Health Care Outlook

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On February 26, 2020, as fears of a potential pandemic caused by COVID-19 spread across the globe, we argued that federal public health powers are ostensibly quite limited, as illustrated by the scope of quarantine powers granted to the U.S. Centers for Disease Control and Prevention. The article flagged the foreseeable risk that conflicts may arise between the federal government and the states over the application of quarantine and other public health powers.

A year later and many of these tensions have been pushed aside for the greater purpose of responding to the pandemic. In doing so, many long-standing principles of state regulation of the practice of medicine and other healing arts have been preempted. This article reflects on some lessons learned and the possible changes ahead, focusing on the federal government’s COVID-19 testing proposal and the use of federal laws to respond to public health emergencies.

On January 21, 2020, COVID-19 first came to U.S. shores in Seattle; by mid-February 2020, a local nursing home had the first outbreak, which indicated that community spread was occurring. Other than short-lived controversy over whether to let a cruise ship dock in San Francisco, and some half-hearted air travel bans and screening, it was clear that quarantines were not going to be an effective tool to prevent the further spread of SARS-CoV-2. By March 11, 2020, the World Health Organization had declared a pandemic, and on March 13, 2020, President Donald Trump declared a national emergency, and health authorities switched strategies to detection and mitigation.

One of the first strategies implemented by the federal government was a widespread testing regime. On March 13, President Trump held an event in the Rose Garden where he announced a drive-through testing strategy involving the large retail pharmacy chains (plus one “big box” store). In this effort, the federal government declared that it would arrange for and manage all of the testing and would provide security, personal protective equipment (PPE), and collection kits. The pharmacies would host the sites, and their employees would collect specimens. The collected samples would be sent to third-party clinical laboratories, and the federal government would arrange for notifications of results to patients, all of this to be powered by a scheduling and management database that would be built by Google, which had “1,700 engineers working on the problem.”

Most of this did not come to pass (at least not as proposed) in spite of best efforts by retailers – because the government could not source test kits or PPE, or provide any testing capabilities, and Google was never engaged to create a scheduling/management database. Nevertheless, the drive-through testing proposal raised a number of interesting questions. The use of retail pharmacy partners to quickly scale testing sites made sense given their geographic footprints, health care supply chain experience, and licensed pharmacists. But state law often restricts the ability of pharmacists to order and administer COVID-19 tests as these are activities characterized – by certain state laws – as beyond a pharmacist’s scope of practice. These scope-of-practice limitations are generally absolute and cannot be circumvented by training, credentialing, or certification.

The practice of medicine – and other clinical practice – is regulated by the states. This concept was deemed so important (at one time) that it is enshrined as the very first paragraph of the Medicare Act, 42 U.S.C. § 1395, which prohibits any federal interference with the “supervision or control over the practice of medicine or the manner in which medical services are provided…” Even if we push aside this statement as a predicate assuagement for passage of a new government social welfare system, it is undisputed that state law sets the requirements for the practice of medicine and other healing arts. States supervise and license physicians, therapists, nurses, optometrists, hospitals, nursing homes, and other providers and clinicians. States decide (usually through professional boards) the scope of practice of each of these professions within the state. Indeed, and specific to the COVID-19 testing proposal, physicians and osteopaths have long opposed expansion of practice by pharmacists, qualified nurse practitioners, and other clinicians, with the American Medical Association even using the social media hashtag #stopthescopecreep. The numerous news articles covering these past debates or “battles” tend to use adjectives like “bitter” and “fierce” in describing scope-of-practice disputes.

Key takeaways
  • Federal government is encroaching on state controls over the practice of medicine
  • COVID pandemic created more reasons for federal preemption
  • PREP Act grants extraordinary preemptive discretion to HHS

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