California MD-PhD Becomes Head of Diagnostics at FDA: Tim Stenzel

Amidst a significant reorganization of the Center for Devices and Radiologic Health (CDRH), Tim Stenzel MD PhD becomes head of the Office of In Vitro Diagnostics and Radiological Health (OIR).

See an August 6, 2018, article at NAMSA (here) and an August 9, 2018, article at MedTech Insight (subscription; here.) 

The position had an acting director since Alberto Gutierrez PhD stepped down in Summer 2017.   Both Gutierrez and his predecessor, Dr. Steve Gutman, had been long time FDA employees and thus internal promotions to director.

Stenzel is a graduate of Duke's MD/PhD, pathology residency, and molecular genetics fellowship.  He worked successively at Abbott, Asuragen, Quidel, and InvivoScribe where he was Chief Operating Officer 2014-2018.

For a full description of the CDRH reorganization, including OIR, see NAMSA here.  See also a 21-page FDA deck on the re-org, archived at Advamed, here.

Stenzel gives a 12 minute presentation, in his prior role at Invivoscribe, at the Personalized Medicine World Conference in January 2018, here (minutes 1-13).
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In other FDA diagnostics news, the FDA recently provided the Hill with what is being described as nearly an FDA plan for legislative reform of diagnostics at FDA; for more see here.
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Steve Gutman was director 1993-2009; Alberto Gutierrez 2009-2018.  Stenzel is only the 3rd director in the division's 25-year history.

Brief Blog: FDA Provides Deep Technical Assistance on Lab Reform Bill

While FDA lab test reform has been kicking around Washington for several years, a new landmark has happened.

FDA has provided detailed technical advice on the Hill legislative draft, according to DotMed.com   Advamed applauds the FDA's effort. 

See the trade journal article here, email registration may be required.   The FDA's information could support another round of hearings on the Hill, one step in the advance of any piece of legislation.  See also Genomeweb coverage, August 8, here.

The top line message:

Washington, D.C. – AdvaMedDx applauds Capitol Hill's release of technical assistance (TA) developed by the Food and Drug Administration (FDA) to draft legislation authored by Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) as a significant, positive step toward enacting legislation modernizing regulation of all diagnostics, including Laboratory Developed Tests (LDTs). 

My understanding is that FDA provided higher level (or shorter) info to Congress in May 2018, as reported by Genomeweb (here).   This would be a longer, deeper-dive form of FDA feedback now.

On August 8, Advamed urged Congress to keep the legislative ball moving forward on diagnostics reform, here.  While in late June, Genomeweb reported that a lot of other stakeholders did not want that ball to move at all, here.

Genomeweb adds:

On Aug. 3, the FDA provided Bucshon and DeGette more detailed recommendations for how they might address regulation of so-called in vitro clinical tests via legislation. The FDA's version includes provisions related to premarket approval, provisional approval, and a precertification program, and makes explicit its authority to revoke approval, request raw data, and take corrective action against test developers in order to protect the public health. 

The FDA's response to the Hill was 59 pages, 23,000 words of legislative-format text; whereas the 2017 draft bill circulated by the Hill for comment was 215 pages and 43,000 words. 

The JAMA/Flatiron Study of Cancer Gene Panels: Why It Couldn't Have Worked

On August 7, 2018, JAMA published a large retrospective observational study of the relative impact of large gene panel testing in stage III/IV lung cancer in a community population (Presley et al.) along with a detailed Op Ed by Bunn et al.   See also coverage and interviews on August 8 at Genomeweb (here).

From a Flatiron Heath database of some 5700 patients in 191 practices, the authors identified about 875 received panel testing (>30 genes) and 4800 received "routine" testing such as EGFR gene and ALK gene alone.  In propensity-matched analysis, there was no increase in 12-month survival in the gene panel group: survival was about 43% at one year in either group.

The study authors, and the Op Ed authors, note various caveats and limitations.  Stil, the study authors conclude with concerns there is limited validation here for the wide use of costly gene panel testing in lung cancer patients.    The Op Ed authors note that the number of testable genes and paired drugs is rapidly increasing, even since an area that spanned 2011-2016. so that results of panel testing in one several-year-period may not apply to the next period.

What's Wrong

The biggest issue for me is that an RCT which is pivoted on the diagnostic test can be a hopeless trial design in some situations, and this is probably one of them.

Surely if you take 200 advanced lung cancer patients, and pivot the design to test only for ALK in one half of them, it's unlikely to show a population wide survival benefit, since the ALK fusion will appear in only a few percent of patients in the second arm, and even then, a good drug may work only half or 2/3 the time. 

Case Study with a Diagnostic for Herceptin

It's like playing a movie backwards: this is exactly why the classical pivotal trial for Herceptin was run in Her2-positive women and not in all women. 

Let's pretend for the sake of real simple math that 30% of women are Her-2 positive, and that in advanced breast cancer it doubles your survival from one year to two years half the time, with half the patients being responders. 

So in a control arm of 100 patients (no Her2 testing), all will get chemo and all survive one year.    

In the Her2 test arm, 100 patients get Her 2 testing.   30 are positive, and 15 respond to drug and live 2 years; the other 85 in Arm Two live one year.    

Result:  In the Her2 test arm, the average survival of the 100 patients getting Her2 testing is 1.15 years, very unlikely to be different than 1 year, when you add in all the diverse noise of surival data in cancer patients.   Yet, you also already KNOW that if you treat the Her2 positive women with Herceptin, the responders will have double survival (2 years) and half of them are responders.

OK.  In the JAMA report this week, we've just run the vision of precision medicine backwards by pivoting the study on the diagnostic test.   You know some patients will do better in the gene panel test population, but they will be washed out in most situations in a randomized control trial pivoted on the precision medicine diagnostic test in the whole population.   This is the whole rationale for setting up precision medicine trials on the positive and negative populations, not the whole population, in the first place.

N.B.:  Authors Found Amazing Lack of Prescription Follow-Through

Another key result of the real world database study was that only about half of patients with a pivotal mutation (like EGFR or ALK) got the corresponding targeted therapy, in data running almost up to the present, to 2016. 

That's an issue that should be getting red-light attention and plans for an intervention.

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Interesting citation.   From just a few weeks ago, June 29, the Op Ed authors cite Sharma et al in J Precis Oncol (here).  This is: Eye-Tracking Study to Enhance Usability of Molecular Diagnostics Reports in Cancer Precision Medicine.  It's a cognitive psychology study that concludes:  "Focused usability studies can help drive our understanding of the clinical workflow for use of molecular diagnostic tests in cancer care. This in turn can have major effects on quality of care, outcomes, costs, and patient satisfaction. This study demonstrates the use of specific usability techniques (eye tracking and think-aloud protocols) to help clinical laboratories improve MDX report design in a precision oncology treatment setting."

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See a March 2018 study by Flatiron on real-world use of immunotherapy in lung cancer (pembrolizumab); Khozin et al., here.

New Rules, Medicare Advantage, Drug Step Therapy: What Really Happened?

On August 7, 2018, there was a rapid flurry of news articles which followed a CMS press release that it was loosening burdensome regulations on Medicare Advantage plans and allowing them to use Step Therapy.   CMS framed this as an important advance for controlling drug costs in the Medicare program, and that this rollback of excess regulation was consistent with ongoing HHS themes.

• See news at PatientEngagementHIT here, at Endpoints here, at CNBC here, at Healthcare Finance News here, at Forbes here.   
• 
  
• More broadly, see articles on the Trump agenda to reduce drug prices (Forbes here, Politico here, 44-page HHS blueprint, here.)   
• 
  
• For the CMS August 7, 2018, press release, here.

What Really Happened?

For years, CMS has had policy that Medicare Advantage plans must provide the same benefits as Part B (or Part A) Medicare. 

For example, let's say that a Part B MAC has a policy to pay for any of drugs A, B, C, D.   A Medicare Advantage plan can't say they only pay for Drug A, or only pay for Drug B and C if drug A fails, and never Drug D.   This wouldn't be "the same coverage for the patient as Part B." 

The 2012 Memo.  A 2012 CMS memo made clarified this.   Exclusion of Medicare Advantag step-therapy was laid out by HHS attorney Danielle Moon in a two-page memo to plans on the simple basis that it conflicted with the concept of matching Part B coverage under LCDs.  (She appears to be at Deloitte now.)   Find this 2012 document and the new 2018 document together in a cloud zip file here.

The 2018 Memo.  The new document is a 4 page memo signed by Administrator Verma (zip file here).  It "rescinds" the 2012 memo.   It states that Medicare Advantage plans can use prior authorization methods, and that step therapy is only a form of prior authorization.  (I guess it is prior authorization where the question is, "Did you try and fail Drug A first?")   Net net, the press release is pretty broad and bold, while the underlying 4 page administrative memo is pretty nerdy, and couched in cautionary language about beneficiary access protections.

Bonus Trick Question

Why are the 2012 memo and 2018 revision concerned only with step therapy in Part B drugs under Medicare Advantage plans?  Because if the drugs were Part D oral drugs, there wouldn't be any fee for service LCD (neither Part A or B) that the Medicare Advantage plan would have to provide the-same-coverage-as. 
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AMA Letter on HHS Drug Policy; Manatt Article on Innovation

 Researching this, I ran across a new July 16, 2018, twenty-page letter from AMA to HHS on drug policy.  Here.    I also ran across a nice paper by Annemarie Wouters of Manatt, on the topic of insurance and innovation, which I hadn't seen before - here.  Both are in my airplane reading folder for today.

Very Brief Blog: AMA Posts Quarterly New PLA Code Agenda for August 2018

AMA CPT runs a quarterly process for creation of new Proprietary Laboratory Analysis codes or PLA codes.

Like other AMA CPT meetings, the meeting is publicly accessible.  However, this meeting is held by webinar only.   Sign up by August 6 for the August 9 meeting at 6 pm Central time.

Webpage including sign-up links, here.  Upcoming agenda as a PDF here.  I count 14 codes on the agenda.

CMS Releases SEP-1 Data - A Sepsis Management Performance Measure for Hospitals

Summary

• Sepsis is a major public health issue, and international guidelines urge rapid interventions.  
• After several years, CMS has just released data on how well hospitals perform to its sepsis rapid intervention metric.   
• About half of US hospitals failed Medicare's sepsis management measure for over half of their patients.
• Academic centers ranged from 23% compliance (Yale) to 71% (Stanford).
• Even Republican health leadership doesn't help - Indiana is near the bottom of national rankings.

Sepsis as a Public Health Crisis
In the past decade, sepsis has increasingly been recognized as a major public health problem.   According to Sepsis Alliance, the cost of sepsis is over $24B and steadily growing, here.  See also a table and links here.   Accordingly, the CDC has a major public health effort on sepsis (home page here).

Surviving Sepsis Guidelines
One aspect of sepsis management is early recognition and intervention.   A global sepsis alliance regularly updates an overall guide to sepsis management, with special focus on activities in the first 1-3 hours of sepsis management, such as rapid fluid resuscitation and rapid blood draw for organism culture.    See links for the Surviving Sepsis Campaign Guidelines here.  There is an increasing focus on actions right in the first hour, here.

NQF Sepsis Measure - NQF-500
As often occurs, guidelines designed by clinical experts can also be reflected in administrative quality measures and metrics.   NQF, the main U.S. body for endorsing measures, manages NQF-500, a 3-hour sepsis measure.  See here and here.  For a 2018 article on the measure, see Pepper et al., here.

State Mandates for Sepsis Interventions
Some states have mandates for quality tracking and reporting on early sepsis intervention, of which the first was New York State.  For entry points see here and here.

CMS Quality Measure "SEP-1"
For its part, CMS adopted the NQF Sepsis Measure 0500 in 2015, but modifies it with additional instructions for CMS hospital reporting.   While closely based on NQF 0500, CMS calls its measure, "SEP-1."  One issue is that while the intervention actions can be described in 50 words or less, providing exhaustive instructions, rules, and exceptions analysis takes >100 pages (for one entry point, here).

See over twenty papers on SEP-1 at PubMed, with a range of pro & con viewpoints, here.    For stakeholder group comments, here.  For, "Why IDSA Didn't Endorse SEP-1," here; for two blogs here, here.  For a recent hospital trade journal essay, see here.  For a June 2018 publication analyzing early actual SEP-1 data, see Rhee et al., 2018, here.  For ins-and-outs of administratively defining sepsis, see Rhee et al., 2017, here.

In August 2018, for Inpatient FY2019 final rulemaking, CMS determined it would drop chart-abstracted (and labor-intensive) metrics except for SEP-1.  In the final rule, CMS made a point to remark that it remained interested in SEP-1 and would continue to track SEP-1.

CMS SEP-1 DATA NOW RELEASED

CMS Just Released The First Hospital-Level and State-Level SEP-1 Performance Data

In late July 2018, CMS released hospital-level and state-level SEP-1 data for the first time.  (See an article at Boston STAT, here.) There are two different routes to this data.   For consumers, CMS provides a brief summary of what SEP-1 is (here) - one of several hospital indexes for "timely and effective care."  You can search for hospitals by name or zip code and among other measures, you'll see their SEP-1 performance (here).

The professional method gives you Excel spreadsheets of hospital performance data.  Go to this professional's page (here) and click on Download Flat Files.  You'll get about 50 Excel files totalling 250MB of unzipped data.  See the ones titled "Timely and Effective Care" for data from the hospital, state, and national levels.

I've Done the Database Work For You (As .XLS)

I've created a 1 mb file of about 8 tabs of SEP1 data - hospitals, hospitals sorted by score, hospitals sorted by number of cases per year.  I've also included tabs for state level data and national data.  It's in the cloud HERE.  (Click the down-arrow to download as XLS.)

A Snapshot of SEP-1 Data

Of about 4800 hospitals listed, about 1700 don't report SEP-1 data. 

Of those that do, about 6 hospitals had a perfect 100% SEP-1 compliance score - but these hospitals had just 15-90 cases in the year.   A handful of hospitals had >700 SEP-1 category cases in the year.   About 190 hospitals had >80% SEP-1 score.

About half of hospitals had <50% score.   500 hospitals had only 30% compliance or worse with SEP-1.  The median hospital scored about 80 relevant patients per year, or about 1.5 per week.

State Level Data
In state data, Hawaii ranked highest at 68%, Puerto Rico lowest at 11% and DC second-lowest at 35%.  Indiana ranked in the lowest ten-percentile, in the bottom 4 of 50 states, at 43%.  (Indiana is the home state of Secretary of Health Azar, CMS Administrator Verma, and Vice President Pence).

SEP-1 Rules Are Complex
Note that the complex SEP-1 rules allow many patients to be excluded from counting, such as patients with sepsis but with DNR or other palliative-care-only status for whom rapid invasive interventions would be inappropriate.  Since SEP-1 is calculated manually through detailed chart review, some hospitals may be better or worse at applying the complicated appropriate or allowable exclusions.

Hospital Touts SEP-1 Score
I've seen one hospital already issue a press release on its high SEP-1 score (here).

Famous Academic Centers As Low as 23% Score
Academic centers had high variance.  Samples include Stanford (71), Johns Hopkins (53), Brigham Women's (42), and Yale (23).

click to enlarge

Charts

The chart below showed state or territory average scores.  Hawaii has a 68, at top left.  Puerto Rico has 11, at bottom right.  Most states fall between 40 and 60.

click to enlarge

In the next chart, below, 3000 hospitals are distributed across the possible scores from 0 (left) to 100 (right).   About 100 U.S. hospitals report SEP-1 scores between 0 and 15 (the three bars to the far left).  About 60 hospitals have scores about 90 (the three bars on the far right.)   Hospitals are pretty broadly distributed for scores between 25 and 75 (about the middle twelve bars). 

About 80% of hospitals fall between 25 and 75, and about 10% each are either above 75 or below 25.

click to enlarge

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Deep Dives Possible
Hawaii had the highest average score, at 68.  Of 23 hospitals in Hawaii, only half (12) reported, the others did not.  Hawaii hospital scores ranged from 41 to 82.  Scores were (41, 44, 51, 52, 53, 62, 68, 70, 71, 78, 80, 82).   Hawaii reporting is based on 2,778 total patients, about 230 average per hospital (range, 58-652, from Kona Community Hospital in Kealakekua [Big Island] to Straub Hospital in Honolulu, respectively).

Puerto Rico had the lowest regional score.  In Puerto Rico, of 51 hospitals, 29 did not report.  Of reporting hospitals, 11 reported between 1% and 88% compliance, with six below 10%.  I'm uncertain if 9 additional PR hospitals reported with a dash as their score, represent "0".

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Footnote.
I was stumped that a category with $24B costs could be the largest health care driver for hospitals.  See data here.   20 categories, with 1%-6% each, tallied just 47% of costs at $181M (2013).   The link just provided is a quite interesting view into hospital cost categories for all payers, Medicare, Medicaid, etc.

Very Brief Blog: Caris' Website Comparison of Caris and FMI

A month ago, I was struck by a back cover advertisement by Caris on the ASCO POST trade journal, Caris positioning as "The Independent and Unbiased Molecular Information Company."

I noticed today the same logo appears on their website here (as of August 3, 2018) - https://www.carismolecularintelligence.com/info/

The website includes a comparison of Caris and Foundation Medicine - Caris launched in 2009, FMI in 2012; Caris test has 592 genes at 750X depth, FMI just 324 genes at 500X, and so on. 

No take home message - just found the marekting or positioning approach and table interesting. Rather than quote it further or use screenshots, I'd direct you to the link above.

Very Brief Blog; McKinsey Publishes Trifecta of Life Sciences Strategy Articles

McKinsey & Co. is a leading global strategy consultancy.  Their Pharma & Life Sciences strategy group regularly publishes detailed open access articles on trends in pharma or, less often, medical devices.

This summer, for airplane or beach reading, see a trifecta of articles at their division website (both web and PDF versions are available; email registration may be required).  Start here.

• Designing a Healthy Future for Medical Devices (6pp)
• Real World Evidence: Driving a New Drug Development Paradigm in Oncology (8 pp)
• Launches in Oncology: Elements of Success (16 pp)

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Also in early August.  On a separate note Endpoints blog has an entry here on a new 15 page PDF report here from IMAK on overpricing in the drug industry based on patent thickets. Press release here.  IMAK is a 503(c) originally titled, Institute for Medicines, Access, Knowledge.  They have a lengthy news item page here.   Secretary of Health Alex Azar has made remarks about "patent gaming."  Trade journal article at MedCity about IMAK, here.

Also in early August, Politico had a piece on drug prices in the and shadow-boxing over price hikes and cuts, here.

Very Brief Blog: CMS Releases Final Inpatient Rule for FY2019

On August 2, 2018, CMS released the final hospital inpatient rulemaking for FY2019, effective 10/1/2018.

The home page for the final rule is here.   CMS has released a "unpublished" early version (typescript); the final typeset version will be released August 17.   The rapid version PDF is here.  It tallies a hefty 2,593 pages.

The most newsworthy item is that CMS will pay for CART therapies (Kymriah, Yescarta) under standard "new tech" payment rules, which pay hospitals 50% of the extra cost - CMS will pay the hospital e.g. $80,000 of an extra $160,000 cost.

Overall, CMS had 15 new tech products under review, and while 4 dropped out for various reasons, it covered 10 of the remaining 11 candidates.   Typically, CMS raises a lot of objections of variable cogency against the products' novelty or value in preliminary rulemaking but is less stringent in final decisions.  However, I believe the win rate for industry is higher this year than usual.[*]  CMS now liberally creates new tech ICD-10 procedure codes as needed to implement new tech payment rules.

CMS produced the final rule only 35 days after the comment period closed (June 25).

Biorobotic Medtech Wins NTAP for Prostate Surgical Treatment

A Bay Area medtech company, PROCEPT Biorobotics, won a New Technology Add-On Payment (NTAP) for its Aquablation procedure for treatment of BPH.   (See pp. 752-782).  The procedure is also up for a Category I CPT code in the 9/2018 AMA CPT meeting.   Procept successfully raised $118M in February 2018.

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[*]  In August 2015, there were only six applicants and four were rejected.  Some organizations complained that CMS standards were unreasonably high (here).

Comment on (Non Lab) CPT Codes Proposed for September AMA CPT Meeting

AMA CPT provides a brief listing of new code applications and accepts public comment a motnh or two before each CPT Editorial Panel meeting.   

Lab codes run on an earlier schedule than non-lab codes.

Go to the home page for the September 27-29, 2018, CPT editorial panel meeting, here.

Scroll down to"Panel Meeting Public Agenda" and download the PDF file (currently here.)

• For lab codes, AMA expected you to request a packet on a code of interest by August 1, and deliver comments to them by August 7.
• For non-lab codes, AMA will accept requests to review an application packet until September 7, and will accept your comments until September 14.

62 Agenda Items

The September 2018 meeting is the last meeting for which new (non lab) codes will enter the CY2020 CPT manual.   Therefore, September meetings tend to be bigger than average.

There are a range of code deletions and new code proposals for "Online Digital Evaluation Services, or E-Visits."   There are new or revised codes for self-measured blood pressure monitoring and other remote physiologic monitoring.  There is a Cat III code for addiction management (tab 58) and for biomechanical computed tomography (tab 57). 

I tally 18 tabs for Category III codes (some of which are agenda items with multiple codes within them; and several are requests to revise codes up from Cat III to Cat I.)

Very Brief Blog: Concert Genetics' Free Website Search of Labs and Charges

This month, I was working on a project to help stakeholders comment on the bizarrely low CMS gapfill price for clinical whole genome sequencing (CPT 81425, CMS proposal $349 [!]). 

One helpful resource was the Concert Genetics open public database of labs, test names, and often charges [email registration required.]. 

Go to https://www.concertgenetics.com/ and in the upper right see "Search Genetic Tests."   For first time users, you'll be guided to open-access registration.   A few screen shots below.  Typical charges for whole genome sequencing are circa $7500.

click to enlarge

Brief Blog: Imminent Lab Comment Deadlines for CMS Gapfill and for AMA CPT September Mtg

Comment Deadlines:

COMMENT ON CMS GAPFILL BY AUGUST 7, 2018

CMS has 18 lab codes under the gapfill pricing method and under public comment.   Go to the CMS lab public meeting home page here, and scroll down to Gapfill.   Submit comments to Mr. Glenn McGuirk by Tuesday afternoon, August 7, eastern time (see email on page).   Scroll to the hot link 2018 CLFS Gapfill Preliminary Determinations - Updated 06/13/2018 [ZIP, 17KB]  to see the proposed prices under comment.

Probably the most bizarre price is for whole genome clinical sequencing (81425) for which CMS MACs propose $349 payment, although whole exome clinical sequencing (81415) is priced at about $4800.   The only thing close to $349 I could find was a price offered by Dante Labs on Amazon.com, and I couldn't find an NPI or CLIA registration for Dante.   Concert Genetics has a public website* of lab offerings, many with charges, and typical whole genome pricing was about $7500 per proband or in one case about $18,000 for a trio (infant, two parents, the typical scenario).  WGS clearly has some high-profile and impactful use cases now (see Faernes et al., 2018, from Rady Children's Hospital in San Diego; here.).

COMMENT ON AMA CPT LAB CODES BY AUGUST 6, 2018

AMA CPT posts brief titles of pending CPT applications a couple months ahead of each meeting, and you can request a full application (about 20 pages), review it, and comment.   The schedule for lab codes runs earlier than all other codes.  AMA wanted you to request the applications by August 1, and comments are due August 6.  Home page here, PDF of lab codes here.  Note that links may change, in which case start from the page I've just listed as "home page."

COMMENT ON AMA CPT "Non-LAB" CODES for SEPTEMBER

AMA CPT has posted the brief titles of all non-lab codes on the same home page for the September 27-29 meeting.  For links see here.

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* You can get into the Concert Genetics website and see labs, offerings by test name, and often charges, but you have to do a free email registration (here).

Brief Blog: California Legislature Approves $2M for Whole Genome Sequencing in Rare Diseases

Not "new news" but here's a link to a June 22, 2018, article that the California legislature had approved a $2M pilot program to provide whole genome sequencing (WGS) to patients with rare diseases in the MediCal program (California Medicaid). 

The program is summarized as:  "The pilot project will serve a minimum of 100 Medi-Cal neonatal and pediatric patients with undiagnosed diseases that have either remained undiagnosed, or had multiple incorrect diagnoses. These patients will be tested using cWGS as a first line diagnostic test. Regular reports to the Legislature and the state Department of Health Services will be required to provide tight oversight on the project’s progress and patient treatment adjustments. The goal of this proof of concept project is to demonstrate both the clinical benefits for Medi-Cal patients and financial benefits for the program as a whole."

Similarly, an incubating House propose in D.C. would providing optional funding for states that wanted to provide WGS to children in their Medicaid programs; see H.R. 5062 sponsored by Rep. Swallwell (here, here).

The California genomics industry is split between the SF and San Diego areas; for example, Thermo Fisher and Illumina have larger centers in both locations.   A recent report attributed the genomics industry as having a $5.6B impact on the San Diego area (here). 

Brief Blog: McDermott Produces Detailed Guide to Medicare Digital Health Progress

McDermott Will & Emery has produced a detailed guide to recent updates, changes, and proposals with regard to how Medicare will pay for, or could pay for, digital health in the coming year. 

See the article here, posted on JDSUPRA open access (email registration might be required).  The article tallies about 4000 words and 11 pages as a Word document.  Authors are posted as Marshall Jackson Jr, Lisa Schmitz Mazur, Michael Ryan, and Dale Van Demark.

See some additional links to Dhealth/Telehealth changes at CMS in my link to the new PFS proposed rule here, one particularly good essay by Foley Lardner here.

July 25, 2018: CMS Releases Annual Outpatient Rule Proposals

On July 25 - almost a month later than normal - CMS released outpatient rulemaking for CY2019.    Public comment is open for 60 days (September 24, 2018).

The CMS homepage for the rulemaking is here.  The CMS press release is here.  For a deeper dive see the "Fact Sheet" here.

The Federal Register home page (includes comment link) is here and the actual rule is here (83 Fed Reg 37046-37240, 195pp, July 31, 2018).

Bonus:
Read a speech presented on the same day by Seema Verma to the California Commonwealth Club, here.