November 13, 2020 Edition

California Issues Travel Advisory, Updated Guidance on Gatherings Amid Increased COVID-19 Transmission

Today, the California Department of Public Health (CDPH) issued a travel advisory amid increasing COVID-19 incidence in many states and countries. California joined Oregon and Washington in issuing the advisory that discourages non-essential travel. Under the advisory, persons arriving in California from other states and countries, including returning California residents, are instructed to self-quarantine for 14 days after arrival. These individuals are expected to limit their interactions to their immediate household. The state’s travel advisory does not apply to individuals who cross state or country borders for specified essential travel.

Further, the state’s travel advisory recommends Californians stay home or in their region and avoid non-essential travel to other states and countries. The full CDPH travel advisory is available here. An announcement on the Western States’ action from the Office of Governor Gavin Newsom is available here.

CDPH additionally issued updated guidance providing a plan for Californians to gather outside their household ahead of upcoming holidays. The guidance applies to private gatherings, defined as social situations that bring people together from different households at the same time in a single space or place, and all other gatherings not covered by existing sector guidance remain prohibited.

Under the private gathering guidance, all persons planning to host or participate in a private gathering must comply with CDPH requirements relative to attendance, location, and COVID-19 precautions. Notably, CDPH indicates that gatherings that include more than three households are prohibited. Gatherings must be held outdoors in counties assigned to the Purple (Widespread) tier of the Blueprint for a Safer Economy, and indoor gatherings are strongly discouraged in all other tiers. The guidance additionally outlines parameters for individuals in high-risk groups, as well as strong discouragement on certain activities such as singing, chanting, shouting, or cheering.

The full guidance on gatherings is available here.

Assembly Convenes Hearing on COVID-19 Response Activities

On Tuesday, the Assembly Budget Subcommittee No. 6 on Budget Process, Oversight, and Program Evaluation and the Assembly Committee on Governmental Organization convened a joint informational hearing to receive an update on California’s response to the ongoing COVID-19 pandemic. The hearing featured an overview of the state’s operational efforts to contain the pandemic, investments in emergency disaster funds, and preparations for vaccine distribution and additional personal protective equipment (PPE) procurement.

The hearing’s first panel included representatives from the Legislative Analyst’s Office (LAO) and Department of Finance (DOF) to provide an overview of the state’s expenditures on COVID-19 response activities. LAO and DOF walked the committees through their fiscal update reports that were published late last week (LAO available here and DOF available here). The LAO discussed options available to the Legislature to ensure oversight of the Administration’s emergency response activities and spending.

The first panel additionally included representatives from the California Governor’s Office of Emergency Services (Cal OES) and California Department of Public Health (CDPH) to provide updates on state activities to mitigate COVID-19 transmission risks, deliver necessary public health, health, and social safety supports to vulnerable residents, and procurement and logistics operations. CDPH Chief Deputy Director Susan Fanelli discussed the state’s planning efforts for a forthcoming COVID-19 vaccination, including ongoing work with local health jurisdictions throughout the state in carrying out response activities, issuing sector guidance, and planning for vaccine distribution.

The second panel included representatives from the Department of General Services (DGS), Cal OES, and the LAO to provide an update on the state’s procurement process and availability of PPE. The bulk of the presentations focused on state contracting, medical supply procurement, and distribution and allocation of PPE throughout the state.

During the question and answer section of the hearing, Assembly Members raised questions around funding equity, legislative involvement in and oversight of state spending decisions, DOF fiscal reporting, COVID-19 public messaging and communications, epidemiological trends, testing and contact tracing, and economic recovery efforts, among others. Notably, Assembly Member Dr. Joaquin Arambula raised questions around the impacts of the pandemic on social determinants of health, including employment, housing, and access to healthy foods.

The hearing agenda is available here. A video recording of the hearing is available here.

Assembly Holds Other Hearings on Health Information Exchange, COVID-19 Impacts

The Assembly Health Committee convened this week to explore California’s Health Information Exchange (HIE) landscape. Members of the Committee heard from several experts who discussed how HIE works currently in California, federal and state policy that has shaped HIE systems, what other states have done to build HIE capacity, and options for California to consider as it expands HIE capability. Links for hearing materials can be found here: agenda and background paper.

Two other Assembly hearings this week focused on COVID-19 and impacts to California’s state correctional system and higher education systems. First up, the Assembly Budget Subcommittee #6 on Budget Process, Oversight, and Program Evaluation heard from state corrections officials including Kathleen Allison, Secretary of the Department of Corrections and Rehabilitation and Clark Kelso, the court appointed federal receiver charged with overseeing California’s correctional healthcare system about their efforts to prevent and contain COVID-19 within their facilities. Materials for this hearing can be found here: hearing agenda and hearing materials.  

The Assembly Higher Education Committee and the Assembly Budget Subcommittee #2 on Education Finance convened a joint informational hearing to discuss the impacts of the pandemic both on higher education budgets and enrollment with testimony provided by officials from the UC System, the CSU system, the community college system, and California’s private colleges and universities. A second panel covered what life has been like on campus for both university/college officials and students. Materials for this hearing can be found here: agenda and materials.

DOF Issues November Fiscal Update on COVID-19 Expenditures

Late last week, the California Department of Finance (DOF) issued a November fiscal update detailing expenditures associated with the state’s COVID-19 direct response activities. DOF estimates the combined total costs across the 2019-20 and 2020-21 fiscal years to be approximately $9.8 billion, with an estimated net General Fund impact of approximately $1.3 billion. In the last DOF update in August 2020, total costs were estimated at $7.4 billion with a $1.7 billion net General Fund impact. Compared to November, General Fund impact decreased as the Coronavirus Relief Fund and other federal funds are being used to offset a greater share of these costs, consistent with the 2020 Budget Act.

DOF indicates that cost increases reflected in the November fiscal update are largely due to the standing up of the state’s Valencia Regional Laboratory, updates and amendments to existing testing contracts for specimen collection associated with the state’s new laboratory, and a public awareness and community outreach campaign. DOF’s update provides total expenditure cost estimates by category, including state response operations, procurements, and statewide testing and contact tracing.

The full DOF report is available here.

U.S. Supreme Court Hears Oral Arguments in Challenge to ACA

On Tuesday, the U.S. Supreme Court (SCOTUS) heard oral arguments on California v. Texas, which seeks to strike down the Affordable Care Act (ACA). Brought by several states, and led by Texas, the case argues that since Congress reduced the individual mandate penalty to zero in 2017, the mandate is now unconstitutional and therefore the entire ACA should be invalidated.

Three significant issues are being considered by SCOTUS including whether the parties (Texas et al) have standing to sue, the constitutionality of the individual mandate, and severability – if the mandate is ruled unconstitutional, will the remaining ACA provisions remain law.

According to court observers, it appears likely the ACA may survive another SCOTUS challenge; however, the individual mandate could be ruled unconstitutional. A final decision will be rendered by the high court sometime next year.

AG Becerra Files Legal Brief Defending Ban on Flavored Tobacco Products

On Thursday, California Attorney General Xavier Becerra filed a brief in the U.S. District Court for the Southern District of California defending SB 793 by Senator Jerry Hill which banned the sale of flavored tobacco products statewide. Recall, SB 793 was nearly immediately signed into law by Governor Gavin Newsom in late August. Following its passage, tobacco industry entities, including R.J. Reynolds Tobacco Company and Philip Morris USA, filed a statewide referendum to attempt to overturn the flavored tobacco ban. Last month, the same entities also sued the State of California in an attempt to stop the measure from going into effect in January 2021.

Plaintiffs in the suit argue that the law is preempted by the federal Tobacco Control Act. Becerra’s legal brief argues that SB 793 is critical in protecting the health and safety of California residents and is a valid exercise of state authority under the federal Tobacco Control Act. Becerra further argues that the court should reject the tobacco companies’ motion for a preliminary injunction because the tobacco companies are unlikely to succeed on the merits and the equities strongly favor allowing SB 793 to take effect as originally scheduled.

In a statement, Attorney General Becerra notes, “Every day, thousands of young Americans will smoke their first cigarette, starting down the path toward a lifelong addiction to nicotine. Postponing enforcement of SB 793 would only serve to put our children’s health and safety at further risk. Tobacco companies have tried and failed to bring this sort of case before, and we believe they will fail again.”

A copy of the legal brief is available here. A press announcement from the Office of the Attorney General is available here.

President-Elect Biden Names COVID-19 Advisory Board

On Monday, President-Elect Joe Biden announced the formation of a Biden-Harris Transition COVID-19 Advisory Board, consisting of leading public health experts who will advise President-Elect Biden, Vice President-Elect Kamala Harris, and the nascent administration’s staff. The advisory board is comprised of:

  • Co-Chair Dr. David Kessler, Professor of Pediatrics and Epidemiology and Biostatistics at the University of California, San Francisco (UCSF)
  • Co-Chair Dr. Vivek Murthy, 19th Surgeon General of the United States
  • Co-Chair Dr. Marcella Nunez-Smith, Associate professor of Internal Medicine, Public Health, and Management at Yale University
  • Dr. Luciana Borio, Vice President at In-Q-Tel
  • Dr. Rick Bright, Former Director of the Biomedical Advanced Research and Development Authority (BARDA)
  • Dr. Ezekiel Emanuel, Vice Provost for Global Initiatives and Chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania
  • Dr. Atul Gawande, Professor of Surgery at Brigham and Women’s Hospital, Professor of Surgery at Harvard Medical School, and Professor of Health Policy and Management at Harvard T.H. Chan School of Public Health
  • Dr. Celine Gounder, Clinical Assistant Professor at the NYU Grossman School of Medicine
  • Dr. Julie Morita, Executive Vice President of the Robert Wood Johnson Foundation
  • Dr. Michael Osterholm, Regents Professor and Endowed Chair in Public Health and Director of the Center for Infectious Disease Research and Policy at the University of Minnesota
  • Ms. Loyce Pace, Executive Director and President of Global Health Council
  • Dr. Robert Rodriguez, Professor of Emergency Medicine at the UCSF School of Medicine
  • Dr. Eric Goosby, Professor of Medicine at the UCSF School of Medicine

The Biden-Harris Transition Team notes that members of the advisory board have served in previous administrations and have “experience engaging with and leading our country’s response to nationwide and worldwide public health crises.”

The full announcement is available here.

HHS to Partner with Pharmacies for COVID-19 Vaccines

This week, the U.S. Department of Health and Human Services (HHS) announced partnerships with large chain pharmacies and networks to increase access to future COVID-19 vaccines. Through the federal partnership with pharmacy chains, approximately 60 percent of pharmacies throughout the 50 states, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Independent pharmacies and regional pharmacy chains will also be part of the federal pharmacy program, further increasing access to COVID-19 vaccines throughout the country.

In addition to traditional brick-and-mortar pharmacies, pharmacists, pharmacy interns, and pharmacy technicians will provide vaccinations in retail and grocery stores. Pharmacies that do not participate in the federal allocation program are encouraged to be part of the solution and are instructed to coordinate with their jurisdiction’s health department to become COVID-19 vaccine providers.

The full announcement from HHS is available here.

Pfizer COVID-19 Vaccine Found to be More than 90 Percent Effective

This week, Pfizer and BioNTech announced their vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants without evidence of prior COVID-19 infection in the first interim efficacy analysis. The study enrolled 43,538 participants and evaluated 94 confirmed COVID-19 cases in trial participants. No serious safety concerns were observed during the interim efficacy analysis, and submission to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) is planned for the third week of November.

The clinical trial will continue through its final analysis of 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. A full announcement from Pfizer and BioNTech is available here.

FDA Issues EUA for COVID-19 Treatment

On Monday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for monoclonal antibody Bamlanivimab for the treatment of mild to moderate COVID-19 in adult and pediatric populations. Bamlanivimab must be administered by intravenous (IV) infusion in non-hospitalized patients. The antibody is being distributed by FDA to state and territorial health departments for allocation to health facilities.

The full EUA approval letter is available here.