Monday, February 27, 2017

Brief Blog: The Villainization of Obamacare

While this blog doesn't normally touch on the broadest health policy issues, I was struck by a series of video clips of politicians denouncing Obamacare as the worst legislation in the history of the U.S., as the biggest crisis facing America, or as the number one disaster on the American continent.*

This doesn't make much sense.

For one thing, Obamacare is not that big.

One layer of Obamacare is the health exchanges.  While about 12M are enrolled in them in 2016, about 5M switched to exchanges from other individual or small group plans.  Exchange enrollment is about 3.8% of the US population (12M/320M).   For some of these people, exchanges offer a better group rate than individual insurance (e.g. the one thing worse than Exchange insurance is individual plans).  Many others have subsidized commercial insurance via the Exchanges, although the high deductibles create problems both for lower middle class enrollees and for providers.

The subsidized participants in Exchanges are funded by a combination of long term Medicare payer and hospital cuts made in 2010, special pharma and med device taxes, and taxes on incomes over $250K.   So the exchanges were paid for, and directly unwinding them, point for point, would meet the social need of lowering taxes on pharma and on people making over $250K.

To the extent Exchanges are now trending worse (an adverse risk death spiral), they can't produce worse results than the individual insurance market, or people would choose the latter rather than Exchange insurance.  And to the extent ACA Exchanges don't work or stop working, Congressman who never wanted them to exist don't have much to complain about.  Neither the declining exchanges (if that happens) for a few million people nor a new replacement plan would be the worst crisis in America.

Another layer of Obamacare is an expansion of Medicaid to not-quite-destitute poor people, which was voluntary at the state level and involves about 6M people - that is, about 1.6% of the US population.   (Data here.)   While this involves inbound federal taxes dollars being redirected outbound back to state Medicaid programs, let's remember the money comes from the states' taxpayers in the first place.    In poorer states, there is a net inflow of tax dollars, while in richer states, there is a net outflow of tax dollars, flowing to the poorer states.   From voting patterns, it seems that the richer states are generally OK with this, while voters in the poorer states want this process stopped right now.  Well, OK.**

I propose that neither (A) having tiny percentages of people in Exchanges funded by pharma and wealthy person taxes nor (B) voluntary expansion of Medicaid which is in part a wash (tax dollars out, tax dollars back) and in part a transfer from richer to poorer states, are the worst things to happen in the history of America.

There are a lot of things to criticize Obamacare for - excessive federal bureaucracy, failure to address larger cost issues, insurance death spirals, or dysfunctional plan design (e.g. $5000 deductibles for people who have $100 in a good month.)   But presenting it as the worst problem the nation has ever faced is inane.  

Healthcare has to solve three problems outside the employer-based system:

  1. Care and support for the severely or profoundly ill such as the quadriplegics and elders with Alzheimers;  
  2. Care for those was just use a wide range of routine care, let's say from vaccinations to insulin.  These are the 80% who use 5-10% of health costs; and finally,
  3. Those with healthcare needs that crash the employment based insurance system because you are too sick to work.  
Handling those three categories, there are enough problems to address without the crazyland rhetoric.

* From Last Week Tonight, which admittedly is liberal-biased but was showing genuine Obamacare ultra-villainy clips.  Here.
** The same argument applies with provincial versus national funding of Canadian healthcare (here). Let's say Manitoba complains it doesn't get enough funding from Ottawa.  It doesn't want to raise taxes in Manitoba.  But the only place Ottawa can get funding from is to raise taxes on Canadians, e.g., in Manitoba.   For US states, somewhere there is a state that is federal tax and federal benefit neutral for Medicaid - let's say State A sends $5B in US taxes to Washington and gets back $5B in Medicaid support.   In theory, you could cancel the federal taxes, displace them with $5B of state taxes, and you'd have exactly the same Medicaid program in that state and exactly the same tax burden.   In a wealthier state, State B, it sends $8B to the feds, and gets $5B back.  Where does the extra $3B in its Medicaid federal tax share go?  Somewhere there is a poorer state, State C, that sends $2B in Medicaid taxes to the feds, and gets $5B back.  

Medicare MAC cancels CAC meetings: Cites Executive Order to Stop Issuing Regulations

On January 24 and January 30, the Executive Branch issued two Executive Orders, one stopping the issuance of new regulations, and one requiring that two regulations be sundowned for each new regulation created.   See coverage and links at Forbes, here.

On Thursday, February 23, the Cahaba MAC issued a notice that it was canceling the CAC (Contractor Advisory Committee) meeting for new LCDs that would have occurred in mid-March.  See Cahaba's notice here.   Cahaba "anticipates" that CAC meetings and LCD production will eventually be resumed, possibly by late June.  Cahaba notes that the change is explicitly based on CMS instructions to halt LCD production until further notice.

Update March 8.  By March 8, at the same website, Cahaba still states that its March CAC meeting is canceled, but has removed the reference to a CMS instruction for having canceled it. Above, a screenshot of the notification - as it appeared originally in February.    Thanks to a reader for the heads-up.

Friday, February 24, 2017


This blog carried an article about expanded carrier screening on February 20 (here).  Unknown to me at that time, this week American College of Obstetrics and Gynecology has issued two new guidance documents on carrier screening, #690 here and #691 here.

ACOG split its discussions into two papers, the first, "Carrier Screening in the Age of Genomic Medicine" (#690) and the second, "Carrier Screening for Genetic Conditions" (#691) which includes sections for Ashkenazi and for panethnic screening.

Medpage covers the new guidance documents here (February 23, 2017).

In my February 20 blog, I noted that the public agenda for a recent AMA CPT meeting included a code proposal for expanded (panethnic) carrier screening.   I also noted that the somewhat dated, decade old available guidance documents were unusual from a health technology assessment or evidence based medicine perspective.  However, that blog is now largely superseded by the new ACOG positions.

For some recent links in the field:

  • Medpage Today (February 23, 2017) ACOG new guidance - here.
  • Huffington Post (February 20, 2017 - not tied to ACOG) - Consumer update - here.
  • Genomeweb (December 5, 2016)- Roche to offer GoodStart Genetics testing - here.
  • Genomeweb (November 2, 2016) - Good Start Genetics and Amazon - here.
  • OBGYN Trade journal (June 16, 2016) - Are you prepared for ECS? - here.
  • JAMA (August, 2016) - Haque et al. study of over 300,000 cases - here.
  • Molec Genet Genom Med (2016) NGS carrier screening cost effectiveness - here.

Tuesday, February 21, 2017

Brief Blog: Tapestry Networks and the Diagnostic Quality Assurance Pilot for CDx

At the 3000-person, 25th annual "Molecular Med TriCon" in San Francisco this week, multiple mentions of the Tapestry Networks "Diagnostic Quality Assurance Pilot."

Here are two entry points.  First, on November 18, 2016, the FDA announced it was dropping for now its plans to regulate LDT diagnostics through guidance.  Second, on February 1, 2017, a consortium of important organizations including the American Cancer Society and the American Society for Clinical Oncology wrote Senate leadership that something must be do to assure LDT laboratory quality (here).

So there's some tension out there - what will happen next?

Along the way, there is the "Quality Assurance Program for Companion Diagnostics," a multi stakeholder effort (leadership ranging from Abbott to Emery) to establish processes "by which all key stakeholders can be satisfactorily assured of molecular test equivalence across laboratories."   Within the multi-purpose Tapestry organization, this is led by a Working Group called, "SPOT/Dx" - "Sustainable Predictive Oncology Therapeutics and Diagnostics."   SPOT/Dx was launched by Tapestry in 2013.

For more information on the QAP-CDx, see these resources:
  • Project homepage at Tapestry Networks, here.
  • 15-page presentation by Barbara Zehnbauer, Emery, at AMP November 2016 (here).
  • 3-page article by Zehnbauer et al. in Journal of Molecular Diagnostics, January 2017 (open access, here.).
  • At the Tapestry website, a 4-page Q&A dated February 2017, here.
More after the break.

Monday, February 20, 2017

AMA Endorses Expanded Carrier Screening Through Online CME Course


This blog was written on February 20, 2017, and was based on AMA CME for expanded carrier screening and the fact that a new code for this service appeared on the AMA CPT agenda recently.  

Much of the further discussion, deeper below, is superseded by new ACOG documents released February 22, 2017.  

I leave the original blog below, but see the newer version, February 24, 2017, here.


Original February 20, 2017 blog:

The American Medical Association has a dedicated website for precision medicine issues and resources, here.    

The AMA precision medicine center includes up-to-date CME modules for Expanded Carrier Screening, prenatal cell-free DNA screening, somatic cancer panel testing, and other topics in clinical genomics.

According to an AMA and Scripps joint press release, the first module released in this CME series was Expanded Carrier Screening (press release here).

The Expanded Carrier Screening CME is here, at AMA, and it is also crosslisted as a CME course on the American College of Obstetrics and Gynecology website, here.

Expanded Carrier Screening In Perspective

This CME is timely, because according to the agenda for the February 2017 AMA CPT meeting, a code for Expanded Carrier Screening was under consideration (also called Panethnic carrier screening).

Usage of this clinical service is estimated to be higher than 200,000 cases per year.   An August 2016 publication in JAMA reported the results of testing in over 300,000 individuals of diverse racial and ethnic backgrounds (Haque et al., here.)

AMA CPT created a code for Ashkenazi Carrier Testing effective January 1, 2016.   However, looking into available guidance documents, the introduction of screening codes for germline genetic panel tests seem to raise unusually complex issues in terms of guideline generation and clinical utility assessment - more after the break.


MolDX's Dr. Gary Spitzer Speaking on Liquid Biopsy Evidence: June 2017, SF

This June, the Second Annual Liquid Biopsy Summit will be held in San Francisco, June 21-23 (website here).    The conference includes 3 short courses, panels, and some 25 presentations.

Dr. Spitzer's Presentation

Dr. Gary Spitzer, the MolDX Director for Clinical Validity and Clinical Utility Evaluation, will be chairing the morning session on Friday, June 23.   In addition, Dr. Spitzer's own presentation will focus on "Clinical Utility Needs of ctDNA Assays versus Research Utility."   Dr. Spitzer's presentation will focus on (a) the optimal use of transparent prospective registries and (b) ways that effective data can be gathered at lower costs.

Dr. Spitzer's Background

Dr. Spitzer has held a series of prominent national roles in oncology, including Deputy Director of the Bone Marrow Transplantion Program at M.D. Anderson, and clinical leadership roles at St. Louis University, Georgetown, and Bon Secours.   He has been a senior clinical consultant to the MolDX program for almost two years, since March 2015.  His LinkedIn webpage is here.

Rapid Advances in Liquid Biopsy

A lot has occurred between the First and Second Annual Liquid Biopsy Summits, with numerous policy advances in the field of Liquid Biopsy.  For example:

  • The FDA approved the Roche Cobas EGFR liquid biopsy test for several mutation sites (see JAMA, here).  
  • The FDA also held a joint all-day conference in Washington with AACR on liquid biopsy last July (here).   
  • NCCN guidelines recommend "If repeat biopsy [in lung cancer] is not feasible, plasma biopsy should be considered."  
  • ASCO's Year-in-Review for CY2016 featured two pages on the emerging clinical importance of advances in liquid biopsy (here).  
  • In the 21st Century Cures Act, Congress allocated $2B for new innovative cancer research, a substantial portion of which will go to public-private efforts in liquid biopsy.  
  • The dedicated liquid biopsy startup Grail announces plans to raise $1B while bringing on board the FDA's leader for precision medicine, Dr. Liz Mansfield.  

The MolDX program has provided technical standards for the approval of liquid biopsy tests for coverage, here.

Brief Blog: Links to Rough Transcripts of Both Price Confirmation Hearings

CSPAN provides onlive video archives of both of Secretary Tom Price's hearings for head of Health & Human Services - January 18 at the HELP committee and January 24 at the SFC, here and here, respectively.

CPAN also provides raw block capital closed captioning text.

I have simply collated the raw real time closed captioning text into one long Word document - page 1-52 for the HELP hearing and 53-157 for the SFC hearing.

It's not pretty but can be read/skimmed better than the 7 hours of video.

  • In the cloud, here.   

Friday, February 17, 2017

Brief Blog: Unique Annotated Transcript of Seema Verma Senate Hearing Here

On February 16, 2017, President Trump's candidate for administrator of CMS was in a 2 1/2 hour hearing at the Senate Finance Committee.

Get an unofficial 59 page cloud transcript of the full hearing Q&A - here.

For additional links and citations to news articles, see our earlier blog, here.

Brief Blog: CMS Candidate Seema Verma Testifies at Senate Finance Committee

On February 16, 2017, CMS leadership candidate Seema Verma testified in a nearly three-hour session of the Senate Finance Committee.
  • C-Span archives the entire video here. [*]
  • For a cloud 59-page unoffical transcript of the hearing, annotated and provided by this blog, here.    

  • The Administration's "Transition 2017" Youtube channel has a few brief sound bites online, here.

  • Early coverage at Modern Healthcare, here; at Reuters, here.
  • Opening Statements (Senate Webpage here.)
    • Senate Hatch: here.   Senator Wyden: here.  Verma: here.
    • All together in one PDF (13pp): here.
  • Later coverage at Fox Opinion (here), Becker's (here), CNN (here), and Atlantic (here).

My original November 2016 collation of articles on Verma, including some updates, is here.

More after the break.

Brief Blog: Narrow Networks in Laboratory Medicine

For several years, Dark Report and other trade journals have discussed the rising role of narrow-network payers and the impact on the lab industry, which often has little control over which payers support the patients whose samples arrive at the lab.

Dark Daily, the open access blog associated with Dark Report, runs an article on narrow networks today, with citations to a study by McKinsey and company.

  • Dark Daily Blog here.
  • McKinsey webpage here and PDF version of the data here.

For a 2014 article at Dark Daily on the same topic, here.  For a 2015 open access article at Health Affairs, not specific to the lab industry, here.

Thanks to Katherine Tynan for highlighting.  This weekend, February 19, several colleagues and I will have the opportunity to teach a short course chaired by Tynan on lab regulatory and reimbursement trends at the Molecular Med TriCon conference in San Francisco. 

Tuesday, February 14, 2017

Brief Blog; CMS Candidate Seema Verma; Senate Confirmation Hearings Will Be Feb. 16

President Trump's candidate for head of CMS, Seema Verma, is scheduled to interview with the Senate Finance Committee on Thursday, February 16.  Story at National Law Review (open access, here).

Verma is nationally known for her consultancy that helps states develop, implement, and manage Medicaid reforms (here).

Brief Blog: Evidence Street and MolDX

In a publicly available deck from December 2016, Dr. Louis Jacques, Chief Clinical Officer at the consultancy ADVI, predicted that in 2017 the BCBS Evidence Street program and the CMS MolDX program would "develop a common portal for lab test dossier submission and review."  (Here, p. 4.)

In a deep-dive subscription article at Genomeweb, journalist Turna Ray updates on the Evidence Street program through interviews with BCBS, Dr. Jacques, and other stakeholders.   For the subscription article, here.

BCBSA Evidence Street displaced the prior BCBSA TEC website, which had been largely open access, with a subscription model.   The Evidence Street website is here.  Favorable reviews are available to companies and can be brought to the public's attention through press releases (e.g., here and here.)   BCBSA itself is careful to position the reviews as evidence reviews, not endorsement of the test relative to any particular higher or lower bar for a coverage decision.

Tuesday, February 7, 2017

Brief Blog: 21st Century Cures and the CMTP Focus on Real-World Evidence

Real world evidence has been extensively discussed in recent years, two Washington highpoints being a June 2016 white paper on RWE by the Bipartisan Policy Center (here) and 21st Century Cures, Section 3022, encouraging the FDA to look deeper into RWE in approval decisions (here, here).

(The FDA weighed in on its view of RWE in the New England Journal, December 8, 2016, here.)

The Green Park Collaborative, organized by the Baltimore-based Center for Medical Technology Policy (CMTP), has set up a resource webpage with multiple detailed documents to help parties assess and validate the quality of Real World Evidence.

Website here.  39-page white paper on the RWE Decoder project, here.

For a video on the evidence framework goals of CMTP, see an interview with its leader Dr. Sean Tunis, here.

For a February 21, 2017 editorial in JAMA on observational evidence, see here.  For a July 2016 FDA guidance on RWE, here.

The FDA"s Regulation for Expanded Carrier Screening

Last summer, there was a publication in JAMA by Haque et al., the largest study ever undertaken of recessive carrier genes distributed over a population of over 300,000 individuals (here).

After a well-known intervention at 23andMe, the FDA released self-implementing regulations for autosomal recessive test systems.  The regulations are unusual and innovative, dependent in large part on the laboratory's webposting of accuracy and validity data.

Most FDA product category regulations (21 CFR 800ff.) are only a few words long, at most a couple sentences.  For example, Agendia Mammaprint and Nanostring Prosigna breast cancer prognostic tests are cleared under 866.6040:
A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.
In contrast to that type of product classification, the regulation for expanded carrier screening is 3000 words long and runs six pages when clipped into a single-spaced word document.

The regulation (866.5940) is copied below, after the break.   The original Federal Register publication (80 FR 65626ff, October 27, 2015) is here.

The regulation requires hyperlinked reference to credible sources of validity information "such as GeneReviews" that is not otherwise reviewed by FDA before presentation to physician and patient.  This is similar to new guidance on biopharma communications with payers on economic evidence, which must be based on "competent and reliable scientific evidence" (CARSE) not otherwise reviewed by FDA (here).

Brief Blog: PMC Publishes Two Open Access Papers on Access to Personalized Medicine

The Personalized Medicine Coalition has published an open-access white paper and an open access journal article on the integration of precision medicine in healthcare.

The five-page white paper is online at PMC, here.  See the contributors list for a who's-who of thought leaders.

The 12-page academic article, by Pritchard et al, is online at the journal Personalized Medicine (14:141-152), here.

  • In addition Pritchard et al:
    • See similarly, a six-page new article in Journal of Precision Medicine by Subha Madhavan, "Barriers to Implementation of Precision Medicine in the US Health System," here.
    • See similarly, a ten-page review in Genome Medicine on barriers to precision cancer medicine, by Bertier et al, here.

    • In October 2016, JAMA op ed by Dzau et al. on barriers to the full potential of personalized medicine in healthcare, here.
    • On a different note, in April 2017, in NEJM Parikh et al. argued that "precision healthcare" should go far beyond "genes" and integrate diverse customization efforts, here

Abstract of Pritchard et al., after the break.

Monday, February 6, 2017

Survey Finds 72% Favor Gottlieb for FDA Chief

Biopharma companies do not pick the next head of FDA - the President nominates and Congress confirms.

That said, columnist John Carroll reports a survey in which 72% of biopharma executives favored Dr. Scott Gottlieb as head of FDA.   Other candidates discussed in recent media tracked far behind - Jim O'Neill at 8%, Joseph Gulfo at 9%, and Balivas Srinivasan at 2%.

See Carroll's article, here.

Sunday, February 5, 2017

Digital Genomics: DarwinHealth as an Oncology Case Study

In early 2016, I gave a talk for the first time on Digital Genomics, creating a short white paper as a leave-behind for attendees (here; see also here).  This coming summer, I have the opportunity to chair a panel on Digital Genomics at the 1000-person NextGenerationDX conference in Washington August 15-18 (here).

The new issue of Nature Reviews Cancer contains a fascinating deep-dive article on the concept lof clinical digital genomics by authors at Columbia University and DarwinHealth, a New York-based genomics startup.

More after the break.

Thursday, February 2, 2017

Brief Blog: CMS Launches Clinical Lab Center Webpage

CMS announced the launch of a Clinical Labs Center webpage.

The webpage has modular organization and provides separate zones for key links for billing, coding, manualized lab policies.   The page includes link to common CMS websites like HCPCS and Transmittals.  

Quirkily, but helpfully, they provide several links to 2001 documents for "Negotiated Rulemaking for Labs."  This was intended to provide uniform national claims requirements so labs could submit claims similarly in all 50 states.  Ironically, 15 years later,  25 states follow special MolDx rules like Z codes (without which, claims are rejected as unprocessable) and 25 states don't.  

CMS has also done some webmastering of its CLFS Meetings page, which tended to have a jumbled collection of erratically named links at the bottom. Now there are clear links for things like this year Proposed and Final pricing recommendations, and handy ZIP files with back-years of annual pricing policies (2012-2016).   2015, 2016 gapfill determinations are listed here (Excel by MAC).

  • The new Clinical Lab Center Webpage here.
  • The improved CLFS Meetings page, here.

Brief Blog: The Short and Obscure Life of the CMS Date-of-Service Demo

In 2007, Medicare introduced a date of service rule for laboratory tests that locked the date of service to the date of specimen collection.  If the date fell within a hospital inpatient stay, the service was unbillable separately due to DRG bundling, even if performed after the patient left hospital (because the "date of service" remained back during the hospital stay.)   Outpatient lab tests shipped to reference, or sole-source labs, could only be billed by the hospital, since the patient was "at the hospital" on the day of service when the tissue was taken or the blood was drawn.

The Affordable Care Act included Section 3113, a demonstration program for up to two years and up to $100M of lab tests, under which reference labs could direct-bill CMS for advanced lab tests.  Because the project blocked tests using "unlisted codes," tests like Oncotype DX could not use the demo, since they did not yet have CPT codes.   CPT assigned the eligible CPT codes primarily as the historic molecular "stack codes," which were deleted by CMS and CPT in mid-demo.

Nonetheless, consistent with Congressional intent, CMS released a report on the demo project.  The report has a cover date of 2015 and a PDF edit date of January 6, 2016.  The report concludes that due to "extremely low utilization" no conclusions on impacts of the demo project could be made.

CMS noted that during the period, 1,476,590 beneficiaries were billed with molecular stack codes, and 458 beneficiaries were billed with molecular stack codes under the Demonstration Project.  CMS states that patients for whom claims were submitted under the demonstration program died at a "much higher" rate than non-demonstration patients.

Only 173 of the 458 beneficiaries with "tests billed" had "tests paid."  Total payments under the $100M demo were $35,000 for independent laboratory claims and $5,500 for hospital outpatient claims.

The report is online here.

Wednesday, February 1, 2017

Brief Blog: AJMC Publishes Special Issue on Diabetes Prevention

Diabetes prevention has been rising in public policy circles, with landmarks like Medicare's creation of a new Diabetes Prevention Program benefit through its Center for Medicare Innovation (here).   The program will include virtual prevention programs (e.g. see Omada) as well as brick-and-mortar one.  In the digital space, other alliances are forming, such as between hardware manufacturers of blood glucose monitors (like Ascensia and Roche) and app/cloud/physician platforms like Glooko (here).   Glooko is deliberately designed to work across many devices, so it can be used by ACOs or clinicians with large numbers of Type 1 and Type 2 patients on diverse meter hardware.

Despite multiple studies with up to ten year outcomes (here), some questions are still raised about the real-world long term impact of diabetes prevention programs, as flagged in a BMJ review article in January 2017 (here).  

In December 2016, American Journal of Managed Care has published a full special issue on diabetes prevention & management, including in the ACO setting (to reach it, click through this article to the PDF button at the end: here).  AJMC also has a special website for diabetes-related articles and news, here.


Also in December, AJMC covered whether the competitive bidding program for diabetes supplies has impaired health access for Medicare beneficiaries; here.

The 21st Century Cures legislation has an "Easter egg" benefit for Medicare diabetes patients on insulin pumps at Section 5004.  It changed reimbursement for pump-based drugs in technical ways which, on average, will save CMS money on drug costs, but will raise Medicare payments for insulin closer to market rates today.  Multiple sources had reported that due to arcane accounting mechanisms, static Medicare rates for pump-based insulin had become so low that access for beneficiaries was notably impaired.

Brief Blog: ICER Releases Value Framework Update For Public Comment

Boston's ICER, the Institute for Clinical and Economic Review, released an updated "value framework" on February 1, 2017, with comment open until April 3.  ICER promises to post finalized updates to its value framework by April 15.   (It gives itself 12 days or less to review and revise based on public comments.)

  • ICER press release here.
  • Project home page, here.
  • 24-page update PDF, here.
  • Coverage at Modern Healthcare, here.

For mostly favorable 2016 articles at STAT, here (April) and here (August).  2016 interview with ICER's head, Steven Pearson, at AJMC, here.  2016 blog at Health Affairs by Pearson, here.  A few weeks ago, Pearson published in JAMA Internal Medicine that national guideline committees for hepatitis and cholesterol management did not fully meet IOM conflict of interest criteria (here).

Assuming that favorable aspects of the work speak for themselves, some contrary viewpoints are:
  • A disgruntled blogger, here.
  • Critical article in Huffington Post, here.  
Some additional notes after the break.

Brief Blog: ACS and Others Ask Hill for LDT Oversight

In November, post-election, the FDA announced it was tabling the release of final guidance documents on LDT regulation (here, here).   Two months later, in mid January, the FDA released a white paper on its latest thinking as a result of two years of back-and-forth on LDT regulation (here, here, here, here).

On January 24, 20-17, 30-plus organizations, including the American Cancer Society, urged that "updating the LDT framework" be a priority of this Congress.   The two-page PDF is online here.

These stakeholders write,
There is no systemic way to be sure of the accuracy and reliability of these tests. Several cases illustrate the challenges with this lack of oversight. Researchers sent samples from the same cancer patients to different LDT providers for cancer testing, and found only 25 percent of the drug recommendations based on test results overlapped.
...The current system of LDT oversight is inadequate and needs updating.
The letter is addressed directly to the Senate Majority Leader and the Senate Minority Leader, rather than to committees in the House or in the Senate.  Coverage at Genomeweb, here.

On February 1, 2017, the trade journal CQ Healthbeat ran an article that LDT regulation is again on the Hill agendas for this year, given the support both of the clinical groups cited above and the joint support for some level of regulation revision at both Advamed and ACLA.

Brief Blog: A Trending Buzzword in Healthcare: Systemness

For its January 30 issue, the back page of the hospital trade journal Modern Healthcare has a full page advertisement for a "Systemness" website.   Turns out, the term has a few years of history in US healthcare and may be a trending buzzword now.

For example, Modern Healthcare ran an opinion piece introducing "systemness" to its readers in 2011.  In a 2013 publication, the ECRI Institute has a cover story on "Systemness," here.  Becker's Hospital Review ran a story in 2014, here.  

A new Modern Healthcare special website is here, sponsored by Dignity Health, with an 11 page PDF white paper here.

Footnote:  In the same vein.   For an interesting new blog on using big data for better healthcare, rather than administrative pains, pointless metrics, and gaming, see Tom Burton of HealthCatalyst, here.