Two Centuries of Disaster Management."    

Trump Chooses Tom Price as Secretary of HHS

Late on November 28, 2016, major news outlets like NYT and WSJ broke articles that the Trump administration is choosing Tom Price MD, a surgeon and senator from Georgia, as Secretary of Health & Human Services.

Price has proposed health policies such as age-adjusted tax credits for people to buy insurance, or allowing people to "opt out" of Medicare in return for a tax credit.   WSJ coverage here.  Profile at HealthcareDive, here.  Profile at Health Affairs, here.

Price, who has served six terms in the House, was an early and consistent supporter of Campaign Trump.

For links to sources on Republican health policies, here.

CDRH/Payer Summit: Washington, December 14, 2016

There is a longstanding annual winter conference in Washington called "FDA/CMS Summit," held this year on December 14/15, 2016 (here).

This year, there will also be a first annual "CDRH/Payer Summit for Medical Devices," held on December 14.   The goal is described as, "facilitating direct dialogue between medical device executives, payers, investors and CDRH regulators to explain complex regulatory and reimbursement policy."   

While this is a commercial summit (sponsored by Informa), CDRH has launched multiple initiatives between FDA and Payers over the past year (for some examples see here), in addition to making FDA/CMS parallel review permanent a few weeks ago (here).  

From FDA, a redacted set of 190 slides used at the conference is in the cloud, here.

21st Century Cures Passes House and Senate; Signed by Obama (Updated)

Coming out of the Thanksgiving holiday, many news reports say that the 21st Century Cures Bill, under discussing throughout 2015 and slowed down during 2016, is likely to move forward was passed by the House on November 30 (392-26), and was passed by the Senate on December 7 (94-5). It was signed by President Obama on December 13, 2016.

• See coverage at Kaiser Health News, here.
• At Biopharma Dive, here.
• At the Endpoints industry blog, here.
• At STAT, here.  "House and Senate Republicans agree, but Dems push for changes."
• As provided by Endpoints, links to:
• A 44 page legislative summary as PDF, here.
• A 996-page House version as PDF, here.
• As noted by Harvard professor Rachel Sachs, some issues are still up for debate, here.
• A detailed but manageable summary at RAPS, here.
• The House E&C Home Page for 21CC is here.
• NIH leaders Kathy Hudson and Francis Collins write on 21CC from an NIH view, NEJM, December 13, 2016, here.

More after the break.

CMS Publishes Final Pricing for CY2017 New Lab Codes (Effective 1/1/2017)

On November 21, 2016, CMS released final pricing decisions for new CPT codes for lab tests (codes effective on 1/1/2017).

The CMS 12-page PDF is online here.  More after the break.