the ABA Health Law Summit in Washington is the premier legal conference focused on health law policy and, therefore, provides insight into key current and future policy issues. But, as always at this conference, there are the issues selected by the conference chairs and formally placed on the agenda – and then there are the issues that experienced practitioners can identify by reading between the lines. Both are discussed below.
COVID-19, telemedicine and privacy
Not surprisingly, these three issues dominated the agenda. While other topics were certainly covered, opioids being the most prominent, even the presentations that didn’t seem to include those topics, like the Antitrust and Mergers panel, touched on at least one and usually all of those topics. .
Foremost among these topics is the current health emergency. The effects of the pandemic on health care were, and are, pervasive, revolutionary and evolving. It impacted everything from A (antitrust) to Z (Z-codes). Without a doubt, the most powerful and most discussed presentation this year was the Taya Briley of the Washington State Hospital Association and Sheniece Smith of North Bay Healthcare discussion of standards of crisis care during the pandemic. Their discussion of the incredibly difficult, trying and exhausting decisions to be made during the worst times of the pandemic – which is far from over – provided new insight into the heroic work being done by so many in health and the challenges we faced and continue to face.
Part of the impact of COVID-19 is a dramatic acceleration in the already rapid growth of telemedecine, and this was reflected in several presentations. Some presenters saw telemedicine as a way to solve some of the biggest problems facing healthcare today: the lack of access to care, the aging medical population and the mental health crisis in the United States. Most presenters expressed concern that once the pandemic is contained, states will return to stricter standards for the use of telemedicine. Prior to the pandemic, payers only reimbursed certain telemedicine services in remote parts of the country and only for certain services provided by particular types of providers. While the public health emergency has necessitated a more flexible approach to telemedicine, many fear that going back to the old way will leave many people without the care that, ironically, they were finally able to access during the pandemic. Although the growth of telemedicine has been dramatic, many challenges remain, including large differences between states, lack of broadband access, and privacy issues. Nevertheless, the pandemic has demonstrated that telemedicine can bring value to patients, providers and payers.
Another challenge of telemedicine is privacy, the third major issue addressed at the summit. Investigations discussed by Rene Quashie of the Consumer Technology Association showed that after cost, the biggest barrier for people trying telemedicine and other consumer health technologies was privacy concerns. While HIPAA generally works for medical privacy and providers are familiar with it, some states have enacted additional laws such as the California Medical Information Privacy Act. While there likely won’t be any federal legislation on this issue in the near future, the European Union’s General Data Protection Regulation could serve as a model for broader privacy law. .
Polarization, Stagnation (sort of) and Litigation
As COVID-19, telemedicine and privacy dominated the official agenda, the issue of polarization in health policy also emerged as a strong theme in presentations. As even casual observers know, America’s political parties and electorate are increasingly polarized, unable to get along and often with little incentive to try to get along. As a result, Congress pursues a steady decline in legislation.
The polarization that has dominated the political landscape in recent years, along with a growing divide between industry and government, is greatly affecting healthcare on the ground. Vaccinations against COVID-19, for example, are proving to be a contentious issue for healthcare workers, adding to the already difficult job that hospitals and their staff have to manage the pandemic.
Presidents and federal agencies have therefore attempted to act through executive orders and agency regulations (both formal and informal). These methods are, by their very nature, more limited. And they are almost immediately challenged in court. The actions of the current administration regarding vaccine or testing requirements through OSHA, CMS and Executive orders, for example, are blocked in court.
This polarization and disputes ultimately lead to stagnation. While we realize the use of the term “stagnation” may be odd given the past rather turbulent and highly active 24 months, it is an accurate description of congressional action on health care. This polarization results in little or no meaningful congressional action on health care; and so federal agencies attempt to fill the void, but their actions are often challenged in court. States have also become active, especially regarding COVID-19. But their efforts are also the subject of a dispute. In addition, their actions are sometimes in direct conflict with federal actions, such as States that have required there to be no vaccine mandates— and with other States. This has resulted in a fragmented approach that discourages healthcare companies from innovating, expanding and growing.
Three Other Miscellaneous Issues: Opioids, Abortion, and Private Equity
There were three other issues too important not to mention. Most importantly, opioid addiction and abuse continues to devastate communities and families across the country, and the pandemic has only exacerbated the problem. Facing the stress of isolation, job loss, and the loss of friends and family due to COVID-19, substance abuse in all its forms has increased over the past two years. Gary Cantrell, Assistant Inspector General for Investigations at HHS OIG, explained that HHS works to identify and stop medical professionals who prescribe too many opioids, and has seen significant success in Appalachia in recent years.
Second, some states have taken steps to limit access to abortions during the pandemic. Are in particular the Texas and Mississippi state laws currently before the Supreme Court. Additionally, they passed laws that, while theoretically focused on abortion, could affect telemedicine more generally. Until the pandemic, the FDA only allowed mifepristone (RU 486) to be dispensed by an approved prescriber in certain healthcare establishments and prescriptions prohibited without a medical visit in person. But the The FDA waived these requirements during the pandemic. It is expected to release the results of a study this month regarding remote distribution security. If, as expected, it is safe, the requirements will likely be removed permanently. However, many states have already put in place or are in the process of passing trigger laws that will prohibit this. However, if these laws are not narrowly defined, they could consequently limit telemedicine more generally.
Finally, although it largely slipped under the radar during the conference, the increase in healthcare investment in recent years has also played a significant role in the growth of the healthcare economy. A significant part of this has been investment from private equity firms. To date, there have been a very small handful of False Claims Act cases in which a private equity firm was involved. During a question-and-answer session, Lisa Re of HHS OIG indicated that ownership and “ownership structure” can encourage company billing and other practices. In addition, the HHS OIG may issue guidelines related to private equity.