The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more
Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also...more
Digital health—that is, medical care enhanced or made possible by the use of technology—has changed the landscape of healthcare in America. Innovation in this sector is at an all-time high and 2024 will no doubt see greater...more
The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
Healthcare providers are scrambling to understand the impacts of the May 11 expiration of the COVID-19 public health emergency (PHE). Luckily for most telehealth providers, the outlook of their operations post-PHE is...more
Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as...more
Another year has come to pass, and it seems the federal Public Health Emergency (PHE) will remain in place for at least the next five months. Why? As the US Department of Health and Human Services (HHS) has continuously...more
Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory...more
The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the...more
The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely...more
Physician Partners of America LLC, a physician practice management company, denies that it violated the False Claims Act by billing Federal health care programs for medically unnecessary testing, among other allegations. The...more
Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
The Centers for Medicare & Medicaid Services released its CY 2022 Physician Fee Schedule final rule on November 2 reflecting the Biden-Harris administration’s goal of increasing access to and quality of care and reducing...more
11/15/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Medicare Part B ,
MIPS ,
Payment Rates ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Telehealth ,
Telemedicine
We hosted a very informative Fast Break session last month on CMS telehealth and RPM updates. If you weren't able to join us, the session was led by healthcare litigation associates Jake Harper and Tesch West, with special...more
The Centers for Medicare & Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning...more
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by...more
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act....more
12/9/2020
/ Civil Liability ,
Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Medical Malpractice ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Telehealth ,
Vaccinations
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services....more
8/14/2020
/ China ,
Coronavirus/COVID-19 ,
Germany ,
Health Care Providers ,
Infrastructure ,
Patient Access ,
Singapore ,
Telehealth ,
Telemedicine ,
United Arab Emirates (UAE) ,
United States
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. ...more
8/5/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Medicare ,
Patient Access ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Trump Administration
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services....more