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Articles

340B Rate Cuts Reversed by CMS for 2023

By Anil Shankar, Stephanie J. Schwartz, Foley & Lardner

The Centers for Medicare and Medicaid Services (CMS) has announced that it “fully expects” to reverse
Medicare Part B rate cuts for separately payable drugs acquired through the 340B Drug Pricing Program,
resulting in an estimated additional $1.96 billion for 340B hospitals. Learn more through this blog post released by Foley & Lardner.

Articles

Remote Therapeutic Monitoring: What You Need to Know About CMS’ Proposed Changes

By Thomas B. Ferrante, Nathaniel M. Lacktman, Rachel B. Goodman, Foley & Lardner

On July 7, 2022, the Centers for Medicare & Medicaid Services (CMS) proposed five new changes to Remote Therapeutic Monitoring (RTM) services under the Medicare program. The changes are part of the proposed 2023 Medicare Physician Fee Schedule rule. To learn more check out this Foley & Lardner article.

Articles

Growing Scrutiny of Private Equity in Health Care

By Lori A. Rubin, Michelle A. Freeman, Samantha Robbins Jamali

The presence of private equity (PE) investment has exploded in recent years in all areas of the health care sector. PE in health care is a good thing when done right: It can pave the way for much needed innovation, efficiency, and nontraditional care delivery models. However, government regulators, media journalists, some health care practitioners, and private parties are watching PE investment with growing suspicion that profit-driven goals may conflict with the quality of care for patients.

Articles

Considerations When Conducting Decentralized Clinical Trials

By Kyle Y. Faget

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.

Articles

Building Biotech with Brains: Strategies for Maximizing Value of AI-Driven Biotechnology Inventions

By Aashish R. Karkhanis, Jeffrey Simon

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.

Articles

2023 Telemedicine & Digital Health Trends

By Thomas B. Ferrante, Rachel B. Goodman, Jennifer J. Hennessy, Jacqueline N. Acosta, Sunny J. Levine, Aaron T. Maguregui, Sarah J. Iacomini, Kristen A. Murphy

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.

Articles

The BioPharma Patent Cliff: 2023 and Beyond

By Jason N. Mock

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.