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March 2019

Washington Scene — Shutdown or Not, Washington Wheels Turn
By Allison F. Viola, MBA, RHIA
For The Record
Vol. 31 No. 3 P. 26

Washington launched into 2019 tenuously, as the government continued with a partial shutdown that saw no end in sight and ended up being the longest shutdown in history. As federal government employees continued to miss paychecks, President Trump stood his ground and demanded that a $5 billion secure southern border wall was essential for the country’s protection from migrants heading north from Mexico and other countries.

During this time, almost all federal activities came to a grinding halt, impacting more than 800,000 federal employees and countless federal contract workers. Finally, on January 25, President Trump agreed to temporarily reopen the government while Congress worked toward negotiating an agreement on border security. On February 15, President Trump signed a spending bill to avoid another government shutdown but also declared a national emergency in accordance with the 1976 National Emergencies Act, which will redirect funds and allow him to circumvent Congress and use the military to build the wall.

Despite suspended government activities, some pockets within the government continued their work as much as was allowed and funded. For example, most of the staff at Health and Human Services were furloughed and only a skeleton crew at the Office of the National Coordinator for Health Information Technology (ONC) was left to conduct an orderly phase down of operations. The shutdown prevented ONC from performing its continued work on standards coordination, implementation, testing, and policy work.

A Busy December
Congress has been keeping an eye on the information blocking rule’s progress. For the most part, it’s committed to the rule, believing it’s a critical component in the effort to better share health information for improved care and quality.

The House Ways and Means Health Subcommittee conducted a hearing on December 11, 2018, titled “Implementing the 21st Century Cures Act: An Update From the Office of the National Coordinator” to receive an update from Donald Rucker, MD, who currently oversees ONC. Although Rucker did not provide specific details on the information blocking rule, he did highlight several of ONC’s accomplishments and its future.

One of the initiatives highlighted was publication of the ONC draft of the Trusted Exchange Framework and Common Agreement (TEFCA) in early 2018 that defined standards for interoperability as required by the 21st Century Cures Act. The goal of TEFCA is to establish an “on-ramp” for health information exchange (HIE) and to support this on-ramp for participants.

TEFCA “seeks to expand health information exchange nationwide and ensure that patients, providers across the care continuum, community and social services, and other stakeholders, such as payers, can access real-time health information.”

Although TEFCA is purely voluntary and enables a nonregulatory approach toward HIE, HIT stakeholders are concerned about ONC’s rip-and-replace method. As a result, they called on the agency to leverage infrastructure that is currently in place to save costs, time, and other valuable resources.

ONC was expected to publish the final TEFCA in late 2018; however, the partial shutdown prevented this from occurring and the industry still awaits its publication.

Addressing EHR Concerns
Several days before the shutdown, ONC, along with the Centers for Medicare & Medicaid Services (CMS), published a draft report, Public Law 114-255, Section 4001, as required by the 21st Century Cures Act, to establish goals, develop a strategy, and provide recommendations to reduce EHR-related burdens that affect care delivery. The report, “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs,” sought comments from the public on the following three overarching goals designed to reduce clinician burden:

• reduce the effort and time required to record health information in EHRs for clinicians;

• reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and

• improve the functionality and intuitiveness (ease of use) of EHRs.

Within the identified goals, the draft report sought to explore issues, strategies, and recommendations associated with clinical documentation, HIT usability and the user experience, EHR reporting, and public health reporting.

The clinical documentation portion explored ways to reduce the burden associated with several administrative requirements. ONC proposed a reduction in documentation requirements around patient visits, continued partnership with appropriate stakeholders to encourage the adoption of best practices related to documentation requirements, and the leveraging of IT to standardize data and processes around ordering services and related prior authorization processes.

HIT usability explored ways in which improving the design and use of IT systems can reduce EHR usability burden. ONC recommended aligning EHRs with clinical workflows, improving decision-making and documentation tools, harmonizing clinical content contained in HIT, and promoting the importance of implementation decisions that impact clinician burden.

EHR reporting addressed several of the programmatic, technical, and operational challenges related to program reporting through EHRs. ONC recommended simplifying program requirements and incentivizing new approaches, leveraging HIT functionality to reduce burdens associated with reporting programs, and improving the value of clinical quality measures while decreasing provider burden.

Public health reporting discussed issues linked to federal, state, local, territorial, and tribal government policies and health programs where EHR-related burden remains a barrier to progress. Strategies reviewed in the report address the increased adoption of electronic prescribing of controlled substances and integration of prescription drug monitoring programs (PDMPs) through improved HIT and provider workflow, and harmonizing requirements across federally funded programs that impact health providers.

ONC and CMS Proposed Rules
After much anticipation, ONC and CMS issued proposed new rules to “support seamless and secure access, exchange, and use of electronic health information” (EHI).  

ONC’s proposed rule, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program,” Section 4004 of the Cures Act, authorizes Health and Human Services to identify reasonable and necessary activities that do not constitute information blocking. 

If the actions of a regulated actor (health care providers, HIT developers, and HIE networks) satisfy one or more of the following exceptions, the actions would not be treated as information blocking and the actor would not be subject to civil penalties and other disincentives under the law:

• preventing harm;
• promoting the privacy of EHI;
• promoting the security of EHI;
• recovering costs reasonably incurred;
• responding to requests that are infeasible;
• licensing of interoperability elements on reasonable and nondiscriminatory terms; and
• maintaining and improving HIT performance.

The CMS proposed policy changes support its MyHealthEData initiative to improve patient access and advance electronic data exchange and care coordination. The Interoperability and Patient Access Proposed Rule outlines opportunities to make patient data more useful and transferable through open, secure, standardized, and machine-readable formats while reducing restrictive burdens on health care providers.  

Within the proposed rules, CMS presented two requests for information seeking input on interoperability and HIT adoption in postacute care settings and the role of patient matching in interoperability and improved patient care. 

Highlights of the rule include the following:

• patient access through application programming interfaces (APIs);
• HIE and care coordination across payers;
• API access to published provider directory data;
• care coordination through trusted exchange networks;
• public reporting and prevention of information blocking;
• increasing the frequency of federal-state data exchanges;
• provider digital contact information;
• revisions to conditions of participation; and
• advancing interoperability in innovative models.

Other Legislative Efforts
On Capitol Hill, Congress will continue its legislative activities to address cybersecurity, privacy, and PDMPs as well as other efforts to address the opioid crisis and telehealth. Proposed cybersecurity and privacy legislation continue to build momentum as ransomware attacks increase and social media sites acknowledge sharing or selling members’ data without their knowledge.

In late 2018, President Trump signed into law a sweeping legislative package featuring more than 70 bills that lawmakers and public health experts believe would curb the country’s growing opioid crisis. The law, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act), directs funds to federal agencies and states to make addiction treatment a priority.

In addition to these efforts, telehealth continues to gain traction, with the most notable development being improved CMS reimbursements in the 2019 Medicare Physician Fee Schedule and Quality Payment Program.

On both the regulatory and legislative fronts, 2019 portends to be an active year. There will be a lot to catch up on with the publication of anticipated regulations and strategies that address and promote information sharing, privacy, patient access, and reducing regulatory burden.

— Allison F. Viola, MBA, RHIA, is a director at Guidehouse.