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Washington Debrief: Health IT Provisions Included in 21st Century Cures Bill Passed by the House

December 5, 2016
by Leslie Kriegstein, Vice President of Congressional Affairs, CHIME
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Health IT Provisions Included in 21st Century Cures Bill Passed by the House

Key Takeaway: Last week, healthcare took center stage yet again as the House of Representatives passed a significant piece of legislation that will greatly impact health IT.

Why It Matters: The 21st Century Cures Act, a bipartisan piece of legislation largely focused on medical research and changing the approval process for new drugs and medical devices, contains several health IT-related provisions, including directives that aim ensure patients are accurately linked to their medical records.

The bill also addresses interoperability and improved transparency of the EHR certification process. CHIME issued a statement in support of the bill, which the Senate is expected to take action on early next week.

A crosswalk of the health IT provisions from last week’s House-passed bill, the 21st Century Cures legislation that first passed the House in July 2015, juxtaposed to those approved by the Senate Committee on Health, Education, Labor and Pensions (HELP) are represented in a table here. The legislation provides the Department of Health and Human Services (HHS), the Office of the National Coordinator for Health Information Technology (ONC) and the Government Accountability Office (GAO) a number of directives with specific deadlines, many of which are outlined here.

Trump Nominates Dr. Tom Price to Lead HHS, Seema Verna to Head CMS

Key Takeaway: President-elect Trump tapped Representative Tom Price, M.D. (R-GA) as his choice to serve as the Secretary of the Department of Health and Human Services (HHS).

Why It Matters: Dr. Price has been a proponent of important reforms to the Meaningful Use program, including pushing for a 90-day reporting period and expanding opportunities to obtain a hardship exemption.

CHIME issued a statement last week pledging to work with the incoming leadership team at the Department of Health and Human Services. The President-elect also announced Seema Verma, MPH, to lead the Centers for Medicare and Medicaid Services (CMS.) Verma brings extensive experience working within Medicaid, including for the state of Indiana, the home state of Vice President-elect Mike Pence.

Meaningful Use Comparison Cheat Sheet Chart

Key Takeaway: Come 2017 there will be three sets of Meaningful Use requirements. 

Why it Matters: Struggling to makes heads or tails of the various and changing sets of Meaningful Use requirements?  CHIME has you covered.  Check out our new comparison chart that compares the three sets of different requirements.  For Medicaid providers, unfortunately the most aggressive set of requirements adopted under Stage 3 are still intact.  CMS has finalized significant changes for Medicare hospitals, however, which will provide substantial relief and flexibility.  For instance, computerized physician order entry (CPOE) and clinical decision support (CDS) while mandatory for Medicaid providers, is no longer a requirement for Medicare hospitals and will not be required under MIPS.  CIOs should also be aware of the different reporting periods.  CMS has adopted a 90-day reporting period for Medicaid providers and Medicare hospitals in 2016 and 2017 but has not yet adopted this for 2018, something CHIME continues to push.  However, CMS has adopted a 90-day reporting period for the Meaningful Use section of MIPS (known as Advancing Care Information) for 2017 and 2018. Moving into the new year, CHIME will continue to advocate for synchronization across programs and greater flexibility all around. Want to chat MACRA? Drop us an email – we want to hear from you.

Quality

Cyber

Key Takeaway: Office for Civil Rights (OCR) issues cyber warning.

Why it Matters: On November 28, 2016 OCR issued a listserv announcement warning covered entities and their business associates about a phishing email that disguises itself as an official communication from the Department. The email prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program, and directs individuals to a non-governmental website, marketing a firm’s cybersecurity services. The phishing email originates from the email address OSOCRAudit@hhs-gov.us and directs individuals to a URL at http://www.hhs-gov.us. This is a subtle difference from the official email address for OCR’s HIPAA audit program, OSOCRAudit@hhs.gov.

As our readers know, OCR is gearing up for the second round of audits. They have notified select business associates of their inclusion in the Phase 2 HIPAA audits.  For more information on the HIPAA Phase 2 Audits visit their website.

Telehealth Addressed in House and Senate Last Week

Key Takeaway: Telehealth proposals continue to garner interest from lawmakers in the House and Senate.

Why It Matters: Lawmakers continue to explore ways to overcome obstacles impeding the expansion of access to telehealth services and reimbursement despite pushback from the Congressional budget office.

In the House, in addition to the telehealth provisions included in the House-passed 21st Century Cures bill, the National Defense Authorization Act (NDAA), contains provisions that will impact the Department of Defense’s (DoD) telehealth policies. The bill passed by the House last week instructed the DoD to enhance access to and the use of telemedicine within 18 months of enactment as a means to improve access to care and improve communication between patients and their providers. The bill suggests services including secure messaging and home health monitoring via tablets, computers and other devices for evaluation, diagnosis and treatment supervision. A provision in the Senate version of the bill that required a provider using telehealth services to be licensed where they are practicing not necessarily where the patient is located was removed.

The Senate, last week, voted 97-0 to pass legislation that would require the Department of Health and Human Services (HHS) to examine potential uses of telehealth to address workforce areas in underserved and rural areas. The Expanding Capacity for Health Outcomes (ECHO) Act (S. 2873) would provide the foundation to expand a small telehealth program meant to connect specialists with rural health facilities. Representative Michael Burgess (R-TX), a physician, introduced the companion bill last June, but the House has yet considered the legislation.


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Epic Plans Meeting for Non-Epic Users on Data Sharing Capabilities

August 16, 2018
by Heather Landi
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Verona, Wis.-based Epic is inviting healthcare provider organizations that don’t use Epic’s electronic health record (EHR) to its “un-Users Group Meeting” at its Verona headquarters to learn how to exchange data with Epic.

The event, planned for September 26, will provide information to healthcare provider organizations about how to exchange charts with providers in their community who use Epic, even if providers use a different EHR— or no EHR at all.

According to Epic’s unUGM website, the event is for “executives and strategic leaders of provider organizations who want to learn and discuss how to exchange with providers in their community who use Epic.”

“Access to a patient’s information, regardless of where he or she has been seen, helps providers deliver the best patient care. The first Un-Users Group Meeting (unUGM) is another way we’re reaching out to the leaders of health systems using other EHRs—or even no EHRs—to help them get connected to the Epic users in their communities,” Dave Fuhrmann, Epic’s vice president of interoperability, said in a prepared statement.

According to the event agenda, topics of discussion include options for exchanging patient data with providers through Carequality, Care Everywhere, health information exchange (HIE) and Direct messaging, as well as patient-directed options, including MyChart, Share Everywhere, Lucy, and Blue Button.

There will also be discussion about interoperability success stories, using both non-Epic and Epic EHRs, and the current state of coordinated care in the U.S. and the use of existing tools to close care gaps, improve communication, and reduce costs.

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Amazon, Google, IBM and Other Tech Giants Pledge to Remove Barriers to Interoperability

August 14, 2018
by Heather Landi
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Six of the world's biggest technology companies, including Microsoft, Google, IBM and Amazon, made a joint pledge at the White House Monday to remove interoperability barriers and to make progress on adoption of health data standards.

The announced came during the Blue Button 2.0 Developer Conference in Washington, D.C. where Microsoft joined with Amazon, Google, IBM, Salesforce and Oracle to jointly commit to support healthcare interoperability by advancing healthcare standards such as HL7 (Health Level Seven International), FHIR (Fast Healthcare Interoperability Resources), and the Argonaut Project. They also pledged to remove interoperability barriers, particularly as it relates to the adoption of technologies enabled through the cloud and artificial intelligence (AI).

Dean Garfield, president and CEO of the Information Technology Industry Council, said in a statement, “Today’s announcement will be a catalyst to creating better health outcomes for patients at a lower cost. As transformative technologies like cloud computing and artificial intelligence continue to advance, it is important that we work towards creating partnerships that embrace open standards and interoperability.

“We commend the White House Office of American Innovation for their leadership in being a catalyst for moving health care beyond siloed systems and varied data standards. As well, we celebrate Amazon, Google, IBM, Microsoft, Oracle, and Salesforce for their commitment to helping to advance open healthcare standard. The opportunity to unleash greater innovation in health care is here and working together we can seize it,” Garfield said.

In a joint statement, the technology companies made a commitment to remove barriers to “frictionless data exchange,” noting that they share “the common quest to unlock the potential in healthcare data, to deliver better outcomes at lower costs.”

The commitment specifically states:

“In engaging in this dialogue, we start from these foundational assumptions: The frictionless exchange of healthcare data, with appropriate permissions and controls, will lead to better patient care, higher user satisfaction, and lower costs across the entire health ecosystem.

Healthcare data interoperability, to be successful, must account for the needs of all global stakeholders, empowering patients, healthcare providers, payers, app developers, device and pharmaceuticals manufacturers, employers, researchers, citizen scientists, and many others who will develop, test, refine, and scale the deployment of new tools and services.

Open standards, open specifications, and open source tools are essential to facilitate frictionless data exchange. This requires a variety of technical strategies and ongoing collaboration for the industry to converge and embrace emerging standards for healthcare data interoperability, such as HL7 FHIR and the Argonaut Project.

We understand that achieving frictionless health data exchange is an ongoing process, and we commit to actively engaging among open source and open standards communities for the development of healthcare standards, and conformity assessment to foster agility to account for the accelerated pace of innovation.”

Gregory J. Moore M.D., Ph.D., vice president of healthcare, Google Cloud, said in a statement, “We are pleased to join others in the technology and healthcare ecosystem in this joint commitment to remove barriers and create solutions for the adoption of technologies for healthcare data interoperability. This will enable the delivery of high quality patient care, higher user satisfaction, and lower costs across the entire healthcare ecosystem.”

Patients should have access to their data, said Mark Dudman, head of global product and AI development, IBM Watson Health, in a statement following the announced commitment. Patients also should have the flexibility to use products and services across different healthcare systems, with confidence that they all are working seamlessly for their care, he said. “We are proud to participate in this pledge and look forward to working with industry and the developer community to ensure appropriate access to data and the use of that data to support vibrant communities and solve health challenges for people everywhere.”

In a blog post, Josh Mandel, chief architect, Microsoft Healthcare, notes that interoperability is an overlapping set of technical and policy challenges, from data access to common data models to information exchange to workflow integration – and these challenges often pose a barrier to healthcare innovation.

Mandel, who previously worked at Google Life Sciences and on the research faculty at Boston Children’s Hospital where he worked on the SMART Health IT Platform, notes that support for the Meaningful Use Common Clinical Data Set grows and it is becoming easier to plug new tools into clinical workflows, analyze clinical histories, collect new data, and coordinate care.” Many of these technical capabilities have been available within small, tight-knit health systems for a long time – but developing these capabilities has required complex, custom engineering and ongoing maintenance and support. Driving toward open architecture makes adoption faster, easier and cheaper,” he wrote.

True interoperability in healthcare requires end-to end solutions, rather than independent pieces, which may not work together, Mandel wrote. “Transforming healthcare means working together with organizations across the ecosystem. Today’s joint interoperability statement reflects the feedback from our healthcare customers and partners, and together we will lay a technical foundation to support value-based care.”

 

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Industry Stakeholders Urge ONC to Move Forward on Information Blocking Rules

August 8, 2018
by Heather Landi
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In a strongly worded letter to National Coordinator Donald Rucker, M.D., several healthcare and health IT industry groups expressed frustration with the Office of the National Coordinator for Health IT’s lack of progress in publishing information blocking regulations, as required in the 21st Century Cures Act.

“It has been 601 days since the 21st Century Cures Act was signed into law. Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” the letter states. Stakeholders including Health IT Now, Research!America, Oracle, the American Medical Informatics Association (AMIA), the American Academy of Family Physicians, Cambia Health Solutions and Claim Your Health Data Coalition signed the letter dated August 6.

In the letter, addressed to both Dr. Rucker and Daniel Levinson, inspector general of the Department of Health and Human Services (HHS), the stakeholder groups note that the 21st Century Cures Act, which was enacted in December 2016, requires the HHS Secretary to “issue regulations to prevent information blocking and to also identify reasonable and necessary activities that do not constitute information blocking.” Further, the law requires ONC to implement a standardized process for the public to submit reports on claims of health information technology products or developers of such products not being interoperable or resulting in information blocking and actions that result in information blocking. “The Office of the Inspector General (OIG) has enforcement authority over vendors and providers who are found to engage in information blocking,” the letter states.

The stakeholder groups also contend that “information blocking poses a significant risk to patient safety and greatly contributes to increased costs and waste in the health care system.”

According to reporting from Politico, during ONC’s 2nd Interoperability Forum this week in Washington, D.C., Rucker told the form audience that ONC is still working on the rule. The rule’s release has been delayed several times and is not expected to be released in September.

“Rucker emphasized Monday that his goal is to make protocols and standards that would let large amounts of health data flow easily between health providers, not just individual patient charts. He and other officials emphasized that ONC’s work is all being done within the confines of HIPAA,” the Politico article stated. Rucker also noted that properly defining which behaviors do and don’t constitute information blocking is “hard to sort out,” and the rule is a “work in progress,” Politico reported.

In a separate statement regarding ONC's delay in issuing an information blocking proposed rule, Douglas Fridsma, M.D., Ph.D., AMIA president and CEO, said, "Information blocking is the absence of interoperability, and there are numerous reasons why information may not flow as intended. Some of these reasons are technical, others for business or policy reasons. The socio-technical interoperability stack is complex and so too is the task of identifying which among its layers is responsible for information blocking. This rule must be critically calibrated to account for these layers, and it must be part of a larger conversation about how we will address other aspects of the socio-technical interpretability stack. Now is the time to initiate this broad conversation through release of the proposed information blocking rule."

In the letter, the industry groups also cautioned that “information blocking impedes provider access to the most current, accurate or complete information on their patients. As the administration proposes and implements new rules related to open APIs and interoperability in Medicare’s payment rules for hospitals and doctors, the lack of clear rules of the road needlessly creates uncertainty for vendors and providers alike.”

“We understand the nuance required but feel that it is past time for a proposal to be made,” the stakeholder groups wrote in the letter.

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