The following is the latest COVID-19 information from the federal government as of 2:30 p.m. on Monday, November 30.

Centers for Medicare & Medicaid Services

• CMS has expanded its March program “Hospitals Without Walls,” which provided broad regulatory flexibility that permitted hospitals to provide services in locations beyond their existing walls, by establishing a new “Acute Hospital Care At Home program” that expands those regulatory flexibilities so hospitals may treat eligible patients in their homes.  The CMS news release announcing the program expansion explains that the agency believes that

… treatment for more than 60 different acute conditions, such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD) care, can be treated appropriately and safely in home settings with proper monitoring and treatment protocols.

The CMS news release also explains that

Participating hospitals will be required to have appropriate screening protocols before care at home begins to assess both medical and non-medical factors, including working utilities, assessment of physical barriers and screenings for domestic violence concerns.  Beneficiaries will only be admitted from emergency departments and inpatient hospital beds, and an in-person physician evaluation is required prior to starting care at home.  A registered nurse will evaluate each patient once daily either in person or remotely, and two in-person visits will occur daily by either registered nurses or mobile integrated health paramedics, based on the patient’s nursing plan and hospital policies.

Learn more from this CMS news release and the agency’s FAQ about the program.  To participate in the program, hospitals will need to obtain a waiver from CMS.  The portal for applying for a waiver is here.

• In the same news release announcing the Acute Hospital Care At Home program, CMS also introduced that it is extending the portion of the Hospitals Without Walls program that applied to ambulatory surgical centers (ASC) by

… clarifying that participating ASCs need only provide 24-hour nursing services when there is actually one or more patient receiving care onsite.  The program change provides ASCs enrolled as hospitals the ability to flex up their staffing when needed and provide an important relief valve in communities experiencing hospital capacity constraints, while not mandating nurses be present when no patients are in the ASC… CMS expects this flexibility will allow… ASCs enrolled as hospitals to serve as an added access point that will allow communities to maintain surgical capacity and other life-saving non-COVID-19, like cancer surgeries.

Learn more about this program from the CMS news release; this FAQ; and CMS’s updated guidance for processing attestation statements from ASCs temporarily enrolling as hospitals during the COVID-19 emergency.

• Effective January 1, 2021, CMS will assign new MS-DRGs to six COVID-19 related conditions:  pneumonia due to COVID-19, multisystem inflammatory syndrome, other specified system involvement of connective tissue, encounter for screening for COVID-19, contact with and (suspected) exposure to COVID-19, and personal history of COVID-19.  Learn more from CMS’s MS-DRG Classifications and Software page and follow this link:  ICD-10 MS-DRGs V38.1 Effective January 1, 2021 (ZIP) (or go to this web page, scroll down, and click the first link under “Latest News”).
• CMS has updated its vaccine toolkit with guidance on coverage and reimbursement for COVID-19 vaccines, vaccine administration, and cost-sharing under Medicaid, the Children’s Health Insurance Program, and the Affordable Care Act’s Basic Health Program.  While the primary audience for this toolkit is state governments and other jurisdictions, it includes useful information for health care providers as well.
• CMS has updated its COVID-19 emergency declaration blanket waivers and flexibilities compendium for health care providers.

Department of Health and Human Services

• HHS has published a request for information on regulatory relief to support economic recovery in the wake of the economic impact of the COVID-19 public health emergency.  This RFI follows the actions of the federal government to adjust regulations in response to the COVID-19 emergency and seeks comment from stakeholders on the impact of those efforts and whether they should be retained or modified.  Comments are due December 28.  Find the RFI here.

Food and Drug Administration

• The FDA has published a new web page that brings together various FAQs on face masks, surgical masks, and respirators intended for use in the response to COVID-19.
• The FDA has approved an abbreviated new drug application for dexmedetomidine hydrochloride in sodium chloride injection, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures, including intubation as treatment for COVID-19.
• The FDA has published its recommended enforcement policy for bioburden reduction systems using dry heat to support single-user reuse of certain filtering facepiece respirators during the COVID-19 public health emergency.
• The FDA will host virtual town hall meetings for COVID-19 test developers on December 2, December 9, and December 16, all at 12:15 p.m. (eastern).  The purpose of these meetings is to help answer technical questions about the development and validation of tests for COVID-19.  Go here for information about how to join the calls.

Centers for Disease Control and Prevention

• The CDC’s Advisory Committee on Immunization Practices has published its ethical principles for allocating the initial supply of COVID-19 vaccines.
• The CDC has updated its FAQs for laboratories that perform COVID-19 tests.
• The CDC has updated its interim guidelines for collecting, handling, and testing clinical specimens for COVID-19.
• The CDC has updated its interim guidance on the collection and submission of postmortem specimens from deceased persons who were under investigation for COVID-19.
• The CDC has updated its data on the effects of COVID-19 on pregnant women.
• The CDC’s weekly morbidity and mortality report presents research about the implementation of hospital practices supporting breastfeeding in the context of COVID-19.