Health Care Law Today

Physician consolidation continued on a robust pace this past year, despite, or maybe because of, the Pandemic. Physician-owned orthopedic practices appear to be no exception to this trend. Interestingly, orthopedic physicians, including spine physicians, are among the most independent of all physicians and have long resisted the urge to sell or combine their practices. This desire to remain independent has been supported by the leverage these practices have by reason of their ownership and operation…
In the 12-month period starting in April 2021, over 100,000 people have died from drug overdoses, a 28.5% increase from the same period the year before. While the opioid crisis has been a declared public health emergency (PHE) since October 26, 2017, overdose deaths remain at an all-time high and have only been exacerbated by the COVID-19 pandemic. To combat this epidemic, physicians and other health professionals have called for additional telehealth flexibilities to allow…
The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators. To enable an “orderly and transparent transition” when the PHE ends, FDA recently released two nonbinding draft guidance documents addressing: (1) EUAs (EUA Guidance); and (2) medical devices falling under
Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to such tests, including the Clinical Laboratory Improvement Amendments (CLIA), which govern most laboratory testing and the operations of clinical laboratories. On November 22, 2021, the Centers for Medicare & Medicaid Services (CMS) published a guidance…
Despite continuing disputes as to the legality and enforcement of the CMS vaccine mandate for certified providers and suppliers, CMS has indicated it will proceed with enforcement of the mandate in those states where it is not enjoined from doing so with clarifying guidance issued on December 28, 2021. See below for immediate action steps for those currently subject to the mandate.  As previously reported, on November 4, 2021 the Centers for Medicare and…
We continue to see affiliation activity among hospitals and health systems, albeit at a slower pace than previously experienced, likely due to the COVID-19 pandemic and the resulting slow down in elective care, staffing shortages and a disinclination of some patients to re-engage with their providers. These impacts, we believe, are transitory and will resolve themselves in due course leading to increases in deal volume. The deals we have seen are more “super regional” in…
The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care. Amidst COVID-19 supply chain shortages, health care facilities began working with 3D printer manufacturers to print medical devices, e.g., face shields, face mask holders, nasopharyngeal swabs, and ventilator parts from locally-available materials directly at the point of care. FDA is considering how health…
On November 16, 2021, U.S. House Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the highly anticipated Cures 2.0 Act (H.R. 6000). Among other things, this 173-page bipartisan bill contain provisions to accelerate medical research, increase patient access to novel therapeutics, and remove current barriers to telehealth services. This bill would also create a new agency called Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH). This…
Three times as many consumers say they plan on continuing to use telehealth services, and more than half of providers view it more favorably now than before. As telemedicine companies stepped up during the COVID-19 (COVID) health crisis, patients and clinicians alike came to value and rely on the model of anywhere care, where an exam, checkup, or therapy session could be performed remotely and safely. Despite the support from consumers, the industry faces policy…
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability to require that certain laboratory developed tests (LDTs), including COVID-19 tests, a type of test that is generally designed, manufactured, and used in a single laboratory, receive premarket approval (PMA) or clearance (510(k)), or emergency use authorization (EUA). FDA has historically asserted…