Legal Insights and Perspectives for the Healthcare Industry
Another year has come to pass, and it seems the federal Public Health Emergency (PHE) will remain in place for at least the next five months. Why? As the US Department of Health and Human Services (HHS) has continuously pledged throughout the COVID-19 pandemic, the federal government intends to give states and healthcare providers at least a 60-day notice before terminating the PHE, which has granted significant flexibilities for furnishing healthcare services covered by Medicare, including in the context of telehealth. That 60-day notice period for the current PHE expiration date came and went on November 12 with no word from Secretary Xavier Becerra that the federal government would seek to wind down PHE flexibilities at the start of 2023. As a result, the PHE in all likelihood will be extended for an additional 90 days in early January 2023, for a revised expiration date of April 11, 2023.
Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.
The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have likewise increased fraud enforcement in this area, including through the issuance of OIG’s recent Special Fraud Alert (SFA).
The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely that the PHE will be extended for at least another 90 days. Previously, the federal government had pledged to states that it would announce an end to the PHE at least 60 days before its expiration. That 60-day time frame ended on May 16 with no indication from the US Department of Health and Human Services (HHS) that it was anticipating the end of the PHE.
Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured Topics” resource page on its website dedicated to telehealth and OIG’s work in evaluating telehealth policies. This telehealth resource page serves as a compendium for all the reports OIG has completed or plans to undertake related to telehealth and virtual care technologies, including several audits and evaluations currently on OIG's 2022 work plan. In addition, the resource page provides a helpful overview of the manner in which telehealth fits into the larger Medicare regulatory framework.

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.

The Centers for Medicare and Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning telehealth, remote physiologic monitoring (RPM), and new remote therapeutic monitoring codes. Coming on the heels of the significant telehealth waivers put in place during the COVID-19 public health emergency (PHE), CMS proposes to continue the steady expansion of virtual care options with this rule.
It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).
In the most recent edition of our global telehealth series, we take a look at the United Kingdom’s telehealth expansion, discussing the UK National Health Services’ recently released guidance providing a set of best practice principles for third-party partners to follow. The LawFlash covers telehealth laws and regulations and the role of the EU General Data Protection Regulation, as well as looks forward to future changes and reform.