Podcasts about century cures

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Best podcasts about century cures

Latest podcast episodes about century cures

Nurses Uncorked
EP 34: Online Patient Threatens Nurse at Peace Health Southwest Medical Center

Nurses Uncorked

Play Episode Listen Later Feb 20, 2024 58:53


Travel RN Coach (@lindseys_leisures), Lindsey, joins Nurses Uncorked to discuss her recent viral video in which a patient made alarming threats against their former ER nurse at Peace Health Southwest Medical Center. The repeated threats included very specific identifying details of the nurse's family, begging the question, how were they able to find this information?   The answer lies in The 21st Century Cures Act, first passed in 2016. Many medical professionals remain unaware of The Cures Act. And patients often do not understand the complications it poses to their care. Why do patients have access to nurses' full names? Is this a safety risk that employers should mitigate? What role do electronic health records, like Epic, Cerner, or Meditech play? Should patients have real-time access to their medical records? Join us as we break down The Cures Act and it's ramifications.    References: https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf National Public Radio (NPR): Winners and losers with the 21st Century Cures bill. http://www.npr.org/sections/health-shots/2016/12/02/504139105/winners-and-losers-if-21st-century-cures-bill-becomes-law.    Follow Lindsey: https://www.tiktok.com/@lindseys_leisures?_t=8k1XIaaTQr9&_r=1 https://www.instagram.com/lindseys_leisures?igsh=MTd5Z2tleHdwYXJsbg== https://lindseysleisures.net/ https://youtube.com/@lindseys_leisures?si=LiWRkky8bgNVbera   New episodes of Nurses Uncorked every Tuesday. Help us grow by giving our episodes a download, follow, like the episodes and a 5 ⭐️ star rating! Please follow Nurses Uncorked at!  https://www.tiktok.com/@nurses.uncorked?_t=8drcDCUWGcN&_r=1 https://instagram.com/nursesuncorked?igshid=OGQ5ZDc2ODk2ZA== https://youtube.com/@NursesUncorkedL https://www.facebook.com/profile.php?id=100094678265742&mibextid=LQQJ4d You can listen to our podcast at: https://feed.podbean.com/thenurseericarn/feed. https://podcasts.apple.com/us/podcast/nurses-uncorked/id1698205714 https://spotify.link/8hkSKlKUaDb https://nursesuncorked.com     DISCLAIMER: This Podcast and all related content [published or distributed by or on behalf of Nurse Erica, Nurse Jessica Sites or Nurses Uncorked Podcast is for informational purposes only and may include information that is general in nature and that is not specific to you. Any information or opinions expressed or contained herein are not intended to serve as or replace medical advice, nor to diagnose, prescribe or treat any disease, condition, illness or injury, and you should consult the health care professional of your choice regarding all matters concerning your health, including before beginning any exercise, weight loss, or health care program.  If you have, or suspect you may have, a health-care emergency, please contact a qualified health care professional for treatment.   Any information or opinions provided by guest experts or hosts featured within website or on Nurses Uncorked Podcast are their own; not those of Nurse Jessica Sites, Nurse Erica or Nurses Uncorked Company.  Accordingly, Nurse Erica, Nurse Jessica Sites and the Company cannot be responsible for any results or consequences or actions you may take based on such information or opinions.

HealthcareNOW Radio - Insights and Discussion on Healthcare, Healthcare Information Technology and More

S2 E7: Host Dr. Jay Anders interviews Lynn Carroll, COO of HSBlox, an Atlanta-based value-based care (VBC) technology company. They discuss the new generation of value-based care and payment and the challenges that face organizations and providers with this new era. The two discuss the genesis of Medicare Advantage alongside interoperability and 21st Century Cures and quality programs, as well as the recent DOJ actions against fraud in the space, and the impact for providers and organizations. As always, data plays a critical role, listen as they talk through how you might make use of it in your organization. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

This Week in Health IT
Keynote: Healthcare Community Transformations: Are Pharmacists the New Primary Care Providers?

This Week in Health IT

Play Episode Listen Later Feb 24, 2023 30:10 Transcription Available


February 24, 2023: The nature of healthcare is changing and many, including Frank Harvey, CEO of Surescripts, have some predictions. Physicians will take up the role of primary care provider once again and the legislature will shift to aid in preventing physician burnout. This is a big problem because what happens when 150,000 physicians pull out of the occupation? How will these transitions impact the big players like CVS and how will it impact IDNs? With pharmacists peaking patient's trust and time, we need to better our compensation structures and legislature. What does the new competition in the field, Walmart and Minute Clinic mean for healthcare? How will hospitals grow their interoperability? Will specialty medications play an even larger role? There is a cooperative future in healthcare and we are working towards closer working relationships all over. Key Points:20% of primary care physicians plan to retire over the next two years.In the first half of this year, over 10 and a half million messages have gone back and forth between physicians and pharmacistsThe pharmacists see patients on average 35 times a year while their primary care doctor sees them only 4 on average.30% of rural healthcare systems will close within the next year21st Century Cures' requirements on the providers and payersSurescriptsHealthcare needs innovative ways to address staffing shortages from clinical to IT employees. Are you curious about how technology can help support your Healthcare staff? Join us on our March 9 webinar, “Leaders Series: The Changing Nature of Work,” to explore how Health IT can be used to supplement Healthcare professionals https://thisweekhealth.com/leaders-series-the-changing-nature-of-work-remote-hybrid-onsite-shortages/Subscribe: This Week HealthTwitter: This Week HealthLinkedIn: Week HealthDonate: Alex's Lemonade Stand: Foundation for Childhood Cancer

The Dish on Health IT
TEFCA & The Intersection of Policy, Standards & Innovation

The Dish on Health IT

Play Episode Listen Later Jan 19, 2023 53:15


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 UtilityPublic HealthCommunity based social servicesPayer-providerIndividual Access ServiceQHINs (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 othersSome 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!

RTÉ - Drivetime
16th Century Cures

RTÉ - Drivetime

Play Episode Listen Later Nov 17, 2022 6:43


Dr. Siobhán Barrett, Post-Doctoral Researcher in the Early Irish Department of Maynooth University

The Dish on Health IT
The Impact of Standards and Policy on Legacy Data

The Dish on Health IT

Play Episode Listen Later Oct 12, 2022 34:52


This episode's guest is Dave Navarro, Senior Director of Data Science for Harmony Healthcare IT, a data management and lifecycle solutions firm. Dave joins the Dish on Health IT host, Ken Kleinberg, and co-host, Jocelyn Keegan,to talk 21st Century Cures Act and the change in the definition of “EHI”, critical components of plans to purge, archive, or transition data to new platforms, and how to marry data in various formats and versions of CCDA and FHIR. Ken kicked off the episode by asking co-host, Jocelyn Keegan, to briefly introduce herself and to share what she's looking forward to learning from today's guest.Jocelyn responded by explaining that she is the payer-practice lead at POCP, devoted to positive change and building/getting stuff done. She went on to say that her focus is on interoperability, prior authorizations, and the convergence of tech, standards, and product strategy. She also serves as the program manager for the HL7 Da Vinci Project. Da Vinci started as a conceptual idea of emulating the great work produced by the argonaut project but with a focus on payers and providers, value-based care, and clinical data interoperability and has become likely the most expansive of the FHIR Accelerators to date, focused on payer-provider collaboration.Ken then asked guest, Dave Navarro to briefly introduce himself and to include his professional background and journey to Harmony Health.Dave reiterated that he is the Senior Director of Data Science at Harmony and that he started his career about 22 years ago in the health IT world. He explained that he started by configuring EHRs and building clinical integrations for financial systems and clinical systems for Cerner Corporation.Dave explained that early on he had a lot of exposure to different data formats and files and that he's been spending the last 17-plus years in the health information exchange world. He landed at Harmony Health to work on the interoperability of legacy data and the legacy data solutions Harmony provides.Ken asked Dave to expound a little more on the work Harmony Health is doing.Dave explained that Harmony helps their clients' archive data from a legacy system or in some cases transition data from a legacy system to a new system.  If data are archived, they must still be in a format that can be managed, accessed, and consumed to inform clinical decisions.Harmony offers the Health Data Archivers solution, which includes extraction services. Clients can also earmark data that they'd like to have posted in their new system.Ken then shifted the conversation by asking how the industry as a whole or different stakeholders in particular view 21st Century Cures differently and whether Dave wishes there was a perspective the industry would share about how they approach compliance.Dave started by admitting that he hasn't read the entire 21st Century's Cures Act but has familiarized himself with the portions related to interoperability. He shared that he believes this legislation is a good thing. Dave pointed out that while it was signed back in 2016, the industry is just now seeing the results.He explained that he believes Cures has pushed the industry towards the adoption of content standards such as USCDI and transmission standards like HL7 CDA and now FHIR. Dave then went on to talk about the data blocking provision explaining that nobody wants to be a data blocker. This portion of the Act helps open the data stream and make data available where EHRs and ultimately patients can view it.Concerning what perspective he wishes the industry would share, Dave explained that it's about FHIR. He realizes that FHIR is a little bit scary to some, but that the industry should be starting with FHIR. Dave explains that one reason he believes this is the relative ease to understand and use FHIR compared to CDA, which has been a bit challenging to figure out. He went on to say that with FHIR, someone can study an implementation guide for an hour and pretty much figure it out. Dave also pointed out the FHIR US Core data set as being a good specification.Dave then went on to explain that while FHIR isn't an architecture guide it can be used to help make architecture decisions when an implementer is getting started. He added that FHIR builds on the work the industry has done on CDA and takes the lessons learned and fixes a lot of what the industry was frustrated by with CDA.Ken asked Jocelyn to share her view of Cures based on her day-to-day work as program manager of Da Vinci Project focused on payer-provider data exchange. Jocelyn expressed that everything Dave said is so incredibly important. From the Da Vinci perspective, she explained that there is an ongoing dialogue about the intersection of and confusion about the year-end USCDI V3 and FHIR R4 capabilities along with everything in the electronic health information (EHI) requirement.  Joce expressed that this is a great example where folks are looking for additional guidance before making new investments. She explained that most EHRs have a big lift to meet that requirement in a meaningful way. Joce continued by saying that FHIR alone isn't necessarily going to get the industry to the semantic interoperability that it's striving for but that if the industry would pick up the FHIR implementation guides in addition to the more advanced workflow guides, the industry would be making progress toward where it wants to be.The group spoke briefly about the expansion of the definition of EHI to expand outside of USCDI V1 and that many stakeholders are not ready to meet the October deadline. Dave pointed out that ultimately every journey starts with one step, and everyone just needs to pick a place to start which ideally would probably be USCDI V3, and start the work.Jocelyn pointed out that by nature stakeholders under regulation want to achieve certification She went on to say that investments were already made in CDA & CCDA and there's lots of CCDA data moving around. She went on to add that the big question is how the industry is going to manage the collision and misalignment of data formats. And how will the industry decide what needs to be codified, and cleansed and what's OK to remain unstructured? There are several stakeholders in the industry that have stood up to say that it's important that data created today needs to be usable and shareable going forward.Dave shared the experience he's had working in the historical archive world. He explained that for the most part, he encounters more organizations simply interested in checking the regulatory and requirements box, but that Cures pushes toward data being structured and codified simply by setting the expectation that patients will be able to access all their data which means that data, even unstructured data isn't going away. He went on to say that even if only minimum pieces of data or data from specific timeframes are migrated to a new system, archives must be able to be queried so a patient can access that data whether it's in the current EHR system or not.  The perpetuity of data required by the info-blocking rule must change the industry's mindset.Ken asked Dave to share some of the surprising or challenging questions from Harmony clients or notable projects. Dave explained that sometimes clients can share their entire database at the start of a project and this is ideal so the Harmony team can go through everything, and it makes extraction a little easier. What is being seen in many of these projects is that as the team goes through and looks for NDC codes, signature lines, problem descriptions, or allergy lists, the data isn't codified. This information will be there as text. For this data to be queried from any archive, it's got to be codified.Dave added that they use the specifications from USCDI and cross-reference them with FHIR US Core. Dave continued to explain in more complex detail some of the data types and mapping that occur to ensure the archived data can be queried effectively in the future. Dave pointed out that as painful as it sounds, he has been through every single element in the FHIR specification for US Core. He expressed how well put together US Core is and it's critical to how they do their work.Ken then asked about how consent is handled during these archiving projects. This led to a robust conversation with Dave sharing that consents get archived if they are found, however the most recent consent on record in the current EHR would likely be applied to how any data pulled from the archive would be shared.The group went on to discuss the complexity of consent and the importance of establishing and maintaining eConsent in a scalable way. Jocelyn pointed out that through the discussions she's had with stakeholders and through her personal experiences, the industry needs to solve this so that patients can manage their consents in a secure, central place so they can update and change their consents based on their changing lives.Jocelyn then shifted the conversation toward the nature of adoption. She explained that she's heard some express resistance to FHIR because they perceive a push to rip and replace everything with FHIR. Jocelyn shared that she and most other industry leaders aren't proponents of that rip-and-replace concept but rather an incremental adoption approach where you adopt and use FHIR in the use cases it can best support and that FHIR can co-exist and interact with other standards. Jocelyn asked Dave to share his thoughts on FHIR adoption.Dave responded by saying that as much as he's been talking about FHIR, he doesn't yet have anyone with FHIR capabilities coming to query and retrieve data. Dave explained that what he has seen are stakeholders on the eHealth Exchange are part of Commonwell and they're familiar with exchanging data via those networks primarily using CDA formats. We start with where our clients are now but it's important to have FHIR capability built in so multiple formats are supported. He went on to say that in some instances you may have an instance where a FHIR API is used to request data in a CDA document. The industry certainly isn't going to be purely FHIR anytime soon if ever.As is tradition, Ken asked Dave to close out the podcast by sharing what he would like to see from the industry.Dave joked that as cliché as it must sound, interoperability is a journey and not a destination. The industry isn't going to fix everything by some policy deadline, and we aren't going to solve everything with just FHIR alone.Dave went on to say that the industry can learn a lot about how to architect their data by examining these standards to help guide those decisions. While FHIR is not intended as a data model, it is a good specification that can inform a well-formed database.Ken thanked guest, Dave Navarro, and co-host Jocelyn Keegan before reminding listeners that they can find and subscribe to The Dish on Health IT podcast on Apple Podcast, Spotify, or whatever platform listeners use to pick up podcasts and that videos of episodes can be found on the POCP YouTube Channel.

Today in Health IT
Newsday - From the Hill: The Looming Interoperability Deadline and Challenging Compliance Landscape

Today in Health IT

Play Episode Listen Later Aug 1, 2022 34:59 Transcription Available


Aug 1, 2022: https://www.linkedin.com/in/mari-savickis-42b9817/ (Mari Savickis), Vice President, Public Policy at https://chimecentral.org/ (CHIME) joins Bill for the news. What's happening on the Hill? The October 6 interoperability deadline is looming. Information blocking. 21st Century Cures. Where are we at? What is https://chimecentral.org/ (CHIME) doing to help prepare its members for this deadline? How much of this is falling on the EHR providers and how much is falling on the systems themselves? Navigating the compliance landscape is challenging. Even for larger health systems who are more well equipped. And what about the problem of the haves and the have nots? Does big tech have too much access to healthcare data? What's being talked about in regards to privacy? What's going on in the telehealth world?   Key Points: A downturn in an economy is not a bad thing. It's an opportunity. Do we need this much labor to provide a level of care that we've provided before?  The Medicare Payment Advisory Commission is conducting a study on the expansions of telehealth services We have a demoralized and depleted workforce, and yet we have amazing technology https://infoblockingcenter.org/ (InfoBlockingCenter.org) https://www.congress.gov/bill/117th-congress/house-bill/2471/text (Consolidated Appropriations Act, 2022 - congress.gov) Webinar: How's Your Front Line? Recruit, Retain and Optimize Your Cybersecurity Team - Thu Aug 11 @ 1pm ET / 10am PT “Cybersecurity-what's your emergency?” “We need help. It's an attack.” “Hello? Hello!” What can we do about the staffing shortage in cybersecurity? With research suggesting that nearly a third of the cybersecurity workforce is planning to leave the industry in the near future, organizations are left in a worrisome position, especially as attack surfaces are growing. So, where do we move forward from here knowing that we are facing low numbers in the field already and it's likely to get even worse?https://thisweekhealth.com/webinar-sempris-cyberstaffing_recruit-retain-optimize-cybersecurity-team/ ( Register here) Webinar: Don't Pay The Ransom - Thu Aug 18 @ 1pm ET / 10am PT Is your health system paying out for attacks on your data? How can we stop the cycle? Rubrik is offering incredible insight into the arising issues in cyber resilience in ransomware attacks, cloud data management with securing Epic in Azure, and unstructured data. In this webinar, we analyze the best practices to initiate in our hospital systems.https://thisweekhealth.com/dont-pay-the-ransom-insight-into-cyber-resilience-in-ransomware-attacks-cloud-data-management-unstructure-data/ ( Register here)

This Week Health: Community
Dr. Brett Oliver and Andy Truscott On IT Trends, Social Connections, and COVID's Effects On Health

This Week Health: Community

Play Episode Listen Later Mar 3, 2022 30:38 Transcription Available


March 3: Today on Townhall, https://www.linkedin.com/in/brett-oliver-md-1b1b6017/ (Brett Oliver), Family physician and Chief Medical Information Officer at https://www.baptisthealth.com/ (Baptist Health) interviews https://www.linkedin.com/in/andrewtruscott/ (Andy Truscott), Global Health Technology Lead for https://www.accenture.com/us-en (Accenture). Health Level Seven or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. What is top of mind for HL7 and how does it relate to the frontline clinicians and organizations taking care of patients? How does it relate to interoperability, cybersecurity and 21st Century Cures? What 2022 trends are we seeing in the healthcare IT space? 

This Week Health: Community
Lee Milligan and Mark Stockwell on Data Governance, 21st Century Cures Act, and Mentorship In Health IT

This Week Health: Community

Play Episode Listen Later Feb 15, 2022 21:29 Transcription Available


February 15: Today on TownHall. https://www.linkedin.com/in/ldm007/ (Lee Milligan), CIO for https://www.asante.org/ (Asante) interviews their Director of ITS Enterprise Services, https://www.linkedin.com/in/mark-stockwell-8ba7928/ (Mark Stockwell). What exactly does a Director of ITS Enterprise Services do? It takes Project Management, technical and leadership skills. Mark gets into the nitty gritty of HL7 interface, transaction engines and serving the medical device integration team and the HIM department including functions, scanning deficiency analysis for release of information plus data governance and the after effects of 21st Century Cures. Plus what is it like coming from a non-healthcare background? How does a leader with extensive IT experience in other industries deal with the shock of the complexity of healthcare?

This Week in Health IT
Health IT Leaders Weigh In On Biggest Moments of 2021: Drex DeFord, Lee Milligan, Anne Weiler & Frank Nydam

This Week in Health IT

Play Episode Listen Later Dec 27, 2021 38:37 Transcription Available


December 27, 2021: What were the biggest moments in healthcare IT in 2021? What do you think will be the biggest movement in 2022? Bill is joined by the Advisors to This Week in Health IT, https://www.linkedin.com/in/drexdeford/ (Drex DeFord) of CrowdStrike, https://www.linkedin.com/in/ldm007/ (Lee Milligan) of Asanta Health, https://www.linkedin.com/in/anneweiler/ (Anne Weiler) of AWS and https://www.linkedin.com/in/franknydam/ (Frank Nydam) of Tausight. What did the Scripps Breach teach us about cybersecurity? Will life in a health system ever be the same as it was pre-pandemic? Are we going to lose critical interactions between the analysts, the technologists and the clinicians if we continue to work remotely? 21st Century Cures didn't come easy but it had a huge impact. And why is it that the VCs are throwing so much money at all of these health startups but the hospitals are still losing money? Key Points: 00:00:00 - Introduction 00:04:30 - Healthcare is really, really hard and Big Tech knows it 00:05:00 - One of the biggest stories of the year was the Scripps breach 00:06:45 - 2021 was the year of The Great Resignation. In 2022 there will be IT staff shortages, nurse shortages and even more people leaving their jobs. 00:26:15 - Hats off to the many primary care physicians who have sat down one-on-one with many of their patients and walked through the pros and cons of vaccination. That is really, really hard work to do.  00:34:50 - Investment in healthcare inequities was big news in 2021

This Week in Health IT
What's Next for This Week In Health IT in 2022?

This Week in Health IT

Play Episode Listen Later Dec 10, 2021 50:12 Transcription Available


December 10, 2021: Welcome to one of our End of Year Shows. Bill gives an update on what's coming up for This Week in Health IT in 2022 plus a chronological look at the healthcare news that shaped 2021. The biggest stories were the pandemic, cybersecurity, diversity, equity and inclusion, the change in government and the vaccine rollout. He also looks at telehealth, patient centric interoperability, 21st Century Cures, the HIMSS, HLTH and CHIME conferences, price transparency, information blocking, care moving to the home, the labor shortage and remote work culture. Hope you enjoy!  Key Points: 00:00:00 - Intro 00:10:00 - The pandemic is the story that shaped all stories 00:14:15 - Healthcare systems took a significant financial hit in the months that they couldn't do elective surgeries 00:19:50 - We made a significant number of mistakes in terms of marketing the vaccine 00:38:20 - Rural healthcare is set for a lot of progress in 2022

The Dish on Health IT
Bridging Interoperability Across Healthcare and Human Services and the Role of Consent

The Dish on Health IT

Play Episode Listen Later Dec 9, 2021 43:54


This episode features guest, Daniel Stein, President of Stewards of Change Institute (SOCI). The discussion explores why connecting the healthcare ecosystem with human services is critical and goes on to highlight the role of consent specifically highlighting the new “Modernizing Consent to Advance Health and Equity” report published by SOCI with industry input.Co-host, Ed Daniels, Senior Consultant with POCP, then introduced himself explaining that he's worked in Health IT for over 30 years and has been working in the world of electronic informed consent over the last several months. Guest, Daniel Stein, President of SOCI then introduced himself and gave an overview of the work of Stewards of Change. He first focused on SOCI, which is a non-profit that cuts across and connects all the public welfare and safety net programs from healthcare to social services. SOCI has worked to bring together all the different players in these realms. Daniel explained that he got started in this work 20 years ago after a career at Kraft Foods working in project management. He started working with a non-profit in California and became intrigued by how certain business practices could be applied in the non-profit world and that's how he started on this path. Daniel explained that he gained insight from work he did related to child welfare in California and New York, he observed there were huge disconnects between the services families really needed and the ability of families to access these services. It was clear these families were already stressed and then were asked to jump through hoops and hurdles to understand eligibility, fill out documentation and such to get the services they needed. On top of that there was a lot of duplication between service providers. He made the point that If you wanted to design a worse program, you really couldn't. Daniel explained that he started to ask how this bumpy process of accessing services could be smoothed out. Ken then pivoted to ask Ed about his background in emergency services and other work he's done to give his perspective of the problem outlined by Daniel. Ed agreed that he recognizes that disconnection Daniel outlined and its impact on people and their families. Ed then pointed out the role of consent in contributing to that problem of disconnection. Ed then asked Daniel how he feels the industry is doing at tackling these issues. Daniel responded by saying that he's encouraged that there has been movement over the last couple of years specifically the acknowledgement of the importance of social determinants of health and the need to explore how to capture that information. While healthcare is taking steps in the right direction, there still seems to be some hesitancy. Healthcare is so large and so complex, it's still somewhat insular with just a few systems and solutions starting to look at connecting outside of healthcare. Ken followed up by asking for Daniel to dig into the work to connect healthcare and human services, and specifically about Project Unify. Daniel responded that in the beginning of the Obama administration, SOCI had the opportunity to work on the Affordable Care Act (ACA) through a contract with the Administration for Children and Families (ACF). In the ACA, there was a provision that explicitly looked to integrate health exchanges, the infrastructure of the ACA and all the services under HHS. This provision is still in the rules and regulations. Recent guidance coming out of CMS has reiterated this provision. SOCI helped translate this provision and communicate it out to the states at the time. Unfortunately, things didn't go as smoothly as one would hope primarily due to the complexities of the ACA. It also became clear that there was a lack of connection between the Centers for Medicaid and Medicare Innovation, CMS, Office of the National Coordinator (ONC) and ACF. SOCI was instrumental in helping bring these federal agencies together to better understand the whole person approach to care. Daniel explained that Project Unify grew out of a 4-year initiative funded by the Kresge Foundation. SOCI's proposal to Kresge outlined the need to bring together subject matter experts (SMEs) from across healthcare and social care to avoid recreating the wheel. SOCI used the funding they received to establish the National Interoperability Collaborative (NIC). The NIC's purpose is to bring all these various stakeholders together to share information about the challenges and initiatives to solve problems being done across the various fields and cross-pollinate. The NIC has been holding conferences and has hosted over 75 webinars over the last several years. While sharing information on these webinars and conferences was helpful, those involved in the NIC wanted to do more than talk and to take on a project that was really doing something. Something. That is how Project Unify was born. The vision for Project Unify was to demonstrate how data interoperability and data exchange could happen across all the siloes of healthcare, human services, and other areas. The work on Project Unify led to the work on consent that SOCI has started to focus on. Ed added that he has participated in several SOCI webinars and recounted a particular session where a local county agency's project to connect the various services in their locale. The attendees of that session expressed that their agencies don't even have standard systems within their own agency. Many expressed that they are just working to create standard forms they can use across agencies and that they'll work on harmonizing the technology later. Ken pivoted to focus of the conversation to health equity and social determinants of health. Daniel explained that SOCI's focus on social factors and health equity grew during COVID. SOCI was preparing for a conference in early 2020 and pivoted to make it virtual rather than cancel because they didn't want to lose momentum and then focused on what the NIC could do during the pandemic to make a difference. The NIC brought together stakeholders almost every week and this effort was nicknamed the “interoperability support group”Daniel went on to say that one of the things that stood out during COVID was that so many of the communities hit hardest by COVID were the poor, black, brown, and undocumented people. The lack of services, access and transportation in these communities exacerbated the issues. It became clear that if these challenges were going to be overcome, that these communities needed to be at the table to offer their perspective. Health equity has become a major focus of the administration and of the industry. For SOCI and NIC, as they began bringing members of these communities into the conversation, the issue of consent, data stewardship and trust bubbled to the surface. Ken picked up the thread of consent and brought up the comprehensive report SOCI recently published entitled “Modernizing Consent to Advance Health and Equity”. Ken explained that as he sees it, consent is a complex and layered issue because most people don't have medical or legal degrees and understanding the information, they have been given access to and the consequences of consenting to give access to others. Ken asked Daniel to explain his perspective and how this paper on consent came to be. Daniel responded by saying that exploring consent has been one of the more fascinating roads he's been down. Over the course of holding all these meetings with this diverse group of stakeholders, they started to ask what one or two things could be done to really make an impact. Through an iterative process, the group came up with about six recommendations and consent was one of them. Consent has such a broad impact and not just in healthcare. For example, if one wants to share school attendance or grades, foster care status, consent is needed. Consent is the blocker of data sharing and interoperability. It became clear that this was a challenge across every area and if small improvements could be made, it could have a tremendous impact.The group recognized that this issue was certainly bigger than healthcare. There needs to be a whole person view through coordinated care. Daniel added that fixing one thing doesn't get us to the goal line but at the root of coordinated care is giving people the ability to access data from different areas. The only way that will ever happen is people can give consent to remove a lot of the friction of sharing data. The technology piece can be figured out later.Ed, who was involved in helping develop this report, added that through talking with various organizations about their challenges and attempts to solve the issue of consent, they gained a lot more insight into the complexities of the issue. In healthcare, privacy has always been a big issue but at the same time we all want the right information to be shared with the right people if it's going to impact our care such as advanced directives or clinical trial matching. Add to that social factors that impact health or indicators of issues in non-healthcare settings would also be helpful to have in the healthcare setting. But the same is true in non-healthcare settings. In social programs having a more complete picture of someone's life can help the program provide more appropriate resources. As people move from state to state, having those consents following them is another factor. Daniel explained that there was consensus across the board that consent is a challenge but there was a lack of awareness of the work being done across jurisdictions, programs, and care settings and it was impossible to build upon the work that's already been done so one of the first things SOCI did was identify and document the consent work already being done so that work can be built from. Daniel added that there is another side of the equation. It may be necessary to temper our enthusiasm for getting and sharing this kind of data. As SOCI has talked to people in these communities, they were told it's very important for this information to be taken back to the family so a decision can be made as a family. Ed agreed and added that while solving the technical ability to document consent, we can't forget that the data being exchanged belongs to a person. We're all patients so this shouldn't be a hard perspective to keep in mind for any of us. Ken brought up 21st Century Cures regarding who regulates the data once the patient has given consent to share it with a 3d party app or another actor not covered by HIPAA. One must wonder if the data is really being protected. Daniel said that they found that most people assume their information is being shared and don't want to be filling out a consent form for the 14th time. Many times, it's the lawyers who are advising multiple documentation of consent to mitigate risk. Ultimately, we have the capability to make this information accessible, but we need more uniformity and not have the data all over the place. Maybe we need a trusted entity that can be the traffic cop and authorize the flow of information and authorize access based on roles to say this person is granted access to this information for this purpose, for this period of time. There is some work in this area that is working to demonstrate how this could work. Ed pointed out that the report goes into all of this in detail, and it may seem daunting. He recommended that readers review the executive summary first and then dive into specific sections of the full report if there is interest to dig a little deeper.Ken, in closing out the podcast, asked Daniel to share any other issues he'd like to highlight or calls to action for the industry. Daniel responded by saying he is heartened by the interest of federal agencies and other organizations in doing work to solve the challenges around consent. Daniel expressed his hope this report will help support the work in this area. SOCI will be holding more webinars over the coming months to discuss consent and other issues and Daniel invited all listeners to get involved by attending some of these sessions which will be posted on either the NIC events or SOCI events pages.Ed added that these events aren't just work, but also have an aspect of fun, networking, and an opportunity to make connections outside of one's normal circles. Ken closed the episode by thanking Daniel for joining the Dish on Health IT podcast. Be sure to follow Stewards of Change Institute on Twitter and LinkedIn to stay up to date on this work. 

This Week in Health IT
Newsday – 2021 on Capitol Hill: A Health IT Update from CHIME's Mari Savickis

This Week in Health IT

Play Episode Listen Later Dec 6, 2021 39:53 Transcription Available


December 6, 2021: Healthcare can't move forward without regulatory guidelines. Health IT leaders need to be in the know. https://www.linkedin.com/in/mari-savickis-42b9817/ (Mari Savickis), Vice President, Public Policy at https://chimecentral.org/ (CHIME) joins us today to discuss interoperability, de-identified data, 21st Century Cures, HIPAA, National Patient Identifier and cybersecurity. Plus the year that was in Washington, DC. HIPAA is so antiquated, but we adhere to it like it's the 10 Commandments. Is there any movement towards redoing it? Language prohibiting the HHS from developing a patient identification standard was removed from the House Labor bill for the 1st time in the Senate. And the FTC clarified their Health Breach Notification rule to include third-party applications that collect consumer's health information under privacy protections. Key Points: 00:00:00 - Intro 00:04:30 - Advocacy led by CHIME's public policy team resulted in https://www.congress.gov/bill/116th-congress/house-bill/7898 (HR 7898) law giving providers credit for cybersecurity best practices 00:09:00 - https://patientidnow.org/ (Patient ID Now) 00:25:00 - CHIME public policy launched the https://infoblockingcenter.org/ (InfoBlockingCenter.org) in 2021. A convenient site to find free resources, FAQs, articles, archived webinars, and cheat sheets to prepare you for compliance. 00:27:00 - All sectors are facing cybersecurity staffing shortages 00:27:30- 3 out of 4 hospitals operate without a designated security leader 00:31:30 - Cyber insurance has gone up by almost 50%  Questions or comments? Please reach out to policy@chimecentral.org Stories: https://chimecentral.org/chime-applauds-federal-trade-commissions-actions-to-secure-consumer-health-data/ (CHIME Applauds Federal Trade Commission's Actions to Secure Consumer Health Data) https://chimecentral.org/survey-of-chime-and-aehis-membership-finds-widespread-cybersecurity-impacts-on-healthcare-need-for-more-government-support/ (Survey of CHIME and AEHIS Membership Finds Widespread Cybersecurity Impacts on Healthcare; Need for More Government Support) https://www.scmagazine.com/feature/leadership/attracting-retaining-healthcare-cisos-maybe-its-not-a-money-problem?mkt_tok=MTg4LVVOWi02NjAAAAGAo4u8i8iqAiGUONUvupwyrwgmJbvhbKMxVTkTwZRSoCMHN7yqps3a1mFTTQ3bSrWqWCUTfcS3Ejusk3Sv160bh1qrp_hwtuhfDgLA-Q (Attracting, retaining healthcare CISOs: Maybe it's not a money problem - SC Media)

Informatics in the Round
21st Century Cures: What Song are People Singing?

Informatics in the Round

Play Episode Listen Later Nov 12, 2021 60:20


Hello and welcome to Informatics in the Round,  a podcast designed to help everyone become a part of the dialog about topics in biomedical informatics.  I'm Kevin Johnson, physician and informatics chair at Vanderbilt. @kbjohnsonmd on twitter, www.kevinbjohnsonmd.net on the web!  ------------------- In this episode of Informatics in the Round, we get some follow-up information.  A few episodes back, Dr. Trent Rosenbloom led a discussion about impending changes and a lot of national concern about a statutory response to information blocking that has resulted in patients having immediate access to clinical encounter summaries but also lab results.  We were wrapped in anticipation of the fallout from implementing this change, and have eagerly awaited hearing from a patient and from Trent.  So…. Here we are! Digging into the aftermath. The nuclear option, or tempest in a teapot? Trent is Professor of Biomedical Informatics, nursing, medicine and pediatrics. He directs the Vanderbilt patient portal, known as MyHealthatVanderbilt.   MyHealth for short.  He's also an avid runner, with his own marathon.  Here's a link to his marathon:   https://www.harpethhillsmarathon.com/ Sarah Bland is a regular guest on this podcast. By day, she's a senior project manager and all around funny person, but, as you've been learning and will hear more about today…she has layers.  She's also at Vanderbilt. We were able to get a friend of Trent's, a geek, and a musician all in one in the form of Karl Kersey.  Karl's band, Doonthebray, represents yet another form of music in Music City. And then there's Karl—He's low key, with a wonderful dry wit, and asks the hard questions. Trent didn't disappoint. He knows this stuff, and had great information to share both in response to questions we asked during the episode, and questions other listeners will undoubtedly be asking.  https://www.facebook.com/doonthebrae ---------- By the way, tell a friend about the podcast. I'd love to get our listenership over 5K, and I need your help. If you have suggestions or ideas, hit me up on Twitter @kbjohnsonmd, or if think tweeting is for twits, email me at kevin1061@comcast.net. I love hearing from you!

This Week in Health IT
Newsday - CIOs Chat Health IT News in the Halls Of CHIME Fall Forum

This Week in Health IT

Play Episode Listen Later Nov 1, 2021 71:38


November 1, 2021: Newsday from the halls of CHIME Fall Forum 2021. Bill talks to Drex Deford from CrowdStrike, Colin Banas with Dr. First, Aaron Miri with Baptist Jacksonville, William Walders from Health First and Lee Milligan from Asante. No topic is left unspoken. Interoperability, supply chain, the first 100 days of a new CIO role, Epic, 21st Century Cures, current employee retention rates, the difference between an academic medical centre and an IDN (Integrated Delivery Network), cybersecurity, state federal partnerships, vaccination statistics and the pandemic. You won't want to miss this.Key Points:00:00:00 - Intro00:08:30 - I thought meaningful use stage two was going to knock things out of the park 00:16:10 - Labor is top of mind for CIOs. They're losing people. It's getting harder.00:35:50 - Florida operates as a family. Texas operates as a business. It's very different. 00:44:30 - You're going to be breached. So you just need to solve the problem really fast. 00:51:40 - Patients should have their information. They should be empowered. We want to empower people. 

Cancer Stories: The Art of Oncology

A mother mourning the loss of her daughter discovers that she has lost something else important to her.   TRANSCRIPT SPEAKER 1: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. SPEAKER 2: Welcome to JCO's Cancer Stories, The Art of Oncology, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. ELIZABETH CONROW: Access Denied, by Elizabeth Conrow. I lost my daughter, Amanda, in 2015. She was diagnosed with a brain tumor at age three and was in treatment for 2 and 1/2 years. Less than two weeks after she died, friends and family were getting on with their lives, but I was still in shock. I couldn't believe that Amanda was really gone. Early in the day, I looked at my kitchen table and tried to imagine her eating a bowl of rice, an unusual breakfast for a five-year-old. But that was Amanda. My eyes filled with tears as they rested on the empty chair. She was really gone. In that moment, standing in the kitchen, I struggled to remember every detail of who she was. It felt like the memory of her was slipping away. My heart beat quickened, and my mind raced with compulsive nagging thoughts. How tall was she the last time we were in the outpatient clinic? How much did she weigh? I realized I would never be able to put her on a scale again or mark her height on the cupboard door. I fear that this information would be lost forever, just like Amanda. I moved to my computer and started to log on to our hospital's online patient portal to see if I could find answers to my questions. How many times had I logged into this system looking for Amanda's test results or to message one of her doctors? How many times did it serve to confirm appointment times or remind me of medicine doses? I clicked the Sign In button, and my heart stopped. I couldn't get in. Instead of viewing her chart, I saw an alarming red stop sign and a message saying "access denied." I stared at the screen in disbelief. Just two weeks after losing my daughter, I faced yet another heartbreaking and unexpected loss. I no longer had access to Amanda's medical records. I no longer had a connection to her medical team and the hospital family I had grown to love and care for. Everything Amanda had been through for the last 2 and 1/2 years was gone. It was as if she never existed. She had vanished. I was caught off guard, deeply saddened, and utterly unprepared to have this connection to the hospital and this connection to Amanda ripped away. I was confused and embarrassed by my emotions. I certainly didn't need this access. But I was devastated that it had been taken away. I reached out to my daughter's oncologist to ask how and why the patient portal had been turned off. I let him know that it was really important to me to be able to view Amanda's records, at least for a time. It had never occurred to him that a parent might want to see this information again. He explained that it was a system designed safety measure that automatically turned off access to an account once a patient had died. I was the first parent to reach out to him with this question. Amanda's oncologist immediately contacted the online records office to reactivate her chart so I could search out answers to some of my questions. It brought me so much comfort to be able to go back in and revisit her medical journey. As I thanked her doctor, I shared with him how important it was to protect families from this type of trauma. I didn't want another family to experience this pain. He listened and helped put a manual reactivation system in place. Going forward when a child died, the online records office would manually reactivate each pediatric account individually. It wasn't a perfect solution, but it was a step in the right direction. It has been six years since Amanda's passing. I am now the bereavement coordinator at the same hospital where she received care. When I started in this role, I was surprised to learn of several families who, like me, had been denied access to their child's medical record. Hadn't the hospital resolved this issue years ago? I was frustrated that our institution hadn't found a better solution in the six years that passed. Last spring, as I followed up with bereaved families from our hospital, I had a conversation with a mother, Diane, that was hauntingly familiar and heartbreaking. Diane and I spoke on the phone shortly after the loss of her son, Evan. As we wrapped up our call, almost as an afterthought, she sheepishly asked about Evan's medical records being deactivated. I was immediately brought back to my kitchen table and the pain I felt when I experienced this secondary loss just two weeks after losing Amanda. I knew why Diane felt silly asking about this. And I deeply understood her need to log in. Diana explained that she was creating a record of everything Evan had been through, every transfusion, every chemo treatment, every inpatient and outpatient visit. And she could no longer complete that task. She shared her experience with me. I know for me, it was really difficult to wake up that very next morning, literally only about 12 hours since he died and not be able to look at it. Even though I know there had been no additional tests run since the last time I had checked, it was my morning routine to look at it. I would check it each morning, even before I got up. It had been that way for months while we were inpatient. First, looking at his ANC and counts, and then in the final month and a half, checking his bilirubin and liver numbers. There was always that hope that things were going to improve. This would be the day. So that first and subsequent time was just a blunt reminder that he was gone and there would be no more checking. I wanted to go back and look at his results, too. Oddly, I thought it would make me feel closer to him and closer to the routine I had while he was alive. Diane wanted to feel closer to her son. I wanted to feel closer to my daughter. Accessing a child's online medical portal is one way a parent begins to come to terms with this impossible loss. Snaman, et al, 2016, suggest that parents who are grieving significantly benefit from the creation and continuation of bonds with a child who has died. Revisiting a child's journey through the lens of the medical portal helps strengthen that bond. As I looked through Amanda's chart and remembered various times we visited the hospital, it helped me picture her more clearly. And it helped me feel a connection to her that I was deeply longing for. Looking through a child's medical record, while painful, can be part of healing and connection. In addition to creating bonds with a child who has died, the medical portal helps parents stay connected to the hospital and the medical team that cared for their child. According to additional research by Snaman, et al, 2016, bereaved parent's benefit from the ongoing support of a hospital throughout a time of grief. When a child dies, the secondary loss of the medical community can leave families feeling abandoned by those they have come to trust and depend on. Anyone who had taken care of Amanda felt like family to me. Sending messages to Amanda's medical team after she died provided a feeling of familiarity when everything else around me was spiraling out of control. A continuing connection with the medical team through the online portal can positively impact grief outcomes for bereaved parents. Accessing a child's medical record provides a grieving family with an easy way to communicate with, and ask lingering questions of the medical team. Access to medical records should not end when a child dies. The 21st Century Cures act acknowledges the need to provide patients with open notes and immediate access to medical information. As we implement real-time access for living patients, continuing access after a loss should also be considered essential. Dr. Alan Wolfelt, from the Center for Loss, discusses the need to say hello to one's grief and welcome it before saying goodbye to the person who died. In those early months, saying hello to grief meant reading through Amanda's medical records, communicating with her medical team, and uncovering every connection I had to her while she was alive. In some small way, logging into Amanda's medical portal and discovering that she was 42 inches tall and weighed 41.2 pounds brought me immeasurable comfort. As parents grieve the loss of a child, comfort and connection should be readily available without having access denied. SPEAKER 3: The guest on this podcast episode has no disclosures to declare. SPEAKER 4: Welcome to Cancer Stories, The Art of Oncology podcast series. With me today is Elizabeth Conrow, bereavement coordinator at the University of Rochester Medical Center and the author of Access Denied. Welcome to the program, Liz. ELIZABETH CONROW: Thank you so much for having me here. It's an honor to be here. SPEAKER 4: It is our pleasure. And first of all, let me start by saying I was very moved by the piece. And I'm so sorry that you lived through this experience. And really interested in knowing how you transformed your personal grief into now, your profession. ELIZABETH CONROW: Sure. Well, it's definitely been a process. Obviously, as a family, we never thought we would be down this road. I never thought I would have a child who had cancer. I never thought that I would have to go through the grief of losing a child and then comforting my own family, and my husband, and those around us through that experience. And I can tell you that for the first couple of years, I really didn't feel equipped to do anything. I felt like I lost my confidence in anything that I had an ability to do prior to this. Simple things like making a meal for someone who was sick became way too overwhelming to even consider doing. So it was definitely a process of years. But when the opportunity came up to work at Golisano Children's Hospital, the same place where Amanda had been cared for, the timing was right. And I knew that it was a great step to take and a way to honor Amanda's life, and really in some way, offer just a little bit of support and comfort to bereaved families, because I understood a little bit of what maybe they were going through. So it just seemed like a really good fit and a really good match for my experience at that point and a way to help and honor Amanda. SPEAKER 4: Let's start by talking a little bit about Amanda. Tell us a little bit about her and her story. ELIZABETH CONROW: Sure. Amanda is one of five children. So she was the fourth of the five. Very silly, loved to wrestle with daddy, had the biggest blue eyes that anyone had ever seen. She was just a delight and a joy. And when she was 3 and 1/2, she was diagnosed with a brain tumor. And we were in the hospital for a number of days. She had surgery and a full resection. And we were told that if after a resection and radiation it never came back, that we would be good. But that if it came back, it would likely be terminal. So we knew at the outset that this was-- we're not dealing with a cold or a headache. We're dealing with something pretty serious. So she went through the surgery beautifully. She went through all of her radiation treatments. We did a clinical trial of chemotherapy. And six months from when she was diagnosed, we really felt like we did well. She did amazing. And we were ready to walk away from everything and just celebrate really, kind of getting through this. And her very first follow-up scan two weeks after she was done with treatment-- her doctor, Dr. Koronas, called us and let us know the very devastating news that the tumor had returned, and it was all in her brain and down her spine and too many places to count. So six months from diagnosis, we knew that this was not going to end well. And we kind of had to struggle to prepare for that, as well as to recognize that in that moment, she was still Amanda. And she was still doing really well. But we knew that time would be limited. And so we had actually a very good year and a half with her, as much as you can say that. She went through additional radiation treatments. And we continued to try other chemotherapies to do what we could. But ultimately, in February of 2015, surrounded by her family in our home she passed away. And we then had a whole new struggle with grief and really, coming to terms with a new life and a devastating loss. But she was a joy. And she was a joy throughout it. So it was not all terrible. SPEAKER 4: She sounds like an extraordinarily little girl. And in your essay, you start by telling us that just after she died, I think a few days or weeks, you're thinking about her, and you want to access her medical record through the portal that you had gotten used to using all the time. And then as you're logging in, you get the signal that says "access denied." And that triggered a tremendous wave of grief for you or something. Tell us a little bit about that and what you did with that. ELIZABETH CONROW: Sure. I think I didn't realize at the time that I was really just trying to hang on to who she was, that I was trying to connect with her in some way. I mean, it was just two weeks after she had died. And I just-- I wanted access to see, what did she weigh? Goodness, if I could recreate her in the form of a stuffed animal, how long would she be? How much would she weigh? And when I went to log in, it was a horribly devastating loss. It really felt like all of the sudden, I knew in my mind she was gone, but logging into this wealth of information that contained all of her blood counts and numbers and information that we had access so often, to all of a sudden have that gone. It was just a punch in the gut reminder that she truly was gone and that her records had disappeared. And she just wasn't here. And I wasn't prepared for that. I really thought that I'd be able to go in and find the things I wanted to find and have peace about that. It was shocking to me. And I remember feeling so embarrassed like, how can I call her doctor and say, I lost this access and I really need it? When she's not here, there's no reason. I don't need it. He's going to think I'm crazy. But it was important enough to me that I reached out to him. And I said, you've got to help me. How can I still access this? SPEAKER 4: So what happened next? ELIZABETH CONROW: So he-- actually, I was pretty surprised. I was the first parent he said, that had ever reached out to him with this issue. And I thought, how is that possible? How is that possible? And I'm guessing other parents had experienced it, but didn't know what to do, didn't know where to turn. And he was very compassionate. And he reached out to our online medical team, our portal team, and tried to figure out a way to reactivate the account for me. And got that done very quickly. And I said, well, it's not enough that it's been reactivated for me. No other parent can go through this. We have to come up with a plan. And so he really did work very hard with our team here to come up with something that would hopefully fix the problem. And it did. I know many families then, had their access turned back on manually, through a manual process that they put in place here. But I know that in the last six years, there have been several families who went to log in and had this experience. And unless you've been there and unless you've been the parent on the end of losing a child and then going in and having more taken away that you didn't expect, you don't understand the pain of that. And so I think the driving force behind me really wanting to write this article was to say, I know that this isn't just my institution. I know this is happening across hospitals. I know that when a child dies, this access is turned off. And that really hurts families. And if there's a way to bring attention to that and say, hey, we can do better, we need to. SPEAKER 4: Now that you have this perspective, I know that you have actually developed some training for oncology fellows and staff to train them a bit to talk with bereaved parents. What are some of the lessons that you want people to learn? ELIZABETH CONROW: That's a great question. I'm working with another doctor here. It's an advanced communication training where we're helping young doctors share bad news for the first time. And it's amazing to me how afraid people are to approach the bereaved. And I guess, having been through it, I see now how poorly we really do bereavement and how afraid we are to kind of approach someone who's lost a child and just wrap our arms around them and say, I'm so sorry. I'm here with you. Everybody wants to fix it. And there's no fix. And people don't want to approach a bereaved parent and bring up their child, because they don't want to make them sad. And what many people realize is that our children are always on our mind. You're not reminding us of anything we're not already thinking about. I was pretty surprised after losing Amanda that someone could be on my mind all the time-- all the time when they're not here anymore. You know, you think about people here and there, time to time, people in your life. But once she was gone, she was right at the front of my mind and still is, every moment of every day. And so if you see a bereaved person, it's OK to mention their child's name. I actually-- I go to the dentist. And the woman who cleans my teeth, every single time I go, will mention Amanda. And I know it's intentional. And I know it's because she wants me to know that she cares. And so those kinds of simple acts that people do as a way of recognizing and honoring the child whose passed means so much to a bereaved parent. SPEAKER 4: Just listening to you and the emotion in your voice, I imagine it must have been difficult in a way to go back to the same place where Amanda was treated and now, work with the staff and the clinicians who treated her. Tell us a little bit about how you've managed those relationships? ELIZABETH CONROW: One of the things I've learned, and that's partly through the role I have now in supporting other bereaved parents is that everyone grieves differently. And I know there are some parents who, the first time they come back to the hospital, it's really, really hard for them. And it's almost like a PTSD moment. For me, I appreciated and cared about all of the medical staff so much that coming back here to me, was a need. I needed to get back here and find a way to connect with these doctors and nurses and the people who cared for Amanda so beautifully while she was here. In those first months of grief, I showed up at the hospital-- I remember there was one day I showed up, and I felt so lost. But I just needed to see those nurses and give them a hug. And I felt awkward and out of place, because suddenly, I'm here and she's not with me. But I just needed to be in a place where she had been and a place that meant so much to us. So coming back here for me, certainly had its hard moments. And there have been challenges with it. But it's been a place of comfort. And being able to talk about Amanda with other parents has really been a gift for me, because it's not an opportunity you have all the time, especially six years later to talk about the child who died. So it's been a gift. SPEAKER 4: What is it like for you to be with other parents now who are going through what you experienced? How does your experience of loss influence your role as a counselor for a newly bereaved parents? ELIZABETH CONROW: I do a lot of listening. I do a lot of listening. And there are some parents who I'll call and follow up with and check in on. And they're good. And they don't need anything. And to be honest, I think when we first lost Amanda, if someone called me and I had never met them before, I might say I'm good. I don't really need any support right now. I've got my family. But there are some parents who I will call, and they will talk to me for 45 minutes. And they will cry. And they will say, you're the first person I've been able to talk to about this, because you understand and you've been through it. And so I'm able just to listen. And when they say things that they think are crazy, I wandered into my son's room and I slept in his bed last night, I say, I understand that. I once found Amanda's socks in a travel bag. And when I found them, I pulled them out and I slept with her socks. So there are things that people think are crazy that I'm able to help them normalize some of those feelings and understand that it's OK. SPEAKER 4: I don't think it's crazy at all. You speak with such knowledge and also such empathy. I wonder if you can help us also understand how you see the clinicians now-- the doctors and nurses who are actually are caring for these patients-- how you see them react to the death of a patient and how they maintain their relationships with what the parents once the kids are gone? ELIZABETH CONROW: It's been very interesting, I guess you could say to be on the other side of this, right? I was on the parents side before, where I was able to receive kind of the love and comfort and support of those who cared for Amanda. And I was able to see them showing up at the funeral and the ways that they would reach out and send notes and cards. But now, being on this side working with many of those same people, I've been really struck, even during our weekly meetings when they talk about different cases and different families and the losses that they've had, how significantly it does impact them, and how much those families and those children really do mean to them. And you know, I've often sat there now wondering, well, what did they say about my family? What did they say about us? And not a conversation I can go back to and sit in on. But I'm just struck by how much they really do care and how much it extends beyond this just being a job for most of-- all of them. SPEAKER 4: Yeah, in your role now, in your professional role, what kind of changes have you implemented in the way clinicians and parents communicate, or the way the system communicates with parents? ELIZABETH CONROW: At our hospital where I work, we have probably around 80 or 90 losses a year. And I came into this and said, I can support these families. And I can follow up with 80 or 90 families in a reasonable manner. But really, we need more parents doing this. We need to expand kind of what we're doing. So I've been trying to work toward implementing a mentoring program of sorts, where bereaved parents who are a few years out in their grief can come alongside newly bereaved parents and really support them, one on one for a year or a year and a half to help them get through that time, so that it isn't just me. And as great as I am, I really know that we can do much, much better by parents if we expand kind of the support network that we have. So I've been trying to grow some of our bereaved parent base. And those who can give input on some of the things we're doing-- because I know bereaved parents have so much wisdom and so much they can share from their own experiences. SPEAKER 4: You sound like a force. I wonder, have you connected with other hospitals, other teams? Or is your-- are you concentrated on your hospital and your community? ELIZABETH CONROW: The greatest support to me, actually has been St. Jude. They have such a fantastic program. Their bereavement, their parent support is really outstanding. Actually, just this week, I was able to sit in on one of their parent mentor trainings to kind of learn, well, how do you train your people, and what do you do? And so that was fantastic. So I'm really grateful-- grateful for their support. So they've been really wonderful. SPEAKER 4: I imagine Amanda's passing really affected your entire family and the other kids. Can you tell us a little bit about how all the other kids dealt with their grief? ELIZABETH CONROW: Sure. I know at the time when Amanda was diagnosed, my oldest was 9, and my youngest was 9 months. So everybody was pretty little. And they went through that at a really young age. And then when she passed, my oldest was 11 and my youngest was 3. So they were still little. And they had been through what I consider to be significant trauma in those early years. And when things first happened, I mean, I had a therapist describe it to me as a children's mobile that hangs over their bed you know, that once it becomes imbalanced, it just tips on its side. And that's the way things felt at home for quite a while. You know, just nothing felt right and things felt out of order. But kids are so resilient and so forward looking. And my kids really did beautifully through it. And I had someone tell me, well, kids are going to revisit grief. And they're going to come back to it from time to time. And it'll surprise you. And I will say, that's so true. You know, I would think everything was going along OK and everyone was coping well. And then, my daughter Jessica, who was closest in age to Amanda, would come down at 10 o'clock at night in tears because she was thinking about her sister. And that would catch me a little bit off guard. And my oldest just went away to college. And she's now 18. And she's had some conversations with me lately just about everything they went through and really revisiting some of her feelings about it all. And so they don't really get over it. But helping them to kind of process it and work through it and really, just talk about her. We talk about her constantly. She's a part of everything we do. We still make her a birthday cake. So we just keep her memory alive and celebrate her life together. But grief for kids is certainly different, and it doesn't end. But they are definitely forward looking and really can handle more than I think sometimes we give them credit for. SPEAKER 4: And your husband and you I hear have also been involved in some activities to talk about this publicly or teach others. What was that like for you as parents? ELIZABETH CONROW: There are a few things that we've really wanted to help move forward in terms of childhood cancer awareness and things that people can do to really help bereaved parents. And I think there's just so much that people don't know or understand. Many people don't realize how underfunded childhood cancer is. So it just means a lot to us to be able to kind of get that message out now. SPEAKER 4: I imagine there's so much work to do. And as we've had this great opportunity to chat about Amanda to remember her, to think about your experience and the amazing work you seem to be doing-- are there any final comments that you want to share with our listeners? ELIZABETH CONROW: It's an honor for me to really share this experience. And that bereaved parents need support, and they need to know that people care and remember, even as time goes on. So just take good care of those who know who are grieving. And love one another. SPEAKER 4: Thank you so much. This is Liz Conrow, author of Access Denied, published in Journal of Clinical Oncology. Thank you very much. Until next time. SPEAKER 1: Until next time, thank you for listening to this JCO's Cancer Stories, The Art of Oncology podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JCO's Cancer Stories, The Art of Oncology podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. [MUSIC PLAYING]

Nobody Told Me That! with Teresa Duncan
EP 88: The Cures Act, Chart Notes and Missing Patients

Nobody Told Me That! with Teresa Duncan

Play Episode Listen Later Oct 20, 2021 57:32


Another insurance nerd joins me on the podcast! Rick Garofolo of Practice Mechanics teaches me about the Cures Act - part of me wishes I didn't know anything about it. BUT it's important and we need to be compliant when it goes into effect. We also discussed some hot topics from his classes at the recent American Association of Dental Office Management's Annual Conference. You may be surprised to learn how you should be tracking inactive patients. We talk about chart notes. I hope you get as excited as we did!

This Week in Health IT
The Many Hats of the CIO with Brian Sterud of Faith Regional Health Services

This Week in Health IT

Play Episode Listen Later Sep 10, 2021 29:24


September 10, 2021: Brian Sterud wears many hats at Faith Regional Health. He's the VP of IT, the CIO and the CISO. In smaller health systems everyone has to muck in. How do they cover it all? How do they manage their time and stay current? Every health system is prepared for a 24 hours or less security risk. But after that, things get complicated. How would a smaller organization handle 30 days? 40 days? What's the biggest learning from having the ERP suite in the cloud? Can you get to the level of customization that you want? What kind of things can you do to improve clinician experience? What's it like to do a comprehensive network upgrade with Aruba? How has that helped security and operations? And what kinds of technology priorities are on the agenda for the next 24 months?Key Points:We can be really nimble because of the multiple hats we wear [00:06:20] There's always something more that you can do in regards to security risks [00:11:30] Take a hard look at endpoint protection and DLP and where that sits within your organization [00:24:30] How do you stay up with Price Transparency and 21st Century Cures? [00:24:44] How do you maintain excellent office culture? [00:26:05]  Faith Regional Health

Today in Health IT
API-Driven Claims Adjudication, Brought to you By 21st Century Cures

Today in Health IT

Play Episode Listen Later Aug 25, 2021 9:46


Would this project have been done without the 21st Century Cures Act?FTAAnthem, Humana and SS&C Technologies have entered into a joint venture named DomaniRx to develop a claims adjudication and pharmacy benefits manager cloud platform, according to documents filed by SS&C Technologies with the Securities and Exchange Commission.PBMs receive and store massive amounts of data in their function of claims adjudication. The use of an Application Programming Interface, or API, allows applications to talk to each other for a faster, seamless process.In December 2020, CMS proposed the Interoperability and Patient Access final rule, which became final on May 1. It is aimed at removing silos of information that prevent patient data exchange and promotes interoperability throughout the healthcare system.Starting July 1, payers were required to give patients access to their data through "open" APIs, subject to the provision of HIPAA. Medicaid, CHIP and individual market Qualified Health Plans payers needed to build, implement and maintain APIs that enabled provider access to their patients' data. They were also required to streamline the prior authorization process.AHIP pushed back against the rule earlier this year, saying it was hastily constructed, requiring insurers to build these technologies without the necessary instructions.-----I don't imagine it would have, but I'm curious what you think.#healthcare #healthIT #cio #cmio #chime #himsshttps://www.healthcarefinancenews.com/news/anthem-and-humana-enter-multi-million-agreement-ssc-api-cloud-platform

The DownEast Emergency Medicine Podcast
OMG, TMI! What does open notes mean for you and your patients?

The DownEast Emergency Medicine Podcast

Play Episode Listen Later Jun 24, 2021 13:41


The 21st Century CURES act has mandated that starting on April 5th, 2021 patient notes (with a few very narrow exceptions) must be easily available to patients via their patient portal. How did this come about, and what does it mean for us? Click Here for full show notes   This lecture was presented at the 2021 Maine Medical Center Winter Symposium. For more information on the symposium click here. Sam Wood, MD

patients md sam wood opennotes century cures
The NACCHO Podcast Series
Podcast from Washington: The All of Us Research Program

The NACCHO Podcast Series

Play Episode Listen Later Jun 24, 2021 15:01


In this week's episode of Podcast from Washington, NACCHO government affairs team members Ian Goldstein and Adriane Casalotti discuss the proposal for the 21st Century Cures 2.0 discussion draft released by Reps. Diana DeGette (D-CO) and Fred Upton (R-MI). They discuss the public health provisions in the bill and its chances of passage. They also discuss the FY2022 appropriations process, as Congress breaks for July 4 recess.    Later in the program, Ian Goldstein speaks with Craig Braquet about the All of Us Research Program, which seeks to break down barriers that exist in medical research studies by expanding the diversity in research and clinical trials to include individuals with disabilities. They discuss the importance of people with disabilities' participation in the program.   

Today in Health IT
CHIME Summer Forum Recap - 7 ONC Coordinators and Aaron Miri

Today in Health IT

Play Episode Listen Later Jun 24, 2021 17:43


What do we learn about the future of interoperability and data sharing when seven former  National Coordinators for health IT covering four administrations are on stage together.Micky Tripathi, Biden AdministrationDon Rucker Trump AdministrationVindell Washington Obama AdministrationKaren Desalvo - Obama AdministrationFarzad Mostashari - Obama AdministrationDavid Blumenthal - Obama AdministrationRob Kolodner - Bush AdministrationThe primary thing we learn is the continuity of the strategy across administrations.    Karen Desalvo summed it up well when she said "And it's just important. I think for the audience to understand that the theme here is that we build on each other's work. And we try to do that in a very nonpartisan way, because that gives the industry a lot more certainty about where the future's going to go."21st Century Cures wasn't a fluke, it was a continuation of a strategy that frees the data from silos in order to bring advances to the patients when they need them.  To give them actionable data and agency over that data in pursuit of health.  To give them choice in their health decisions and to provide clinicians with powerful tools to make them more effective in the delivery of care.Mistakes have been made on the journey, but the direction remains the same across the last two decades of work by the ONC national coordinators.  #healthcare #healthIT #chime #himss #cio #cmio 

mistakes forum coordinators chime miri health it onc karen desalvo century cures national coordinators
Digital Health Unfiltered
21st Century Cures, and the Patient Portal

Digital Health Unfiltered

Play Episode Listen Later Jun 24, 2021 20:30


21st Century Cures Act is already making waves. But the most impactful change is yet to come: the API provisions go live next year. Will this put patients in the driver's seat for sharing data, and jumpstart health entrepreneurship? Nick and Sudipto make the case.

Pharma Intelligence Podcasts
Pink Sheet Podcast: Emergent On Capitol Hill, Second Cures Bill, US FDA’s Public Sponsor Rebuke

Pharma Intelligence Podcasts

Play Episode Listen Later May 21, 2021 34:41


Pink Sheet reporters and editors discuss Emergent BioSolutions’ congressional appearance, plans for the next 21st Century Cures bill, and the FDA’s statement on the clinical trials for CytoDyn’s investigational COVID-19 therapy.

This Week in Health IT
Next in Health IT with Andrew Rosenberg, M.D.

This Week in Health IT

Play Episode Listen Later May 19, 2021 50:08


May 19, 2021: In healthcare, a significant portion of the workforce have to be on site. How do leaders of today support and manage flexible, hybrid and remote work? Our guest today is  Andrew Rosenberg, CIO at Michigan Medicine who shares his insights on virtual care, 21st Century Cures, innovation, information blocking, telehealth and the cloud. How do we take the lessons of virtual care and continue to really shift the paradigm, not just with care at home, but how do we improve capacity in our tertiary hospitals and improve patient engagement in clinics? Are we at a point now where technology is driving the business strategy? Or are we still at a point where technology serves the business strategy and therefore the business strategy dictates the technology? What about application modernization and how it relates to cybersecurity and business continuity? Have we entered a new era in our cyber journey? And do you build your own technology products or buy them from vendors? There's a reason for both.Key Points:As a moderator it's essentially impossible via Zoom or Teams to spark a fun and educational debate versus doing it in person [00:04:20]Ambulatory care always had a relatively low volume of virtual visits. The peak in 2020 was 70-80% being virtual but it’s gone back down to 20%. [00:29:03]Patients love telehealth. They don't have to drive and wait around to be literally seen for two minutes. [00:35:05]It's not about information blocking. It’s about interoperability and availability. [00:37:25]The typical person does not understand the depth of their medical data. They seek a trusted professional to help them. [00:38:45]The pursuit of healthcare is constantly trying to shift from things that we deem as inefficient to more patient centric, more humane and less expensive [00:25:20]Michigan Medicine

Informatics in the Round
21st Century Cures: Curing our Anxiety or Causing It?

Informatics in the Round

Play Episode Listen Later May 15, 2021 66:39


Our third episode of this year covers a very important, timely, and relevant topic.  Every so often the Federal government passes landmark legislation.  We’re going to see what’s happening at Vanderbilt, which is a microcosm of what’s happening in your world as a result of 21st Century Cures and the specific actions it is requiring to stop information blocking.  Huh?  Yea, we’ll get into what that means. We have Dr. Trent Rosenbloom, an expert in biomedical informatics and especially technologies that are used by patients to manage their health information.  Trent’s been at the forefront of this issue and has way more than one podcast to share with us. We might well have him back in a few months to discuss how this is going in more detail.   Trent is joined by Sarah Bland, one of the very insightful and quick witted people I have the pleasure of working with on this podcast from time to time. Thanks, Sarah, as always.  Although the masks she was wearing on our zoom recording were next-level weird.  You’ll see those pics on our podbean-based website for Informatics in the Round, on our Facebook site, on Twitter, on Instagram, and maybe soon even on TikTok!   One thing I love about Nashville—Music City as it’s often called—is that you can find a fantastic singer or songwriter almost everywhere you look. This episode is no exception!  Will Comstock, one of the amazing, affable, and always professional administrative staff in my department, is also a wonderful musician and songwriter and blessed this show with his voice and his creativity.  He also, by the way, shared an important piece of personal insight, from which part of the opening clip was snipped.

This Week in Health IT
How Far We've Come: 400 Episodes and a Look Back at Healthcare IT

This Week in Health IT

Play Episode Listen Later May 7, 2021 52:01


May 7, 2021: Today is a very special episode. It’s our 400th show. How far have we come in healthcare IT over the last three and a half years? Tess Kellogg, Director of Marketing at This Week in Health IT joins Bill to celebrate the insights of our incredible community of contributors including David Bensema on telehealth, Dale Sanders on architecture, David Chou on ransomware, Tressa Springmann on Apple Health, David Muntz on handling talent shortage in IT and Ed Marx on life, death and everything in between. You’ll also get a behind the scenes look at building up a podcast from 28 downloads to over 250,000 in one year alone. What were the conversations in 2018, 2019 and 2020? The pandemic was tragic in so many ways. And yet for healthcare it seemed like it shocked the system in a way that it needed to. The healthcare industry has achieved things over the past 12 months that were never thought possible. Key Points:There’s no way the average American can understand pricing and what they're getting themselves into when they walk into the hospital [00:17:25] 2018 will be known as the high water mark for reimbursement for healthcare [00:22:10] 2019 was “Grow to Greatness” [00:22:24] 2020 was all about clear focus which led to digital transformation [00:32:30] What the pandemic really catalyzed in healthcare was external pressure [00:37:50] 2021 is about 21st Century Cures, information blocking, AI and machine learning [00:40:50] 

This Week in Health IT
A Discussion with Kevin Manemann from Providence on Tech in Healthcare

This Week in Health IT

Play Episode Listen Later Apr 16, 2021 56:58


April 16, 2021: The patient experience changed dramatically during COVID. Workflows had to adjust and change as part of that. We asked Kevin Manemann, Chief Executive Southern California at Providence, what expectations do patients now have? What are the most impactful steps you can take to meet those expectations? What home care technologies are emerging as critical? Can we sustain telehealth? Has the covered lives business grown for Providence? What does a CIN look like in Southern California? What are the technologies, the communication platforms and the data that you need to bring together? How do you move seamlessly from multiple EMR platforms to just one? What is the complexity of delivering on bundled payments and what are some of the strategies to approach that? Plus learn more about Providence St. Joseph Health’s “Own It” program and how it has impacted the organization.Key Points:When COVID hit, within 2 weeks we had 8,000 providers set up on telehealth [00:04:15] Have we finally gotten rid of clipboards? [00:06:21] About 20 to 30% of care that is provided is unnecessary [00:11:50] Text technology adds to a seamless patient experience [00:20:15] What value will 21st Century Cures create for patients and providers? [00:25:20] If we could monitor diabetic patients and intervene in the moments of concern, more times than not you could figure out what to do without them having to come into the emergency room [00:26:32] The administration that we have now really needs to put pressure on EMR vendors to open up [00:35:00] Providence

The Dish on Health IT
Going Beyond "Checking the Box" for Policy Adherence

The Dish on Health IT

Play Episode Listen Later Apr 6, 2021 40:20


On this episode of The Dish on Health IT, Alix Goss vice president and senior consultant at Imprado joins our hosts Ken Kleinberg, Pooja Babbrah and Jocelyn Keegan to talk historical policy and standards milestones, how they brought us to where we are today and why it's important for the industry to go above and beyond the mentality of just checking the box for policy adherence in order to gain a competitive advantage and achieve better patient outcomes. Kens asks Alix to give us a breakdown of how we got to where we are today in health IT. Alix kicks off the podcast by explaining that for several decades, we've been trying to address improved affordability and outcomes in our healthcare system. It's about the right data at the right time for the right patient and in the right format. In 1996, under the Health Insurance Portability and Accountability Act, we set off on a journey that forced us to be on a trajectory, as a nation, in our information exchange for administrative simplification. Think of that as governing, or establishing, pharmacy and medical standards along the way, in the 1999 to 2003 timeframe.Then, we rolled up our sleeves and tried to make all of that work only to realize we really needed to bring clinical aspects into it too. We started working on the American Health Information Community (AHIC) under the Bush administration, which helped us figure out what clinical data exchange needed to look like. A lot of the work was memorialized under the Health Information Technology and Economic and Clinical Health Act (HITECH) of 2009. Shortly after, we got the Affordable Care Act. Then came the Medicare Access and CHIP Reauthorization Act of 2015, which established a robust Quality Payment Program, changing the way Medicare rewards for clinical value over volume. Most recently, our journey continued with the 21st Century Cures Act in 2016, which promotes and funds the acceleration of research and drug and medical device development. In the end, HIPAA gave us administration simplification and now 21st Century Cures is bookending decades of progress and forcing us into this intersection of clinical administrative data all around the patient.Ken asks Alix if she believes Fast Healthcare Interoperability Resources (FHIR) application programming interfaces (APIs) and rated standards are innovative. She responds with a question. What is your definition of innovation? If you're in other industries you're probably thinking, yeah, not so much. But for healthcare, we're so complex with the variability of all the data elements. Our current transaction evolution to adopt FHIR will provide us with greater flexibility throughout the entire process. Alix thinks FHIR is the way we're going to bridge a great deal of problems, but she does not necessarily see electronic data interchange (EDI) going away. It's gotten into the DNA of our architectures and our business decisions. It's the way we do things. We like to adopt new standards, but where we always fall short is doing the cultural transformation of workflows as opposed to sometimes just having a “check the box” mentality.Jocelyn, who has extensive FHIR Accelerator experience, notes it is no longer just about the rules or the laws that have gone into effect, it really has to do with if we're not figuring out how to make value-based care work, what is our alternative? What will push people to make the shift? The pandemic further exposed current weaknesses in our ability to exchange clinical data, to let us roll out vaccines at scale across our public health infrastructure. There could not be a more compelling business case for why it's so imperative for everyone to start picking up existing tools and implementing. As data starts to free and more players implement, those that don't react or those that have the “check the box” mentality are going to put themselves in a significant competitive disadvantage in the coming years.Pooja has examined these issues from a patient, CARIN Alliance perspective. She is concerned with how we make it easier for patients to access and share their data. FHIR APIs finally get us to that point where it's easier for patients to download their data. We're getting to the point, thanks to some of the recent technology and standards, where it is easier for patients and consumers to download their information and to do searches on price transparency. Ken moves the conversation to payers. He asks Alix if this stakeholder group is embracing change or just “checking the box”. Alix says it is a very mixed landscape out there as far as opinions and corresponding strategies. There are some who are only going to come along when the axe (aka penalties) comes down. Then there are others who are pushing the envelope and pulling folks along. Alix thinks there is a landscape in the payer community that feels overburdened and has its own compliance fatigue. She believes there is also skepticism around what might change. That skepticism coupled with longer term trust dynamics in the payer-provider community plus the sustainability themes for payers (rapidly changing business models) has caused them to start considering things with different lenses that they've never had to before. Past approaches have trained the industry to wait for regulations and incentives to create movement, meaning there is far more “check the box” mentality than anything. Alix is optimistic though, especially under the FHIR Accelerator community, that there is a group of thought leaders who are leaning in and trying to drive a stronger course forward for us all.Ken asks Jocelyn what her comments are about payers being burdened. She notes it is a fair point and that there a couple of factors at play here. To Alix's point, there's a lot of entrenched operational support and infrastructure in place that's been running to support EDI for a number of years, and there has been minimal effort in doing clinical data exchange with payers. Because of the historical combative relationship between payers and providers, we haven't seen much progression yet. However, with the Da Vinci Project, we get to see daily how those relationships are changing. Payers who leverage modern APIs will transform their organizations, how they work and how they view their relationships with provider partners. They will be the ones who come through the curve faster.Pooja notes we are essentially flipping the entire model payers are operating under today. They're not used to opening up their data to others. It's the same in the PBM space. On the pharmacy side, we're not quite there yet but how do we make it easier for data to be shared? How do we make it easier for patients to access their data?Pooja also brings up that payers are having to meet interoperability, patient access and price transparency rules, which is a lot. She has a feeling payers might default to just “checking the box” because they will all be in a rush to meet what's in place today. The point is though, we need people to be thinking outside of “checking the box”. Where can they focus? What are the specific use cases that they could look to in order to achieve a market advantage? Pooja thinks that's where payers need to be paying attention.Alix comments that we're not just transforming standards, we're transforming culture. How does a patient become informed? We have an educational foundation here of using technology to interpret information in collaboration with someone's payers, providers, benefit plans and their family's budget. That's how we stitch this all together. However, to Pooja's point, the history of payers and the cultural transformation is one of our shortcomings in implementation efforts that we've undertaken in the last 30 years.Ken asks Alix how she sees the new federal administration playing out over the next few years. Alix says public infrastructure has been duct taped together and underfunded for decades. The work people have done at a local and state level in partnership with the Centers for Disease Control and Prevention (CDC) has been amazing. It is also amazing how the commercial sector relies on registry and public health information. So many use the data, yet very few people help support the public health infrastructure. So, Alix thinks we are going to see a lot of transformation in the public health space (for the good). Having a new national coordinator like Micky Tripathi is going to really help leverage implementation efforts and take us to the next round of progress. Additionally, Alix does see FHIR as a key factor in bridging a number of issues out there, but she's not expecting a hard left turn in this next administration.Ken asks Alix for her final thoughts. Alix stresses for people to get educated and involved in standards development, both policy and technology standards. If you can't play at the national level directly, you can always offer your public comment on proposed rulemaking. We all have experiences to share and we all should exercise our voice to strengthen our nation's trajectory and agility to respond to all the amazing technology and medical advances that are yet to come. So if you can't get involved directly, tap into the expertise of the folks at Point-of-Care Partners or Imprado because they can inject that knowledge and add your story to their library of perspectives from which we influence.

This Week in Health IT
Maximizing EHR Potential, MyChart, and Interoperability with Epic VP of Patient Experience

This Week in Health IT

Play Episode Listen Later Apr 2, 2021 46:45


April 2, 2021: Patients relied heavily on virtual tools to connect with providers throughout the pandemic. A single click to a doctor is the holy grail. So is having access and control over your data. Our guest today is Sean Bina, VP of Access and Patient Experience for Epic. What role does MyChart play in this virtual care world? How is Epic working with the innovation community to optimise patient experience? What is their role in the vaccination effort? How has Epic been working with clients to streamline vaccine scheduling? What about interoperability? How can healthcare information be connected across health systems, retail pharmacies and statewide registries? Sean and Bill also dive deep into remote monitoring, telehealth, 21st Century Cures, MyChart Care Companion, Epic Health Research Network and the Vaccine Credential Initiative.Key Points:The hurdles for becoming a MyChart user are much fewer and easier to get over than ever before [00:07:40] In a study around remote monitoring  of their hypertensive patients, Oschner saw a 40% increase in the number of patients that were meeting their goals. That’s a huge reduction in readmissions. [00:13:20] As the FHIR standard continues to develop and grow it's becoming even easier for Epic to make connections to third parties and other vendors [00:17:35] Epic is helping to establish privacy standards to make sure the goal of 21st Century Cures is achieved [00:24:35] EpicMyChartMyChart Bedside Epic Health Research Network

This Week in Health IT
Leading on Innovation and Quality Care in a Pandemic with CIO Ed Kopetsky of Stanford Children's

This Week in Health IT

Play Episode Listen Later Feb 12, 2021 48:35


February 12, 2021: Ed Kopetsky, CIO for Stanford Children’s Health joins us. Ed is a CIO of the Year. He is a lifetime achievement award winner. He talks about what distinguishes a great CIO from a good one. The organizing principle during the pandemic is safety and speed. How do you determine what projects to do moving forward? What are the biggest challenges facing pediatric health in California today? What’s it like to work in the inspiring community of Silicon Valley? What’s the deal with the transparency rule and 21st Century Cures compliance? And learn about Ed’s incredible work on the Opioid task force made up of leading edge clinicians in addiction medicine.Key Points:Children's hospitals have really gone retail [00:04:35]There's no flu season this year because of our isolation, not bringing people into clinics and using virtual care. So safety wise and quality wise, that's been a significant advancement. [00:14:55] Great CIO's have great networks [00:23:50] Children's hospitals are kind of like Switzerland. They have to partner with everybody. [00:34:45] Addiction is not an acute illness. It's a chronic lifelong illness. [00:44:00] When COVID hit, mental health went to the wayside again. Our overdose mortality rate is up 50%. [00:44:45] Stanford Children’s Health

This Week in Health IT
What 2021 Will Bring to Healthcare with Children's Hospital CIO Theresa Meadows

This Week in Health IT

Play Episode Listen Later Feb 3, 2021 37:16


February 3, 2021: Artificial intelligence, chatbots, machine learning, remote work, price transparency, leveraging the cloud and 2021 technology priorities. Join today’s conversation with Theresa Meadows, CIO for Cook Children's Healthcare System. Children's hospitals are unique in that their interoperability strategy has to be REALLY good. What does it look like? What kinds of regulatory things must be considered? What does a children's integrated delivery network (IDN) look like? Do these health systems rely on their EHR? Or do they use a third party? What about homegrown data solutions? The topic of work culture is huge in 2021. How do you manage productivity with a remote workforce? Key Points:IT projects are never over. They are living breathing entities that last forever. [00:09:50] Cook Children’s two IT goals: 1. To enable our patients to be more mobile. 2. To enable our employees to be more mobile and more agile in their work. [00:19:35] 21st Century Cures and price transparency [00:25:55] The technology priorities for 2021 are mobile and digital [00:19:00] There are a lot of repetitive things that we do in IT that RPA is perfect for. E.g. password creation and password termination. [00:33:10] Cook Children's Healthcare System

Today in Health IT
Vaccine Credential Initiative is a Proof Point for a decade of Interoperability Iniatives

Today in Health IT

Play Episode Listen Later Jan 15, 2021 10:34


Start the clock. The Vaccine Credential Initiative (VCI) will show how far we've come with interoperability.Rewind three years. The idea that Cerner and Epic would participate in anything together, at least anything that was more than just a CYA announcement would be unheard of. Now they are both in on VCI.More on VCI.-----FTAParticipating organizations will agree to offer individuals with digital access to their vaccination records using the open, interoperable SMART Health Cards specification based on W3C Verifiable Credential and HL7 FHIR standards, according to VCI.------This will be a great test. The urgency created by the pandemic, coupled with the progress on interoperability fueled by FHIR and 21st Century Cures are coming together. Now we get to see what can happen when all players have a shared will to make something happen.The speed and proliferation of a solution will tell us if we are on the right path and give us a metric by which to measure all future interoperability efforts by these players.

This Week in Health IT
Optimizing Health IT to Improve Health System Performance - Rand Corporation

This Week in Health IT

Play Episode Listen Later Nov 13, 2020 48:13


November 13, 2020: It’s been about a decade since the passing of the HITECH Act when we as a country decided to invest many billions of dollars into our health IT infrastructure. So it’s the perfect time to look back and see how things are going. Bob Rudin of the Rand Corporation, a nonprofit think tank, shares their research. The working paper is called “Optimizing Health IT to Improve Health System Performance.” They interviewed executives from 24 health systems around the country. We see all kinds of efficiencies in every industry, why isn’t it happening in healthcare? What’s going on? What’s the problem? Are we getting value from all the new technology? If not, why not? How can we do better? What about distribution? How do we get apps out to the masses? How do we get the clinicians to adopt them? And with so many mergers happening, is there a secret sauce?Key Points:Looking at health IT in the context of health systems and how we're trying to use it to improve performance [00:05:25] There's now industry consensus that it’s better for a health system to be on one electronic health record rather than on more. There’s so many efficiencies you gain from doing that. [00:11:25] The 10 year foundation has been laid but it was 5 years ago when the 21st Century Cures was signed into law that we really saw the first seeds [00:34:05] Can we all agree that evidence-based medicine makes the most sense? The answer to that is not always. [00:43:45] "Optimizing health IT to improve health system performance"

This Week in Health IT
Healthcare in the 21st Century with Aneesh Chopra

This Week in Health IT

Play Episode Listen Later Aug 7, 2020 51:32


August 7, 2020: Aneesh Chopra, First CTO for the US elaborates on 21st Century Cures. How should CIO’s prepare? How do we scale an interoperability strategy that is built on the patient's right of access? Our industry finally has a chance to self organize and standardize data elements for sharing. Why have the banking, education and energy industries beaten us to the punch? How do we approach intellectual property issues? We also look at payment reform and value based care.Key Points:Data sharing policies for COVID lab reporting [00:12:36] Interoperability in support of the patient equals better health outcomes, better health and a better community. [00:13:21]One doctor who’s had an electronic record for 30 years can’t even give a list of patients who smoke because it was not a structured field in the EHR! [00:19:19] How dangerous is a compliance mindset? [00:27:47] 21st Century Cures [00:28:05] Information blocking [00:32:16]Intellectual property issues [00:33:33]Why has healthcare, 10 years after the initial data set was published, not added a single data element beyond the minimum required in the open source domain? [00:21:33]Apple Health [00:41:17]

CMIO Podcast
Interview with Dr. Justin Mazzillo, assoc-CMIO

CMIO Podcast

Play Episode Listen Later May 23, 2020 32:54


When I read through the summaries of the 21st Century Cures act, I interpreted the line about not having to release information that could cause harm to a patient to mean that we did not have to auto-release pathology results. I held that belief until I got a message from Justin pointing out the discussion in the Q&A section of the final rule. Sure enough, they clearly state that having a policy for withholding results across the board is considered information blocking; the requirement to withhold information must be individualized. Justin and I discuss the implications of this including the possibility of patients learning they have the genes for Huntington's disease or the diagnosis of cancer from the hospital electronic portal. Yikes. We also discuss their use of chatbots during the COVID crisis and their journey towards better clinical decision support at the University of Rochester. They have a great informatics team at U of R. I have been fortunate enough to interview a few members of their team and they are doing great things.

CMIO Podcast
CMIO News to Know for the Week of Oct 21

CMIO Podcast

Play Episode Listen Later Oct 20, 2019 25:36


Does the Information Blocking Rule in the 21st Century Cures act basically require systems to release their provider notes via their patient portal (OpenNotes)? I discuss this issue and some other news stories in this weeks CMIO News to Know.

cmio century cures
Product Hacker
Mini-sode: The 21st Century Cures Act Is About to Change Digital Health Forever

Product Hacker

Play Episode Listen Later Jul 31, 2019 10:14


New healthcare data regulations are on the way, and they're going to totally change the way we think about patient data, privacy, and more. In this mini-sode, Product Hacker does a deep dive on the 21st Century Cures act: what it is, why it matters, and how it's going to change digital health forever. Produced by Martin R. Schneider. Music by Prox-C and Blue Dot Sessions

The Syneos Health Podcast
Episode 031: Real World Evidence in Europe

The Syneos Health Podcast

Play Episode Listen Later Mar 20, 2019 13:13


According to the Syneos Health 2019 Health Trend Ten, perhaps the biggest shift for 2019 and beyond is global focus on understanding what product differentiation looks like in real-world environments.  In Europe in particular, countries are implementing more stringent measures that will impact how value is assigned in the future – and real world evidence (RWE) will play a key role.Alastair MacDonald, Senior Vice President, Real World and Late Phase at Syneos Health, discusses the complex landscape in Europe, why “real world” and “late phase” are no longer synonymous, the four key stakeholders driving the need for RWE, and more.For more content related to real world evidence, check out our interview with David Thompson in Episode 001: The Real World Evidence Revolution, our Syneos Short in Episode 020: 21st Century Cures and our recent white paper on determining Which Real-World Research Design is Best.Do you like what you're hearing?  Please be sure to subscribe, rate and review us!

ASCO in Action Podcast
Exclusive Interview: NCI Director Talks Big Data, Clinical Trials, the Cancer Research Workforce—and Why He Lives to Conquer Cancer

ASCO in Action Podcast

Play Episode Listen Later Mar 6, 2019 30:29


Subscribe to the podcast through iTunes and Google Play.    Dr. Clifford A. Hudis: Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Ned Sharpless, the director of the National Cancer Institute. The NCI is the largest funder of cancer research in the world, and it has helped to drive many of the major prevention and treatment advances we've seen over the past 50 years. This includes things like HPV vaccination and the identification of the link between HER2 status and breast cancer outcomes and treatment, as well as new discoveries that have dramatically improved outcomes for childhood cancer. Dr. Sharpless, welcome, and thank you for joining me today. Now, we really have a whole lot to discuss, but before we get to our planned topics, I have to jump ahead and start with the president's State of the Union address, when President Trump mentioned that he wants to see $500 million appropriated for childhood cancers over the next decade. Can you talk a little bit about how you expect that, specifically, to play out? What will the NCI be able to do with those new specified funds for pediatric research? Dr. Ned Sharpless: Sure. I think childhood cancer-- childhood cancer is an area where the National Cancer Institute has had a long interest and a robust portfolio of research. And I think it is an area where we've made some progress, in terms of mortality, over the last few decades. But you have to say two things about childhood cancer. While progress has been good, and we're making-- more kids are surviving cancer therapy today than ever-- there's still a long way to go. Too many kids dying of cancer in the United States, and even the kids that we're able to cure have these significant lifelong survivorship challenges, in some cases. So the therapy that is curative may leave patients with side effects of surgery and chemotherapy and radiation for the rest of their lives. So better treatments for kids and less toxic treatments for kids are what we are really looking for. And with that amount of money, I think a good-- the thing that it appears to me that one could do to most quickly move the needle in childhood cancer-- which, as you know, is a collection of less common cancers, even rare cancers-- is really a more intentional effort at aggregating and using and linking clinical data with molecular data and other sorts of patient data, so that we can really learn from every child with cancer in the United States, so that we can really figure out what's working in certain populations and then disseminate that information as rapidly as possible-- without having, in all cases, to rely on slower clinical trial structures that are challenged for certain populations where accrual can be difficult. So I think that is the vision for the president's initiative, is to, with additional funding, allow for very aggressive, intentional, and organized data linkages and data aggregation so that we can learn from every trial and therefore treat every child's cancer in a better, more effective way. Dr. Clifford A. Hudis: You know, I think that's great. And that actually provides two different segues-- one I'm going to pick up right now, and one I want to come back to. The first is about data-- big data, specifically. We'll come back to that. The second is about the way the pediatric oncology community for years has really led in designing studies that could accrue the majority of children diagnosed with various specific diseases. And that leads me, that idea of eligibility and the structure of research, to ask about the way that you're thinking about modernizing clinical trials. This is something I know you wrote about in JAMA Viewpoint in the last couple of months. You addressed financial pressures, the need to increase overall rates of accrual to the trials, especially representing patients from underserved populations. Can you expand a little bit on that effort and what kind of progress you see as possible in the coming months and years? Dr. Ned Sharpless: Yeah, I think everything we do successfully in cancer today is in some ways the results of a clinical trial. And this is clearly one of the most important things the NCI does, in terms of moving basic science into patient care through experimental clinical trials. And it's an area where we-- frankly, a lot's changed in the last couple of decades. When I was a wee fellow, the clinical trials apparatus was very different from the way it is 20 years later today. And we need to make sure that we modernize the clinical trials process to keep up with the changes in our understanding of the biology and the new kinds of therapy we have for cancer. So that brings up a bunch of items that are areas where the NCI is really doing a lot of things. So, for example, one of the first problems I noticed when coming to the National Cancer Institute was that the clinical trials infrastructure, the big networks that we have for doing these kinds of trials, were under-resourced, that they had a funding problem. And they were becoming non-competitive with the trials sponsored by industry. And this showed itself in many ways, in accrual fees for patients, or the wait times to get the trial open, or the slow accrual once the trial was open. And so they were laboring under a number of problems. And so we decided we had to invest in the Clinical Trials Network and have been doing that and will be continuing to doing that in a number of ways-- through direct funding to attempt something like the National Clinical Trials Network or the NCORP, for example, the NCORP organization, but also by additional funding for biobanks and data aggregation initiatives, targeted clinical trials, et cetera. I think we've also-- there are some structural problems with the clinical trials that you alluded to. For example, eligibility criteria, I think, hadn't really kept pace with modern clinical trials. And I think ASCO and other groups have played a really important leadership role in identifying what are good eligibility criteria and which ones are not as necessary anymore. And then, do we have to have the same criteria in all the trials, and be more thoughtful about how those are used as a way to enhance accrual, because often we have a-- superfluous eligibility criteria can limit accrual. And increasing accrual by a variety of measures is really important. And we've thought a lot about how to do this through novel ways of clinical [? house ?] matching. I think one of the more successful efforts we've had in clinical trials accrual recently has been the MATCH trial, the NCI MATCH trial, which was able to accrue 6,000 patients at 1,100 sites in the United States, filling a targeted accrual two years ahead of schedule. It's the fastest-accruing trial in the history of the NCI. And I think one of the things MATCH teaches you is that if you have an interesting trial that's written in a nimble way that is open in the community-- that patients don't have to drive six hours to a cancer center, but can go to a local NCORP site, for example-- then those trials will accrue. We can accrue quickly, and we can accrue underserved populations, and we can accrue rare cancers. And that framework is more nimble than, say, the large phase III randomized trial run only at cancer centers that we had 10 years ago. There is still a role for large, randomized, phase III trials. The NCI is not backing away from that, or where we will support those. But I think, as we discussed in the JAMA piece, we really have to be thoughtful about where the NCI needs to be involved with those kinds of trials, compared to which of those should be supported by industry, for example. Dr. Clifford A. Hudis: It sounds like you're alluding to something I think you and I discussed even when you first got into your current role, which is the identification of those trials that industry should run, essentially, itself, and those trials that the NCI should support as complementary to industry trials. Can you expand a little bit on how you see that distinction and where you draw that line? Dr. Ned Sharpless: Yeah, the thing to know about clinical trials in oncology in the United States right now is most are actually paid for by industry. There's a huge pharmaceutical industry spend on clinical trials, and from my point of view, that's great. The fact that industry is paying for trials to develop therapies for cancer patients-- that's less money the NCI has to spend on those same questions. So we think that's a wonderful development and healthy for cancer research. But if that's the way it's going to be, then the NCI has to ask itself-- for the precious moneys that we have to spend on clinical trials, we need to use those in a way that's maximally effective and, in particular, not duplicative with what industry sponsors are doing. It's important to say, we do a lot of work with industry. So it's not just us either-or. Many of our trials, through these agreement processes called CRADAs, allow us to do trials with pharma sponsors and use their compounds in our trials. And that's a real boon to our research effort, as well. But there are certain kinds of trials that are very important where we really want to know the answer, but they're a bad fit for what industry is going to fund. For example, a de-escalation trial-- that's a trial where there's a standard of care that's pretty good, but the therapy is toxic. And so we'd like to see if we can get the same good outcome in a population using less aggressive therapy. A very important example of this was the TAILORx trial recently, where we showed that based on a genetic risk score, an RNA-based risk score of the breast cancer, women with estrogen receptor positive breast cancer-- many of them could forego cytotoxic chemotherapy and just take anti-hormonal agents and have the same good outcome in terms of their long-term survival. So that's a trial that is not going to be industry-led, for a variety of reasons. But I think it is the kind of question that's really important for patients. It's important, also, to say that de-escalation trials are hard to do. They require a lot of thought. They don't always work. And so they require these comprehensive thoughtfulness and infrastructure that the National Clinical Trials Network can provide. So an additional example is these multi-modality trials we have, where maybe two different agents come from two different pharmaceutical companies, and then there's some surgery and some radiation. There's very complex, multi-integrated care. And those can be very hard for a single sponsor to run, but, again, can be a very good fit for the NCI. And there are many other examples like this. But I think the real question we have to ask is, if our budget is limited and finite, what are the trials that the NCI really should do and lead on? Dr. Clifford A. Hudis: Yeah. And I think one of the points there is you need to conduct-- we need to conduct-- trials as efficiently as possible, getting the most so-called bang for the buck. You alluded to the fact that the NCI, along with ASCO, has been working on making trials essentially more efficient by making them more representative of the actual cancer population we end up treating. And a specific area of focus for us at ASCO, in this collaboration and also in our TAPUR trial, has been driving the eligibility age down below 18. My understanding is that this is something that you're adopting as a recommendation across the NCI, as well. I guess my question is, how broad and how quickly do you expect to see this implemented? Dr. Ned Sharpless: We have a number of efforts related to these barriers to accrual. You mentioned age as one of them and other sorts of exclusion criteria. And we've looked deeply and thought about this sort of care across the continuum of life-- both age limits on the less than 18 side, but also at the greater than 65-year-old side, where we see, often, eligibility criteria structured around a maximum age that don't often make a lot of sense. So that is one of several topics that we are addressing. As you know, we have a variety of networks and programs, and we fund a variety of kinds of trials. Some are led predominantly by the academic institution. Some are led through NCI networks. And so we are rolling out these policies, not in a one shot fits all way, but across these networks at different scales. They often require scientific buy-in from the other participants, and you know how that process works. I think this is an area, fortunately, where there is a lot of buy-in, where we're not having lengthy debates about whether or not we should do this. Really, the question is how we operationalize it and make it happen as quickly as possible. Dr. Clifford A. Hudis: That's great. And you know how strongly supportive we are, on lots of levels, for this effort and the related ones, in terms of barriers to accrual. I want to pivot, though, back to something that you introduced earlier about the big data. And my understanding is, in the annual plan and your bypass budget for 2020, you specifically called out the need to harness big data to speed up all of our work across the cancer research enterprise. And there are many companies, organizations-- we ourselves at ASCO have CancerLinQ-- that are involved in trying to collect data, share it, analyze it, and advance science and clinical care. But what exactly do you see as the NCI's role in facilitating this, and what do you think is our biggest challenge going forward? Dr. Ned Sharpless: Yeah, it's an interesting topic. I think the-- it's maybe two things to say off the top about big data in cancer research. The first is the NCI already has one very important example of how big data can transform a field, and that's The Cancer Genome Atlas, which later became the Genomic Data Commons. This is petabytes of genomic data that we make available in the cloud now to any researcher, basically, who is interested in cancer. And that set of data has led to thousands of papers and just a fundamental reorganization of how we think about cancer biology in many ways. And it's been a huge success, I would argue, and well worth the investment of the NCI to do it. And the data has been used in ways we never envisioned. We never thought of some of the papers and applications that would come out of the analysis of the Cancer Genome Atlas, for example. But the problem, then, one quickly sees, is that while that data set is great, it's limited. It doesn't have the clinical data, it doesn't have radiology and histology, it doesn't have-- we don't really have a way of binning big epidemiologic cohort data, for example. So the GDC, the TCGA, the Genomic Data Commons, proves how useful these kinds of data aggregation efforts can be, but also makes very clear what the shortcomings of our modern efforts are. The second thing to say is that this is a problem where the NCI is well-poised to be a leader, right? There are a number of issues around data sharing and data aggregation that really benefit from a Switzerland-like federal entity, a non-conflicted, dispassionate entity like the NCI that just wants to create the data structure in a way that's maximally beneficial for everyone, so that there are-- this is an area where the imprimatur of the federal government really allows us to play a role that would be hard for other groups to take on directly. And so I think this is a reason why so many groups have been looking to the NCI for leadership on this topic. So what are the challenges to big data? Well, I think that one challenge that has been spoken about a lot publicly is this issue of data hoarding by scientists and physicians and people who have these sets of data they don't want to share for academic competitive reasons. That is a problem. I'm not going to say that doesn't exist. But I don't actually think that's the biggest problem. I think a bigger problem around data sharing is just it turns out to be really hard to do. And by hard, I mean expensive. It turns out to be-- these various data sets were not created, initially, with the intent of sharing them. They're often in different formats. They're often governed by different kinds of data use agreements, which are governed by the consent form that the patient signed to have their data included. And so linking them can be both very technically difficult, from just a computer science point of view, and can also provide a lot of administrative and logistical hassles from the data sharing, data use agreement point of view. And so each one of these things is just something the NCI has got to work through, or someone like the NCI-- is figuring out how to link disparate data sets, how to get the right kind of data abstracted from charts that we want, how to develop the right work force to study big data with big data analytics, and then that is a big problem. So there are a number of areas where the NCI can address the challenges. And I think we'll make progress. I mean, the good news is that we understand these problems. This is not like we need to-- there's some fundamental problem of biology that we need to figure out. The bad news is that the problems are weedy, complex, and many, many layered, and require us working through them. But that's what we can do. We have support from the government for this. The moonshot had a lot of funding for data initiatives, which we've been employing to get these structures going. And now the Childhood Cancer Data Initiative, for example, I think could really-- that's a nice demonstration project, if you will, because it's the right size. Childhood cancer is about 16,000 cases a year. And so I think we can show what this radical data sharing, if you will, this data liberation project can do-- you know, that population and how useful it could be to larger groups of patients like lung cancer, breast cancer, things like that. So I think that these are the kinds of things the NCI can do with help from other federal agencies and academic partners and groups like ASCO. This is certainly not an area where we plan to go it alone. There are a lot of stakeholders and a lot of great ideas. And I think that by organizing and convening these initiatives, we'll make progress. Dr. Clifford A. Hudis: Well, I really, first of all, appreciate your calling out the fact that data hoarding in isolation is not the single biggest problem, because I think that's a frequently-cited limit. And I agree with you that it's less of an issue than all of the other ones that you highlighted. In that regard, I understand that you just announced a new office. I think it's the Office of Data Sharing? Can you expand on or explain how that relates to these challenges and what it's going to, hopefully, accomplish for us? Dr. Ned Sharpless: Sure. The Office of Data Sharing is something within our Center for Bioinformatics and Information Technology. It's getting stood up now. It's been around for about a year, even less than that. It has a new leader and a few FTs, and it has a number of jobs intended for it. I mean, there are a number of ways that we would like the Office of Data sharing to-- a number of problems that we think that the ODS can help serve with the external community in terms of data sharing, like these issues around consent and data privacy that I mentioned. But right now, an intense focus of that office, because it's something we really need to solve, are related, really, to the issue of accepting data and allowing access to NCI data at present. So we have this complex structure whereby academic investigators can give data sets to the NCI. That's harder than it sounds, because we have to make sure the data are of good quality and they're properly consented, and we understand the data usage agreements and that kind of stuff. And then we have a means to allow access to those data to accredentialed investigators. And there are a bunch of issues with that that are more complicated than you and I would want to go into right now. But I think that's consuming a lot of the bandwidth at that office right now, is the problems around, for example, the dbGaP entity, whereby different investigators give data to the NCI and the rest of the NIH. That has caused a bit of a bottleneck, and so we're trying to work through some of those issues. One thing, for example, that I think the ODS can do and is doing already is this sort of concierge-like function. For people who have large, valuable data sets that they'd like to give to the NCI, we should be able to take those data sets as quickly as possible. But something that's happened in the transmission of those data is that we've realized the quality isn't quite what we wanted or the format isn't exactly right, and so we have these questions, and they go back to the investigator. And there's this sort of cyclical loop that can take months and really substantially delay the process. And so the ODS is jumping in there early on and intervening on that loop and making sure the data are the right format and the right quality at the time of initial submission, so that we don't have this back and forth that wastes a lot of time. So I think those data access and data transmission issues are a prime focus for the office right now, although it has a much larger mission as it gets stood up. Dr. Clifford A. Hudis: Yeah, a little bit like CENTRA that Rich Schilsky runs for us here at ASCO, in terms of access. But at any rate, I want to take the remaining time we have, and maybe this is a speed round on the cancer research workforce. So a couple of quick questions, perhaps-- first of all, has the Cancer Moonshot Initiative had an impact directly on the kinds of awards that you're making available to researchers? And if so, how do you think that might evolve in the next couple of years? Dr. Ned Sharpless: I think the moonshot, as you know, was intended to focus on these 10 areas identified by a blue-ribbon panel that were thought to be ripe for clinical translation, just about ready to go into clinic and to benefit patients in a very direct, immediate way. So the moonshot per se didn't include funds for things like really hardcore basic science or training, although certainly moonshot moneys are being used to some extent in both those areas, as necessary, as part of these translational efforts. So I think that what the moonshot has done-- it's done a couple of things. So first of all, that most of the awards granted by the moonshot mechanisms are more these-- are not the traditional R01, but are more of these consortia and network grants. And I think we've built a lot of infrastructure for research efforts, say, in immuno-oncology or in pediatric cancer or in survivorship. And those networks will both-- well, they will live on beyond the moonshot in some cases, I'm sure. And those networks will provide integrated research efforts, but also some training opportunities. So most of those include junior scientists and junior clinical investigators, and so there will be some opportunity for the moonshot both to drive the scientific area of study and also provide some training opportunity for the new people coming up. Dr. Clifford A. Hudis: Well, speaking of junior and new, I listened to your conference call, I guess, about a week or two ago talking about the pay line. Can you expand on your plans to support young investigators right now, given the always-present constraints in funding? Dr. Ned Sharpless: Right. This is a particular problem for the National Cancer Institute, because we've seen this relatively-- there's no other word than "massive" influx in the number of applications for the so-called R01 grants, the independent investigator-initiated award at the NCI. And this is-- our award number is something up like 60% over the last nine years or so. So this rapid increase-- which is, in most ways, a very good thing. I mean, that says that new scientists are coming to our field with new ideas and new ways to treat cancer, and the NCI can pick among these many applications and fund the very best ones. But it has this pernicious bad effect for the academic investigator community, and that is that their individual chances of getting a grant are lower. If paylines are really the number of funded awards divided by the number of applications, and the denominator goes up faster than the numerator-- both are going up, but the denominator goes up faster-- then the paylines are going to go down. And we think this is particularly a problem for junior scientists, because established scientists have seen paylines come and go and funding realities change. But new scientists aren't as used to the life of the independent researcher and, we think, are most likely to either leave science or move out of cancer research to another area of science. And we'll have to try and minimize that from happening, to the extent possible. So one of the things we've done at the behest, in fact, of 21st Century Cures, which included language asking the NCI in the United States to do this, was really focused on these so-called early stage investigator, the ESI. So the ESI is faculty. That's someone who's gotten a job, generally in an academic institution, and is now writing their first R01 grant, their first independent scientist grant. And we've done a few things for this population. One thing that's really important is we give them a special payline. We give them, effectively, a higher chance of getting funding. So if, say, paylines are on the order of 8% now for all Comer grants, for ESIs they'll be more like 14%, right? So a significant-- or 12%, in that range. So, significantly higher than what the general community is. I want to point out, also, that paylines are lower than the actual success rates of the NCI, which is a better number. The reason success rates are higher is because we do fund a lot of grants outside of the score. It's a little bit of inside baseball. But generally, if you write a grant to the NCI, your chance of getting it is more like 12%. And if you're an early stage investigator, it's more like 16%. Dr. Clifford A. Hudis: Thanks, Ned. To switch gears a bit, I know you've worked with the NCI throughout your career. But now you've been at the Institute's helm for nearly a year and a half. Has your understanding of the NCI and its role in cancer research changed or evolved in this newest assignment? Dr. Ned Sharpless: I think it has to be said that I was an NCI watcher my entire research career, and I thought I knew the National Cancer Institute and the National Institutes of Health pretty well-- as well as one can know these organizations from the external perspective. But since starting at the NCI, I've really learned that this amazing organization is much larger than even I realized, and that the scale and scope of the NCI is truly both awe-inspiring and, in some ways, daunting. I had a series of meetings as I started as NCI director where I would learn about these sprawling comprehensive cancer prevention and control efforts or new areas of basic research or clinical trials. And I just really had had no idea that the NCI was involved in some of these activities. So it was very illuminating. In some ways, it's thrilling, the things the NCI is doing. But I think it also made very clear to me another thing that I think I knew at some level, but didn't really appreciate the full scale of this until becoming NCI director, and that's the issue of-- although the NCI is huge and has this great reach and comprehensive nature, we are limited in scale. Our resources are finite, and the NCI, therefore, is really forced to make these difficult choices about which areas of cancer research to fund and how best to address our mission of reducing cancer suffering. So I think I was surprised both by the scale and scope of the NCI, but also by the fact that, despite how big the NCI is, it still has significant limitations on what it's able to do and has to make these difficult choices. Dr. Clifford A. Hudis: ASCO recently launched the "I lived to conquer cancer" awareness campaign that spotlights federally-funded cancer researchers and the patients who inspire them. I want to close out our conversation today by asking you, why do you live to conquer cancer? Dr. Ned Sharpless: Yeah, I think like just about everybody in the United States, my life has been personally touched by cancer. I've had friends and family members get cancer, and my father even died from cancer. Both of my sisters are cancer survivors. So I think I have a real personal stake-- like everyone in the United States, almost-- in seeing the reduction of cancer suffering and conquering cancer, if you will. I also find the problem fascinating from an academic point of view. I was drawn to cancer research because I found the biological questions of cancer research so fascinating. So I live to conquer cancer from this intellectual point of view, as well. And lastly, I have the experience of being a doctor, of being a medical oncologist taking care of patients with cancer. And I've had the frustrating experience of having patients not do well who I thought, I wish we could have done more for-- as well as the experience of taking someone who has a pretty terrible cancer but yet driving it into remission with therapy and then watching that person effectively survive the disease and become cured of it over years. And that is so special and so thrilling to be a part of that as a physician. So I live to cure cancer because it's personally touched my life, because I am a scientist who is fascinated by the biology of cancer, and as a doctor I've had the experience of helping people survive their cancer. And once you do that once, you just want to do that over and over again. Dr. Clifford A. Hudis: That's really great, Ned. It's fascinating to hear why progress against cancer is personally so important to you. And I'm sure all of our listeners enjoy hearing that, as well. I want to thank you again for joining me for this ASCO in Action podcast and for all the work you do at the NCI and across the entire cancer care community. Well, thank you for having me. As you know, one of NCI's most important partners in this effort against cancer is really ASCO. And so it's great to speak to you today. And thanks for all the things that you guys do for patients with cancer. Again, thanks to all of you for listening today. Those of you who want to follow Dr. Sharpless on Twitter, he's @NCIDirector. And you can always follow me @CliffordHudis, as well as ASCO @cancer. If you do that, you can stay connected to our work, of course, on social media. You can also go to the NCI's website, which is NCI.gov. With that, again, I want to thank Dr. Sharpless for joining me today. And thanks to all of you for tuning in.    

The Syneos Health Podcast
Episode 020: A Syneos Health Short - 21st Century Cures

The Syneos Health Podcast

Play Episode Listen Later Jul 9, 2018 8:15


The 21st Century Cures Act was passed at the end of 2016 in an effort to accelerate the discovery, development and delivery of new therapies. But what's in it? And what does it mean for biopharma companies? In this first "Syneos Health Short" episode, Jeff Stewart reviews the top ten things you need to know about 21st Century Cures - and how one word changed everything. See our full list of podcast episodes here. The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter. The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. Syneos Health reserves the right to make alterations or deletions to the content at any time without notice to you. Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content. The information, data and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any Syneos Health clients, customers or other contacts.

Perspectives on Health and Tech
Ep. 46: The ONC's Dr. Donald Rucker on the Cures Act and More

Perspectives on Health and Tech

Play Episode Listen Later Nov 14, 2017 14:08


The 21st Century Cures act was passed in December 2016 with the goal of improving EHR interoperability through information blocking provisions and streamlining of standards development. It’s legislature intended to have real and immediate impact on the health IT industry. In this episode of The Cerner Podcast, we're joined by Dr. Donald Rucker, the national coordinator for Health Information Technology. The ONC is considered the beating heart of American health care policy, and one of its primary platforms is the promotion of nationwide health information exchange to improve health care. In this episode, Rucker will discuss the health IT provisions in the 21st Century Cures Act and what else we can look for from the ONC.

Pharma Intelligence Podcasts
Device Week Podcast - Episode 97

Pharma Intelligence Podcasts

Play Episode Listen Later Jun 9, 2017 10:03


On this week's Medtech Insight podcast: amendments targeting device accessories, medical imaging and post-market surveillance tacked onto FDA Reauthorization Act; a project funded by the US Department of Homeland Security aims to improve device cybersecurity; FDA moves to implement more 21st Century Cures legislation; the Sentinel Cerebral Protection System gains de novo clearance; a report from the MiXii Biomed Life Sciences and Technology Conference in Tel-Aviv.

Pharma Intelligence Podcasts
Device Week Podcast - Episode 89

Pharma Intelligence Podcasts

Play Episode Listen Later Apr 14, 2017 11:24


On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.

device kimberly clark week podcast us fda diagnostic accuracy innovation act century cures
Congressional Dish
CD145: Price of Health Care

Congressional Dish

Play Episode Listen Later Feb 26, 2017 114:27


Former Congressman Tom Price is our new Secretary of Health and Human Services, making him the chief law enforcement officer of health care policy in the United States. In this episode, hear highlights from his Senate confirmation hearings as we search for clues as to the Republican Party plans for repealing the Affordable Care Act. We also examine the 21st Century Cures Act, which was signed into law in December. Please support Congressional Dish: Click here to contribute with PayPal or Bitcoin Click here to support Congressional Dish for each episode via Patreon Mail Contributions to: 5753 Hwy 85 North #4576 Crestview, FL 32536 Thank you for supporting truly independent media! Recommended Congressional Dish Episodes CD048: The Affordable Care Act (Obamacare) CD123: Health or Profits Bill Outline H.R. 34: 21st Century Cures Act Bill Highlights Title I: Innovation Projects & State Response to Opioid Abuse Authorizes funding for research programs, if money is appropriated Authorizes $1 billion for grants for States to deal with the opioid abuse crisis The effects of this spending on the Pay as you Go budget will not be counted Title II: Discovery Creates privacy protections for people who participate as subjects in medical research studies Orders the Secretary of Health and Human Services to a do a review of reporting regulations for researchers in search of regulations to cut, including regulations on reporting financial conflicts of interest and research animal care. Allows contractors to collect payments on behalf of the Secretary of Health and Human Services Title III: Development Gives the Secretary of Health and Human Services additional data options for approving drug applications Expedites the review process for new "regenerative advanced therapy" drugs, which includes drugs "intended to treat, modify, reverse or cure a serious or life-threatening disease or condition" or is a therapy that involves human cells. Allows antibacterial and antifungal drugs to be approved after only being tested on a "limited population" The drugs will have have a "Limited Population" label Speeds up the FDA approval process for new medical devices that help with life-threatening or irreversibly debilitating conditions and that have no existing alternatives. Devices addressing rare diseases or conditions are allowed be approved with lower standards for effectiveness; this provision expands the definition of "rare" by doubling the number of people affected from 4,000 to 8,000. Each FDA employee involved in drug approvals will get training for how to make their reviews least burdensome. Title IV: Delivery The new Secretary of Health and Human Services will have to develop a strategy to "reduce regulatory and administrative burdens (such as doucmentation requirements) relating to the use of electronic health records" Prohibits health information technology developers from certification if their system allows information blocking. Developers, networks, or exchanges caught blocking information can be fined $1 million per violation. "Public-private partnerships" will develop the rules for exchanging health record information. Creates a job in the Medicare & Medicaid Services department for an investigator of pharmaceutical and medical device manufacturer complaints. Title V: Savings Reduced funding for the Prevention and Public Health Fund Sells more oil from the Strategic Petroleum Reserve Title VII: Ensuring Mental and Substance Use Disorders Prevention, Treatment, and Recovery Programs Keep Pace With Technology Authorizes money to be used for mental health services and substance abuse treatment Title IX: Promoting Access to Mental Health and Substance Use Disorder Care Creates a telephone and online service to help people locate mental health services and substance abuse treatment centers. Title XIV: Mental health and safe communities Creates a pilot program to test the idea of having court cases with mentally ill defendants heard in "drug or mental health courts" Title XVII: Other Medicare Provisions Prevents the government from canceling contracts with Medicare Advantage organizations due to their failure to achieve a minimum quality rating before 2019. Additional Reading Article: Trump's HHS Nominee Got A Sweetheart Deal From A Foreign Biotech Firm by Jay Hancock and Rachel Bluth, Kaiser Health News, February 13, 2017. Article: Tom Price belongs to a doctors group with unorthodox views on government and health care by Amy Goldstein, The Washington Post, February 9, 2017. Article: New stock questions plague HHS nominee Tom Price as confirmation vote nears by Jayne O'Donnell, USA Today, February 8, 2017. Article: HHS Pick Price Made 'Brazen' Stock Trades While His Committee Was Under Scrutiny by Marisa Taylor and Christina Jewett, Kaiser Health News, February 7, 2017. Article: Tom Price, Dr. Personal Enrichment by David Leonhardt, The New York Times, February 7, 2017. Article: Donald Trump's Cabinet Pick Invested in 6 Drug Companies Before Medicare Fight by Sam Frizell, TIME, January 17, 2017. Article: First on CNN: Trump's Cabinet pick invested in company, then introduced a bill to help it by Manu Raju, CNN, January 17, 2017. Publication: How Repealing Portions of the Affordable Care Act Would Affect Health Insurance Coverage and Premiums, Congressional Budget Office, January 17, 2017. Article: Under 21st Century Cures legislation, stem cell advocates expect regulatory shortcuts by Kelly Servick, Science, December 12, 2016. Article: Highlights of Medical Device Related Provision in the 21st Century Cures Act by Jeffrey K. Shapiro and Jennifer D. Newberger, FDA Law Blog, December 8, 2016. Article: Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes by Sheila Kaplan, STAT, November 27, 2016. Article: Introduction to Budget "Reconciliation" by David Reich and Richard Kogan, Center on Budget and Policy Priorities, November 9, 2016. Article: PhRMA companies push hard on House bill to ease testing of new drugs by Alex Lazar, OpenSecrets.org, June 16, 2015. References Financial Disclosure: Periodic Transaction Report: Thomas Price, United States House of Representatives, September 6, 2016. OpenSecrets: Senator Mitch McConnell 42 U.S. Code: Office of the National Coordinator for Health Information Technology, Cornell University Law School. Senate Vote: H.R. 34: 21st Century Cures Act Innate Immunotherapeutics:Top 20 Shareholders Innate Immunotherapeutics: Company Overview GovTrack: H.R. 4848 (114th): HIP Act Sound Clip Sources Hearing: Health and Human Services Secretary Confirmation, Senate Health, Education, Labor and Pensions Committee, January 18, 2017 (Part 1) and January 24, 2017 (Part 2). Watch on CSPAN Part 1 Part 2 Timestamps & Transcripts Part 1 47:45 Senator Patty Murray: I want to review the facts. You purchased stock in Innate Immunotherapeutics, a company working to develop new drugs, on four separate occasions between January 2015 and August 2016. You made the decision to purchase that stock, not a broker. Yes or no. Tom Price: That was a decision that I made, yes. Murray: You were offered an opportunity to purchase stock at a lower price than was available to the general public. Yes or no. Price: The initial purchase in January of 2015 was at the market price. The secondary purchase in June through August, September of 2016 was at a price that was available to individuals who were participating in a private-placement offering. Murray:It was lower than was available to the general public, correct? Price: I don’t know that it was. It was the same price that everybody paid for the private-placement offering. Murray: Well, Congressman Chris Collins, who sits on President-elect Trump’s transition team, is both an investor and a board member of the company. He was reportedly overheard just last week off the House floor, bragging about how he had made people millionaires from a stock tip. Congressman Price, in our meeting, you informed me that you made these purchases based on conversations with Representative Collins. Is that correct? Price: No. What I— Murray: Well, that is what you said to me in my office. Price: What I believe I said to you was that I learned of the company from Congressman Collins. Murray: What I recall our conversation was that you had a conversation with Collins and then decided to purchase the stock. Price: No, that’s not correct. Murray: Well, that is what I remember you hearing it—say—in my office. In that conversation, did Representative Collins tell you anything that could be considered “a stock tip?” Yes or no. Price: I don’t believe so, no. Murray: Well, if you’re telling me he gave you information about a company, you were offered shares in the company at prices not available to the public, you bought those shares, is that not a stock tip? Price: Well, that’s not what happened. What happened was that he mentioned—he talked about the company and the work that they were doing in trying to solve the challenge of progressive secondary multiple sclerosis which is a very debilitating disease and one that I— Murray: I’m well aware of that, but— Price: —had the opportunity to treat patients when I was in practice. Murray: I’m aware— Price: I studied the company for a period of time and felt that it had some significant merit and promise, and purchased the initial shares on the stock exchange itself. Murray: Congressman Price, I have very limited time. Let me go on. Your purchases occurred while the 21st Century Cures Act, which had several provisions that could impact drug developers like Innate Immunotherapeutics, was being negotiated, and, again, just days before you were notified to prepare for a final vote on the bill. Congressman, do you believe it is appropriate for a senior member of Congress actively involved in policymaking in the health sector to repeatedly personally invest in a drug company that could benefit from those actions? Yes or no. Price: Well, that's not what happened. 1:06:50 Senator Bernie Sanders: The United States of America is the only major country on earth that does not guarantee healthcare to all people as a right. Canada does it; every major country in Europe does it. Do you believe that healthcare is a right of all Americans, whether they’re rich or they’re poor? Should people, because they are Americans, be able to go to the doctor when they need to, be able to go into a hospital, because they are Americans? Tom Price: Yes. We’re a compassionate society— Sanders: No, we are not a compassionate society. In terms of our relationship to poor and working people, our record is worse than virtually any other country on earth; we have the highest rate of childhood poverty of any other major country on earth; and half of our senior, older workers have nothing set aside for retirement. So I don’t think, compared to other countries, we are particularly compassionate. But my question is, in Canada, in other countries, all people have the right to get healthcare, do you believe we should move in that direction? Price: If you want to talk about other countries’ healthcare systems, there are consequences to the decisions that they’ve made just as there are consequences to the decision that we’ve made. I believe, and I look forward to working with you to make certain, that every single American has access to the highest-quality care and coverage that is possible. Sanders: “Has access to” does not mean that they are guaranteed healthcare. I have access to buying a ten-million-dollar home; I don’t have the money to do that. Price: And that’s why we believe it’s appropriate to put in place a system that gives every person the financial feasibility to be able to purchase the coverage that they want for themselves and for their family, again, not what the government forces them to buy. Sanders: Yeah, but if they don’t have any—well, it’s a long dissert. Thank you very much. Price: Thank you. 1:46:34 Senator Michael Bennet: So, I ask you, sir, are you aware that behind closed doors Republican leadership wrote into this bill that any replacement to the Affordable Care Act would be exempt from Senate rules that prohibit large increases to the deficit? Tom Price: As you may know, Senator, I stepped aside as chairman of the budget committee at the beginning of this year, and so I wasn’t involved in the writing of— Bennet: You have been the budget committee chairman during the rise of the Tea Party; you are a member of the Tea Party Caucus; you have said over and over again, as other people have, that the reason you’ve come to Washington is to reduce our deficit and reduce our debt. I assume you’re very well aware of the vehicle that is being used to repeal the Affordable Care Act. This is not— Price: Yes. Bennet: —some small piece of legislation. This is the Republican budget. Price: Yes, I'm aware of the bill. Yes. Bennet: But do you support a budget that increases the debt by $10 trillion? Price: No. What I support is an opportunity to use reconciliation to address the real challenges in the Affordable Care Act and to make certain that we put in place at the same time a provision that allows us to move the healthcare system in a much better direction— Bennet: Do you support the budget that was passed by the Senate Republicans— Price: I support— Bennet:—to repeal the Affordable Care Act that adds $10 trillion of debt to the budget deficit? Price: Well, the reconciliation bill is yet to come. I support the process that allows for and provides for the fiscal year ’17 reconciliation bill to come forward. 2:38:37 Senator Chris Murphy: But do you direct your broker around ethical guidelines? Do you tell him, for instance, not to invest in companies that are directly connected to your advocacy? Because it seems like a great deal: as a broker, he can just sit back, take a look— Tom Price: She. Murphy: —at the positions that you’re taking— Price: She. She can sit back. Murphy: She can—she can sit back— Price: Yeah. Murphy: —in this case—look at the legislative positions you’re taking, and invest in companies that she thinks are going to increase in value based on your legislative activities, and you can claim separation from that because you didn’t have a conversation. Price:Well, that’s a nefarious arrangement that I’m really astounded by. The fact of the matter is that I have had no conversations with my broker about any political activity at all, other than her— Murphy: Then why wouldn’t you tell her— Price: —other than her congratulating— Murphy: Why— Price: —me on my election. Murphy: But why wouldn’t you at least tell her, “Hey, listen; stay clear of any companies that are directly affected by my legislative work”? Price: Because the agreement that we have is that she provide a diversified portfolio, which is exactly what virtually every one of you have in your investment opportunities, and make certain that in order to protect one’s assets that there’s a diversified arrangement for purchase of stocks. I knew nothing about— Murphy: But you couldn’t have— Price: —those purchases. Murphy: But you couldn’t have a diversified portfolio while staying clear of the six companies that were directly affected by your work on an issue? Price: Well, as I said, I didn’t have any knowledge of those purchases. Murphy: Okay. 2:54:20 Senator Elizabeth Warren: One of the companies—it’s the company raised by Mr. Franken, Senator Franken—and that is Zimmer Biomet. They’re one of the world’s leading manufacturers of hip and knees, and they make more money if they can charge higher prices and sell more of their products. The company knows this, and so do the stock analysts. So on March 17, 2016 you purchased stock in Zimmer Biomet. Exactly six days after you bought the stock, on March 23, 2016, you introduced a bill in the House called the Hip Act that would require HHS secretary to suspend regulations affecting the payment for hip and knee replacements. Is that correct? Tom Price: I think the BPCI program to which I think you referred I’m a strong supporter of because it keeps the decision making in the— Warren: I’m not asking you about why you support it. I’m just asking, did you buy the stock, and then did you introduce a bill that would be helpful to the companies you just bought stock in? Price: The stock was bought by a direct—by a broker who was making those decisions. I wasn’t making those decisions. Warren: Okay, so you said you weren’t making those decisions. Let me just make sure that I understand. These are your stock trades, though. They are listed under your name, right? Price: They’re made on my behalf, yes. Warren:Okay. Was the stock purchased through an index fund? Price: I don't believe so. Warren: Through a passively managed mutual fund? Price: No. It’s a broker— Warren: Through an actively managed mutual fund? Price: It’s a broker-directed account. Warren: Through a blind trust? So, let’s just be clear. This is not just a stockbroker, someone you pay to handle the paperwork. This is someone who buys stock at your direction. This is someone who buys and sells the stock you want them to buy and sell. Price: Not true. Warren: So when you found out that— Price: That’s not true, Senator. Warren: Well, because you decide not to tell them—wink, wink, nod, nod—and we’re all just supposed to believe that? Price: It’s what members of this committee, it’s the manner of which— Warren: Well, I’m not one of them. Price: —members of this committee—Well, I understand that— Warren: So, let me just keep asking about this. Price: —but it’s important to appreciate that that’s the case. Warren:Then, I want to understand. When you found out that your broker had made this trade without your knowledge, did you reprimand her? Price: What—what I did was comply— Warren: Well, you found out that she made it. Price: What I did was comply— Warren: Did you fire her? Did you sell the stock? Price: What I did was comply with the rules of the House in an ethical and legal and— Warren: I didn’t ask whether or not the rules of the House— Price: —above-board manner— Warren: —let you do this. Price: —and in a transparent way. Warren: You know, all right. So, your periodic transaction report notes that you were notified of this trade on April 4, 2016. Did you take additional actions after that date to advance[audio cuts out] the company that you now own stock in? Price: I’m offended by the insinuation, Senator. Warren: Well, let me just read what you did. You may be offended, but here’s what you did. Congressional records show that after you were personally notified of this trade, which you said you didn’t know about in advance, that you added 23 out of your bill’s 24 co-sponsors; that also after you were notified of this stock transaction, you sent a letter to CMS, calling on them to cease all current and future planned mandatory initiatives under the Center for Medicare and Medicaid Innovation; and just so there was no misunderstanding about who you were trying to help, you specifically mentioned— Unknown Speaker: Your two minutes are up, Senator Warren. Thank you. Warren: —hip and knee replacement. 2:58:20 Senator Johnny Isakson: This is very important for us to all understand under the disclosure rules that we have and the way it operates, any of us could make the mistakes that are being alleged. I’m sure Senator Franken had no idea that he owned part of Philip Morris when he made the statement he made about tobacco companies, but he has a WisdomTree Equity Income Fund investment, as disclosed in his disclosure, which owns Philip Morris. So, it’s entirely possible for any of us to have somebody make an investment on our behalf and us not know where that money is invested because of the very way it works. I don’t say that to, in any way, embarrass Mr. Franken but to make a point that any one of us who have mutual funds or investment managers or people who do that, it’s entirely possible for us not to know, and to try and imply that somebody’s being obfuscating something or in otherwise denying something that’s a fact, it’s just not the fair thing to do, and I just wanted to make that point. Senator Al Franken: This is different than mutual funds. Isakson: It’s an investment in Philip Morris. Unknown Speaker: Alright. Unknown Speaker: Thank you. Warren: And my question was about what do you do after he had notice. Unknown Speaker: Senator Warren, your time has been generously… Senator Kaine. 3:21:09 Senator Tim Kaine: Do you agree with the president-elect that the replacement for the Affordable Care Act must ensure that there is insurance for everybody? Tom Price: I have stated it here and— Kaine: Right. Price: —always that it’s incredibly important that we have a system that allows for every single American to have access to the kind of coverage that they need and desire. Kaine: And he’s— 3:31:52 Senator Patty Murray: You admitted to me in our meeting that you, in your own words, talked with Congressman Collins about Innate Immuno. This inspired you to you, in your own words, study the company and then purchase its stock, and you did so without a broker. Yes or no. Tom Price: No. Murray: Without a broker. Price: I did not. Murray: You told me that you did this one on your own without the broker. Yes? Price: No, I did it through a broker. I directed the broker to purchase the stock, but I did it through a broker. Murray: You directed the broker to purchase particularly that stock. Price: That's correct. Murray: Yeah. 3:34:42 Senator Patty Murray: Will you commit to ensuring all 18 FDA-approved methods of contraception continue to be covered so that women do not have to go back to paying extra costs for birth control? Tom Price: What I will commit to and assure is that women and all Americans need to know that we believe strongly that every single American ought to have access to the kind of coverage and care that they desire and want. 3:36:38 Senator Patty Murray: The Office of Minority Health was reauthorized as part of the ACA. So will you commit to maintaining and supporting this office and its work? Tom Price: I will commit to be certain that minorities in this country are treated in a way that makes certain—makes absolutely certain—that they have access to the highest-quality care. Murray: So you will not commit to the Office of Minority Health being maintained. Price: I think it’s important that we think about the patient at the center of all this. Our commitment, my commitment, to you is to make certain that minority patients and all patients in this country have access to the highest-quality care. Murray: But in particular—so you won’t commit to the Office of Minority— Price: We—Look, there are different ways to handle things. I can’t commit to you to do something in a department that one, I’m not in—I haven’t gotten it yet— Murray: But you will be. Price: —and— Murray: You will be, and— Price: Let me put forward a possible position that I might find myself in. The individuals within the department come to me and they say, we’ve got a great idea for being able to find greater efficiencies within the department itself, and it results in merging this agency and that agency— Murray: I think—I think that— Price: —and we’ll call it something else. Murray: Yeah. I—okay. Price: And we will address the issues of minority health— Murray: I just have a minute left, and I hear your answer. Price: —in a big, big way— Murray: You’re not committed, okay. Price: —and make certain that it is responsive to patients. Part 2 14:50 Senator Ron Wyden: Congressman Price owns stock in an Australian biomedical firm called Innate Immunotherapeutics. His first stock purchase came in 2015 after consulting Representative Chris Collins, the company’s top shareholder and a member of its board. In 2016 the congressman was invited to participate in a special stock sale called a private placement. The company offered the private placement to raise funds for testing on an experimental treatment it intends to put up for FDA approval. Through this private placement, the congressman increased his stake in the company more than 500 percent. He has said he was unaware he paid a price below market value. It is hard to see how this claim passes the smell test. Company filings with the Australia’s stock exchange clearly state that this specific private placement would be made at below-market prices. The treasury department handbook on private placement states, and I will quote, they “are offered only to sophisticated investors in a nonpublic manner.” The congressman also said last week he directed the stock purchase himself, departing from what he said was typical practice. Then, there’s the matter of what was omitted from the congressman’s notarized disclosures. The congressman’s stake in Innate is more than five times larger than the figure he reported to ethic’s officials when he became a nominee. He disclosed owning less than $50,000 of Innate stock. At the time the disclosure was filed, by my calculation, his shares had a value of more than $250,000. Today his stake is valued at more than a half million dollars. Based on the math, it appears that the private placement was excluded entirely from the congressman’s financial disclosure. This company’s fortunes could be affected directly by legislation and treaties that come before the Congress. 30:49 Senator Orrin Hatch: First, is there anything that you are aware of in your background that might present a conflict of interest with the duties of the office to which you have been nominated? Tom Price: I do not. 51:36 Senator Ron Wyden: Will you commit to not implementing the order until the replacement plan is in place? Tom Price: As I mentioned, Senator, what I commit to you and what I commit to the American people is to keep patients the center of healthcare, and what that means to me is making certain that every single American has access to affordable health coverage that will provide the highest-quality healthcare that the world can provide. 1:24:34 Senator Richard Burr: Are you covered by the STOCK Act, legislation passed by Congress that requires you and every other member to publicly disclose all sales and purchases of assets within 30 days? Tom Price: Yes, sir. Burr: Now, you’ve been accused of not providing the committee of information related to your tax and financial records that were required of you. Are there any records you have been asked to provide that you have refused to provide? Price: None whatsoever. Burr: So all of your records are in. Price: Absolutely. Burr: Now, I’ve got to ask you, does it trouble you at all that as a nominee to serve in this administration that some want to hold you to a different standard than you as a member of Congress, and I might say the same standard that they currently buy and sell and trade assets on? Does it burn you that they want to hold you to a different standard now that you’re a nominee than they are as a member? Price: Well, I—we know what’s going on here. Burr: Oh, we do. Price: I mean— Burr: We do. Price: It’s—and I understand. And as my wife tells me, I volunteered for this, so… 1:26:49 Senator Richard Burr: As the nominee and hopefully—and I think you will be—the secretary of HHS, what are the main goals of an Obamacare replacement plan? Tom Price: Main goals, as I mentioned, are outlined in those principles, that is imperative that we have a system that’s accessible for every single American; that’s affordable for every single American; that is incentivizes and provides the highest-quality healthcare that the world knows; and provides choices to patients so that they’re the ones selecting who’s treating them, when, where, and the like. So it’s complicated to do, but it’s pretty simple stuff. 1:34:58 Senator Johnny Isakson: Any one of us can take a financial disclosure—and there’s something called desperate impact, where you take two facts—one over here and one over there—to make a wrong. Any one of us could do it to disrupt or misdirect people’s thoughts on somebody. It’s been happening to you a lot because people have taken things that you have disclosed and tried to extrapolate some evil that would keep you from being secretary of HHS when, in fact, it shouldn’t be true. For example, if you go to Senator Wyden’s annual report, he owns an interest in BlackRock Floating Rate Income Fund. The major holding of that fund is Valeant Pharmaceuticals. They’re the people we jumped all over for 2700 percent increases last year in pharmaceutical products. But we’re not accusing the ranking member of being for raising pharmaceutical prices, but you could take that extrapolation out of that and then indict somebody and accuse them. Is that not true? 1:51:30 Senator Michael Bennet: I wonder whether you also believe that it’s essential that there be a floor for insurance providers. You know, some of the things that the Affordable Care Act require for coverage include outpatient care; emergency services; hospitalization; maternity and newborn care; prescription drugs; rehab services; lab services; preventative care, such as birth control and mammograms; pediatric services, like vaccines; routine dental exams for children younger than 19. I’m not going to ask you to go through each one of those, but directionally, are we headed to a world where people in rural America have to settle for coverage for catastrophic care; are we headed to a place where there is regulation of insurance providers that say if you are going to be an insurance market, you need—particularly if we’re in a world where your son had crossed state lines —there has to be a floor of the services you’re willing to pay for? Tom Price: I think there has to be absolutely credible coverage, and I think that it’s important that the coverage—that individuals ought to be able to purchase this coverage that they want. 1:56:45 Senator Pat Toomey: When we talk about repeal, sometimes I hear people say, well, we’ve got to keep coverage of pre-existing conditions because, you know, we’ve got to keep that. And when I hear that, I think that we’re missing something here, and here’s what I’m getting at. There’s obviously a number of Americans who suffer from chronic, expensive healthcare needs. They’ve had these conditions sometimes all their lives, sometimes for some other period of time. And for many of them the proper care for those conditions is unaffordable. I think we agree that we want to make sure those people get the healthcare they need. Now, one way to force it is to force insurance companies to provide health-insurance coverage for someone as soon as they show up, regardless of what condition they have, which is kind of like asking the property casualty company to rebuild the house after it’s burned down. But that’s only one way to deal with this, and so am I correct: is it your view that there are other perhaps more effective ways—since, after all, Obamacare’s in a collapse—to make sure that people with these pre-existing chronic conditions get the healthcare that they need at an affordable price without necessarily having the guaranteed-issue mandate in the general population? Tom Price: I think there are other options, and I think it’s important, again, to appreciate that the position that we currently find ourselves in, with policy in this nation, is that those folks, in a very short period of time, are going to have nothing because of the collapse of the market. 2:18:05 Tom Price: Every single individual ought to be able to have access to coverage. 2:29:45 Senator Tim Scott: My last question has to do with the employer-sponsored healthcare system that we’re so accustomed to in this country, that provides about 175 million Americans with their insurance. In my home state of South Carolina, of course, we have about two and a half million people covered by their employer coverage. If confirmed as HHS secretary, how would you support American employers in their effort to provide effective family health coverage in a consistent and affordable manner? Said differently, there’s been some conversation about looking for ways to decouple having health insurance through your employer. Tom Price: I think the employer system has been absolutely a remarkable success in allowing individuals to gain coverage that they otherwise might not gain. I think that preserving the employer system is imperative. That being said, I think that there may be ways in which individual employers—I’ve heard from employers who say, if you just give me an opportunity to provide my employee the kind of resources so that he or she is able to select the coverage that they want, then that makes more sense to them. And if that works from a voluntary standpoint for employers and for employees, then it may be something to look at. Scott: That would be more like the HRA approach where— Price: Exactly. Scott: —employer funds an account, and the employee chooses the health insurance, not necessarily under the umbrella of the employer specifically. Price: Exactly. And gains the same tax benefit. 2:58:00 Tom Price: What I’m for is making certain, again, that the Medicaid population has access to the highest-quality care possible, and we’ll do everything to improve that because right now so many in the Medicaid population don’t have access to the highest-quality care. 3:20:50 Tom Price: Our goal is to make certain that seniors have access to the highest-quality healthcare possible at an affordable price. Senator Bob Menendez: Well, access without the ability to afford it, and I’ll end on this— Price: That's what I said, affordable price. 3:28:45 Senator Sherrod Brown: If you and he are working together, are you going to suggest to him that we find a way in repeal and replace to make sure there is guaranteed healthcare for our nation’s veterans? Tom Price: Well, I think it’s vital, again, as I’ve mentioned before, that every single American have access to affordable coverage that’s of high quality, and that’s our goal, and that’s our commitment. 3:30:52 [regarding a disabled child coverd by Medicaid] Tom Price: We are absolutely committed to making certain that that child and every other child and every other individual in this nation has access to the highest-quality care possible. Senator Bob Casey Jr.: Okay, so not an access—he will have the medical care that he has right now or better—if you can come up with a better level of care, that’s fine—but he will have at least the coverage of Medicaid and all that that entails that he has right now. And that’s either a yes or no; that’s not— Price: No, it’s not a yes or no because the fact of the matter is that in order for the current law to change, you all have to change it— Casey: No, but here’s— Price: —and if I’m given the privilege of leading at the Department of Health and Human Services— Casey: Here’s why it’s yes— Price: and I respond to— Casey: You should stop talking around this. You have led the fight in the House, backed up by Speaker Ryan, for years— Price: To improve Medicaid. Casey: —to block grant Medicaid, okay? Price: To improve Medicaid. Casey: To block grant Medicaid. What that means is, states will have to decide whether or not this child gets the Medicaid that he deserves. That’s what happens. So you push it back to the states and hope it works out… Cover Art Design by Only Child Imaginations

Penn Science Policy Podcast
21st Century Cures & Antibiotics

Penn Science Policy Podcast

Play Episode Listen Later Feb 8, 2017 32:24


In this first episode of the Penn Science Policy Podcast, Ian McLaughlin & Liana Vaccari discuss 3 topics. First, a way to help voters contact their legislators who are involved in either appropriating funds to, or regulating, federally funded science. Second, we discuss the nature of the last bill to be passed that appropriates funds to biomedical science. Finally, we discuss some of the challenges regarding the use of antibiotics

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Tennessee Politics
Sen. Lamar Alexander on 21st Century Cures and Obamacare

Tennessee Politics

Play Episode Listen Later Dec 9, 2016 9:21


Sen. Lamar Alexander of Tennessee spoke with Tennessean Engagement Editor David Plazas about the 21st Century Cures Act, the impending repeal of the Affordable Care Act and other priorities for him.

CQ on Congress
Repealing Obamacare Could Undermine New Mental Health Initiative

CQ on Congress

Play Episode Listen Later Dec 7, 2016 13:19


Democratic Congressman Frank Pallone of New Jersey discusses his fear that a bipartisan $6.3 billion health package that would also overhaul the mental health system could be undercut by GOP efforts to repeal the health care law. He tells CQ Roll Call’s Health reporter Andrew Siddons and Managing Editor Adriel Bettelheim that Medicaid cuts are of particular concern. Congress passed the bipartisan “21st Century Cures” bill, which would, among other things, provide extra money for brain research at the National Institutes of Health, help fight the opioid epidemic, fund Vice President Joe Biden’s ‘Moonshot’ cancer project and better integrate mental health care into standard medical practice.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Hello PhD
062: FLSA and 21st Century Cures are laws that impact the lab

Hello PhD

Play Episode Listen Later Dec 5, 2016 42:10


The 2016 presidential election was divisive, dramatic, and distracting.  That’s why you probably missed a series of rulings and regulations that could have a profound impact on your research. But fear not, Daniel and Josh are back with news on the recent legislation and how it affects your funding and focus. Fair Labor for Postdocs […] The post 062: FLSA and 21st Century Cures are laws that impact the lab appeared first on Hello PhD.

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The Ripon Society Policy and Politics Series Podcast
Upton, Blackburn, and Welch Address The Ripon Society on September 22, 2016

The Ripon Society Policy and Politics Series Podcast

Play Episode Listen Later Sep 23, 2016 15:03


Discussion on 21st Century Cures.