Wednesday, November 30, 2016

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.



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.


Tuesday, November 29, 2016

CMS Posts CY2017 CLFS File (November 29, 2016)

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.  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.


Monday, November 28, 2016

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 permament a few weeks ago (here).  


21st Century Cures Likely to Move Forward

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.
  • 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.
  • The House E&C Home Page for 21CC is here.

More after the break.

Monday, November 21, 2016

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.

Brief Blog: Cancer, Emperor of All Maladies at PBS

"The Emperor of All Maladies," the 600-page 2010 book on cancer by Dr. Siddhartha Mukherjee, was brought to the screen as a four-part, seven-hour documentary last year.

The PBS homepage is here.  As of November 2016, it still streams for free online.  The Wikipedia page for the film is here.   It's directed by Barak Goodman and produced by Ken Burns.  It was narrated by actor Edward Hermann, who died of cancer before the film's release.

Even for those who work in oncology, or might have read the book, the film brings to life a wide range of topics in cancer - from the pioneering efforts to introduce toxic chemotherapy in leukemia in the 1940s and 1950s, to the recent discoveries of genomics and targeted therapies.  But the palette is broad, and includes the patient and family view, the special issues of pediatric oncology, the important role of prevention, the sociopolitical origins of Nixon's War on Cancer, the role of hospice, and issues of economics.  


Also available on DVD, Amazon pay-for-download, and other formats.


Patrick Soon-Shiong Meets with Trump: Biotech, Genomics, and the Trump Administration

The weekend of November 20, biotech industry leader Patrick Soon-Shiong had dinner with both President-Elect Trump and Vice President-Elect Michael Pence.
  • For coverage at John Carroll's blog Endpoints, here
  • For coverage at the Trump website GreatAgain, here.
  • For Dr. Soon-Shiong's tweet, here.
GreatAgain writes,
Dr. Patrick Soon-Shiong joined President-elect Trump and Vice President-elect Pence for dinner this evening. 
The renowned doctor has appeared on the cover of Forbes for his advances in finding a cure for cancer. They discussed innovation in the area of medicine and national medical priorities that need to be addressed in our country.

Soon-Shiong's Nanthealth, which IPO'd in June 2016, aims to provide a range of services for health innovation from digital to genomic.  One is its panomic oncology test GPS, which assesses DNA, RNA, and protein.   Nanthealth has been discussing the potential of GPS to assign best-odds cytotoxic chemotherapies (here).   

Like all genomic tests performed on cancer tissue biopsied in a hospital inpatient or outpatient setting, such tests collide with Medicare's bizarre 14-day rule, delaying testing, treatment, and reimbursement for Medicare beneficiaries with cancer.   Maybe in the coming months the genomics and biopharma industry can get get the President's ear on this, for a quick action point that could make a real difference for innovation and health outcomes.

Appropriate Use Criteria by Force of Law: Should Everyone Be Paying Attention?

Outside the imaging community (including radiology and cardiology), I've seen relatively little discussion of the mandatory Appropriate Use Criteria imposed by Section 218 of the PAMA law.   CMS devoted almost 30 pages of discussion in the November 2016 final PFS rulemaking, and implementation is coming over the next year or two.   The issues could be applicable to areas like genomics or even non-diagnostic areas of clinical decision making.

The original law, PAMA Section 218, is here.  November 15, 2016, CMS policymaking stretches from page 80403 to page 80429 of the Federal Register.  (Original Fed Reg link here; for a downloadable subsection in the cloud, here. CMS homepage, here.)  For reaction to the rulemaking at Imaging Technology News, here.  For coverage at American College of Cardiology, here.   For coverage at Advisory Board, here.

The law requires ordering professionals to consult with AUC criteria, through a Clinical Decision Support Mechanism (CDSM), for all Medicare patients receiving advanced imaging, such as cardiac nuclear imaging, CT, and MR.   AUCs may vary in scope (e.g. pan-imaging AUC or orthopedic or cardiac), and must be developed by a "provider led entity" or PLE.  Exceptions are limited, e.g. rural physicians without access to internet.   More after the break.


Brief Blog: Trends for 2017 - Digital Therapeutics

One of the emerging buzzwords in healthcare is "digital therapeutics," which is now appearing in the titles of industry reports.  The Healthcare Blog writes that:
      Most digital health companies deploy software modules as an enhancement, or even a substitute, to a prescription drug. They are affordable and effective and poised to become a critical component of digital health, thereby substantially improving the efficiency of American healthcare. Digital therapeutics is already roughly a $500 million market and positioned to balloon into a $6 billion market, according to a research report by Goldman Sachs, supported by analysis by digital health venture firm Psilos Group.
      Digital therapeutics improves health outcomes by addressing chronic conditions such as Type 2 diabetes, depression and anxiety, and drug addiction through behavioral changes, before they become worse and require elaborate treatment. This 21st century modality marries the latest developments in behavioral economics, smartphone apps, gameification, biometric sensors, data analytics and artificial intelligence. In some cases, digital therapeutics modalities get approval from the U.S. Food and Drug  Administration.
See the New York based venture capital firm Psilos here.   See the San Francisco incubator and dHealth early investor Rockhealth here.  

For an 8 page report by Psilos, here.   For a 54 page report by Goldman Sachs, here.  For a 200-page, $5000 commercial report, from July 2016, here.

Saturday, November 19, 2016

Dark Report Cracks the Mystery on PAMA Pricing; Genetic Coverage Still Tough Going

In a special 24-page issue devoted entirely to PAMA, Dark Dilay (November 7, 2016) provides the largest insights yet available as to what will happen under PAMA CLFS price reporting.  Dark Report is available by subscription only; here.

CMS requires US labs to report pricing by payer and by test for tests paid in 1H2016; reporting occurs in 1Q2017, and CMS will announce results around August/September 2017.   Until now, some data was published in a government report (OIG, here) and a report by ACLA/Avalere (here).  Dark Report goes into far more detail and is probably more relevant.  In collaboration with XIFIN, the articles assess average commercial pricing for general independent labs, hospital outpatient labs, special genomic labs, and drug tox labs.  In general, commercial prices are circa 20% lower for independent labs, relative to the CLFS, and circa 20% higher for other lab categories.   The special issue will probably be mandatory reading for industry observers.

However, there is considerable variation.  For example, in the specialty genomics category, of 20 top genetic codes, commercial average payments in the Xifin database on a per-code basis vary from -65% to +230% relative to the CLFS.  This suggests that contracts are not made solely as flat percents of the CLFS.       (More after the break).

Friday, November 18, 2016

FDA Will Not Finalize LDT Guidance

On November 18, 2016, Genomeweb broke an important new announcement: that FDA will not finalize its 2014 proposal to regulate laboratory developed tests (LDTs).   Genomeweb's story is here (subscription required).  See a rapid press release from ACLA, here.  Further coverage at WSJ, here, and RAPS and STAT, open access here and here; Bloomberg here.

As I had noted to clients earlier this week, the election sharply raised this outcome.  If anything were to happen in the next year, it would resemble the Senate proposal to upgrade clinical utility review under CAP (or other outsourced bodies like New York State) - but even this is unlikely, following the reasoning below.