AMA to Hill: Do Regulate MAAA Tests at FDA

This article provides links to the AMA's February 2015 comments to the Hill, favoring tighter FDA regulation of "black box" algorithm-based genomic tests.  Details after the break.

Why FDA's Go-Ahead for 23andMe is Significant

On February 19, the FDA (here) and 23andMe (here and here) announced that the FDA has cleared a Bloom syndrome carrier screening genetic test developed by 23andMe - and has cleared it for direct-to-consumer marketing, fitting the 23andMe business model.

The announcement was quickly picked up by Forbes (here), Genetic Engineering News (here), and by subscription sources like Genomeweb and Gray Sheet (here, here).

Although the FDA's press release does not link to the 10-page clearance letter, another source does, here.

Your Quick Guide to Understanding the Weird 14 Day Rule (CMS Billing for Lab Tests)

Note: There have been several updates after this 2015 blog, most notably, a 2018 rule, implemented in 1/2020, that outpatient genomic tests are billed by the lab that performs them (be it the originating hospital lab or the reference lab).  See ongoing updates at CMS home page for 14-day-rule:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Lab-DOS-Policy#:~:text=In%20general%2C%20the%20date%20of,patient's%20discharge%20from%20the%20hospital.

ORIGINAL BLOG 2015

Babe Ruth marveled that he got "paid for playing baseball," since it was so much fun.  I marvel that I get paid for explaining Medicare's lab test "14 day rule" - because it is so bizarre.

For some examples of how unpopular this rule is in policy circles, see here.   More after the break.

Keeping up with AMP: Numerous Recent Policy Statements

The Association for Molecular Pathology is elevating its position as a stakeholder group for molecular medicine even further with a rapid series of significant policy statements in the past few months.  Brief summary and links after the break.

www.amp.org

If They Don't Like Your Service, CMS Can Suspend Your Enrollment!

On December 5, 2014, CMS finalized a rule with the obscure title, "Medicare Program, Requirements for the Medicare Incentive Reward Program and Provider Enrollment."   It's hard to see the "Incentive Reward" part of it, because the prologue immediately summarizes all the bad stuff: Expand how and when a felony conviction can kill your enrollment; they can also keep you out for having "a relationship" with a prior entity that had Medicare debt.  (79 Fed Reg 72500ff, here).

The more interesting (for us non felons) and open-ended part is authority to revoke billing privileges for "a pattern of submitting claims that fail to meet Medicare requirements."  (42 CFR 424.535(a)(8)(iii).)

CMS Goes Live with New Oncology Payment Pilot Program

What happened? New Oncology Payment System at CMS?

On February 12, 2015, CMS released a request for applications for providers who can actually deliver under a new, packaged or bundled oncology care bundle.  The 33-page request for applications is here.   For the CMS press release, see here.  A concurrent Federal Register announcement is here.  A CMS webinar on the project is here.

Details after the break.

NIH February 2015 Workshop on Precision Medicine, 1M Genomes

On February 11-12, 2015, the NIH hosted a workshop on the "opportunities and challenges" of precision medicine, featuring a multidisciplinary range of speakers.   The webcast will be available online.   In addition, the NIH released a number of white papers for the conference agenda.   Details after the break.  Representing the changing face of genomics stakeholders, the conference participants include not only some of the usual suspects - Geisinger, Illumina - but Google Life Sciences, Apple, and Intel.

The Forgotten "Coverage with Evidence Development": HCFA and Heart Transplants

"Coverage with Evidence Development" (CED) has received increasing attention since 2006, when CMS authorized the National Oncologic PET Registry to track and monitor expanded use of PET scans in less-common cancers.   By 2012, total scans in the program had exceeded 200,000 (here), which, at $1000 per scan, represents over $200M of nuclear imaging tests conducted under a "real-world evidence" paradigm.  By comparison, the Obama Precision Medicine Initiative, announced with much fanfare in January 2015, has been proposed with a budget of...circa $200M.

A search of the phrase "Coverage with Evidence Development" at PubMed yields over five dozen hits (e.g. here).  The Medicare agency maintains a webpage for "Coverage with Evidence Development" programs (here), and recently updated its policy guidance for CED (here).   Two Medicare contractors, Novitas and Palmetto GBA, have published guidance for local CED programs (e.g. MolDX Manual, accessed 2/3/2015, page 6, here).   The Center for Medical Technology Policy, headed by Sean Tunis, has a webpage devoted to CED white papers and articles (here).  Tunis  has authored numerous articles on CED (e.g. here).   Finally, on the Hill, in early 2015, draft legislation proposed additional authorities for Medicare's implementation of CED (see here, title II, Section H.)

Arguably, the first clear example of the CED concept actually occurred 35 years ago.

Update: See also, Evans RW et al, Insurance coverage of heart transplantation in the United States, J Heart Lung Transplant 36:1294 (2017), PMID 29173390.  I did not have this at the time of writing.  Evans covers many of the same historical documents in a peer-reviewed format.

Commissioner Hamburg Says NGS Requires New Rules

In a blog posted January 30, 2015, FDA Commissioner Hamburg states that next generation sequencing (NGS) testing may require new concepts and regulatory paradigms, as they don't represent "one gene one disease" testing.  Her remarks foot perfectly with a one-sentence remark in President Obama's speech on predictive medicine earlier on the same day [here].

Is the Learning Healthcare System Almost Suddenly Here? From ASCO and MolDX?

2007:  We starting hearing the phrase "learning healthcare system," used as the title of an Institute of Medicine report (here) and rapidly entering the health policy vernacular.  In recent years, the idea has particularly circulating in the context of cancer care, where it's been called the innovative relief valve for "a cancer care system in crisis" (for this 2013 U.S. IOM report, here; for the same idea in Canada, 2015, here.)

However, from one source or another, in 2015 and 2016, the big bang for the learning healthcare system may finally be ready to occur.  For a peek-a-boo, see the Med-C website (here).  Details after the break.

Hear a Liz Mansfield FDA interview about regulating LDTs

The website and podcast site MENDELSPOD (here) has released a 25 minute interview with Liz Mansfield, director of personalized medicine at the FDA, on January 26, 2015.

Hear online at the website, here, or on a smartphone podcast app after subscribing to Mendelspod.

Mansfield hopes that additional guidance on topics like harmonization of FDA and CLIA requirements under the FDA LDT guidance will be available to the public soon.   She felt that there were some interesting new proposals for solutions at the recent two-day public workshop, but that too many participants echoed the same misconceptions about the FDA's proposals again and again.  The interviewer asked several questions about medical directors pointing doctors to innovative off label tests (or improvements, such as new mutations), and whether this clashed with "off label promoting."  Mansfield noting that the issue was not new for LDTs, but exists as well for kit tests.  Mansfield emphasized that at the upcoming February 20, 2015, public workshop on NGS regulation, the FDA wants to focus on innovative oversight that won't stifle rapid advances.

Further details here.