Leveraging Pharmacies for Rapid Diagnostics (Conference, August 2015)

For conference website, see here.  Partial clippings below.

RETAIL PHARMACY CASE STUDY:

12:00 pm Reimbursement of Point-of-Care Testing in a Retail Health Clinic Setting 

 Daniel R. Kerls, MBA, OTR/L, Director, Ambulatory Operations, CVS MinuteClinic

This presentation will focus on how point of care labs influence overall reimbursement in a retail health setting and provide an overview of current challenges and opportunities, as well as considerations of supplies and control testing.

CAPABILITIES OF PHARMACIES

1:50 Chairperson’s Opening Remarks

Allison M. Dering-Anderson, BA, Pharm.D., RP, FAAIM, Clinical Assistant Professor, Pharmacy, University of Nebraska College of Pharmacy

2:00 Community Pharmacies: The Face of Neighborhood Healthcare

Alex J. Adams, Pharm.D., IOM, Vice President, Pharmacy Programs, National Association of Chain Drug Stores (NACDS)

Community pharmacists are among the most accessible and trusted healthcare professionals; 95% of all Americans live within 5 miles of a pharmacies. Increasingly the public is turning to pharmacies for expanded services such as immunizations and point-of-care tests. This session will describe the community pharmacy landscape and opportunities to bring tests truly to the point-of-care.

2:30 Utilizing Pharmacists in Point-of-Care Testing: Scope of Practice Opportunities and Barriers

Krystalyn K. Weaver, Pharm.D., RPh, Director, Policy and State Relations, National Alliance of State Pharmacy Associations

This session will provide information on pharmacists’ education and training as it relates to point-of-care testing. An overview will be provided on how state laws and regulations that define pharmacist scope of practice create opportunities and barriers for the implementation of point-of-care testing programs in community pharmacies.

EXPLORING PHARMACY NEEDS AND DIAGNOSTIC CAPABILITIES

KEY INFORMANT INTERVIEWS:

3:00 Key Informant Interviews: Preliminary Results and Next Steps

Kenneth C. Hohmeier, Pharm.D., Assistant Professor, Clinical Pharmacy; Director, Community Affairs, College of Pharmacy, University of Tennessee

This session will present preliminary results from key informant interviews of diagnostic test manufacturers and pharmacy leaders. Manufacturers will have an opportunity to ask questions about the pharmacy market and pharmacy representatives will provide insight into the needs of the pharmacy market. The session will also include an opportunity for the audience to inform future interviews.

5:15 The Shifting Landscape of Diagnostic Testing 

Harry Glorikian, Senior Executive/Board Director/Healthcare Consultant

Diagnostic technology is continually evolving to meet changing models of care. This talk will discuss the trends driving the shift of where testing is performed. We will also discuss existing and emerging technologies in relation to diagnostics. We will discuss CLIA-waived tests and rapid tests that don’t require extensive processing but also other emerging trends that affect patient care and management. Finally, potential clinical and business opportunities for this market will be addressed.

5:45 What Tests Are Currently Available and Do They Fit into a Community Pharmacy Practice

Michael E. Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy

The emerging market to use of CLIA-waived POC tests in community pharmacies will be discussed. Existing and developing care models will be explored. A review of test characteristics that would be attractive for pharmacy use will be provided. Opportunities and barriers for implementation of CLIA-waived POC test integrated care models will be explored.

THE BUSINESS OF HEALTHCARE: SOCIAL, ECONOMIC, AND LEGAL IMPLICATIONS

10:55 Chairperson’s Opening Remarks

Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center

11:00 Point-of-Care Diagnostics: Business Case and Patient Perceptions

Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center

This program will discuss research studies examining patient acceptance of and willingness to pay for pharmacy based point-of-care tests.

11:30 Point-of-Care Diagnostics: Regulatory Perspective

Allison M. Dering-Anderson, BA, Pharm.D., RP, FAAIM, Clinical Assistant Professor, Pharmacy, University of Nebraska College of Pharmacy

This program will focus on the regulatory and statutory issues that may be encountered by pharmacies conducting Point-of-Care Tests or planning to conduct Point-of-Care Tests. It will also be useful to test manufacturers and developers who are looking to enter the community pharmacy market.

AMP February 2015 Webinar on Microcosting of Molecular Tests

Webinar on Pricing/MicroCosting of Genomic Procedures (Next Gen Sequencing) 

(February 13, 2015)

In the July 2014 Medicare CLFS public meeting, AMP proposed some novel costing approaches to price next gen sequencing procedures.  CMS did not accept them as crosswalk pricing (CMS is allowing its contractors to gapfill the NGS CPT codes for CY2015).  AMP is continuing to develop its concepts, with a webinar presented on February 13, 2015.  Video and PDF are available online (here, here).  AMP notes that two expert consulting groups, Tynan Consulting and Boston Healthcare Associates, have assisted in the project.

June 3, 2015: Elizabeth Holmes, Charlie Rose

http://www.charlierose.com/watch/60570963

 These are my personal "notes to self" as I listened to the television program.

20150603

Elizabeth Holmes at Charlie Rose

www.charlierose.com

Elizabeth Holmes, Found and CEO, Theranos, blood analytics, innovation.

Tests detect dozens of medical conditions on a few drops of blood.
Transform healthcare through prevention and early detection.

Started when she was 19, it is now worth $9B.  One of TIME's most influential people of 2015.

PEPPERDINE:
Define what is non negotiable to you, what you will fight for.  That is our mission.

Realizing a change in a stagnant industry that resulted in so much loss and pain.

One day - people won't say good buy to soon to dying loved ones.

Theranos is a vehicle to do well by doing good, what I am doing with "My time in the world."

Charlie Rose:

We've wanted you here for a while.  Tell me about the speech.

EH:

Our mission is to make actionable information, accessible to every person, when it matters.

Realizing a world where early detection and prevention are realities of healthcare.

If we can make it possible to see the onset of disease, in time for therapy, we change outcomes.

Often today we find out someone is really sick when it's too late.

Earlier intervention - we can facilitate that, and change the cost structure.

CR:
Personalized medicine - you don't have to go to a lab?

EH:
Yes, we are still a lab, but it's decentralized, distributed access, a local retail pharmacy.

Late at night.  On a weekend.

CR:
The process is easier, finger prick.

EH:
I'm scared of blood draws myself.

Smaller samples, period, for urine, blood, we can do finger drops.  Or from the arm, but less blood.

CR:
Less expensive? Quicker? If widespread, you could have a huge impact?

EH:
That's our goal and dream.

We're just getting started.  12 years building the tech infrastructure.

We're now applying it.  Transforming cost and accessibility.

With recent work in changing the AZ law, to make people have the human right to order lab tests.

We'll see the shift in information.  

CR:
Not through a physician.

EH:
That's right, with protections for physician engagement.

The purpose of direct access, IS to engage a physician.

But there has been such liabilities to prevent physicians from engaging with consumers.

We added blanket protections for physicians.

CR: 

Part is process, it's also science.  You get the same results, if in fact they want to a doctor.

EH:
We do.  The same.

CR: 

What are the results?

EH:
Lab results, like a lab report from a traditional doctor visit.

Chemistry, glucose, blood count.  

We want the report, so individuals can better engage with it.

We are the first to say, every lab test should be submitted to the FDA.

Lab tests haven't historically been regulated by FDA.

CR:
Can you share the process, so it can be applicable beyond Theranos?

EH:
We want to share the work.

We're early.

CR:
Ten years, beyond blood testing?  

EH:
Maybe...it's far away.  We're doing broader lab testing already.

How we can build distributed care, infrastructure.

CR:
Scaling, the next 18 months?

EH:
Scaling the right way, incredibly high quality.

CR;

Primary growth in Arizona? the US?

EH:
We'll expand into more states from there.  We have a wellness center in Palo Alto.

We're looking at other metropolitan areas.

CR:
With the idea, the mission, I see something I find unacceptable, how do you from that (mindset) to Theranos?

EH:
You're here to make a difference in the world, I feel I was born to do this.

I believe this problem, there's nothing more than matters to save lives.

I was doing this, not going to classes, at Stanford, where I strated in Chem and Electrical Engineering.  

I filed a patent, and was doing this 24/7.

CR:

One aspect, you have a board of directors...enormously respected.  Henry Kissinger...

Where did that idea come from?  Superb judgement...And how do you get them?

EH:

It both evolved. Over 10 years.  We didn't have a website or press release.

Then we realized we could begin serving individuals directly.  I wanted the strategically brilliant guidance.

We billed Medicare and Medicaid, for the first time ever, at less than they are willing to pay.

Rates will drop.

We'll have savings without raising taxes or cutting programs.

CH:
So you called these board members?

EH:
I met them over time.  George Schultz wrote a book on healthcare.

[Shoeven & Schultz, 2008, Putting our House in Order; Social Security & Health Care Reform]

He saw it as something that could be very meaningful.  Person by person - I met these people after that.

They are all helping us because it is a mission that will have such enormous implications.

CH:
How will this change physician/patient relationships?

EH:
Raise engagement earlier, not when all the symptoms appear.

People only get lab tests from insurance when the present with a symptom.

Otherwise "payment was not justified." And 40-60% of Americans don't fulfill the test order.

People are so far progressed in their disease (when detected) so we recreate the system,

we the lab facilitate the engagement before you are sick.

CH:

What's the scientific change? You discovered, created - what?

EH:

There's many elements.  Test by test, redeveloping the chemistry of the traditional lab.

Working on small samples.

Redevelop the hardware.  The software.  Automating.  Collection technology.

It's an engineering question...

We've invested in all the areas.  And bring them together.

CH:
I'm interested, ideas are born by asking questions, is there a better way.

Going out and figuring out, can it be yes?

Has anyone challenged the science? Why don't you show us, we'd be comfortable.

EH:
The major lab companies [say that.]  They...we had been...we didn't talk...

We wanted to do it, then talk.

So we did.

Now we talk about it.  We want people to understand.  The information is transformative.

The response of major labs, "Too much secrecy...why don't they show us?"

We're small, we don't need to tell competitive companies.

CR:
Competitive businesses are concerned about ideas in products...

But you want people to understand it's revolutionary...

EH:
We have a long term plan.  Someone says, "We want to know" we don't have to respond.

CR:
You went to FDA?  Can people do something else?

EH:
We think the first place is the FDA. FDA may review a platform for years.

You have to enroll prospective studies.  FDA will be sure the data is right, no

one will look as thoroughly as FDA.  Without question, the best way for a binary test,

right or wrong, the FDA is the gold standard.  Decision summaries will come out

through the FDA process.

CR:
Rather than some other appraisal.  This approach is in your interest...to be able to document the results.

EH:
We have no issues with the independent appraisal process, as we work with hospital systems, they will do that also.

No laboratory has ever done publications around the integrity of their lab developed tests.  That's what we were asked to do.

CR:
Some might suggest, for the best of reasons, created a company that produces something to change healthcare,

but your reason, like Steve Jobs, he was very protective about his closed system of products.

This is a business decision.

EH:
Without question, we are the first lab to publish our data on our website, our scores, audits, customer satisfaction, turnaround time.

We can talk about accuracy that way.  The timing for disclosing more pieces, not reactive, part of a business plan.

CR:
Starting when?

EH:
With the FDA.  (How long?"  I can't predict.  

CR:
What will FDA tell you?

EH:
We have a really good relationship.

CR:
Don't they focus on no falsehood in communication?

EH:
Integrity of the test, how it performs, precision, and it should be used this way.

For individuals, FDA does the clinical piece, the use, that's central to interpretation.

CR:
Do you worry about...if you do good, why worry...but people are developing systems that will

even eliminate a needle?  Maybe you are too?

EH:
This is the amazing thing about USA, Silicon Valley, we love the speed of innovation.

You have to be on version 10 when everybody else is on version 1.

CR:
If we can eliminate the small blood test, we will!

EH:
Only the paranoid survive, said Andy Grove.

CR:
His book.

Does making a difference, within you, you feel, I have to do this, important things.

EH:
I grew up in a house with pictures of my Dad in tough places in the world, as a disaster relief worker.

I thought I would do that.

If today were my last day on earth, I could say, the people who have never been able to afford the ability to get care for their family, now can.

People who have gone through hell, can get the test done.

Then I've done something to make the world a better place.

CR:
Is how much you are worth, is it a measure of the importance of the company?

EH:
Personal worth ($) is not what matters.  It is to do more, better, less expensive, it's about that.

CR:
Your life is at work, go the stories.  Unless you are there, you may miss something.

Whatever you miss outside work, what satisfies you is being "there" at Theranos.

EH:
It is.  I've thought alot, it's what I love.  I love it more, I have a very simple life, this work and my family.

It becomes addictive!

CR:
Thank you.