Tag: Telehealth

Summary of article from Womble Bond Dickinson, by Melissa Ratliff:

Telehealth, which has evolved significantly over centuries, has revolutionized modern healthcare by providing patients with remote access to medical services. However, this advancement brings complex legal challenges, including state-specific licensure requirements, standards of care, privacy and confidentiality under HIPAA, informed consent, online prescribing regulations, reimbursement and billing policies, and technology platform compliance. Healthcare providers must navigate these issues to ensure legal and ethical telehealth practices. Understanding these legal nuances is essential for maintaining compliance and delivering quality care.

Summary of article from Husch Blackwell, by Jonathan Porter:

On June 13, 2024, the Justice Department arrested two executives of Done Global Inc., a digital health company, marking the first criminal case against telehealth executives for allegedly causing illegal prescriptions of controlled substances. The charges include a drug dealing conspiracy, a healthcare fraud conspiracy, and obstruction of justice. Key lessons from the case include the importance of adherence to state and federal laws when prescribing controlled substances via telehealth, the risks of restricting prescribers’ access to patients and incentivizing prescriptions without follow-up evaluations, and the potential for prosecution under a drug-dealing conspiracy rather than the Anti-Kickback Statute. The case also highlights the potential challenges of proving such charges, particularly in light of the 2022 Supreme Court Ruan case, and the illegality and risks of deleting documents during an investigation. Despite this case, telehealth remains a valuable practice, but healthcare innovators should be mindful of the risks associated with restricting the physician-patient relationship.

Summary of article from mHealth Intelligence, by Anuja Vaidya:

The US Department of Justice (DOJ) and the Federal Trade Commission (FTC) have filed an amended complaint against telehealth companies, including Cerebral Inc., Zealthy Inc., Gronk Inc., and Bruno Health P.A., alleging misuse of patients’ personal health data, deceptive cancellation practices, and unauthorized disclosure of sensitive data. The complaint also accuses the companies of deploying online tracking technologies for targeted advertisements without user consent. The government alleges that the companies violated the Federal Trade Commission Act (FTC Act), the Opioid Addiction Recovery Fraud Prevention Act of 2018, and the Restore Online Shoppers’ Confidence Act (ROSCA). While the claims against Cerebral have been settled, with the company agreeing to pay $5 million in consumer redress and a $2 million civil penalty, the government continues to pursue claims against the other companies and individuals involved. Cerebral has also been scrutinized for its controlled substance prescriptions and alleged “unlawful business practices”.

Summary of article from McDermott+Consulting, by Jeffrey Davis, Rachel Stauffer:

The article discusses the potential expiration of temporary Medicare waivers for telehealth services, which were instated during the COVID-19 pandemic and are set to expire by the end of 2024. Without further action from Congress, Medicare telehealth will revert to a rural-only benefit from 2025, and patients will have to visit an “originating” site to receive services. Congress is currently considering another extension, but the uncertainty is causing confusion among patients and providers. The Centers for Medicare & Medicaid Services (CMS) must establish payment policies for 2025, but the legislative uncertainty makes it challenging. Key issues include determining which telehealth services will be added to the Medicare list, the reimbursement rates for these services, the adoption of new telehealth codes, and decisions about other telehealth flexibilities.

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.

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.