Serving Harris, Brazoria, Fort Bend, Montgomery and Galveston Counties
HOUSTON
Volume 10 | Issue 9
Inside This Issue
September Edition 2020
CMS “Hospitals Without Walls” Flexibilities – New Opportunities and Risks Neal D. Shah, JD, Polsinelli, PC
New Sleep Medicine Service Offers Insight into Link Between Sleep Quality and Well-Being See pg. 7
INDEX Oncology Research......... pg.5 Healthy Heart....................... pg.8 Financial Forecast............ pg.10 The Framework.................. pg.12
Telehealth’s Risks to Physicians and Patients See pg. 13
O
ne of the most frightening risks of the COVID-19 pandemic is the potential for health systems to become overwhelmed. Houston, like many other regions of the country has seen rapid, often unpredictable increases of cases requiring intensive care and extended hospitalization, prompting serious concerns about bed capacity. In an effort to allow hospitals to maximize capacity and create more effective physical separation between COVID and non-COVID patients, CMS has authorized new regulatory flexibility to support “hospitals without walls” models. In theory, these models will allow hospitals to provide hospital-level care for patients in non-traditional settings including their homes. However, in practice hospitals should be aware of a number of open issues and regulatory complexities involved
with delivering care in such locations. In an interim final rule (CMS-5531-IFC, published at 85 Fed Reg 27550 on May 8, 2020) CMS used its special Pubic Health Emergency waiver authority under Section 1135(b) of the Social Security Act to authorize hospitals to provide care in “temporary expansion sites.” First, CMS waived a number of the hospital “conditions of participation” (or CoPs) including provisions on the “physical
environment” hospitals must maintain. Any location still must be consistent with a state’s emergency preparedness or pandemic response plan. Second, CMS used its waiver authority to create a number of changes to the rules on providerbased hospital locations. Last year, CMS finalized rules allowing temporary relocation of provider based sites during traditional, see CMS... page 14
Rice University Ventilation Unit Gets FDA Emergency Approval
A
n enhanced version of the Emergency Use Authorization (EUA) by ApolloBVM designed by Rice the U.S. Food and Drug Administration University engineers has received as an emergency resuscitator for use during the COVID-19 pandemic. The device, as further developed by the Houston manufacturer Stewart & Stevenson Healthcare Technologies LLC, a subsidiary of Kirby Corporation, is designed to deliver air to the lungs of adult patients who require ventilation while they await the availability of a full ventilator. The manufactured version, dubbed Apollo ABVM, is a sturdy and
portable system the company believes can be rapidly deployed in emergencies during the EUA period. Open-source plans for Rice’s ApolloBVM remain online and available to the maker community. The plans have been downloaded by nearly 3,000 registered participants in 115 countries. “The COVID-19 pandemic pushed staff, students and clinical partners to complete a novel design for the ApolloBVM in the weeks following the see Ventilation Unit ... page 14
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