Several healthcare IT associations have submitted comments to the Office of the National Coordinator for Health IT (ONC) in response to the agency’s federal draft strategy on reducing administrative and regulatory burden on clinicians caused by technology such as EHRs (electronic health records).
In late November, the Department of Health and Human Services (HHS) issued its 74-page draft strategy, which was developed by the health IT arm of the federal government—ONC—in partnership with the Centers for Medicare & Medicaid Services (CMS), and which was required in the 21st Century Cures Act.
The strategy outlined 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 healthcare organizations; and improve the functionality and intuitiveness of EHRs.
The draft strategy then laid out four focus areas—including clinical documentation, health IT usability and user experience, EHR reporting, and public health reporting—setting forth dozens of recommendations to reduce administrative and regulatory burden.
Stakeholders were encouraged to comment on the document up until January 28. Healthcare Innovation recently reported the comments made by the Pew Charitable Trusts, which focused mostly on emphasizing patient safety and improving care coordination—through effective API (application programming interface) use.
Now, the thoughts of other trade groups have also been made public, such as those of the Charlotte-based Premier, which stated the importance of prioritizing data availability at the point of care and within the clinical workflow; and reiterated that APIs should be standardized, openly published, and consistently implemented.
Premier also stressed the need for additional efforts to reduce provider administrative and reporting requirements, such as: more reasonable timelines; increased provider flexibility around reporting, promoting interoperability and documentation; more appropriate and valuable quality and promoting interoperability measures; reduced program overlap; the development, implementation, and consistent adoption of and support for data and interoperability standards; and more timely access to data such as behavioral health, substance abuse disorder and Medicaid data. Finally, Premier urged HHS to use specific policy levers to hold EHR vendors accountable for demonstrating and ensuring interoperability (particularly providing app developers access to and interaction with data in the workflow) and usability of their products.
Meanwhile, the Bethesda, Md.-based AMIA (American Medical Informatics Association), said that it “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 (FFS) billing requirements and business processes for regulatory/administrative compliance, rather than reflect clinical observation and treatment.”
The group also noted that while the Promoting Interoperability Program and Merit-based Incentive Payment System (MIPS) are prominent examples of regulations impacting the use of health IT and clinical workflows, there are many other programs and policies that create burden related to the use of health IT 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, according to AMIA.
To this point, the Electronic Health Record (EHR) Association stated in its comments, “As HHS takes important steps toward reducing clinician burden, it is important to recognize that a key contributor to the frustration of providers with EHR documentation requirements has been compliance with outdated guidelines which are geared to billing and policy requirements rather than patient care. The current proposed strategy and CMS's ‘Patients Over Paperwork’ initiatives are welcome steps toward more focused documentation requirements.”
MGMA Weighs In
The Colorado-based Medical Group Management Association (MGMA) further detailed a variety of actions that it would like ONC to take, including addressing prior authorization; publishing electronic attachment standards; reducing general burdens that physicians are experiencing in the MIPS (Merit-based Incentive Payment System) program; modify the Promoting Interoperability program within MIPS; extend Stark law and anti-kickback harbors; explore the HL7 FHIR standard; and “consult with the physician practice community.”
In a recent interview with Healthcare Innovation, MGMA director of health information technology policy, Robert M. Tennant, noted that many of the issues in the draft are actually beyond the scope of ONC, and are more CMS-related elements—such as reducing clinical documentation burdens. Tennant said in the interview, “Even though it was an ONC document, they still had the HHS Secretary and CMS Administrator write introductions. So that tells us that they’re not looking strictly at HIT policy…”
He also noted that his group has responded to government RFIs like this one a number of times before. “So yes, it’s a new RFI [request for information], but the questions they’ve asked, they’ve asked many before. Our concern is that they keep asking questions, but we’re not seeing a lot of policy action. So we’re hoping this is the final time they go out to the industry. Now, absorb what the industry is telling you, and turn that into policy action; that’s our real hope, that they’re not just soliciting industry input,” he said.
42 CFR Part 2 Considerations
Also of note in the stakeholder comments were recommendations from the Partnership to Amend 42 CFR Part 2, that urged HHS to examine how to align the privacy regulations more closely with HIPAA. Currently, the federal law known as 42 CFR Part 2 prevents the sharing of the sensitive treatment records without a patient's explicit consent. But many people believe the law is severely outdated since it doesn’t always give providers the whole picture of a patient’s medical history.
When The Opioid Crisis Response Act of 2018 was passed last fall, there was thought that a provision would be included to modernize the data-sharing aspect of 42 CFR Part 2, but according to reports, this element ultimately got dropped in negotiations.
In its recent comments, the Partnership stated, “Part 2 is not compatible with the way healthcare is delivered in the 21st Century. Part 2 presents enormous barriers to patient safety and coordinated care, and it creates a clinical burden for physicians.”
The comments continued, “The draft strategy recommendation in this area suggests that HHS provide additional guidance about HIPAA privacy requirements and Part 2 requirements. We agree that additional guidance is necessary. We strongly recommend that new guidance changes current regulations so that Part 2 is aligned with HIPAA to allow for the transmission of Part 2 records without written consent for the purposes of treatment, payment, and healthcare operations.”