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President Obama Signs 21st Century Cures Act into Law

December 13, 2016
by Heather Landi
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With President Barack Obama’s signature today, the 21st Century Cures Act, widely considered to be landmark healthcare legislation, was passed into law.

The bill, which was more than two years in the making, gained bipartisan support and was passed by both chambers of Congress during a lame duck session. The bill passed in the Senate last week with a vote of 95-4, and two weeks ago, the U.S. House of Representatives approved the bill by a vote of 392-26.

The sweeping legislation largely focuses on medical research and changing the approval process for new drugs and medical devices but also includes a number of health IT provisions aimed at improving interoperability and electronic health information exchange.

More broadly, the $6.3 billion package of medical innovation bills contained in the 21st Century Cures Act includes $4.8 billion to the National Institutes of Health (NIH). That NIH funding includes $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). Additionally, the bill includes $500 million in funding to the U.S. Food and Drug Administration (FDA) over 10 years with the aim of moving drugs and medical devices to patients more quickly. 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.

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In his remarks before signing the bill, President Obama praised the bipartisan support behind the legislation and focused specifically on the funding for NIH research efforts, such as the Precision Medicine Initiative, the Cancer Moonshot and the BRAIN initiative. “This legislation is bringing to reality the possibility of new breakthroughs to some of the greatest health challenges of our time,” he said during the signing ceremony.

Regarding the Precision Medicine Initiative, President Obama said the legislation would help to support the efforts to “use data to modernize research and accelerate discovery so treatment and healthcare can be tailored to individual patients,” and also noted that this spring, the NIH will launch its groundbreaking research cohort.

President Obama also noted that NIH’s Cancer Moonshot initiatives in the legislation had been named in honor of Vice President Biden’s son, Beau, who died of brain cancer in 2015. “It is a bittersweet day. My mother was two and a half years younger than I am today when she died of cancer. Being able to honor those we’ve lost in this way, and to know we may be able to prevent other families from feeling that same loss, that makes it a good day and I’m confident that there will be better years and better lives for millions of Americans,” Obama said.

Vice President Joe Biden said that the bill “will fundamentally change the culture of our fight against cancer.”

As it relates to healthcare information technology, 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. A number of health IT industry organizations have expressed strong support for the legislation, specifically the focus on EHR interoperability and efforts to improve patient records matching.

In an interview two weeks ago when the legislation was making its way through Congress, 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.”

In a statement, Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), praised the enactment of the 21st Century Cures Act for spurring interoperability.

“The 21st Century Cures Act will help pave the way to greater interoperability and improve electronic health information exchange. The law reflects the growing need to develop a standards-based information exchange infrastructure. CHIME has been at the forefront of advocating for greater attention to standards development and for improving interoperability,” Branzell said.

CHIME also lauded the bill’s provisions that address the issue of accurately identifying patients and matching them to their health records. CHIME is sponsoring a $1 million challenge, the National Patient ID Challenge, focused on finding a solution for accurate patient identification.

“While that $1 million-challenge continues, and we hope to identify a winner in 2017, we welcome the opportunities laid out in the 21st Century Cures Act that could allow us to collaborate with our federal partners on this important patient safety issue,” Branzell said.

Further, Branzell stated, “CHIME also supported language in the law that will create a more transparent process for certifying electronic health record systems; a process that will include real-world testing for interoperability. This will add a layer of confidence that health IT systems are capable of supporting the transition to a more integrated and value-based delivery system.”

On the CHIME website, the organization provides a summary of the health IT provisions and a timeline of actions directed by the legislation.

The law establishes authority for the U.S. Department of Health and Human Services (HHS) Office of the Inspector General to investigate claims of information blocking and assign penalties for practices found to be interfering with the lawful sharing of EHRs. Organizations that are found to have committed information blocking face civil monetary penalties up to $1 million. Additionally, the law instructs HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of EHRs. 21st Century Cures also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking by establishing 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.

Smith noted that while the 21st Century Cures Act authorized funding for NIH, it does not appropriate funds. "I think the funding is going to be an important piece to watch," Smith said in an interview two weeks ago.

 


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DirectTrust Touts 2018 Growth in Data Exchange Volume, Participants

January 23, 2019
by Rajiv Leventhal, Managing Editor
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DirectTrust, a nonprofit organization that supports health information exchange via the Direct message protocols, has announced continued steady growth in the number of healthcare organizations using its interoperability services during 2018.

The organization also noted an upsurge in the number of Direct message transactions, patient use, and addresses. According to year-end 2018 metrics:

  • There were nearly 274 million Direct message transactions between DirectTrust addresses in 2018, a 63-percent increase over the 2017 total of 168 million transactions. There were more than 110 million Direct messages transmitted during the fourth quarter of 2018 alone.
  • The number of patients/consumers involved using Direct increased approximately 35 percent to nearly 248,000.
  • The number of healthcare organizations served by DirectTrust accredited health information service providers (HISPs) increased 30 percent to nearly 139,000, compared with approximately 107,000 at year-end 2017.
  • The number of trusted DirectTrust addresses able to share PHI across the DirectTrust network increased 16 percent to more than 1.8 million since the end of 2017.
  • Eleven healthcare organizations joined DirectTrust during 2018, bringing the organization’s total membership to 115.

Last July, DirectTrust named former Cerner executive Scott Stuewe its new CEO to replace founding CEO Dr. David Kibbe. In a recent interview with Healthcare Informatics, Stuewe spoke about working more closely with EHR vendors and expanded opportunities for his organization’s trust framework.

He told Healthcare Informatics at the time that his organization could make more headway by engaging with the EHR (electronic health record) vendors who so far have not been very engaged with DirectTrust. “There are some gaps in features among the EHRs that frankly are the same gaps we saw in query-based exchange in CommonWell. There are usability problems; the way a given feature surfaces in one EHR is so different than another that you can’t even do the same work flow across the two systems,” Stuewe said.

Stuewe also noted that DirectTrust’s technical trust framework is about “stretching the highest security mechanism across identity-proofed endpoints,” which, he said, “is kind of a unique model.”

A recent data brief from the Office of the National Coordinator for Health IT (ONC) revealed that about four in 10 surveyed hospitals participated in more than one nationwide health information exchange network, such as Surescripts, the e-Health Exchange, DirectTrust, CommonWell, or Carequality. Surescripts was the most commonly network used; 61 percent of hospitals participated. The next highest participation rates were in DirectTrust and the e-Health Exchange; about a quarter of hospitals participated in each.

 

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Hospitals Outline Agenda to Accelerate Interoperability

January 22, 2019
by Heather Landi. Associate Editor
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Hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, but collaboration across many private and public sector entities, including technology vendors and policymakers, is necessary to achieve comprehensive interoperability, according to a new report from national hospital associations.

The report reviews the current state of interoperability, which show promises but is still a patchwork system, as well as outlines current challenges and provides an agenda for steps to take to improve interoperability among health IT systems. The report was compiled by seven national hospital associations—America’s Essential Hospitals, American Hospital Association (AHA), Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association, Federation of American Hospitals and the National Association for Behavioral Healthcare.

“We see interoperability in action all around us. Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions,” AHA President and CEO Rick Pollack said in a statement.

“For the best care today, it’s the data stupid. Quality care depends on having the right information at the right time, so our patient’s records need to be available in the hospital or wherever our patients receive care. Hospitals are joining together to support improving interoperability because it is the key to assuring the best for our patients,” Federation of American Hospitals President and CEO Chip Kahn said in a prepared statement.

The report highlights that hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, up from 27 percent in 2012. What’s more, 88 percent of hospitals are sharing records with ambulatory care providers outside their system, up from 37 percent in 2012. And, 87 percent of hospitals enable patients to download information from their health record, up from 16 percent in 2012.

“We are inching closer to, but still short of, the ideal of seamless interoperability. In health care, this refers to the capacity to send and receive a patient’s health information from multiple sources between different systems and locations with its integrity intact,” the report authors wrote. “The information communicated must be useful to the receiving care provider, patients and families, and result in the care decisions that are best for them. Today, interoperability is a partially-achieved aim, working well in some but not all settings.”

The report authors note that the key to leveraging health data’s full potential for improving patient care is the establishment of a framework for compatible technical and linguistic (semantic) standards adopted by all parties that “lead us to a generic, vendor-neutral data exchange platform.” “We currently lack universally agreed upon ways of sharing and using information — “rules-of-the-road” that make possible the uncorrupted transfer of patient data between differing (and often proprietary) health record systems,” the report authors wrote.

Looking at progress made to date, hospitals and health systems have invest hundreds of billions over the past decade in electronic health records (EHRs) and other IT systems that record, store and transfer patient data securely among medical professionals. In 2017 alone, hospitals and health systems invested $62 billion in these IT systems.

According to the Office of the National Coordinator for Health Information Technology (ONC), the vast majority of hospitals use multiple mechanisms to share health information, and more than half must use four or more. Furthermore, most hospitals devote significant resources to manually matching patient records, since we do not have a national patient identifier, the report states.

And, according to 2010 AHA survey data, only 16 percent of hospitals had a basic EHR system in place. By 2017, 97 percent of surveyed hospitals had adopted a certified EHR system.

What’s more, hospitals and health systems have made efforts to link via health information exchanges (HIEs), however, the report notes while HIEs do deliver on some of the promises of interoperability, the exchangeable data is often limited to a regional or statewide scale. “In addition, some HIEs cannot reliably carry out full data exchange within a health system among different source technologies, or data

 

 

exchange across health systems including ambulatory or post-acute settings,” the report authors wrote. Also, HIEs may not enable individual patients to access their data.

The report authors also outline the ongoing barriers to comprehensive interoperability. According to an AHA analysis on barriers to health data exchange and interoperability, 63 percent of respondents cited the lack of capable technology as the biggest barrier. That survey also identified difficulties matching or identifying the correct patient between systems also as additional costs to send or receive data with care settings and organizations outside their system as significant interoperability barriers as well.

“Barriers to interoperability must be addressed in order to support the level of electronic sharing of health information needed to provide the best care, engage people in their health, succeed in new models of care, and improve public health. Doing so requires collaboration across many private and public sector entities, including hospitals and health systems, technology companies, payers, consumers, and federal and state governments,” the report authors wrote.

The report also outlines “pathways” to advance interoperability with a particular focus around privacy, security, standards and infrastructure as well as industry stakeholders committing to share best practices and lessons learned.

Among the report’s recommendations, new standards are needed to overcome the significant gaps making communication difficult between systems. “For example, APIs (application programming interfaces), including those based on the FHIR (Fast Healthcare Interoperability Resources) standard, allow for more nimble approaches to accessing needed data. Health care will benefit most from use of standard, secure, non-proprietary APIs that minimize the added costs associated with proprietary solutions and gatekeeping. API access should support both patient access to information from providers and other stakeholders, and the use of trusted third-party tools to support clinical care,” the report authors wrote.

“While we have made much progress, at present, we have the incomplete outline of a national data-sharing system in place, one that lacks the agreed upon rules of the road, conformance, technical standards and standardized implementations to ensure that all HIE platforms can communicate correctly with each other,” the report authors concluded.

The report authors note that true interoperability that advances improved health care and outcomes is within reach with effective federal policies and key stakeholders doing their part. The report calls on health systems to use their procurement power to drive vendors toward compatibility in systems design and lend a voice to the development process.

EHR and IT vendors, in turn, should commit to more field testing and consistent use of standards, the report authors wrote, and avoid pricing models that create a “toll” for information sharing. Vendors also should offer alternatives to expensive, labor-intensive workarounds that drain providers’ time and energy.

 

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HL7 Model Identifies Clinical Genomics Workflows, Use Cases

January 16, 2019
by David Raths, Contributing Editor
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Domain Analysis Model covers pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics

HL7’s Clinical Genomics Work Group has published an HL7 Domain Analysis Model (DAM) to identify common workflows and use cases to facilitate scalable and interoperable data standards for the breadth of clinical genomics scenarios.

The Domain Analysis Model (DAM), which has underdone a rigorous ISO/ANSI-compatible balloting process, covers a myriad of use cases, including emerging ones such as pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics.

The effort “builds on the DAM Clinical Sequencing work that is already being used to design precision medicine workflows at hospitals across the country,” said Gil Alterovitz, Ph.D., an HL7 Clinical Genomics Work Group co-chair, in a prepared statement. He also serves as a Harvard professor with the Computational Health Informatics Program/Boston Children’s Hospital.

The Clinical Sequencing DAM fueled the design of FHIR Genomics, the subset of HL7’s FHIR standard designed to communicate clinical genomic information. “By extending to broader domains, it can serve as a standard going forward to aid in the design of workflows, exchange formats as well as other areas,” Alterovitz added,

The document presents narrative context and workflow diagrams to guide readers through the stages of each use case and details steps involving the various stakeholders such as patients, health care providers, laboratories and geneticists. This contextual knowledge aids in the development and implementation of software designed to interpret and communicate the relevant results in a clinical computer system, especially a patient's electronic health record.

The HL7 Clinical Genomics Work Group developed several new applications and refinements in the Domain Analysis Model beyond its original scope of clinical sequencing. One notable addition is the analysis of the common workflows for pre-implantation genetic diagnosis (PGD). For those undergoing in-vitro fertilization, advanced pre-implantation genetic screening has become increasingly popular as it avoids the implantation of embryos carrying chromosomal aneuploidies, a common cause of birth defects. Implementers can follow the workflow diagram and see the context for each transfer of information, including the types of tests performed such as blastocyst biopsy and embryo vitrification.

As the clinical utility of proteomics (detecting, quantifying and characterizing proteins) and RNA-sequencing increases, the DAM also outlines clinical and laboratory workflows to capitalize on these emerging technologies.

HL7 notes that future challenges arise from uncertainty about the specific storage location of genomic data, such as a Genomics Archive and Computer/Communication System (GACS), as well as the structure of a patient’s genomic and other omics data for access on demand, both by clinicians and laboratories. Best practices in handling such considerations are being formulated within HL7 and include international input from across the spectrum of stakeholders. In parallel, the HL7 Clinical Genomics Work Group has been preparing an implementation guide for clinical genomics around many of these use cases, to be leveraged alongside the newly published HL7 FHIR Release 4 standard.

 

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