Federal COVID-19 Info

 
 

OPENING UP AMERICA AGAIN – On April 17th, the President hosted a call with the nation’s governors, discussing a framework for reopening America.  Following that, during the evening’s press conference, the President and his Task Force unveiled Guidelines for Opening Up America Again, a three-phased approach based on the advice of public health experts. 

Other resources from the press conference include a fact sheet and for your convenience, click here for the slides used in today’s briefing outlining the guidelines. 

Testing and Treatment
New Resource to Find Public Health and Testing Information: The White House announced a new collaboration by Schema.org to help Americans find the most up-to-date public health guidance and the most relevant information on testing facilities in their communities. Standard tags were created that can be added to any website’s code, making it easier to find COVID-19 prevention measures, disease spread statistics, quarantine rules and travel guidance, and testing information through online search engine results. All federal websites will incorporate these new Schema.org standard tags. The private sector, state and local governments, and the academic community are encouraged to do the same.

Donating Blood Plasma: FDA is putting out a call to donate blood plasma for recovered COVID-19 patients. Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important to evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate. The FDA has launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also provides information for those interested in participating in the expanded access protocol, conducting clinical trials or submitting eIND applications. The American Red Cross has also set up a website for interested donors (www.redcross.org/plasma4covidExternal Link Disclaimer) and the FDA continues to work with others in this area to help encourage additional donations. Additionally, BARDA and the American Red Cross (ARC) are collaborating on systems and procedures to recruit donors who have recovered from COVID-19. Through this collaboration the ARC will prepare procedures for the collection of plasma for investigational use in treating patients infected with COVID-19.

Expanding Availability of Systems to Measure Body Temperature: FDA issued an immediately-in-effect guidance that provides a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency. The advantage of using telethermographic systems for initial temperature assessment for triage use is the potential use in high throughput areas (e.g., airports, businesses, warehouses, factories) and in settings where other temperature assessment products may be in short supply. FDA believes the policy set forth in this guidance may help address urgent public health concerns raised by shortages of temperature measurement products by helping to clarify the regulatory landscape and expand the availability of telethermographic systems used for initial body temperature measurements for triage use during this public health emergency.

Policy for Compounding Drugs: FDA issued an immediately-in-effect guidance that communicates temporary policy for the compounding of certain human drug products for hospitalized COVID-19 patients by registered outsourcing facilities. Some hospitals are experiencing difficulties accessing drug products used for patients with COVID-19. In addition, due to the large number of persons infected with COVID-19 and subsequent hospitalizations, it is possible that other drug products may become harder to acquire. To help the situation, the FDA will allow specific medicines that are used to aid people on ventilators to be compounded in bulk.

Rapid Diagnostic Test: BARDA is collaborating with Hememics Biotechnologies, Inc. on the development of a rapid, Bluetooth-connected SARS-CoV-2 diagnostic test. The test is being designed to detect SARS-CoV-2 antigen from nasal swab samples and associated antibodies in 60 seconds or less through a finger-prick. Using the nasal swab antigen test, healthcare providers can triage patients infected with SARS-CoV-2 rapidly and make informed treatment decisions. Furthermore, antibody testing of blood to identify serological antibodies indicates which patients have been previously infected, even without showing symptoms, and recovered or those who could be potentially developing an infection but asymptomatic and need care. The added convenience of this test being Bluetooth-connected to cloud-based data management networks may aid public health officials with real-time geographical mapping of outbreaks.

Vaccine Update: BARDA and Sanofi Pasteur, the vaccines global business unit of Sanofi, are expanding their collaboration to develop a SARS-CoV-2 vaccine. The previously announced research for a COVID-19 vaccine using a recombinant DNA platform will accelerate into non-clinical studies and a Phase 1 clinical trial to demonstrate initial safety and efficacy of the vaccine candidate. The technology was developed with BARDA support to make millions of doses of vaccine quickly in an influenza pandemic, and Sanofi uses the platform for its FDA-licensed seasonal influenza recombinant vaccine.

Serology Tests: The FDA issued two new emergency use authorizations (EUAs) for serology tests to detect for the presence of coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics, Inc. for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio Diagnostic Systems, Inc. for its DPP COVID-19 IgM/IgG System.

Contact Tracing App: NIH funded MD2K who launched the new mobile app, called mContain, for download by residents of the greater metropolitan area of Memphis, Tennessee. Once downloaded and installed on a personal mobile device, the mContain app collects location traces and sends notifications to users if they have had a recent encounter with a COVID-19 positive individual. The app reduces the chance of community transmission by providing an early warning to users who may be at the risk of infection from a COVID-19 positive individual. The mContain app provides two primary alert services: it can give users crowding information and provide notification to users who have had contact with a COVID-19-positive individual. The crowding alert feature provides information that should encourage social distancing within the community, indicating concentrations of users. The contact alert is expected to anonymously reduce community transmission of the COVID-19 virus and other infectious diseases. The data necessary to inform the app about positive test results is collected voluntarily.

Warnings Against Fraud: The FDA and Federal Trade Commission (FTC) issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earth Angel Oils, offers essential oil products that are unapproved and misbranded drugs for the prevention and treatment of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

Diagnostics Update to Date: During the COVID-19 pandemic, the FDA has worked with more than 315 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for COVID-19 tests. To date, 36 emergency use authorizations have been issued for COVID-19 tests. The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Summary of FDA Actions: The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The agency intends to regularly update this resource on efforts related to medical products and equipment, vaccines and therapeutics, food supply and more.

PPE and Supplies
Expanding Ventilator Supply: HHS announced a new contract for ventilator production rated under the Defense Production Act (DPA), to General Electric (GE), in partnership with Ford. GE’s contract, at a total contract price of $336 million, is for 50,000 ventilators to be produced by July 13. In total, combined with contracts announced this month, HHS has finalized contracts to produce or acquire more than 41,000 ventilators by the end of May, and over 187,000 ventilators by the end of the year.

Reuse of N-95 Respirators: NIH released results of their study that validates decontamination methods for re-use of N95 respirators. N95 respirators can be decontaminated effectively and maintain functional integrity for up to three uses, according to National Institutes of Health scientists. The study was conducted in a controlled laboratory setting and the findings are not yet peer-reviewed but are being shared to assist the public health response to COVID-19. Decontamination methods tested included vaporized hydrogen peroxide (VHP), 70-degree Celsius dry heat, ultraviolet light, and 70% ethanol spray. The authors concluded that VHP was the most effective decontamination method, because no virus could be detected after only a 10-minute treatment. UV and dry heat were acceptable decontamination procedures as long as the methods are applied for at least 60 minutes.

Decontaminating Respirators: The FDA issued an emergency use authorization (EUA) for the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for use in decontaminating compatible N95 and N95-equivalent respirators for single-user reuse by healthcare personnel.

Information for Specific Populations
Crisis Standards of Care and Civil Rights Law: ASPR released a document on crisis standards of care which is intended to provide information about crisis standards of care in a resource constrained setting, such as the COVID-19 pandemic, to state, local, tribal, and territorial policymakers, healthcare systems leadership, and other decision-makers. Certain jurisdictions may be developing or implementing potentially discriminatory policies that negatively impact vulnerable populations (e.g., older adults and persons with disabilities). These policies are addressing the application of crisis standards of care in resource-constrained settings in the context of the COVID-19 pandemic. OCR also announced that they have resolved a complaint filed against the Pennsylvania Department of Health (PDH) after PDH revised its Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines (CSC Guidelines) to ensure that persons will not be discriminated against based on disability if providers in the state were to begin triaging life-saving health care services. This is the second enforcement action OCR has taken since OCR issued a Bulletin reminding covered entities of the continued applicability of civil rights laws during the COVID-19 public health emergency.

Considerations for Pharmacies: CDC updated their guidance on Considerations for Pharmacies. Recommendations include: everyone entering the pharmacy should wear a face covering, regardless of symptoms; cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance; pharmacists and pharmacy technicians should always wear a facemask while they are in the pharmacy for source control; postponement and reschedule delivery of some routine clinical preventive services, such as adult immunizations, which require face to face encounters; and special considerations for clinics that are co-located in pharmacies.

FAQs on FFCRA and CARES Act: CMS posted an FAQ document with multiple questions on how the relief legislation applies to Medicare and Medicaid programs. Topics include the emergency period, new optional Medicaid group, benefits and cost-sharing for COVID-19 testing and diagnostic services, implications for CHIP, BHP and other questions.

FAQs for Clinicians: CDC has updated their FAQ document for healthcare professionals. Topics include COVID-19 risk, transmission, testing, diagnosis and notification, treatment and management, obstetrical care, drug and investigational therapies, waste management and additional resources.

Guidance on Cleaning and Disinfecting Vehicles and Facilities: CDC released recommendations for Non-emergency Transport Vehicles that May Have Transported Passengers with Suspected/Confirmed COVID-19. People who are known or suspected to have COVID-19 may use non-emergency vehicle services, such as passenger vans, accessible vans, and cars, for transportation to receive essential medical care. The guidance includes recommendations on how to clean different areas of the vehicle and at a minimum, recommends owners to clean and disinfect commonly touched surfaces in the vehicle at the beginning and end of each shift and between transporting passengers who are visibly sick. CDC’s guidance on Cleaning and Disinfecting Your Facility includes everyday steps, steps when someone is sick, and considerations for employers.

CMS Hospital Payment and Inpatient Rehabilitation Facility Waivers: CMS issued guidance implementing the CARES Act that impacts inpatient prospective payment system hospital payment and provides new flexibilities for inpatient rehabilitation facilities and long-term care hospitals. The Coronavirus Aid, Relief, and Economic Security (CARES) Act increases payment for Inpatient Prospective Payment System (IPPS) and long-term care hospital (LTCH) inpatient hospital care attributable to COVID-19. CMS provided guidance for IPPS hospitals and LTCHs on how to code claims to receive the higher payment. The CARES Act also waives the requirement that Medicare Part A fee-for-service patients treated in inpatient rehabilitation facilities receive at least 15 hours of therapy per week. During the public health emergency period, LTCHs will be paid at higher rates and will not be penalized for accepting patients that would not typically be treated at an LTCH. CMS also updated their summary of emergency declaration blanket waivers for healthcare providers.

Guidances to Assist with Grief Management: ASPR has posted resource documents to assist with the management of grief. The resources include Tips for Healthcare Workers Managing Grief and Recommendations for How to Handle the Death of a Colleague during COVID-19,

Resources for Programs Providing Treatment for Opioid Use Disorder: The document lists guidance and resources for in-patient and out-patient programs and facilities providing Medication Assisted Treatment (MAT) for individuals with opioid use disorder (OUD). These resources are available to provide continuity of care and to help mitigate the potential surge of patients seeking inhospital treatment. Resources are continually changing; visit the Substance Abuse and Mental Health Services Administration (SAMHSA) COVID-19 website for the most recent information.

Suspension of 2% Payment Adjustment for Medicare FFS Claims: The Centers for Medicare & Medicaid Services (CMS) recently issued guidance implementing Section 3709 of the Coronavirus Aid, Relief, and Economic Security Act, which temporarily suspends the 2% payment adjustment currently applied to all Medicare Fee-For-Service (FFS) claims due to sequestration. The guidance notes that the suspension is effective for FFS claims with dates of service from May 1 through December 31, 2020.

CMS Waiver Flexibility Update: CMS has approved 52 COVID- related emergency waivers, 31 state amendments, 11 COVID-related Medicaid Disaster Amendments and one CHIP COVID-related Disaster Amendment in record time. CMS recently approved two additional COVID-related emergency Medicaid waivers, delivering urgent regulatory relief to ensure the Commonwealth of Puerto Rico and the Commonwealth of the Northern Mariana Islands can quickly and effectively care for their most vulnerable citizens. CMS also approved COVID-related Medicaid Disaster Amendments that bring relief to Arkansas and Rhode Island. These approvals help to ensure that states have the tools they need to combat COVID-19 through a wide variety of state plan flexibilities. CMS continues to authorize amendments to ensure emergency flexibilities in programs that care for the elderly and people with disabilities, including most recently for Colorado, Louisiana and Nevada. These approved flexibilities support President Trump’s commitment to a COVID-19 response that is locally executed, state managed, and federally supported.

Not HHS, but relevant for healthcare:
FCC COVID-19 Telehealth Program. The Federal Communications Commission (FCC) just approved an Order to create a $200 million telehealth program to support healthcare providers responding to the ongoing coronavirus pandemic, using funds appropriated as part of the CARES Act. The COVID-19 Telehealth Program will help healthcare providers purchase telecommunications, broadband connectivity, and devices necessary for providing telehealth services. Applications from healthcare providers will be accepted and processed on a rolling basis as soon as application forms are published in the Federal Register. Details on information that applications must include are on page 14 of the Order.
Stay safe, colleagues. If you have questions, reach out to [email protected] .

Laura

Laura C. Trueman
Director, Office of Intergovernmental and External Affairs
U.S. Department of Health and Human Services
200 Independence Avenue SW
Washington D.C. 20201
[email protected]

A Note About This HHS Email: On Monday, March 23rd, I started sending out a daily email bundling the many COVID-19-related items coming out across the HHS enterprise. It is not exhaustive, but close. Judging by requests to be added to the distribution list and other feedback, this seems to be meeting a real need – and saving many from having to check multiple sites (CDC, FDA, CMS, and our main site, for example). If you started getting this and don’t want it, just let me know. I will do this as long as volume and need for information dictates.

If You Want a Broader View of the Entire Administration’s Work on COVID-19: Email the White House Office of Public Liaison — which sends out a nightly recap– and ask to be added to their list. Email: [email protected]

By Zachary Sherwood and Brandon Lee | April 17, 2020 07:01AM ET | Bloomberg Government

 

Days after insisting he had absolute authority to steer the country’s economic recovery from the coronavirus outbreak, President Donald Trump instead handed over the keys to governors and businesses.

Trump issued guidelines yesterday for states to consider as they decide whether to relax stay-at-home orders and other social-distancing measures enacted to curb the spread of the virus. The brief document lays out a three-stage process and leaves many difficult decisions to statehouses.

The president set no deadlines, demanded no particular action and offered little federal assistance. One page of the document says that states undertaking a resumption of normal life should plan to “independently” secure protective gear and medical equipment for their hospitals. Businesses are advised to come up with their own protocols for temperature checks, protective gear, sanitation and testing.

“A national shutdown is not a sustainable long-term solution,” Trump said yesterday at his daily White House news conference. “Now that we have passed the peak in new cases, we’re starting our life again.”

Trump said that 29 of the 50 states qualified to begin the reopening process his administration laid out or would be ready soon, naming Montana, North Dakota and Wyoming. He agreed with a questioner who suggested Hawaii.

In the best case, a state could abandon all but minimal social distancing practices within a month, under the plan. Yet it’s not clear whether most governors, business owners and workers share the president’s optimism that it will soon be safe to risk easing measures that only now appear to be slowing the virus’s spread in some hot spots, while cases and deaths continue to rise across the country.

In North Dakota and Wyoming, the number of cases is still rising, which may disqualify those states from attempting to reopen under Trump’s guidelines. Hawaii Governor David Ige, a Democrat, is “working with his cabinet and others to determine what specific milestones will be needed for Hawaii to begin a phased reopening,” spokeswoman Cindy McMillan said.

McMillan said the state does not yet believe it meets the federal criteria. Read more from Josh Wingrove, Justin Sink and Polly Mosendz.

U.S. to Lead Global GDP Contraction: Few countries in the world have been spared from the devastating economic consequences of the coronavirus outbreak. But no economy will have a bigger impact on global growth than the U.S. The leader in confirmed Covid-19 cases, the U.S. is expected to account for 31% of this year’s decline in worldwide gross domestic product, according to Bloomberg calculations using International Monetary Fund data. That’s more than twice the country’s share of global output. Overall, the IMF forecasts the glo bal economy will contract 3%, the most in almost a century, before soaring almost 6% in 2021. Read more from Alex Tanzi and Wei Lu.

What to Watch Today

The House holds a pro forma session at 11 a.m.

Trump holds a phone call with faith leaders on the economy.

The White House holds a Coronavirus Task Force briefing at 5 p.m.

Economic Actions & Industry Pains

SBA’s Response Was Swift, But Not Smooth: Congress handed the colossal task of quickly getting $349 billion in pandemic relief for mom-and-pop firms to a small, understaffed federal agency that was overwhelmed from the program’s start.

Yet, after a glitch-plagued beginning, the Small Business Administration managed to approve applications and guarantee all the loans in just 13 days, dwarfing its previous record of $30 billion spread out over an entire year. With the funds now tapped out, many businesses remain in the cold, while some that received loans are still wondering when money will move into their accounts.

Questions remain about the handling of loans, including potential inequities between states — for example, why Texas got more than California, according to the most recent figures available — and whether the rapid pace at which money is being approved raises questions about the potential for fraud. Read more from Mark Niquette and Naomi Nix.

Congress is debating adding an additional $250 billion to PPP, and small business advocates are calling on lawmakers to add more money for the disaster loan program as well. About 100 members of Congress signed a letter yesterday to SBA Administrator Jovita Carranza with concerns about the EIDL program, saying they would strongly back a request for more funding. House Minority Leader Kevin McCarthy (R-Calif.) told reporters he supports adding money to the program, and a Senate Democratic bill floated last week included money for it.

Senate Minority Leader Chuck Schumer (D-N.Y.) and Speaker Nancy Pelosi (D-Calif.) spoke with Treasury Secretary Steven Mnuchin yesterday afternoon, and talks are ongoing, according to a statement released last night by a Schumer spokesperson. Democrats wants changes to the small business loan program, as well as more funding for hospitals and state and local government. Read more from Mark Niquette and Jennifer Jacobs.

  • Meanwhile, local and state governments renewed calls for federal support. At least $250 billion for local government relief is needed from Congress, the National Association of Counties, National League of Cities and the U.S. Conference of Mayors said yesterday in letters to Congress and the Trump administration. Three Democratic governors from Michigan, Wisconsin and Pennsylvania in a letter to Trump backed a bipartisan call from the National Governors Association for $500 billion to support the states during the crisis, in addition to funds for local governments, Sam McQuillan and Michael J. Bologna report.

States will likely opt out of extending the full swath of federal pandemic relief to their businesses, as they face shuttered state houses and potentially limited benefits. The federal tax code changes in the latest stimulus law are meant to help businesses suffering from economic upheaval during the pandemic. Included in the package was a temporary increase of the tax code Section 163(j) limit on deductions for business interest payments to 50% from 30% of adjusted taxable income. Read more from Tripp Baltz, Michael J. Bologna and John Herzfeld.