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5 Trends to Watch 2023: Health Care & FDA

  1. Growth of Medicare Advantage. Since its inception in 2006, the private plan alternative to traditional Medicare now covers nearly 48% of the entire country’s Medicare population—about 28.4 million Medicare beneficiaries nationwide. This figure is expected to pass the 50 percent mark in 2023 and reach 69 percent in 2030. Given that Medicare Advantage can offer extra benefits to those individuals in Medicare, it is likely to continue growing.

  2. New Cosmetic Regulatory Requirements. The Modernization of Cosmetic Regulation Act of 2022 is the first statutory change to the Food and Drug Administration’s (FDA) authority over cosmetics since 1938 and now requires manufacturers, importers, and processors of cosmetics to abide by requirements related to safety substantiation, adverse event reporting, product registration/listing, ingredient labeling, good manufacturing practices, and recordkeeping. The law also gives FDA mandatory recall authority over cosmetics and allows FDA to establish standardized testing methods for detecting and identifying asbestos in talc-containing products.

  3. Medicaid Eligibility and Enrollment Post-Public Health Emergency (PHE). The current PHE requires states to maintain Medicaid coverage for all individuals who enrolled during the COVID-19 pandemic, even if those individuals later experienced a change in circumstances that made them no longer eligible for Medicaid. Upon the end of the PHE, however, the Centers for Medicaid & Medicare Services has announced that states will have one year to initiate all eligibility reassessments and 14 months to complete them, which will likely result in millions of individuals losing Medicaid coverage. Most states have developed plans on unwinding certain requirements or finding ways to extend modify health professionals’ licensing requirements that have created greater efficiencies in offering services.

  4. Mergers & Acquisitions in 2023. In 2023, we expect that health care M&A will likely change as certain entities may require debt restructuring, there will be valuation changes in some markets. There are some areas that M&A may focus on, including Contract Research Organizations (CROs), U.S. manufacturing sites for devices, drugs, and biologics, continuing activity in the physician and dental practice management space, and continued alignment of providers and insurance plans to create greater synergies.

  5. Price Transparency. Federal price transparency requirements will continue to disrupt the healthcare industry in 2023. Unlike the 2021 Hospital Price Transparency Rule, the 2022 Transparency in Coverage Rule applies to health plans and health insurance issuers. Designed to phase-in over time, the Transparency in Coverage Rule first required health plans and health insurance issuers to publish certain basic patient cost-sharing information. Starting January 1, 2023, the federal government will require an internet-based self-service price comparison tool to generate cost-sharing estimates for 500 items and services. Whether these transparency requirements improve quality or outcomes for patients remains controversial, but insurers are required to comply or face stiff penalties.

* Special thanks to Law Clerk/JD Nicole Baptista for her valuable contributions to this article.

About The Authors

Greenberg Traurig’s multidisciplinary Health Care & FDA Practice provides strategic counsel to a diverse group of companies and other organizations, helping them to respond proactively to the rapidly changing health care marketplace. The group combines dedicated experience in health care regulatory compliance and operational matters with the firm’s capabilities in corporate & securities, finance, tax, antitrust, ERISA, commercial and governmental litigation, restructuring, intellectual property and biotechnology, in order to provide a wide range of legal services.