Friday, November 16, 2018

Very Brief Blog: Forbes Publishes Deep Dive Article on Flatiron

At Forbes, in the November 30 issue, journalists Matt Herper and Ellie Kincaid publish a deep-dive, 4000-word article about Flatiron Health.   Its all here; the intrepid young founders; the tentative startup within Google; the funding round over $100M and what they did first with it; the alignment with Foundation Medicine and soon Roche.

Online here.


CMS Releases CY2017 SEP-1 Hospital Sepsis Management Data; Academics Perform Badly

On October 31, 2018, CMS released hospital performance data on quality measures, for CY2017.   This gave the first full year of data for SEP-1, a measure of how well hospitals live up to CMS management standards for patients with sepsis.   (The measure requires several actions within six hours, such as managing the septic patient by drawing blood for culture, starting fluids, and starting antibiotics.) 

I reviewed earlier partial year SEP-1 data on August 4, and the full original article is here.  The median hospital performance is 49% - meaning 49 patients out of every 100 diagnostically septic patients get the CMS protocol of interventions. 

About 500,000 patients were under the measure, and it's a very complicated chart-reviewed metric that may require up to an hour per patient to classify.  (That means at 2000 hours of work per year, 250 FTE's were squirreling away their statistics on this CMS measure.  So much for "patients over paperwork.") 

Rather than repeat all the findings in the August blog, let me highlight a few here.  For one, academic hospitals (per the US News & World Report ranking) did terribly.  Exactly half of them scored below 40% (remember that a perfect score is 100%), and three actually scored below 25%, the lowest being Vanderbilt at 15%.   (That's very close to the performance of the lowest-ranked of states or territories, Puerto Rico at 11%.)  The highest academic center score was 78%, at Baylor, followed by 72%, at NYU Langone.

How Did Henry Ford Hospital Do?

Remarkably, Henry Ford Hospital in Detroit, which is the measure steward of record for the National Qualify Forum for this metric, performed below the national median, at 48%, meaning less than half of its own patients got care that passed the CMS quality metric.   For two press releases by Henry Ford touting its role in creating the metric, now required by all hospitals seeing Medicare's 40M patients, here (2013) and here (2018).  For Forbes article on Henry Ford and sepsis measures, here.  As far as I can tell, there is no Henry Ford press release touting its actual, below-median performance.

NIH faculty criticized SEP-1 publicly earlier this year, bringing a rebuttal defending use of SEP-1 in patients from Henry Ford authors, although Henry Ford is at best below-median in actually using SEP-1 in patients.

How Did Mayo Clinic Do?

Mayo Clinic was also well below the national median.

Recent Literature

Use of the measure has been criticized in some circles (e.g. here for summary and here for recent article in Annals of Internal Medicine by Pepper et al.)   For a current article in JAMA by Klompas et al. at Harvard, here.  Rhee at Harvard has published some of the first articles on SEP-1.  Rhee et al. reports that, in early data, meeting or not meeting the SEP-1 measure was not associated with an impact on outcomes in corrected data; here.  She discusses other limitations of SEP-1 relative to measuring quality, here.  (Rhee has also written about biomarkers to help manage antibiotics in sepsis; here; SEP-1 lacks any biomarkers except lactic acid for organ failure.)

Wide variation in SEP-1 performance was reported as early as January 2018 by Venkakesh, here, for which an op ed commented, "SEP-1: A measure in need of resuscitation?" (here).

The background of creating SEP-1 was reviewed by Faust & Weingart (here).  For critique in MedPageToday, here.  For a strong article on the challenges and dilemmas of sepsis metrics across populations and subpopulations, here.

Does CMS Get What It Pays For?

CMS pays for diagnosing sepsis, as this can upgrade DRG payments markedly, driving by electronic medical records keyed to billing systems.  Other than posting SEP-1 performance, as discussed in this blog, CMS does not penalize hospitals if they don't do things like draw culture or start antibiotics.

The Rankings

Of the top 20 medical school medical centers in the US, only 4 even ranked in the top-fourth of the 3000 community and other hospitals reported by CMS.


For additional links and sources for the actual CMS data, entry point here.

Making It Personal

I was cheered that the closest hospital me, Olympia Medical Center in Los Angeles, and next to the preschool my kids went to, was tied for the top 6 nationally, at 99%.

Bringing back memories, I logged time at four of the top twenty.  Three of the places I trained or worked - Stanford, NYU, and Northwestern - were above the median; one (UCLA) was not.

CMS Releases CY2019 Final Crosswalk Pricing

On October 19, 2018, CMS released final gapfill pricing for CY2019 lab codes that were under the gapfill process.

On November 16, 2018, CMS released final crosswalk (or gapfill) decisions for CY2019.
  • See the CMS final crosswalk PDF here (41pp). 
    • 99 codes went through this new code crosswalk/gapfill process.

A Few Results

Thermo Fisher Oncomine FDA Test
The code for the Thermo Fisher Oncomine test, an FDA-approved lung cancer gene panel test covered under the CMS NGS cancer NCD, was originally proposed at a $600 price - much lower than its circa $2000 MAC price.   The final CMS decision is to gapfill code 0022U in CY2019.   Presumably, this will memorialize the existing MAC prices for the 2020 fee schedule.   Because the NCD promises coverage to all FDA-approved tumor gene panel tests within their FDA labeling, there is likely to be an influx of tests from multiple venders (or sole source labs) popping up with FDA approval over the next 12-24 months.   This should promote competition (for example, for turnaround time or sample size or gene panel or helpful remotes) against the Foundation Medicine test, a sole-source gene panel currently priced by CMS at $3500. 

CMS also upgraded the valuation of 0040U (a high-sensitivity FDA-approved BRC/ABL1 test from MolecularMD) from 1x81206 (the legacy LDT price) to 2.5x81206.

Pan-Ethnic Carrier Screening
A new Category I CPT code for expanded carrier screening, 81443, is crosswalked to the existing code for Ashkenazi carrier screening, 81412 ($2448).

BRCA
AMA CPT produced a new largely new set of BRCA codes for CY2019.   However, as public data has previously documented, nearly all current CMS BRCA testing is either under codes 81162 (for combined BRCA1-2 full sequence and full dup del, $2027 in CY2019 and $1825 in CY2020), or under a gene panel codeset 81432/81433.   New codes were created for BRCA1-BRCA2 sequencing alone, BRCA1-BRCA2 dup del analysis alone, BRCA-1 testing alone, BRCA-1 dup del analysis alone, and BRCA2 dup del analysis alone.  (A code for BRCA-2 sequencing alone previously existed and isn't changed.) 

Pricing of new BRCA codes was finalized, I believe, as proposed.   Like with other codes, CMS used codes in the Tier 2 code set as price benchmarks when possible.
  • 81163, B1B2 SEQ, is 81406+81216, or $282+$185, or $467.   
    • Code 81216, BRCA-2 sequencing alone, had a low PAMA price of only $185, which CMS is re-using here.    
  • 81164, B1B2 DUP DEL, is 81405+81406, or $302 + $282, or $584.*   
  • 81165 B1SEQ, 81406, $282.   
  • 81166 B1 DUP DEL, 81405, $302.
  • 81167 is B2 DUP DEL, 81406, $282.
New BRCA Codes Likely to Be Obscure and Rarely Used 
Prior codes, or similar codes, for these piecemeal BRCA services were virtually never used in either PAMA commercial payer data nor in CMS data. 

Since the new codes have prices that would "code stack" below 81432/81433 or below 81162, they are unlikely to be used more than very rarely.  (There is no incentive to use them, which there would have been if they code stacked to payments well above 81162). 

As far as I could tell from the relevant AMA CPT meeting in San Diego in February 2018, AMA was simply proposing to make equal and similar codes for any possible combination of BRCA1 or BRCA2 sequencing or dup del analysis, regardless of how often that service was ordered on its own or whether it had any literature on its own.**

Appeal Process

The 2019 prices can be appealed by submitting a formal appeal to CMS in the next 60 days.   The result would be that the code you appealed will simply re-enter the crosswalk/gapfill decision process again next summer.



____

Appeals Fizzle

Two codes were under appeal (81326 PMP22, and 81334 RUNX1) and CMS declined to change existing pricing.

____

Gapfill = 18 Codes, Or About 18% of New Codes

Using a wordsearch method across the 99 codes, I counted 18 under gapfill (0018U, 0019U, 0021U, 0022U, 0023U, 0029U, 0030U, 0035U, 0041U, 0042U, 0043U, 0044U, 0048U, 0050U, 0053U, 0055U, 0056U, 0057U.)   That's about the same number as were under gapfill this past season.  In some cases CMS used gapfill because there was truly no comparable test; in other cases, because CMS was concerned that code stacking of CPT codes might not reflect economies of scale.   

Your Little PLA Code Could Be $3873!

Several codes were finalized with a crosswalk to 81519, the Oncotype Dx test, including PLA codes that received this favorable pricing.

____

* Note that the Tier 2 system is quirky.  Each tier reflects more extensive sequencing than the tier below, but there is a rank order anomaly between 81405 at $302 and the higher more complex code 81406 at $282.

** BRCA coding is now like those Staples ads, "Yeah, we've got that."  AMA, you got a code for BRCA-1 sequencing alone?  Yeah, we got that.   OK, AMA, you got a code for BRCA-2 dup del analysis alone?   Yeah, we got that.






Monday, November 12, 2018

Next AMA PLA Conference Call on New Codes: November 19, 2018

Get the holiday Thanksgiving week off to an exciting start by listening in on the quarterly AMA PLA Applications public conference call, November 19, 2018.

With a warning that these links may be updated by AMA, the home page for PLA code policy is here  The listing of current long descriptors (circa 79) as finalized in September for October 1, 2017, is here.

The next public panel call is November 19, 2018, at 7 pm CT (8 pm ET).  Register by Friday November 16 via thilani (dot) attale (at) ama-assn.org  .   This is also on the PLA home page cited above.

The Public Agenda for this November PLA meeting is here.  There are 7 new codes and one minor text revision on the docket.  If I read the calendar correctly (here). this round of applications was due October 9 and posted publicly by AMA on October 16, with a window until October 23 for public comment submissions.  The PLA subcommittee voted on November 6, which is not a final AMA vote but rather, sends recommendations forward to THIS public hearing on November 19.   You can listen in, just like you can attend and watch a CPT meeting, but often these final public calls are pretty brief ("Questions?  Hearing none, please vote.") 

These 4Q2018 PLA codes are finaled and public on January 1, but I believe CMS requires a quarter of cycle time before adopting them on April 1.

____

I noted in a previous blog that this PLA cycle is sort of like a solar eclipse - it is the shortest possible cycle time between getting a PLA code and getting a market based PAMA rate.   Your code will be active in Q2 2019 (for CMS purposes.)   Let's say you envision a market price of $1000, but in July 2019, CMS crosswalks your code to $200.    That $200 price will hold for CY2020.  However, in early 2020, CMS will collect your market price data - let's say it is $1000 per payment for your private payers during Q2-2019.   That private payer rate of $1000 will then become your CMS PAMA payment in CY2021, 2022, 2023.   You will only be exposed to the CMS low crosswalk price of $200 for one year (CY2020).    This is the shortest possible exposure to undervaluation, according to current PLA and PAMA cycles.




Tuesday, November 6, 2018

Very Brief Blog: Google AI System Speeds Surgical Pathology Work

In the field of radiology, Qure AI has raised over $30M to bring AI methods into radiologic diagnostics (here), and the impact of AI on radiology is widely discussed (here, here, here).

The Dark Daily news blog this week highlights a publication in Am J Surg Path finding that pathologists self-report faster and easier detection of lymph node micrometastases with AI-assisted vision.   Dark Daily here.  (Includes numerous links of further interest).   The new article is open-access at Am J Surg Path; see here by Steiner et al.

It's AI work coming of Google/Verily.   Verily has a college-campus-sized set of glass buildings in South San Francisco, just north of SFO and just west of the Genentech campus.




___

For a trade journal article on pharma investments in digital, here.

For November 2018 trade press on "Deep Lens" and affordable AI for pathology, here.

For a November 2018 article in APLM on new FDA approval for whole slide imaging, Evans et al., here.

Very Brief Blog: Scott Gottlieb Discussed FDA's New Vision at Milken Institute (October 2018)

On October 24, 2018, as part of the Milken Institute Future of Health Summit, Scott Gottlieb gave a detailed interview on his vision for the FDA, interviewed by Tanisha Carino, executive director of Faster Cures.

See the Milken agenda here.  See a detailed transcript and links to the Youtube video interview here.

_____


Gottlieb, a physician with a background ranging from federal policy to investing, and a cancer survivor himself, dicussed keeping FDA focused on a "values oriented strategy" and one that incorporates patient perspectives.

He noted that FDA will soon release new guidance on incorporating digital apps and monitors into drug approvals.  (See also an open access article at ISPOR, here.)  He noted that digital tools could also have post-market or post-regulatory roles.   (For a November 2018 trade journal article on pharma investments in digital, here.)

He discussed the new for new regulatory tools in areas like neurologic diseases, and improving cognitive tools in Alzheimer's. 

He noted that FDA was restructuring the drug pipeline and wants to move things like filling spreadsheets away from expert medical reviewers and let them focus on high-impact medical decision making during the review process.  He also noted that the FDA needs much better knowledge management systems in house.   This is the classic dilemma in organizations, "How do we know what we know?"  The agency is also committed to more objective public disease-specific guidances (less need to rely on tacit experience or to reinvent the wheel.)   The agency will create "problem based review memos based around "critical questions."

He discussed the wave of pending retirements and that the FDA is a highly technical working agency, not just one that assigns and passes through money.

He referred to the agency's commitment to areas of self-regulation or self-certification (e.g. in some areas of digital health) and to the 70 pages of comment FDA recently submitted to Congress proposing new legislation for regulating LDTs.

There was a discussion, pivoting off of a Harvard economist Amitabh Chandra presentation, the R&D in pharma wasn't well aligned to major public health needs (e.g. too directed to orphan diseases rather than pneumonia and heart disease).   Some disease areas are piled high with "good-enough generics" that are a barrier to new research.

He noted, as he has in several recent speeches, that sometimes we don't get reimbursement right, and that is a barrier to progress as well.   He raised the concern that some areas may get stuck with "natural monopolies" of one or two drugs and it's too hard for more diverse new entrants to get a foothold.










Very Brief Blog: Resources on Pharma Digital Disruption (McKinsey); Opioid Addiction Digital Disruption (Rock Health)

Citations to two detailed white papers today.

Digital Disruption in Pharma 

McKinsey provides a whopping 204 page collation of its articles on digital disruption in the biopharma industry, online here.

Digital Disruption in Opioid Addiction

The Hill passed opioid addiction funding and legislation in October - 98 to 1 in the Senate, 393 to 8 in the House (here).  Funding breakout here

Rock Health provides a very up-to-date 12-page (or 50 iPhone screen) review of digital medicine and startups in the field of addiction treatment, online here.  


Friday, November 2, 2018

Very Brief Blog: CMS Publishes Notice of Future Rule on Innovative Medical Devices

Over the past several months, summer/fall 2018, there have been several "tips" dropped in the press that CMS is planning to produce a rulemaking change to encourage faster coverage of innovative devices.

A full year ago, back about 12-18 months, there were rumors that Advamed and other stakeholders and CMS might shortly come up with a new special program for breakthrough devices and rapid coverage.  But the topic went radio silent, at least on the CMS side, around the beginning of 2018.  (I summarized this in a February 2018 blog, here.  The CY2017 keywords for this topic included "EXCITE" and "PACER.")

Now in late 2018, Holland & Knight's Ethan Jorgensen-Earp has a great pick-up in a new essay on CMS device innovation policy.   Here.    He reports that CMS has published notice of a "proposed rule" (meaning a future publication) for streamlined Medicare coverage of breakthrough technologies.  It will be called CMS-3372-P and has a notification webpage, here.  All we know, is that this is a new rule in the CMS rule pipeline.  We don't know when it will appear.

click to enlarge


Don't Confuse with Recent LCD Rules Update 

In early October, 2018, CMS released a wide set of updated LCD process rules, to be effective on or before January 1, 2019.  Here.  These were touted as "speeding the LCD process" but I don't see it at all. 

For example, LCD reconsideration requests under the current rules, must get a yes/no reply within 90 days.  

Under the "new rules," the MAC is now only allowed to respond that it has accepted the reconsideration and that...wait for it...that the MAC may or may not do an LCD, which may or may not be favorable, and may or may not occur at any unknown time in the future.  Not an improvement to my eye.   I believe the motivation was to avoid any risk of pre-public leaks of financially important information (see trial about CMS leaks, with criminal convictions,  here), but the net result of not knowing the LCD reconsideration review decision, perhaps ever, is unsatisfactory.

...All the MAC now has to do is reply, after receipt, that they may or may not do an LCD that may or may not be positive and may or may not occur at any unknown time int he future.   A perverse or overworked MAC would hardly even have to read the data to send back such a "Dear John" letter. and it would be a "true" letter, and would conform to the new rules.

Thursday, November 1, 2018

Very Brief Blog: Access CMS Final CY2019 Rules for Physician Fee Schedule, Outpatient Fee Schedule, ESRD/DME

On November 1, 2018, CMS released final rules for CY2019 for ESRD & DME, and for the Physician Fee Schedules.   Final Federal Register typeset versions will appear later in November.
  • Fact Sheet, Physician Fee Schedule, here.
    • Rule (inspection copy), here.
  • Fact Sheet, Outpatient & ASC Fee Schedule, here.
    • Rule (inspection copy), here.
  • Fact Sheet, ESRD/DME, here.
    • Rule (inspection copy), here.
For the lab industry, CMS will somewhat liberalize rules for hospital reporting under PAMA including use of hospital outpatient UB1450 claim information (see inspection copy, p. 706ff).  CMS noted it received conflicting comments on this issue.   Genomeweb summarizes the PAMA changes, here

A side note, CMS has proposed in July a huge bubble in the price of several key ISH/IHC reagents, but generally walked these back in November (here).

For physicians, CMS will substantially revamp E&M payments (deferred to 2021) and provides new codes for some digital health services.  For a trade journal report, Healthcare Dive, here.  For insights into the degree this helps digital health, MedCityNews, here.

CMS entertained comments on new approaches to DME gapfill pricing for new products that would be less adverse to innovators but drew no conclusions (see inspection copy, p. 440ff).

Wednesday, October 31, 2018

Consortium Paper Sets High Water Mark for a Diagnostics Strategic Landscape (Case Study: AST)

A new paper in Nature Reviews Microbiology sets a high standard for thinking about the dynamics and strategies of commercialization of a class of novel diagnostics.

It's a case study based on an active area of innovation, antibiotic sensitivity testing.  However, I'd emphasize the the scope and logic of the thinking applies to other kinds of diagnostics (or even other kinds of medical innovation) as well.

  • Nature Reviews open access paper here.
  • Nature Reviews tweet here.
  • Blog by coauthor John Rex here.



Tuesday, October 30, 2018

Very Brief Blog: Bay Area "Business of Personalized Medicine Summit" - December 6, 2018

Thursday, December 6, 2018, is the 15th Annual Business of Personalized Medicine Summit, to be held at the SFO Westin.

Sponsors include Foley Lardner, Personalized Medicine Coalition, Analysis Group, Deloitte, BIO, and Slone Partners.

See the home page here and the agenda page here.   (I'm speaking on a panel in the afternoon). 

Highlights include:

  • Keynote by Helmy Eltoukhy, Co-Founder, Guardant Health
  • Investments and Exits, Jonathan Norris, Silicon Valley Bank
  • Finance and VC Panel
  • Big Data Panel
  • Disruptive Innovation Panel
  • FDA & Regulatory Panel
  • Payment and Reimbursement Panel
  • Clinical Integration Panel
  • Closing Keynote: Harry Glorikian


Register here.

Very Brief Blog: CAP Today Highlights Revenue Cycle Management

With the excitement of the World Series behind us, we can turn attention to the excitement of revenue cycle management.

One of the most remarkable statements I've seen in 2018 was a quote in the Foundation Medicine final investor report before it was wholly absorbed into Roche:
"Most of the commercial third party payors that reimburse us do so based upon CPT codes, or based on other methods such as percentages of charges or other formulas that, to our knowledge, are not specific to us and not made known to us." 
Pretty amazing financial facts for a company being bought for $2.4B !

Addressing rationale responses to the bizarre world of laboratory economics and claims processing, see a detailed article in CAP TODAY for October 2018 - "Revenue Cycle Services," here.   

The article focuses on one industry player, Telcor, but the pains are industry wide.   Good article.

___

Parts of the article reminded me of Jonathan Bush's 2014 book, "Where Does It Hurt," about founding the large company Athena Health based on building up software and rulebooks that understood the bizarre world of payer claims processing.  In October 2018, Athena's market cap was about $5B, revenue $1.2B.

ISPOR Value in Health Journal: Six Article Set on NGS and Value

Value in Health is the official journal of ISPOR, the international society for pharmacoeconomics and outcomes research.   (See their international conference in Barcelona November 10-14, 2018).

The September 2018 issue has a special six-article set on next generation sequencing and clinical value.  (Subscription required).  See the home page for Value in Health, September 2018, here.   
The articles are headlined by an op ed by Kathryn Phillips PhD, head of the TRANSPERS NIH-funded program at UCSF for translational genomics. 
For more on precision medicine in health policy, see also the special issue of Health Affairs, which appeared May 2018.
I'll be highlighting some of these publications in a webinar on value in genomics, November 27, here.


click to enlarge


Very Brief Blog: DHealth Conference for SoCalBio - November 9, 2018

SoCal Bio, an LA-focused biotech and medical device association, holds its second annual Digital Health conference on November 9, 2018, in Long Beach.   (Last year's first annual conference, held at USC, was outstanding).   The theme is medical grade wearables.

The conference website is here and the extensive online agenda is worth checking out.




Very Brief Blog: California Clinical Lab Association Meeting; MolDx Speakers

The California Clinical Lab Association annual conference will be November 7-9, 2018, in Costa Mesa, California [Orange County].   See the conference website here.   Download the agenda here.

The October-30-version agenda is below; check for updates.    Both of the new MolDx medical directors, Dr. Bien-Willner and Dr. Gerrard, are on the agenda for Thursday November 8.  They are also speaking the prior day, November 7, in San Diego at the AdvaMed Dx West Coast Summit (here).   

On a separate note, November 9 is the SoCalBio digital health 2nd annual conference, to be held in Long Beach; last year's first annual DHealth conference was excellent.

October 30 Version (click to enlarge)