Health Law Highlights

Telehealth and the Evolving Landscape of Medicare Requirements

From Verrill, by Amanda Beauregard, Andrew Ferrer:

Telehealth Importance and Changes Post-Pandemic: Telehealth has been crucial during the COVID-19 pandemic, especially for behavioral and mental health services. The U.S. Department of Health & Human Services (HHS) facilitated its expanded use by easing Medicare regulations. Key changes included recognizing a patient’s home as an “originating site” and allowing telehealth without an initial or periodic in-person visit. However, with the end of the Public Health Emergency (PHE), Medicare rules for telehealth services are changing.

Permanent Telehealth Flexibilities: Some telehealth flexibilities will remain post-PHE, including Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) serving as “distant site” providers for behavioral/mental telehealth services, no geographic restrictions for these services, and the allowance of audio-only communication platforms. 

Temporary Telehealth Flexibilities: Many telehealth flexibilities are set to expire after December 31, 202These include FQHCs and RHCs serving as a distant site provider for non-behavioral/mental telehealth services, no geographic restrictions for an “originating site” for non-behavioral/mental telehealth services, and using audio-only communication platforms for non-behavioral/mental telehealth services.

Advocacy Efforts for Permanent Telehealth Flexibilities: Several trade associations and lawmakers are advocating for making all Medicare telehealth flexibilities permanent. They aim to ensure equitable payment for FQHCs and RHCs, remove geographic and “originating site” restrictions, eliminate the periodic “in-person” rules, maintain coverage for audio-only treatment, and expand the list of eligible Medicare providers.

Legislation Introduced for Telehealth: Several bills have been introduced to further these goals, including the CONNECT for Health Act, Telemental Health Care Access Act, Telehealth Expansion Act, Telehealth Benefit Expansion for Workers Act of 2023, and TREATS Act. These proposed laws aim to remove geographic requirements, add homes as “originating sites,” remove in-person evaluation requirements, and extend exemptions for telehealth services, among other things.

Health Law Highlights

Telehealth’s Roadblock: The Issue with State Licensure Requirements

From Epstein Becker Green, by Amy Cooperstein, Amy Lerman, and Kyla Portnoy:

The surge in telehealth services due to COVID-19 has highlighted regulatory challenges faced by providers. These regulations, which vary by state, govern aspects such as who can provide telehealth services, what services can be provided, and where providers must be located. A common requirement is that providers must be licensed in the state where the patient resides.

In December 2023, a lawsuit was filed challenging New Jersey’s reinstated telehealth rules, specifically the requirement for providers to be licensed in New Jersey to provide telehealth services to residents. The plaintiffs, including families requiring care from out-of-state providers and doctors licensed in other states, argue that the regulation violates the Commerce Clause, Dormant Commerce Clause, Privileges and Immunities Clause, First Amendment, and Due Process Clause. 

This case highlights a broader issue of restrictive licensure requirements that can hinder providers’ ability to offer proper care. The process of obtaining separate licenses for each state is time-consuming, costly, and can discourage expansion of telehealth services. Efforts to simplify the licensure process, such as the Interstate Medical Licensure Compact and the Nurse Licensure Compact, have been limited in their effectiveness.

The outcome of the MacDonald case could have significant implications for telehealth restrictions and could influence future regulation and access to telehealth services.


Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).

Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a medical practitioner to conduct at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. There are seven exceptions, one of which is during a public health emergency.

For the past three years, many telehealth providers have become accustomed to prescribing controlled substances following a telehealth visit, without first conducting an in-person exam.

With the PHE coming to an end in May, an in-person exam will be required. However, the Drug Enforcement Agency (DEA) has proposed rules to that will create additional flexibilities on the timing and manner for obtaining an in-person exam.

Federal Register


Telehealth Expansion in Texas

The COVID-19 pandemic forced many patients and practitioners to find new ways to connect. The most obvious tool is telehealth, the use of audio-visual platforms to allow practitioners to assess and communicate with patients remotely. Patients and practitioners both were encouraged by how beneficial and flexible telehealth can be. Federal and state governments alike are rushing to loosen restrictions to usher in wider adoption of telehealth tools. The Texas Legislature passed, and Governor Abbott signed, two telehealth bills that aim to provide greater access to care with telecommunication technology.

SB 40 expands the Texas Occupations Code to make permanent certain waivers granted by Gov. Abbott during the pandemic. For practitioners regulated by the Texas Department of Licensing and Regulation (TDLR), the definition of “direct” patient observation now allows the use of telehealth platforms. It also allows TDLR to adopt rules governing telehealth services that are provided by its regulated professionals.

HB 4 expands the Government Code and the Health and Safety Code to give practitioners more flexibility to use telehealth services with Medicaid, CHIP, and other public benefit program recipients. Health and Human Services Commission (HHSC) is tasked with implementing greater telehealth integration by the end of this year. Medicaid Managed Care Organizations (MCOs) are granted greater flexibility to conduct assessments and provide coordination of care services through telecommunication technology. Rural access hospitals and federally qualified health centers (FQHCs) are also eligible for reimbursements of telehealth fees.


Patient Recruiter Convicted in $2.8 Million Telemedicine Scheme Against Medicare

The owner of an Orlando-area telemarketing call center was convicted for his role in a kickback scheme involving expensive genetic tests and fraudulent telemedicine services that resulted in the payment of approximately $2.8 million in false and fraudulent claims to Medicare.

Ivan Andre Scott, 34, of Kissimmee, Florida was convicted after a four-day trial of one count of conspiracy to commit health care fraud, three counts of health care fraud, one count of conspiracy to defraud the United States and pay and receive health care kickbacks, and three counts of receiving kickbacks.

The evidence showed that Scott targeted Medicare beneficiaries with telemarketing phone calls falsely stating that Medicare covered expensive cancer screening genetic testing, or “CGx.” The tests could cost as much as $6,000 per test. After beneficiaries agreed to take the test, the evidence showed Scott paid bribes and kickbacks to telemedicine companies to obtain doctor’s orders authorizing the tests.

Between November 2018 and May 2019, labs submitted more than $2.8 million in claims to Medicare for genetic tests Scott referred to them, of which Medicare paid over $880,000. In that timeframe, Scott personally received approximately $180,000 for his role in the scheme.

Source: Patient Recruiter Convicted in $2.8 Million Telemedicine Scheme Against Medicare


HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health Law Blog


OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty

In its final rule, the OIG defined what constitutes “telehealth technologies” more broadly than in its proposed rule, but otherwise chose to track the conditions for the exception contained in the underlying statute and not to implement any of the additional conditions that were included in the proposed rule.

Source: OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty