CMS to Hold MEDCAC on Chronic Venous Disease (July 20, 2016)

On May 6, 2016, CMS announced it will hold a July 20, 2016, MedCAC on chronic venous disease of the lower extremities.  Webpage for the meeting here.  The deadline for meeting registration and/or PowerPoint submissions for presentations is June 13, 2016.  Federal Register announcement, here.

CMS abstract for the meeting, below the break.  This summer's meeting follows a MEDCAC last summer on peripheral arterial disease (here).

AHRQ has a current evidence collection on "Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease" June 9-July 9, here.   Earlier, AHRQ also posted a March 2016 protocol for the review of this topic, here.

FDA approves new PET scan tracer; for prostate cancer

The FDA approves new PET scan agents fairly rarely.

On Friday, May 27, 2016, the FDA approved Axumin, a new PET agent for detecting prostate cancer metastatic lesions.   The typical patient would have elevated recurring PSA (post definitive treatment), but the elevated PSA is of unknown anatomic origin.  FDA press release here.

Clinical studies looked at the correlation between the Axumin image and biopsy/histopathology in 105 patients.  A second study with 96 patients looked at the correlation between the Axumin image and Choline C11 PET imaging.   Choline C11 was previously approved by the FDA as a PET agent for prostate cancer in September 2012 (here).

For CMS, in the hospital inpatient and outpatient setting, PET imaging agents (regardless of cost) are bundled as part of the base cost of the PET scan (after an initial two year cost pass-through period.) For Part B claims at freestanding centers, due to uncertainties in the Medicare regulations for pricing radioimaging agents, MACs have some discretion in pricing radiotracers (e.g. invoice or other methods).

Coverage for new FDA approved oncologic agents after March 2013 can be determined by MACs (see NCD 220.6).

• Effective for dates of service on or after March 7, 2013, local Medicare Administrative Contractors (MACs) may determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their Food and Drug Administration (FDA) approved labeled indications for oncologic imaging.

EMA Publishes 19-page Guidance on Genomics & Drug Studies

The European Medicines Association (EMA) published a 19 page guidance the use of pharmacogenomics studies in drug development.   Appearing in May, the original PDF document is here and an article summarizing it is available at RAPS, here.  The document includes links to about a dozen prior and related EMA guidances, such as on pharmacogenetics.

EMA is accepting public comments until September 16, 2016.

MolDX Creates Guidelines for Circulating Tumor DNA Validity Studies (Liquid Biopsy)

When will payers have explicit policies covering liquid biopsy...soon?   Possibly, since Medicare's MolDX policy group has issued analytical validity guidelines for circulating DNA somatic tumor mutations.   There wouldn't be much reason to have these test assessment guidelines - which look like a lot of effort and detail - unless there was some foreseeable point when the tests would be covered.

The guidelines 8 pages long and were originally issued May 20, 2016.

The UPDATED V2 was posted by MolDx four days later, on May 24, and is here.

Foundation Medicine Patent Applications

On May 17, 2016, Foundation Medicine announced issuance of a patent, 9340830, entitled "Optimization of Multigene Analysis of Tumor Samples."  For FMI"s press release, here.  For additional trade press, here.   For attached litigation, here.

• The actual patent is online at the USPTO, here.  
• It's lengthy; transferred into Word I get 222 pages and 110,000 words.   
• Faqs.org collates online patent applications for FMI, listing 9, here.   
• 13 listed for GHDX, here.  41 listed for MYGN, here.  

CMS Opens NCD on Leadless Pacemakers; NCD on gender assignment surgery to appear June 3

CMS currently has four open NCD topics, the fourth having been opened on May 18, 2016.

Leadless Pacemakers
The newest topic is a coverage decision on leadless pacemakers.   Leadless pacemakers have some advantages (they are - leadless!) but some disadvantages as well.   CMS is soliciting public comments until June 17, 2016, and then will go into research mode until releasing a draft NCD around November 18, 2016.

Gender Reassignment
Another open NCD process is considering coverage for gender reassignment surgery.  CMS had a negative NCD from 1981 until May 2014, when a judicial decision threw out the old noncoverage as not based on reasonable science (the actual decision here).  The new NCD process was announced in December 2015, and a draft NCD will appear by June 3, 2016 (request letter here; CMS website here).   Between May 2014 and a future finalization date of the in-process NCD (September 1, 2016), gender reassignment surgical coverage is at MAC discretion.

Lumbar Surgery; Hepatitis B Screening
To finish the tally of four open NCDs, an NCD for percutaneous image guided lumbar decompression is underway until a draft decision in October 2016, and an NCD on the Hepatitis B screening test coverage is underway until a draft decision in July 2016.

Theranos Voids Two Years of Test Results (WSJ)

On May 18, 2016, the Wall Street Journal reported that Theranos had voided two years of lab test results based on its Edison device.  WSJ here.   Open access story at Ars Technica, here.

Regarding the latest news, biotech journalist Matthew Herper writes at Forbes, "Theranos isn’t very good at running a diagnostic testing business."

"For a library of links on Theranos, here.

Noridian MolDX Posts, Withdraws, Consolidated Breast Cancer LCD Mirroring ASCO Guidelines

Noridian Jurisdiction E (including California) posted a draft LCD which appears to consolidate coverage for breast cancer prognostic markers, early in the week of May 16, 2016.  

The LCD was posted online at CMS here.  However, according to several sources, Noridian is canceling this LCD for this LCD cycle.

An archival copy of the May 16 LCD is in the cloud, here.

The proposal for a single breast cancer biomarker LCD very closely matched Medicare coverage to February 2016 ASCO guidelines for breast cancer prognostic markers - regardless of whether that guideline is broader or narrower than existing Medicare LCD coverage.  (For the ASCO document, see Harris et al., here.)

A listing of all current draft LCDs in J-E is here.  For this LCD cycle, there is an open comment period from June 2, 2016, to August 8, 2016.

Us Against Alzheimer's Group Posts Detailed Study of Drug Pipeline

For nearly twenty years, since the 1990s, Alzheimer's drugs have had difficult challenges and new drug approvals trickled to a stop despite large numbers of candidates.  For news article see here and for an open access study see here.

A wide variety of drugs, against diverse targets, are under study today.  The Us Against Alzheimer's organization has produced a comprehensive seven page infographic (a highlight screen shot is shown below).  In addition to high-level timelines, the report provides a detailed six page table with further characteristics of each study included.  Press release here; infographic seven page table as PDF, here.

The EU released new draft guidelines for Alzheimer drug approvals in January 2016 (here, here).  In 2013, the Center for Medical Technology Policy (CMPT) produced a 29-page consensus document on evidence for Alzheimer drug trials (here).

Hill Holds Hearing on Part B Nationwide Drug Pricing "Demo"

In March, CMS opened a 60 day comment period on a nationwide drug pricing demonstration, which illustrated the extremely wide-ranging authority granted to the Center for Medicare and Medicaid Innovation (CMMI) under 2010 legislation.   (The CMMI can waive any Medicare law it chooses to, based on a small clause that received little attention at the time.)

On May 17, 2016, the House Energy & Commerce Committee will hold a hearing on the demo proposal.  The House website is here; proposed legislation to stop the implementation of the demo is here; and a House background document on the demo is here.   The hearing will start at 10 ET and will be webcast.

In the backgrounder, House staff write:

...While these concerns are numerous, the mere scope and design of this proposal,including waiving several parts of statute, its nationwide application, the untested application of value based purchasing mechanisms, and the dramatic reduction in reimbursement have led many to call for a withdrawal of the proposed rule. 

Some on the Hill support the CMMI demo (as long as implementation is cautious to concerns); see a 4 page May 16 letter to HHS from Sens. Warren, Franken, and nine others; here.

A coalition against the CMMI proposal has a website, StopCMSCuts.   My original and updated blog on the proposal, here.

FDA releases Next Gen Clinical Sequencing Guidance: For Infectious Disease

On May 13, 2016 FDA released a draft 46 page guidance on how device manufacturers in the next generation sequencing industry can approach approval for diagnostics related to infectious disease.

The guidance is online here.  Comments are accepted for 90 days (until about August 12, 2016).  The guidance follows a workshop on microbial sequencing held two years ago, on April 1, 2014, and also adapts information from an April 2015 colloquium held in conjunction with ASM.

Two high Value Media Hits for Precision Oncology: Sunday NYT Magazine, and Harold Varmus in Science

Two high value media hits for precision oncology in a short interval.

The Sunday, May 15, New York Times magazine is devoted to advances in oncology, with seven lead articles covering topics ranging from from genomic targets in cancer to super-responders to hospice care.   Here.

The April 8 issue of Science was devoted to the new science of metastasis, and featured an editorial by Harold Varmus, former head of NCI and currently holder of an endowed chair at Weill Cornell School of Medicine.  Of note, Varmus calls on CMS to cover molecular profiling in cancer patients:

More after the break.

One Down, Two to Go: CMS Posts Date & Codes for July 2016 Gapfill Meeting

In the near future, CMS is (1) posting information on the July CLFS pricing meeting, (2) posting the "Spring" full list of proposed 2016 gapfill prices from its MACs, and (3) releasing final rulemaking for PAMA Section 216.

One down, two to go.  

The July 2016 CLFS meeting is going to be on Monday, July 18, 2016.  The CMS agenda is online here.  Stated separately in a Federal Register meeting announcement (here) the morning will be crosswalk/gapfill discussions and the afternoon will be a session of the PAMA CMS laboratory advisory board.

(For the advisory board session, look for an eventual agenda here.)

Details after the break.

CMMI Haters Make a Website!

In March 2016, the Centers for Medicare and Medicaid Innovation announced a nationwide program to abruptly change drug payment policy for the agency (article and links here).   CMMI had traditionally run relatively small demo's, but realized it had the legal authority, via a petite phrase tucked into the law, to waive any Medicare law it wants to.   (This is like getting one wish, and the wish is, to have as many wishes as you want.)

At the home page domain STOP CMS CUTS an elaborate website now exists...

NextGxDx: Helping Payers and Providers Manage Genetic Tests

After receiving daily advertisements to attend the AHIP conference in Las Vegas in June (here; Jeb Bush is keynote speaker), I clicked through and browsed around, coming across a May 16 webinar on controlling genetic test utilization sponsored by AHIP and a startup management company called NextGxDx:

More after the break.

Patient centered...medical billing???

In the May 10, 2016, Federal Register, CMS launches a proposal to solicit ideas to make medical billing in the U.S. easier to understand.  Article at HealthcareDive here.   The "challenge" co sponsored by AARP has its own webpage, here.   The Federal Register announcement is here (81 Fed Reg 27783).

There is an article on exactly the same topic - "Drowning in a Sea of Paperwork: Toward a More Patient Centered Billing System in the United States" - by Semigran et al. in the May 3, 2016 issue of Annals of Internal Medicine.  The Semigran article, though almost simultaneous, does not refer to the CMS/AARP effort.   See the article here.

WSJ Lead Article on Advanced Diagnostics in Prostate Cancer

A May 9, 2016 article by Melinda Beck in the Wall Street Journal provides deep-dive coverage for its readers on the boom in more precise prostate cancer testing, and how such tests are targeting different points in the cycle (from handling an abnormal PSA, to deciding whether to do a prostatectomy, to deciding whether to add adjuvant radiation.)   The subscription article is here.   

Tests noted in the article include Prolaris by Myriad Genetics, 4KScore by OPKO Health, Prostate Health Index PHI by Beckman Coulter, SelectMDX by MDX Health, a forthcoming urine-based test from Exosome Diagnostics, the University of Michigan's Michigan Prostate Score (MPS), ConfirmDX from MDxHealth, OncotypeDX Prostate by Genomic Health, ProMark by MetaMark Genetics, and Decipher by GenomeDx Biosciences...ten tests.

The article should be read in context with a current JAMA letter on how badly misinterpreted some RCTs of PSA testing are (here).

CMS Releases Massive Physician Data Files for CY2014

On May 5, 2016, CMS released the third annual set of data files on physician and laboratory behavior: comprehensive multi hundred megabyte data sets of CPT codes and who used them and where.

For the CMS press release, here.   For a short article at HealthcareDive, here.  For the actual data set page (where you can find 2012, 2013, 2014 in sequence), at CMS, here.

For a short blog on the data set, here.

Why Did CMS Hold a MedCAC on Treatment Resistant Depression? (Answer)

On April 27, 2016, CMS held a MEDCAC meeting on "Treatment Resistant Depression," covered a bit in the CMS press.  The CMS webpage for the meeting, including agenda, prepared documents, and (eventually) a transcript, is here.

I noticed that two different trade journal articles, MedPageToday (here) and Modern Healthcare (here), noted that CMS had not stated "a reason for holding the meeting."

The rationale have its roots in a 2014 appeal of the one NCD that addresses treatment resistant depression, an NCD for vagal nerve [electrical] stimulation, which covers therapy for epilepsy but does not allow coverage for treatment resistant depression.

The Brouhaha around a DMEMAC Lower Extremity Prostheses LCD Revision

In September 2015, the WSJ ran an article on a proposed LCD revision in the DME MAC world, which would change some coverage standards for lower extremity prostheses (see WSJ, here.)  The topic appears again in the May issue of the trade journal Insider CMS (subscription; here).  Inside CMS describes that an Energy & Commerce legislator's effort to "slap a moratorium on the LCD until July 2017" and a House effort to "give CMS more power over local coverage policies in general."   The American Orthotic and Prosthetic Association is also "shopping a bill" on the topic.  The article also describes "a protest from amputees."

An April 28, 2016 letter from four House members to HHS Secretary Burwell is described.  CMS posts that the LCD is on hold pending further workgroup study.

Precision Medicine IPO: NantHealth Files for IPO

NantHealth, a Culver City based company led by billionaire Patrick Soon-Shiong MD, has filed for a $92M IPO under the symbol NH.  The S-1 is available here.  The summary begins at page PDF p. 8; the full business plan description begins on page PDF p. 103.

[Update, an update was filed May 24 with new information including a proposed share price of $12-15; news here; document here].

Current investors include Allscripts, Verizon, Blackberry, Kuwait, and Celgene.  In the past year, Nanthealth reports $58M revenue and a $72M net loss, suggesting spending at the rate of about $130M per year.

A 7-point analysis by Neil Versel at MedCity News is here.  An 8-point analysis by HIT Consultant, here.  Coverage at FierceMedicalDevices here.

NantHealth's home page is here.  For an April, 2016 video interview between Soon-Shiong and Eric Topol, here (website includes transcript).

New Data on the Ways "PSA Screening" RCTs Can Be Very Misleading

This is the May 5, 2016, letter in NEJM from Columbia and Cornell showing that  in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, in the "control" arm, PSA testing rates were very high, higher than generally known.

The findings mean that it was not really an RCT of the additive impact or benefit of PSA screening, since PSA was 'de facto' being screened in both arms.  This shows one of the hazards of a rigorous "intention to treat" analysis when the control group actually veers to pragmatic treatment very similar to the treatment group.

[M]ore than 80% of the participants in the control group without baseline screening contamination (which for PSA wasdefined as ≥2 tests within 3 years before trial entry)reported having undergone at least 1 PSA test during the trial, with more than 50% undergoing testing within the past year and 70% within the past 2 years.

Overall, including the 10% of control participants with baseline PSA screening contamination, the proportion of control participants who reported having undergone at least1 PSA test before or during the trial was close to 90%.

Foundation Medicine to Open Lab in North Carolina; Billing to Palmetto/MolDx Policy System

In its investor call for first quarter results, held May 3, 2016, Foundation Medicine (FMI) noted that it will be opening a laboratory center in Research Triangle Park, North Carolina.  A lab in that location would bill to a different Medicare MAC for all its Medicare fee for services patients.  Some of the complexities are unraveled after the break.

Price Transparency Deja Vu: Advertising Lab Services in the 1920s

We read something about the missing value of "transparent pricing" almost daily in American health care.

Archives of Pathology and Laboratory Medicine just published a historical review of changes in the pathology profession and industry in the 1920s (by James Wright. University of Calgary; here and here.  This epublication appears to be open access, at least this week.)

One of the dramas of the 1920s was that some commercial laboratories were openly advertising their prices, and professional pathologists/physicians felt this was a violation of ethics codes "as if tests were commodities" since physicians ought not advertise prics.   A screenshot below.  As Wright describes, there were actually several full cycles of debate over the relative pro's and con's of advertising laboratory prices in JAMA and other medical journals (advertising might prevent the unscrupulous from overcharging [other] physicians.)

Can Pragmatic Trials and Real World Evidence be "Certified?" A Published Proposal

Can real world evidence be 'certified' for validity and lack of bias, including when sponsored by industry?

Maybe so, according to a proposal by Hopkins, Univ. Washington, and other policymakers.

Open access article here.   Abstract clipped after the break.  For a Washington white paper on RWE, appearing in June 2016, see here.

Giant Consolidations: IMS/Quintiles to follow Payers, Hospitals, and Pharmas in Consolidation Bonanza

Articles on the ongoing rollup of physicians into hospital networks, hospitals into bigger networks, pharmas into mergers, and payers into mergers...are legion.   For an April 29, 2016 article at NYT, here.   

The healthcare information, R&D, and value measurement industry is gaining a colossus worth about $20B with the merger of Quintiles and IMS Health, announced on May 3.  For an article at MedCity News, here.   Writing in part:

Two heavyweights in healthcare and biopharma Big Data, IMS Health and Quintiles Transnational Holdings, are coming together in what the companies are calling a “merger of equals.” The all-stock transaction brings together companies with a combined enterprise value of upwards of $23 billion and current market capitalization of $17.6 billion.  “This combination addresses life-science companies’ most pressing needs: (1) to transform the clinical development of innovative medicines, (2) demonstrate the value of these medicines in the real world and (3) drive commercial success,” said Quintiles CEO Tom Pike.

_______

For an acquisition that brought together a lab and a CRO, recall the $6B acquisition of Covance by Labcorp in early 2015.

Aaron Bossler's 62 Slide Deck on "The Squeeze on Molecular Pathology"

Aaron Bossler MD, University of Iowa, has been highly active in the Association for Molecular Pathology and co-authored a new paper on both the lab economics and healthcare economics of molecular testing (here; open access).

His 62-slide deck, 'The Squeeze on Molecular Pathology," is online at ARUP's website, here.  It has a PDF creation date of 12/2015.

His March, 2015 45-slide deck on molecular lab costs and pricing for Pathology & Laboratory Medicine Executive War College is online, here.

Extra Credit Reading:

For a 38 slide deck from 2014 by Michael Watson for ACMG, on similar themes, see here.

Noridian JE Finalizes West Coast MolDX Cardiac Biomarker LCD

Over the past year, MolDX and other MACs have been bringing out more stringent LCDs on the use of cardiac biomarker testing, probably in the wake of high billing at the HDL commercial laboratory in Virgnia (here).

In April 2015, Noridian finalized its cardiac biomarker LCD with relatively few changes - but there are a few.  Details after the break.

Comments Are In: CMS Asks Public About MAC Contracting

MACRA (the 2015 SGR Reform) Section 509 extends MAC contracting from 5-year to 10-year periods.  (CMS website for these changes, here.)

In December 2015, CMS also issued a "Request for Comments" on MAC performance and the MAC contracting process.  The Docket for the request (#2015-32027, CMS-1653-NC) is here.  The full text of the CMS public request for information is here (html) or here (80 Fed Reg 27343-5).

In total, 23 comments were submitted (here).  Details after the break.

CMS Happy Talk Animated Breezy Explanation of MACRA

CMS released an animated three minute explanation of the 950 page MACRA rulemaking.  It's on YouTube, here.  

These are boom days for explanatory animations where you either see graphics and words appearing as if hand drawn in real time, or, you may (as here) see the animators hand whizzing on and off the animation.   Khan Academy was an early producer of these.  Vi Hart produces particularly offbeat ones on math and other topics (here).   Hart once remarked it takes two weeks or more to produce a 2 minute video of this type in her style.

This category of explanatory animation video may have (or deserve) a dedicated name, but I haven't found it.

While it lacks music, the CMS video may remind musical fans of the Dr. Pangloss description of the workings of the world in Candide, see here at the 18:00 minute mark.  Of course, Pangloss was being portrayed as a happy talk idiot by Voltaire and his later theatrical partners.