- Increased Telehealth/Telemedicine/Telemonitoring – With a wide range of health care providers cleared during the COVID-19 pandemic by the Food and Drug Administration (FDA) to deploy these methods under Emergency Use Authorization (EUA), many are seeking regulatory and state approval to continue providing them after the Public Health Emergency (PHE) ends. Now that many providers and patients are comfortable with remote health care services, expect to see this trend take hold on a more permanent basis.
- Rising Number of Home Health Care Company Acquisitions – As COVID-19 became prevalent in nursing homes nationwide and many beds were left unoccupied, home health care was in high demand. This trend, paired with a cash flush market and low interest rates, fueled a large number of acquisitions of home health companies of varying sizes that is expected to continue into 2022.
- Continued Staffing Shortages Disrupt Care Provision and Send Some Providers Into Bankruptcy – The shortage of virtually all types of health care professionals due to burnout, provider vaccine mandates driven by Medicare funding, and other issues is creating epic disruption in the industry. Expect to see providers grappling with unions and seeking assistance from the government to find solutions.
- Confusion Over How to Comply with the No Surprises Act – The act, which went into effect Jan. 1, 2022, is meant to ban most unexpected medical charges from out-of-network providers. But its complexity leaves many health care entities with more questions than answers as they look for guidance on how to comply and several key legal challenges to the act move through the courts.
- FDA Shifts Focus from Product Approval to Enforcement – The numerous products available to the public that went to market over the past two years without the necessary FDA approval may be recalled as the regulator cracks down on non-compliance.
- U.S. Supreme Court Decision on 340B Hospital Discounts – In late 2021, the court heard oral arguments in two cases involving the federal government’s 340B Drug Pricing Program, which requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. At issue is whether 340B hospitals will retain discounts on Medicare Part B drugs. The court’s decision is expected in June 2022.
About the Authors
Greenberg Traurig, LLP's Health Care & FDA Practice is nationally recognized for handling transactional, litigation, regulatory, product approval, enforcement, and compliance matters for organizations across many diverse industries. We offer clients practical know-how that comes from firsthand experience working in their industries and in their regulatory circles. Our interdisciplinary team has the experience and scope of knowledge needed to steer our clients ahead in an ever-evolving, dynamic health care space.