Thomas Ferrante on Food and Drug Administration (FDA)

Remote Patient Monitoring: OIG Issues Consumer Alert

On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more

11/29/2023 / Criminal Investigations , Durable Medical Equipment , False Claims Act (FCA) , Food and Drug Administration (FDA) , Fraud , Health Care Providers , Healthcare Fraud , Kickbacks , Medicare , OIG , Telehealth , Telemedicine

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

8/15/2023 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Fraud and Abuse , Health Care Providers , Licensing Rules , Medical Devices , Medicare , Reimbursements , Software

Decentralized Clinical Trials Blog Series: Introduction

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

6/26/2023 / Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Telehealth , Telemedicine

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.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

5/8/2023 / Biologics , Clinical Trials , Coronavirus/COVID-19 , Draft Guidance , Food and Drug Administration (FDA) , Investigations , Pharmaceutical Industry , Prescription Drugs , Privacy Laws , Reimbursements

Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

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

3/31/2023 / American Telemedicine Association , Controlled Substances , Coronavirus/COVID-19 , DEA , Food and Drug Administration (FDA) , Proposed Rules , Public Health Emergency , Telemedicine

2021 Medicare Remote Patient Monitoring FAQs: CMS Issues Final Rule

On December 1, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote patient monitoring aka remote physiologic monitoring or “RPM,” reimbursed under the Medicare program. The...more

12/7/2020 / Centers for Medicare & Medicaid Services (CMS) , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Healthcare Workers , Medical Devices , Medicare , Physician Fee Schedule , Physician Medicare Reimbursements , Physicians , Telehealth

Top Ten Medicare Remote Patient Monitoring FAQs for 2021

On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a number of clarifications and proposals on remote patient monitoring (RPM) services reimbursed under the Medicare program. The changes, part of...more

8/5/2020 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , Healthcare Workers , Medical Devices , Medicare , Physician Fee Schedule , Proposed Rules , Public Health Emergency , Telemedicine

Thomas Ferrante

Foley & Lardner LLP

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