Search Results: Regulatory

image_pdf

Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws.  These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and other information related to the cost, development, and sale of drugs.  By October 2021, approximately twenty states have passed…

Read More

Don’t Forget about the States! Understanding the Maze of State Billing Laws for Physicians and Laboratories Providing Anatomic Pathology Services

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…

Read More

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets, including healthcare, noting that industry consolidation has exacerbated racial, income and wealth inequality and emphasizing that robust competition is critical…

Read More

Disrupt + Innovate + Transform: Key Regulatory Issues for Digital Health Companies Webinar

Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…

Read More

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Read…

Read More

Goodwin Webinar - Healthcare Issues + Trends: The False Claims Act and Other Government Enforcement

Healthcare companies are facing unprecedented challenges as a result of the COVID-19 crisis. This includes heightened enforcement risks. A key area of risk is the federal False Claims Act (FCA), a powerful tool for the DOJ to seek substantial penalties including three times the amount of money a company received…

Read More

FDA’s COVID-19 Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders

Developers of certain digital health devices for treating psychiatric disorders may be able to take advantage of an FDA enforcement policy, which remains in effect for the duration of the COVID-19 public health emergency.  The policy applies to certain prescription computerized behavioral therapy (CBT) devices for psychiatric disorders, digital health…

Read More

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

columns

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. § 247d-6d. This Declaration activated immunity from personal injury, property damage,…

Read More

Update: U.S. Health and Human Services Clarifies Broad Eligibility of Providers for Payments Under $30 Billion CARES Act Healthcare Provider Relief Fund

Lady Liberty

As discussed in Goodwin’s prior Client Alert, on April 10, 2020, the U.S. Department of Health and Human Services (HHS) began disbursing $30 billion to Medicare providers and suppliers under the Public Health and Social Services Emergency Fund (PHSS Emergency Fund). HHS is requiring providers to agree to certain terms and…

Read More

12