On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid … Continue Reading
The CARES Act funding was a lifeline for many health care organizations and life sciences companies, but came with significant attached strings. Related fraud charges are already making headlines and bring with them the serious risk of False Claims Act litigation, which can have bet-the-company implications for companies. Please join us this Wednesday, August 5 … Continue Reading
While the life sciences sector has proven more resilient than most, COVID-19 has undoubtedly caused a dramatic slowdown in deal activity globally across industries. Please join Reed Smith and a panel of strategic, private equity, and venture capital leading deal makers for an engaging discussion on the impact COVID-19 has had on deal making in … Continue Reading
By Tilman Siebert and Dr. Corinna Kammerer on Posted in EME Life Sciences
The German Federal Ministry for Economic Affairs and Energy implemented further amendments to the Foreign Trade and Payments Ordinance (Außenwirtschaftsverordnung – AWV) due to the COVID-19 pandemic to prevent the buyout of German companies active in the life sciences and infection protection sectors by investors from outside the EU (or EFTA). The amendment entered into … Continue Reading
California Governor Gavin Newsom’s Executive Order N-43-20 (the Order), which went into effect on April 3, 2020, relaxes various telehealth reporting requirements, penalties, and enforcements otherwise imposed under state laws, including those associated with unauthorized access and disclosure of personal information through telehealth mediums. The Order acknowledged that telehealth services may help reduce the spread of … Continue Reading
The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales. A team of Reed Smith life sciences and health care lawyers, including Scot T. Hasselman, Robert J. Hill, Carol Colborn Loepere, Kevin M. Madagan, Paul W. Pitts, James … Continue Reading
The Telephone Consumer Protection Act (the TCPA) restricts telemarketing and the use of automated telephone equipment for phone calls, faxes, and text messages. In an effort to ease restrictions in light of the COVID-19 outbreak, the Federal Communications Commission (FCC) has issued guidance clarifying that informational calls that are directly related to the imminent health or safety … Continue Reading
Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an … Continue Reading
If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation. This recommendation is designed to accelerate the time to market for these products, provided that … Continue Reading
