[co-authors: Michelle Fong, and Adrienne Peng]
New Federal Developments
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On April 15th, the U.S. Department of Health & Human Services (HHS) announced the renewal of the Public Health Emergency (PHE).
The COVID-19 PHE will be renewed for another 90 days, beginning on April 21 (the date the PHE was previously scheduled to expire) and extending through July 21, 2021.
This update enumerates the key regulatory flexibilities and funding sources that are linked to the PHE, as well as key emergency measures with independent timelines that are not directly affected by the PHE renewal.
On April 15th the Federal Communications Commission (FCC) announced the second round of the COVID-19 Telehealth funding will open April 29th.
The Daily Yonder Report: As Obstetrics Units in Rural Hospitals Close, Black Rural Moms and Infants Face Higher Mortality Rates The research found that that more units are being closed in counties with majority non-white populations. The closures tend to affect small hospitals, often designated as Critical Access Hospitals, more often.
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A new study from the University of Minnesota Rural Health Research Center has found that when rural hospitals close their obstetrics units, it puts Black and Indigenous mothers at a far greater risk.
Julia Interrante, and Katy Kozhimannil, co-authors of the report, said that the closures of the obstetrics units in hospitals mean black women and infants are more at risk of mortality because of those closures. That’s because the hospitals that close their obstetrics units are more likely to be located in counties where the majority of residents are non-white or Hispanic.
Kamala Harris talks about the Black Maternal Health crisis in roundtable for Black Maternal Health week
Lawrence Jackson (via White House) / Wikimedia Commons Tuesday, April 20, 2021 8:58 AM UTC
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Last week, Vice President Kamala Harris hosted a roundtable event to mark Black Maternal Health Week. During the roundtable event, Harris addressed the issue of Black maternal mortality in the US.
As part of the Biden-Harris administration’s efforts to address the maternal health crisis in the country, Harris hosted the roundtable event made up of Black women who shared their experiences in pregnancy, childbirth, and postpartum. They also discussed the advocacy and research by the women in the addressing of the maternal health issue. Recent data showed that Black women are two to three times more likely to die from complications in pregnancy compared to white women.
House Passes Eight Health Care Bills
House Members Divided on Fentanyl Analogue Scheduling
Rep. Kevin Brady to Retire
Senate
Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests
Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule
Administration
HHS Secretary Becerra Approves Illinois Waiver for One-Year Postpartum Coverage
HHS to Roll Back Title X “Gag Rule”
HHS Secretary Becerra Confirms That Department Will Have Feedback Process on Surprise Billing
CMS Extends 2022 Deadline for Primary Care First Demonstration
Consumers First Coalition Recommends CMS Undertake Medicare Reforms
IRS Suspends Requirement That Taxpayers Repay Advanced Premium Tax Credits
FDA Details Plan for Remote Facility Inspections
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, President Biden signed a bill extending a moratorium on Medicare sequestration through the end of 2021. Read more about the law and other news below.
I. Regulations, Notices & Guidance
On April 15, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to describe how the agency will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; an