As if telemedicine companies didn’t already have enough regulatory complexities, a number of states have begun to implement “telemedicine business registrations” prior to launching services in new states. Among them is...more
What is the Telehealth Extension and Evaluation Act?
The Telehealth Extension and Evaluation Act would establish a two-year extension for certain COVID-19 emergency telehealth waivers. The legislation aims to extend the...more
2/15/2022
/ Beneficiaries ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Extensions ,
Legislative Agendas ,
Medicare ,
New Legislation ,
Ryan Haight Act ,
State Legislatures ,
Telehealth ,
Waivers
On December 21, 2021, New Jersey amended its telemedicine laws via SB 2559. The new changes expressly allow the use of asynchronous store-and-forward telemedicine as a standalone modality, remove prior prohibitions on...more
The Centers for Medicare & Medicaid Services (CMS) has finalized its rule on in-person exam requirements for Medicare coverage of telehealth-based mental health services when the patient is located at home. The Frequently...more
On November 16, 2021, the Drug Enforcement Agency (DEA) issued an advance notice of proposed rulemaking, exploring whether or not to create new federal regulations governing the practice of telepharmacy. These regulations...more
Three times as many consumers say they plan on continuing to use telehealth services, and more than half of providers view it more favorably now than before.
As telemedicine companies stepped up during the COVID-19...more
Continuing the trend of expanded Medicare reimbursement for remote monitoring, the Centers for Medicare and Medicaid Services (CMS) released the 2022 Physician Fee Schedule final rule on its new Remote Therapeutic Monitoring...more
The regulatory scrutiny on telemedicine and digital health companies continues to tighten, whether it is privacy warning shots, new direct-to-consumer (DTC) advertising limits, a wave of reimbursement audits, or multistate...more
10/11/2021
/ Apple ,
Audits ,
Data Collection ,
Data Retention ,
Department of Justice (DOJ) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Investigations ,
Mobile Apps ,
Privacy Policy ,
Risk Assessment ,
Telemedicine
During the ongoing COVID-19 pandemic, the U.S. has experienced a troubling rise in alcohol consumption with parallels to an increased number of individuals struggling with alcohol use disorder (AUD). Enter a new wave of...more
The Federal Trade Commission (FTC) just released a Policy Statement emphasizing how telemedicine and digital health apps can be held accountable under the Health Breach Notification Rule, even if the company is not subject to...more
Telemedicine companies seeking to advertise on Facebook’s social media platforms will first need special approval and certification before running advertisements. In a recently-announced policy, Facebook introduced additional...more
The Florida Board of Medicine will hold a rule development workshop to discuss updating the provisions of its rule for prescribing obesity drugs. Under the current rule (Florida Administrative Code 64B8-9.012), a physician...more
...On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released an advance copy of the calendar year (CY) 2022 Medicare Physician Fee Schedule (PFS) proposed payment rule, to be published on July 23, 2021....more
...The Centers for Medicare & Medicaid Services (CMS) has proposed permanent Medicare coverage of audio-only mental health telehealth services. Currently, Medicare covers audio-only telehealth under temporary waivers that...more
The Centers for Medicare & Medicaid Services (CMS) has proposed a new category of digital health services—Remote Therapeutic Monitoring (RTM)—to complement the existing suite of Remote Physiological Monitoring (RPM) codes...more
Florida’s telehealth emergency waivers ended on June 26, 2021, after Governor Ron DeSantis’ Office allowed the waivers to expire. The waivers were originally contained in Emergency Orders 20-002 and 20-003. On July 1, 2021,...more
New York’s telehealth emergency waivers have expired, according to a June 25, 2021 announcement issued by Governor Andrew Cuomo’s Office declaring the waivers (contained in Executive Orders 202 through 202.11 and 205 through...more
Throughout the COVID-19 pandemic, federal agencies have sought to allow health care companies more flexibility to use popular technology and applications to better engage with their patients. One example is the Department of...more
The Joint Commission recently announced it has changed its accreditation rules to enable more hospitals and telemedicine companies to use the streamlined “credentialing by proxy” process. Under the change, the distant site...more
Telemedicine and remote patient monitoring companies often want to maintain open communication channels with patients, whether it be scheduling, medication reminders, engagement pings, or even new product and service updates....more
3/8/2021
/ Class Action ,
Enforcement Actions ,
FCC ,
Federal Trade Commission (FTC) ,
Fines ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Notifications ,
Statutory Damages ,
TCPA ,
Telemedicine ,
Texting ,
Written Consent
Companies who feel the Public Health Emergency (PHE) waivers and exceptions have rendered telemedicine “immune” from compliance oversight might be surprised to learn what federal regulators have in the works. The Office of...more
3/1/2021
/ Audits ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fraud ,
Home Health Agencies ,
Home Health Care ,
Medicaid ,
Medicare ,
Medicare Part B ,
Mental Health ,
OIG ,
Public Health Emergency ,
Telehealth ,
Telemedicine ,
Waivers
The telemedicine and digital health industry has a new organization, the Telehealth Equity Coalition (TEC), which seeks expanded, meaningful access to health care. Launched in February 2021, the TEC works with nonprofit,...more
The Public Health Emergency introduced a myriad of changes to federal and state telemedicine and digital health laws and rules. There were expansions to telehealth coverage and reimbursement, suspension of enforcement on...more
For years, Foley has monitored legal policy in the telemedicine and digital health industry, following how advances in technology have coupled with improved state regulations to supercharge the growth of telehealth and...more
CMS just issued a correction to its guidance on 2021 Medicare rules for remote physiologic monitoring (RPM) services. The correction is effective January 1, 2021 and revises the preamble commentary in the Medicare Physician...more