Interesting report from Thorn Run Partners...
TRP Special Report: HIT Reform is Gaining SteamSeveral regulatory proposals scheduled for publication over the next few months could ameliorate bipartisan frustration with slow pace of policy modernization.
After a lull of several years on the public policy front, health information technology (IT) has emerged again as a "hot issue," driven in large part by provisions in the 21st Century Cures Act. This major health legislation is reinvigorating discussion - and action - around some of the pivotal questions in this era of health IT reform. Meanwhile, the Trump administration has introduced their own slate of priorities in this space, as health care agencies seek to implement an agenda addressing on value-based health care systems and medical device cybersecurity. And while lawmakers continue to grumble that these reforms are only inching forward, a regulatory sprint over the next three-four months is expected to provide clarity on the future of health IT policy.
21st Century Cures Implementation
The 21st Century Cures Act created the Trusted Exchange Framework and Common Agreement (TEFCA) to develop key processes and requirements around interoperability, as well as requirements pertaining to information blocking. The Administration is also on the cusp of releasing several proposals stemming from the Cures Act - several proposed regulations are officially scheduled for release later this year and early in 2019, with the final products potentially providing an opportunity to strengthen the market for health IT stakeholders as well as organizations seeking to support the transition to a value-driven health care system.
Still, policymakers on Capitol Hill are pushing agencies to expedite their work because the promise of patient identification at the point of care and interoperability still need more clarification, guidance, and direction. There is growing frustration in Congress with the slow pace of progress on the issue - and lack of information around implementation of the Cures' interoperability requirements. The Senate recently approved a funding measure with language demanding that the Office of the National Coordinator (ONC) provide a status report on the Cures provisions by September 30th, but no such report has yet materialized. Further, oversight hearings are expected to occur later this year, with the House Energy & Commerce staff reportedly planning to demand Administrations officials testify at a 21st Century Cures update hearing after the November elections.
Trump Administration Agenda
Additionally, the Trump Administration's health care agenda includes significant work on patient empowerment and a value-based health care system. A key component to achieving success with this agenda is advancement of health IT and interoperability of electronic health care records. To that end, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma has worked closely with the White House's Jared Kushner on a patient-centered initiative, MyHealthEData, which aims to ensure that patients have control of and electronic access to their health records. Administrator Verma also has finalized a plan to revamp the Medicare and Medicaid 'meaningful use' program. Additionally, she signaled that CMS will continue to utilize the full extent of its authority to improve interoperability in Medicare and Medicaid, including the possibility of tying interoperability requirements to the Medicare Conditions of Participation (CoPs) to increase electronic data sharing.
With respect to medical devices, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a Medical Device Safety Action Plan, which outlines the agency's vision for how it will continue to enhance programs and processes to assure the safety of medical devices through advancing cybersecurity, revamped related guidance, and pursued new collaborations to strengthen its work to address cybersecurity threats. The Administration is still hoping to secure funding in fiscal year 2019 to create a Center of Excellence for Digital Health (CoE), which would include a cybersecurity unit to complement the advances in software-based devices. New resources also would go towards establishing a public-private multi-disciplinary effort to bring together expertise to serve as a resource for industry and the FDA to assess cybersecurity vulnerabilities and incidents and help identify effective solutions, among other efforts.
Looking Ahead
The legislative agenda around health IT issues will begin to take shape early in 2019. Regardless of which party controls Congress, lawmakers will be active in employing their oversight authority. They may also initiate a new round of legislative proposals, some of which could stem from a forthcoming GAO report addressing current ONC policies and activities to ensure appropriate patient matching to protect patient privacy and security and recommendations and recommendations to improve ONC's work. Other proposal could address Congress' growing interest in addressing the cybersecurity threats to medical devices. The likelihood of success for such proposals will be shaped by the political make-up and dynamics of the new Congress.
Meanwhile, the regulatory landscape heading into 2019 will remain focused on finalizing requirements of the Cures Act. As we have seen this year, CMS may pursue new ways to leverage the Medicare and Medicaid programs to help advance interoperability within the health care system. The Administration is still hoping to secure funding for FDA for fiscal year 2019 to create a Center of Excellence for Digital Health (CoE) with a cybersecurity unit to complement the advances in software-based devices and support the agency's proposal to establish a public-private multi-disciplinary effort to bring together expertise to serve as a resource for industry and the FDA around cybersecurity vulnerabilities.
Regulatory Timeline
The following chart provides a snapshot of the status and anticipated action around upcoming Health IT regulations.
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Robert Still FRBMA
Executive Director
Radiology Business Management Association (RBMA)
Fairfax VA
(703) 621-3363
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