News & Analysis as of

Regulatory Requirements Digital Health Department of Health and Human Services (HHS)

McDermott Will & Schulte

OIG continues focus on RPM services in new data-driven report

On August 25, 2025, the US Department of Health and Human Services Office of Inspector General (OIG) issued a report analyzing Medicare billing for remote patient monitoring (RPM) services. With nearly one million Medicare...more

McDermott Will & Schulte

HHS announces information blocking enforcement “crackdown”

The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

Sheppard Mullin Richter & Hampton LLP

Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions

I. Overview of Telehealth and Tele-Prescribing Landscape Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

McDermott+

Health Information Technology Policy Under the Trump Administration

McDermott+ on

Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Arnall Golden Gregory LLP

OIG Approves Arrangement That Provides Cash Equivalents to Patients in Digital Contingency Management Program

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the “Opinion”), analyzing a program whereby the Requestor provides comprehensive digital...more

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