the ABA Washington Summit on Health Law is the premier legal conference focused on health law policy and, therefore, offers an overview of key current and future policy issues. But, as always at this conference, there are the issues selected by 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 in the first place, even presentations that didn’t seem to include these topics, like the panel on antitrust and mergers, touched on at least one and generally all of these topics.
Foremost among these subjects is the current public health emergency. The health care effects of the pandemic were, and are, pervasive, revolutionary and evolving. This impacted everything from A (antitrust) to Z (Z codes). Without a doubt, the most powerful and 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 – shed new light on the heroic work done by so many in the health field. 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: lack of access to care, an aging physician population and the mental health crisis in the United States. Most presenters expressed concern that once the pandemic is under control, states will revert to more stringent standards for the use of telemedicine. Before the pandemic, payers only reimbursed certain telemedicine services in remote areas of the country and only for certain services provided by particular types of providers. Where the public health emergency has required a more flexible approach to telemedicine, many fear that a return to the old way will leave many people without the care that, ironically, they were finally able to access during the pandemic. While the growth of telemedicine has been spectacular, many challenges remain, including large differences between states, lack of broadband access, and privacy concerns. Nonetheless, the pandemic has demonstrated that telemedicine can bring value to patients, providers and payers.
Another challenge for telemedicine is privacy, the third major question addressed at the Summit. Surveys discussed by René Quashie from the Consumer Technology Association has shown that after cost, the biggest barrier for people trying telemedicine and other consumer health technologies is 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 Health Information Privacy Act. While there is likely no federal legislation on this issue in the near future, the European Union’s General Data Protection Regulation could serve as a model for a broader privacy law.
Polarization, stagnation (of kinds) and litigation
While COVID-19, telemedicine and privacy dominated the official agenda, the issue of polarization in health policies also emerged as a strong theme through the presentations. As even casual observers know, America’s political parties and electorate are increasingly polarized, unable to get along, and often have 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 dramatically affecting healthcare on the ground. Vaccinations against COVID-19, for example, are proving to be a controversial issue for healthcare workers, adding to the already difficult job hospitals and their staff have in dealing with the pandemic.
Federal presidents and agencies have therefore attempted to act through agency decrees and regulations (both formal and informal). These methods are, by their very nature, more limited. And they are almost immediately challenged in court. Current Administration actions regarding vaccine or testing requirements through OSHA, CMS and Executive orders, for example, are blocked in court.
This polarization and these disputes ultimately lead to stagnation. While we realize that while the use of the term “stagnation” may be odd given the past 24 rather turbulent and very active months, it is an accurate description of congressional action relating to health care. This polarization results in little or no meaningful action from Congress on health care; and so federal agencies try to fill the void, but their actions are often challenged in court. States have also become active, especially in relation to COVID-19. But their efforts are also the subject of a dispute. In addition, their actions sometimes conflict directly with federal actions, such as States that have required that there be no vaccine warrant– and with other states. This has resulted in a fragmented approach that discourages healthcare companies from innovating, thriving and expanding.
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 continue to devastate communities and families across the country, and the pandemic has only exacerbated the problem. In the face of the stress of isolation, job loss, and the loss of friends and family due to COVID-19, drug addiction in all its forms has increased over the past two years. Gary Cantrell, Assistant Inspector General for Investigations at HHS OIG, explained that the HHS has worked to identify and stop healthcare professionals who prescribe too many opioids and has had significant success in Appalachia in recent years.
Second, some states have taken steps to limit access to abortion during the pandemic. The most notable are the Texas and Mississippi state laws currently before the Supreme Court. In addition, they have passed laws that, while theoretically focused on abortion, could affect telemedicine more broadly. Until the pandemic, the FDA only allowed mifepristone (RU 486) to be issued by an approved prescriber in certain health establishments and prescriptions prohibited without an in-person medical visit. But the The FDA waived these requirements during the pandemic. It is expected to publish the results of a remote distribution security study this month. If, as expected, it is safe, the requirements will likely be lifted permanently. However, many states have already put in place or are in the process of passing trigger laws that prohibit this. However, if such laws are not narrowly defined, they could therefore limit telemedicine more generally.
Finally, although it went largely unnoticed at the conference, the increase in investment in healthcare in recent years has also played an important role in the growth of the healthcare economy. A big part of this has been the investment of 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. In a question-and-answer session, Lisa Re of HHS OIG noted that ownership and “ownership structure” can drive company billing and other practices. In addition, HHS OIG may issue guidelines relating to private equity.