Combating the Novel Coronavirus (COVID-19): Week of Aug. 24
Posted on August 28, 2020
The MHA continues to keep members apprised of developments affecting Michigan hospitals during the pandemic through email updates and the MHA Coronavirus webpage. Important updates are outlined below.
Interim Final Rule Ties COVID-19 Reporting to Medicare Conditions of Participation
The Centers for Medicare & Medicaid Services (CMS) Aug. 24 issued an interim final rule that, among other provisions, makes collecting COVID-19 data and reporting it daily to the Department of Health and Human Services (HHS) a condition of participation (CoP) for hospitals that participate in Medicare. The MHA is disappointed in this rule that seeks to obtain data by penalizing hospitals as they continue to fight against a global pandemic.
The rule takes effect upon publication in the Federal Register, after which comments will be accepted for 60 days. The date the rule will be published is currently unknown.
The rule requires hospitals to daily report data including, but not limited to, number of confirmed or suspected COVID-19-positive patients, intensive care unit beds occupied and availability of supplies and equipment. By making this data reporting a CoP, the potential penalty for a hospital’s noncompliance could be termination from the Medicare program unless appropriate corrective action is taken.
While the MHA works to diminish the negative effects of this rule, hospitals are urged to report data through the HHS TeleTracking portal on a daily basis to avoid potential violation of the rule when it is published. Members needing assistance in meeting the reporting requirements should contact Jim Lee at the MHA.
Raising Awareness of Importance of Flu Vaccinations During Pandemic
The MHA is teaming up with Gov. Gretchen Whitmer and other healthcare organizations to promote flu vaccination during the upcoming influenza season. The potential for a surge of COVID-19 and severe outbreaks of influenza circulating simultaneously could overwhelm the healthcare system. MHA CEO Brian Peters participated in a news conference Aug. 25 to stress the importance of improving flu vaccination rates in Michigan (see related article).
FDA Approval or Authorization Unnecessary for Laboratory Developed Tests
The HHS recently announced that the Food and Drug Administration (FDA) will not require developers to submit a premarket approval application, premarket notification or emergency use authorization (EAU) for laboratory developed tests (LDTs). Laboratories opting to use LDTs would not be eligible for Public Readiness and Emergency Preparedness Act coverage and would remain subject to CMS regulation under the Clinical Laboratory Improvement Amendments of 1988 and its implementing regulations, the HHS said. LDT developers may voluntarily apply for approval, clearance or an EUA, and the FDA will adjudicate those submissions.
LDTs are developed, validated and performed by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs. The American Hospital Association has urged the agency not to regulate LDTs as medical devices, which would reduce patient access to many critical tests and hinder technological and clinical innovation.
Sept. 9 Twitter Chat to Focus on Mental Health During the Pandemic
A recent Kaiser Family Foundation poll determined that 53% of adults in the U.S. are experiencing poor mental health due to worry and stress over COVID-19. To help educate and encourage conversation around mental health as it relates to COVID-19 and National Suicide Prevention Awareness Month, the MHA will host a Twitter chat from 1 to 2 p.m. Sept. 9. The chat will feature input from guest expert Brian Ahmedani, PhD, director, Center for Health Policy & Health Services Research at Henry Ford Health System (@bahmedani).
Those interested in participating may follow along through the MHA’s Twitter (@mihospitalassoc) or by searching the hashtag #MHAHealthChat over the course of the hour. Additional details will be emailed to MHA members prior to the event. Those with questions may contact Lucy Ciaramitaro at the MHA.
Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC). Members with MHA-specific questions should contact the following MHA staff members:
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