MedClimate Health News Daily http://medclimate.com/feed en-us Copyright MedClimate, Inc2018 Policy Enablers and Barriers: Hear How Two HIMSS Davies Award Winners Successfully Navigated HIT Policy http://medclimate.com/external/index.php?https://www.healthcareitnews.com/resource/policy-enablers-and-barriers-hear-how-two-himss-davies-award-winners-successfully-navigated http://medclimate.com/external/index.php?https://www.healthcareitnews.com/resource/policy-enablers-and-barriers-hear-how-two-himss-davies-award-winners-successfully-navigated Tue, 09 Oct 2018 12:00:00 CDT aulm at Healthcare IT News - Government & Policy Author: HIMSS Learning CenterSponsor: HIMSSPrimary topic: Government & PolicyTopic: AnalyticsElectronic Health Records (EHR, EMR)Government & PolicyResource Central: Upcoming WebinarsExternal url: https://www.himsslearn.org/policy-enablers-and-barriers-hear-how-two-himss-davies-award-winners-successfully-navigated-hit?source=HITNwebsiteThumbnail: Body: Join us to hear how two Davies Award-winning organizations navigated the intersection between what they are achieving through health IT optimization and the policy implications of their working environments. Discover how to leverage EHR tools to increase communication and patient satisfaction scores while decreasing office visits, as well as how to leverage analytics to change opioid prescribing behavior. Primary Topic: PolicyAdditional Topics: PolicyAnalyticsDataTechnologyEHRPolicySpecific Terms: Electronic Health RecordsCustom Tags: AnalyticsElectronic Health RecordsDisable Auto Tagging: Short Headline: Hear How Two HIMSS Davies Award Winners Successfully Navigated HIT PolicyNewsletter hed: Policy Enablers and Barriers: Hear How Two HIMSS Davies Award Winners Successfully Navigated HIT PolicyNewsletter teaser: Join us to hear how two Davies Award-winning organizations navigated the intersection between what they are achieving through health IT optimization and the policy implications of their working environments. Discover how to leverage EHR tools to increase communication and patient satisfaction scores while decreasing office visits, as well as how to leverage analytics to change opioid prescribing behavior.
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Join us to hear how two Davies Award-winning organizations navigated the intersection between what they are achieving through health IT optimization and the policy implications of their working environments. Discover how to leverage EHR tools to increase communication and patient satisfaction scores while decreasing office visits, as well as how to leverage analytics to change opioid prescribing behavior.

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Hear How Two HIMSS Davies Award Winners Successfully Navigated HIT Policy
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Join us to hear how two Davies Award-winning organizations navigated the intersection between what they are achieving through health IT optimization and the policy implications of their working environments. Discover how to leverage EHR tools to increase communication and patient satisfaction scores while decreasing office visits, as well as how to leverage analytics to change opioid prescribing behavior.
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Be patient with ACOs, they need time to generate savings: Avalere http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/be-patient-acos-they-need-time-to-generate-savings-avalere-finds?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/be-patient-acos-they-need-time-to-generate-savings-avalere-finds?utm_source=internal&utm_medium=rss Tue, 18 Sep 2018 15:34:10 CDT Rose Meltzer at FierceHealthcare: Payer Experience in the Medicare Shared Savings Program seems to predict ACOs’ success more accurately than the amount of risk they assume, healthcare consulting firm Avalere recently found. Why then, is CMS pushing for ACOs to take on risk? Report: A single day of downtime in CMS' Enrollment Database would cost $47M http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/a-single-day-downtime-cms-enrollment-database-would-cost-47m-oig?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/a-single-day-downtime-cms-enrollment-database-would-cost-47m-oig?utm_source=internal&utm_medium=rss Tue, 18 Sep 2018 12:11:31 CDT Eli Richman at FierceHealthcare: Payer The Centers for Medicare & Medicaid Services needs to improve the cyber resiliency of its Enrollment Database, according to the Office of Inspector General. If not, the office warned the daily financial impact of a nonfunctional database could reach $47 million. VA will open bidding for VistA EHR support, maintenance http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/va-will-open-bidding-vista-ehr-support-maintenance http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/va-will-open-bidding-vista-ehr-support-maintenance Tue, 18 Sep 2018 11:36:12 CDT jfinison at Healthcare IT News - Government & Policy The U.S. Department of Veterans Affairs modified its request for information on Monday, with plans to open bidding for a vendor to maintain and support its legacy VistA EHR architecture and imaging operations for the next five years. According to the amended RFI, the agency plans to submit request for proposals on Sept. 21 through the General Service Administration’s IT Schedule. VA will seek “technical, managerial and administrative services” that will include “engineering support and engineering changes, updates, repairs” for VistA. The vendor will also need to provide the necessary technology, while maintaining the system and providing help desk and operations support. The contractor will also need to deliver monthly progress reports that outline all required work during the reporting period, including any problems and how they were resolved. “Due to the mission critical nature of the VistA and VistA imaging systems, VA’s objective is to ensure these systems are operational and accessible without interruption,” the draft performance plan stated. The contractor will need to ensure VistA remains in a “state of readiness and operation.” Currently, the VA is developing a new Cerner EHR system to align with the Department of Defense. The RFI is not surprising, given VA officials have continually stressed that VistA can’t just be shut off and will need to be maintained throughout the 10-year Cerner rollout. There are over 130 versions of VistA operating at more than 140 sites, and former VA Secretary Shulkin told Congress in February that VistA must be maintained for the duration of the Cerner project. Congress expressed concerned, both that the planned $10 billion budget does not include VistA maintenance and that it may not be possible to turn off the legacy system. Twitter: @JF_Davis_ Email the writer: jessica.davis@himssmedia.com Primary Topic: Electronic Health RecordsAdditional Topics: TechnologyEHRPolicyTechnologyEHRSpecific Terms: Electronic Health RecordsElectronic Health RecordsCustom Tags: Electronic Health RecordsElectronic Health RecordsDisable Auto Tagging: Short Headline: VA will open bidding for VistA EHR support, maintenanceNewsletter hed: VA will open bidding for VistA EHR support, maintenanceNewsletter teaser: Beginning Sept. 21, VA will start accepting proposals for contractors to handle the technical and administrative services of its legacy EHR throughout the duration of the Cerner modernization project.HOT @HIMSS: Featured Decision Content: 

The U.S. Department of Veterans Affairs modified its request for information on Monday, with plans to open bidding for a vendor to maintain and support its legacy VistA EHR architecture and imaging operations for the next five years.

According to the amended RFI, the agency plans to submit request for proposals on Sept. 21 through the General Service Administration’s IT Schedule. VA will seek “technical, managerial and administrative services” that will include “engineering support and engineering changes, updates, repairs” for VistA.

The vendor will also need to provide the necessary technology, while maintaining the system and providing help desk and operations support. The contractor will also need to deliver monthly progress reports that outline all required work during the reporting period, including any problems and how they were resolved.

“Due to the mission critical nature of the VistA and VistA imaging systems, VA’s objective is to ensure these systems are operational and accessible without interruption,” the draft performance plan stated. The contractor will need to ensure VistA remains in a “state of readiness and operation.”

Currently, the VA is developing a new Cerner EHR system to align with the Department of Defense. The RFI is not surprising, given VA officials have continually stressed that VistA can’t just be shut off and will need to be maintained throughout the 10-year Cerner rollout.

There are over 130 versions of VistA operating at more than 140 sites, and former VA Secretary Shulkin told Congress in February that VistA must be maintained for the duration of the Cerner project. Congress expressed concerned, both that the planned $10 billion budget does not include VistA maintenance and that it may not be possible to turn off the legacy system.

Twitter: @JF_Davis_
Email the writer: jessica.davis@himssmedia.com

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NHS hospital kicks off Axe the Fax initiative http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/nhs-hospital-kicks-axe-fax-initiative http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/nhs-hospital-kicks-axe-fax-initiative Tue, 18 Sep 2018 11:33:49 CDT jfinison at Healthcare IT News - Government & Policy Leeds Teaching Hospitals NHS Trust is pledging to remove nearly all of its fax machines by 2019 amid increasing criticism over the NHS’s heavy reliance on outdated technology. Legacy fax machines and the privacy, security and patient safety issues they potentially represent are not just a problem in the UK, either. In the U.S., Centers for Medicare and Medicaid Services Administrator Seema Verma last month called on hospitals and other healthcare providers to strive to be fax-free in two years, meaning by 2020. And in Australia, Queensland Health is amid efforts to eradicate fax machines, though a recent development in which Ipswich Hospital mandated that clinicians use only fax machines for urgent referrals shows how tricky eliminating fax machines altogether will be. In the UK, Recent research released by the Royal College of Surgeons (RCS) found NHS hospitals trusts in England owned more than 8,000 fax machines, prompting calls to modernise the IT infrastructure of the health service as figures provided by the RCS indicated that only ten organisations included in the analysis did not own any of the outdated gadgets. At the time, Richard Kerr, RCS Council Member and Chair of the Commission on the Future of Surgery, said it was ‘farcical’ the NHS was investing in Artificial Intelligence and yet still using fax machines. Having already scrapped 20 of its 340 devices, Leeds Teaching Hospitals NHS Trust’s new campaign, dubbed Axe the Fax, has been launched to identify all the fax machines within its premises, their location, phone numbers and intended use before seeking to replace them with other processes. “The use of nhs.net is far more secure and safe than the use of faxes. We are aiming to help services safely decommission their faxes and move to email in the first instance and take it from there,” said Chief Digital and Information Officer Richard Corbridge, warning that the trust could not ‘afford to continue living in the dark ages’. A 2017 report on DeepMind Health released by a panel of Independent Reviewers noted that the NHS retained ‘the dubious title of being the world’s largest purchaser of fax machines’. "As a clinician the major concern I have with fax, is has it been sent to the right machine, been read by the right person, and appropriate actions have been taken. “That is why we are in the process of developing a modern auditable referral system that is embedded within our electronic health record,” said Andy Webster, Consultant in Emergency Medicine and Chief Clinical Information Officer. The trust has reportedly rolled out Managed Print Service (MPS) devices, with nearly 50,000 communications sent electronically during April and August this year ahead of plans to move to scan-to-email only, removing the fax option. Meanwhile, new research released by Check Point last month, dubbed Faxploit, found that hackers could exploit vulnerabilities in fax machine communication protocols, and the only information required to carry out a cyber-attack was a fax number. While the analysis focused on HP devices, the researchers said they had “every reason to believe the same exploit can be applied to fax machines of other vendors.” Check Point researchers and HP worked closely to provide a patch to HP customers, already rolled out as an automatic update. This article originally appeared in Healthcare IT News sister site The British Journal of Healthcare Computing. Healthcare Security Forum The Boston forum to focus on business-critical information healthcare security pros need Oct. 15-16. Primary Topic: PolicyAdditional Topics: PolicyTechnologySecurityPolicySpecific Terms: Privacy & SecurityCustom Tags: Privacy & SecurityDisable Auto Tagging: Short Headline: NHS hospital kicks off Axe the Fax initiativeNewsletter hed: NHS hospital kicks off Axe the Fax initiativeNewsletter teaser: Countries around the globe are dealing with legacy fax machines and the UK organization is looking to get rid of its devices by 2019.HOT @HIMSS: Featured Decision Content: 

Leeds Teaching Hospitals NHS Trust is pledging to remove nearly all of its fax machines by 2019 amid increasing criticism over the NHS’s heavy reliance on outdated technology.

Legacy fax machines and the privacy, security and patient safety issues they potentially represent are not just a problem in the UK, either. In the U.S., Centers for Medicare and Medicaid Services Administrator Seema Verma last month called on hospitals and other healthcare providers to strive to be fax-free in two years, meaning by 2020. And in Australia, Queensland Health is amid efforts to eradicate fax machines, though a recent development in which Ipswich Hospital mandated that clinicians use only fax machines for urgent referrals shows how tricky eliminating fax machines altogether will be.

In the UK, Recent research released by the Royal College of Surgeons (RCS) found NHS hospitals trusts in England owned more than 8,000 fax machines, prompting calls to modernise the IT infrastructure of the health service as figures provided by the RCS indicated that only ten organisations included in the analysis did not own any of the outdated gadgets.

At the time, Richard Kerr, RCS Council Member and Chair of the Commission on the Future of Surgery, said it was ‘farcical’ the NHS was investing in Artificial Intelligence and yet still using fax machines.

Having already scrapped 20 of its 340 devices, Leeds Teaching Hospitals NHS Trust’s new campaign, dubbed Axe the Fax, has been launched to identify all the fax machines within its premises, their location, phone numbers and intended use before seeking to replace them with other processes.

“The use of nhs.net is far more secure and safe than the use of faxes. We are aiming to help services safely decommission their faxes and move to email in the first instance and take it from there,” said Chief Digital and Information Officer Richard Corbridge, warning that the trust could not ‘afford to continue living in the dark ages’.

A 2017 report on DeepMind Health released by a panel of Independent Reviewers noted that the NHS retained ‘the dubious title of being the world’s largest purchaser of fax machines’.

"As a clinician the major concern I have with fax, is has it been sent to the right machine, been read by the right person, and appropriate actions have been taken.

“That is why we are in the process of developing a modern auditable referral system that is embedded within our electronic health record,” said Andy Webster, Consultant in Emergency Medicine and Chief Clinical Information Officer.

The trust has reportedly rolled out Managed Print Service (MPS) devices, with nearly 50,000 communications sent electronically during April and August this year ahead of plans to move to scan-to-email only, removing the fax option.

Meanwhile, new research released by Check Point last month, dubbed Faxploit, found that hackers could exploit vulnerabilities in fax machine communication protocols, and the only information required to carry out a cyber-attack was a fax number.

While the analysis focused on HP devices, the researchers said they had “every reason to believe the same exploit can be applied to fax machines of other vendors.” Check Point researchers and HP worked closely to provide a patch to HP customers, already rolled out as an automatic update.

This article originally appeared in Healthcare IT News sister site The British Journal of Healthcare Computing.

Healthcare Security Forum

The Boston forum to focus on business-critical information healthcare security pros need Oct. 15-16.

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NHS hospital kicks off Axe the Fax initiative
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Countries around the globe are dealing with legacy fax machines and the UK organization is looking to get rid of its devices by 2019.
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Senate passes sweeping opioid response bill with eRx, EHR, PDMP provisions http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/senate-passes-sweeping-opioid-response-bill-erx-ehr-pdmp-provisions http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/senate-passes-sweeping-opioid-response-bill-erx-ehr-pdmp-provisions Tue, 18 Sep 2018 11:31:10 CDT jfinison at Healthcare IT News - Government & Policy With a rare near-unanimous vote, the United States Senate passed The Opioid Crisis Response Act of 2018 on Monday evening. It's a massive bill comprising a wide array of proposals drawn from five Senate committees, and has many implications for the use and funding of health IT. Senate Majority Leader Mitch McConnell, R-Kentucky, called the bill – drawn up using input from more than 70 senators and passed by 99-1 vote – a "landmark" piece of legislation meant to combat the nationwide opioid epidemic from all angles. The legislation comes amid an ongoing opioid crisis in the U.S. as policymakers and technology vendors are working to address the issue, while hospitals are piloting apps to find blindspots in prescription drug monitoring programs and using mobile technologies to write fewer prescriptions. It contains funding for stopping the flow of illegal opioids from other countries, and for supporting local programs for prevention, treatment and recovery. The bill also seeks to spur research and development of new non-addictive painkillers and stem "doctor shopping" by boosting prescription drug monitoring programs. It also has funds to give behavioral and mental health providers the tools they need to offer treatment and recovery – including potential electronic health record incentives – and for hospitals to better care for infants with neonatal abstinence syndrome. The legislation's sponsor, Senate HELP Committee Chairman Lamar Alexander, R-Tennessee, said he is working to combine the Senate bill and a similar House version passed in June "into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly." The Senate bill contains many new proposals specifically related to information technology. Among them, it would: Call for the U.S. Department of Health and Human Services to "develop best practices for prominently displaying substance use treatment information in electronic health records, when requested by the patient." Enable the Centers for Medicare and Medicaid Services to test various models that "provide incentive payments to behavioral health providers for the adoption and use of certified electronic health record technology to improve the quality and coordination of care through the electronic documentation and exchange of health information." Require physicians to prescribe Part D-covered controlled substances electronically and direct CMS specify a list of exceptions and outline the penalty for failure to comply when the e-prescribing requirements. Require that prior authorizations related to Part D e-prescriptions use a standard format to improve the way the authorizations are processed. Provide support for states and localities to improve their Prescription Drug Monitoring Programs and "implement other evidence-based prevention strategies, encourages data sharing between states, and supports other prevention and research activities related to controlled substances." Reauthorize HHS's NASPER grant program, allowing states to "develop, maintain, or improve PDMPs and improve the interoperability of PDMPs with other states and with other health information technology." Authorize new program through the Substance Abuse and Mental Health Services Administration for the establishment of comprehensive opioid recovery centers. "These entities may utilize the ECHO model, which supports care coordination and services delivery through technology." Give support for states to collaborate on strategies to improve care substance-exposed infants, including the development and upgrades of new technology and monitoring systems to more effectively implement plans of safe care. Require CMS to set up an online portal to enhance communication between the agency, Medicare Advantage plans with prescription drug plans, stand-alone drug plans and Medicare Drug Integrity Contractors.   Opioid Crisis: Tech fights epidemic Learn how tech is being used to battle abuse. Twitter: @MikeMiliardHITN Email the writer: mike.miliard@himssmedia.com Primary Topic: Electronic Health RecordsAdditional Topics: TechnologyEHRPolicyTechnologyEHRSpecific Terms: Electronic Health RecordsElectronic Health RecordsCustom Tags: Electronic Health RecordsElectronic Health RecordsDisable Auto Tagging: Short Headline: Senate passes sweeping opioid response billNewsletter hed: Senate passes sweeping opioid response bill with eRx, EHR, PDMP provisionsNewsletter teaser: The landmark legislation would disburse nearly $8 billion to HHS, CMS, CDC and state governments, with big goals for population health, care coordination and patient safety.HOT @HIMSS: Featured Decision Content: 

With a rare near-unanimous vote, the United States Senate passed The Opioid Crisis Response Act of 2018 on Monday evening. It's a massive bill comprising a wide array of proposals drawn from five Senate committees, and has many implications for the use and funding of health IT.

Senate Majority Leader Mitch McConnell, R-Kentucky, called the bill – drawn up using input from more than 70 senators and passed by 99-1 vote – a "landmark" piece of legislation meant to combat the nationwide opioid epidemic from all angles.

The legislation comes amid an ongoing opioid crisis in the U.S. as policymakers and technology vendors are working to address the issue, while hospitals are piloting apps to find blindspots in prescription drug monitoring programs and using mobile technologies to write fewer prescriptions.

It contains funding for stopping the flow of illegal opioids from other countries, and for supporting local programs for prevention, treatment and recovery.

The bill also seeks to spur research and development of new non-addictive painkillers and stem "doctor shopping" by boosting prescription drug monitoring programs.

It also has funds to give behavioral and mental health providers the tools they need to offer treatment and recovery – including potential electronic health record incentives – and for hospitals to better care for infants with neonatal abstinence syndrome.

The legislation's sponsor, Senate HELP Committee Chairman Lamar Alexander, R-Tennessee, said he is working to combine the Senate bill and a similar House version passed in June "into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly."

The Senate bill contains many new proposals specifically related to information technology. Among them, it would:

  • Call for the U.S. Department of Health and Human Services to "develop best practices for prominently displaying substance use treatment information in electronic health records, when requested by the patient."
  • Enable the Centers for Medicare and Medicaid Services to test various models that "provide incentive payments to behavioral health providers for the adoption and use of certified electronic health record technology to improve the quality and coordination of care through the electronic documentation and exchange of health information."
  • Require physicians to prescribe Part D-covered controlled substances electronically and direct CMS specify a list of exceptions and outline the penalty for failure to comply when the e-prescribing requirements.
  • Require that prior authorizations related to Part D e-prescriptions use a standard format to improve the way the authorizations are processed.
  • Provide support for states and localities to improve their Prescription Drug Monitoring Programs and "implement other evidence-based prevention strategies, encourages data sharing between states, and supports other prevention and research activities related to controlled substances."
  • Reauthorize HHS's NASPER grant program, allowing states to "develop, maintain, or improve PDMPs and improve the interoperability of PDMPs with other states and with other health information technology."
  • Authorize new program through the Substance Abuse and Mental Health Services Administration for the establishment of comprehensive opioid recovery centers. "These entities may utilize the ECHO model, which supports care coordination and services delivery through technology."
  • Give support for states to collaborate on strategies to improve care substance-exposed infants, including the development and upgrades of new technology and monitoring systems to more effectively implement plans of safe care.
  • Require CMS to set up an online portal to enhance communication between the agency, Medicare Advantage plans with prescription drug plans, stand-alone drug plans and Medicare Drug Integrity Contractors.

 

Opioid Crisis: Tech fights epidemic

Learn how tech is being used to battle abuse.

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

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Elliott Management drops bid for Athenahealth, tanking the health tech company's stock http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/elliott-management-drops-bid-for-athenahealth-tanking-health-tech-company-s-stock?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/elliott-management-drops-bid-for-athenahealth-tanking-health-tech-company-s-stock?utm_source=internal&utm_medium=rss Tue, 18 Sep 2018 09:14:44 CDT Eli Richman at FierceHealthcare: Payer Athenahealth's share price plummeted Tuesday morning after reports indicated that Elliott Management was backing away from its bid for the company. Elliott's Paul Singer was considering a $160-a-share bid. How Texas Tech health built an app for alternative payment models http://medclimate.com/external/index.php?https://www.healthcareitnews.com/blog/how-texas-tech-health-built-app-alternative-payment-models http://medclimate.com/external/index.php?https://www.healthcareitnews.com/blog/how-texas-tech-health-built-app-alternative-payment-models Tue, 18 Sep 2018 07:00:23 CDT walmeida at Healthcare IT News - Government & Policy Electronic Health Records (EHR, EMR)Financial/Revenue Cycle ManagementGovernment & PolicyWhen its EHR vendor wasn’t going to be ready until 2020, the IT team took matters into its own hands in a low-budget open source project that is already paying off.Corey ShankWorking in healthcare and technology for over a decade and a half, one thing I’ve noticed is that innovation is slowed and often nixed because we look at how an incremental achievement fits into the current mega-sized health I.T. environment. I’ve experienced numerous times where operations, clinical or administrative personnel bring up problems that they are encountering that could easily be solved by technology, and when those problems are assessed by the IT department, most often they are acknowledged and solutions are even considered. But it’s during the consideration process where the solutioning breaks down. This is due to the uber static situation health IT is in. For example, I recently was given the opportunity to manage a very large alternative payment initiative facilitated by CMS and the State of Texas. For years, this initiative was project oriented, and payments were made for design work and infrastructure development. Now, however, the initiative’s remuneration model has changed to outcomes-based care for patients with chronic diseases. Having people trained to conduct A1C tests or 3-part foot exams for diabetic patients wasn’t enough anymore, we actually needed to improve performance on these measures. The obvious operational solution was to identify our patients who have chronic diseases, and ensure that when they come in for appointments, we do the necessary tests and exams to achieve the measure. We’d also need to identify our patients with diabetes, and if they do not have an appointment scheduled, we would need to try and get them to come in for a check-up, and conduct the important tests. With all this, and with limited staff, we knew we needed a system to help us proactively manage these requirements. My team has been responsible for reporting for many years, and we knew there was a way to identify our patients through a series of queries in our EMR; theoretically we knew it was possible. So I proceeded to spend some time with our EMR leadership and ask them how we could tap into the system and build workflows to allow our practices the ability to be made aware of required activities. The answer: Good News! We are working with our EMR vendor, and we are looking into a new product that they will be providing to help us case manage our patients, and flag when certain tests, exams, or services are required based on patients’ with chronic diseases. Needless to say I was stoked, until I got the answer to my final question: “When will this be available?” The answer to my last question was, “2020?” Well, in my experience, that’s not bad for a big 3 EMR -- but my issue was that I was responsible for a lot of money in 2018 and 2019 in this alternative payment model. Innovation foundation already in place Before I go any further, I do want to acknowledge that I was in a very fortunate situation, in the sense that my employer and predecessor had set us up well by being forward-looking strategic thinkers. We have a great team of developers and project managers that have enabled us to create the systems I am about to talk about. Considering the value of the initiative I am managing, waiting 2-years for a system, and hoping that organically through communications, education, and auditing we’d meet our objectives was not gonna cut it. And, buying a bolt-on case management system, and getting set up was both out-of-budget and would take too long. So, we had to come up with a solution. After several meetings with the developers, project managers, and subject matter experts, we decided to build our own application, that would allow case managers to see patients who are on the schedule, and who are diagnosed with a chronic disease, and who need one or more of the tests, exams, or services required by CMS/Texas. Here is how it worked: First, we needed access to the data. Since our department has been a reporting area for years, we already had SQL-level access to EMR data, through a ‘Clinical Data Warehouse’ So, that was good! Over the years of the initiative, the team and their EMR partners had developed queries for reporting on patients who had chronic disease diagnoses, and they had developed ad hoc capabilities for reporting the HEDIS requirements we were looking for. All we needed to do then was turn those queries on earlier, to be proactive.   Next, we needed a delivery medium. Believe it or not, even in 2018 in healthcare, Microsoft Excel is still often thought of as an acceptable delivery vehicle for a ‘work queue’. No, we wanted to create a real application, with performance measurement, auditability, and reporting capabilities, and we wanted something easy to access and maintain. Design and Development Once we identified our toolset -- an open source UX/UI template, we needed to address our design and development process. In my many experiences over the years, I have learned to be cautious of two things: Competing with the EMR, and Creating a tool that is too purpose-built Competing with EMRs is tough, it’s like a local, organic farmer trying to collaborate with Albertson’s. Not to say it’s impossible, just not the easiest thing to do. We needed to work with the EMR, but creating a competitive solution, for something in their pipeline would not have been smart. So, we decided to keep our application simple, and also recognize things we could not accomplish, such as bi-directional communications. More simply: we knew we would not be able to post data back into the EMR systematically. Knowing our limitations, and knowing that our users would still need to work in the EMR, we were able to build workflows that were simple to follow, meaningful, but not redundant. We always asked, “will the user have to do this in the EMR, and if so, do we have to have them do it in our app, too?” This mindset has allowed us to build applications that the users actually enjoy using, and do not find terribly intrusive to their daily work. The second concern we dealt with was ensuring our design process would be open-ended enough to potentially solve other problems, too. Leveraging our industry knowledge from SME’s we asked what other types of problems could our application potentially solve? We didn’t obviously get an exhaustive list, but we did identify several, and we are now incorporating four other alternative payment models into the application we’ve built. So, what have we done? This is what we’ve accomplished, so far. What you see above is a work queue of (fake) patients who are scheduled to come in for an appointment, who have a chronic disease, and who are “at risk” for certain HEDIS health indicators. All of this information is from the EMR, and we are just re-organizing it, to focus on case management concerns. It provides a case manager with the important information, to conduct their work, to ensure that patients are given quality care, in accordance to our alternative payment model. This, is the patient profile: What you see in this screen are action items. Such as the ability to assign a patient to me, so I can work with them, even after the appointment, to keep them engaged with their health. You can also see the option on the ‘At Risk Quality Indicators’, to allow me to create a checklist, and give that to the nurse and/or doctor, to let them know in advance of the appointment what patient Sam needs. Lessons learned This all took us about 6-months to build, to get us to the version we’re at now. Since this application has been in production, we have had 5 case managers, in two departments, facilitate thousands of patients’ care with their provider. Without this tool, we would have either needed to hire 15 or more case managers, or, we would have just crossed our fingers and hope that we are successful. Here is the moral of the story: With the right mind-set, and the willingness to try something different, even in health IT you can achieve great success without millions in investment, and without having to wait years for features to come out of the “pipeline.” If in 2020, our EMR comes out with a solution that kills our app, guess what, no harm done. This has been a nominal sunk-cost, and our ROI expectation is exponential, based on the value of the alternative payment models we’re already working on, and the several we’re going to incorporate over the next few weeks. Corey Shank is Director of Strategic Initiatives at the Texas Tech University Health Sciences Center, in Lubbock Texas. Primary Topic: Electronic Health RecordsAdditional Topics: TechnologyEHRRevenue CycleFinanceFinancial ManagementFinancePolicyTechnologyEHRSpecific Terms: Electronic Health RecordsElectronic Health RecordsCustom Tags: Electronic Health RecordsRevenue CycleFinancial ManagementElectronic Health RecordsDisable Auto Tagging: Short Headline: How Texas Tech health built an app for alternative payment modelsNewsletter hed: How Texas Tech health built an app for alternative payment modelsNewsletter teaser: When its EHR vendor wasn’t going to be ready until 2020, the IT team took matters into its own hands in a low-budget open source project that is already paying off.Featured Decision Content: 
When its EHR vendor wasn’t going to be ready until 2020, the IT team took matters into its own hands in a low-budget open source project that is already paying off.

Working in healthcare and technology for over a decade and a half, one thing I’ve noticed is that innovation is slowed and often nixed because we look at how an incremental achievement fits into the current mega-sized health I.T. environment.

I’ve experienced numerous times where operations, clinical or administrative personnel bring up problems that they are encountering that could easily be solved by technology, and when those problems are assessed by the IT department, most often they are acknowledged and solutions are even considered.

But it’s during the consideration process where the solutioning breaks down. This is due to the uber static situation health IT is in. For example, I recently was given the opportunity to manage a very large alternative payment initiative facilitated by CMS and the State of Texas. For years, this initiative was project oriented, and payments were made for design work and infrastructure development. Now, however, the initiative’s remuneration model has changed to outcomes-based care for patients with chronic diseases. Having people trained to conduct A1C tests or 3-part foot exams for diabetic patients wasn’t enough anymore, we actually needed to improve performance on these measures.

The obvious operational solution was to identify our patients who have chronic diseases, and ensure that when they come in for appointments, we do the necessary tests and exams to achieve the measure. We’d also need to identify our patients with diabetes, and if they do not have an appointment scheduled, we would need to try and get them to come in for a check-up, and conduct the important tests.

With all this, and with limited staff, we knew we needed a system to help us proactively manage these requirements. My team has been responsible for reporting for many years, and we knew there was a way to identify our patients through a series of queries in our EMR; theoretically we knew it was possible. So I proceeded to spend some time with our EMR leadership and ask them how we could tap into the system and build workflows to allow our practices the ability to be made aware of required activities.

The answer: Good News! We are working with our EMR vendor, and we are looking into a new product that they will be providing to help us case manage our patients, and flag when certain tests, exams, or services are required based on patients’ with chronic diseases. Needless to say I was stoked, until I got the answer to my final question: “When will this be available?”

The answer to my last question was, “2020?”

Well, in my experience, that’s not bad for a big 3 EMR -- but my issue was that I was responsible for a lot of money in 2018 and 2019 in this alternative payment model.

Innovation foundation already in place

Before I go any further, I do want to acknowledge that I was in a very fortunate situation, in the sense that my employer and predecessor had set us up well by being forward-looking strategic thinkers. We have a great team of developers and project managers that have enabled us to create the systems I am about to talk about.

Considering the value of the initiative I am managing, waiting 2-years for a system, and hoping that organically through communications, education, and auditing we’d meet our objectives was not gonna cut it. And, buying a bolt-on case management system, and getting set up was both out-of-budget and would take too long. So, we had to come up with a solution.

After several meetings with the developers, project managers, and subject matter experts, we decided to build our own application, that would allow case managers to see patients who are on the schedule, and who are diagnosed with a chronic disease, and who need one or more of the tests, exams, or services required by CMS/Texas.

Here is how it worked:
First, we needed access to the data. Since our department has been a reporting area for years, we already had SQL-level access to EMR data, through a ‘Clinical Data Warehouse’ So, that was good! Over the years of the initiative, the team and their EMR partners had developed queries for reporting on patients who had chronic disease diagnoses, and they had developed ad hoc capabilities for reporting the HEDIS requirements we were looking for. All we needed to do then was turn those queries on earlier, to be proactive.

 

Next, we needed a delivery medium. Believe it or not, even in 2018 in healthcare, Microsoft Excel is still often thought of as an acceptable delivery vehicle for a ‘work queue’. No, we wanted to create a real application, with performance measurement, auditability, and reporting capabilities, and we wanted something easy to access and maintain.

Design and Development

Once we identified our toolset -- an open source UX/UI template, we needed to address our design and development process. In my many experiences over the years, I have learned to be cautious of two things:

  1. Competing with the EMR, and
  2. Creating a tool that is too purpose-built

Competing with EMRs is tough, it’s like a local, organic farmer trying to collaborate with Albertson’s. Not to say it’s impossible, just not the easiest thing to do. We needed to work with the EMR, but creating a competitive solution, for something in their pipeline would not have been smart. So, we decided to keep our application simple, and also recognize things we could not accomplish, such as bi-directional communications. More simply: we knew we would not be able to post data back into the EMR systematically.

Knowing our limitations, and knowing that our users would still need to work in the EMR, we were able to build workflows that were simple to follow, meaningful, but not redundant. We always asked, “will the user have to do this in the EMR, and if so, do we have to have them do it in our app, too?” This mindset has allowed us to build applications that the users actually enjoy using, and do not find terribly intrusive to their daily work.

The second concern we dealt with was ensuring our design process would be open-ended enough to potentially solve other problems, too. Leveraging our industry knowledge from SME’s we asked what other types of problems could our application potentially solve? We didn’t obviously get an exhaustive list, but we did identify several, and we are now incorporating four other alternative payment models into the application we’ve built.

So, what have we done?

This is what we’ve accomplished, so far.

What you see above is a work queue of (fake) patients who are scheduled to come in for an appointment, who have a chronic disease, and who are “at risk” for certain HEDIS health indicators.

All of this information is from the EMR, and we are just re-organizing it, to focus on case management concerns. It provides a case manager with the important information, to conduct their work, to ensure that patients are given quality care, in accordance to our alternative payment model.

This, is the patient profile:

What you see in this screen are action items. Such as the ability to assign a patient to me, so I can work with them, even after the appointment, to keep them engaged with their health.

You can also see the option on the ‘At Risk Quality Indicators’, to allow me to create a checklist, and give that to the nurse and/or doctor, to let them know in advance of the appointment what patient Sam needs.

Lessons learned

This all took us about 6-months to build, to get us to the version we’re at now. Since this application has been in production, we have had 5 case managers, in two departments, facilitate thousands of patients’ care with their provider.

Without this tool, we would have either needed to hire 15 or more case managers, or, we would have just crossed our fingers and hope that we are successful.

Here is the moral of the story: With the right mind-set, and the willingness to try something different, even in health IT you can achieve great success without millions in investment, and without having to wait years for features to come out of the “pipeline.”

If in 2020, our EMR comes out with a solution that kills our app, guess what, no harm done. This has been a nominal sunk-cost, and our ROI expectation is exponential, based on the value of the alternative payment models we’re already working on, and the several we’re going to incorporate over the next few weeks.

Corey Shank is Director of Strategic Initiatives at the Texas Tech University Health Sciences Center, in Lubbock Texas.

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Short Headline: 
How Texas Tech health built an app for alternative payment models
Newsletter hed: 
How Texas Tech health built an app for alternative payment models
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When its EHR vendor wasn’t going to be ready until 2020, the IT team took matters into its own hands in a low-budget open source project that is already paying off.
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]]>
Senate passes massive opioid package, bill to ban gag clauses http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/senate-passes-opioid-package?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/senate-passes-opioid-package?utm_source=internal&utm_medium=rss Mon, 17 Sep 2018 16:51:22 CDT Tina Reed at FierceHealthcare: Payer The opioid package will now head to reconciliation with the House of Representatives before advancing for the president's signature. The Senate also passed a measure aimed at addressing high drug prices by banning contract clauses that stop pharmacists from telling patients they can save money by not using their insurance. Experimental nasal influenza vaccine tested in kids, teens http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/experimental-nasal-influenza-vaccine-tested-kids-teens http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/experimental-nasal-influenza-vaccine-tested-kids-teens Mon, 17 Sep 2018 16:00:00 CDT NIH News Release NIH-supported Phase 1 trial of potential broadly protective vaccine. ]]> Study says Medicaid expansion in Michigan improved beneficiaries' financial health http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/study-says-medicaid-expansion-michigan-improved-beneficiaries-financial-health?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/study-says-medicaid-expansion-michigan-improved-beneficiaries-financial-health?utm_source=internal&utm_medium=rss Mon, 17 Sep 2018 15:10:41 CDT Rose Meltzer at FierceHealthcare: Payer Newly eligible beneficiaries saw their bills in collection, especially medical bills, decrease by hundreds of dollars between 2014 and 2015. Gene variations linked to severity of Zika-related birth defects, small NIH study suggests http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/gene-variations-linked-severity-zika-related-birth-defects-small-nih-study-suggests http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/gene-variations-linked-severity-zika-related-birth-defects-small-nih-study-suggests Mon, 17 Sep 2018 13:00:00 CDT NIH News Release Highly affected children were likely to have a mother with natural variations in genes for a key enzyme. ]]> NIH and Children’s National partner to advance pediatric clinical research http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/nih-childrens-national-partner-advance-pediatric-clinical-research http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/nih-childrens-national-partner-advance-pediatric-clinical-research Mon, 17 Sep 2018 12:15:00 CDT NIH News Release Inaugural symposium highlights collaboration in allergic, immunologic and infectious disease research. ]]> Health IT Roundup—Minnesota hospital filmed patients without consent; Are providers ready for the death of faxes? http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/health-it-roundup-are-providers-ready-for-death-faxes-minnesota-hospital-filmed-patients?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/health-it-roundup-are-providers-ready-for-death-faxes-minnesota-hospital-filmed-patients?utm_source=internal&utm_medium=rss Mon, 17 Sep 2018 09:40:12 CDT Eli Richman at FierceHealthcare: Payer CMS wants to kill the fax machines, but providers and IT staff might not be ready; Fairview Southdale Hospital in Minnesota was found filming patients without their knowledge or consent; plus more health IT news of note. Daily low-dose aspirin found to have no effect on healthy life span in older people http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/daily-low-dose-aspirin-found-have-no-effect-healthy-life-span-older-people http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/daily-low-dose-aspirin-found-have-no-effect-healthy-life-span-older-people Sun, 16 Sep 2018 14:15:00 CDT NIH News Release Large NIH-funded study examined outcomes in United States and Australia ]]> Counties with greatest well-being for seniors cost Medicare thousands less, study finds http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/counties-greatest-well-being-cost-medicare-thousands-less-study-finds?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/counties-greatest-well-being-cost-medicare-thousands-less-study-finds?utm_source=internal&utm_medium=rss Fri, 14 Sep 2018 15:54:39 CDT Rose Meltzer at FierceHealthcare: Payer Medicare spends nearly $1,000 less per beneficiary in counties where residents are not only healthy, but happy and satisfied with their lives. More than half of consumers don't understand basic aspects of the healthcare system, survey finds http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/more-than-half-consumers-don-t-understand-basic-aspects-healthcare-system-survey-finds?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/more-than-half-consumers-don-t-understand-basic-aspects-healthcare-system-survey-finds?utm_source=internal&utm_medium=rss Fri, 14 Sep 2018 13:57:53 CDT Rose Meltzer at FierceHealthcare: Payer Ensuring that consumers understand their insurance could save billions in administrative costs, according to an Accenture analysis. The best way to do this? Simplify the system. How FDA is evolving to keep pace with innovation in healthcare http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/how-fda-evolving-keep-pace-innovation-healthcare http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/how-fda-evolving-keep-pace-innovation-healthcare Fri, 14 Sep 2018 12:55:49 CDT walmeida at Healthcare IT News - Government & Policy The U.S Food and Drug Administration serves a critical role in healthcare innovation by regulating a range of medical devices and digital health tools. As the industry continues its feverish pace of advancement, the agency itself has been evolving to better vet and approve emerging technologies. Over the last year, in fact, FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting technology and medications out to the public. This is evidenced by the new Pre-Cert program which would uproot the way software as a medical device is regulated, with the possibility of deeming a company safe instead of focusing on each individual product. Here is a look at some of the biggest news out of the FDA in the last year: Fast track to innovation? FDA’s Pre-Cert program The FDA first introduced the idea for the Pre-Cert program in August of 2017, which proposes to allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway. Big names like Johnson & Johnson, Apple and Fitbit were among the first companies to go through the Pre-Cert program. But it also included up and coming players in the field like Pear Therapeutics, which is working on a digital therapeutic to treat opioid addiction, and smaller entities like Tidepool, which helps people with diabetes track their patterns. “Because of software’s faster iterative design, development, and validation, traditional implementation of the premarket requirements may impede or delay patient access to advances in software technology that would improve public health,” the FDA wrote in a Pre-Cert update ahead of the workshop in February. “Since issuing the action plan, we have partnered with a range of digital health software companies and other stakeholders to begin developing a precertification program that could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others.” The first version of the Pre-Cert program is scheduled to launch this December, but has already had input from stakeholders and the public. Over the course of the year the FDA has released drafts of a working model for the program. In late June the FDA released the second draft of its Pre-Cert framework, where it laid out 12 categories that the agency can look at when evaluating an organization. Those areas include leadership, transparency, people and risk management. This second draft was released following a 17-page first draft in April. The first draft spells out two levels of pre-certifications within the software as a medical device (SaMD) space, one for companies with experience developing SaMD and another for businesses developing SaMD for the first time. However, in the latest draft the lines between the two levels are less set in stone; instead companies can test into either category regardless of past experience. Right now it looks like developers will have the ability to opt into the Pre-Cert program and will be able to take the traditional route if they so choose. But some are questioning if this option will create a new norm for the industry. If the pilot goes well and Pre-Cert discussions finalize in the future, startups could potentially go straight into the program before launching any products. “If Pre-Cert is done the right way, then Pre-Cert becomes something you start with and that your funders will say, let’s go to the Pre-Cert concept from day one and you’ll have a quicker path to launch,” Morgan Reed, the President of ACT | The App Association, told MobiHealthNews in February. But the program certainly has its critics. Some fear that the Pre-Cert program would actually give the FDA more power over the industry. “This is a good old-fashioned trade,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, said in an email to MobiHealthNews in April after the first draft guidance. “Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.” In a recent op-ed published in MobiHealthNews, Thompson also highlighted that not all companies will be qualified to participate in the program due to the excellent standards set forth. He also called into question the FDA’s ability to inspect medical device establishments once through the program. Regardless of the criticism, according to the FDA’s webpage, the agency is currently finalizing Pre-Cert 1.0 and integrating stakeholder feedback lessons learned and other input. The agency is also in the scenario testing phase, which will look at program objectives and lessons learned. By December the first version of the Pre-Cert program will be launched. At that time the organization will also be coming out with next steps for the program. A new center for digital health With more digital health companies cropping up across the country the FDA has announced plans to create a Center for Excellence for Digital Health with the goal of modernizing regulatory approach to help the industry while still protecting patients. “This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices,” the FDA wrote in a statement. The agency said the idea is to help developers create innovations that will benefit patients. “With these advances has come a new swath of companies that are investing in these new opportunities,” the agency wrote. “These firms may be new to healthcare products and may be new to healthcare products and maybe not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas.” The agency cited the latest medical apps launched by Apple yesterday, saying that the FDA worked closely with tech giant as they developed and tested the software. The statement went on to say that traditionally the healthcare industry has been behind the times when it comes to adopting new technologies, in part because of regulations. “But momentum toward a universal digital future in healthcare is advancing. Due to the great promise of these technologies and the rapid pace of change,” the agency wrote, “the FDA is working to modernize our regulatory approach to better enable and more efficiently spur innovation in this novel area to improve the health and quality of life of consumers and patients.” Genomics As consumer genomics companies like 23andMe and Helix continue to expand its reach, the regulations in this space have also been evolving. After years in the grey zone, in June the FDA finally announced a new ruling that exempts individual genetic risk tests from 510(k) premarket approval. This means that companies, like 23andMe offering genetic risk tests, only have to go through a one-time premarket review of its testing apparatus. Companies going through the new process will still need to meet the same standards as before this ruling, but they they won’t have to go through the entire approval process for each test before launch. However, if a company makes false claims they will be subject to FDA sanctions. This has been coming down the pipeline for a while. Last November the FDA announced that it was working on a new pathway for consumer genomics. "The FDA is taking steps to implement a novel regulatory approach for the regulation of [genetics home reference (GHR)] tests that applies proper oversight in a flexible, new way," FDA Commissioner Scott Gottlieb said in a statement in November. "It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers.” But in the past genomics companies have run into difficulties navigating FDA regulations. Notably, 23andMe the FDA ordered the company to immediately stop selling its testing services until it went through the de novo process. The company eventually landed a de novo close to three years later, which allowed them to sell direct-to-consumer kits. “The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an FDA statement when 23andMe landed the de novo. “By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results.” Amending the guidances Last fall the FDA released a slew of new draft guidances. One of the most controversial, proposed to change the way that clinical decision support tools are regulated, so that instead of a CDS device being regulated based on risk it will depend on the on the degree of human involvement. Under the new draft guidance a CDS tool does not have to be regulated if a doctor can independently review and understand the basis of the software’s decision. Experts have split into two camps. Some like healthcare lawyer Nathaniel Lacktman praised Gottlieb for loosening regulations and recognizing “the need not to over-regulate our industry.” But others, like Thompson, who is also the CDS Coalition leader, say the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market. In February the CDS Coalition sent a letter, penned by Thompson, to the FDA, voicing its concerns and recommending that the FDA exempt low risk CDS software. “FDA’s approach would basically extend regulation to any software that offers insights that the user might not be expected to come up with on his or her own,” Thompson wrote in the letter.  “FDA would thus end up regulating any software that does not simply do mundane calculations that users could do themselves.” Also announced last December were updates to the medical software policy based on Congressional mandates in the 21st Century Cures Act. In the Cures Act guidance, the FDA listed four categories of devices that the FDA won’t regulate, which are the same as the ones in the law that was passed in 2016, and include software used for administrative purposes in a hospital; wellness software for “maintaining or encouraging a healthy lifestyle;” EHR software; and software for transferring, storing or displaying data. While in place since 2016, it is important to note that included in the Cures Act is guidance about using real world data (RWD) and real world evidence (RWE) in healthcare decisions. Both RWD and RWE can now be used to support regulatory decision making. "Over the past decades, the use of computers and other electronic tools to gather and store huge amounts of health-related data has been increasing,” the FDA writes on its webpage. “This data holds potential to allow us to better design and conduct clinical trials in the health care setting to answer questions previously though infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.” Focus on Innovation In September, we take a deep dive into the cutting-edge development and disruption of healthcare innovation. Twitter: @lauralovett7 Email the writer: laura.lovett@himssmedia.com Primary Topic: InnovationAdditional Topics: InnovationTechnologyCustom Tags: Innovation (6491)Disable Auto Tagging: Disable Auto TaggingShort Headline: FDA evolving to keep pace with healthcare innovationNewsletter hed: How FDA is evolving to keep pace with innovation in healthcareNewsletter teaser: Though not without critics, the FDA has advanced regulatory processes for apps, medical devices, genomics and clinical decision support. HOT @HIMSS: Featured Decision Content: 

The U.S Food and Drug Administration serves a critical role in healthcare innovation by regulating a range of medical devices and digital health tools. As the industry continues its feverish pace of advancement, the agency itself has been evolving to better vet and approve emerging technologies.

Over the last year, in fact, FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting technology and medications out to the public. This is evidenced by the new Pre-Cert program which would uproot the way software as a medical device is regulated, with the possibility of deeming a company safe instead of focusing on each individual product.

Here is a look at some of the biggest news out of the FDA in the last year:

Fast track to innovation? FDA’s Pre-Cert program

The FDA first introduced the idea for the Pre-Cert program in August of 2017, which proposes to allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.

Big names like Johnson & Johnson, Apple and Fitbit were among the first companies to go through the Pre-Cert program. But it also included up and coming players in the field like Pear Therapeutics, which is working on a digital therapeutic to treat opioid addiction, and smaller entities like Tidepool, which helps people with diabetes track their patterns.

“Because of software’s faster iterative design, development, and validation, traditional implementation of the premarket requirements may impede or delay patient access to advances in software technology that would improve public health,” the FDA wrote in a Pre-Cert update ahead of the workshop in February. “Since issuing the action plan, we have partnered with a range of digital health software companies and other stakeholders to begin developing a precertification program that could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others.”

The first version of the Pre-Cert program is scheduled to launch this December, but has already had input from stakeholders and the public.

Over the course of the year the FDA has released drafts of a working model for the program.

In late June the FDA released the second draft of its Pre-Cert framework, where it laid out 12 categories that the agency can look at when evaluating an organization. Those areas include leadership, transparency, people and risk management.

This second draft was released following a 17-page first draft in April. The first draft spells out two levels of pre-certifications within the software as a medical device (SaMD) space, one for companies with experience developing SaMD and another for businesses developing SaMD for the first time. However, in the latest draft the lines between the two levels are less set in stone; instead companies can test into either category regardless of past experience.

Right now it looks like developers will have the ability to opt into the Pre-Cert program and will be able to take the traditional route if they so choose. But some are questioning if this option will create a new norm for the industry.

If the pilot goes well and Pre-Cert discussions finalize in the future, startups could potentially go straight into the program before launching any products.

“If Pre-Cert is done the right way, then Pre-Cert becomes something you start with and that your funders will say, let’s go to the Pre-Cert concept from day one and you’ll have a quicker path to launch,” Morgan Reed, the President of ACT | The App Association, told MobiHealthNews in February.

But the program certainly has its critics. Some fear that the Pre-Cert program would actually give the FDA more power over the industry.

“This is a good old-fashioned trade,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, said in an email to MobiHealthNews in April after the first draft guidance. “Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.”

In a recent op-ed published in MobiHealthNews, Thompson also highlighted that not all companies will be qualified to participate in the program due to the excellent standards set forth. He also called into question the FDA’s ability to inspect medical device establishments once through the program.

Regardless of the criticism, according to the FDA’s webpage, the agency is currently finalizing Pre-Cert 1.0 and integrating stakeholder feedback lessons learned and other input. The agency is also in the scenario testing phase, which will look at program objectives and lessons learned. By December the first version of the Pre-Cert program will be launched. At that time the organization will also be coming out with next steps for the program.

A new center for digital health

With more digital health companies cropping up across the country the FDA has announced plans to create a Center for Excellence for Digital Health with the goal of modernizing regulatory approach to help the industry while still protecting patients.

“This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices,” the FDA wrote in a statement.

The agency said the idea is to help developers create innovations that will benefit patients.

“With these advances has come a new swath of companies that are investing in these new opportunities,” the agency wrote. “These firms may be new to healthcare products and may be new to healthcare products and maybe not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas.”

The agency cited the latest medical apps launched by Apple yesterday, saying that the FDA worked closely with tech giant as they developed and tested the software. The statement went on to say that traditionally the healthcare industry has been behind the times when it comes to adopting new technologies, in part because of regulations.

“But momentum toward a universal digital future in healthcare is advancing. Due to the great promise of these technologies and the rapid pace of change,” the agency wrote, “the FDA is working to modernize our regulatory approach to better enable and more efficiently spur innovation in this novel area to improve the health and quality of life of consumers and patients.”

Genomics

As consumer genomics companies like 23andMe and Helix continue to expand its reach, the regulations in this space have also been evolving.

After years in the grey zone, in June the FDA finally announced a new ruling that exempts individual genetic risk tests from 510(k) premarket approval. This means that companies, like 23andMe offering genetic risk tests, only have to go through a one-time premarket review of its testing apparatus.

Companies going through the new process will still need to meet the same standards as before this ruling, but they they won’t have to go through the entire approval process for each test before launch. However, if a company makes false claims they will be subject to FDA sanctions.

This has been coming down the pipeline for a while. Last November the FDA announced that it was working on a new pathway for consumer genomics.

"The FDA is taking steps to implement a novel regulatory approach for the regulation of [genetics home reference (GHR)] tests that applies proper oversight in a flexible, new way," FDA Commissioner Scott Gottlieb said in a statement in November. "It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers.”

But in the past genomics companies have run into difficulties navigating FDA regulations. Notably, 23andMe the FDA ordered the company to immediately stop selling its testing services until it went through the de novo process. The company eventually landed a de novo close to three years later, which allowed them to sell direct-to-consumer kits.

“The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an FDA statement when 23andMe landed the de novo. “By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results.”

Amending the guidances

Last fall the FDA released a slew of new draft guidances. One of the most controversial, proposed to change the way that clinical decision support tools are regulated, so that instead of a CDS device being regulated based on risk it will depend on the on the degree of human involvement. Under the new draft guidance a CDS tool does not have to be regulated if a doctor can independently review and understand the basis of the software’s decision.

Experts have split into two camps. Some like healthcare lawyer Nathaniel Lacktman praised Gottlieb for loosening regulations and recognizing “the need not to over-regulate our industry.”

But others, like Thompson, who is also the CDS Coalition leader, say the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.

In February the CDS Coalition sent a letter, penned by Thompson, to the FDA, voicing its concerns and recommending that the FDA exempt low risk CDS software.

“FDA’s approach would basically extend regulation to any software that offers insights that the user might not be expected to come up with on his or her own,” Thompson wrote in the letter.  “FDA would thus end up regulating any software that does not simply do mundane calculations that users could do themselves.”

Also announced last December were updates to the medical software policy based on Congressional mandates in the 21st Century Cures Act. In the Cures Act guidance, the FDA listed four categories of devices that the FDA won’t regulate, which are the same as the ones in the law that was passed in 2016, and include software used for administrative purposes in a hospital; wellness software for “maintaining or encouraging a healthy lifestyle;” EHR software; and software for transferring, storing or displaying data.

While in place since 2016, it is important to note that included in the Cures Act is guidance about using real world data (RWD) and real world evidence (RWE) in healthcare decisions. Both RWD and RWE can now be used to support regulatory decision making.

"Over the past decades, the use of computers and other electronic tools to gather and store huge amounts of health-related data has been increasing,” the FDA writes on its webpage. “This data holds potential to allow us to better design and conduct clinical trials in the health care setting to answer questions previously though infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.”

Focus on Innovation

In September, we take a deep dive into the cutting-edge development and disruption of healthcare innovation.

Twitter: @lauralovett7
Email the writer: laura.lovett@himssmedia.com

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EHR interoperability for VA and DoD, who’s responsible? Lawmakers, officials can't agree http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/ehr-interoperability-va-and-dod-who’s-responsible-lawmakers-officials-cant-agree http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/ehr-interoperability-va-and-dod-who’s-responsible-lawmakers-officials-cant-agree Fri, 14 Sep 2018 12:47:41 CDT jfinison at Healthcare IT News - Government & Policy The Interagency Program Office (IPO) has not fulfilled its legal mandate to be the single point of accountability between the Department of Defense and Department of Veterans Affairs interoperability efforts. But both officials and lawmakers can’t decide who should reconcile the differences. The inaugural House Veterans Affairs Subcommittee on Technology Modernization hearing, held on Thursday, revealed, not surprisingly, governance and accountability are still major points of contention for the project. Government Accountability Office Director of Management Issues Carol Harris testified that while the VA has signed the contract with Cerner, created a program management office and drafted high-level governance plans -- program officials haven’t designated “what role, if any, IPO is to have in the governance process.” Rep. Jim Banks, R-Indiana, supported Harris, remarking that the IPO is “one of the few aspects of EHR modernization mandated by law.” He also stressed IPO’s governance role in the projects was not only important -- but permanent. The departments need to clarify the IPO’s powers, which was established in 2008 to not only oversee the initial EHR collaboration -- it gave them authority to resolve these differences, said Banks. “My hope is DoD and VA will hash out what that looks like and come to mutual agreement,” Banks said. “I am willing to give them additional time to do that, but I will not wait forever.” GAO is recommending the VA clearly outline the role IPO will have over the EHR project, specifically around governance, as “focusing on a single point of accountability is critical in moving forward to make sure that interoperability is functional,” said Harris. But the VA Office of EHR Modernization Office’s acting Chief Information Officer John Windom told the committee that he doesn’t believe IPO has any decision-making authority of his office. And IPO Director Lauren Thompson pointed out that her office isn’t equipped to be the single point of accountability for VA-EHR interoperability, citing a lack of authority, resources and staff. “At this point in time, we do not have the decision-making authority,” said Thompson. But Harris continued to press that the law makes IPO the “single point of accountability, so that would include responsibility, authority and decision-making.” In fact, the testimonies of both Windom and Thompson are in conflict with the statute’s expectations. Further, Harris stressed that both DoD and VA have ignored GAO advice over the years on empowering the IPO. The role needs to be clearly defined, such as through Congress, which could relieve the office of its legal responsibilities. “If the IPO continues the way that it is operating today, we are going to continue to have dysfunction in moving forward,” Harris said. Discussions on better governance policies are ongoing, Windom testified. The conversations are overlapping with the VA rollout of its Cerner EHR. VA and DoD continue to work through the data sharing roles at the agencies, as well. Thompson proposed governance should be broken down into three boards. One, a functional governance board, would handle disputes among clinicians and other healthcare employees. Two, a technology-focused governance board, would have the same function but for purely tech issues. The final board would be solely focused on decision-making, designed to resolve problems the other two boards could not, said Thompson. But Windom quickly countered Thompson’s idea, and said those low-ranking disputes could be resolved on the ground -- without having to involve “high-ranking staff members.” “I can't impress upon the committee enough that governance has to be successful at the lowest possible level,” sad Windom. “Things can’t rise to the superior level on every matter.” Harris agreed: With that many boards involved, accountability is “diffused so when the wheels fall off the bus you can’t point to a single entity… When everyone is responsible, no one is responsible.” In the end, no clear decision was made at the hearing. Rep. Scott Peters, D-California, said the issue may need to be resolved by either Congress or the president, as the single point won’t be created without help. Indeed, VA has struggled with both maintaining leadership and with governance issues for the past year. Since the dismissal of former VA Secretary David Shulkin, MD in March, at least 42 senior staffers have left the VA. The most recent came from the EHR project office itself, with the departure of its CHIO Genevieve Morris and CMO. VA officials continue to double down on their projected 2020 go-live of its own pilot EHRs in the Pacific Northwest, designed to follow the DoD rollout. But GAO may also be investigating the DoD project, after an audit deemed the new system “not operationally suitable.” Twitter: @JF_Davis_ Email the writer: jessica.davis@himssmedia.com Primary Topic: Electronic Health RecordsAdditional Topics: TechnologyEHRPolicyInteroperabilityTechnologyPolicySpecific Terms: Electronic Health RecordsCustom Tags: Electronic Health RecordsInteroperabilityDisable Auto Tagging: Short Headline: VA, DoD officials can't agree on EHR interoperabilityNewsletter hed: VA DoD EHR interoperability, who’s responsible? Lawmakers, officials can’t agreeNewsletter teaser: The first House VA Subcommittee on Technology Modernization hearing revealed that officials and congressional members are not on the same page when it comes to governance.HOT @HIMSS: Featured Decision Content: 

The Interagency Program Office (IPO) has not fulfilled its legal mandate to be the single point of accountability between the Department of Defense and Department of Veterans Affairs interoperability efforts. But both officials and lawmakers can’t decide who should reconcile the differences.

The inaugural House Veterans Affairs Subcommittee on Technology Modernization hearing, held on Thursday, revealed, not surprisingly, governance and accountability are still major points of contention for the project.

Government Accountability Office Director of Management Issues Carol Harris testified that while the VA has signed the contract with Cerner, created a program management office and drafted high-level governance plans -- program officials haven’t designated “what role, if any, IPO is to have in the governance process.”

Rep. Jim Banks, R-Indiana, supported Harris, remarking that the IPO is “one of the few aspects of EHR modernization mandated by law.” He also stressed IPO’s governance role in the projects was not only important -- but permanent.

The departments need to clarify the IPO’s powers, which was established in 2008 to not only oversee the initial EHR collaboration -- it gave them authority to resolve these differences, said Banks.

“My hope is DoD and VA will hash out what that looks like and come to mutual agreement,” Banks said. “I am willing to give them additional time to do that, but I will not wait forever.”

GAO is recommending the VA clearly outline the role IPO will have over the EHR project, specifically around governance, as “focusing on a single point of accountability is critical in moving forward to make sure that interoperability is functional,” said Harris.

But the VA Office of EHR Modernization Office’s acting Chief Information Officer John Windom told the committee that he doesn’t believe IPO has any decision-making authority of his office.

And IPO Director Lauren Thompson pointed out that her office isn’t equipped to be the single point of accountability for VA-EHR interoperability, citing a lack of authority, resources and staff.

“At this point in time, we do not have the decision-making authority,” said Thompson.

But Harris continued to press that the law makes IPO the “single point of accountability, so that would include responsibility, authority and decision-making.” In fact, the testimonies of both Windom and Thompson are in conflict with the statute’s expectations.

Further, Harris stressed that both DoD and VA have ignored GAO advice over the years on empowering the IPO. The role needs to be clearly defined, such as through Congress, which could relieve the office of its legal responsibilities.

“If the IPO continues the way that it is operating today, we are going to continue to have dysfunction in moving forward,” Harris said.

Discussions on better governance policies are ongoing, Windom testified. The conversations are overlapping with the VA rollout of its Cerner EHR. VA and DoD continue to work through the data sharing roles at the agencies, as well.

Thompson proposed governance should be broken down into three boards. One, a functional governance board, would handle disputes among clinicians and other healthcare employees. Two, a technology-focused governance board, would have the same function but for purely tech issues.

The final board would be solely focused on decision-making, designed to resolve problems the other two boards could not, said Thompson.

But Windom quickly countered Thompson’s idea, and said those low-ranking disputes could be resolved on the ground -- without having to involve “high-ranking staff members.”

“I can't impress upon the committee enough that governance has to be successful at the lowest possible level,” sad Windom. “Things can’t rise to the superior level on every matter.”

Harris agreed: With that many boards involved, accountability is “diffused so when the wheels fall off the bus you can’t point to a single entity… When everyone is responsible, no one is responsible.”

In the end, no clear decision was made at the hearing. Rep. Scott Peters, D-California, said the issue may need to be resolved by either Congress or the president, as the single point won’t be created without help.

Indeed, VA has struggled with both maintaining leadership and with governance issues for the past year. Since the dismissal of former VA Secretary David Shulkin, MD in March, at least 42 senior staffers have left the VA. The most recent came from the EHR project office itself, with the departure of its CHIO Genevieve Morris and CMO.

VA officials continue to double down on their projected 2020 go-live of its own pilot EHRs in the Pacific Northwest, designed to follow the DoD rollout. But GAO may also be investigating the DoD project, after an audit deemed the new system “not operationally suitable.”

Twitter: @JF_Davis_
Email the writer: jessica.davis@himssmedia.com

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Former Allscripts CEO Glen Tullman: The future of innovation is patient empowerment not EHRs http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/former-allscripts-ceo-glen-tullman-future-innovation-patient-empowerment-not-ehrs http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/former-allscripts-ceo-glen-tullman-future-innovation-patient-empowerment-not-ehrs Fri, 14 Sep 2018 08:10:23 CDT at Most Popular News from healthcareitnews.com Glen Tullman has served as the CEO of a major EHR vendor and the founder of a startup app maker focused initially on diabetes. That background gives him a unique insight into the possibilities and constraints of each. For our Focus on Innovation, I spoke with Tullman about the foundation EHRs have created for the future of digital health, what to expect next from Livongo, and where he expects next-gen innovations to come from. NIH launches initiative to accelerate genetic therapies to cure sickle cell disease http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/nih-launches-initiative-accelerate-genetic-therapies-cure-sickle-cell-disease http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/nih-launches-initiative-accelerate-genetic-therapies-cure-sickle-cell-disease Thu, 13 Sep 2018 17:45:00 CDT NIH News Release Effort will take advantage of the latest genetic discoveries and technological advances. ]]> MACPAC continues to ponder value of collaborations between states http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/macpac-continues-to-ponder-value-collaborations-between-states?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/macpac-continues-to-ponder-value-collaborations-between-states?utm_source=internal&utm_medium=rss Thu, 13 Sep 2018 15:30:48 CDT Rose Meltzer at FierceHealthcare: Payer At its monthly meeting on Thursday, the Medicaid and CHIP Payment and Access Commission continued its discussion of whether federal policies can—or should—help states collaborate to bolster their administrative capacity. This time, two key officials chimed in. Neurons absorb and release water when firing, NIH study suggests http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/neurons-absorb-release-water-when-firing-nih-study-suggests http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/neurons-absorb-release-water-when-firing-nih-study-suggests Thu, 13 Sep 2018 15:15:00 CDT NIH News Release Findings in rat cell cultures could lead to new method for tracking communications throughout the brain. ]]> CVS' Larry Merlo defends rebates, touts pending Aetna deal at Morgan Stanley conference http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/cvs-larry-merlo-defends-rebates-role-pbms?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/cvs-larry-merlo-defends-rebates-role-pbms?utm_source=internal&utm_medium=rss Thu, 13 Sep 2018 12:45:30 CDT Tina Reed at FierceHealthcare: Payer With the Trump administration's focus on curbing high prescription costs, drug rebates negotiated by pharmacy benefit managers have become a popular whipping boy. But CVS CEO Larry Merlo said he doesn't foresee either going away anytime soon. Russian Twitter trolls attempted to cull opposition to the ACA during repeal attempts http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/russian-twitter-trolls-attempted-to-cull-opposition-to-aca-during-repeal-attempts?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/russian-twitter-trolls-attempted-to-cull-opposition-to-aca-during-repeal-attempts?utm_source=internal&utm_medium=rss Thu, 13 Sep 2018 05:35:25 CDT Rose Meltzer at FierceHealthcare: Payer Twitter and the government must do more to stop the spread of messages that can deceitfully sway public sentiment, experts say. States are trying to lower drug prices. Here's how their efforts are being thwarted http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/states-are-trying-to-lower-drug-prices-here-s-how-their-efforts-are?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/states-are-trying-to-lower-drug-prices-here-s-how-their-efforts-are?utm_source=internal&utm_medium=rss Wed, 12 Sep 2018 16:09:52 CDT Caitlin Burke at FierceHealthcare: Payer Those states are finding their efforts hit by heavy opposition, according to a perspective piece published in The New England Journal of Medicine on Wednesday. CMS announces plan to make it easier to avoid ACA's tax penalty http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/cms-streamlines-process-for-obtaining-a-hardship-exemption-from-individual-mandate?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/cms-streamlines-process-for-obtaining-a-hardship-exemption-from-individual-mandate?utm_source=internal&utm_medium=rss Wed, 12 Sep 2018 14:07:39 CDT Rose Meltzer at FierceHealthcare: Payer Consumers who do not buy a plan this year can claim a hardship exemption without obtaining an exemption certificate number when they file their taxes next spring, according to a document released by the Centers for Medicare & Medicaid Services on Wednesday. Apple unveils Watch Series 4 with FDA-approved ECG http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/apple-unveils-watch-series-4-fda-approved-ecg http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/apple-unveils-watch-series-4-fda-approved-ecg Wed, 12 Sep 2018 13:48:55 CDT walmeida at Healthcare IT News - Government & Policy Apple on Wednesday announced Apple Watch Series 4 and, in so doing, confirmed speculation that the new device would bring ECG features cleared by the U.S. Food and Drug Administration.  Apple Chief Operating Officer Jeff Williams, in fact, said today at an event in Cupertino that the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4 when it becomes available on Sept. 21. Williams announced several other new health features as well, most notably fall detection, which takes advantage of the device's new accelerometer and gyroscope. "I’m also pleased to say we’ve received clearance from the FDA," Williams said at the event. "This is a De Novo clearance, so it’s the first of its kind. The irregular heart rhythm alert has also received FDA clearance. Both of these features will be available to US customers later this year and we’re working hard to bring them to customers around the world." Healthacre IT News sister site MobiHealthNews was half right when it predicted in February of this year that an algorithm for detecting atrial fibrillation could be the Apple's first FDA-cleared product. The company did receive clearance for such an algorithm, likely using data from the recently-concluded Apple Heart Study to submit the application. "Apple Watch can now screen your heart rhythm in the background and it sends you a notification if it detects an irregular rhythm that appears to be atrial fibrillation," Williams said. "Now it won’t catch every instance of a-fib, but this is going to help a lot of people who didn’t realize they had an issue." Williams also announced that the Watch will alert users to low heart rates in addition to high ones. But the far bigger news is the ECG, which is accomplished by adding electrodes to the digital crown and the back of the Watch. "In addition to an optical heart sensor there is a new, Apple-designed electrical heart sensor that allows you to take an electrocardiogram, or ECG, to share with your doctor, a momentous achievement for a wearable device," designer Johnny Ives said in a prerecorded video played at the event. "Placing your finger on the digital crown creates a closed circuit with electrodes on the back, providing data that the ECG app uses to analyze your heart rhythm." It takes about 30 seconds for a user to take an ECG, which is then stored in Apple's Health app. This means, via Apple Health Records, some users will also be able to send readings directly to their doctors. "It’s amazing the same watch that you wear every day to make phone calls and respond to messages can now take an ECG," Williams said. Fall detection Apple's addition of fall detection is likely to be overshadowed by the ECG news, but it's also an impressive acheivement. "It’s interesting, identifying a fall may seem like a straightforward problem but it requires a tremendous amount of data and analysis," Williams said. "We collected data on thousands of people and captured data on real-world falls and we learned something. ... When you trip, your body will naturally pitch forward and your arms will go forward to brace yourself. However, if you slip, there’s a natural upward motion in the arms. These are motions Series 4 is ideally suited to recognize. With a new accelerator and gyroscope, the Watch analyzes wrist trajectory and impact acceleration to determine when a fall occurs. And from that it issues an alert." When the Watch detects the fall, it will give the user an opportunity to call an emergency contact. But if it detects that the user is immobile for one minute after the fall, it will automatically reach out to authorities using Apple's emergency alert system. It also sends a message to emergency contacts in that situation. Loading... Focus on Innovation In September, we take a deep dive into the cutting-edge development and disruption of healthcare innovation. Twitter: @JonahComstock Email the writer: jonah.comstock@himssmedia.com Primary Topic: PolicyAdditional Topics: PolicyTechnologyTelehealthTechnologyTelehealthSpecific Terms: Mobile Health ITMobile Health ITCustom Tags: Mobile Health ITMobile Health ITDisable Auto Tagging: Short Headline: Apple unveils Watch 4 with ECGNewsletter hed: Apple unveils Watch Series 4 with FDA-approved ECGNewsletter teaser: This is the first FDA clearance for Apple and pushes the Watch further into healthcare than ever before.HOT @HIMSS: Featured Decision Content: 

Apple on Wednesday announced Apple Watch Series 4 and, in so doing, confirmed speculation that the new device would bring ECG features cleared by the U.S. Food and Drug Administration. 

Apple Chief Operating Officer Jeff Williams, in fact, said today at an event in Cupertino that the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4 when it becomes available on Sept. 21.

Williams announced several other new health features as well, most notably fall detection, which takes advantage of the device's new accelerometer and gyroscope.

"I’m also pleased to say we’ve received clearance from the FDA," Williams said at the event. "This is a De Novo clearance, so it’s the first of its kind. The irregular heart rhythm alert has also received FDA clearance. Both of these features will be available to US customers later this year and we’re working hard to bring them to customers around the world."

Healthacre IT News sister site MobiHealthNews was half right when it predicted in February of this year that an algorithm for detecting atrial fibrillation could be the Apple's first FDA-cleared product. The company did receive clearance for such an algorithm, likely using data from the recently-concluded Apple Heart Study to submit the application.

"Apple Watch can now screen your heart rhythm in the background and it sends you a notification if it detects an irregular rhythm that appears to be atrial fibrillation," Williams said. "Now it won’t catch every instance of a-fib, but this is going to help a lot of people who didn’t realize they had an issue."

Williams also announced that the Watch will alert users to low heart rates in addition to high ones. But the far bigger news is the ECG, which is accomplished by adding electrodes to the digital crown and the back of the Watch.

"In addition to an optical heart sensor there is a new, Apple-designed electrical heart sensor that allows you to take an electrocardiogram, or ECG, to share with your doctor, a momentous achievement for a wearable device," designer Johnny Ives said in a prerecorded video played at the event. "Placing your finger on the digital crown creates a closed circuit with electrodes on the back, providing data that the ECG app uses to analyze your heart rhythm."

It takes about 30 seconds for a user to take an ECG, which is then stored in Apple's Health app. This means, via Apple Health Records, some users will also be able to send readings directly to their doctors.

"It’s amazing the same watch that you wear every day to make phone calls and respond to messages can now take an ECG," Williams said.

Fall detection

Apple's addition of fall detection is likely to be overshadowed by the ECG news, but it's also an impressive acheivement.

"It’s interesting, identifying a fall may seem like a straightforward problem but it requires a tremendous amount of data and analysis," Williams said. "We collected data on thousands of people and captured data on real-world falls and we learned something. ... When you trip, your body will naturally pitch forward and your arms will go forward to brace yourself. However, if you slip, there’s a natural upward motion in the arms. These are motions Series 4 is ideally suited to recognize. With a new accelerator and gyroscope, the Watch analyzes wrist trajectory and impact acceleration to determine when a fall occurs. And from that it issues an alert."

When the Watch detects the fall, it will give the user an opportunity to call an emergency contact. But if it detects that the user is immobile for one minute after the fall, it will automatically reach out to authorities using Apple's emergency alert system. It also sends a message to emergency contacts in that situation.

Loading...

Focus on Innovation

In September, we take a deep dive into the cutting-edge development and disruption of healthcare innovation.

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Email the writer: jonah.comstock@himssmedia.com

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Apple unveils Watch Series 4 with FDA-approved ECG http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/apple-unveils-watch-series-4-fda-approved-ecg http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/apple-unveils-watch-series-4-fda-approved-ecg Wed, 12 Sep 2018 13:48:55 CDT at Most Popular News from healthcareitnews.com This is the first FDA clearance for Apple and pushes the Watch further into healthcare than ever before. Hospital groups sue HHS over long-delayed 340B final rule http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/american-hospital-association-340b-hhs-lawsuit-america-s-essential?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/american-hospital-association-340b-hhs-lawsuit-america-s-essential?utm_source=internal&utm_medium=rss Tue, 11 Sep 2018 16:03:27 CDT Paige Minemyer at FierceHealthcare: Payer Four national healthcare organizations have filed suit against HHS over the long delay of its final rule that would implement price ceilings in the 340B drug discount program. The fate of work requirements in Michigan remains up in the air as state looks to institute policy for second time http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/fate-work-requirements-michigan-remains-up-air-as-state-looks-to-institute-policy-for-second?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/fate-work-requirements-michigan-remains-up-air-as-state-looks-to-institute-policy-for-second?utm_source=internal&utm_medium=rss Tue, 11 Sep 2018 15:20:17 CDT Rose Meltzer at FierceHealthcare: Payer While not as controversial as a prior proposal, Michigan's work requirement waiver is still eliciting controversy—and its fate remains to be seen. High blood sugar during pregnancy ups risk of mother’s type 2 diabetes, child’s obesity http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/high-blood-sugar-during-pregnancy-ups-risk-mothers-type-2-diabetes-childs-obesity http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/high-blood-sugar-during-pregnancy-ups-risk-mothers-type-2-diabetes-childs-obesity Tue, 11 Sep 2018 15:00:00 CDT NIH News Release Researchers followed mothers and their children 10-14 years after birth. ]]> Poll results: CVS-Aetna outpaces Amazon as most likely to disrupt healthcare http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/poll-results-cvs-aetna-outpaces-amazon-most-likely-disrupt-healthcare http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/poll-results-cvs-aetna-outpaces-amazon-most-likely-disrupt-healthcare Tue, 11 Sep 2018 09:11:06 CDT at Most Popular News from healthcareitnews.com Readers pointed to the incumbent’s domain expertise and broad member base outweighing Amazon’s innovative nature. Omada Health made its name with its technology. Now it’s luring insurers with operational innovation http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/omada-health-diabetes-digital-health-operational-innovation-cigna-bcbs-minnesota-sean-duffy?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/tech/omada-health-diabetes-digital-health-operational-innovation-cigna-bcbs-minnesota-sean-duffy?utm_source=internal&utm_medium=rss Mon, 10 Sep 2018 22:56:31 CDT Evan Sweeney at FierceHealthcare: Payer Even Omada Health's CEO Sean Duffy half-jokingly refers to the company as a provendor—a reference to the digital health company's high-tech roots melded with the billing approach of a provider (complete with an NPI). The identity has caused headaches for insurer contracts, but it may be forging a new path for digital therapeutics. Early stage clinical trial of antimalarial drug begins http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/early-stage-clinical-trial-antimalarial-drug-begins http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/early-stage-clinical-trial-antimalarial-drug-begins Mon, 10 Sep 2018 15:15:00 CDT NIH News Release In 2016, an estimated 216 million new malaria cases and 445,000 deaths occurred. ]]> Payer Roundup—Payers not leaving ACA market in 2019; Medicaid coverage insufficient for foster children http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/payer-roundup-payers-not-leaving-aca-market-2019-bcbs-tennessee-stops-covering-oxycontin?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/payer-roundup-payers-not-leaving-aca-market-2019-bcbs-tennessee-stops-covering-oxycontin?utm_source=internal&utm_medium=rss Mon, 10 Sep 2018 14:56:06 CDT Rose Meltzer at FierceHealthcare: Payer A survey from eHealth says more than half of private payers will expand their individual market offerings in 2019, and only 7% will reduce them. Plus, Medicaid isn't meeting foster children's complex needs. Can managed care plans help? NAACOs says ACOs saved Medicare nearly twice as much as CMS' estimates http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/naacos-says-cms-improperly-estimated-aco-savings?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/naacos-says-cms-improperly-estimated-aco-savings?utm_source=internal&utm_medium=rss Mon, 10 Sep 2018 13:35:13 CDT Rose Meltzer at FierceHealthcare: Payer NAACOs found a huge difference in how much ACOs save the Medicare program—a difference that has profound policy implications, it says. With $200M investment, cancer practices launch startup OneOncology to help doctors keep independence http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/oncology-partners-team-up-to-create-oneoncology?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/hospitals-health-systems/oncology-partners-team-up-to-create-oneoncology?utm_source=internal&utm_medium=rss Mon, 10 Sep 2018 13:00:15 CDT Tina Reed at FierceHealthcare: Payer With a dedicated EHR platform through Flatiron Health, three large cancer practices are partnering to create economies of scale and push back against consolidation by pulling together more than 200 oncology providers at more than 100 care locations. Cerner President Zane Burke to step down this fall http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/cerner-president-zane-burke-step-down-fall http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/cerner-president-zane-burke-step-down-fall Mon, 10 Sep 2018 09:49:51 CDT at Most Popular News from healthcareitnews.com Cerner President Zane Burke, who first joined the company in 1996 and held several executive roles there before being named president, will step down on Nov. 2. John Peterzalek, Cerner's executive vice president of worldwide client relationships, will take on Burke’s responsibilities, with the title of Chief Client Officer, the company said. A look inside Epic, Cerner and Allscripts app store programs http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/look-inside-epic-cerner-and-allscripts-app-store-programs http://medclimate.com/external/index.php?https://www.healthcareitnews.com/news/look-inside-epic-cerner-and-allscripts-app-store-programs Mon, 10 Sep 2018 09:28:19 CDT at Most Popular News from healthcareitnews.com Executives explain how the developer initiatives work and why they’re fueling innovation and shaping future direction of their platforms.