Very Brief Blog: Patient Centered....Lab Utilization Services!

A few years ago, everything was -omic: genomics, proteomics, metabolomics, microbiomics...  More recently, one of the flypaper catchphrases has been "patient centered:"  ...patient centered EHRs, patient-centered outcomes, patient-centered trial design. 

A new one to me is Patient Centered Laboratory Utilization Guidance Services, or PLUGS.   See a website based at Seattle Children's Hospital, here, and this consortium of 70+ entities is holding a conference in Seattle this week, PLUGS Summit 2018, here.   See full agenda here.

For another entry point into the quickly changing economics and management tactics of labs, see nearly any issue of Dark Report and see a recent textbook from MGH, Dr Kent Lewandroski's Utilization Management in the Clinical Laboratory, 300pp, 2017, Springer.

I've clipped a few speech titles below.  MolDx's Dr Girish Putcha is also a speaker.

Very Brief Blog: New Consensus Paper on Liquid Biopsy in Lung Cancer

There is a steady drumbeat of activity in liquid biopsy, especially lung cancer, where both Foundation Medicine and Guardant have NGS panel tests under FDA review.

With an Accepted date of May 26, 2018, Journal of Thoracic Oncology has published a open access position paper by IASLC on the use of liquid biopsy in lung cancer (Rolfo et al.).   See the paper here.

The paper states in part:

A multidisciplinary panel of experts in the field of thoracic oncology with interest and expertise in liquid biopsy and molecular pathology, was convened by the International Association for the Study of Lung Cancer (IASLC) to evaluate current available evidence with the aim of producing a set of recommendations for the use of liquid biopsy for molecular analysis in in guiding the clinical management of advanced NSCLC patients as well as identifying unmet needs....

Currently, there are two important scenarios in which the liquid biopsy might confer an
advantage to patients with advanced NSCLC: initial molecular diagnosis and progression during targeted therapy. However, a treatment strategy that takes into account the patient’s clinical status, clinical relevance of test results, and local feasibility of the different testing methods has to be considered when planning diagnostic procedures in order to avoid potential delays in identifying therapeutically actionable resistance mechanisms. 

CMS Coverage
My reading of the current CMS NCD on genomics in lung cancer is that new NGS based LBX CDx tests will be covered per FDA indications on a rolling basis under the existing text.   PCR based tests would fall outside the NCD but could be covered by LCDs on a rolling basis.

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The same issue has a paper on racial disparities in lung cancer survival Jones et al here and a paper on PDL1 immunohistochemistry concordance here (Tsao et al, Blueprint project). 

Very Brief Blog: CMS Posts Preliminary Gapfill Prices for 2018

On June 11, 2018, CMS posted gapfill preliminary prices for the 2018 year long gapfill process.

See the CMS webpage here and look for "Test Codes and Payment Determinations" and then 2018 CLFS Gapfill Preliminary Determinations (zip file containing XLS).   Direct zip file link should be: here (unless they update it again).

• The AGENDA the CMS CLFS June 25 new codes has also been posted, with 32 agenda items (speakers); here.  Note that while I am listed the agenda here, the New Codes Meeting agenda is basically unrelated to the gap fill proposals.

Note that the first version of the gapfill pricing spreadsheet had errors; see a version dated June 13 or later.

Gapfill prices for 17 codes range from $24 to $2030, but almost all are below $1000.

CMS accepts public comment for 60 days (to August 7), submit comments to Glenn McGuirk at CMS; his email is on the CMS webpage.   CMS then transmits these public comments to its MACs, who return revised prices to CMS in August, which are posted by CMS in early September.   There is a rather vaguely defined internal appeal process for 30 days (no public meetings are held); CMS posts final prices by mid November which sometimes vary from the September prices due to this final appeal process.

Longest Journey.  The code with probably the longest journey is 81327 SEPT9, which was in the new code crosswalk process in CY2016, the appeal process in CY2017, and is now in the gapfill process throughout CY2018. 

Most Illogical.  The most illogical pricing is probably Genome or Comparator Genome at $349, which must be substantially below real world costs.   For those who can dodge the various firewalls, see a very favorable current article in Washington Post on genome testing for acutely ill children, here.  CMS prices Exome at $4900.

A couple comments from me:

• No Rationale.  CMS stated in PAMA rulemaking that it would begin providing MACs' "rationales" for prices.  No sign of that publication yet.
• Median of MACs?  PAMA regulations state that CMS shall calculate medians of "MACs," but rather than listing the circa ten modern MACs, it lists the historical 57 CLFS pricing zones from the 1970s.   
• MolDx Bloc.  All the MOLDX MACs price together for all codes (Noridian, WPS, CGS, Palmetto and Palmetto/Former Cahaba), except for one code that might be a typo.  
• This MolDx "Bloc" of states or MACs is large enough to drive the median.
• All Prices Match MolDX Price.  All median prices matched the MolDx bloc price.

Nerd View

I checked for cases where there was a proposal from any MAC that is lower than the Median.  This occurs for 81327 (where most bids are around $150 or $190), and for 81471, 81470, 0001U, where at least one MAC offered 20-50% less than others.  See the "min" and "max" columns in the table below.  Gapfill proposals:

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Agenda for New Code June 25 New Codes Meeting (this is entirely different than the gapfill table above):

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##
Appendix.

Social Security Act 1834A(c)(2-4) requires CMS to post rationale for any gapfill or crosswalk price. See also 81 FR 41086, 6/23/2016.

(2) Gapfilling process described.— The gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available:

(A) Charges for the test and routine discounts to charges.  (B) Resources required to perform the test.  (C) Payment amounts determined by other payors.   (D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.   (E) Other criteria the Secretary determines appropriate.

(3) Additional consideration.— In determining the payment amount under crosswalking or gapfilling processes under this subsection, the Secretary shall consider recommendations from the [advisory] panel established under subsection (f)(1).

(4) Explanation of payment rates.—In the case of a clinical diagnostic laboratory test for which payment is made under this subsection, the Secretary shall make available to the public an explanation of the payment rate for the test, including an explanation of how the criteria described in paragraph (2) and paragraph (3) are applied.

Very Brief Blog: HHS Wants Help Setting Up an Effective Public-Private Partnership Channel

On Thursday, June 7, 2018, HHS published a Request for Information to help it set up a new board to discuss and propose ways to improve Public-Private Partnerships within HHS.

It's called, "Facilitation of Public Private Dialogue to Increase Innovation and Investment in the Healthcare Sector."  Comments are due in 30 days (about July 5).

The goal is "constructive, high level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry."   However, the policymakers don't presume to know exactly what a workgroup should look like or exactly what its agenda should be.  They want your advice.  Should the workgroup start by assessing recent trends in health innovation and investment?  Should it encourage private investment?  How should its membership and meetings be structured?   How can HHS develop a "durable and consistent approach" to public private partnerships and innovation to improve public health?

Find the document and comment homepage here.

See some trade press here and here.

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I wrote about something on-tangent a few days ago.  For example, Federal preventive benefit regulations make it far easier to create a new Medicare screening benefit for colon cancer than for lung cancer, ovarian cancer, liver cancer, etc.   Does that really make sense?  It stimulates investment in one cancer and prejudices against investment in other cancers.  My blog here.

Appearing just a few days after the HHS request for advice, FDA's Scott Gottlieb issued a major policy memorandum about the need for innovative commercialization pathways for antibiotics.   See his speech here, and press coverage here.  He focused on "new reimbursement" for antibiotics, such as hospital based licencing, a topic pretty far afield from his home base at the FDA. 

Very Brief Blog: New Legal Actions re Constitutionality of Affordable Care Act

• Takeaway:   New legal issues for ACA focus on "pre existing conditions."   However, among the legal documents, other issues like "preventive benefits" are also drawn into the fray.  

Background

Much press since Thursday June 7, when HHS filed a brief that key parts of the Affordable Care Act were now unconstitutional, since Congress repealed a penalty aka "tax" for not having insurance.  The brief was part of a case running for months at the behest of numerous states.

Most of the attention has focused on whether or not the Administration should defend the law against threats, or whether it is OK for the Administration to side with those who argue the law isn't constitutional.   Beyond the individual mandate, it's worth looking at what different sides of the case argue regarding other parts of the ACA such as mandating copay free services that are endorsed by the USPSTF.

I'm a non-attorney so I provide only a simple review of my understanding of key facts.  For an entry point, see U Michigan attorney Nicholas Bagley's blog here. 

Phase One

There was a Supreme Court challenge that the ACA was unconstitutional since it "mandated individuals to buy insurance."   Argued, there was no constitutional authority for Congress to do that.  (Although Congress may regulate interstate commerce, raise an Army, and so forth.)   The Supreme Court actually tries to affirm that laws are constitutional if it can find a way to do so, and Court found that the penalty for not having insurance was, in essence, a tax, and Congress can tax.   Here.

Phase Two

Congress 2017 repeals the ACA tax on individuals who don't have insurance.

Phase Three

A number of states filed suit that without the tax, the Supreme Court judgement is no longer effective, as it was based on "the tax."   See State case here, 33pp.   States argue that without the individual tax, the individual mandate isn't legally justified and without that, US had already argued that other parts of the law like guaranteed issue despite preexisting conditions, don't make sense.   (It's like the scene in the movie where the good guy drops his pistol and the bad guy picks it up.)

Arguing both with US government prior statements, and with reference to a prior "severability" case (Alaska v Brock 1987), States argue that all of the ACA doesn't make sense without the individual tax, which no longer exists.

Note, as below and on several other pages, States argue that guaranteed issue must now be stripped from the law, AND OTHER regulations on insurance such as essential health benefits and the requirement to cover preventive services.  See:

Phase Four

June 7 sees the "Federal Defendants' Memorandum Response" to the above States' application for preliminary injunction against the ACA.  Here.   (See also a 3-page letter from Jeff Sessions to Paul Ryan, here.)

A) Preliminary Injunction not needed. Feds argue that a preliminary injunction against the ACA is not required, but they agree in part with the States' case and would see it affirmed in the court's decision memo.

B) Feds: Concur with States; kill pre existing condition law.  Feds argue that the guaranteed issue aspect of the ACA (no pre existing conditions) is inseparable from the tax, and guaranteed issue should be struck down now, absent the tax.

C) Feds:  Preserve rest of law.  However, Feds do NOT argue (as did States) that "all" of the ACA is unconstitutional.   One section of the Fed document states "guaranteed issue and community rating requirements are NOT severable" and another section states, "ACA's other provisions ARE severable."   Feds also argue that Congress specifically repealed the individual mandate tax (and a range of other tweaks), but if Congress wanted to do so, it could have repealed more of the ACA itself.[*]   For example, "There is no reason the ACA's expansion of Medicaid should hinge on the individual mandate."  At best, the States offer a chain of "speculative hypotheticals" in a difficult attempt to connect various parts of the ACA to the individual mandate.

Summary

We are in a rare epoch where the head of HHS, Alex Azar, is not only an attorney, but a really smart attorney, so the Fed position would carry his endorsement.

If the Court sided with the Federal brief, it would strike down the guaranteed issue (re pre existing conditions) but it would leave other aspects of ACA intact (such as Medicaid expansion and preventive services.)


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* Of course, following the HHS's own line of thought here, Congressional elves could at one blow have repealed both the tax and the preexisting condition rule, if that was the Hill's intention, rather than repealing the tax while leaving the dependent pre-existing rule for a contentious multi year court case.

Very Brief Blog: CareDx Breaks Market Cap Ceiling of $500M

One of the most heartening stories in specialized diagnostics companies recently is CareDx.  The company markets the AlloMap test for cardiac transplant rejection (where a blood test can sometimes replace a cardiac biopsy) and more recently the AlloSure test (screening for kidney transplant rejection by finding free circulating donor organ DNA in blood).   Both are covered by the Medicare program, specifically, the Noridian/MolDx program.   See an AlloSure publication, Bloom et al, 2017, here.

A year ago, on June 5, 2017, share price was $1.07.  Today, June 8, 2018, it's $15.11, up fifteen times.   This gives a market cap of $523M today, as opposed to about $16M last summer.

2015 revenue was $28M; by 2017 revenue rose to $48M.   Quarterly revenue was up 17% from 2017Q2 to 2018Q1.

2017 net income was -$55M.
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Other companies are also looking at the cfDNA & renal transplant space; see a UCSF/Natera collaboration announced in 2016 here.

Very Brief Blog: Tucson's ACCELERATE DIAGNOSTICS Hits Market Cap of $1B

This morning, I noticed that Accelerate Diagnostics has a lead position on June 13, 2018 at a Harvard conference on antibiotic resistance (here).   They also had a cover article in CAP TODAY for May 2018, describing them as part of a "seismic shift" in microbiology.

CAP TODAY
According to CAP Today, the platform and molecular kits "handily outstrip traditional identification and antibiotic susceptibility testing" for bloodstream infections.  See Anne Paxton's article here.

PubMed
Besides CAP Today, there have been a flurry of recent articles about Accelerate Pheno on PubMed (Charnot here, Marschal here, Pantel here, Elliott here, Lutgring here). 

Financials
Accelerate Diagnostics (symbol AXDX) is based in Tucson.  According to Yahoo Finance, today's market cap is $1.1 billion.  Share price, $21 today, has been in the $18-26 range for several years.   2017 revenue was $4M with a $64M operating loss.  See a recent quarterly transcript at Seeking Alpha, here.  One financial blogger discusses the company here.  Company website here.

FDA
See an FDA press release from February 2017 here, which is a good entry point for understanding the test design and positioning.   For more technical detail, see the FDA De Novo 510(k) decision summary here, reclassification order here, DEN160032.  The FDA reviewed a primary clinical study of 1850 positive blood cultures, using slower traditional methods as a gold standard.

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Bay Area molecular diagnostics company Karius is working on rapid detection of 1250 pathogens as an NGS based reference lab test; here.  It raised $50M ten months ago in August 2017, here.   Bay Area startup mFluiDx is working on rapid POCT molecular diagnostics; here.

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In a talk at ASM June 2018, quoted in Genomeweb, Biomerieux's Alex Van Belkum noted that current approaches to AST are accepted and cheap, and that sequencing based AST has "a long way to go."  Here.

Very Brief Blog; Harvard Genomics Conferences (June, November, November)

The Petrie Flom Center for Health Law Policy, Biotechnology, and Bioethics is part of Harvard Law School and runs an interesting website, publications, and conferences - here.  See their book on big data and health law, here; at Amazon here.

This week they flagged several other conferences at Harvard:

June 2018
On June 26, 2018, the Harvard Medical School Department of Biomedical Informatics hosts a conference in "Precision Medicine 2018: Assembling the Puzzle."   See website here.

November 2018
On November 1-2, 2018, the Program in Quantitative Genomics hosts a conference on Biobanks. * See website here.

November 2018
In November, we'll also be up to the 14th Annual "Personalized Medicine Conference" hosted by the Personalized Medicine Coalition (PMC) and held at HMS.  November 13-15, 2018; Website here.

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Harvard also hosts a conference on Antibiotic Resistance, June 13, 2018, here.

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*Regarding big biobanking, the All of Us program to sequence 1M genomes established its biobank at Mayo; e.g. NIH website here,  5 year funding is $130M; 35M biospecimens will be handled; articles here and here and here.

Very Brief Blog: Rogers (2018) On Hidden Costs of Shipping Hospital Tests Out

People have been talking about drivers of lab testing costs, including hospital lab tests, for decades (see 1984 here and 1993 here and 2001 here.)    Lately, there's been much attention to "higher costs of hospital based testing," for example, arguments that PAMA pricing would be higher if hospital labs reported their payer prices (here).  Dark Report has recently been reporting that labs buy small hospitals just to access their higher price payer contracts (!), and that large reference labs are again working to tighten their relationships with specific payers, and thus, with select populations of patients within a hospital's system.

Into this whirlpool lands an article by Rogers et al. at Children's Healthcare of Atlanta.  (The context above is by me, not the authors).   See Archives of Pathology and Laboratory Medicine, here.  In the abstract, they write that: 

Disruption of outpatient laboratory services by routing the samples to commercial reference laboratories may seem like a cost-saving measure by the payers, but results in hidden costs in quality and resources to support this paradigm...Outpatient testing was sent to 3 different laboratories, specified by the payer.

My internist is affiliated with a famous health system, and I've had lab reports in different years come back with circa $150 test charges (from the health system outreach lab) or circa $50 charges (from a reference lab), so I can see the payers' point of view. 

Here's the new contribution.   Rogers et al. document that turn around times (TAT) to result rise from 1.3 hrs at the hospital lab to 39 hours at the reference lab, and that thousands of delays per annum occurred (such as miswritten date of birth).   They assert there are many hidden costs to forced routing of outpatient lab tests away from the health system lab.

Article was covered by Genomeweb's 360DX website, here.

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The article contains some interesting information on salary costs for different levels of staff, including computer staff (epub p 2), and interest distribution-of-costs of different phases of lab testing (e.g. their p5 color bar chart, epub p 5).
 

Very Brief Blog: Survey of Physician Salaries by Specialty for 40-year-olds

Medscape publishes a survey of salaries of physicians who have finished training but are under 40, as below.   Link here.    Pathologists, family medicine, and pediatrics are clustered among the bottom five or six.   The two highest categories are plastic surgery and orthopedics, followed by a cluster that includes gastroenterology, anesthesiology, and otolaryngology.  Psychiatry, which to my memory used to be in the lower 1/4, is in the middle in this survey.

click to enlarge

Very Brief Blog: FDA Finalizes Exemption for 510(k) for Some Genetic Tests

FDA has two different processes for downclassifying its regulatory system for diagnostics.  One is to downclassify a product from Class III (PMA) to Class II (510(k).   The next is to downclassify a Class II test so that it is "510k exempt."

Last November, FDA announced it planned to make some genetic tests self-certifying, that is, 510(k) exempt.   The proposed rule appeared November 7, 2017 (here).  The final rule appeared June 5, 2018 (here). 

An Exemption "After" First Review
The exemption applies somewhat confusingly to future 510(k)s after a specific test device has received a one time review by FDA.  Yes, a naive reader might think it's more of a "510k revision exemption" than a "510k exemption."

Mystery Commenter Opposed FDA's Rule
The FDA discussed in the new June 2018 rulemaking that it received "one comment" on its proposal - an objection - although the corresponding Regulations.gov webpage lists "0 public comments" (here).     The comment, dealt with in Q&A format as is usual, was from "a professional organization opposing [the] exemption."   It would be interesting to know which organization this was or why it's comment isn't available at regulations.gov.

Exemption from 510(k) Followed Downclassification from Class III to Class II
The June 2018 finalization was largely a "coda" to events last November, such as the downclassification from Class III to Class II of the 23andMe personal genome service test (aka Genetic Health Risk Assessment System, per new FDA category 866.5950). 

The Class III to Class II de novo 23 page review is here and an FDA press release here.  Note that these are for DTC tests.

Lengthy Analytical Validity Requirements in Regulation
FDA argues that full analytical validation is established by following stated regulations (see 21 CFR 866.5950(b)(3)(iii)).   FDA allows the self-certification with four limitations.  The health-risk tests cannot be any of these:  (1) indicated for prenatal testing, (2) predisposition to cancer where the may lead to confirmatory treatments or procedures, (3) genetic variants that impact drug metabolism, (4) assessment of autosomal dominant variants.

The device regulation category 866.5950 is 4700 words long; most FDA classification categories are only several words long.

Neither Cleared nor Approved?
Some CMS rules refer to "cleared or approved" tests, such as the spring 2018 NCD on genomic tests in cancer.   Tests that are self-certified under novel types of FDA regulations or potentially under novel lawmaking might not be pigeon-holed as either "cleared or approved" but rather in a different gray space as "authorized."

Trade Press Links

For more information see:

• June 2018: RAPS, MobiHealth, Becker's, 
• March 2018:  WSJ.    
• November 2017:  STAT, Duke.
• The DUKE article gives a detailed listing of the initially authorized genes and a bullet point description of the extensive controls.

Brief Blog: VA Endorses Wider Use of Pharmacogenomics

This spring, I had the chance to write a white paper for Thermo Fisher Scientific on adoption of pharmacogenomics in health system (online here).

On June 1, 2018, VA authors issue a report in Genetics in Medicine strongly advocating wider use of pharmacogenetics in their health system.  A nice online article in Genomeweb here.   See the original article by Vassy et al. here.   4 gene drug pairs were strongly recommended and and additional 12 were recommended, totaling 16.   

I believe if you are able to click on the article link from the Genomeweb news article, it will take you to a website that gives you access to read the whole original article online (but not download it.)

On June 27, 2018, I'm chairing a session on genomics and health disparities at the National Academy of Sciences, and we will have Larry Meyer, National Director, Genomic Medicine, V.A., on the panel  

Medicare Trivia Tidbits: Specimen Validity Testing, MACs and RACs, and Digestive Enzymes

Medicare issues hundreds of transmittals a year to its contractors (see 2018 here).  There have been about 13,000 from 2008 to 2018.   They cover topics both things that are major and minutiae.

What's interesting is there is often a story behind them.

Absolutely-Never-Ever-Never Bill Specimen Validity Testing
Document SE18001, issued March 29, 2018, informs drug testing labs that they absolutely, definitely, for sure, must not report specimen validity testing separately (e.g. pH or specific gravity testing).  The codes already say this ("sample validitation not reported separately") but someone at CMS wanted to be extra sure the message was clear.

MACs to the left of you, RACs to the right
In the past, as RACs (recovery audit contractors) developed audit programs, they were supposed to confer with regional MACs.  Document CR10349, issued in January 2018, says the MACs don't have to do that any more.   MAC stays on its side of the street, RAC on theirs.

Saga: Getting a HCPCS Code in Emergency Session
There must be a saga behind this one.  At the May 2017 HCPCS application public meetings, one of the most interesting was from a company that provided a special digestive enzyme cartridge which helps patients on enteral nutrition digest certain fats.   Like most code applications, in November 2017, CMS turned down that one as not necessary.  See the turn-down here (HCPCS 2017, #17.084, Alcresta Therapeutics, RELiZORB, here.)  CMS argued the product was already bundled into codes for feeding tube home supplies (B4034, '35, '36, based on syringe, pump, or gravity methods).

However, CR10626, June 1, 2018, issues a Q code (a special rapid CMS code) for the product, effective July 1, 2018.  It will be Q9994, "in line cartridge containing digestive enzymes, for enteral feeding, each."   My point is, there must be be an active back story with stakeholders up and down the hallways of the agency between December and June.  Congratulations on their success.

Why I Remember the Digestive Enzyme HCPCS Code Presentation:
Lesson Learned

I was in attendance at the May 2018 HCPCS meetings, and one of the nicest (clear, convincing) presentations was from Alcresta.   The speaker, with a right-sized set of good slides, explained that some patients had major problems with lipid digestion, that pre-digested lipids were unstable, and several clearly documented benefits of lipase enzyme supplements had major clinical impacts on patients with these lipid digestion problems.   When he finished, a CMS medical director asked, "Don't we already cover a hydrolyzed amino acid product?"   The speaker turned pale and hesitated a moment.   "This is...about..lipid digestion, not amino acids."   The medical director adjusted his glasses and shuffled his notes and nodded, "Yes, I think maybe you did mention lipids."    The take home lesson is that it's safest to assume your listener (and the key decision maker) is only processing about 10% of what you are saying, even after you've revised your 8-slide deck ten times and practiced your speech ten times.

Behind the Headlines: Forbes' Article on Freenome and CRC Screening Investment

On May 23, 2018, Forbes ran an article by Matthew Herper about how liquid biopsy and AI company Freenome plans to develop a colorectal cancer screening test.  Such tests require large FDA trials (>3000 patients).   Article here.

The natural comparison is to Exact Sciences, makers of Cologuard, a DNA-based stool screening test.  Exact's market cap is over $7B.

Colorectal screening tests benefit from a back door in Medicare's statute, allowing preventive benefits to be created directly by CMS staff through an NCD.   In other cases, preventive benefits need to be created by Congress or need to be first endorsed by USPSTF and then secondarily taken up by a CMS NCD.

I'd illustrate it as below.  The first pathway (at top) and the longest pathway is an Act of Congress.

The second two pathways are the small circles.  Both the statutory prostate screening benefits (for PSA) and colorectal screening benefits (for FOBT and colorectal) contain a phrase allowing CMS to update the benefits as appropriate for new technologies.   Review of the CMS NCD for Cologuard confirms that this is the trap door that Cologuard legally squeezed through as a preventive benefit.

If you're not endorsed by Congress or endorsed by a CMS NCD for a CRC or prostate test, you have only one other pathway:  to sequentially obtain USPSTF endorsement with a high rating (years), and then, later, being taken up for an NCD (at CMS's discretion) and passing.  USPSTF review (including public comment on draft versions) takes a couple years.  Lung cancer LDCT screening went through this extended pathway, with several years passing slowly from the time USPTF took up a review of the issue to the time the NCD was completed.

See graphically as below:

click to enlarge

The business lesson is, by developing a CRC screening test, Freenome can get its product through the "statutory little doors."  If they tried to develop an ovarian or pancreatic or breast or lung cancer screening test, Freenome would need a legislative solution or take several years to work through the slow USPTF review process, presumably after the FDA process, and before the NCD process. 

As a cross-check, see the venturous and impressive commercial investments taken, or being taken, in colorectal cancer screening tests by Exact and Freenome.  (You can even get the FDA and CMS decisions on the same day, as Exact did, through the FDA-CMS parallel review process, which has no parallel in the USPSTF pathway.)  In contrast, lung cancer LDCT trials relied on public NIH investments for which payback was not commercially relevant.  This is good for future victims of CRC, but puts future victims of other cancers at a disadvantage.

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Addendum
On June 1, 2018, Clinical Genomics Technologies, in which Quest is an investor, raised $26M for the development of a liquid biopsy CRC screening test as well as a CRC recurrence test; here.  This brings total funding to $48M.
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Relevant statute -

• 1861(pp) covers CRC screening tests, defined as FOBT, sigmoidoscopy, or colonoscopy, at intervals determined by CMS, along with new technologies approved by CMS.
• 1861(oo) covers prostate screening, defined as digital exam or PSA test, or, new technologies found appropriate by CMS.
• 1861(ddd) allows USPSTF approved services to be imported as Medicare benefits via an NCD.  You'd wait a year for FDA, then two years for USPSTF, then another year for an NCD.

The Cologuard NCD states:

Sections 1861(s)(2)(R) and 1861(pp) of the Social Security Act (the Act) and regulations at 42 CFR 410.37 authorize Medicare coverage for screening colorectal cancer tests under Medicare Part B. The statute and regulations authorize the Secretary to add other tests and procedures (and modifications to tests and procedures for colorectal cancer screening) as the Secretary finds appropriate based on consultation with appropriate experts and organizations.

Very Brief Blog: Rohr et al. on Value of Diagnostics in Healthcare

We frequently hear the number that lab tests are 2% of healthcare costs but drive 70% of decisions.  The first number is true; the financials are a matter of record.

But the "70%" of decisions is both very widely quoted and occasionally critiqued as an "urban myth" without a good original source.

• Update:  See another large study on the decision impact rate of lab tests; at Ngo et al, J Appl Lab Med, 1/2017, here.
• For my prior blog on concerns that 70% impact is just an "urban myth," here.
• For an article that 25% of tests are overused, 45% underused, Zhi et al. 2013, here.

Rohr et al. PLOS One

This month, Dr. Fernando Chaves, global head of medical affairs at Ortho, has an op ed at MedCityNews about the value of diagnostics (here).  Moreover, he cites a paper that's new to me, Rohr et al. 2016, which reported that 66% of decision making was based on IVDs.  Find Rohr et al. at PLOS One, here.

Notably, 80% of the doctors interviewed estimated that >5% of healthcare costs were expenses for diagnostics, so they markedly overrate the size of the lab industry and its small role in total costs.

For impact on decision making, see Rohr et al. Table 2, below.  The study was funded by Roche.

Inaccurate tests: From $1 to $6 to $1B

In another interesting Roche-funded study with Ventana contributors, authors Vyberg et al. assert that for every $1 saved by labs using "cheaper reagents" in IHC, costs to the health care system are $6.  See here.  See similarly Garrison et al. here, estimating the annual US socioeconomic loss (including lost QALY) due to inaccurate Her2neu results at $1B.