Overview
Title
Expansion of Buprenorphine Treatment via Telemedicine Encounter
Agencies
ELI5 AI
The government has made a new rule so doctors can help people with medicine for feeling better from bad drugs over the phone. They also made sure people picking up these medicines from the pharmacy show who they are to stop any bad stuff from happening.
Summary AI
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have finalized a rule expanding the ability for practitioners to prescribe certain controlled substances for opioid use disorder (OUD) treatment through telemedicine, including audio-only calls. Under these new rules, practitioners can prescribe a six-month supply of these medications after reviewing the patient's prescription drug monitoring program data, with the possibility of extending prescriptions through telemedicine or after a face-to-face evaluation. Additional safeguards include identity verification by pharmacists before filling prescriptions to prevent misuse. The rule aims to continue the telemedicine flexibilities introduced during the COVID-19 pandemic while addressing the opioid crisis and concerns about substance misuse.
Abstract
The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in- person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder.
Keywords AI
Sources
AnalysisAI
The document finalized by the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) expands the use of telemedicine in prescribing treatments for opioid use disorder (OUD). The new rule allows practitioners to prescribe a six-month supply of certain controlled substances for OUD treatment via telemedicine, including audio-only sessions, provided they review the patient's prescription drug monitoring program (PDMP) data. Extended prescriptions can be arranged through other telemedicine means or following an in-person evaluation. This development seeks to maintain the telemedicine benefits introduced amidst the COVID-19 pandemic to continue combating the opioid crisis, while also incorporating safeguards to prevent misuse and diversion of these medications.
Significant Issues or Concerns
The document, although promising advancements in telemedicine, presents several issues. It is inherently dense and contains complex legal references, which could make it challenging for non-experts to fully grasp without careful review. This complexity includes numerous footnotes and references, demanding readers to frequently consult external resources to fully comprehend the document.
There is a concern regarding the new administrative responsibilities imposed on practitioners. For instance, mandatory checks on PDMP data and pharmacists' identification verification might entail additional costs. In states where these regulations already exist, the redundancy might not only be unnecessary but also burdensome for pharmacies.
Furthermore, while consultations and feedback sessions informed the development of the rule, the document does not explicitly detail how all feedback was considered or which suggestions were dismissed. This lack of clarity could lead to concerns about the transparency of the regulatory process.
The document does mention potential cost savings and public health benefits, but without being readily quantifiable, readers might question the actual financial impact. Assumptions regarding DEA-registered practitioners' familiarity and compliance with the system fail to account for possible challenges faced by newer practitioners or small entities.
Public Impact
Broadly, this rule could significantly impact the availability and accessibility of OUD treatments, making it easier for patients—especially those with limited access to in-person healthcare due to remote or rural living situations—to continue or begin therapy without the restrictions of an in-person visit. This approach addresses some of the logistical issues that deter individuals from seeking necessary treatment, potentially lowering the prevalence of opioid overdoses through improved access to medication.
Stakeholder Impacts
Patients: The rule is poised to positively impact patients, particularly those in rural or underserved communities. By facilitating access to necessary medication through telemedicine, it reduces the hurdles related to traveling to healthcare facilities. However, there is a risk for patients who might misuse the system if safeguards are not robustly implemented.
Practitioners: Practitioners face an increase in administrative tasks, particularly with the need for PDMP data review and adherence to regulations around telemedicine prescribing. For some, this could create additional work that detracts from patient care.
Pharmacists: Pharmacists are tasked with verifying patient identity before dispensing prescriptions made under these new rules, a requirement that anticipates preventing misuse but potentially adds to their workload, particularly in states where similar regulations are not prevalent.
Conclusion
This rule embodies a positive stride towards addressing the opioid crisis by harnessing telemedicine's flexibility to expand access to necessary treatments. Yet, it must strike a delicate balance by imposing necessary safeguards against prescription misuse and ensuring that administrative duties do not overburden healthcare providers. By addressing these aspects, it can more effectively serve the dual goals of public safety and healthcare accessibility.
Financial Assessment
The document outlines a set of regulations related to the prescription of buprenorphine for opioid use disorder, which includes relevant financial considerations. It is crucial to understand how these financial aspects are intertwined with the rule's implementation and its broader implications.
The document identifies the annual cost of PDMP reviews as a significant financial concern. The cost is estimated at $191,171 annually, derived from the process of checking prescription drug monitoring program data before issuing prescriptions. This is particularly significant as it represents a direct cost associated with ensuring compliance with the new rules. The cost per review is calculated to be approximately $2.83, based on an hourly rate of $169.80 for practitioners. Although this might seem small on an individual basis, it aggregates to a significant total, emphasizing the administrative burden placed on practitioners.
In the context of treatment costs, the annual cost of buprenorphine for a stable patient in a certified opioid treatment program is cited as $5,980. This figure serves as a benchmark for understanding the financial burden on patients and their healthcare providers. However, the treatment benefits—both financially and from a public health perspective—are considerable. A study highlighted in the document estimates a $60,000 cost savings per person due to the treatment benefits, which exceed the treatment costs by a ratio that could cover the costs for ten additional patients. This contrast exemplifies the potential for cost savings in healthcare and criminal justice systems.
The document further details societal costs associated with opioid use disorder, noting an estimated $1.02 trillion total cost in 2017, with $471 billion attributed to non-fatal costs. This figure underscores the financial impact of opioid addiction on society, including healthcare, productivity losses, and criminal justice expenditures.
From an economic impact perspective, the document estimates average annual salaries for affected practitioners at $248,640 for physicians and $118,553 for mid-level practitioners (MLPs). These salaries provide a backdrop for assessing the relative economic impact of the new rule's administrative costs.
Identified issues suggest that the document's complexity and administrative requirements may impose additional burdens on practitioners. These include the mandatory verification procedures by pharmacists, which, while ensuring proper dispensing practices, could lead to redundant efforts in states with existing regulations. The document acknowledges these financial and logistical concerns but also highlights that the potential cost savings and public health benefits of expanded access to telemedicine encounters might outweigh these burdens. Overall, the financial elements focus on balancing regulatory compliance costs with the anticipated long-term savings and benefits associated with effective opioid use disorder treatment.
Issues
• The document is lengthy and dense, which could make it difficult for some readers to understand the full scope and implications without careful study.
• Some language in the document is complex and may be difficult for laypersons to fully understand, such as legal references and citations (e.g., '73] Numbers shown are rounded for presentation and clarity.').
• While the document aims to ensure expanded access to medical treatment, it does place several new requirements which may impose administrative costs on practitioners (e.g., PDMP data checks, verification of identification by pharmacists).
• The requirement for pharmacists to verify patient identity might place additional burdens on pharmacists and could be seen as redundant in states already having such regulations.
• The document references extensive consultations and feedback sessions; however, it does not provide clear explanations of how all feedback was incorporated or dismissed, leading to potential concerns about transparency.
• The potential cost savings and public health benefits are mentioned but not quantified in an easily digestible manner, which could result in questions about the actual financial impact of the rule.
• The document includes numerous references and footnotes that might be overwhelming, as they require the reader to frequently consult additional resources for full comprehension.
• The economic impact analysis assumes all DEA-registered practitioners are authorized and familiar with the system, which might not account for new entrants or changes in regulation affecting small entities.
• Potential risks of diversion are acknowledged, but the efficacy of new safeguards, such as requiring pharmacists to verify patient identity, is not thoroughly discussed.
• The distinction between telehealth practices before and after the COVID-19 pandemic could be more explicitly detailed to avoid reader confusion.