This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
Today, Monday, March 28, President Joe Biden unveiled his Fiscal Year (FY) 2023 budget request, the second of his presidency. The $5.7 trillion proposal calls for $1.7 trillion in discretionary spending and $3.7 trillion in...more
Befitting a year in which the lingering COVID-19 pandemic caused delays in almost every aspect of daily life, Pullman & Comley’s annual survey of notable health law cases from Connecticut’s trial and appellate courts makes...more
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
Mental Health/substance abuse providers and providers treating HIV/AIDS patients are held to a higher standard when it comes to protecting medical records, requiring additional levels of consent and analysis prior to...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Must every silver lining come with a drenching cloud? Medicine has made major advances in treating fearsome conditions like cancer, HIV-AIDS, congenital heart disorders, and infectious diseases. This progress has won deserved...more
Concluding one of the longest merger reviews in history, on September 4, Judge Richard Leon, District Judge for the District of Columbia, issued his final ruling in United States v. CVS Health, approving the proposed...more
On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-109 “An Act Concerning The Prevention Of The Human Immunodeficiency Virus” (PA 19-109) which increases access to preventative and prophylactic...more
The “105-Day Expanded Maternity Leave Law,” which became effective on March 8, 2019, extends maternity leave benefits to all female workers in the government and private sectors, including those in the informal economy,...more
On Aug. 7, 2018, the 11th Circuit Court of Appeals affirmed the dismissal of a whistleblower case brought under the federal False Claims Act. The principal grounds for affirmance was a finding that the employee exemption to...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
Today, the HUD Office of Inspector General (OIG) published a bulletin indicating that it is unclear if undocumented immigrants have access to certain HUD Community Planning and Development (CPD) programs – namely the Housing...more
The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more
Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that...more
HUD has issued a Federal Register Notice offering initial implementation guidance for the Housing Opportunities through Modernization Act of 2016 (HOTMA) (Pub. L. 114-201). The notice highlighted both the HOTMA provisions...more
Current law permits a hospital, health system, or medical school to organize and become a member of a medical foundation, which can practice medicine through its employees or agents who are physicians, chiropractors,...more
Leading the News - Nigeria: On December 1st, the United Nations (U.N.) reported nearly 450 schools have reopened in Borno state, Nigeria since October after being closed for more than 18 months following the Boko...more
On the occasion of World AIDS Day, the EEOC released two new publications designed to assist employees and their health care providers in handling HIV/AIDS in the workplace. The new publications got us (and some other...more
User-Friendly Documents for Doctors and Individuals Living With HIV Infection Explain Workplace Protections Under the Americans with Disabilities Act - WASHINGTON - The U.S. Equal Employment Opportunity Commission...more
Progress, and faith in progress to improve human lives, has been a cornerstone belief in American civilization (and, indeed, Western civilization generally, at least since St Augustine argued that Christ's death put an arrow...more
Leading the News - Burkina Faso: On September 25th, the United Nations (U.N.) Security Council issued a statement welcoming the reinstatement of President Michel Kafando and the transitional authorities of Burkina...more
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more