FR 2021-00989

The document is a formal notice from the Health Resources and Services Administration (HRSA), a part of the Department of Health and Human Services. It concerns HRSA's submission of a revised Information Collection Request (ICR) to the Office of Management and Budget (OMB) for procedures related to the National Practitioner Data Bank (NPDB). The NPDB is intended to uphold the quality of healthcare by collecting and tracking adverse actions taken against healthcare practitioners, such as medical malpractice claims or disciplinary measures. The public has the opportunity to comment on these proposed revisions until February 18, 2021.

The document fulfills a legal requirement under the Paperwork Reduction Act of 1995 to seek public input on information collection practices. Such consultations aim to ensure that data collection serves its intended purpose without imposing unnecessary burdens on respondents involved in the data collection process.

Significant Issues and Concerns

One concern is the uncertainty regarding the burden this data collection might place on entities, such as hospitals and medical boards, required to submit reports to the NPDB. For instance, the time and resources required to collect, process, and report information are not adequately detailed. A clearer breakdown would help stakeholders understand the expected workload and resource allocation.

Furthermore, the document references specific legal jargon and regulatory citations, like "45 CFR Part 60," which may not be easily understood by laypersons or entities unfamiliar with federal regulations. This complexity underscores a need for additional clarity or simplification to foster better comprehension among the public.

The document also touches upon the eligibility criteria for entities engaging with the NPDB but does so in a manner that could be simplified. Clearer examples and explanations would be helpful in clarifying which entities are eligible and what their specific responsibilities are.

Moreover, while the announcement mentions that electronic submissions will be done through a secure portal, it does not provide information about the measures in place for data protection and privacy compliance. This omission might raise concerns about whether the NPDB aligns with best practices in data security.

Lastly, there is no mention of the funding or budget allocated for this data collection process, nor are there specific details on the proposed changes to enhance data integrity. Such omissions could lead to questions about the feasibility and oversight of the NPDB's implementation and the effectiveness of the proposed revisions.

Impact on the Public and Stakeholders

This initiative, while technical, has broad implications for the healthcare system, impacting hospitals, healthcare professionals, and licensing bodies who must comply with new or revised reporting requirements. Overall, the NPDB acts as a safeguard for healthcare quality, helping to prevent practitioners with harmful histories from moving unnoticed between states.

For the general public, such measures potentially improve patient safety by ensuring that healthcare providers are more thoroughly vetted through a centralized system that accounts for previous conduct. However, any increased administrative burden on healthcare entities could indirectly affect patients if the costs or operational implications are passed along.

For stakeholders, the changes might mean additional paperwork, adjustments to existing systems, and potential training for staff involved in these functions. However, they also stand to benefit from improved data integrity, as more reliable information could enhance decision-making processes related to hiring, credentialing, and disciplinary actions.

Enhancing awareness of these elements could ensure that stakeholders are better prepared to engage with the NPDB revisions and provide constructive feedback during the public comment period.