DSIIS Meeting 3 Report

The Deputy Secretary’s Innovation and Investment Summit (DSIIS) convened its third meeting in Washington, DC over two days on July 8 and 9, 2019. Deputy Secretary Eric Hargan and leaders from HHS agencies led DSIIS participants in a discussion to further explore the potential future state of the U.S. healthcare system. The primary goal of this meeting was to gain more breadth and depth of knowledge about current innovation challenges by bringing in subject matter experts to contribute broader perspectives to the ongoing dialogue. These additional participants were invited to speak on one of the four DSIIS topics most relevant to their work, specifically focusing on their key challenges, lessons learned, and suggestions for improvement as it pertains to the role of both HHS and the industry. Ultimately, DSIIS participants aimed to further define and highlight impactful potential next steps towards the future as a result of this meeting. Once all subject matter experts (SMEs) shared their viewpoints, the group discussed each topic at length, determining the urgency and importance of potential action items in order to create a vision for how the benefits of innovation might be realized in healthcare.

The discussion was split into segments by DSIIS topic area, as described in further detail below.

Best Practices in Regulatory Approval and Reimbursement

The first day kicked off with a discussion of Best Practices in Regulatory Approval and Reimbursement. The SMEs that were featured as a part of this conversation were Heather Brown (Senior Vice President of Market Access and Reimbursement) of HeartFlow and Bill Doyle (Executive Chairman) of Novocure. They each shared their individual experiences navigating the regulatory and reimbursement landscape, noting several overlapping challenges and thus allowing for key themes to emerge.

It became clear through these presentations that the FDA approval and CMS reimbursement processes could be streamlined to be more aligned from the perspective of innovators. It was however noted that the FDA’s highly communicative process already is particularly valued. Still, members of the group believed that even if a burgeoning technology receives FDA approval, is peer reviewed, and has significant backing in terms of financial investments, there is still limited line of sight to CMS reimbursement. Investors also noted that return on capital for a fund often or usually has a shorter time horizon than the CMS approval and reimbursement process, making many investments on otherwise good technologies challenging.

“It comes down to being able to disrupt your own bureaucracy; bureaucracy serves a purpose but over time you have to ask, is this bureaucracy serving the purpose we initially intended it to serve?” -Heather Brown, PhD, Senior Vice President, Market Access and Reimbursement, HeartFlow

Ultimately, a considerable number of participants seemed to agree that transparency, predictability, and expedited timelines where possible are the three most important factors conducive to technology investments. Several participants suggested that the most urgent and important next step would thus be to close the gap between FDA approval and CMS coverage in order to shorten and streamline the overall process. Many participants identified that timelines should be clearer and more efficient – but not necessarily less stringent. For instance, in other countries, approvals are often more difficult to obtain than in the United States. However, the process in other countries is more transparent, and thus technologies are still able to emerge at a relatively rapid pace, because investment is still able to flow.

In addition, a discussion of artificial intelligence (AI) raised the point that approvals in this space must be dynamic, because AI technologies have a high potential for unintended consequences in healthcare delivery.  It was specifically mentioned in this dialogue that FDA approval of AI technologies is a limiting factor for investment. Several subject matter experts and core participants noted that post-market surveillance, for example, could be key to ensuring that these technologies remain just as safe and effective as they were at the time of approval, while simultaneously allowing them to evolve to provide the greatest benefit.

Finally, participants and SMEs were anonymously surveyed on their opinions of various topics within the broader framework of regulatory approval and reimbursement. These polling questions were presented as a way to gauge the pulse of the room on certain overarching issues within the broader context of the conversation. The results of these questions are depicted below (sample size: approximately 21 respondents per question).

Transitioning to Value-Based Care

The second discussion topic was on Transitioning to Value-Based Care. The SMEs that shared their experiences and expertise on this topic were Dale Wollschleger, RPh (President/CEO and Founder) and Marty Butler (CFO) of ExactCare, Vance Moore (President, Business Integration) of Mercy Virtual, Mike Pyskosz (CEO) of Oak Street Health, Arvind Rajan (Co-Founder and CEO) of Cricket Health, and David Snow (Chairman and CEO) of Cedar Gate Technologies. They shed light on their success stories, the obstacles they face, and their aspirations to transform the Fee-For-Service (FFS) environment into a Value-Based system to deliver better health outcomes at lower costs.

“HHS will do nothing short of changing the entire healthcare system in the U.S. and will take it in a value-driven direction.” -Alex M Azar II, Secretary, HHS Office of the Secretary

The participants noted, among other things, that innovation surrounding data and technology are needed; not having access to the right data at the right time, or being able to use data insights appropriately is a barrier to measuring and reporting on value-based outcomes. Companies transitioning to value-based care need to prove that they add value, and that their approach is both sustainable and scalable. Leveraging technology and unlocking data will enable companies to prove a value-based approach is viable and scalable. Further, participants discussed data and technology can help them not just track value, but determine how to deliver it; companies are seeing success initiating outcomes-based efforts to create solutions aimed at specific problems derived from understanding the needs of target patient populations.

Several participants also lamented at how limited the healthcare system is when it comes to providing incentives for patients to be more engaged in their healthcare. This leads to challenges in engaging and incentivizing patients to be more healthy and involved in managing their own care. Certain participants  emphasized that change management, the ability to incentivize the right behaviors for patients who are willing to engage, and making their participation as easy as possible is the most important way to inspire healthy change. Recent efforts, such as reforming the Stark Law or the anti-kickback statutes, which are aimed at creating more flexibilities that allow companies to solve problems and take on more risk, were discussed by several participants with optimism.

Further, attendees highlighted that some of the best caregivers and cost reducers are nonclinical workers or resources and expressed the imperative for creating more ways to reimburse nonclinical care delivery that impact health outcomes.

Ultimately, the group emphasized that the most impactful factor in a successful transition to value-based care is creating aligned incentives across entities. A value-based care environment would create the right incentives to dismantle some of the misaligned incentives that exist in the regulatory and reimbursement space and could remove some of the current barriers to driving better consumer engagement and empowerment. HHS attendees variously noted  continuing efforts at the Department to align incentives through Medicare Advantage, Reimbursement Models from CMMI, and President Trump’s executive order released on June 24 aimed at increasing transparency to lower costs and empowering patients with information received positive responses.

“When you’re 70%/30% fee-for-service/value-based, you have a dichotomy of incentives that you can’t solve for. If we are 50% or more fee-for-service, then we are misaligned by definition.” - David Snow, Chairman & CEO, Cedar Gate Technologies

Lastly, participants and SMEs were surveyed on their opinions of the current state and future state of Value-Based Care. These polling questions were presented as a way to gauge the pulse of the room on certain overarching issues within the broader context of the conversation. The results of these questions are depicted below (sample size: approximately 21 respondents per question).

Consumer Engagement and Empowerment

The dialogue around Consumer Engagement and Empowerment featured the following SMEs: Brenda Schmidt (Founder and CEO) of Solera Health, Kristen Valdes (Founder and CEO) of b.well Connected Health, Michael Vaughan (Executive in Residence and Co-Founder/Former COO of Venmo) of Oak HC/FT, David Vivero (Co-Founder and CEO) of Amino, and Shawn Wagoner (Co-Founder) of Bind. Notably, this topic brought out more varied perspectives than the others. The group had differing opinions on whether or not consumers want to be empowered and engaged in their healthcare and how they want their engagement  to look. Still, participants largely agreed that for a consumer to be empowered and engaged, price, quality and access are all influencers. While price is often thought of as most impactful to the consumer, many participants believed that price  is not enough to drive consumer decision-making on its own. A truly engaged consumer is informed by quality data and may also prioritize convenience in his/her personal healthcare management.

“We’ve taught people you get what you pay for—so when people are very sick, they often don’t want the lowest cost option. They want the highest cost option because they presume it automatically means better and more comprehensive care.” -Kristen Valdes, Founder & CEO, b.Well Connect Health

Ultimately, several participants expressed that the system must allow flexibility to ensure that there are tools and incentives in place for those who wish to be engaged in their healthcare, but that there will always be some consumers who do not want to be significantly engaged in their healthcare. Either way, several participants noted that HHS must think about how to meet consumers where they are – at their starting points. For instance, if a consumer has an ailment and is given the choice of going to the hospital, seeing their primary care provider, buying an over-the-counter medication, or consulting the internet or an app, what decision will he or she make and what informs that decision? Participants viewed the recent Executive Order on liberating data in terms of quality and price as a strong start in terms of uncovering that information and moving the needle on consumer empowerment.

In conclusion, participants and SMEs were surveyed on their opinions of various topics within the Consumer Engagement and Empowerment landscape. These polling questions were presented as a way to gauge the pulse of the room on certain overarching issues within the broader context of the conversation. The results of these questions are depicted below (sample size: approximately 21 respondents per question).

Liberating Data to Drive Value

The two-day meeting wrapped up with Liberating Data to Drive Value, a topic that in many ways fed into the three others and thus served as a fitting culmination. The SMEs engaged to provide insight in this part of the conversation were: Bobby Green (CMO) of Flatiron Health, Blackford Middleton, MD (Chief Informatics and Innovation Officer) of Apervita, Laurent Rotival (Senior Vice President) of Cambia Health, and Niko Skievaski (Co-Founder and President) of Redox. Secretary Azar had previously contributed to this discussion, providing further context around President Trump’s recent Executive Order on price and quality transparency in healthcare. He shared that the drug pricing market will be disrupted as a result of these efforts, and Medicare Advantage claims and encounter data will be freed in certain ways in order to inform new policies. The group valued this perspective and asserted that liberated data is key to every next step desired as part of the future state. HHS CIO Jose Arrieta also actively engaged with the SMEs during this topic and further emphasized the need for liberated data.

Many of the participants represented as urgent the need  to gather, formulate, and analyze data in a way that is actionable – for a plethora of stakeholders. Other perspectives that were shared follow: the  current state of data was described as messy and fraught with bias, especially in AI technologies; it will thus be important in the future state to ensure that data is clean and valid. If the data is meaningless, then meaningful insights cannot be drawn from it, and a determination of value is impossible. As such, government and industry will need to work together to collaboratively develop the right standards for liberated data that can be used at scale. Developers will be an important stakeholder in this topic, because they can assist in that data standardization. To this end, several members of the group were enthusiastic about the proposal to adopt FHIR as a standard to liberate data from EHRs.

“For every inefficiency out there, I believe there’s an entrepreneur trying to get their product to market to solve this problem. We do not have an innovation problem in healthcare, we have a technology adoption problem.” -Niko Skievaski, President & Co-Founder, Redox

In addition, several attendees noted that access to data is currently a barrier. As noted above, technological innovation exists, but there is a problem of adoption. Several participants suggested that data access could thus be granted through business-associate agreements (BAA) or similar agreements in order to streamline the process.

Finally, several participants mentioned HIPAA concerns around data being near-term and urgent. It will be important when standardizing and enabling access that HIPAA is reformed to reflect this updated environment of liberated data.

One final time, the group took to their devices to respond to anonymized survey questions relevant to the topic of Liberating Data to Drive Value. These polling questions were presented as a way to gauge the pulse of the room on certain overarching issues within the broader context of the conversation. The results of these questions are depicted below (sample size: approximately 21 respondents per question).

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Looking Ahead

Coming out of the third DSIIS meeting, HHS and the DSIIS participants discussed more specific actions that might help move closer to realizing innovation in healthcare.  Aligning incentives, removing uncertainty in the reimbursement and approval process, adoption of data standards and  allowing for patients to be incentivized were just some of the actions discussed that could help realize the benefits of innovation.   As HHS looks toward the 4th and final DSIIS meeting, the Department will be summarizing the discussions of the DSIIS, highlighting some of the recent activities taken by HHS that might impact innovation and discussing the DSIIS effort and how HHS might continue to stay connected to the innovation community and accelerate innovation in healthcare to improve the health and wellbeing of all Americans.

More details on the date and location of this meeting will follow.