On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30...more
On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (PHE) on May 11, 2023.
The PHE has been in place for over three years during which time many telehealth and...more
2/8/2023
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
OIG ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth
The Consolidated Appropriations Act, 2022 (the Act), was passed by the U.S. House and Senate on March 9th and 10th, 2022, and signed into law by the President on March 15, 2022. The Act extends certain telehealth...more
3/17/2022
/ CARES Act ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
HDHP ,
HSA ,
Medicaid ,
Medicare ,
MedPAC ,
Mental Health ,
Public Health Emergency ,
Rural Health Care Program ,
Telehealth
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
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
...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
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
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more
1/12/2021
/ American Telemedicine Association ,
California Consumer Privacy Act (CCPA) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicare ,
OIG ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Reimbursements ,
Telehealth ,
Waivers
The Centers for Medicare and Medicaid Services (CMS) just released its 2021 Final Rule (Physician Fee Schedule), with telehealth policy changes and a list of new services covered under Medicare. Actions taken by CMS during...more
12/3/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
HCPCS ,
Medicare ,
Mental Health ,
Nursing Homes ,
Physician Fee Schedule ,
Public Health Emergency ,
Reimbursements ,
Secretary of HHS ,
Telehealth
...Our prior article discussed federal law barriers to entry for the use of telehealth in substance use disorder (SUD), and specifically, opioid use disorder (OUD) treatment, and highlighted notable opportunities to use...more
...As COVID-19 cases spread across the U.S., another public health issue continues to escalate: the rise of opioid-related overdose deaths. For patients with a substance use disorder (SUD), the pandemic has increased feelings...more
8/4/2020
/ Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Medication-Assisted Treatment (MAT) ,
Opioid ,
Public Health Emergency ,
Ryan Haight Act ,
SAMHSA ,
Social Security Act ,
Substance Abuse ,
Telehealth
On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) issued the advance copy of its proposed 2021 Physician Fee Schedule rule, which contains new telehealth services covered under Medicare. Compared to...more
The Centers for Medicare and Medicaid Services (CMS) has introduced a new crop of temporary regulatory flexibilities in response to the COVID-19 public health emergency (PHE) in the form of new blanket waivers, implementing...more
On the evening of March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (IFC) introducing a new crop of temporary regulatory waivers and new rules to equip the American health care...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) into law. The CARES Act contains several provisions affecting healthcare benefits and the expansion of...more
With the rapid spread of the novel coronavirus (COVID-19) pandemic and the looming possibility of large scale isolations and quarantines, lawmakers continue to demonstrate willingness to expand access to telehealth to combat...more
3/21/2020
/ Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
Over the last week, the number of COVID-19 cases in the United States has spread to nearly all 50 states, with the number of confirmed cases changing by the minute. Federal, state, and local officials are evaluating options...more
The recent coronavirus outbreak is gaining world attention as it spreads, with increasing focus on outbreaks and containment efforts throughout the United States. On March 6, 2020, President Trump signed into law an emergency...more