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Regulatory Update25 min read·December 31, 2025

DEA Extends Telemedicine Flexibilities Through December 2026What This Means for Medstra Partners

The federal government just extended critical telemedicine protections through the end of 2026, ensuring uninterrupted access to testosterone replacement therapy and other controlled medications for telehealth patients nationwide.

Medstra Legal Team

Medstra Legal Team

Regulatory Compliance

DEA Extends Telemedicine Flexibilities Through December 31, 2026

On December 31, 2025, the Drug Enforcement Administration (DEA), jointly with the Department of Health and Human Services (HHS), issued their fourth extension of COVID-19 era telemedicine flexibilities, allowing practitioners to continue prescribing controlled substances (including testosterone) via audio-video telemedicine through December 31, 2026, without requiring an initial in-person medical evaluation.

For Medstra Brand Partners, especially those focusing on testosterone replacement therapy (TRT), this is exceptionally good news.

Here's what you need to know, why this matters, and what this means for your business.

Extension Period

January 1, 2026 December 31, 2026

12 months of regulatory certainty for telehealth TRT operations

01What Just Happened: The Fourth Extension

The Regulatory Update

On December 31, 2025, the DEA and HHS published a temporary rule extending telemedicine flexibilities that have been in place since March 2020.

A DEA-registered practitioner is authorized to prescribe schedule II-V controlled substances via telemedicine to a patient without having conducted an in-person medical evaluation of the patient if all of the conditions listed in paragraph (c) of this section are met.

DEA Fourth Temporary Rule

What This Covers

Schedule II-V Controlled Substances including:

  • Testosterone (Schedule III)(Critical for TRT)
  • Semaglutide/Tirzepatide combinations with controlled substances
  • Certain ADHD medications
  • Certain anti-anxiety medications
  • Other controlled medications prescribed via telehealth

Requirements (All Must Be Met)

  1. Prescription issued for legitimate medical purpose
  2. Practitioner acting in usual course of professional practice
  3. Communication via interactive telecommunications system (audio-video)
  4. Practitioner is DEA-registered for the controlled substance class
  5. Prescription complies with all other DEA regulations

Why the Extension Was Necessary

The DEA warned of an impending “telemedicine cliff”: the abrupt reinstatement of pre-pandemic restrictions that would have required in-person visits before any controlled substance prescriptions via telemedicine, creating massive backlogs and disrupting care for millions nationwide.

44.6M

Controlled substance prescriptions in 2024

Across 258 organizations

7M

Issued without in-person evaluation

Approximately 16% of total

24%

Reduction when Medicare expired

In first 17 days

What Happened with Medicare

When Medicare's telemedicine flexibilities expired on September 30, 2025 (before Congress extended them), the impact was immediate:

  • 24% reduction in fee-for-service telemedicine visits in the first 17 days
  • Nearly 40% or more reduction in states like Florida, Louisiana, Washington, Tennessee, Maryland, Oklahoma, and New York

02Why This Matters Specifically for TRT

Testosterone is a Schedule III controlled substance under the DEA's Controlled Substances Act. Without telemedicine flexibilities, prescribing testosterone would require an in-person visit first.

Without Extension

  • In-person visits required for new patients
  • Existing telehealth patients disrupted
  • Geographic barriers restored
  • Massive operational restructuring needed
  • Loss of competitive advantage

With Extension

  • New patients onboard via telemedicine
  • Existing patients continue care
  • National access maintained
  • Business as usual operations
  • Competitive advantage preserved

For Medstra Brand Partners

If you're operating a TRT-focused telehealth brand through Medstra, here's what this means:

Uninterrupted operations through December 31, 2026
No changes required to your current patient acquisition model
New patients can onboard without in-person visits (through end of 2026)
Existing patients continue care without disruption
Rural and remote patients maintain access to your services
Competitive advantage maintained over in-person only clinics

03What Makes Medstra Compliant with This Extension

The DEA extension requires practitioners to meet specific conditions. Medstra's infrastructure is designed to satisfy all of these requirements.

01

Legitimate Medical Purpose

DEA Requirement

The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

How Medstra Complies

Independent Medical Group (IMG) physicians:

  • • Conduct comprehensive medical history reviews
  • • Review lab work (testosterone levels, complete metabolic panel, etc.)
  • • Make independent clinical determinations
  • • Prescribe ONLY when medically appropriate
  • • Exercise independent medical judgment (not influenced by business considerations)
02

Audio-Video Telemedicine

DEA Requirement

The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system.

How Medstra Complies

Medstra's platform uses HIPAA-compliant audio-video telemedicine for all controlled substance consultations. Not just forms or questionnaires, but actual audio-video physician consultations with real-time interaction.

03

DEA-Registered Practitioners

DEA Requirement

The practitioner is authorized under their registration to prescribe the basic class of controlled substance specified on the prescription.

How Medstra Complies

All Independent Medical Group (IMG) physicians are:

  • DEA-registered to prescribe controlled substances
  • Licensed in the states where they practice
  • Authorized to prescribe Schedule III controlled substances (testosterone)
  • Credentialed by Medstra's compliance team
04

All Other DEA Regulations

DEA Requirement

The prescription is consistent with all other requirements of 21 CFR part 1306.

How Medstra Complies

All prescriptions meet standard DEA requirements:

  • • Valid prescription elements (patient name, address, date, etc.)
  • • Issued for legitimate medical purpose in usual course of practice
  • • Proper documentation maintained
  • • State-specific requirements followed
  • • Pharmacy verification processes in place

04What This Extension Does NOT Change

It's important to understand what remains the same.

Corporate Practice of Medicine (CPOM) Still Applies

CPOM laws (state-level):

  • • Still require physician ownership of medical practices
  • • Still prohibit non-physicians from employing doctors
  • • Still prohibit non-physicians from controlling medical decisions

Medstra's three-entity structure still required: Brand Partner (your marketing company), MSO (infrastructure provider), IMG (100% physician-owned medical practice)

Anti-Kickback Statute (AKS) Still Applies

AKS (federal criminal law):

  • • Still prohibits paying for referrals or prescriptions
  • • Still requires Fair Market Value physician compensation
  • • Still requires outcome-independent payments

Medstra's safe harbor-compliant payment structure: Flat-fee physician compensation ($60/consult whether they prescribe or not), Fair Market Value rates, compensation NOT tied to business volume.

What DID Change

Only one thing changed: The requirement for an initial in-person medical evaluation before prescribing controlled substances via telemedicine.

Before Extension

Required in-person visit before prescribing testosterone via telemedicine

With Extension

Can prescribe via audio-video telemedicine without initial in-person visit

05What Medstra Brand Partners Should Know

For Current Brand Partners

What You Need to Do

Nothing.

Your operations continue exactly as they have been. Same patient acquisition process, same audio-video telemedicine consultations, same physician prescribing process, same compliance framework, same business model.

For Prospective Brand Partners

If you're considering launching a TRT brand through Medstra:

You can launch with confidence knowing telehealth prescribing is protected through end of 2026
No in-person visit requirement for new patients (massive competitive advantage)
National patient acquisition possible (not limited to local geography)
Regulatory certainty for 12 months
Same compliant infrastructure that's been validated since March 2020

For TRT-Focused Partners

This extension is critical to your business. Testosterone is Schedule III. Without telemedicine flexibilities, your business model would require in-person initial consultations for every patient.

With this extension, you can continue the audio-video only model through Dec 31, 2026, maintain national patient acquisition capability, keep cost structure lean (no physical clinic infrastructure), and preserve 78% gross margins on patient economics.

Questions about this extension?

Contact your Medstra partnership team for personalized guidance.

Get in touch

06Looking Ahead: What Happens After December 31, 2026?

The DEA is working on permanent regulations for telemedicine prescribing of controlled substances.

The Special Registration for Telemedicine NPRM

On January 17, 2025, the DEA published a Notice of Proposed Rulemaking (NPRM) proposing a new registration category for practitioners prescribing controlled substances via telemedicine, with additional requirements for recordkeeping and reporting, plus a framework for direct-to-consumer (DTC) telemedicine platforms.

Public Comment Period

Over 6,475 comments received. DEA is reviewing feedback which will inform final regulations.

Provide the DEA with additional time to finalize and implement effective regulations that balance access to care with the necessary safeguards against diversion.

DEA Statement

Medstra's Preparation

When final regulations are published, Medstra will:

Achieve full compliance before effective date
Update infrastructure to meet new requirements
Support Brand Partners in any transition
Maintain uninterrupted patient care

Brand Partners will not need to navigate new regulations alone. Medstra will handle compliance at the infrastructure level.

07Why This Extension Represents Regulatory Maturity

This is the fourth extension of telemedicine flexibilities. The pattern is clear: The DEA and HHS consistently extend these flexibilities because they work.

March 2020

COVID-19 PHE flexibilities granted

May 2023

First Temporary Rule

October 2023

Second Temporary Rule

November 2024

Third Temporary Rule

December 2025

Fourth Temporary Rule

The Federal Government's Position

By extending flexibilities four times, the federal government has demonstrated:

Telemedicine prescribing works when properly regulated
Patient access matters and should be protected
Regulatory framework can balance access with diversion control
Permanent regulations are coming but must be thoughtfully developed

This is not a temporary accommodation. This is the foundation for permanent telemedicine access to controlled medications.

08What Medstra Has Built for This Moment

Medstra's infrastructure was designed from day one to comply with federal telemedicine regulations. Everything the DEA requires, Medstra provides.

Audio-Video Platform

  • HIPAA-compliant platform
  • Real-time consultations
  • Encrypted communications
  • Documented records

Physician Network

  • DEA-registered physicians
  • Licensed in 50 states
  • Credentialed and verified
  • Schedule III authorization

Medical Purpose Framework

  • Medical history collection
  • Laboratory work requirements
  • Physician independent judgment
  • Clinical guidelines

Compliance Infrastructure

  • Three-entity CPOM structure
  • Safe harbor AKS payments
  • HIPAA compliance
  • Ongoing monitoring

09What This Means for Your Business in 2026

Certainty Through Year-End 2026

You have regulatory certainty for the next 12 months. This allows for strategic planning, patient promises, competitive positioning, and financial forecasting.

What You Should Do

Current Brand Partners

  1. Continue operations as normal
  2. Scale patient acquisition with confidence
  3. Focus on growth (framework is stable through 2026)
  4. Monitor updates from Medstra on final regulations

Prospective Brand Partners

  1. Launch with confidence (12 months certainty)
  2. Build your brand on proven infrastructure
  3. Acquire patients nationally via telemedicine
  4. Trust Medstra to handle regulatory transitions

10The Bottom Line: This Is Good News

The DEA's fourth extension of telemedicine flexibilities is overwhelmingly positive for Medstra Brand Partners.

What It Confirms

  • Telemedicine prescribing is here to stay
  • Federal government recognizes telehealth value
  • Permanent regulations will preserve access
  • Your business model is protected through 2026

What It Prevents

  • Telemedicine cliff (abrupt loss of prescribing)
  • Patient care disruption (millions losing access)
  • Forced pivot to in-person requirements
  • Loss of national reach

Your business is protected. Your patients are protected.

Your future is secure.

Ready to Launch?

Build your TRT brand with 12 months of regulatory certainty

Visit medstra.com to learn how to become a Brand Partner and build your telehealth business on federally compliant infrastructure.

Schedule a Call

11Frequently Asked Questions

Frequently Asked Questions

Yes. Through December 31, 2026, you can onboard new patients via audio-video telemedicine without any in-person visit requirement.

Conclusion: Regulatory Certainty for Growth

The DEA's fourth extension provides exactly what Medstra Brand Partners need: regulatory certainty. Through December 31, 2026, audio-video telemedicine prescribing of controlled substances (including testosterone) is authorized, no in-person visit requirement for new or existing patients, operations continue uninterrupted, and your business model remains viable and competitive.

Medstra's infrastructure is compliant today and will remain compliant tomorrow. The three-entity CPOM structure is permanent. The safe harbor-compliant AKS payment framework is permanent. The audio-video telemedicine platform is permanent. The DEA-registered physician network is permanent.

The foundation is built. You focus on acquiring patients and building your brand. Medstra handles regulatory compliance.

Regulatory Disclaimer

This article is for informational purposes only and does not constitute legal or medical advice. The DEA's Fourth Temporary Rule extends existing telemedicine flexibilities through December 31, 2026. All Medstra Brand Partners must continue to comply with applicable federal and state laws, including but not limited to Corporate Practice of Medicine statutes, the Federal Anti-Kickback Statute, HIPAA, and all DEA regulations. Medstra provides compliant infrastructure but each Brand Partner is responsible for ensuring their specific operations comply with all applicable laws. Consult with qualified healthcare attorneys for specific legal guidance.

About Medstra

Medstra provides compliant MSO infrastructure for telehealth operators, including three-entity CPOM-compliant structure, safe harbor-compliant AKS payment framework, and DEA-registered physician networks operating via audio-video telemedicine platforms. Our infrastructure is designed to comply with current DEA telemedicine flexibilities and will be updated to satisfy eventual final regulations when published.