FR 2025-05007

General Summary

This document, issued by the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS), announces a postponement of the effective date for two significant telemedicine rules. Initially planned to take effect on March 21, 2025, these rules will now be delayed until December 31, 2025. The first rule, "Expansion of Buprenorphine Treatment via Telemedicine Encounter," allows the prescription of medications for opioid use disorder via telemedicine. The second rule, "Continuity of Care via Telemedicine for Veterans Affairs Patients," facilitates the prescription of controlled substances to certain Veterans Affairs patients through telemedicine. This postponement aims to provide additional time to address various questions of fact, law, and policy, and also considers public feedback received through comments.

Significant Issues or Concerns

The document presents several concerns:

• Complex Legal Language: The document contains complex and technical legal language, making it potentially challenging for the general public to fully comprehend without a background in regulatory or legal matters.

• Lack of Specificity on Delay Reasons: There is a lack of detailed reasoning for delaying the effective date beyond a general reference to the need for further review. This lack of transparency leaves questions about the specific issues prompting the delay.

• Insufficient Context: The document references various prior federal registers and effective dates without providing a comprehensive background. This may make it difficult for readers unfamiliar with previous announcements to fully understand the timeline and implications of these changes.

• Unclear Justification for New Date: The choice of December 31, 2025, as the new effective date is not explained in detail. The document doesn't clarify how this date aligns with the objectives of the DEA and HHS.

• Limited Discussion of Public Comments: While it notes receiving 32 public comments, the document gives a limited explanation of how these influenced the decision. Details about specific comments and their impact on the decision are notably absent.

• Economic Impact Exploration: Although it is stated that the delay does not affect the economic impact calculation previously conducted, there is no detailed exploration of any potential short-term financial impacts of the delay.

Public Impact

Broadly, this delay may have notable implications for the larger community:

• General Public: For the general public, particularly patients and families affected by opioid use disorder or those reliant on Veterans Affairs healthcare, the delay could mean a postponement in accessing potentially beneficial telemedicine services.

• Healthcare Accessibility: This delay means that the anticipated changes in telemedicine practices that could improve healthcare accessibility remain postponed, maintaining the status quo for an additional period.

Stakeholder Impact

• Healthcare Providers: Practitioners who were preparing to expand their telemedicine services under these rules might need to adjust their plans. They may face continued limitations on their ability to prescribe certain controlled substances without an in-person examination.

• Veterans Affairs System: Stakeholders within the Veterans Affairs system, who were preparing for the implementation of new telemedicine capabilities, may experience operational delays and need to continue with existing procedures.

• Policymakers and Regulatory Agencies: For policymakers and regulatory bodies, the delay allows additional time to refine and address all legal, factual, and policy questions, possibly resulting in a more robust framework upon eventual implementation.

Overall, the document reflects a decision to prioritize thorough review and public consultation over immediate implementation, aiming to ensure that the rules, once in effect, are sound and comprehensively address concerns from various stakeholders.

The Federal Register document discusses the extension of effective dates for two final rules concerning telemedicine practices, specifically focusing on the Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients. These rules primarily involve the Department of Justice and the Department of Health and Human Services.

Financial Implications

The document includes an important financial reference under the Unfunded Mandates Reform Act of 1995. According to the assessment, the rule change is determined not to result in any significant financial impact, notably: "this action would not result in any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year."

Relation to Identified Issues

1. Complex Legal Language: The document contains technical and legal language that might be challenging for a general reader to understand. This complexity persists despite referencing high financial thresholds like the $100,000,000 marker to address concerns under the Unfunded Mandates Reform Act.

2. Lack of Detailed Financial Breakdown: While the document mentions that the action will not result in large expenditures, it does not provide a detailed financial analysis or breakdown of costs potentially avoided by these rules. The lack of intricate financial details regarding the delay might leave lay readers with questions around potential cost implications or savings.

3. Contextual Gaps: There is minimal context provided around how this $100,000,000 threshold aligns with the objectives and the strategic decisions to delay the rules' implementation until December 31, 2025. This makes it difficult for readers to understand the broader financial picture and justifications.

4. Impact of Public Comments on Finances: It is noted that public comments played a role in the decision-making process regarding the delay. However, there is no linkage made between these comments and any potential financial impact, be it direct costs or savings, as might have been addressed in the public's feedback.

Overall, while the document assures that no significant financial burden is anticipated as a result of the delays, the lack of detailed financial analyses or contextual information might leave readers with unanswered questions regarding the economic implications behind these administrative decisions.