In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more
Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue.
Companies interested in providing clinical trial...more
In this two-part blog series, we dive into the key points for telemedicine providers in the several hundred pages of the No Surprises Act interim regulations (NSA). The good news for the telemedicine industry is that the...more
The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more
7/16/2021
/ Audits ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FQHC ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
OIG ,
Public Health Emergency ,
Relief Measures ,
Rural Health Care Providers ,
Telehealth
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
The COVID-19 pandemic has created nothing short of a seismic shift in the delivery of health care services, especially where telehealth is concerned. Following the President issuing a proclamation that the COVID-19 outbreak...more
On March 13, 2020, the President of the United States issued a proclamation that the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) outbreak in the United States constitutes a national emergency...more
5/19/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Social Security Act ,
Stafford Act ,
Telehealth ,
Telemedicine
On April 23, 2020, the Centers for Medicare & Medicaid Services (CMS) released the “State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth” (the Toolkit). Telehealth allows...more
In light of the COVID-19 public health emergency (Pandemic), on April 2, 2020, Governor Brad Little of Idaho issued a proclamation (Proclamation) that suspended 18 regulations (in addition to the 125 previously suspended...more
On March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
HIPAA Privacy Rule ,
Medicaid ,
Medicare ,
State of Emergency ,
Telehealth ,
Telemedicine ,
Waivers
On March 15, 2020, in response to the a state of emergency due to the outbreak of the 2019 novel Coronavirus (COVID-19), Massachusetts Governor Charlie Baker executed an Order Expanding Access To Telehealth Services And To...more
Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner LLP will be addressing each of...more
The Massachusetts Medicaid Program (known locally as MassHealth) issued a new All Provider Bulletin in January, setting forth new policies for certain behavioral health services delivered to MassHealth covered patients. The...more