Buy-and-Bill for Costly Drugs Shifts Away from Physician Offices (2004-2014): New Study

According to an April 14, 2016, column at Drug Channels, based on a Milliman report commissioned by the Community Oncology Alliance:

• Administration of chemotherapy infusion has shifted dramatically from lower-cost physician offices to higher-cost hospital outpatient settings. 
• From 2004 to 2014, the buy-and-bill market share at physician offices dropped from about 90% to about 50%.

Links after the break.

Epigenomics Epi proColon - Part of the Story Behind the Story

After a several-year journey through FDA advisory boards, extra studies, and FDA reviews, PMA approval of the Epi proColon test was announced on April 13, 2016.

Epigenomics, based in Berlin and Maryland, is publicly traded overseas.  The stock has roughly tripled from January to April 13.  As of today, it has a market cap of 124M euros.*  The stock popped 20% today, probably not more because the company has been assuring investors since January that FDA approval was expected and imminent.

Part of the "story behind the story" is at the website Seeking Alpha under the EP Vantage newsletter channel.  Interesting reading (here).  More after the break.

CMS Proposes Major Sanctions Against Theranos

On April 13, 2016, news broke that CMS had proposed major sanctions against Theranos, including a two year suspension.   The CMS letter to Theranos is 44 pages long and was written on March 18.

Some of the penalties are stated to take place "8 days" from the "date of notice of imposition" while others take place at 60 days.   CMS had given Theranos until March 28, 2016 to respond.  Major news article links are provided after the break.

How Fast is Liquid Biopsy Going? Insights from Sacher's Paper on ddPCR in Lung Cancer

On April 7, 2016, JAMA Oncology published a 180-patient study in which each lung cancer patient had paired liquid biopsy samples (ddPCR for EGFR and KRAS) along with tissue biopsies.  The data is extremely interesting and seeing a paired blood/tissue study with this many patients is very helpful for understanding how fast the clinical adoption of liquid biopsy is likely to move.  The paper is online here.  It's listed as "Free."  Details after the break.

CMMI Announces Launch of "Comprehensive Primary Care Plus" in FFS Medicare

The Center for Medicare & Medicaid Innovation has been on a roll, launching a new Oncology Care Management program, a comprehensive and mandatory regional Comprehensive Care for Joint Replacement program, a vast national Part B drug payment reform (proposed only), and proposing to transfer a past demo program in Diabetes Prevention to a permanent Medicare benefit based on its interpretation of the demo as cost saving (here).   Now there's a new one: Comprehensive Primary Care Plus.  Details after the break.

FDA Announces July 19, 2016 Workshop on Liquid Biopsy Cancer Tests

Update (July 21, 2016)
A detailed subscription article on this conference is available at Genomeweb (here).


As a follow-on meeting to the FDA's February workshop on genome panel tests in tumors, the FDA has announced a workshop on liquid biopsies in oncology on Tuesday, July 19, 2016.

The FDA has posted the agenda here.   Registration is open.  The workshop will be held in Washington rather than on the FDA campus.

The FDA writes, "Lquid biopsy technologies are advancing quickly...are likely to be rapidly incorporated into clinical care."

The workshop is co-sponsored by the American Association for Cancer Research.  Over the past year, the AACR has urged the FDA to regulate cancer LDT's as devices  (here).

For a non official transcript of the February oncogene panel workshop, here.

MolDX Announces Expansion to WPS MAC

On April 6, 2016, MolDX updated its FAQ of general questions.  They've added WPS to the list of MACs following the program (Medicare MACs J5, J8).

See here.   Quoting:

3. What laboratories will be affected?All private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare in JE, JF JM, J15 J5, or J8 on a CMS 1500 Claim Form or electronic claims on a 5010-837P are affected by this program. (Please reference the specific jurisdiction MDT policy for effective dates.)
5. Is the MolDX Program national in scope?The MolDX Program currently covers JE (CA, NV, HI), JF (WA, OR, ID, MT, WY, AZ, ND, ND, HI, UT, Aleutian Islands), JM (NC, SC, VA, WV), J15 (TN, OH), J5 (IA, MO, KS, NE) and J8 (MI, IN). Labs that perform services for patients in those states, must register in order to submit a Medicare claim.
10. Will the MolDX Program expand to other jurisdictions?At this time CMS has not determined how MolDX will be expanded. Palmetto GBA will continue to administer active LCDs and articles published in JM, Noridian will administer the MolDX in JE and JF, CGS will administer MolDX in J15, and WPS will administer MolDX in J5 and J8.

Implementation details don't seem to be up on the WPS website yet.
By my count, MolDX now provides diagnostics policy and pricing to 24 states and 44% of the Medicare population.

Government Tries to be Helpful: Integrated Web Portals for Mobile App Regulation

Digital health investments surprised some industry watching by continuing to grow in Q12016 (Rock Health, here).    However, complaints about a murky regulatory structure for some industry segments like healthcare apps with clinical decision support continue (Gray Sheet, here).    

Seemingly in response, the FDA, FTC, and Office of the National Coordinator (ONC) released a web-friendly guide to mobile app regulation (the web site here, article about it at RAPS, here).

The multi-agency website, housed at the FTC, will not solve all problems but provide a fast orientation to the major issues.  A binary of questions/answers guides the reader through need-to-know bullet points on HIPAA, FDA, and FTC issues.  (The FTC has a "sister website" with more detail on its issues, here).

Details after the break.

Quick Cornucopia of New, Free, Pharma Value-Based Pricing White Papers and Op Eds

The pricing of pharmaceuticals has always been in the news - always meaning from the 1890s to the 1950s and forward.  But it's especially in the news in the past couple years; see an April 2016 article in Forbes here.

A number of new pieces on value based pricing have just appeared.  ICER, the Boston-based thinktank for drug pricing that was cited several times in CMMI's current Part B value based drug payment proposal, released a "scoping document" for upcoming reviews of multiple myeloma drugs in February 2016 (here) and a final version in March (here).

• Update to this blog: The ICER draft report appeared on April 7, 2016, here, here.

On March 31, Amgen released a response to ICER, focused on the future evaluation of its drug Kyprolis (carfilzomib) - here.

Also on March 31, Steve Ubl of PHRMA and Dan Leonard of the National Pharmaceutical Council (NPC) released a joint OpEd in The Hill / Congress Blog on what should be the principles of value assessment that is appropriately patient centered - here.

The OpEd points to a 10 page NPC white paper on "guiding practices" for value based assessments (here) and see also a 15 page NPC white paper on the "landscape" of current value based frameworks (here).  Authors of the "landscape" specifically describe it as carrying forward and adding detail to a December 2015 NEJM article by Neumann & Cohn (here).

For an opinionated and colorful blog on ICER, here, here.

AMA Releases Planned Agenda for May AMA CPT Meeting in Chicago

The next AMA CPT will be held in Chicago on May 10-12, 2016 (website here).   Cheerfully, it will be held at the downtown Loew's Hotel (a new glass tower near Navy Pier) and not at O'Hare.

The draft code agenda has been released (here, may require free registration).

Topics include McKesson quarterly codes; 3 proposals for new genetic codes; new telemedicine codes; and revisions to the AMA CPT literature requirements.  More after the break.

Unofficial Transcript of FDA Workshop on NGS Tumor Panels (2/20/2016)

On February 20, 2016, the FDA held a workshop on potential regulation of NGS tumor panels.  FDA website here.   The FDA immediately posted a webcast (see website) and a 200 slide consolidated deck (at website or here).

New March 29: An unofficial transcript of the meeting, based on the archived webcast, is in the cloud, here.   

FDA and Liquid Biopsy?  Note that on page 5, Reena Phillips of FDA (division director for genetics and molecular pathology) says that on "July 19" there will be a workshop on NGS and liquid biopsy.   That workshop has been posted here and will be co sponsored by the American Association for Cancer Research.

Additional Links.  For additional links such as trade journals, see my original blog for the workshop, here.

Short link: tinyurl.com/fda20160220

CMMI's Diabetes Prevention Demo: A Policy Wonk Analysis

On March 23, 2016, Secretary of Health Burwell announced that a major Center for Medicare & Medicaid Innovation Demonstration Program had been completed and had met statutory criteria for saving costs and improving health quality.  This means that, under the demonstration law, CMS can institute the program as a permanent health benefit for Medicare beneficiaries.

Update: CMS released the proposed structure of the program on July 15, 2016, as part of the annual Physician Fee Schedule rulemaking; see here.

I am strongly in favor of the program, and glad this is happening.  Broadly, Diabetes Prevention Counseling is supported by multiple trials and endorsed by USPSTF.  For a favorable NYT article on DPP in generation, here and here; for a favorable NEJM Op-Ed, here.

That said, in this essay, I am concocting a critic's viewpoint of what is happening.  Why?  Because things that payor policymakers do not like are often subjected to withering analysis - pecked to death, so to speak.

What would happen if the more typical, even hypercritical coverage posture was applied to the YMCA Diabetes Prevention Program findings?

MAC LCD Comments Review: How Long?

Medicare MACs are required to post draft LCDs for 45 days of public comment and then to allow a 45 day public notice when the LCD is finalized and pending its effective date.

How long does the review of comments take?  It's highly variable/..but around seven months.

I pulled data today from the Noridian J-E Part B website for draft LCDs under comment and review periods (here).  Eight LCDs were recently finalized, with an average contemplation time of 200 days (almost 6-7 months), range 101 to 348 days, standard deviation +/- 68 days.

Noridian Finalizes and Activates the Lung Cancer Gene Panel LCD for California

Back in January 2015, over a year ago, the MolDX program publishes a limited coverage LCD for lung cancer gene panels, limited to light and non smokers and requiring some coverage with evidence reporting.  By summer and fall, more and more commercial carriers were providing similar coverage, based on recommendations for broader gene panels by major clinical associations.

In July 2015, the Noridian MAC published a corresponding MolDX LCD for J-E and J-F.  In February 2016, the LCD was finalized with no changes although a Q&A comment document was also published.  It will be active and effective in J-E and J-F in April 2016.  Links after the break.

Observational Study Reports Competitive Bidding May Have Harmed Diabetic Patients

 In March 2016, a large observational study reported that quality outcomes were materially harmed by the DME competitive bidding demonstration with regard to diabetic supplies and meters, especially in minority populations.  Details after the break.