COVID-19 Updates and Developments (Week of November 30)
- December 04, 2020
A bipartisan group of lawmakers are trying to restart stalled negotiations for additional COVID-19 relief, unveiling December 1 a $908 billion package that includes unused Coronavirus Aid, Relief, and Economic Security (CARES) Act funds and liability protections.
The emergency relief framework appeared to gain some traction as the week progressed. Senators Mitt Romney (R-UT), Joe Manchin (D-WV), Susan Collins (R-ME), Mark Warner (D-VA), Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), Lisa Murkowski (R-AK), Angus King (I-ME), and Maggie Hassan (D-NH) are the lawmakers who joined the bipartisan effort to craft the proposal.
The package includes roughly $560 billion in repurposed funds from the CARES Act, with roughly $348 billion in new spending, the lawmakers said. The measure also includes a temporary suspension of COVID-19 liability lawsuits at the state and federal levels. Romney said the provision would give states time to enact their own liability protections.
The measure would add $35 billion in health care provider relief funds, according to a breakdown of the proposal.
Agency Action
Centers for Medicare & Medicaid Services (CMS)
November 25—With surging cases of COVID-19 straining the capacity of the health care system in a number of areas, CMS announced new flexibilities that build on its Hospitals Without Walls initiative started in March so patients can receive care outside the hospital setting. CMS launched the Acute Hospital Care At Home program, which provides regulatory flexibilities that allows hospitals to treat certain patients in their homes for more than 60 different conditions such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease care. The program requires screenings and in-person physician evaluations before a patient can start care at home. A registered nurse must 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. CMS already has approved six health systems for waivers under the program: Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa). Other waiver requests may be submitted through CMS’ online portal. The agency also clarified that ambulatory surgical centers participating in the Hospitals Without Walls program need only provide 24-hour nursing services when there is actually one or more patient receiving care onsite.
Centers for Disease Control and Prevention (CDC)
December 2—The CDC issued revised guidelines that shorten quarantine periods for those exposed to COVID-19. CDC previously recommended a quarantine period of 14 days, but under the updated guidelines indicates that quarantine can end after ten days without testing if an individual has reported no symptoms and after seven days if a person has a negative diagnostic test with no symptoms. In the latter scenario, the test must be collected and performed within 48 hours before the planned quarantine ends. In both cases, monitoring for symptoms and masking should continue for 14 days. CDC hopes that reducing the length of quarantine will help increase community compliance.
December 1—The Advisory Committee on Immunization Practices (ACIP) recommended that health care personnel and residents of long term care facilities should be the first to receive a COVID-19 vaccine once a candidate is authorized by the Food and Drug Administration (FDA). The ACIP, an independent advisory group to the CDC, approved the recommendation by a 13-1 vote at an emergency meeting on December 1. The CDC Director adopted the recommendation.
Department of Health and Human Services (HHS)
December 3—HHS issued an amended declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that authorizes health care personnel to use telehealth to order or administer “covered countermeasures,” such as diagnostic tests with emergency authorization, against COVID-19 across state lines. The declaration preempts any local or state restrictions on telehealth for ordering or administering covered countermeasures to patients in different states. Under the declaration, health care providers have PREP Act immunity for the on-label use of covered countermeasures that are authorized by the FDA to combat COVID-19 during the public health emergency. The declaration also, among other things, extends immunity to more health care providers like pharmacists, pharmacy, interns, and pharmacy technicians who could administer COVID-19 or other vaccines by modifying and clarifying training requirements.
Other Developments
December 2—The American Hospital Association (AHA) is asking HHS to increase flexibilities around health care staffing, provider resource allocation, and accessibility to care to help providers respond to the COVID-19 pandemic. While the agency initially provided a number of these flexibilities, CMS over the summer began reinstating some previously waived requirements, including allowing states and private accreditors to resume in-person routine compliance surveys and requiring hospitals to resume reporting quality data, AHA President and CEO Richard Pollack noted in a letter to HHS Secretary Alex Azar. AHA urged CMS, among other things, to suspend routine survey process and quality data reporting requirements, delay implementation of the price transparency rule, and require Medicare Advantage plans and federal marketplace issuers to cover all approved or authorized COVID-19 therapies at rates that cover costs.
December 2—Representatives Brad Schneider (R-IL) and David McKinley (D-WV) introduced the bipartisan Medicare Sequester COVID Moratorium Act to prevent cuts to hospital payments through the duration of the COVID public health emergency. The CARES Act delayed the 2% Medicare payment reductions, which have been in effect since 2011, through the end of this year. With COVID-19 cases rising across the country, “[n]ow is not the time to reinstitute across the board cuts to our providers,” said Schneider.
November 30—Moderna Inc. is applying for an Emergency Use Authorization from the FDA for its vaccine candidate, mRNA-1273, after primary efficacy analysis showed 94.1% efficacy against COVID-19, the company said in a statement. Further data analysis also indicated the two-dose vaccine candidate had a 100% efficacy against severe cases of COVID-19. The company will submit data from the late-stage clinical trial that includes more than 30,000 participants in the United States to a peer-reviewed publication, Moderna said. An FDA advisory panel is expected to review the safety and efficacy data for mRNA-1273 on December 17.