The "PreSubmission Process" at Palmetto MolDX

This blog just highlights an important webpage at the Palmetto MolDX website, which gives a presubmission discussion & review process.  (Search for "pre-submission" using a hyphen or go to Topics>Technology Assessment>Article List> Pre-Submission.)

Details after the break.

Annual Reports from MEDPAC, ASCO.

MEDPAC, the Medicare Payment Advisory Commission, released its annual Report to Congress, this year running 460 pages.  Opens with executive summary.  Here.

ASCO released its annual "State of Cancer Care" white paper, this year 47 pages.  Summaries and infographics available.  Here for home page, here for PDF.

Supreme Court Touches on Big Data, National Healthcare Policy...and ERISA

Over the last few days, many articles are blogs have appeared on a March 1, 2016 Supreme Court (SCOTUS) decision, Gobeille v Liberty Mutual Insurance Company.   The case decided that a Vermont law requiring claims data from "all payers" violated a federal law called ERISA, that generally shields employer-self-insured plans from state regulation.   The case has some interesting implications for big data in health care, and attracted a 102 page amicus curiae filing from the U.S. government.  Details after the break.

FDA Emergency Approval for CDC Zika IgM test; Warning to Another Company

On February 26, the FDA and CDC collaborated to announce that the CDC could undertake emergency distribution of a Zika IgM test with emergency FDA approval (here).  The CDC test is called the "CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA)."

However, FDA is not overlooking unapproved emergency tests.  On  March 4, the FDA sent a warning letter to "MD Bioscience" that its Zika Virus RNA (RT PCR) assay was an unapproved test in the eyes of the FDA, not under 510(k) nor PMA nor emergency approvals (here).  The FDA's letter to MD Bioscience in St. Paul MN is online here.  The FDA notes specifically that the RNA RT PCR assay was "intended to provide a reliable, accurate and rapid method of testing for Zika virus."  The FDA adds drily that this phrasing "appears to meet the definition of a device."

Quick post: Update on where to get Part B data files

A client asked me this and I'm posting the general answer.

There are two main CMS sources of open access Part B data.  Details after the break.

Medicare to Slash Physician Drug Payment Incentives...by Zip Code

A few weeks ago, there was a briefly posted and then deleted CMS Transmittal (instruction to contractors) to set up systems that could vary drug pricing by zip code (here).   On Wednesday March 9, both the NYT and WSJ carry lead stories that CMS will soon begin a demo program that tests payment cuts to doctors who "buy and bill" drugs for their Medicare patients.

Early Coverage (March/April) 
Open access coverage at Medscape, here. NYT here, with NYT follow-up article here, and NYT op-ed here.  WSJ here.  WSJ also reported that overall drug spending rose 14% in CY2014 (here).  For a further list of sources, see Mediapost (here).  Subscription coverage at Law360, here.  A four page review by Avalere, here.

Closing Coverage (May)
A May 2016 update at Health Affairs from Brookings Institute, here. A May 2016 update from Politico on the kickback, here.  A similar summary of the best links at PHRMA, here.  AHIP response here, and here in full.  An Anti-CMS website is here.  For the May 2011 House hearing on the proposal, here.

CMS Links
For the full 119 page Federal Register announcement, here.  For the CMS press release, here.  A new 16 page HHS/ASPE report on drug spending, timed to the CMMI proposal, here, here; blog on the HHS report, here. 

Details after the break.

IOM Releases Report on Biomarkers for Therapies: Unlocking Precision Medicine

On March 4, 2016, the IOM released a new ebook, Biomarkers for Targeted Therapies: Unlocking Precision Medicine.   The 231-page PDF ebook is available as a free download, here (click on box in upper right, free PDF, download).

In addition, on March 10, 2 eastern, the IOM will hold held a webinar about the book, find out more and register here.

A two pager summary of the 10 goals/recommendations is in PDF form, here.  My summary of the ten goals after the break.

Update: 
A belated OpEd on this IOM book appears in the NEJM, July 7, 2016 (here).

Health Care Futurism from a Mainstream Source: Health Affairs

On a normal day, Health Affairs is like a magnifying glass on the health system as-it-is... this is happening in Medicare Part D, that is happening with behavioral health carveouts at commercial insurers, this is happening in Medicaid, here is a study of copayments for patients in bronze plans on federal exchanges.

This month, Health Affairs has a dozen open access articles based on a Yale symposium, "The New Healthcare Industry" here, including video archive; cloud-archived here).    For all the links and titles at Health Affairs, visit here.

Elizabeth Holmes (Theranos) Withdraws from Scripps Diagnostics Conference

Elizabeth Holmes, CEO of Theranos, was scheduled to speak at the March 4, 2016 Scripps conference on genomic medicine.  According to Medscape, she had no further comment (here).

For more on the Scripps conference, here.   For a two-year listing of Theranos articles, here.

Simple Math, Big Media Visibility: The New Study on Drug Wastage & Costs

Traditionally, Medicare and other payers compensate doctors for unavoidable wastage from single dose vials.   For example, the patient needs 80 mg of drug but only vials of 100 mg are sold. Single use vials are labeled "not for reuse" and generally do not contain preservatives for refrigeration and reuse.  In other cases, components may be brought up from powder to saline and not be stable in liquid form.

Peter Bach of Memorial Sloane Kettering published an article on the national mathematics of this in the BMJ (British Medical Journal) and it was immediately picked up by the New York Times.  Links follow.

AJMC News Summary: Diagnostic Testing is a "Wild West"

In November 2016, I was a panelist at the American Journal of Managed Care 4th annual conference, "Patient Centered Oncology Care."   While I wasn't able to attend the whole conference, I didn't quite have the impression conveyed by their just-released news summary "Diagnostic Testing is a Wild West of Unknowns, Perils."   The online conference report is here, with a publication date of March 2, 2016.

The same week, JAMA published an opinion piece by John Ionnanidis and two Harvard colleagues that the impact of some genetic variants may be overinterpreted or overstated - Manrai et al., online here.  Related, Feero's January JAMA editorial on clinical validity of arrythmia-related genetic variations, here.  Ionnanidis is best known for his 2005 article, "Why Most Published Research Findings are False" (open access, here.)  He has been profiled a number of times, e.g. the Atlantic 2010, here, and at Mendelspod in 2016, here.

FDA Workshop on Return of Genetic Test Results (March 2, 2016)

On March 2, 2016, the FDA held a workshop on "Patient and Medical Professional Perspectives on the Return of Genetic Test Results."

The FDA workshop website is here.  At that website, you can access the agenda, videocast online, and eventually a transcript.  For coverage at Gray Sheet (subscription), here.

A few days earlier, the FDA held a workshop on next generation sequencing and cancer gene panels (here).

Scripps Future of Genomic Medicine Conference (March 3-4, 2016)

On March 3-4, Scripss held its ninth conference on "The Future of Genomic Medicine."  I didn't have a chance to attend, but to keep up with the Scripps view of cutting-edge trends this spring, see the conference brochure online here, or archived in the cloud here.  Some pre-press appeared on Medscape a week earlier (here).  For Medscape's ongoing coverage, here.  For tweets (#FOGM16), here.

Obama Precision Medicine Summit: Transcript Here! (2 hrs, 40 pp)

You heard about the Precision Medicine Summit held by President Obama on February 26.  You've seen some of the trade press...

You can get a full length transcript: in the cloud here.

For even more - including news summary, Youtube link to the two hour video, and downloadable MP3 file - see here.

As a Senator, Obama introduced the "Genomics and Personalized Medicine Act of 2006" - S.3822 of 2006.  News article here, text of the GPMA still online, here.

 

This blog, short link:
tinyurl.com/PMISTranscript
Linked In citation here.

Physician Office, Hospital Outpatient and Other Payment Differentials: Avalere Study

On November 2, 2016, the President signed the Bipartisan Budget Act which included Section 603, blocking future conversions of physician practices into hospital outpatient centers (here).  As a flurry of debate on the implementation of this law continues, Avalere publishes a comparison of Medicare's site of service payment differentials.  I have included the Avalere study and about ten other relevant documents in one 10 mb zip file in the cloud, here.  Details after the break.