Health Regulations

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Promise, Adoption, and Reality: Dispatches from Connected Health 2018

It’s a rare feat to be engaged, educated, and entertained at the same time, but the Oxford-style debate at Connected Health on telehealth’s effectiveness did all three. Moderated by new Chief Digital Officer for Partners Healthcare, Alistair Erskine, MD, with Ateev Mehrotra, MD debating that telehealth is not effective, and head of the American Telemedicine Association, Andrew Watson, MD debating that it is, the format and discussion delivered a provocative closing session on Day 1 of Connected Health. As decided by the audience, the winner was Dr. Watson, citing effective programs like telestroke, consults and expert referrals, and rural medicine. However, applause for Dr. Mehrotra was also strong, and I suspect that his major points that telehealth has not reached broad adoption, and in fact there have been observations that telehealth is actually increasing utilization as people follow a telehealth visit with an in-person visit. The question is whether that visit wouldn’t have happened and we’d see worse health outcomes, or whether the person had a problem that couldn’t be helped with telehealth.

In another deep dive session on telehealth, “Making Connected Health Work for Physicians”,  Kevin Fickenscher, MD talked about a unique program to train clinicians on virtual visits. Given that the diagnostic capabilities are different, for example, you can’t touch the patient, this makes perfect sense. Questioning and listening skills are going to be more important than physical exam, and observation may be limited by (current) video technology. Also in this session, Ami Blatt MD from Partners, talked about how her young and mobile patients essentially lead her to telemedicine, by insisting that was how they wanted to communicate: the consumerization of healthcare in action. She also recommended to any physicians wanting to deploy a telemedicine solution to make sure that the goals of the program align with the financial incentives available for the hospital.

So, what do we take away from this? Twenty years later, telemedicine is still in the promise stage. Practice and reimbursement needs to change even more to find true breakthroughs, and perhaps we should look at pattern matching to find other successful workflows and outcomes that resemble the benefits for telestroke.

In no particular order, here are some other observations from the conference:

  • Patients are taking a bigger role, whether that was a patient co-presenting in a session on Patient Generated Health data, the Wego Health Awards honoring LupusLady as an activated and collaborative patient, or the society for Participatory Medicine pre-day with patients included, the voice of patients is increasingly being listened to with a real seat at the table.
  • Digital therapeutics and behavioral health are hot. There was a special pavilion on the tradeshow floor dedicated to digital therapeutics where our fellow Seattle health innovators, 2Morrow presented great results from their smoking cessation programs.
  • Patient-generated data is starting to show promise and much greater acceptance by clinicians, particularly in the ability for clinicians and patients to talk to each other. However, we’d still like to see a better connection of data and actionable care plans, and there was still some mention of the data being better because patients cheat when verbally relating data like blood sugar after the fact. Data alone isn’t enough to support patients or change behavior, and it shouldn’t be continued punitive.


From Session: PGHD End User Experience: Patients and Providers

  • There’s a continual blurring of the lines with engagement, particularly member and patient engagement, and there were a ton of new companies in this space (again), all offering to get members and patients engaged. From their overviews it was hard to tell how targeting providers and payers was even different aside from the terminology.
  • Although a full-day devoted to voice interfaces definitely showed it’s a hot topic, AI was definitely the buzzword of the show.

We’re already gearing up for HIMSS 2019 where we hope the buzzword of the show will be “outcomes”. We just heard that our talk on the (really positive) results of the REACH study has been accepted. See you there?

Posted in: Health Regulations, Healthcare motivation, Healthcare Technology, Healthcare transformation, HIMSS, M-health, patient engagement, Patient Satisfaction, patient-generated data, Telemedicine, Voice

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Digital Transformation in Pharma: Digital Pharma West

Like the rest of the healthcare industry, the pharma industry is also grappling with lots of data, disconnects from end-users, and shifting to a digital-first experience while grappling with ongoing regulatory and privacy challenges. Actually it’s pretty much what every industry is grappling with, so the good news is that no one is getting left behind in this digital revolution.

In pharma though, the division between commercial and R&D creates both delays and lags in implementing new technology and the regulatory challenges cause specific issues in communication with both providers and patients.

Last week, I was invited to speak at Digital Pharma West about our work in voice-enabling care plans for people with Type 2 diabetes, and also how our participation in the Alexa Diabetes Challenge enabled us to engage with pharma. It was my first ‘pharma-only’ conference, so it was interesting to contrast with the provider and healthcare IT world.

If you think that there are a lot of constituents who care about digital health in provider organizations, pharma rivals that. For example, there was a discussion about the value of patient-facing digital tools in clinical trials. While everyone agreed there could be real value in both efficiencies of collecting data, and engaging patients and keeping them enrolled in trials, a couple of real barriers came up.

First the question of the impact of the digital tools on the trial. Would they create an intended impact on the outcomes, for example a placebo effect? Depending on how the “usual care condition” is delivered in a control group, it might not even be possible to use digital tools in both cohorts, which could definitely impact outcomes.

Another challenge with digital technology in randomized control trials is that technology and interfaces can change much faster than drug clinical trials. Considering that elapsed time between Phase 1 and Phase 3 trials can be years, also consider that the technology that accompanies the drug could change dramatically during that period. Even technology companies that are not “moving fast and breaking things” may do hundreds of updates in that period.

Another challenge is that technology may advance or come on the market after the initial IRB is approved, and while the technology may be a perfect fit for the study, principle investigators are hesitant to mess with study design after IRB approval.

Interestingly, while in the patient-provider world the number of channels of communication are increasing significantly with mobile, texting, web, and voice options, the number of touch points in pharma is decreasing. Pharma’s touchpoints with providers are decreasing 10% per year. While some may say that this is good due to past overreach, it does make it difficult to reach one of their constituents.

At the same time, regulations on approved content for both providers and patients means that when content has had regulatory approval, like what you might find in brochures, on websites, and in commercials, the easiest thing to do is reuse this content. However, new delivery channels like chatbots and voice don’t lend themselves well to static marketing or information content. The costs of developing new experiences may be high but the costs of delivering content that is not context or end-user aware can be even higher.

At the same time, these real-time interactive experiences create new risks and responsibilities for adverse event reporting for organizations. Interestingly, as we talk with pharma companies about delivering interactive content through the new Wellpepper Marketplace, these concerns surface, and yet at the same time, when we ask the difference between a patient calling a 1-800 line with a problem and texting with a problem there doesn’t seem to be a difference. The only possible difference is a potential increase in adverse event reporting due to ease of reporting, which could cause problems in the short term, but in the long term seems both inevitable and like a win. Many of the discussions and sessions at the conference were about social media listening programs for both patient and provider feedback, so there is definitely a desire to get and make sense of more information.

Like everyone in healthcare, digital pharma also seems to be at an inflection point, and creativity thinking about audiences, channels, and how to meet people where they are and when you need them is key.

Posted in: Adherence, Clinical Research, Data Protection, Health Regulations, Healthcare Disruption, Healthcare Policy, Healthcare Research, Healthcare Social Media, Healthcare Technology, HIPAA, M-health, Outcomes, pharma, Voice

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Dispatches from the Canadian E-Health Conference: The same but different

Bear statue in VancouverThe annual Canadian E-Health Conference was held in Vancouver, BC last week. I had the opportunity to speak about the work we’re doing at Wellpepper in applying machine learning to patient-generated data, and in particular the insights we’ve found from analyzing patient messages, and then applying a machine-learned classifier to alert clinicians when a patient message might indicate an adverse event. Our goal with the application of machine-learning to patient generated data is to help to scale care. Clinicians don’t need to be alerted every time a patient sends a message; however, we don’t want them to miss out if something is really important. If you’d like to learn more about our approach, get in touch.

My session was part of a broader session focused on ‘newer’ technologies like machine-learning and blockchain, and some of the other presenters and topics definitely highlighted key differences between the US and Canadian systems.

Aside from the obvious difference of Canada having universal healthcare, there were subtle differences at this conference as well. While the same words were used, for the most part: interoperability, usability, big data, and of course blockchain and AI, the applications were different and often the approach.

Interoperability: Universal doesn’t mean one

Each province has their own system, and they are not able to share data across provinces. Unlike the UK which has a universal patient identifier, your health records in Canada are specific to the province you live in. As well, apparently data location for health records is sometimes not just required to be in Canada, but in the actual province where you reside and receive care. As for interoperability, last we heard, British Columbia was doing a broad roll out of Cerner while large systems in Alberta were heading towards EPIC, so Canada may see the same interoperability challenges we see here if people move between provinces.

Privacy: The government is okay, the US is not

What’s interesting is as a US company, is that whenever we talk to health systems in Canada they bring up this requirement, but as soon as you mention that the PIPEDA requirements enable patients and consumers to give an okay for out of Canada data location they agree that it’s possible. Regardless, everyone would rather see the data in Canada.

What was possibly the most striking example of a difference in privacy was from one of my co-presenters in the future technologies session, who presented on a study of homeless people’s acceptance of iris scanning for identification. 190 out of 200 people asked were willing to have their irises scanned as a means of identification. This identification would help them access social services, and healthcare in particular. The presenter, Cheryl Forchuk from the Lawson Health Research Institute said that the people who participated didn’t like to carry wallets as it was a theft target, that they associated fingerprinting with the criminal justice system, and that facial identification was often inaccurate due to changes that diet and other street conditions can make. When I tweeted the 95% acceptance rate stat there were a few incredulous responses, but at the same time, when you understand some of the justifications, it makes sense. Plus, in general Canadians have a favorable view of the government. The presenter did note that a few people thought the iris scan would also be a free eye exam, so there may have been some confusion about the purpose. Regardless, I’m not sure this type of identification would play out the same way in the US.

Reimbursement: It happens, just don’t talk about it

The word you didn’t hear very much was reimbursement or when you did, from a US speaker the audience looked a bit uncomfortable. The funny thing is though, that physicians have billing codes in Canada as well. It’s just that they are less concerned about maximizing billing versus being paid for the treatment provided and sometimes even dissuading people from over-using the system. Budgets were discussed though, and the sad truth that money is not always smartly applied in the system, and in a budget-based system, saving money may decrease someone’s future budget.

Blockchain: It’s not about currency

Probably the biggest difference with respect to Blockchain was the application, and that it was being touted by an academic researcher not a vendor. Edward Brown, PhD from Memorial University suggested that Blockchain (but not ethereum based as it’s too expensive) would be a good way to determine consent to a patient’s record. In many US conferences this is also a topic, but the most common application is on sharing payer coverage information. Not surprisingly this example didn’t come up at all. If you consider that even though it is a distributed ledger, a wide scale rollout of Blockchain capabilities for either identification or access might be more likely to come from a system with a single payer. (That said, remember that Canada does not have a single payer, each province has its own system, even if there is federal funding for healthcare.)

“E” HR

Physician use of portalFor many of the session the “E” in e-health stood for EHR, which while also true in the US, the rollout of wide scale EHRs is still not as advanced. Cerner and EPIC in particular have only just started to make inroads in Canada, where the a telecommunications company is actually the largest EHR vendor. In one session I attended, the presenter had done analysis of physician usage of a portal that provided access to patient labs and records, but they had not rolled out, what he was calling a “transactional” EHR system. Physicians mostly accessed patient history and labs, and felt that if the portal had prescribing information it would be perfect. Interesting to see this level of access and usage, but the claim that they didn’t have an EHR. What was also interesting about this study is that it was conducted by a physician within a health system rather than an academic researcher. It seemed like there was more appetite and funding for this type of work within systems themselves.

Other Voices: Patients!

Patients on the mainstageDuring the interlude between the presentations and judging for the well-attended Hacking Health finals, and on the main stage, presenters interviewed two advocate patients. While they said this was the first time they’d done it, both patients had been at the conference for years. So while the mainstage was new, patient presence was not, and patient advocate and blogger Annette McKinnon pushed attendees to go further when seeking out engaged patients. Noting that retirees are more likely to have the time to participate in events she asked that they make sure to seek out opinions for more than 60 year old white women.

There was also an entire track dedicated to First Nations Healthcare. Think of the First Nations Health authority as a VA for the indigenous people of Canada, which incorporates cultural differences and traditional practices of the First Nations people. The track started and concluded with an Elder song and prayer.

Manels

Speaking of diversity, I didn’t witness any manels.

Best Quote

 

Posted in: big data, Clinical Research, Health Regulations, Healthcare Disruption, Healthcare Research, Healthcare Technology, Healthcare transformation, Interoperability, M-health, patient-generated data

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Pointing Fingers at Healthcare Problems

I’m only halfway through Elizabeth Rosenthal’s “An American Sickness: How Healthcare Became Big Business and How You Can Take It Back” which means that I haven’t gotten to the “what you can do about the problem” part. It’s a slow read, not because it’s not compelling but because it’s too compelling, and if like the current President, you were surprised at how complicated healthcare is, this book will do nothing to dissuade you. It’s really really complicated.

So far, I have two main takeaways from the book, that are easily illustrated through my recent experience of breaking and dislocating my finger: a simple, non-life-threatening problem, that unearthed a couple of key dysfunctions and unintended consequences.

My first takeaway is that everyone is complicit, and yet seem to manage to finger point at everyone else. Rosenthal spares no punches in unearthing decisions that are not made with the best interest in of the patient at heart. Providers, healthcare organizations, payers, pharma, and employers all are complicit in the mess that is our current healthcare system.

This past fall, I broke and dislocated my finger. It wasn’t a big deal, but because it happened on a Saturday night, my only option for care was at the ER. Last week I received a letter in the mail from my insurance company, that according to the envelope required my urgent reply. In the letter, the insurance company suggested that perhaps someone other than them may be on the hook for my ER bill. While I understand they wanted to make sure this wasn’t a worker’s compensation claim, the form was basically for me to tell them whose fault my injury was so that they could go after another insurance company to pay. This was a sports injury in a game of Ultimate Frisbee, a game so granola-like that there are no referees: players call fouls on themselves. . No one was at fault, and even if they were, I would never have considered suing. However, the form didn’t give me that option: only gave me the option of saying whether I had settled my claim. I created a new box that said “NA” and checked it.

When I received the letter, I couldn’t help but think back to Rosenthal’s book, and also consider the amount of effort and cost that was going into finding someone else to blame and pay. Just imagine what this effort and cost would have been if there were legal action….

The second takeaway is that the original intention of a decision always has much farther reaching implications than anyone who agreed on what seemed like a reasonable decision though. Again with the finger, I was asked a number of times if I wanted a prescription for OxyContin. I did not. As has been well publicized we have an opioid addiction problem in North America. While my finger hurt, aside from morphine during inpatient for an appendectomy, I hadn’t had opioids, and really didn’t think that it was necessary, which I explained to the physician. It wasn’t. Tylenol worked fine—however, it seemed that it was very important that I be the one to make this call, not the physician.

One of the unintended consequences of patient satisfaction scores may be the over prescription of pain medication, as many of the questions on the HCAHPS are about whether the patient’s pain was well managed. In Rosenthal’s book, I was also surprised to learn that a finger fracture where an opioid is prescribed has a different billing code than if it is not prescribed, and that with the fracture plus opioid billing code, hospitals get paid more. Now, if you are wondering how this may be the case, if you think about it, a fracture that requires an opioid must be more severe than one that doesn’t and therefore the billing code reflects the severity. This is exactly where the unintended consequences of billing codes can result in exactly the wrong behavior for patient care and safety.

It’s quite possible that the physicians on duty were not aware of either of these two drivers for prescribing, especially the billing code one. They may have just been told “this is our standard of care” and were following guidelines.

If a simple finger fracture and dislocation can shine a light on two key problems in our healthcare system, just imagine what else is out there. Actually, you don’t have to, just get a copy of Elizabeth’s book yourself, and let’s compare notes when I get to the part about what the fix is. It’s going to take all of us.

Posted in: Health Regulations, Healthcare costs, Healthcare Disruption, Healthcare Legislation, Healthcare Policy, Healthcare transformation, Opioids

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Disruptive Innovation, Sparks of Light, or the Evolution of Care: Recap of Mayo Transform Conference

In what has been a roller-coaster year for healthcare legislation, it’s the annual touchstone of the Mayo Clinic Transform Conference provided a welcome opportunity to reflect on where we are. This conference, sponsored by the Mayo Clinic Center for Innovation attracts powerhouse speakers like Andy Slavitt and Clayton Christensen, and yet manages to fly under the radar. This year’s theme was about closing the gap between people and health, so the social determinants of health were a key topic, as was whether disruption alone would solve the problem.

Dr Robert Pearl

This was my third year attending, and second year speaking at the conference, and I’ve noticed a trend: the conference starts by articulating the problem, and building up solutions and creative ways to reshape the problems over the course of the two days. This year the conference was deftly moderated by Elizabeth Rosenthal, MD,Editor-In-Chief of Kaiser Health News and author of “An American Sickness.” Rosenthal, an MD herself, and former NYTimes journalist, peppered her moderation with real-world examples of both waste and inefficiencies and effective programs based on her investigative journalism.

I’ve been wanting to write a blog post for a while that riffs on the theme of “You Are Here” trying to outline where we are in the digital evolution in healthcare, but it’s clear that we don’t know where we are, digital or otherwise: too much is currently in flux. There are points of light with effective programs, and things that seem very broken. The panel I was on, was titled “Disruptive Innovation” and I’m afraid we let the audience down, as while we are doing some very interesting things with health systems, we are not turning every model on its head. We work with providers and patients to help patients outside the clinic. Truly disruptive innovation would work completely outside the system, which leads to the question, can health systems disrupt themselves or will it come from entirely new entrants like say Google, Apple, or Amazon?

Dr. David Feinberg of Geisinger reads from debate opponent Dr. Robert Pearl’s book

Clayton Christensen, the closing keynote speaker, likens hospitals to mainframe computers, and basically says they will be overtaken by smaller more nimble organizations, much like the PC and now smartphone revolution. Organizations like Iora Health who holistically and preventatively manage a Medicare Advantage population are the epitome of these new entrants, and we’ve seen some hospitals struggle this year, but will they go away entirely? The answer to this question may lie in the excellent debate session “Is The US Healthcare System Terminally Broken” hosted by Intelligence Squared and moderated by author and ABC News Correspondent John Donovan.

 

Shannon Brownlee, senior VP of the Lown Institute and visiting scientist at the Harvard T.H. Chan School of Public Health, and Robert Pearl, MD, and former CEO of the Permanente Medical group were arguing that the system is broken, vs Ezekiel Emmanuel, MD, Senior Fellow Center for American Progress, and David Feinberg, MD, CEO of Geisinger.

While prior to the debate the audience favored the idea that the system is irreparably broken, by the end, they had come around to the idea that it’s not, which would point to the ability for healthcare to disrupt itself. The debate

Is Healthcare Terminally Broken

The final audience vote

was ridiculously fun, partially from the enthusiasm of the debaters, and because the topic was so dear to all attendees. You can listen to the podcast yourself. However, the posing of the question set up an almost impossible challenge for Pearl and Brownlee: they had to argue the patient is terminal, but without any possible solution. No one in the room wanted to hear that, and so when Emmanuel and Feinberg were able to point to innovative programs like the Geisinger Money Back Warranty or Fresh Food Pharmacy that just needed to find scale, the audience latched onto the hope that we can fix things, and we all have to believe in these points of light, to face each new day of challenges.

Posted in: Health Regulations, Healthcare Disruption, Healthcare Legislation, Healthcare Policy, Healthcare Technology, Healthcare transformation

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Making Patient-Generated Health Data Count

We’re strong advocates for the power and benefits of patient-generated data. In analyzing results from patients using Wellpepper, we’ve been able to derive insights that wouldn’t be possible if patients weren’t tracking and self-managing. In addition to improving care, using patient-generated data can impact quality, which is why we’re happy to see patient-generated data being included as a valid feedback source for Medicare quality measures. This measure in particular, which is a result of a collaboration between Healthloop, Livongo, and Wellpepper, is a first step in this.

We believe that collaboration and open data is going to be much more powerful if we work together, rather than against each other. This is the new spirit of openness, interoperability, and collaboration that will help move healthcare IT forward. If your vendors aren’t interested in working together, you might want to ask yourself why not.

Here’s the text of the proposed measure on Patient-Generated Data.

 

 

You can find it on page 181 of this document in CY 2018 Updates to the Quality Payment Program, which is open for public comment until August 21st.

There are other measures that would also benefit from including patient-generated data as a validation source. In particular, measures for tracking patient-reported outcomes, care coordination, and discharge and follow-up instructions, use and reconciliation of medications, blood pressure, and blood sugar tracking. As home sensors and connectivity to those are clinically validated and improve, there is even greater opportunity to streamline the process of quality reporting and reduce the burden for physicians and health systems.

Posted in: Health Regulations, Outcomes

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Telehealth 2.0: Our picks for Orlando

File-2016-3478-2017_ATATradeshow_1920_25I am really looking forward to heading to Orlando for the American Telemedicine Conference, aka Telehealth 2.0. Seattle has been under a rain cloud this entire year, and I want to see the sun. I’m also looking forward to sharing our findings in using asynchronous mobile telehealth for remote rehabilitation with patients recovering from total joint replacement. I’ll be speaking with our colleagues from Hartford Health, Reflexion, and Miami Children’s Hospital on Sunday during the first breakout sessions. Hope to see you there!

In addition to the topics about legislation and regulations, it’s great to see these sessions on value, quality, and new treatment models. Here are some of Wellpepper’s picks for the conference.

Sunday

Monday

Tuesday

Now with all this great content, networking and a talk to prepare, when will I see the sun?

Posted in: Adherence, Behavior Change, Health Regulations, Healthcare Disruption, Healthcare Legislation, Healthcare Policy, Healthcare Research, Healthcare Technology, patient engagement, Telemedicine

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Using AWS with HIPAA-Protected Data – A Practical Primer

When we started building the Wellpepper platform four years ago, we thought carefully about how to build for privacy and security best practices as well as HIPAA compliance, since we work with customers in the healthcare industry. We chose to build the system entirely on Amazon Web Services (AWS), and learned a few things in the process about building HIPAA compliant applications on AWS. Hopefully this will be helpful to others considering AWS as the home for their healthcare online service, whether you’re a software company hoping to sell to healthcare systems (as a “Business Associate” in HIPAA terminology) or an internal development team at a health system (a “Covered Entity”).

It’s Not Rocket Science

As you probably already know, the Health Insurance Portability and Accountability Act (HIPAA) is made up of several parts. Usually when IT people talk about “HIPAA compliance”, they are talking about the Title II Security Rule which governs privacy and security practices for electronic protected health information (ePHI).

Many of the requirements in the HIPAA Security Rule are simply best practices for security and data privacy that have been written into law. Things like encrypting traffic travelling over a network. Anyone building good, secure software, should be following these principles anyway. You need to be informed of the requirements, and you need to make sure you establish ongoing practices for maintaining security and privacy, but it’s not rocket science. In fact, your health system (or healthcare customers) may actually have more stringent or additional data security requirements to what is required by HIPAA.

Our experience is that HIPAA isn’t a major departure from what we would have built anyway.

Stay Up To Date

HIPAA was established in 1996, with the final Security Rule being published in 2003. In some cases, the guidance has not kept up with current threats and practices in 2017. If you are developing healthcare software, you should be applying industry best practices in combination with the HIPAA requirements. Your ultimate goal needs to be protecting patient data, not just regulatory compliance. Invest in training yourself and your team and staying current. Some resources we found helpful:

Take Responsibility

Compliance usually isn’t at the top of an engineering team’s list of fun things, so it’s tempting to look for solutions that can abstract away the responsibility. There are a few online healthcare platform-as-a-service hosters that make claims in this direction. Be wary of these. No service can remove your responsibility for compliance.

We decided that using AWS infrastructure services was the best level of abstraction. This let us build new services, host data, and install 3rd party applications in our VPC with high confidence that we were living up to our promises to protect patient data.

In addition to thinking about your software solution, compliance also covers your business practices and policies for things like training, background checks, and corporate device security – securing your people. These are often overlooked areas that are really important, since security researchers complain that people are the weakest link in the security chain. As with your software design, the application of commonsense practices and good documentation will go a long way.

There is no single group that certifies systems as HIPAA compliant. However, HHS can audit you at any time, whether you’re a covered entity or a business associate. You should do your own internal assessments against the HIPAA Security Rule both when you are building new capabilities, and on an annual basis. Augment this with external third party reviews. You’ll want to be able to show summarized reports of both your internal process and a stamp of approval from an external auditor.

HHS produces a tool called the SRA tool which you might find useful in performing security rule assessments: https://www.healthit.gov/providers-professionals/security-risk-assessment-tool. We used this for a couple years, but now just use an Excel Spreadsheet to evaluate ourselves. Bonus: this is probably what your auditor will want to see.

This Risk Toolkit from the HIPAA Collaborative of Wisconsin is a good starting point, and looks very similar to the spreadsheet we use: http://hipaacow.org/resources/hipaa-cow-documents/risk-toolkit/ (look at the Risk Assessment Template).

Share the Responsibility

AWS certifies a subset of their services for HIPAA compliance. This includes restrictions on how these services are used, and requires that you enter into a Business Associate Agreement (BAA) with AWS. This agreement establishes the legal relationship needed to handle ePHI, and ensures that you’ll be notified in the unlikely event that there is a data breach.

When you sign a BAA, you enter into a shared responsibility model with AWS to protect ePHI. AWS largely covers physical security for their facilities and networks. You can view their SOC audit results on request. You own the security for your applications and anything else from the OS on up. For example, if you use Elastic Compute Cloud (EC2) instances, it’s your responsibility to keep those instances patched.

AWS occasionally adds new services to their HIPAA-certified services, so you’ll want to check occasionally to see if there are new services you might be able to take advantage of.

Draw a Bright Line Around Your ePHI

At any time, you should be able to quickly say exactly which parts of your system (which servers, which network segments, which databases, which services) have or store ePHI. These systems are inside your bright line defense perimeter, are subject to HIPAA regulations including breach notifications. That means if you lose data on one of these systems, you need to notify your patients (or if you are a Business Associate, notify the Covered Entity so that they can notify the patients).

EC2, Simple Storage System (S3), Elastic Load Balancing (ELB), when used in accordance with guidelines can be HIPAA compliant. Make sure you read the guidelines – there are usually certain restrictions on usage in order to be covered. Many of AWS’ platform-as-a-service offerings are currently not offered under the AWS HIPAA umbrella (for example Kinesis and Lambda). You can still use these services, just not with ePHI.

Many modern systems designs make use of 3rd party framworks and SaaS offerings for things like analytics, monitoring, customer support, etc. When you are holding and conveying ePHI, you will need to be careful about which dependencies you take. For example, in one of our recent product updates we were considering using an external web & mobile analytics platform to better understand our traffic patterns. We walked through our use cases and decided that while none of them required us to send any ePHI to the analytics platform, the risk of accidentally sending some piece of protected data was too high. So we came up with a different plan that allowed us to keep PHI within our safe boundary and under our direct control. Many of your decisions will be grey-area tradeoffs like this.

Secure at Rest and Over the Wire

This is often the first question we see on any healthcare IT security review. How do you protect data at rest and over the wire? Use strong SSL certs with robust SSL termination implementations like ELB. If you terminate your own SSL connections, they need to be well patched due to evolving threats like Heartbleed, POODLE, etc. You may choose to do further application-level encryption in addition to SSL, but SSL should usually be sufficient to satisfy the over-the-wire encryption requirements.

For at-rest storage, there are many options (symmetric/asymmetric) that will depend on what you are trying to do. As a baseline, AWS makes it incredibly easy to encrypt data with AES-256 both in S3 or in the Elastic Block Store (EBS) drives attached to your EC2 instances. There’s almost no reason not to use this, even if you are using additional encryption in other layers of your architecture. AES-256 is usually the “right answer” for IT reviews. Don’t use smaller keys, don’t use outdated algorithms, and especially never try to roll your own encryption.

Good guidance in this area is easy to find:

Logging and Auditing

A key HIPAA requirement is being able to track who accessed and changed patient records and verify the validity of a record. Even if you don’t make this available through a user interface, you need to log these actions and be able to produce a report in the case of an audit or a breach. Keeping these logs in encrypted storage in S3 is a good way to do this. You’ll want to restrict who has access to read/write these audit logs as well.

In addition to automatic audit trails generated by your application-level software systems, remember to carefully keep track of business-process events like granting someone access to a system or revoking access. AWS CloudTrail can help track system changes made to AWS resources like servers, S3 buckets, etc.

Authentication

All healthcare applications will need a way to identify their users and what permissions those users have. HIPAA is not specific about authentication systems beyond being “reasonable and appropriate” (164.308(a)(5)(ii)(D)), but does require that you have good policies in place for this. Here you should follow well-established security best practices.

For starters, you should try not to build your own authentication system. In purpose-built systems, you may be able to integrate into an existing authentication system using oAuth, or SAML (or maybe something more exotic if you’re plugging into some legacy healthcare application). In patient-facing applications, you may be able to integrate with a patient portal for credentials – this is something that will probably show up on your requirements list at some point anyway. If neither of these apply, you may be able to use another identity provider like AWS’ Identity and Access Management (IAM) system to manage user credentials. We briefly tried using consumer-facing oAuth using Facebook, but quickly found that consumers are (rightly) worried about privacy and chose not to use this method.

If you find that you need to build an authentication system, be sure to follow current best practices on things like how to store passwords securely, as well as other tricky areas like password resets.

Since Wellpepper is often deployed standalone before being integrated into other back-end systems, we offer a built-in username + password authentication system. One silver lining to building this ourselves is the ability to build meaningful password complexity rules, especially for patients. Some of the traditional healthcare systems have truly draconian rules that are not only user un-friendly, but actively user-hostile. Thankfully, the best practices in this area are changing. Even the draft NIST password recommendations, updated in August 2016, trade some of the human-unfriendly parts of passwords (multiple character classes) for more easily memorable, but still secure ones (length). Also, consider the difference between health-system password requirements for clinicians with access to thousands of records and those for patients who only access a single record.

Once your users are authenticated, they will need to be authorized to access some set of resources. As with authentication, if you can delegate this responsibility to another established system, this is probably the best approach. If you are adding unique resources with unique access control rules, you will need to make sure that your authorization mechanisms are secure and auditable.

Conclusion

Creating a HIPAA-compliant service doesn’t have to be a big scary problem, but you do want to make sure you have your ducks in a row. If you’re reading this blog post (and hopefully others!), you’re off to a good start. Here are some additional resources that we found handy:

Posted in: Data Protection, Health Regulations, Healthcare Policy, Healthcare Technology, Uncategorized

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What’s True Now?

 

Health systems and payers alike are scrambling to figure out what the incoming administration means by repealing Obamacare. The payers admitted to having no contingency plans if Trump won. Trump doesn’t have a clear model, and the Republican party has a number of proposals. Some involve changing the names of programs or offering them in a different way. Some involve scrapping large sections of the affordable care act.

Rather than second-guessing what’s to come, at Wellpepper, we are focusing on what’s true now and what will remain true going forward.

We believe these things will continue to hold true:

  • Innovation will continue. If anything we hope that new innovation in healthcare, and technology innovation in particular is driven by market forces rather than legislation which created winners out of what was not always the best technology.
  • Consumer-focus is good. 20M newly insured individuals and high-deductibles helped create a market for new care organizations like local urgent care and patient-focused primary care. This consumer evolution will continue as patients demand that their healthcare dollars deliver good service.
  • Value and outcome focused approaches will be rewarded. Whether it’s traditional payers or self-insured employers, the light has been shone on areas to improve care AND reduce costs. Healthcare organizations have seen investments in outcomes pay off as well.

It’s time for a new patient experience that is real-time, connected, and based on the individual. We need to take advantage of the ability of technology to scale, analyze, and deliver personal experiences to leapfrog the current technology implementations in healthcare and deliver better outcomes and greater value in healthcare.

Posted in: Health Regulations, Healthcare Legislation, Healthcare Policy, Outcomes

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Let’s Talk About Poop

The ups and downs of the first two keynotes at the 2016 Mayo Transform Conference were mirrored in the session The Challenges of Change which highlighted the story of Cologuard. Cologuard is a joint venture between Mayo Clinic and Exact Sciences whose sole goal for the venture was to create a less invasive way for early detection of colon cancer. They succeeded in this goal and were also the first product to receive FDA clearance and CMS reimbursement on the first day. Cologuard launched to much fanfare on national news.

Did they knock it out of the park? Yes. Are they wildly successful today? No. Why? Keep reading and I’ll tell you.

First let’s start with the problem. Colonoscopies, while effective, are not favored by most people. The preparation is extremely uncomfortable, they require general or partial anesthesia, and people need to take time off work. In addition, in some remote communities, it is difficult to get access to care from specialists. As a result, people put off or skip getting colonoscopies and by the time cancer is detected it is often too late. A clinical challenge with colonoscopies is that they are good at detecting left-side tumors but not right side tumors, the incidence of which has been increasing since the 1980s.

CologuardCologuard solves all of these problems. The test is designed to be used at home and is basically a nicely-packaged stool collection kit combined with specialized testing at Cologuard’s lab. No time, and no procedure required for an individual. As well, Cologuard is more effective than colonoscopy at detecting right side tumors, and comparably effective at left-side tumors. Since it’s a home collection, and all tests are processed at Cologuard, access to care is not an issue either and it’s widely used in the Alaska Native Tribal Health Consortium, which was presented as a success story.

Sounds great, yes? Everyone (aka people who at some point will need a colonoscopy or have already had one) I talked to about it thought so. So what’s the problem? As usual, what’s preventing this innovation is an issue of reimbursement. Colonoscopies are a profit center for healthcare organizations, and they are effective, so this isn’t necessarily a case of a better technology losing. It’s the case of a more patient-friendly technology losing, except in Alaska where there really isn’t a viable option for delivering colonoscopies. As well in violation of CMS, some payers are refusing to cover Cologuard.

Cologuard CEO Kevin Conroy was evasive when asked about pricing, which is more expensive than other screenings but pales in comparison to the coimg_0060sts of a procedure that requires booking an operating room and an anesthesiologist.

Let’s hope that a shift to value-based care changes this. From a patient’s perspective it can’t come soon enough.

PS Apparently a lot of single Cologuard kits are being ordered by cardiologists and other specialists. Conroy thinks they’ve recognized the value and are using the kits on themselves. Harrumph.

Posted in: Clinical Research, Health Regulations, Healthcare Disruption, Healthcare Legislation, Outcomes, Patient Advocacy, patient engagement, Patient Satisfaction

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Our Picks for APTA CSM 2016

APTA CSM 2016Wellpepper CTO Mike Van Snellenberg will be at APTA CSM in Anaheim this year, and here are a few of the sessions you might see him at. If you want to be sure to see him, book a meeting.

As usual we’re following sessions about healthcare transformation, patient experience and patient centered care, patient reported outcomes, and interventions that include technology. With the conservative care and physical therapy being an important part of new bundles like CMS’s Comprehensive Care for Total Joint Replacement, these are hot topics as well.

Here are a few session picks from Wellpepper.

Patient-Centered Care

Exercise and Diabetes: Tools for Integrating Patient-Directed Practice

The Customer Experience in Health Care: The Game Changer, Part 1

Words Mean Things: How Language Impacts Clinical Results

Acute Care Productivity Measurement, “What about the Patient?” The Time has Come to Shift to a Value Based Measurement System

Technology

Wearable Technology Meets Physical Therapy

Virtual Reality and Serious Game-Based Rehabilitation for Injured Service Members

Tracking Outcomes

Changing Behavior Through Physical Therapy: Improving Patient Outcomes

Functional Reconciliation: Implementing Outcomes Across the Continuum

Using Outcomes Data to Improve Provider, Patient and Payer Engagement and Demonstrate the Value of Your Services

Healthcare Transformation and New Models of Care

Exceptional Care and Profitability in Light of Health Care Reform for Patients with Chronic Musculoskeletal Pain

The Complicated Hip: A New Debate

Emerging Issues in Medicare and Health Care Reform, Part 2

Bundled Payment Implementation for Primary Total Joint Patients

Managing Patient-Centered Care in a Changing Reimbursement World

Health System PT’s Leading the Transition to Value-Based Health Care

Posted in: Adherence, Health Regulations, Healthcare Disruption, Healthcare motivation, Healthcare Policy, Healthcare Research, Physical Therapy, Prehabilitation, Rehabilitation Business

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Hot topics of 2015 from the Wellpepper Blog: It’s All About Value

As we get ready for big changes in 2016, especially in the world of value-based payments, let’s take a quick look at our most popular blog posts of 2015. Not surprisingly, they are related to changes coming with bundles and value-based payments, and the role of patient-reported outcomes and patient engagement.

In no particular order, here are our most popular blog posts from 2015.

From Wellpepper CTO, Mike Van Snellenberg.

http://wellpepper.wpengine.com/decreasing-the-patient-survey-burden-for-total-joint-pros

From Wellpepper, VP of Business Development, Robin Schroeder-Janonis

http://wellpepper.wpengine.com/does-healthcare-need-a-call-to-minga

And from Wellpepper CEO, Anne Weiler

http://wellpepper.wpengine.com/value-based-bundles-for-total-joint-the-glass-is-more-than-half-full

And from Wellpepper Business Analyst, Liz Zampino

http://wellpepper.wpengine.com/2016-the-year-of-telehealth

 

Posted in: Health Regulations, Healthcare Disruption, Healthcare Policy, Healthcare Research, Healthcare transformation, Outcomes

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Does Healthcare Need a “Call to Minga”?

ihi-logoIn the most recent months, I have experienced a lot of “firsts” since I have joined Wellpepper. Although still in healthcare, I have ventured into the patient engagement space which has opened up a whole to new world. This technology is evolving in the marketplace with the charter of quality, value and engagement, specifically around the patient. This is one of the reasons why I joined Wellpepper…..we are about improving the patient experience.

Attending the Institute for Healthcare Improvement National Forum in Orlando (IHI) last week was another “first”. This conference was focused around how we change and improve healthcare for the patient. There was a real sense of community at this conference among the attendees. Everyone was focused on the patient and how to better serve and improve outcomes.

Unlike other conferences I have attended, I was able to participate in several sessions. Even though we exhibited at this forum, attending the sessions provided me with a different perspective on what healthcare professionals are really concerned about and how they are looking to learn from others on how to “fix” it. Again, another “first”.

The atmosphere at the conference was very upbeat and optimistic but there is a transition happening at the helm of IHI. Maureen Bisognano, President and CEO for the last 12 years, she will be retiring after 27 years at IHI. She gave the opening keynote which was very inspirational and echoed the commitment of IHI to improve the quality in healthcare for the better of the patient. Her theme was all about collaboration among the healthcare teams to give care with the patient and not just to the patient. Quality should be everyone’s job and that is why they developed the Breakthrough Collaborative at IHI. This brings together patients, families and health systems to improve the care.

We need to understand what matters to the patient and not what we think matters. In the session, “Thriving in a Value-Based Environment”, Anna Roth, CEO of Contra Costa Health Services, emphasized what matters to patient might not be their health problem but their ability to buy food, pay rent, and job security. So value for that patient goes beyond addressing their health issue but rather access to other life sustaining needs. Furthermore, when you engage with your patients be prepared to act. Lisa Schilling from Kaiser added during this session – “find the problems that really matters and then find an elegant solution”.  This can lead to innovation both from a technology perspective and re-design of care plans for that patient community. As an example, physicians are now prescribing community parks as part of their treatment plans to help address obesity and get their patients moving.

This theme echoed with the other keynote speakers such as Earvin “Magic” Johnson. He was on course with his message of bringing together a sense of community to improve healthcare access and services in the urban cities. He stressed people can make a difference if we just listen to what matters to the community. He has engaged with many charities to address the food deserts that plague our urban cities.  Providing better options to fruits and vegetables will result in healthier communities.

However, the keynote from Craig Kielburger really hit home for me. Craig is the co-founder of Free the Children, an international charity; Me to We, an innovative social enterprise; We Day, a signature youth empowerment event. His journey to where he is today started when he was 12 years old. He was touched by a tragic event with a young Pakistani boy by where he felt compelled to make a difference in children’s lives. Today, he is building schools and empowering our young to make a difference.

So what has this got to do with a “Call to Minga” and healthcare? Craig experienced a “Call to Minga” for the first time more than a decade ago when he and his brother Marc (co-founder of Free the Children) went to Ecuador to build a school with volunteers. Given unforeseen obstacles such as transportation for building materials was difficult and the time to transport was longer than anticipated, his team was falling short of completing the school….in fact, they didn’t even get a chance to start it.  They were two days from traveling back to North American when he and his brother had to explain to the Chief of the village that they would not be able to complete their task. At that moment, the Chief went outside her hut and called “Minga”. The next day, people from surrounding villages ascended upon this village and began to work on building the school and completed it. The “Minga” was a call to action. It is a community coming together to work for the benefit of all.

This is what was happening at IHI, a call to action. We must come together as a healthcare community and work to improve healthcare for patients and overall, our country. Our community consist of caregivers, educators, innovators and the patient. With all the resources available to us, we can have a “Minga” moment. Here at Wellpepper, our “Minga” moment is now. Health systems are hearing the call to action to engage their patient in a fashion that supports their live style along with the technology they use every day.  Our technology allows patients to personalize their care plans that will drive ownership and improve outcomes because we are able to provide them with what matters. This is a “first” for the patient!

Since this is probably my last blog post of 2015, I invite you to consider your call to Minga at your organization for 2016. There is so much we can do together!

Posted in: Health Regulations, Healthcare Disruption, Healthcare motivation, Healthcare Policy, Meaningful Use, Outcomes, Patient Satisfaction

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Digital Health and the Influence on Healthcare: Wearables, Telehealth, & Treatment

Things are looking up in the world of digital health at least this was the view from “Digital Health and the Influence on Healthcare: Wearables, Telehealth, & Treatment.” The WBBA held their last event of the season with a panel on digital health, hosted by Russell Benaroya, CEO of Everymove, and featuring Dr. John Scott, Director of Telemedicine at UW Medicine, Davide Vigano CEO and co-founder of Sensoria, Mike Blume, independent healthcare consultant, and myself. I’d characterize the overall event as being optimistic and realistic, both from the panel and the attendees.

Digital health event

It was a dark and stormy night

No one said that the road to digital health was easy or fast, but the consensus that things like moving to the cloud, and the acceptance and adoption of patient-driven digital care is reaching a turning point.

Both Sensoria and Wellpepper’s business models are made possible by the cloud. For Sensoria this was the ability to process millions of datapoints coming from their wearable technology. For Wellpepper, this is our ability to rapidly implement solutions working with department heads facing a particular challenge in patient engagement and outcome tracking and improvement. Dr. Scott remarked on the dramatic drop in the cost of telemedicine solutions over the years he’s been an advocate and solutions due to both Moore’s Law and cloud computing over his tenure running telemedicine at UW.

Sensoria's Quantified Socks

Sensoria’s Quantified Socks

As well, although Dr. Scott highlighted how telemedicine was limited by arcane reimbursement models that did not allow for patients to receive telemedicine consults in their homes, he and other panelists discussed that they were not waiting for billing codes to do the right things in using technology to deliver better care. As usual, the Affordable Care Act was seen as a big driver as patient-centered and digital care.

Possibly because there were two ex-Microsoftees on the panel (Davide and me) a cloud-based platform approach was touted as the best way to both collect, analyze, and sort the data that came in directly from patients. In the case of Sensoria and Davide, this was to look for trends and patterns coming from sensor-integrated clothing, and in the case of Wellpepper it was to collect patient outcomes in the context of care and compare these across patients, procedures, and healthcare organizations.

This view led to a discussion about the proliferation of data, and everyone agreed that digital health has the ability to overwhelm health systems with data that they are currently not prepared for. EMRs are not set up to include sensor or patient-reported data, and as Dr. Scott pointed out, physicians are not looking for every data point on a patient, only the anomalies, like glucose out of range.

One audience member asked about whether healthcare organizations had an overall data strategy, and whether digital health data should be collected as part of that. It’s an interesting idea to consider but it seems like it’s still a long way off in healthcare. Does your organization or CIO have an overall data strategy? It seems that quality measures and the need for patient reported outcomes are introducing new requirements for data, but this is at the departmental or initiative level. Grappling with questions like this will be important as connected devices, digital, health, and patient reported outcomes enter the mainstream.

Posted in: Health Regulations, Healthcare Disruption, Healthcare Policy, Healthcare Research, Healthcare Technology, Healthcare transformation, M-health, Outcomes, Telemedicine

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Decreasing the Patient Survey Burden for Total Joint PROs

At Wellpepper we believe strongly about the value of patient-reported outcomes, especially when they are delivered as part of the patient care plan. However, the recent trend towards collecting PROs for reimbursement, plus HCAHPS and other surveys can result in some over-surveying of patients. We were pleased to hear at AAHKS that there is a movement to decrease the number of questions for total joint replacement with a proposal of using a HoosJr and a KoosJr. Outcomes-mobile.screen3

The HOOS and KOOS surveys are standard, validated survey instruments that are commonly used for measuring hip and knee function. We’ve heard that CMS is moving towards requiring these measures for evaluating outcomes of TJAs and other surgical procedures. A group of surgeons representing the major American orthopedic associations (American Association of Hip and Knee Surgeons, the American Association of Orthopedic Surgeons, The Hip Society and The Knee Society) has recently proposed shortened version of these surveys to lower the patient data collection burden. Details were presented at the 2015 AAOS and AAHKS conferences. These shortened versions are being called HOOS Jr. and KOOS Jr. Note that these are different than the lesser-used HOOS-PS and KOOS-PS physical short form surveys. The updated surveys are designed to be used standalone or in combination with a general health survey like VR-12, or PROMIS 10 Global. The number of questions is reduced from 40 to 6 (for HOOS) and from 42 to 7 (for KOOS), while retaining reliable, responsive output scores. With a patient completion time of under 3 minutes, these shortened surveys should dramatically aid in increasing survey response rates. Wellpepper supports HOOS and KOOS today, and looks forward to supporting HOOS Jr. and KOOS Jr. as soon as scoring rules are released.

Posted in: Health Regulations, Healthcare Technology, Outcomes, Patient Satisfaction

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Value-Based Bundles for Total Joint: The Glass Is More Than Half-Full

The bundles are coming! The bundles are coming! While many health systems have been delivering care in value-based bundles for some time, the broad implementation of bundles was made a reality when the Centers for Medicare and Medicaid announced the Comprehensive Care for Total Joint proposal to go into effect in early 2016. Navigating this new world, was the focus of the session “The Business of Total Joint Replacement: Surviving and Thriving” at the American Association of Hip and Knee Surgeons annual meeting. This was one of the best sessions we’ve attended on this topic: both realistic and optimistic about the opportunity to impact patient-centered care and change. This is a long post because the session was jam-packed with information, and I was only able to attend the first part. Heads must have been reeling for those who were fortunate to attend the entire 5-hour session.

The session was kicked off by Mark I. Froimson, MD, MBA EVP and Chief Clinical Officer of Trinity Health who took questions from the audience to start the day to ensure that their needs were addressed. A survey of the room showed that roughly half of the attendees were surgeons or physicians and the rest of the audience was comprised of included administrators, nurses, and physical therapists involved in care. This was apropos as much of the theme of the conference was about how care teams will need to work together across settings in a new patient-centered model to deliver on care.

Questions fielded showed that the audience had done their homework and included concerns about business models and outcome tracking for revisions. The Baby Boomer’s desire to stay active has resulted in earlier joint replacements which means revision surgery in the future. Audience members were concerned that revisions wouldn’t have as strong outcomes and they would be penalized by that. Participants from smaller organizations asked whether there were other metric tracking schemes they could participate in to offset the Meaningful Use incentives if they weren’t able to participate. (We have an idea: how about reimbursement for engagement with digital patient treatment plans?) Complex cases were also of concern: the system needs to ensure that systems will not be penalized for complex case that may also have weaker outcomes. Without risk adjustment for complex cases which are more likely be done at large in-patient facilities rather than ambulatory surgery centers, some organizations could be unfairly penalized.

Risk-sharing

Dr. Fromison handed the session over to the extremely optimistic Kevin J. Bozic, MD, MBA, Chair of Surgery and Perioperative Care, Dell School of Medicine. While value-based the goal of bundled payments is to improve outcomes and lower costs, Dr. Bozic spoke directly to the audience about the value for them: in the current fee-for-service model, the best surgeon gets paid the same as the worst. There is no incentive for efficiency. In the new model, surgeons that can deliver better outcomes at lower costs will be rewarded accordingly.

Interestingly though, the team-based medicine approach and the focus on surgical prep and post-operative care, means that it’s not clear which physician in the team will see the benefits of performance bonus: the primary care or physiatrist, the anesthesiologist, or the surgeon. This will be interesting to watch play out. In the past some surgeons considered their work to be finished after the surgery and others stepped in for post-acute care. As well, there was discussion about how to get hourly workers in the care team on board and aligned with the new models. As we’ve talked to countless organizations and individuals about the move to value-based payments, the common theme is that the patient outcome driven approach is better for patients: perhaps this can be the rallying cry for alignment.

This team-based partnership is not just within an organization or care team. Since 40-50% of costs of a total joint replacement are in post-acute care, surgeons and health systems must partner with post-acute care facilities. We’ve observed this trend directly with both inpatient and outpatient rehabilitation joining health systems and creating new ACOs to share risk.

Dr. Bozic handily turned the negative connotations of risk-sharing on their heads, when he was asked whether these new models were just a measure to shift risk to the providers. His answer was a positive “Yes” and encouraged the audience that providers were really the only ones who could manage performance and appropriateness of care. Note that payers still bear the risk of who gets a disease (although with more health systems focusing on wellness this could change), while providers bear the risk for the outcomes. Because of this, Bozic recommended that a strong physician needed to lead the change and own the bundle implementation within a health system.

Outcomes, Outcomes, Outcomes

Today with the focus on outcomes it’s hard to believe that a surgeon from Massachusetts General, largely seen as the father of outcome tracking, was run out of town and eventually lost his license for suggesting that physicians should track and be accountable for the outcomes of the interventions they performed.

Refreshingly, Dr. Bozic asked the audience to go beyond standardized outcome tracking as it relates to reimbursement, and consider which outcomes matter most to patients. We’re excited about this idea as we track outcomes both based on standardized outcome measures like the HOOS and KOOS (and soon the Hoos Jr & Koos Jr) but also at the task level and soon based on the patient’s own goal.Outcomes-mobile.screen4.jpg Outcomes-mobile.screen5.jpg

Without data transparency and sharing, improvement can’t happen. Finding out where the waste is in the 100-300% variation in inpatient total joint cost is key. Dr. Bozic is suspicious of organizations that boast that they are better than average on all measures: he believes that they are actually are unaware of their flaws and not driving a culture of continuous improvement.

We’ve been at surgeon-focused conferences before, and the booths that were busiest were those promoting joints and surgical instruments. Dr. Bozic told the audience they needed to be evaluating vendors that could help them collect, measure, and act on outcomes, which was music to our ears.

Patients and Prevention

The third speaker was Dr. David Halsey, MD from Vermont, who echoed many of the themes of the previous speakers, especially in the need for outcomes, but also posited a question we haven’t heard before, Dr. Halsey asked who better to do population health for arthritis than orthopedic surgeons? In our travels, we think that both physiatrists and physical therapists might want to join in that population health management, however, if it starts with the surgeons then they would be more incented to try other approaches before surgery, which can be accomplished through preventative care. Preventative care includes patient education and shared decision making and requires new tools to involve and engage patients in their care. It also includes making the patient’s goals front and center to improve care, and understanding and managing their expectations. Today’s patients have higher expectations to have a high level of mobility post surgery, and a low level of pain. Physicians need to engage with patients both to understand and to manage their expectations.

Moving Forward

While we’ve heard some people grousing about the squeeze that is being put on orthopedics through the CCJR, this glass-half-full group sees this as an opportunity for orthopedists to lead the way and actively engage with CMS. Data collection and transparency are the way to do this, and the current tools (aka EMRs) don’t cut it. (While this is our message at Wellpepper, it came directly from the speakers: times are changing!) Expectations are that other specialties will follow the total joint guidelines, spinal surgery is considered to be next, so orthopedists have the opportunity to set the standard for how value-based bundles are implemented in their organizations, while collecting and analyzing real-time data and leading an interdisciplinary team of course. Onwards! We’re ready!

Posted in: Health Regulations, Healthcare Disruption, Healthcare Policy, Healthcare Technology, Healthcare transformation, M-health, Outcomes

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P4 Medicine, How You Can Live To Be 100

I was fortunate enough to be on the guest list for the event, “An Evening Discovering Scientific Wellness” hosted by Arivale at Chihuly Garden and Glass this past week.  The space was packed with over 600 guests, which included: students, scientists, nurses, entrepreneurs, investors, doctors, schoolteachers, software engineers and really anyone with an interest in being part of a new transformation in healthcare.   My fascination with what Arivale plans to do originates from three different perspectives: as a scientist with an undergraduate degree in Neurobiology, a healthcare provider (Registered Nurse) and most currently as a graduate student in Clinical Informatics with a penchant for technology. Arivale plans to bring together all of my interests in science, clinical data and technology to create a personalized plan to optimize wellness.

Be forewarned, P4 Medicine (Predictive, Preventative, Personalized and Participatory), is not for the squeamish.  Maybe you have seen the funny coffee table book “What’s Your Poo Telling You?” Well, now it can tell you more than you ever imagined. Arivale, a new Seattle start-up co-founded by biomedical pioneer Leroy Hood, MD, PhD, actually aims to analyze your microbiome (the polite word for poop and/or the bugs inside you) as one part of their unique approach to transform how we think about our health.

Clayton Lewis, CEO and co-founder of Arivale, introduced co-founder Lee Hood (who probably needs no introduction in Seattle) as a visionary man who “speaks about the future in the present tense.”  Dr. Hood described how Arivale evaluates samples of blood, saliva, microbiome, genetic sequencing and Fitbit data to give participants an entirely personalized set of actionable health data. The fundamental piece is a personal coach who will create a tailored wellness plan.  Not only will the coach call each month to check-in and guide the participant but, they will also integrate any new data and make adjustments to the original plan.

After hearing Arivales pitch, I do question how they plan to deal with the FDA and providing P4 medicine complete with health recommendations to consumers. This is not entirely dissimilar what 23andMe tried to do 2 years ago marketing Personal Genomic Services directly to consumers and shortly thereafter, the FDA required them to stop. Since then, 23andMe has gone through several rounds of R&D and now has the official blessing from the FDA. Along with the FDA approval of 23andMe earlier this year, the FDA also announced two important pieces of regulatory information making the path for other companies like Arivale easier.

  1. FDA is [sic] classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review.
  2. The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.

Why is P4 Medicine so important? The crowd of at least several hundred let out a collective murmur of surprise when Dr. Hood dropped the factoid, ‘living to be 100 is going to be new norm for children being born into the next generation’. He jokingly followed with, “We want to get you to 100 and then you are on your own.” He pointed out that while our genetics may give us the predisposition for certain diseases, they don’t necessarily define our health.  If genetic variants are known, you can do something about them. Arivale wants to provide people with meaningful, personalized diagnostic information so as to optimize as many aspects of their health as possible.  The goal is to make those 100 years of life full of vigor, fitness and optimal health.

Next, two of the original 100 Arivale pioneers took the stage and spoke about their experiences.  The first woman explained her diagnosis of a ‘suspect immune system’ and not having enough T-cells.  This came along with a daily dose of antibiotics and lot of ‘no’s’ to activities she enjoyed such as long distance running.  The microbiome testing revealed that the antibiotic was not wiping out her endogenous gut flora.  Based on genetics, hiking in the woods, not long distance running, was the best exercise for her.  With Arivale, she realized her body was resilient, adaptive and was able to literally ‘start trusting her gut.’  In describing her experience with Arivale, she ended by saying, “Instead of seeing myself as a sickly, non-running person, I now see a person with a diverse life, a diverse gut and an adaptive life.”

The second woman opened by recounted her entertaining experience of giving birth during the 2nd quarter of the Superbowl last year. Her motivation to join the current cohort of 300 Arivale participants, was due in part to optimize her health but she also wants to be around as long as possible for her child. She is part way through the program, has received stellar results on her blood work and just the day before received her genetics phone call. Her genetics revealed a moderate risk for obesity and that her body had difficulties disposing of toxins. Going forward, Arivale will make recommendations on for life style changes based on these revelations.

Patient engagement is one of the newer buzzwords in healthcare and Arivale really gives it a new spin. We are entering a new era where people have access to the data and tools available to truly be active participants and take more control over their health outcomes.  We can no longer lay the blame on genetics because as Arivale is proving, we can now make informed decisions that can alter the expression of our genes and help us to achieve our wellness potential.

After the presentations were over, I went to the Info table to see how I could be part of this second set of 300 beta participants in the Greater Seattle area this fall. Sadly, it is not free this time around, the cost is now $1,999.

Posted in: Health Regulations, Healthcare Disruption, Healthcare motivation, Healthcare transformation, Seattle

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