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Pooja Babbrah, Point-of-Care Partners Payer & PBM Lead kicked off the episode by acknowledging guest, Dr. Steven Lane, Chief Medical Officer with Health Gorilla and Point-of-Care Partners co-host, Jocelyn Keegan , Payer/Practice Lead and HL7 Da Vinci Project Program Manager. 

Pooja then outlined the discussion for this episode. The hosts talked with Dr. Lane about: 

• Trusted Exchange Framework and Common Agreement (TEFCA)
• Information blocking…or rather information sharing, 
• Dr. Lane's transition from being part of a large health system to joining the health IT company, Health Gorilla and the different perspectives on innovation and change that come with operating in these quite different organizations. 
• The cycle of innovation and the role of policy. 

Before jumping into the discussion both Jocelyn and Dr. Lane introduced themselves and explained that over the years they have worked with each other several times through the HL7 FHIR (Fast Healthcare Interoperability Resources) Accelerators with Dr. Lane participating in the Da Vinci Project and Jocelyn serving as the program manager of Da Vinci. Today’s hosts, Pooja, Jocelyn and the guest are all interoperability champions and share a passion for leveraging technology to improve healthcare. 

This episode’s guest, Dr. Steven Lane, Chief Medical Officer of Health Gorilla, member of the Health Information Technology Advisory Committee (HITAC) and longtime advocate for interoperability identifies as being a clinician first and that role brought him into the health IT space. 

Dr. Lane shared that he started using an EHR (Electronic Health Record) back in 1989. Worked on EHR implementation during the 1990’s and helped launch one of the first patient portals connected to an EHR back in 2001. He explained that he’s had more of an opportunity to engage in health IT throughout his career than most primary care physicians. He explained that the importance of interoperability started to be a real focus starting in 2008 and he had the opportunity to work with HIEs (Health Information Exchanges) and then was invited to take part in an ONC (Office of the National Coordinator) taskforce and just continued to say yes to any the opportunities that have come his way so he could contribute to progressing interoperability. He continued to say that in his view if we’re going to fix healthcare, we need to first focus on improving the health of our population. Second, improve the value of the healthcare being provided (reduced costs with optimal outcomes). Third, improve the overall experience of obtaining and delivering healthcare for the patients and for the providers, acknowledging that physician burnout is a real issue. Last, improving health equity. 

Pooja asked Dr. Lane to share a little more about the mission & vision of Health Gorilla to familiarize the audience.

Dr. Lane explained that Health Gorilla started initially by addressing physician burden around lab orders and results. From there, they built a platform and started aggregating data they were exchanging and created a private HIE (Health Information Exchanges). They build a robust record service, master patient index, and then aggregate, normalize and de-dupe the records. The focus really being on data quality and utility. He compared the work to some of the regional HIEs, but Health Gorilla’s audience is much broader. 

Health Gorilla made early connections with CommonWell, eHealth Exchange, Carequality framework – Epic Care Everywhere, with Direct messaging through 3rd party health information service providers (HISPs)

Dr. Lane shared that what he found special about Health Gorilla is the commitment to innovation and bringing in more data types like social determinants of health or data from wearables. 

Pooja then asked Dr. Lane to share his view of TEFCA and why Health Gorilla decided to apply to become QHIN (Qualified Health Information Networks)?

Dr. Lane described the history of TEFCA, the initial idea for it being included in the 21st Century Cures legislation. He recalled that while interoperability had been a major focus of policymakers and the industry, providers and other stakeholders were still voicing frustration that they still couldn’t access the data they needed. 

The idea of TEFCA was for it to be an onramp to support all kinds of interoperability, data exchange and use cases. He expressed that he has had to learn patience as things in health IT never move as quickly as one might want. 

Dr. Lane went on to convey that early on after the announcement of TEFCA, Health Gorilla came out with a public commitment to apply to be a QHIN and be part of a diverse community of regional and national private and not-for-profit entities. 

He continued that becoming a QHIN for a private company is a big deal. They are inviting government oversight and commit to robust governance, state-of-the-art privacy, security and compliance practices. 

Health Gorilla is committed to supporting a broad range of cases and user communities like:

• Health Data Utility
• Public Health
• Community based social services
• Payer-provider
• Individual Access Service

QHINs (Qualified Health Information Networks) will pursue multiple architectural approaches. Health Gorilla will be a data aggregator and platform. Health Gorilla will leverage TEFCA exchange as they do current HIN (health information networks) exchange to continue to build their secure cloud-based repository of health data with the goal to become the nation’s largest and most secure repository of high quality, high utility health data.

Dr. Lane likened his vision of the role of a QHIN to that of a dance studio operator. He went on to explain that a dance studio operator creates a safe supportive space for people to come to dance. Different types of people - individuals or groups. Different types of dances – flamenco, ballet, private party. Everyone is invited to creatively use the space within specified constraints to ensure safety and privacy. 

Pooja followed up to clarify whether Dr. Lane likened becoming a QHIN as more opportunity for innovation. 

Dr. Lane said that absolutely it does. He explained that TEFCA is supplying a framework or single on-ramp and allows for more innovation in various use cases from treatment to payment and operations to public health. 

Pooja asked Dr. Lane to talk about TEFCA and FHIR. She explained that there has been some feedback in the industry voicing concern that even with the TEFCA FHIR roadmap there isn’t enough alignment between TEFCA and the FHIR community. 

Dr. Lane responded that many were disappointed that when TEFCA was originally announced there was no mention of FHIR at all but since then the TEFCA FHIR Roadmap was published. Some may not be satisfied with the current roadmap but it’s a good step in the right direction.

Related to the TEFCA FHIR Implementation guide, Dr. Lane summarized some of the responses explaining that there were 16 commenters – Provider organizations, EHR and other HIT (Health Information Technology) vendors, public health departments, HL7, DirectTrust, HISPs, and others

Some commenters called out the challenges of scale especially around registering and managing endpoints. Others pointed out the need to leverage and align with other work in the FHIR community. Others still pointed out the need to clarify the priority between developing to IHE (Integrating the Healthcare Enterprise) document vs. FHIR exchange for specific use cases.

Dr. Lane went on to point out that there has been concerns about “if we build it will they come” but the number of QHIN applicants and the engagement seen with the comments submitted are a great sign that people are engaged with TEFCA.

Pooja asked Jocelyn to chime in and share what she is hearing from the FHIR Accelerator community related to TEFCA and FHIR? 

Jocelyn agreed with Dr. Lane about seeing the level of engagement being a great sign. She added that there is starting to be a little bit of a cultural shift related to thinking about data outside of clinical data and how to use data to support billing, operations and more and how to use FHIR to do some of those things. 

Jocelyn explained that we’re starting to see a lot more traction. After attending the Carequality, Sequoia and eHealth Exchange meetings in DC in December and hearing the cacophony of voices talking about how to make TEFCA a reality and leverage FHIR was amazing. 

From a community perspective, Jocelyn explained that she is hearing a lot of positive feedback after seeing more real alignment happening with TEFCA and the FHIR community and there seems to be a feeling there is more of an openness akin to what happens in the standards development communities which was a needed next step. 

Jocelyn went on to say that in the near future the industry will need the volunteers to help pilot some of this work and prove we can move beyond point to point and settle the trust issue through these networks. What will be critical is technology meeting us where we are and solving real business challenges. Ultimately, while documents will continue to be part of certain transactions we really have to strive to get to codified data to get to the level of automation the industry needs. 

Dr. Lane seconded the notion of piloting now and not waiting until policy deadlines are looming. This is the time test, pilot and work out the bugs. 

Pooja remarked that it will be interesting to see how Sequoia as the Recognized Coordinating Entity (RCE) of TEFCA decides to engage more closely or not with the Accelerators, specifically FHIR at Scale Taskforce. 

Then Pooja asked Dr. Lane to discuss the huge transition from working for Sutter health, a huge health system to working with a health IT company. Pooja asked him to explain the different approaches to innovation he’s noticed. 

Dr. Lane acknowledged that it is a big challenge to change the course of the huge ship that is healthcare. Things have evolved over the last 100 years or so resulting in the way healthcare is delivered today and it can be hard to change. Many providers may be resistant to change but then you have big disrupters like telehealth and other innovations that force that change. 

Dr. Lane explained that he has personally been deeply passionate about health IT and being innovative but for many years, he was the only provider in the room for years. That’s starting to shift but if the industry wants to see more engagement and willingness to change by providers, there needs to be the right incentives. The most efficient way to innovate is to have all parties at the table with representation to make sure the work being done is solving the right problems. 

Dr. Lane expressed that he’s been at this for 20-30 years and he has recognized the improvement in the process for standards development, policy changes and innovation with people thinking about how we can do this in a coordinated and repeatable way to gain efficiencies. 

From a policy perspective, Dr. Lane explained, there will always be a need for carrots and sticks. 

Pooja then asked Jocelyn to share her perspective on the health systems that are members of Da Vinci and whether there are common attributes/factors that lead some systems to be more open to engaging with standards development and FHIR adoption?

Jocelyn shared that before she jumps in she wants to point out that CMS (Centers for Medicare and Medicaid Services) has done a lot over the last decade to move the policy levers shifting the industry from a pay for service to a value-based care. This shift will require real-time interaction from a 60-90-day lag in information in provider systems. Health systems likely to be at the standards development table have recognized this shift to real-time exchange and own and master their own data. 

Jocelyn explained that one of the big attributes she’s seen in health systems who are more engaged in standards development are those that area a little further along in the value-based care journey and have strong partner relationships. A second attribute is having a willingness to go first and help prod their partners to move a little faster. 

Jocelyn went on to say that it isn’t just the big health systems that can engage, APIs will help level the playing field and enable smaller systems to operate more efficiently. She went on to say that sometimes all it takes is an individual with a passion like Dr. Lane to volunteer, come to the table and be willing to speak up and share the challenges they are facing during use case development. Standards development isn’t just for big health systems to participate and represent providers, it isn’t just for developers and implementers. For valuable work to be done the standards development process needs to understand the real-world problems that need to be solved. There is space for providers, pharmacists, grad students, really anyone in the ecosystem. 

Pooja made the point that this discussion is really about innovation, there is a role for and intersection of policy and standards development and the importance of stakeholder engagement and participation in these areas. She asked Dr. Lane to share his view of the policy role in innovation. 

Dr. Lane responded by saying that Jocelyn had it right when she talked about the importance of having different perspectives represented, especially when creating the initial use cases. 

Dr. Lane went on to say that in his role on HITAC and working on USCDI (United States Core Data for Interoperability). After the first version, other stakeholders were invited to the table to contribute and provide feedback and now there is a repeatable process that is done to update USCDI annually. He added that HL7 has been invited in as well and there is coordination there to ensure implementation guides reflect the latest coming version of USCDI. 

Pooja responded by saying that policy is really important in moving the industry forward but there is also a solid connection between standards development and policy and that in her role as chair of the NCPDP board, she may be biased, but feels organizations who don’t participate in standards development are really missing a big opportunity. HL7 and NCPDP see the value of coordinating and working together and CMS and ONC have made it clear through their roadmaps that standards will be named in coming policy so why not come to the table and make sure your organizational interests are being represented while also working to solve the big, complex issues in healthcare? 

Pooja then shifted the conversation mentioning that as we close out, we like to ask our guests if they have any final message or calls to action, they want to send to the industry?

Dr. Lane responded by saying that he sees TEFCA as a once in a decade opportunity to really take nationwide interoperability to the next level. Right now, the general public probably has no idea what TEFCA is and that there should probably be more of a nationwide, public discourse and awareness so people can move towards it versus being dragged along. 

Pooja then asked Jocelyn for any concluding thoughts or calls to action she would like to send out. 

Jocelyn expressed her agreement with Steven, what are you doing to advance us as an industry, we’re all consumers of this data and ecosystem. 

She added that we are at an unprecedented time when the industry is leading and CMS and ONC are playing a critical role in alignment. The standards version advancement process (SVAP) is a notable example of CMS and ONC listening to the industry. They are no longer putting a ceiling on the level of advancement and progress the industry can make but rather focusing on establishing a floor. 

Jocelyn reiterated her encouragement of organizations and individuals to come and participate in the standards development process and give voice to your challenges so the industry can solve real problems. 

Pooja thanked cohost and interop expert Jocelyn Keegan and the well-informed guest, Dr. Steven Lane from Health Gorilla And thanks to our audience for tuning in! 

A friendly reminder to new listeners that you can find us on Apple Podcast, Spotify or whatever platform you use to pick up your podcasts, including HealthcareNOW Radio and the Podcast Channel. We also post videos of our podcast episodes, sometimes longer versions, on the POCP YouTube channel. And don’t forget, Health IT is a dish best served Hot!

Pooja Babbrah, Pharmacy & PBM lead with Point-of-Care Partners (POCP), NCPDP Board of Trustees Chair, and host of The Dish on Health IT kicked off the episode. This last episode of 2022 featuring POCP Regulatory Resource lead, Kim Boyd and Payer & Provider Practice Lead and Da Vinci Program Manager, Jocelyn Keegancame together to break down all the big things that have happened in 2022 and what we expect for 2023. 

Pooja explained that while this episode's discussion will primarily be policy related, the panelists will also talk about some of the real progress being made in the standards world and the interconnectedness between federal and state health IT policy and legislation and between standards and policy, and what it means to the industry. 

Pooja asked Jocelyn and Kim to briefly introduce themselves and to tell the audience what topics they are most excited about discussing. 

Jocelyn introduced herself as the POCP payer practice lead, devoted to positive change and building/getting stuff done. She went on to say that her focus at POCP is on interoperability, prior authorizations, and the convergence of tech, standards, and product strategy. She explained that she has spent her career moving people and organizations towards APIs, unleashing data for their highest, best-purpose uses. She expressed that she couldn't be more excited about where we've been this year and the precipice of where we are headed next year.

Kim expressed that it's always a pleasure convening with Pooja and Jocelyn to discuss the exciting world of health IT.  She went on to share her background which has spanned medical and pharmacy operations and implementations, with years of policy, industry, and standards development work on ePA, cost transparency, ePrescribing, and taking what she learned in these areas to work with policymakers on smart policies to advance interoperability and patient care.  Kim stated that it has been an exciting year leading POCP's Regulatory Resource Center and that so much is happening in the state and federal regulatory spaces that ties to the innovations and acceleration the industry has been experiencing in health care.   

Pooja thanked them both for their introductions and then dug into the discussion by asking each of them to share the biggest Health IT highlights of 2022. 

Kim explained that four things really stand out in 2022:

1. the requirements of the transparency in coverage and no surprises act going into effect and the various provisions requiring data and cost transparency and giving patients and their care teams access to information that will help them make informed decisions.  Many in the industry have been clamoring for transparency of this type for some time.
2. The incredible work happening to advance interoperability via the SDOs and Accelerators, like HL7 Da Vinci, CodeX, FAST, and NCPDP's Pharmacy Technology and Innovations group. 
3. how Federal agencies are collaborating on aligning requirements for interoperability, like the use of standards and FHIR-based standards specifically. This collaboration and proceeding regulatory action will help align the technical and interoperability stars.  
4. the all-hands-on-deck focus on patient health equity is a big area of concentration for not only innovators in the market but the White House, HHS, standards organizations like NCPDP and HL7, and community and public health organizations.  There is just so much happening to try and close gaps in equitable care and the data/digital transformation that needs to happen to help facilitate change.     

Jocelyn followed Kim to share her perspective on the biggest highlights of 2022 first joking that Kim got to go first and steal some of the things she was going to say.She laughingly shared that she agrees with all of Kim's points and then said that she wanted to focus more on the tone and the tenor of the work happening in the industry. Jocelyn shared that from her perspective it feels as though the industry has moved from thinking about interoperability projects as something that will happen "someday" to action and reality.  She clarified that this may not be the case for everyone, but many organizations and projects are moving forward to not only do the IT work but the business transformation. The examples she gave included the real progress made on TEFCA, real-world deployments of FHIR guides, live usage of APIs, prior authorization (PA) on pharmacy getting an infusion with last year's Medicare Part D

Jocelyn added that she wanted to focus on and add to Kim's comment about coordination at the federal level. She explained that policymakers at the federal level have been working for well over a decade and using their levers to make change extraordinarily well.  Jocelyn went on to say that as she sees it there are three camps of folks; people and organizations who are working ahead of policy by paying attention to published roadmaps and reading between the lines of public statements, folks trying to get their organizations prepared to respond to the next wave of policy, and others playing the waiting game to see if it's real and if they'll have to follow or if another path will emerge. 

Finally, she added, that the last highlight from 2022 is all the waiting! The industry keeps waiting for certain regulations to drop. She explained that she doesn't think she remembers another year where there has been this much policy anticipation at year-end. 

Pooja thanked Jocelyn and Kim for sharing their perspectives. She shared two important topics that have been more under the radar but are growing in importance and focus. The first is consent, specifically eConsent. Stewards of change published the report “Modernizing Consent to Advance Health and Equity” to bring more attention to the need to solve this issue – not only in the context of healthcare but also social services as those are such an important tie-in to health outcomes.  Add to that, the ONC half-day discovery workshop on eConsent.  Pooja explained to those who may not have attended – that it was an amazing session that brought together so many different people across the continuum of care in addition to the people working in the social services arena.

The other area is pharmacy and the growing role of pharmacists in the care team and the work that is being done to ensure that they have access to more data and information to support care teams and support patients.  Pooja explained that there has been a lot of movement by retail chains to add primary care services to their offering and community pharmacies are supporting more clinical services.  This has led to more focus and a flurry of discussion around interoperability in the pharmacy space. Pooja gave the example of the Health Information Technology Advisory Committee (HITAC) recently proposing adding a pharmacy-focused subcommittee which is a huge indicator. 

Pooja shifted the discussion to policy highlights, specifically, requirements that went into effect and whether the industry met the deadlines or is still working on it. She explained that she is thinking specifically of: 

• No Surprises Act
• Transparency in Coverage Rule
• Information Blocking

Kim jumped in by saying that with the No Surprises Act there is still some pushback and uncertainty about how providers are going to comply with having to pull together all the data to provide Advanced EOBs (AEOBs) and good faith estimates (GFEs) when there are multiple providers involved in delivering the expected care; however, the Da Vinci Project is working on advancing implementation guidance to support patient cost transparency. Kim encouraged folks and organizations listening to this episode to get involved in these efforts. Kim added that she expects to see more price transparency-related policies, especially given the latest request for information on AEOBs. 

Kim went on to say that compliance with the ONC 21st Century Cures Final Rule on information blocking has been a mixed bag. She added that she wished ONC had called this "information sharing" instead of information blocking. Kim went on to say that most of the non-compliance has been on the provider side because it is challenging when a provider falls under the rule as an actor but maybe the health system they work in does not, especially when the health system may hold the data being requested. She added that most of the EHRs have spoken with are up-to-speed on the full EHI sharing requirement. 

Jocelyn added her perspective on information sharing specifically around EHI. Technically all of this information needs to be put out there, while the industry waits for USCDI to fully encapsulate patient information, there is probably a lot of non-codified data in the system that isn't actionable or really useable. The EHR certification requirements will likely do more to move the industry forward.  Jocelyn confessed that she fell down the RFI response rabbit hole and spent an hour looking at the feedback to the RFIs.  She thinks there is a disconnect between the goal of the rule and how to operationally do the work. An example she provided was around PA and that it isn't automating the submission of the PA alone but how to automate the 10 steps that need to happen before a PA is submitted. 

Pooja shifted the conversation to ask Kim to talk a little about the state activity around price transparency and why it's so important for stakeholders to pay attention not only to federal policy but what's happening in the states.

Kim agreed that so many organizations forget that state policy is a big part of the equation too.  She shared that on the data and cost transparency side, states doubling down to move the needle on data fluidity. The POCP Regulatory Resource center has its finger on this pulse.  From the required patient-specific cost, benefit, coverage, and eligibility data sharing to confirmation of compliance enforcement of the No Surprises Act and Hospital Transparency, just to name a few.

Pooja concurred and added that many people forget the states can add enforcement teeth above and beyond federal enforcement. She then remarked that this has been a year of anticipation and asked Kim to share where the burden reduction and prior authorization rule that was shelved back in 2020 is currently. 

Kim responded by explaining that there has been so much anticipation and even angst for some when the original rule came out in 2020 but then was pulled back.So many in the industry have been endeavoring to fulfill the promise the Da Vinci CRD, DTR, PAS IGs provide on solving for medical PA. Probably the most promising sign from CMS is the rule sitting at OMB since mid-October, waiting for review and then ultimately release. Given OMB has a max of 90 days to take action on the review, health plans, vendors, providers, and their partners should be closely monitoring for OMBs response and action.   

Jocelyn joined in to say that the rule that came out in 2020 was definitely more than just burden reduction and it would have codified the use of patient-access APIs. She added that the 2020 rule didn't just require FHIR but named a particular implementation guide or "recipe" for the industry to use. Jocelyn anticipates that the version of the rule that has reemerged and is sitting with OMB likely includes Medicare Advantage plans which weren't included in the 2020 version. She's really interested to see what the NPRM will include. Jocelyn added that there is legislation pending that includes prior authorization and many are hoping the proposed rule drops before the legislation passes. 

Pooja thanked Jocelyn for bringing up the pending legislation and then moved on to ask about the recent CMS requests for information out there. She asked about what kinds of questions is the government asking and what do these questions tell us about where their heads are at? 

Jocelyn started by saying that the industry is seeing an unprecedented amount of coordination and policy-making activity. It has been a challenge to marshall the resources to respond to these RFIs and participate in the conversations and discussions these RFIs generate. Clearly, the industry is leading and the RFIs are an indication that CMS and ONC want industry input into their policymaking. 

Jocelyn went on to say that after reviewing the comments to these RFIs, the common themes were that the industry needs time and an incremental approach is needed but no one is saying what is being explored can't be accomplished. 

Kim added that she was struck by how aligned the agencies releasing these RFIs seemed to be on solving for interoperability, digitization, using/reusing or referencing FHIR resources for use and across different areas of health care, from the public health infrastructure, TEFCA, Certification of HIT, PAs and more, even the RFI from CMS related to the National Directory wants to hear from health care on the applicability of the use of FHIR standards. 

In transition, Pooja remarked that POCP and everyone on the podcast work in the standards development space through the support of some of the Accelerators like FAST, CodeX, CARIN Alliance, and of course, Da Vinci. She asked for the discussion to now cover the biggest accomplishments so far and what's expected in 2023. 

Kim responded by saying that while not officially announced, the CodeX PA in Oncology Use case – focused on solving for automating PA for cancer patients using the Da Vinci IGs is progressing to the Execution Phase. Members represented in this use case are payers, EHRs, physician groups, and health systems and they have collaboratively moved the needle on this use case and will execute the proof of concept for prostate cancer in 2023. 

Kim added that she is proud that NCPDP for their October Pilot launch announcement of the National Facilitator Model to strengthen pandemic and epidemic preparedness using industry standards and technology to enable pharmacies, prescribers, and government agencies to access real-time information on prescription, testing, immunization, and related data – across state lines - to support patient health interventions during public health crises. The model can also be used to effectively support public health surveillance.

Jocelyn chimed in to express her awe at the pace of work on IGs and new use cases. She added that another big milestone is that FHIR at Scale Taskforce (FAST) transitioned out of ONC into the HL7 Accelerator program. FAST progressed work on Security, Identity, and Exchange and they are pulling the TEFCA team in to align their work. 

She added that Da Vinci has made a lot of progress on Risk Adjustment, allowing payers and providers to share information to inform a change in a patient's risk status. 

Jocelyn went on to say that there are also some exciting real-world implementations happening with a specific shout out to the team comprised of MultiCare, Providence, Regence, leadership from Optum, and Da Vinci champions launching the first in the nation FHIR-based pre-authorization embedded into the clinical workflow. 

Pooja seconded the kudos for the NPCPD vaccine pilot and she also mentioned the CodeX REMS use case which is marching toward a pilot and is once again bringing NCPDP and HL7 together. Pooja went on to recognize Helios as an Accelerator that is starting to gain traction and the industry should pay attention to their work. 

Pooja commented that while price and cost transparency for the patient will always be a passion of mine, the growing role of pharmacists in the care team is another area she is really excited about. Additional services are being performed by pharmacists, the prescribing authority is being extended to pharmacists, and the need for standards and technology to enable clinical data to flow from pharmacists to care team members in other environments like doctors' offices and hospitals. 

Pooja continued by saying that the pandemic and really the Federal PREP act accelerated this movement.  Now pharmacists can administer pretty much any vaccine on CDC's list, and there are around 25 states that allow pharmacists to prescribe HIV medications. Pooja explained that this expanding role and some of the regulatory requirements make pharmacy interoperability and connection with the rest of the care team critical. For example, for pharmacists to prescribe Paxlovid, they must order or access labs for the patients.  Unless pharmacists are in a health system they will likely not have access to a patient's lab report.  If the industry wants pharmacists to continue to support providers and patients with more clinical services – there has to be a focus on interoperability. 

Kim agreed that it is an exciting time for the pharmacy community.  The need for clinical and administrative data access, use, storage, and exchange to improve and coordinate patient care knows no boundaries – the whole of the care team, including the pharmacist, must be able to operate in an environment where this takes place. 

Kim added that the NCPDP Strategic Planning Committee Value-Based Care Subcommittee acknowledged that the industry is well positioned to support pharmacists as a part of a value-based arrangement and we have the standards to support all types of clinical care and exchange so pharmacists can provide services like dispensing, screening for Social Determinants of Health or taking and reporting labs or blood pressure, etc.   

2023 will be filled with opportunities within the NCPDP standards development process, the industry, and policy, to further the role of the pharmacist, closing gaps in care and the innovations needed for the future of pharmacists as part of the care team.

Pooja asked to do a round-robin weigh-in on TEFCA, HIPAA 2.0, and Health Equity. What's new, what's real, and what should our listeners be on the lookout for in 2023? 

Jocelyn responded by saying that each of these topics has so many sub-topics and what will be interesting is to see how these all intersect with one another. She added that there is a movement to the platform where companies are partnering to solve some of the challenges related to these areas and make data fluid but secure. 

Kim responded by saying that there is still confusion and conflict between HIPAA and the ONC Information blocking rules.  Technology has evolved and new interpretations and requirements are needed that provide patient data security without limiting data sharing.  The industry will see some movement from OCR in 2023.

TEFCA is real and moving forward in establishing the infrastructure model and rules that will govern how different networks and their stakeholders (including providers, payers, and public health) securely share clinically relevant information with each other. Nine organizations have provided letters of intent to the Sequoia Project, the recognized coordinating entity on behalf of ONC, to apply to become QHINs including EHR vendors such as Epic and Nextgen, national networks such as the eHealth Exchange and the CommonWell Health Alliance, and tech vendors such as Health Gorilla. More organizations are expected to apply. It will be interesting to see how successful TEFCA will be in incorporating FHIR into the framework over the next few years 

There is a united effort that includes government entities, health systems, pharmaceutical companies, private payer groups, and community organizations working together to overcome disparities and improve equity. This requires improved access to shared clinical and social needs data. 

Just last week CMS released its “Path Forward to improving data to advance health equity solutions” which aims to increase the collection of standardized sociodemographic and social determinants of health (SDOH) data across the healthcare industry as an important first step towards improving population 

In closing, Pooja asked everyone to share what they are most hopeful to see in 2023. She kicked it off by saying that for her it's the continued focus on pharmacists. 

Kim responded by saying many great things are happening in health care and that she is excited as a patient. There is more focus on helping patients grow as consumers of their own health care, providing data and insights into what options are available to obtain quality, timely and cost-effective care. 

She also expressed excitement about working with industry and policymakers to advance medical ePA in 2023 via the HL7 Da Vinci standards and leading the CodeX work on a pilot to advance PA for cancer patients. 

She concluded by echoing what Pooja said about her excitement about leading and partnering with others at NCPDP to promote and advance the role of the pharmacist as a part of the care team. 

Jocelyn joined in to say that she is hopeful for the momentum that has built up and she is super excited to see stakeholders build their toolboxes and embark on real-world implementations. 

Pooja closed out the episode by thanking her POCP cohosts, Jocelyn and Kim, and wishing our audience the happiest of holidays and the best for 2023. 

She reminded listeners that they can find The Dish on Health IT on Apple Podcast, Spotify, or whatever platform they use to pick up their podcasts, including HealthcareNOW Radio and the Podcast Channel. And that videos of the podcast episodes can be found o on the POCP YouTube channel. Adding, Health IT is a dish best served Hot!

On this episode of the Dish on Health IT podcast, guest Troy Trygstad, Executive Director of Community Pharmacy Enhanced Services Networks (CPESN) speaks with Ken Kleinberg and Pooja Babbrah about how pharmacy is evolving as a key part of the health value chain. 

Troy started with a brief overview of his background, which includes a degree in health economics and pharmacy policy with over 15 years in primary care. While in primary care, his focus was on accountable care, value-based care, clinical integration, grants, innovation, the state and commercial payers. All his learnings on the medical side were a great trajectory to transferring this knowledge to the pharmacy field where he set up the same version from a regulatory structure, operations, and data integration that you would see on the clinical side. 

Ken posed the question of: How do you see the role of pharmacy evolving to meet the needs of value-based care? Troy commented that, “This is nothing new, leaders in pharmacy have been saying this for 30 years. What it really took was market dynamics, payment reform, alternative payment models coming from a purchaser marketplace saying that they have had enough. This finally stimulated action. You just can’t be fee-for-service anymore, and it was prompted by market change and that is happening in pharmacy now.”

Pooja responded to Troy’s answers and agreed in full. She also mentioned the point that manufacturers of medication are working on providing the best value for medications, but there is no way to track this effort. In pharmacy, this is where we can really see a difference. For example, a pharmacist sees their patients and can directly prove outcomes. She used smoking cessation tactics as one example. Troy’s response was, “What is past for medical is becoming prologue for pharmacy.”

Ken moved the discussion to focus on what CPESN does, for example, eCare plans specifically, helping the industry improve communications, closing the gaps, improving communications, and focusing on quality and asked Troy to talk more about that. 

Troy responded by giving a brief overview of a project he worked on with the Center for Medicare & Medicaid Innovation (CMMI), which was to answer the question of how to integrate care processes in order to pay pharmacies differently and explore what a value-based contract even looks like. A year into the project, participants started to say that requiring providers to log into another system wasn’t working with workflow. The project did a 180-degree turn and moved to working within systems that providers already work in. 

This led to a call with CMS and Office of the National Coordinator (ONC) about a high-impact pilot project to find a standard to share clinical information in and out of a native community pharmacy system of record. This led to 18 vendors that serve at least 20,000 pharmacies. Troy said, “So here we sit now with millions of care plans that now transact under the Health Level Seven (HL7) pharmacist electronic care plan standard. Which is not great for claims adjudication.” The main goal is to get all the information in one transaction. 

Pooja responded by saying that there is a lack of awareness and that we need to start talking about this more. From a payer and reimbursement side specifically. ONC is looking at adopting this as well, and we need to get this out in the industry and get more support because the systems are in place. 

Troy added that back when he was doing practice transformation and going through ePrescribing adoption and then HITECH/ARRA era and we always said it’s much easier to go from paper to EMR than going from EMR to EMR. Sometimes there is an advantage to getting into the game a little later. Of the 18 health IT vendors that offer care plans, 17 of them use FHIR and not CCD-A so, it is already baked in. He went on to say, for example, that if you already have your labs, vitals, and drug therapy problems, then the next step is that you must have a user interface so that you can enter labs, etc. We need the pharmacies to meet the standards so that they can enter these contracts. 

Ken’s next question was, “The N in CPESN in for network-- how do you see the role of a national look-up for example and ability to do patient matching here- and how does this integrate with the workflow of pharmacists and other stakeholders?”

Troy responded that we need to flip the priorities and the sequencing, but you have to start with the easy things first. The first reason data started to be collected was the regulatory obligation to collect clinical information based on improving quality and reducing variation. Once we got the information, we had to decide who we shared it with-- a university, care managers, care coordinators, etc. Then, when you get to the hard stuff it takes a community. It takes, NCPDP, ONC and a much larger community-- when you start talking about switchboards, you’re just in a whole other level. You must determine who it is you’re working with, how do I load the directory, what am I able to send to help support care coordination. Starting with the easy and then working towards the hard is something that’s really good to see the industry doing. 

Pooja then responded that we are making strides on the medical side, wrapping the value-based contract between the providers and pharmacies. It is particularly important to get a better handle on FHIR endpoint directories which hasn’t even been solved on the clinical side of the house.

Troy went on to say that there is going to have to be some sort of incentive and marketplace innovation financially absent from a federal mandate for this to happen. Federal mandates in pharmacy aren’t expected since pharmacy has been left out of regulations to date.

Ken countered that pharmacies are considered an actor in 21st century cures and information blocking, so how do you see the focus in Washington as it relates to pharmacy and your goals? 

Troy quipped, “How many podcasts do you have?” Right now, pharmacy is a 100 million dollar industry, that is peanuts in healthcare! The denominator in healthcare is in the trillions. We need to focus on the industry to go from 100 million dollars to the billions to get government funding. We are not even in the right arena right now.

The market currently sees pharmacy as a vendor. The value-based contract comes after the billing. We currently provide a service and should get paid for it. For example, smoking cessation programs offered by pharmacies should be reimbursed now before we can answer the question, how many quit? We have to get to the point where we can bill for a service first. The pharmacy has to be recognized as a service provider instead of a vendor in order for a baseline to be established so pharmacies can truly enter into value-based agreements and get paid based on outcomes. 

Pooja picked up on the pharmacy as provider status thread. “Just with the changes we’ve seen and the impact of COVID, in some states pharmacists are recognized as providers, but until we get this recognition at the federal level, and allow pharmacists to charge for their services that it’s a huge barrier and an especially important thread. Right now, there is just talk about ’pharmacists are trying to get provider status,’ but if you unpack the reasons why and if you take anything from this podcast, that is a crucial point to watch out for and that is a path down the road to success.” 

Troy responded that pharmacies have been providing services this whole time but getting paid at the prescription fill level doesn’t make any sense, especially when that fill fee has gotten smaller and smaller over time. “So, don’t pay pharmacies for each prescription fill, but pay them in a different way, if you want to call it ’provider status‘ then call it what you will.” 

Ken posed the question, with the caveat that the discussion may have covered it to some extent already, but how is the market evolving in the financial space for pharmacy?

Troy compared the market to the game Blokus. The basis of the parable is: So, what most people think is the best strategy is to protect your spaces on the board (block), but the trick is that there are not enough spaces in your corner of the world to play all your blocks. This is what is happening in pharmacy right now, there is not enough money in dispensing. 50% of the drug cost is 2% of the fills. Three to five years from now, it could be 80% of the drug costs is 3% of the fills. The key to winning Blokus is to penetrate other’s defenses and that’s what pharmacy has to do. It is all about whose territory you are going to invade.  

Pooja added that in the pharmacy industry we must be thinking outside of the box. We are set up in a position to change things in the pharmacy. “I see CMS and ONC starting to focus more on pharmacy. The real question is, how do you make sure that you can stay as a viable business in pharmacy and get paid? How do you make sure you’re able to collect the data you need? We should be working more directly with the payers and thinking in a broader spectrum.”

Troy followed up by saying, “Do the math. Most pharmacies are only operating at 1.5%  average profit margins. So, if you are a 10 million a year pharmacy (which is successful)-- what is 1.5 % of 10 million? $150,000, that is nothing. In comparison, services industries average 40% margin. So, pharmacy must understand this shift. It’s about what you bring in that you can keep. COVID has provided a ’craft beer’ moment for pharmacy. Meaning what matters is consumers and purchasers and COVID has changed people's mindset that pharmacy is a provider of care. Pharmacy Quality Solutions (PQS) Trend Report has great data. One data point is a question to payers about whether they would pay to get A1C results, blood pressure, and other biometrics from pharmacies if it was available in a structured way. Three quarters of the payers responded that they would. Payers have come a long way in adopting new technologies when they used to be the laggards. So, now it is pharmacy IT that is really behind.” 

Ken closed out the discussion by asking whether there is anything you would like to ask the industry and our listeners to do today. 

Troy responded with two key points. The first being that he is on a mission to communicate to the world that we need some sort of consensus-based or the Pharmacy Quality Alliance (PQA) to step up services billing and value based contracting process. “What is our compass, how are we getting together as an industry? What does that look like? Second, pharmacies should be paid differently. Our associations need to make that happen. We need advocates going to the consumers and saying, you are in harm’s way if you do not pay us.”

Pooja closed the podcast by saying that consensus building is key. “We talk all the time about needing a Da Vinci-type Accelerator program for pharmacy to help do this work and build the consensus and I am all for that. I am excited to hear Troy’s take and consider what the future in pharmacy holds.” 

Learn more about academic opportunities in Health Policy and Law at UCSF and UC Law San Francisco.

BONUS EPISODE

As part of Policy Spotlight, a new virtual event series from Health Affairs, The Commonwealth Fund President David Blumenthal welcomed Micky Tripathi, the national coordinator for health information technology (IT), to an in-depth discussion of Biden administration's plans and priorities for health care data.

The interview was conducted on July 1, 2021.

At the Department of Health and Human Services, Micky Tripathi leads the formulation of the federal health IT strategy and coordinates federal health IT policies, standards, programs, and investments. Guest host David Blumenthal held the same post during the Obama administration from 2009 to 2011.

The discussion covered a number of topics, including information blocking, interoperability, Biden's equity project, social determinants of health data, artificial intelligence, data privacy, and much more.

Policy Spotlights feature conversations with influential health policy experts in Washington, DC, and beyond. Interested in attending future events? Sign up for Health Affairs Today or Health Affairs Sunday Update newsletters to be the first to hear about the upcoming events.
 
Health Affairs is grateful to the Robert Wood Johnson Foundation and The Commonwealth Fund for their support of the “Affordable Care Act Turns 10” issue.

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The accelerated pace of innovation in digital health, record-breaking investments in the sector and even some of the technology developed to navigate the pandemic wouldn’t have been possible without groundwork laid by The Office of the National Coordinator for Health Information Technology (ONC). And there’s probably no one who understands ONC’s past, present and future role better than Steve Posnack.

Steve is a fixture at ONC, joining a year after it was formed in 2004 and serving for the past 16 years in various capacities through four administrations. Since 2019, Steve has served as Deputy National Coordinator, playing an integral role in policy development, technology initiatives and investments, budget prioritization and industry-wide coordination.

In this episode of Healthcare is Hard, Steve gives a background and history of ONC, explaining how it fits into the Department of Health and Human Services and the overall role it plays in the federal government. He shares insights that anyone in the healthcare innovation ecosystem should understand and his conversation with Keith Figlioli covers a number of topics including:

• Wins and regrets of ONC. As someone who has been at ONC for nearly its entire history, Steve has a rare vantagepoint to reflect on initiatives that have gone smoothly and lessons-learned for those that haven’t. For example, he discusses successes and challenges of Meaningful Use, recognizing its imperfections, but all the innovation that it made possible as well.
• Cybersecurity in healthcare. Steve entered ONC after earning a dual master’s degree in cybersecurity and health policy from Johns Hopkins University, giving him a unique skillset to address the security issues with healthcare IT that are becoming increasingly more critical. He talks about the need for better cyber hygiene industry-wide and shares thoughts about meeting that goal. But he doesn’t predict any federal mandates for security in the near future.
• Improving data quality. According to Steve, poor data quality is a sore point for public health professionals and an area where the private sector can help in order to benefit everyone. He says the people tasked with tracking and consolidating data spend precious time doing “data detective work,” and it’s been especially challenging through the pandemic. This requires looking upstream to know where data is coming from and where it’s going to figure out how gaps occur and how to address them.
• The future role for ONC. Taking all of ONC’s accomplishments into account, Keith and Steve discuss if there’s more work to be done, or if the public sector should start taking over. From Steve’s perspective, there’s a lot for the private sector to build on, but he also says there’s a lot the industry is still asking ONC to push forward. As just two examples, he talks about how work around the social determinants of health and the convergence of clinical and research operations still need broader coordination.

To hear Steve and Keith talk about these topics and more, listen to this episode of Healthcare is Hard.

On this year-end episode of The Dish on Health IT podcast, host Gary Austin and co-hosts Ken Kleinberg, Pooja Babbrah and Jocelyn Keegan discuss prognostications on the year ahead in the areas of COVID-19, technology innovation, health data, and price transparency. 

Gary begins the episode by addressing the elephant in the room: the ongoing impact of COVID-19. He asks Pooja to open the discussion by giving her thoughts on the impact of the healthcare vertical COVID-19 is going to have in 2021. Pooja says COVID-19 is going to impact a lot of things, starting off with the vaccine. For the vaccines that are beginning to roll out, two different doses are needed for it to be effective. Tracking immunizations will be tricky for HIEs. Who has received the first dose? The second? Adherence will be critical. We need to make sure those who received the first dose of the vaccine also receive the second dose. Even the payers and pharmacies are going to be impacted by COVID-19 not just with the vaccine, but with how people are seeing their doctors. Pooja references past The Dish on Health IT podcasts that covered telehealth, the expanding role of pharmacists such as giving vaccinations, and the opportunity to better include community pharmacists in efforts, which all will remain relevant moving into the new year.

Jocelyn agrees with Pooja in saying we need to drive volume in this market to the most suitable place that can best serve a patient and have the right tools and connectivity to make sure that data is comprehensively gathered. Jocelyn does see two things we will have to grapple with when moving into the new year. The first is the impact of profits and loss from a provider organization standpoint. There is massive loss happening for those in the direct line of care. She thinks when we look at 2021, it will be about leveraging the tools in front of us and taking advantage of the new technology that is being laid down. The second issue at hand will be impacts of market readiness. We wanted these rules to be put in place and then the rules were put in place. Will delays on these rules slow us down when we were at a point in time when we could have had a perfect storm to push through a lot of technology change? How fast do we allow ourselves to move? How much do we acknowledge what our provider teams are dealing with?

Ken believes the vaccine will be key. He recently read an article that correlated the degree of someone’s education with their willingness to take the vaccine. If you had an advanced degree, you would be most likely to want to take the vaccine. The less education a person had, the less likely they were willing to take it. There are big trust and education factors here that payers, providers, IT vendors – all of us really – need to take responsibility in helping with that. 

Gary moves the discussion to the next topic: health technology, specifically telehealth, FHIR APIs and health information exchanges (HIEs). What are your thoughts as to where these technologies are going in 2021? Ken notes that all three of these technologies have something in common and that is that they are connecting stakeholders together. We’ve experimented and piloted. We’ve had our successes and less so over the last two decades, but now we are seeing these technologies come together and become mainstream. This could be due to leadership, regulations, relaxation of regulations (in the case of telehealth), or simply the need to fight the pandemic. Once data starts to flow, we will be able to run advanced analytics with more varied data sources. This can inform decision support, risk stratification, analysis of social determinants of health, precision health and so forth. Ken is particularly excited about the promise of natural language processing and AI machine learning. 

Pooja agrees with Ken in saying these technologies are essentially connecting people together and sharing more information, which brings up trust. We are starting to open up more data. We have HIPAA which spans across our business entities. What will happen when we open up data to the patient? Patients having trust in applications will be critical for them in getting their information. Then comes the issue of who the patients are willing to share the information with. eConsent plays a huge role in this. Who are patients going to share the data with? Do they understand that when they share their record, it will essentially share their entire patient record? Is that something they want to do? Moving into 2021, trust and eConsent will be a huge focus. 

Jocelyn points out that if a problem is big enough, we can make the existing artificial barriers disappear. She goes on to explain that people have been leveraging tools that are available to them. When you’re in the middle of a pandemic, it is about what tools are there that are being underutilized such as the HIE. She goes on to address new technologies and the unleashing of data by using APIs predominantly through FHIR. The pandemic has clearly shown how important these projects are and will allow stakeholders to progress towards more real work in the upcoming quarters. Payer and provider rules continue to get dropped. Jocelyn feels the work around FHIR and APIs is truly a nonpartisan topic. We are seeing universal agreement and will continue to push forward. 

Gary moves to the next topic, which is health data. What do you see happening with health care data in 2021? Jocelyn sees a couple of things happening here. First, payers and EHRs, around the information blocking rule, are mastering their information in a way that they haven’t had to before; being able to comprehend where their clinical and claims data are. What’s most interesting is the scope of data that’s under regulation and having people meet those initial regulations. Secondly, we are realizing this is real. There are the people who are getting their house in order and then there are people who are trying to just check the box to get through this set of regulations. 

Ken notes that terminology and code set management have been important to providers and now to payers as well. Payers will need to get a handle on the clinical data they have and share it. Ken says some may only do the bare minimum while others will use this as a business advantage.  

Jocelyn hopes that the next round of USCDI addresses some of the deficits in the payer-based data. 

Pooja adds that while we often talk about clinical and claims data, we need to also be thinking about pharmacy data. With USCDI 2.0, we need to start thinking about those stakeholders who haven’t been involved like pharmacies. To have clinical, claims and pharmacy data together would be a very powerful thing.

Gary asks Pooja to address price transparency. Pooja says that real time benefit check feels old hat now since it has been in the market for five years. With consumer-facing, there are implementation guides in place, and we are starting to see some PBMs pick those up and start to look at it. The biggest thing though is the final rules that dropped a couple weeks back for the payers and providers. Pooja thinks that’s where we’re going to see a lot of traction in 2021. Payers and providers need to be looking at this as a way to give themselves a market advantage. There is a long way to go, but it all comes down to freeing data and putting more opportunity in the consumers’ hands. To find the care they need at a price they can afford it.  

Ken says that consumers can play a very important role with price transparency. He wonders how we educate the consumers to operate in the proper vector. The more information you provide them, in an easily-digestible way, can make a difference. Ken believes these final rules can be used as a market differentiator that could lead to stronger consumer loyalty. 

Gary asks Jocelyn to discuss accelerators in terms of price transparency. Jocelyn says the name of the game with price transparency is that it needs to be patient-focused. It’s about information equity, having the same information as my provider, which requires all the players to be involved. Jocelyn thinks that if we look across the board, that’s the sentiment of what’s happening. That’s the foreseeing function we see coming out of these rules is make the data available so that we can have the innovation we need to get to a well-educated consumer. 

The final topic relates to the new administration. Gary first asks Jocelyn where she sees CMS and ONC going? She predicts that we can expect public health to get some money to actually do real work. Since this is a non-partisan topic, she also expects regulations to continue to come through. Jocelyn is confident that with the work coming out of the ONC and CMS teams around regulations and the work we are seeing come out of cross collaborations, we are making real meaningful progress in helping our consumers. 

Pooja adds that with CMS, we are still waiting on a final rule for the consumer-facing real time benefit check transaction. These topics seem to have bi-partisan support, so she does not see many changes in these focus areas. 

Ken gives his final thoughts. He thinks 2021 is going to be one of the most intense years in decades for health plans, providers, and IT vendors as they start to tackle all the game changing open API regulations that are going to require them to share data. 

Jocelyn thinks we have never been better positioned to impact change. We are in a unique situation with the move toward FHIR and APIs. It is rare to be able to fundamentally change how an industry works. That’s what we’re doing. 

Pooja closes by saying she thinks this pandemic has opened our eyes to everything that is wrong. The CMS and ONC rules were coming out just as we were going on lockdown. It makes you wonder, if we had these rules in place just on our own without being forced to do it, how much of this heartache and struggle we are going through now could have been avoided? Pooja was frustrated to see the rules get delayed. We are in the middle of a pandemic. We should not be slowing things down; we should be speeding them up. 

If 2020 was not bad enough already, we lost Ruth Bader Ginsburg on September 18, 2020. She was admired by many lawyers and legal scholars, not just in the United States - she was a legal giant, and a great advocate for equality for all. Paul Breitbarth and K Royal discuss the impact Justice Ginsburg had on the legal field and how she inspired respect and devotion.  Our homage goes beyond her legal decisions to remember her as the icon she was, and always will be.

In addition, Paul and K touch on a few topics in privacy law, such as whether the US really will pass a federal privacy law and reconsideration of the actions taken towards Facebook in Ireland  Also, in the US, there is perhaps an overlooked part of US privacy, a final rule published by the Office of the National Coordinator which implements a portion of the 21st Century Cares Act, on Information Blocking - a rule that has quite a bit in common with the EU’s General Data Protection Regulation.

Join us as we pay our respects to the late Ruth Bader Ginsburg, the second woman ever appointed to the US Supreme Court and one who blazed trails for equality in the US, followed by some frank conversation on some current privacy topics.

Resources

• Justice Ruth Bader Ginsburg - picture of her clerks
• U.S. Federal Privacy Law Hearing 23 September: Revisiting the need for federal data privacy legislation
  • Julie Brill, Maureen Ohlhausen, Jon Leibowitz, William Kovacic (all former FTC) and Xavier Becerra (CA A-G) 
  • Quotes from The Register:
    • Julie Brill argued that not only will a company want to have the option to trade with Europe at some point, but that a stronger and clearer data privacy law across the US would be beneficial: it would enable companies to “engage more respectfully and increase trust in those companies.” It would increase competitiveness.
    • Agreement that a patchwork of state laws needs to be avoided. 
    • Becerra: “Give us a playbook. But don't preempt smart, nimble privacy protections that let states meet the varying challenges coming at us.”
• WSJ Article: Irish DPC Schrems-II enforcement follow up:
• The West Wing - S01E09 -

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