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Clinical Updates

ACS President Valerie W. Rusch, MD, FACS, Provides Insights on Ramping Up Elective Operations

Valerie W. Rusch, MD, FACS, President of the American College of Surgeons (ACS), in a video interview with Medscape, described the conditions under which it is safe to provide elective operations to patients during the COVID-19 pandemic. Dr. Rusch outlined the College’s guidelines for reopening elective services as well as the precautions in place at Memorial Sloan Kettering, New York, NY, where she is a thoracic surgeon.

Promising Therapeutics Update

As the race to develop effective and safe vaccines to prevent SARS-CoV-2 infection heats up, there is increasing attention to how best to quickly prove efficacy in prevention of COVID-19. One controversial proposal is to deliberately infect volunteers to receive the virus after vaccination and then assess response, safety, and efficacy.

An article published recently in The Lancet discusses triple anti-viral drug therapy for COVID-19 improving outcomes compared with standard therapy. The use of a combination drug (lopinavir/ritonavir), ribavirin, and interferon beta-1b showed more rapid clearance of the virus, shortened hospital stay, and symptom improvement. Importantly, this trial was performed in COVID-19 patients within seven days of symptom onset with mild to moderate disease, not severe disease.

Everyone Is Talking About Testing, But They’re Thinking About It All Wrong, According to This Perspective in Health Affairs

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - A Letter to Health Care Providers from the FDA

To Reopen or Not to Reopen? American College of Physicians Offers Guidance

The American College of Physicians (ACP) has developed public policy guidance for federal, state, and local authorities, and other stakeholders to address the increasing calls for the U.S. and state and local governments seeking to “reopen” certain economic, social, and medical care activities. The ACP maintains that some of these policies are in conflict with what public health experts believe to be the best, safest, and most effective approaches to slow the spread of the COVID-19 virus and lower mortality rates.

Virologist Recovering from COVID-19 Offers Perspective on Overcoming the Pandemic as Published in Science

A virologist who has spent his career fighting infectious diseases, including human immunodeficiency virus and Ebola, describes his experience as a COVID-19 patient. In his article, published in a recent edition of Science, Peter Piot, director of the London School of Hygiene & Tropical Medicine, U.K., states, “Without a coronavirus vaccine, we will never be able to live normally again. The only real exit strategy from this crisis is a vaccine that can be rolled out worldwide. That means producing billions of doses of it, which, in itself, is a huge challenge in terms of manufacturing logistics.” He urges reform of the World Health Organization to “make it less bureaucratic and less dependent on advisory committees in which individual countries primarily defend their own interests.”

Latest Updates from Department of Health and Human Services

The U.S. Department of Health and Human Services (HHS) has taken further action on the following COVID-19-related issues:

Remdesivir: HHS announced the allocation plan for the drug remdesivir. The allocation to all 50 states, the District of Columbia, and U.S. territories is from a donation by Gilead Sciences, Inc. The donated doses of treatment, which received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), will be used to treat severely ill hospitalized COVID-19 patients.

Testing plan: HHS officials and the Administration have announced a plan to help states test 2 percent of their population in May. The federal government is providing states with testing resources to meet this goal including $11 billion from the CARES Act and 12.9 million swabs, which will be disseminated to states, territories, and tribes.

First antigen test authorized: The FDA has issued the first EUA for a COVID-19 antigen test.

Expanding laboratory testing capacity: The Centers for Medicare & Medicaid Services (CMS) issued guidance on how Medicare Pharmacies and Other Suppliers May Temporarily Enroll as Laboratories to Help Address COVID-19 Testing.

Coordinating across sectors to accelerate vaccine development: The National Institutes of Health (NIH) released a perspective piece stating that a coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key.

Respirator decontamination system: The FDA issued an EUA for the Duke Decontamination System for use in decontaminating compatible N95 or N95-equivalent respirators for reuse by health care personnel when insufficient supplies of these respirators are available.

Addressing drug shortages: The FDA approved an Abbreviated New Drug Application for lidocaine hydrochloride injection USP, 1 percent, which is indicated for production of local or regional anesthesia and a drug listed in the FDA Drug Shortage Database.

COVID-19 and mental and substance use disorders: The Substance Abuse and Mental Health Services Administration updated Considerations for the Care and Treatment of Mental and Substance Use Disorders in the COVID-19 Epidemic.

CDC activities and initiatives: The Centers for Disease Control and Prevention (CDC) released a document on Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again.

Medicare hospital payment rules: The Centers for Medicare & Medicaid Services (CMS) released the proposed rule for inpatient prospective payment systems (IPPS) and long-term acute care hospitals (LTCH). The deadline for submitting comments is July 10.

Medicare accelerated and advance payments: CMS updated its information for states and by provider type on the program payouts as of May 2. The CMS Accelerated and Advance Payment (AAP) Program is designed to increase cash flow to Medicare providers and suppliers impacted by the COVID-19 pandemic.

Additional flexibilities for hospitals and facilities: CMS continues to release additional blanket waivers during the duration of the public health emergency.

Additional flexibilities for states: CMS has approved more than 175 requests for state relief in response to the COVID-19 pandemic, including recent approvals for Alabama, Alaska, California, District of Columbia, Georgia, Maine, Massachusetts, Minnesota, Mississippi, Montana, Nebraska, New Mexico, Oregon, South Carolina, Rhode Island, Tennessee, Virginia, and Wisconsin.

Telehealth and Medicare coverage: CMS updated a video that answers common questions about the expanded Medicare telehealth services benefit during the COVID-19 public health emergency.

AI Might Help You Maximize Elective Surgery

To help surgeons work through “elective” backlogs more quickly, safely, and efficiently, Qventus, the leader in AI-based patient flow automation systems, has released a predictive model to enable hospital administrators to maximize operating room time available to surgeons on a daily basis and more accurately forecast how long windows of opportunity will remain open.

Remind Patients They Save Multiple Lives When They Wear Masks in Public

The available evidence suggests that near-universal in adoption of non-medical masks when out in public, in combination with complementary public health measures, could successfully reduce effective-R to below 1.0, thereby stopping community spread. Economic analysis suggests that the impact of mask wearing could save the U.S. thousands lives and dollars per person, per mask.

Critical Guidelines and Selected Readings

Which COVID-19 Data Can You Trust?