May 8, 2020: National Advocacy Update


On May 4, the U.S. Food and Drug Administration (FDA) issued updated policy on antibody (serology) testing for COVID-19. The new policy is more restrictive on test manufacturers, after a flood of serology tests came to market, some with poor performance and fraudulent labeling. FDA will now require all commercial test manufacturers to apply for an Emergency Use Authorization (EUA) to offer their tests on the market. The FDA has also provided recommended performance criteria for these tests. Tests developed as laboratory-developed tests will still be allowed to be offered without going through the EUA process. 

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Importantly, FDA has noted the many limitations of serology tests currently in the marketplace, including the significant risk of false positive results where there is low disease prevalence. FDA noted that these tests should currently be used in limited circumstances, such as population-level study, to evaluate potential donors for convalescent plasma and in other well-defined testing plans in concert with other clinical information.  The AMA has ongoing concerns about the performance of many serology tests currently being marketed and does not recommend these tests be used by individuals as a determination of individual immune status. Similarly they should not be used to discontinue physical distancing and individuals should continue to follow all current public health recommendations to stop the spread of COVID-19.

On April 30 the Centers for Medicare and Medicaid Services (CMS) issued a second interim final rule (PDF) with comment period that gives providers additional regulatory flexibilities during the current public health emergency. Among some of these regulatory changes are a few provisions that will be especially beneficial for graduate medical education (GME) students and residents during this time. Firstly, indirect medical education (IME) payments will not be affected by the number of available beds in a hospital and the available bed count will be "considered to be the same as it was on the day before the emergency was declared." Additionally, CMS is allowing teaching hospitals to claim the full-time equivalent (FTE) time of residents at other hospitals on its Medicare hospital cost report during the declared emergency under certain circumstances. Moreover, teaching physician supervision rules have changed. Now the list of services that may be provided through the primary care exception have been expanded, and teaching physicians may "review the services provided with the resident, during or immediately after the visit, remotely through virtual means via audio/video real time communications technology."

A bipartisan collection of 90 members of the House of Representatives sent a letter (PDF) requesting that an anticipated fourth piece of legislation to address the coronavirus pandemic incorporate policies to help physicians and other health care workers cope with the mental health burdens of treating COVID-19 patients. Representative Raja Krishnamoorthi (D-IL) spearheaded the letter to House Speaker Nancy Pelosi (D-CA) and Majority Leader Kevin McCarthy (R-CA) that requests the Department of Health and Human Services (HHS) establish a grant program to allow health care employers and facilities to confidentially assess and treat the mental health of coronavirus front line health care workers. In addition to grants, the letter urges HHS to fund and complete a comprehensive study on health care worker mental health that emphasizes organizational, systemic, and occupational factors that contribute to stress and burnout, as well as ways to mitigate these issues. The AMA worked closely with Rep. Krishnamoorthi on the specific policy proposals to highlight to House leadership and the letter was ultimately endorsed by more than 50 medical organizations. Rep. Krishnamoorthi, in conjunction with the AMA and other medical specialty organizations, are actively pursing the inclusion of these mental health policy proposals in future coronavirus legislation.  

The AMA sent a letter to the Acting Secretary of the Department of Homeland Security (DHS) requesting that the department investigate reports that pregnant women seeking asylum in the United States have been denied timely access to health care by U.S. Customs and Broder Protection agents. There is still much that is unknown about the effects of COVID-19 on pregnant women and their unborn children, and the AMA recognizes the need for programs and staff training to address the distinctive health care requirements of detained women and adolescent females, including gynecological and obstetrics care for pregnant and post-partum women. AMA is urging DHS to ensure that it has appropriate medical policy surrounding maternal health and that it adequately trains its staff on the protocol and special needs of pregnant and postpartum women.