Post-PHE Telehealth Compliance: Avoid Repayment Risk (42 CFR § 410.78(f))

Executive Summary

The end of the COVID-19 public health emergency (PHE) shifted Medicare telehealth policy from temporary waivers back to the standing regulatory framework in 42 CFR § 410.78. Small practices must now align telehealth workflows with the regulation’s conditions for patient location (originating site), technology modality (including limited audio-only use), and documentation to reduce claim denials and repayment exposure. This article explains the applicable rules in 42 CFR § 410.78 and provides a structured compliance checklist designed for practices with limited staff and resources.

Introduction

The COVID-19 PHE expanded Medicare telehealth access by relaxing certain requirements that historically limited where patients could be located and what technologies could be used. After the PHE ended, not all flexibilities continued. Medicare coverage for telehealth services is governed by 42 CFR § 410.78, which sets payment conditions for covered telehealth services, defines key terms such as originating site and interactive telecommunications system, and establishes service-list maintenance procedures.

For small practices, the risk is operational drift—continuing PHE-era processes without verifying whether the underlying Medicare payment conditions still apply. The most common failure points are: (1) misunderstanding which patient locations qualify as originating sites, (2) using audio-only modalities without meeting the regulation’s specific conditions and modifiers, and (3) applying outdated timing standards for in-person mental health visit requirements. This checklist-based article is designed to make those requirements auditable and repeatable.

Understanding the Post-PHE Telehealth Compliance Requirements Under 42 CFR § 410.78

Understanding the Post-PHE Telehealth Compliance Requirements Under 42 CFR § 410.78

Medicare Part B pays for covered telehealth services on the CMS telehealth list when they are furnished via the required telecommunications system and when the conditions of 42 CFR § 410.78 are met. Compliance for small practices typically centers on five elements:

  1. Service eligibility (service must be on the Medicare Telehealth Services List)

  2. Eligible distant-site practitioner type (must be one of the practitioner categories listed)

  3. Originating site eligibility (patient location must qualify, subject to defined exceptions)

  4. Technology modality (audio-video generally required; audio-only allowed only under defined conditions)

  5. Documentation (must support modality choice, location, and when applicable, required in-person visit timing)

Patient Location Rules: Originating Site Requirements

General originating site rule

For most Medicare telehealth services, the patient must be located at an approved originating site at the time of service. The regulation includes multiple approved originating sites such as a physician office, hospital, rural health clinic, federally qualified health center, skilled nursing facility, community mental health center, renal dialysis facilities for specific purposes, and certain home-based circumstances listed in the regulation.

Patient home as an originating site (not universal)

The patient’s home may qualify as an originating site only in defined situations. Examples include:

  • Home dialysis monthly ESRD-related clinical assessment (specific scope)

  • Treatment of substance use disorder (or a co-occurring mental health disorder) under the applicable criteria

  • Mental health disorder telehealth furnished to a beneficiary in the home, subject to timing and documentation conditions (see next section)

Small practices should treat home-based telehealth as service- and condition-specific, not as a universal originating site category.

Technology Modality: Interactive Telecommunications System and Audio-Only Limits

Audio-video is the baseline standard

Medicare telehealth generally requires an interactive telecommunications system that includes two-way, real-time audio and video communication between the patient and the distant-site practitioner.

Audio-only is permitted only when conditions are met

Audio-only telehealth is permitted only when:

  • The distant-site practitioner is technically capable of using interactive audio-video telehealth, and

  • The patient is not capable of, or does not consent to, video technology, and

  • The claim includes the required modifiers that verify these conditions were met.

Required modifiers for audio-only:

  • CPT modifier “93”

  • For RHCs and FQHCs, Medicare modifier “FQ” (in addition to CPT modifier 93)

Small practices should treat audio-only as a conditional exception, not as a general alternative modality.

Mental Health Telehealth in the Patient Home: In-Person Visit Timing Rules

Small practices frequently misapply the in-person visit timing requirements for mental health telehealth furnished to a beneficiary in their home. The regulation contains time-bound provisions that must be applied correctly based on the applicable period.

Period tied to the end of the emergency period (through December 31, 2024)

For certain mental health telehealth services furnished in the patient’s home during the period beginning on the first day after the end of the emergency period and ending December 31, 2024, payment is conditioned on:

  • An in-person visit within 6 months prior to the initial telehealth service, and

  • An in-person visit at least once within 12 months of each subsequent telehealth service, unless the practitioner and patient agree the risks/burdens outweigh benefits and that rationale is documented.

Services furnished on or after January 1, 2025

For services furnished on or after January 1, 2025 for the diagnosis, evaluation, and/or treatment of a mental health disorder, the geographic requirements do not apply, but payment is conditioned on:

  • An in-person visit within 6 months prior to the initial telehealth service, and

  • An in-person visit within 6 months of any subsequent telehealth service (subject to the applicable documentation requirements in the regulation).

Small practices must ensure scheduling and documentation workflows reflect the correct timing rule based on service date.

Eligible Distant-Site Practitioners

Telehealth services may be billed only when furnished by a practitioner type recognized in the regulation (for example, physicians, physician assistants, nurse practitioners, clinical psychologists, clinical social workers, registered dietitians/nutrition professionals, certified registered nurse anesthetists, and certain other practitioner categories specified). Small practices should map each telehealth-billing clinician to the applicable practitioner category and confirm services billed align with that scope.

The Role of the Medicare Telehealth Services List and 42 CFR § 410.78(f)

Small practices should distinguish between:

  • The conditions of payment and definitions found throughout 42 CFR § 410.78(a)–(e), and

  • The process for adding or deleting services from the Medicare Telehealth Services List, addressed in 42 CFR § 410.78(f).

Section (f) describes how changes to the telehealth list are made (typically through annual physician fee schedule rulemaking, with a subregulatory process during the PHE). It does not replace the broader payment conditions in the rest of the section.

Step-by-Step Compliance Guide for Small Practices

Step 1: Verify service eligibility

Confirm the CPT/HCPCS code is on the CMS Medicare Telehealth Services List for the relevant period and billing context.

Step 2: Confirm eligible practitioner type

Verify the rendering clinician qualifies as an eligible distant-site practitioner under the regulation for the service billed.

Step 3: Capture and document patient location (originating site)

At the start of the visit, capture where the patient is located and document it in the medical record. Confirm that location qualifies as an originating site for the service type.

Step 4: Document modality (audio-video vs audio-only)

Record whether the visit was audio-video or audio-only. If audio-only, document the reason video was not used consistent with the regulation’s conditions.

Step 5: Apply required modifiers (audio-only)

If audio-only was used, ensure the claim includes:

  • CPT modifier 93, and

  • Modifier FQ for RHCs/FQHCs (when applicable)

Step 6: For mental health services in the home, track in-person timing

Maintain a tracking method to ensure in-person visit timing requirements are met:

  • Apply the correct rule based on service date (through 12/31/2024 versus on/after 1/1/2025)

  • Document any permitted exception rationale where applicable

Step 7: Conduct routine claim sampling

Review a defined sample of telehealth claims monthly to confirm location, modality, modifiers, and mental health timing requirements are supported in documentation.

Simplified Self-Audit Checklist (Use Monthly)

  • Service code is confirmed on the CMS Medicare Telehealth Services List

  • Rendering clinician is an eligible distant-site practitioner category

  • Patient location is documented and qualifies as an originating site (or an applicable exception applies)

  • Modality is documented (audio-video vs audio-only)

  • Audio-only visits include required documentation and modifiers (93; and FQ if RHC/FQHC)

  • For mental health services in the home, in-person visit timing is met for the applicable period

  • Documentation supports the claim elements submitted

Table: Telehealth Compliance Elements Small Practices Should Validate

Compliance Element

What Must Be Verified

Common Failure Point

Service eligibility

Code is on the Medicare Telehealth Services List

Billing telehealth for non-listed services

Practitioner eligibility

Clinician category qualifies under regulation

Billing under ineligible practitioner type

Originating site

Patient location qualifies (or exception applies)

Assuming “home” always qualifies

Modality

Audio-video standard met; audio-only only when conditions met

Treating audio-only as broadly permitted

Modifiers

Audio-only modifiers applied correctly

Missing CPT 93 or missing FQ for RHC/FQHC

Mental health timing

Correct in-person interval applied by service date

Using outdated 12-month rule after 1/1/2025

Documentation

Record supports all claim conditions

Incomplete location/modality notes

Compliance Oversight (CMS vs. OCR)

Compliance Oversight (CMS vs. OCR)

CMS enforcement (Medicare payment and billing compliance)

CMS and Medicare contractors enforce compliance with Medicare telehealth payment rules and may deny or recoup claims that do not meet the requirements of 42 CFR § 410.78 or related Medicare billing rules.

OCR enforcement (HIPAA privacy and security, not Medicare payment rules)

The Office for Civil Rights (OCR) enforces HIPAA privacy and security obligations for protected health information. OCR oversight may apply to telehealth platforms, safeguards, and breach response, but OCR does not enforce Medicare telehealth coverage or billing requirements under 42 CFR § 410.78.

Common Pitfalls to Avoid

Common Pitfalls to Avoid

  • Not documenting patient location at the time of service

  • Treating patient home as a universal originating site

  • Using audio-only without meeting the regulation’s conditions or adding required modifiers

  • Applying outdated in-person timing requirements for mental health services after January 1, 2025

  • Failing to maintain repeatable documentation standards for modality and eligibility

Building a Culture of Compliance Around Telehealth

Compliance must be integrated into daily operations. Small practices can maintain telehealth readiness by assigning a single responsible owner for telehealth compliance, using standardized intake scripts to capture location and modality, maintaining a controlled reference for service eligibility, and conducting routine claim sampling to prevent drift. Consistent documentation and a simple audit routine are often the difference between sustained reimbursement and avoidable repayment exposure.

Concluding Recommendations

Following the end of the PHE, Medicare telehealth coverage is governed by 42 CFR § 410.78, which requires practices to verify service eligibility, practitioner eligibility, patient location, technology modality, and documentation. Small practices can reduce denials and repayment risk by implementing a repeatable checklist and auditing telehealth claims for the conditions required under the regulation.

To further strengthen your compliance posture, consider using a compliance regulatory tool. These platforms help track and manage requirements, provide ongoing risk assessments, and keep you audit-ready by identifying vulnerabilities before they become liabilities, demonstrating a proactive approach to regulators, payers, and patients alike.

Official References

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