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U.S. House Passes 21st Century Cures Legislation

November 30, 2016
by Heather Landi
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The legislation will now move to the Senate and could be voted on next week.
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The U.S. House of Representatives today passed sweeping, bipartisan legislation, called the 21st Century Cures Act, comprised of a $6.3 billion package of medical innovation bills including $4.8 billion to the National Institutes of Health as well as $1 billion in state grants to fight opioid abuse. The legislation, which passed by a vote of 392-26, will now move to the Senate and could be voted on next week.

The legislation, which was included as an amendment to H.R. 34, also includes changes to the mental health system and could enact regulatory changes for drugs and medical devices.

Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s (FDA) oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.  

Rep. Erik Paulsen (R-MN) called the legislation “an innovation game-changer” during the debate prior to the House vote, noting that it “supports more NIH research, gives patients more input into the healthcare delivery process and important reforms to mental health.”

During the debate on the House floor, Rep. Pat Tiberi (R-Ohio) said the bill “provides regulatory relief to providers” and “gets America back in the driver’s seat with medical innovation.”


Advancements in Healthcare: Interoperability, Data Exchange, and More

Micky Tripathi, President and Chief Executive Officer of the Massachusetts eHealth Collaborative, is one of the most well-informed and well-respected healthcare IT leaders in the U.S. Tripathi has...

The legislation will provide $4.8 billion to NIH, including: $1.4 billion for President Obama’s Precision Medicine Initiative; $1.8 billion for Vice President Biden’s Cancer Moonshot; and $1.6 billion for the BRAIN initiative. The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). The bill also includes $500 million in funding to the FDA over 10 years with the aim of moving drugs and medical devices to patients more quickly. Additionally, with regard to mental health, the bill aims to strengthen the enforcement of the mental health parity law which requires insurers to cover mental illness as they would treatment for other diseases.

As previously reported by Healthcare Informatics, House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25th. In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN) said the legislation will “advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices. It will address the needs of the one in five adult Americans who suffer mental illness.”

Regarding the health IT components of the bill, Jeffrey Smith, vice president of public policy at the American Medical Informatics Association (AMIA), said, “Essentially what this legislation does is give matching orders to both the public and the private sectors towards trying to improve the state of health IT and interoperability and usability.”

Smith continued, “One of the unknowns, heading into a new Administration and a new Congress, is the status of precision medicine, and the Cancer Moonshot, and the BRAIN initiative, in addition to the opioid and mental health legislation. I think that this legislation is incredibly important to try to assuage those who are concerned about the unknowns of the Trump administration, and the willingness of the 115th Congress, to fund what is really seen as a game of catch-up in terms of funding the NIH and research.”

The bill has many health IT-related provisions, including instructing the Secretary of HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of electronic health records. The bill also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking. The legislation would establish a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security to help providers better choose EHR products.

What is missing from the updated 21st Century Cures Act is the three-star grading system established in Sen. Bill Cassidy’s Trust IT Act (S. 2141). Earlier this week, before the House vote, Smith said, “The star rating system that was part of the Senate language, it was more of a report card approach to improving the performance of health IT and what this new language will do is essentially use a mechanism of transparency. Rather than grading each of the electronic health records (EHRs) on how they perform vis-à-vis usability, security and interoperability, this language just basically says they have to report on how they perform and then these would need to be made publicly available,” Smith says.

Smith added, “There are still some very consistent structural pieces in the legislation and how they define interoperability is more consistent with what the House is thinking. However, I think it remains to be seen exactly what impact the definition will have in a practical way.”

In a statement, Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), applauded the health IT provisions in the 21st Century Cures Act. Branzell said the “landmark legislation” would “significantly improve the ability of hospitals and other providers to exchange accurate patient data and advance personalized care.”

“CHIME is especially encouraged that in a number of sections the bill addresses the critical issues of accurately identifying patients and matching them to their health records. The absence of national solutions for patient identification and patient matching not only pose serious risks to patient safety, but also lead resources being wasted on cleaning up duplicative medical records, as well as creating other inefficiencies. Among other things, the legislation would direct the Government Accountability Office to evaluate the current state of patient matching and determine what steps the Department of Health and Human Services could take to better ensure that patients are linked to their records. We believe that accurate patient identification is central to improving patient matching.”

Additionally, Branzell said in his statement, “The bill, which has bipartisan support, also reflects the growing need to develop a standards-based information exchange infrastructure. If we are going to improve information exchange and interoperability, we need to begin the hard work of finalizing a set of standards that will help providers share patient information in a seamless manner.”

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Advancements in Healthcare: Interoperability, Data Exchange, and More

Tuesday, December 4, 2018 | 3:00 p.m. ET, 2:00 p.m. CT

Micky Tripathi, President and Chief Executive Officer of the Massachusetts eHealth Collaborative, is one of the most well-informed and well-respected healthcare IT leaders in the U.S. Tripathi has an inside look at the most significant interoperability trends that are happening nationwide and will discuss varying interoperability and data exchange efforts fit together in the bigger picture of U.S. healthcare.

Tripathi will also discuss the future of data exchange, advancements of standards such as FHIR, the reality of information blocking challenges, and more in this latest Healthcare Informatics webinar, which gives a high-level view on the many market forces that impacting nationwide interoperability.

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Epic Lowers App Orchard Program Fees, Introduces New Low-Cost Tier

November 1, 2018
by Heather Landi, Associate Editor
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Verona, Wis.-based Epic plans to lower program fees for health IT developers participating in its App Orchard program, and will launch a new entry-level program tier, called Nursery.

Epic announced the App Orchard updates at its App Orchard conference last week at its Verona headquarters, according to reporting from Politico published Oct. 26.

In an email statement, Brett Gann, App Orchard director, confirmed the company is reducing and simplifying the costs associated with participating in the app developer program. The three tiers of the program will see program fee reductions ranging from 33 to 80 percent as part of the update, Gann said.

Epic launched its App Orchard in 2017 as an online marketplace for third-party developers with 13 applications.

To date, more than 350 companies in the healthcare industry participate in Epic’s app developer program, where they have access to hundreds of application programming interfaces (APIs), documentation, testing tools, individual technical support, training, conferences, and integration with the Epic community, Gann said,

Gann also said the program updates announced last week at the annual App Orchard Conference in Verona will “engage a broader community of developers and increase access to APIs through simplified and reduced costs.”

The updates will help drive healthcare innovation as interested developers have the opportunity to build on top of Epic’s health record platform, using emerging industry standards such as FHIR (Fast Healthcare Interoperability Resources), Gann said.

Epic also announced a new program tier, Nursery, that will enable early-stage startups to enroll in the app developer program to access Epic’s public API documentation, tutorials, and sandboxes. Early-stage startups also will have access to FHIR, SMART on FHIR, and CDS Hooks, Gann said.

Enrolling in the Nursery program tier will cost participants $100 per year, Gann said, and when a company is prepared to go to market with its product, it may graduate to one of the other three tiers.

Nursery members will have access to Epic’s FHIR sandboxes, classroom and online learning opportunities, and the ability to engage with the online community of Epic, health system, and vendor developers and experts.

In addition to the program fee reductions, as part of the update, Epic will offer new program benefits to participants in the other three tiers, such as additional training opportunities, developer events, support services, sandboxes, and program accounts.

Gann also said Epic has simplified the pricing model for API-based integrations, eliminating the minimum fees, and reducing the cap. “It’s our expectation these updates will be a price reduction for nearly all program members,” he said.

Some developers, particularly smaller developers, have complained in the past that the fees to participate in the vendor app store are too steep.

Earlier this year, Politico reported the experiences of Rick Freeman, CEO of Interopion. Freeman told Politico that a family planning questionnaire app he developed for HHS’s Office of Population Health could have cost him up to $750,000 to run on Epic or Cerner for a year.

As reported by Politico in its October 26 report, in response to the program updates, Freeman said he is “very happy with the changes.”

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Improving the Communication Infrastructure: Healthcare’s Next Big Wave?

October 31, 2018
by Rajiv Leventhal, Managing Editor
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CHIME’s latest report, which surveyed the association’s C-suite provider membership, looks at several trends and challenges in the health IT landscape today

With access to patient health information now commonplace among providers, the next core investment could be in communication channels with patients, according to CHIME’s 2018 HealthCare’s Most Wired survey.

The survey findings, released on October 31 at the College of Healthcare Information Management Executives (CHIME) 2018 Fall CIO Forum in San Diego, included more than 600 participants, and revealed an array of findings related to interoperability and integration, data security, value-based care and population health, and patient engagement.

This is the first year that CHIME conducted the Most Wired survey and the first year a trends report based on survey data has been made available for the industry, according to the associations’ officials.

Many organizations reported that they do have the capability to consume data from outside entities such as an external hospital system or a retail pharmacy, although less so with home health agencies, skilled nursing homes and chronic care facilities.

Meaningful use has helped drive the development and use of patient portals, and progressive providers have adopted several additional capabilities, according to the analysis. And, many patients have readily transitioned to mobile apps offered by most portals. Regulations on application programming interfaces (APIs) under Promoting Interoperability, the Centers for Medicare and Medicaid Services’ renaming for meaningful use, will expand engagement opportunities with patients but also pose security challenges for providers, according to officials who presented the findings at the CIO Forum.


Advancements in Healthcare: Interoperability, Data Exchange, and More

Micky Tripathi, President and Chief Executive Officer of the Massachusetts eHealth Collaborative, is one of the most well-informed and well-respected healthcare IT leaders in the U.S. Tripathi has...

The report specifically noted, “As healthcare adopts and leverages new technologies, it is becoming increasingly complex to maintain an ecosystem in which data can be reliably shared. Poor communication between disparate systems can be one of the greatest impediments to clinicians being able to access the information necessary to provide effective patient care. Communication technologies, like remote access capabilities and emergency alerting, can improve the speed at which critical data is delivered to caregivers.”

Indeed, nearly all of the survey’s participating organizations reported that at least 95 percent of their clinicians regularly access clinical information electronically. This includes medical history, nurse notes, order sets, care plans, diagnostic study results, operative reports, medication reconciliation, discharge instructions, care plans, and clinical summaries. Similarly, almost all physicians can electronically access their organization’s EHR, CPOE, clinical guidelines, medical images, and evidence references while in the hospital or clinic.

However, only about half of physicians can access these same resources via mobile applications. Adoption of secure messaging also lags behind other remote-access functions; both represent opportunities for the industry to advance the current communication infrastructure, according to the analysis.

What’s more, over three-fourths of participating organizations send the following patient-monitoring data directly to the EHR: blood glucose, bedside blood pressure, bedside pulse oximetry, and EKG data. But there are still significant gaps in the integration between EHRs and patient-monitoring equipment—only 25 percent of participating organizations send data from their IV pumps directly to their EHR, and only 10 percent send data directly from in-bed scales. Furthermore, when tracking hospital-acquired infections, 59 percent integrate this data with their EHR, 33 percent store the data electronically, and 8 percent use manual processes.

Regarding security, few organizations (29 percent) have a comprehensive program in place, which CHIME outlines as doing all of the following: reporting security deficiencies and security progress to the board; having a dedicated CISO (chief information security officer) and cybersecurity committee; providing security updates to the board at least annually; and having a board-level committee that provides security oversight.

Indeed, having a dedicated CISO and regularly reporting security updates to an executive committee are some of the first steps to mitigating cybersecurity vulnerabilities. However, for most organizations, establishing these security foundations is still a work in progress, the report revealed.

When it comes to value-based care and population health, data aggregation is the first step toward effectively leveraging population health management technology, and while the industry has made progress, there is still room to improve data aggregation across the continuum of care, according to the report. About 57 percent of healthcare organizations are using clinical and billing data as well as an HIE to identify gaps in care. However, only one-quarter of organizations are using these tools and have the ability to access registry data at the point of care.

The analysis noted that care-management practices for areas outside of the inpatient setting are still maturing, especially for home management of chronic diseases. While most provider organizations’ population health strategies target diseases like COPD, congestive heart failure, diabetes, heart disease, and hypertension, few are tracking behavioral health, sickle cell anemia, or end-stage renal disease. Additionally, few organizations currently allow patients at home to do things like manually submit self-test results or report their medication management compliance via email.

The survey also asked participants about their patient engagement and telehealth capabilities. Within the hospital setting, adoption of patient engagement capabilities is shallow. Less than one-third of organizations support patient and family functions for ordering meals based on dietary restrictions, planning for discharge processes, controlling environments, reporting non-clinical problems, and accessing traditional whiteboard information. And roughly one-third support patient engagement–related staff functions for initiating patient pathways, while one-quarter have adopted real-time engagement.

Obstacles remain in order to truly engage patient communities, with one example being that price transparency is still emerging—only 27 percent of participating organizations provide the public with cost calculations for common procedures.

Virtual care is gaining traction, with over one-third of participating organizations offering virtual visits in a non-clinical setting. While this may seem low compared to adoption of other capabilities, it is actually high given that virtual care is still developing, and few patients have participated in it, according to the report’s analysts.

And while barriers such as reimbursement limitations and evolving regulations currently prevent healthcare organizations from harnessing the full potential of telehealth services, 89 percent of participating organizations offer some form of telehealth services. Most of these organizations are still early in their telehealth journey; few offer focused telehealth services such as eICU, rehabilitation, genetic counseling, or skilled nursing services.

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