This blog focuses on the Biden Administration’s announcement on its intention to end the COVID-19 public health emergency (PHE) on May 11, 2023. For Federally Qualified Health Centers (FQHCs), flexibilities offered under the PHE expanded opportunities to be paid for telehealth services, particularly for Medicare patients. Any FQHC relying on PHE flexibilities should begin preparing for the end of the PHE to ensure its service offerings are in compliance with post-pandemic requirements.
This article focuses on the Centers for Medicare & Medicaid Services (CMS) massive rule (Final Rule)2 amending regulations for Medicare Advantage (MA or Part C), Medicare Cost Plan, the Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE).
This blog post focuses on health care companies who are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply antitrust law to the modern, data-driven economy. Amid these myriad changes in technology and the law, the time is ripe to consider what the growth of AI in health care means for antitrust compliance.
This article focuses on the changes to the Medicare Advantage (MA) and Part D programs marketing rules at 42 C.F.R. parts 422 and 423, which are applicable for all contract year 2024 marketing and communications beginning September 30, 2023.
This article highlights key considerations for hospitals in evaluating, developing, and implementing an ASC transaction, with a focus on fraud and abuse considerations related to investing alongside physicians. It also highlights the type of regulatory analysis that providers and others contemplating transactions involving health care entities must consider and address.
The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require special consideration during development of a patent portfolio, stakeholders across engineering, legal, and executive teams in both established companies and start-ups can leverage it to create valuable intellectual property (IP) assets in the marketplace.
Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will sunset at varying times.
Between now and 2030, the biopharma sector is expected to be rocked by a number of high-profile patent cliffs that are likely to reshape the market in potentially unpredictable ways. A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch.
Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.