Life Sciences Perspectives

On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”).  Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days after the end of the designated public health emergency (“PHE”).[1] Prior to the PHE, in order to qualify for Medicare coverage: A patient receiving telehealth services…
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated to stay home across the country. Prior to the COVID-19 PHE, approximately 12,5000 Medicare beneficiaries received telehealth services and only 106 telehealth services were reimbursable. By October 2020, over 24.5 million (of 63 million) Medicare beneficiaries received telehealth services. Read the client alert. The…
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for transitioning the multitude of devices brought to market under these circumstances to full compliance with FDA requirements: Transition Plan for Medical Devices Issued Emergency Use…
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials.  Acknowledging that technological advances “have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals” and that “DHTs [ ] are playing a growing role in health care and offer important opportunities in clinical research,” the FDA issued during the last week of December 2021…
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016.  For full text of the bill, click here.  The 21st Century Cures Act included a variety of measures seeking to accelerate medical product development and bring advancements and innovations to patients more efficiently. Cures 2.0 seeks to improve and expand on those…
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) released a report in September 2021 that found many state Medicaid programs do not sufficiently evaluate whether telehealth improves access to care, reduces costs, or boosts the quality of care for Medicaid recipients receiving behavioral health…
Laboratory tests play a critical part of the healthcare system.  Ordering and billing for these tests, however, is not always cut-and-dry.  Compliance with federal laws and rules (like the Clinical Laboratory Improvement Amendments (CLIA), the Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA) – not to mention Medicare billing requirements is essential.  but, laboratory testing companies and physician practice groups must also pay attention to an array of state laws and regulations…
As the COVID-19 pandemic progresses and the expanded use of telehealth has appeared to stabilize over the past year according to a July report from McKinsey & Company, Federal agencies have continued the recent trend of enforcement actions and audits of telehealth providers. On September 17, 2021, the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) announced their latest enforcement action, totaling…
The use of telehealth continues to grow rapidly across the U.S.  Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely engaging with healthcare providers is here to stay.   In fact, the National Center for Health Statistics and the Centers for Disease Control and Prevention reported that between April and July 2021, 24.5% of adults in the U.S. had a virtual care…
The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal health care program loses.  DOJ recouped a total of $1.8 billion dollars in connection with healthcare fraud allegations. Since the public health emergency was announced in March 2020, the Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services (“HHS”),…