Overview
Title
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Agencies
ELI5 AI
The CMS is asking people to tell them what they think about a new plan to make it easier for patients to see their health records online, but they need help explaining complex rules and ensuring people's personal data stays safe.
Summary AI
The Centers for Medicare & Medicaid Services (CMS) is inviting public comments on its plan to collect information under the Paperwork Reduction Act of 1995. This involves a proposed reinstatement of a previously approved information collection related to patient access through Application Programming Interfaces (API). The aim is to improve the interoperability of health information, allowing patients better electronic access to their health records. Public comments are being accepted until January 6, 2025, and can be submitted through the specified online portal.
Abstract
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Keywords AI
Sources
AnalysisAI
The document titled "Agency Information Collection Activities: Submission for OMB Review; Comment Request" is issued by the Centers for Medicare & Medicaid Services (CMS) under the Department of Health and Human Services. It informs the public of CMS's intentions to collect information related to patient access via Application Programming Interfaces (APIs) and invites public comment as part of the Paperwork Reduction Act of 1995.
General Summary
The proposed action aims to advance health information interoperability, allowing patients to electronically access their health records more effectively. This is seen as part of a broader strategy to place patients at the center of their healthcare by making information exchange between various healthcare stakeholders more seamless. CMS plans to enforce these new policies across Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and qualified health plans in certain areas. The public is encouraged to submit comments by January 6, 2025, which can be done through a specific online portal.
Significant Issues or Concerns
One key issue raised is the complexity of language, particularly regarding network adequacy criteria, which may present comprehension challenges to those not versed in healthcare regulation. This could limit the effectiveness of public engagement. Furthermore, there is a lack of transparency on how the estimated burden of 589,950 total annual hours for information collection was calculated, leading to potential concerns about the validity or fairness of the burden on those affected.
Another critical concern is the safeguarding of patient data within this framework of increased electronic access. The document does not address specific security measures that will be implemented, which might lead to apprehension about data privacy and security among stakeholders and the general public.
The document also notes its original publication date as August 22, 2024, and acknowledges a delay in submission to the Office of Management and Budget (OMB). However, no explanation for this delay is provided, opening up questions about CMS's timelines and administrative efficiency.
Impact on the Public
For the general public, primarily patients who utilize these health services, the proposed information collection could significantly enhance how they manage their health. Having electronic access to health information might empower individuals to make more informed healthcare decisions and improve clinical outcomes.
Impact on Stakeholders
Specific stakeholders such as healthcare providers, private sector entities, and health plan issuers will find their operations impacted by these requirements. Providers and insurers might face additional administrative burdens or costs in adhering to interoperability standards and setting up the necessary IT infrastructure to support APIs. For entities not directly covered by the rule, such as issuers only offering standalone dental plans, the document does not provide sufficiently clear explanations on their exclusions, leaving room for possible confusion.
In conclusion, while the document outlines a potentially transformative approach that could benefit patient access to health data, several issues remain. These include the clarity of regulatory language, data safety assurances, and the administrative transparency of CMS’s processes. Public and stakeholder participation in the commentary period will be crucial to addressing these concerns and refining the proposed measures.
Issues
• The document lacks detailed information on how the estimated total annual hours (589,950) for information collection were calculated, making it difficult to assess the accuracy of the burden estimate.
• The language in the section describing network adequacy criteria and compliance with CMS regulations is complex and may not be easily understandable to the general public or stakeholders without educational or professional backgrounds in healthcare regulation.
• The requirement for maintaining standards-based APIs for patient information access does not specify what safeguards are in place to protect patient data, which may cause concerns about privacy and data security.
• There is little clarity on how public comments will influence the final decision-making process for the information collection request.
• The description of who is excluded from the interoperability rule, such as certain QHP issuers, might benefit from a clearer explanation to avoid ambiguity.
• Although the document mentions that this notice was originally published on August 22, 2024, it does not provide an explanation for the delay in submission to the OMB, which could raise concerns about administrative inefficiencies.
• The form number and control number details are included (CMS-10767, OMB control number: 0938-1412), but it is not clear what specific information these identifiers relate to, which might confuse readers unfamiliar with administrative processes.