Industry Insight

AMIA Calls on HHS to Decouple Clinical Documentation and Administrative Requirements

In comments recently submitted to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), AMIA recommended that Health and Human Services (HHS) orient its documentation burden reduction strategy towards a long-term goal of decoupling clinical documentation from billing, regulatory, and administrative compliance requirements.

In late November 2018, ONC and CMS released its draft “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.” The strategy, which is required by the 21st Century Cures Act, outlines three overarching goals that aim 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 of EHRs.

The draft strategy laid out four focus areas—clinical documentation, HIT usability and user experience, EHR reporting, and public health reporting—setting forth dozens of recommendations to reduce administrative and regulatory burden.

In response, AMIA “strongly supported” the HHS strategy and the organization highlighted the “tremendous opportunity to leverage informatics tools and methodologies to decouple clinical documentation from billing and better integrate regulatory compliance requirements so that clinical decision support (CDS) and quality/performance reporting are better positioned to improve care for patients and reduce burden for clinicians.” However, the group warned that “the core challenge and dominant threat to [the HHS] Strategy is that most EHRs are designed to support transaction-based, fee-for-service billing requirements and business processes for regulatory/administrative compliance, rather than reflect clinical observation and treatment.”

The group noted that while the Promoting Interoperability Program and Merit-based Incentive Payment System are prominent examples of regulations impacting the use of HIT and clinical workflows, many other programs and policies create burden related to the use of HIT and EHRs. For example, Medicare Conditions of Participation, the Medicare Claims Processing Manual, and the Office of Inspector General Work Plan each compel EHR workflow design for their own purposes that increase provider burden.

In commenting on clinical documentation, AMIA recommended that both HHS and regulated industry (developers, providers, and payers) must agree to decouple clinical documentation from billing, administrative, and regulatory requirements with the expectation that documentation is used downstream for CDS and quality/performance reporting as a biproduct of care delivery.

AMIA emphasized the achievable goal of decoupling clinical documentation from billing, regulatory, and administrative compliance requirements by creating an authoritative body from professional and specialty societies to assess clinical documentation requirements; evaluate present technological capabilities to extract then report data; and define a financial mechanism to remunerate clinicians, hospitals, and health care systems for their work.

“AMIA and the informatics community have a rich history of innovation, implementation, and evaluation of IT-enabled documentation,” says AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “Rather than be the focal point of a clinical visit, technology should be invisible to our clinicians’ workflows. Our regulatory and policy approaches need a paradigm shift so that our informatics tools can realize their potential to heal health care.”

AMIA also called on ONC, the National Library of Medicine, and the Agency for Healthcare Research and Quality to dedicate funding to documentation-related R&D. Relatedly, AMIA reiterated its recommendation that these agencies should work together to develop a generalizable metric that captures the cost of data collection and identifies ways to leverage this metric across programs that require deliberate collection of data outside routine care delivery.

In response to the HIT usability and the user experience section of the strategy, AMIA encouraged ONC to “leverage its Certification Program more explicitly and adopt a national universal set of standards for EHR symbols, shapes, and colors for ancillary service reporting and medication labeling nomenclature.” AMIA also urged ONC to encourage Certified EHR Technology developers’ usability and user experience data available to researchers “so that we can learn from tracking, trending, aggregating, investigating patterns of problems at the transaction unit of the patient encounter.”

Finally, AMIA applauded CMS and ONC efforts to identify program requirements that encourage clinicians to engage in higher-value HIT functionality and meet multiple programmatic requirements. However, it cautioned CMS against the inclination to reduce or eliminate public health reporting measures. Keeping such measures in place, AMIA argued, will help to enable convergence on a diversity of standards and requirements across federal, state, and local jurisdictions. AMIA instead encouraged CMS to “partner with other federal agencies, state and local agencies, and professional groups to develop ‘model’ reporting standards that would foster greater consistency in public health reporting.”

“As our health care system continues to evolve, new technologies will fundamentally alter how the patient’s story is captured, communicated, and understood,” Fridsma says. “We must ensure that our regulations and programs enable this transformation—not inhibit it.”

— Source: AMIA

Researchers Receive $1 Million Grant to Improve Medical Data Security

In the age of big data in the health care industry, massive amounts of digital information are produced, stored, shared, analyzed, processed, and transferred around the world from clinics, hospitals, universities, government agencies, pharmaceutical laboratories, and insurance companies every second.

To help protect this wealth of medical information from cyberattacks, the National Science Foundation (NSF) has awarded a three-year grant totaling nearly $1 million to a team of researchers, led by Yan Luo, PhD, of University of Massachusetts Lowell’s department of electrical and computer engineering, to develop a secure cyberinfrastructure for translational research.

Translational research, also known as translational medicine or translational science, refers to the effort of translating or harnessing knowledge from basic biomedical research in the lab into potentially new drugs, therapies, medical devices, diagnostic screening, or treatment for patients and bringing these innovations to market.

“Translational research has been driven by the increasing amount of diverse datasets collected from medical instruments, sensors, patient records, and genetic samples,” says Luo, director of the university’s Advanced Computing and Networking Systems Laboratory and leader of the NSF project.

“Our research will explore and experiment with new ways of sharing data across different organizations that are compliant with HIPAA,” he explains. “This will enable new, efficient collaboration among patients, medical researchers, and practitioners, potentially benefiting global digital health care and personalized medicine.”

The NSF envisions “cyberinfrastructure” as a collaborative research environment in which computing systems, data storage systems, visualization tools, advanced instruments, and scientists are all linked by high-speed networks to provide powerful capabilities for driving innovation and discoveries not otherwise possible within a single institution.

According to Luo, clinical researchers rely heavily on cyberinfrastructure to understand trends, derive correlations, and/or identify anomalies that are instrumental to the accurate diagnosis and effective treatment of diseases as well as the discovery of “precision” drugs that target specific illnesses.

A secure cyberinfrastructure enables researchers to quickly access and share vast datasets with their external counterparts and industry partners, and allows for faster and more efficient virtual experiments and simulations as well as building better health profiles and predictive models for individual patients.

“In this context, the security of patient data is critical,” Luo says, adding that the NSF project will enable sharing and computing of sensitive datasets between private computer clusters, a shared high-performance computing facility (such as the Massachusetts Green High Performance Computing Center in Holyoke), and/or a HIPAA-compliant cloud.

“We will leverage technologies such as software-defined infrastructure [SDI], blockchain, and secure domain name system to extend the boundary of computing to sensitive and private data,” Luo says.

SDI refers to the operation of IT infrastructure entirely under the control of software and with little or no human intervention.

“This is the first project to bring the agility and resilience of SDI to clinical research activities,” Luo says. “The resulting infrastructure can be applied to a wide range of cyberinfrastructure that handles sensitive data, including homeland security and counterterrorism.”

— Source: University of Massachusetts Lowell