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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

Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications: Second Time is the Charm

On October 6, 2023, the Drug Enforcement Administration (DEA) released a second temporary rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This second extension, issued...more

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): A Deep Dive into Proposed Medicare Changes

On July 13, the Centers for Medicare & Medicaid Services (CMS) released its annual Proposed Rule updating the Medicare Physician Fee Schedule (PFS) for calendar year (CY) 2024, which includes various proposed changes related...more

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

DEA: Potential New Telemedicine Special Registration for Controlled Substances Prescribing to be Discussed in Special Listening...

At long last, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination. On August 4,...more

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

Gender Affirming Care Restricted Under Missouri Bill

On May 10, 2023, the Missouri legislature passed a bill restricting access to gender affirming care for individuals under the age of 18. The bill is now headed to Governor Parson’s desk for signature...more

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

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

Florida’s Bill Targeting Gender Affirming Care Impacts Minors and Adults

On May 4, 2023, SB 254 passed the Florida Senate by a safe majority vote of 83 to 28 and is now on Governor DeSantis’s desk for approval. Once signed (expected shortly) , this law will take immediate effect and disrupt the...more

Florida Passes Bill to Allow Telehealth Renewals for Medical Marijuana

On May 4, 2023, the Florida Legislature passed HB 387 expanding the use of telehealth for medical marijuana recertification. Once signed by Florida Governor, Ron Desantis, the new law will become effective July 1,...more

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

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

2023 Telemedicine & Digital Health Trends

Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will...more

Public Health Emergency Ends May 11: What Telehealth Companies Need to Know

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

Another Extension of Telehealth Relief for HDHP/HSA Plans

The Consolidated Appropriations Act of 2023 (2023 CAA) further extends the HSA safe harbor allowing high deductible health plans (HDHPs) to offer first dollar coverage of telehealth services without ruining HDHP members’...more

CMS Finalizes Changes for Telehealth Services for 2023

On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) released its final 2023 Medicare Physician Fee Schedule (PFS) rule. As finalized, some of the most significant telehealth policy changes include: ...more

Medicare Remote Therapeutic Monitoring: Top FAQs for 2023

On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The changes, part of the...more

Medicare Telehealth Services for 2023 – CMS Proposes Substantial Changes

On July 7, 2022, the Centers for Medicare and Medicaid Services (CMS) released its proposed 2023 Medicare Physician Fee Schedule (PFS) rule. The rule, if enacted as proposed, will: Create three new permanent telehealth...more

Remote Therapeutic Monitoring: What You Need to Know About CMS’ Proposed Changes

On July 7, 2022, the Centers for Medicare & Medicaid Services (CMS) proposed five new changes to Remote Therapeutic Monitoring (RTM) services under the Medicare program. The changes, part of the proposed 2023 Medicare...more

3 Considerations for Telemedicine Companies Shifting Reimbursement Models

In what feels like an instant, telemedicine has gone from an emerging niche to a must-have. The pandemic created an opportunity for telemedicine providers to grow — rapidly — giving even more reason for venture capital and...more

Congress Extends Telehealth Flexibilities: 7 Things You Need to Know

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

The Federal Telehealth Extension and Evaluation Act: What You Need to Know

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

2022 Medicare Remote Therapeutic Monitoring FAQs: CMS Final Rule

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

Medicare Proposes New Changes for Telehealth Services in 2022

...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

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