POLICY BRIEFING – WEEK IN REVIEW

Yesterday several major healthcare insurers announced a change to their reimbursement rates for virtual healthcare visits, effectively limiting the impact of a policy that has proved vital to many Americans during the pandemic. Both UnitedHealthcare and Anthem have announced that they will no longer cover the full cost of virtual visits unrelated to covid-19, with Anthem applying cost-sharing measures based on a member's existing plan. When asked for specific estimates on cost to members, UnitedHealthcare cited $50, while Anthem would not commit to any figures, citing differences between types of plans and individuals.

The problem extends beyond just those patients covered by these insurers; as one company, or two in this case, begins restricting benefits, others tend to follow suit to cut down on expenses. This in turn forces healthcare providers to reconsider the services offered as well as the cost borne by the patient. While the Centers for Medicare and Medicaid Services has committed to expanded telehealth coverage in 2021 via the annual Physician Fee Schedule (which determines how much physicians are paid for their work in treating Medicare and Medicaid patients), individual companies have been known to make their own adjustments. That these two decided to do so in the middle of the pandemic seems particularly harsh. Various. 2 October 2020.

For-profit pharmaceutical companies including AstraZeneca, Baye, Eli Lilly, Gilead, Johnson & Johnson, Pfizer, and Merck & Co. have partnered with the Bill & Melinda Gates Foundation to initiate "the most expansive and ambitious pandemic R&D response effort in history, with the promise of a range of interventions that can help end the pandemic." This commitment will involve developing clinical trials to represent racial, ethnic and socioeconomic demographics across the globe and a promise to develop scalable technologies that can be implemented in low-income settings. The hope is that these efforts will address disparities that have been reported in other clinical trials related to covid-19.

The signed letter outlines a focus on timeliness, affordability, equitable technology distribution, and R&D transparency for eventual recipients around the globe. The document closes by calling on governments to develop evolving guidance on how innovations are to be implemented in each distribution setting, while, "enhancing country readiness and in-country delivery systems."

It remains to be seen whether calling on countries to prepare for incoming aid is enough to ensure effective implementation of technologies meant to end the covid-19 pandemic, or whether the planned $38 billion in funding will materialize from wealthier entities such as Britain, the European Union, and the United States. 1 October 2020.

The United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the first antibody point-of-care (POC) covid-19 test. POC tests generally refer to tests that generate results on-the-spot without the need to send the sample to a laboratory for analysis or processing. Home pregnancy tests are a common example of a POC test.

Initially authorized for use by certain labs in July, the EUA has since been expanded to authorize POC use on fingerstick samples (note: fingerstick samples refer to small amounts of blood drawn from a pinprick needle applied to the tip of a finger; blood glucose levels are often obtained in this way). This EUA will allow the covid-19 antibody test to be deployed in any setting, unlike the original agreement, which required shipment to a central lab for analysis. The FDA has granted over 50 serology (i.e. blood tests) EUAs, most recently an inexpensive self-contained test in September, as well as novel salivary tests. But this latest authorization marks the first POC test with such simple collection and processing.

While the expanded amount of data this test will provide may be beneficial in contact tracing and exposure, it is not yet known what degree of immunity, if any, the presence of antibodies gives to patients, nor how long such proteins and the immunity they provide may last after exposure. For a more complete list of FDA EUAs related to the pandemic, please visit the FDA's dedicated portal. The Food and Drug Administration. 28 September 2020.

Last month Brief19 featured an update about the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma's threatening to withhold Medicare reimbursement if hospitals did not submit coronavirus data directly to the Department of Health and Human Services (HHS), a move that was highly criticized for removing the Centers for Disease Control and Prevention (CDC) from the process.

A new draft letter from CMS reveals the details of the new plan, requiring hospitals to provide daily accounts of the number of coronavirus cases and supply of remdesivir (the drug has some evidence to support of its use in covid-19 patients; it appears to shorten duration of hospital stays among those patients well enough to be sent home) directly into the HHS system. In addition, periodic updates on various hospital supplies are required for reporting. Failure to comply after repeated warnings will result in termination of the facility's Medicare agreement. This would have astronomical implications for any hospitals running afoul of the policy. While HHS claims the data is necessary for planning and mitigation purposes, hospitals have described the unfunded mandate with shifting reporting requirements as creating unnecessary stress and distraction. Various. 30 September 2020.