On December 9, CMS posted updates to FAQs and an infographic about coverage and payment for monoclonal antibodies to treat COVID-19. The FAQs include general payment and billing guidance for these products, including questions on different setting types. The infographic has key facts about expected Medicare payment to providers and information about how Medicare beneficiaries can receive these innovative COVID-19 treatments with no cost-sharing during the public health emergency (PHE). CMS’ November 10, 2020 announcement about coverage of monoclonal antibody therapies allows a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the Food & Drug Administration’s Emergency Use Authorization (EUA), and bill Medicare to administer these infusions. Currently, two monoclonal antibody therapies have received EUA’s for treatment of COVID-19.

For More Information:

• Therapeutics Coverage Infographic
• Section BB of the FAQs: billing and payment for COVID-19 monoclonal antibody treatments
• Monoclonal toolkit and program guidance

Helpful overviews include FDA Combating Covid-19 with Therapeutics and a video interview with the Operation Warp Speed lead on types of treatments and ongoing research.

• What treatments for COVID-19 are approved for use? As of Nov. 23, the FDA has approved one treatment for COVID-19, the antiviral drug Veklury (remdesivir), for use in adult and pediatric patients 12 years of age and older. Five other treatments are currently authorized for Emergency Use – including convalescent plasma and monoclonal antibodies.
• What’s the difference between convalescent plasma and monoclonal antibodies? Basically, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Convalescent plasma is from patients who have already recovered from COVID-19 and may contain antibodies against the virus.
• What other treatments are in development? FDA created the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of therapeutics.  As of Oct. 31, there were more than 370 active trials and more than 560 development programs for therapeutic agents in the planning stages. Visit the CTAP’s dashboard.
• Why is there a national call for plasma? As COVID-19 infections spike nationwide, the demand for convalescent plasma is outpacing donations. Americans who have recovered from COVID-19 in the last three months can donate now. Visit local blood collection center, American Red Cross or America’s Blood Centers or visit org to become a donor.

HHS Announcements & News

Vaccine Development and Distribution Update

• CDC’s Advisory Committee on Immunization Practices (ACIP) met last week and voted on general recommendations for how to prioritize vaccine distribution when supply is initially scarce.
• CDC then published the MMWR with their vaccine priority recommendations to jurisdictions. Bottom line: The 24 million vaccines will first take care of the 21 million healthcare workers and then approximately 3 million seniors and frail living in long term care facilities second.
• The 64 jurisdictions are working on distribution plans and will use these recommendations and their own best judgment to develop allocation plans based on what makes sense in their circumstances.
• , Dec. 10, FDA’s Vaccine Advisory Board will meet to discuss an emergency use authorization request for Pfizer’s vaccine.
• , Dec. 17, FDA’s Vaccine Advisory board will review the clinical trial data submitted by Moderna for emergency authorization of its vaccine.
• What can we do? When vaccines become available, it’ll be our turn to get vaccinated and encourage our communities to do the same. Read and share the CDC’s website and videos with quick things to know about the science of vaccines.

New Study on First U.S. Cases of COVID-19

CDC highlighted a study that shows that the virus that causes COVID-19 may have been in the U.S. as early as mid-December 2019, a month before the first confirmed case, based on antibodies found in donated blood.

COVID-19 Infection, Hospitalizations, and Deaths Among Persons Hispanic/Latinos

CDC released an MMWR for the period between March and Oct. in Denver, Colorado.  The majority of adult COVID-19 cases (55%), hospitalizations (62%), and deaths (51%) were among Hispanic adults, double the proportion of Hispanic adults (24.9%).

COVID-19 Emergency Webinar for Community Based Organizations: Vaccines

Wed., Dec. 16, 2020. 3:00 p.m. ET. Register here.

CDC Foundation President and CEO Dr. Judy Monroe, CDC Principal Deputy Director Dr. Anne Schuchat will discuss the current COVID-19 response, including the latest information about vaccines, and vaccine distribution plans. A local expert will also speak about vaccine-related challenges and opportunities.

Register now! USDA Faith Fellowship and Food Security Virtual Convening

USDA will host a Faith and Opportunity Fellowship convening bringing together faith leaders, faith-based organizations, and houses of worship to engage with peers, discuss common challenges, and hear best practices related to food security and community food system resilience.  Register here. Reach out to alex.cordova@usda.gov with any questions.

The Colorado Hospital Association (CHA) and its partners released a new resource to assist rural health care systems nationwide develop emergency response plans for COVID-19 and beyond. This playbook, Re-imagining Leadership: A Pathway for Rural Health to Thrive in a COVID-19 World, seeks to empower rural health care leaders create tailored responses that take the unique identities of their communities into account.

Rural communities nationwide have been particularly hard-hit by the COVID-19 pandemic, and the disparities facing rural health care systems are more apparent now than ever. Creating a meaningful resource to assist rural health care leaders weather these challenges requires the insight and direction of those on the frontlines within those communities. With that in mind, CHA and its partners distilled dozens of personal interviews, extensive literature review and an analysis of rural health care data into this playbook.

“There can be no scripted guide or silver bullet to address the unique challenges faced by each rural community,” said Benjamin Anderson, CHA vice president of rural health and hospitals. “That is why this playbook offers a framework that can be tailored to fit the individual strengths, challenges and identities of our rural partners here in Colorado and across the country.”

CHA was proud to partner with the Eugene S. Farley, Jr. Health Policy Center at the University of Colorado Anschutz Medical Campus on this playbook, which was made possible by generous funding from the ZOMA Foundation and CPSI.

About Colorado Hospital Association

Colorado Hospital Association (CHA) is the leading voice of Colorado’s hospital and health system community. Representing more than 100 member hospitals and health systems throughout the state, CHA serves as a trusted, credible and reliable resource on health issues, hospital data and trends for its members, media, policymakers and the general public. Through CHA, Colorado’s hospitals and health systems work together in their shared commitment to improve health and health care in Colorado.

The Technical Assistance and Services Center (TASC), in coordination with the Federal Office of Rural Health Policy (FORHP), are pleased to provide another update of the COVID-19 Funding Sources Impacting Rural Providers guide. This funding resource is intended to support rural health care providers, along with their state and local partners, navigate the availability of federal funds to support the novel coronavirus (COVID-19) pandemic response and recovery efforts. This guide is updated regularly to capture changes in funding sources.

Seven tables, or matrices, are provided for quick reference at the beginning of this resource. The tables can be used to check eligibility of participation in funding sources by provider types: rural prospective payment system (PPS) and critical access hospitals (CAH), rural health clinics (RHC), federally qualified health centers (FQHC), long-term care (LTC) or skilled nursing facilities (SNF), tribal facilities, and emergency medical services (EMS). The tables also provide an at-a-glance view for each provider type sharing the different types of funds that may be accessed from various funding sources dependent on their participation eligibility. Each funding source is described in its own section of this resource with an executive summary followed by further detail on the use of funds, reporting requirements, hyperlinks to the legislation and detailed information.

One of the main updates for this version is the addition of the RHC COVID-19 Testing Program found on Page 57.

The guide can be found in COVID-19 Collection located on The National Rural Health Resource Center’s website. This collection consists of trusted and reliable resources, such as the COVID-19 Funding Sources Impacting Rural Providers Guide, along with standing links to additional organizations’ COVID-19 resources, FAQs, webinars, tools, and trainings. The Center aims to help direct the most up-to-date and relevant tools and resources to rural hospitals, clinics, and their communities. This Collection will be updated regularly to help assist with the abundance of circulating information relating to COVID-19.

Pennsylvania Department of Conservation and Natural Resources (DCNR) Secretary Cindy Adams Dunn announced the department has canceled all in-person events and programs organized by its staff and volunteers in all state parks and forests, beginning Sunday, December 6.

“Safety of all our state park and forest visitors always has been paramount with DCNR and we are taking this temporary but necessary action in response to the continuing rise of COVID-19 cases across the state,” Dunn said. “Throughout the pandemic we have kept our lands open to all so they enjoy outdoor recreation and the positive physical and mental health it provides. That will not change but we must limit social interaction at this time.”

This decision, affecting approximately 150 planned events, will be in effect until further notice. People who have registered for programs will be notified.

This action also includes a move away from DCNR’s normally organized group First Day Hikes that were planned for New Year’s Day, January 1, 2021. Instead, many alternatives for individual hiking that day in state parks and forests will be made available later by DCNR.

State parks and forests will remain open for use by the public.  DCNR staff will be taking additional steps to offer self-guided programming only or virtual events. Check the Calendar of Events for scheduled programs.

Out-of-state visitors who are planning to stay overnight at state park and forest facilities must have a negative COVID-19 test within 72 hours of entering the commonwealth. If someone cannot get a test or chooses not to, they must quarantine for 14 days upon arrival in Pennsylvania before visiting a state park or forest. Pennsylvanians visiting other states are required to have a negative COVID-19 test within 72 hours of their return to the commonwealth or to quarantine for 14 days upon return. Visitors who don’t comply may be fined between $25 and $300.

The department’s most recent action is in line with other preventive steps taken, including requiring testing or quarantining for all out-of-state visitors to parks and forests.

Visitor center exhibit halls and interpretive areas will be closed, and all indoor programs will be canceled. Restrooms will continue to be available.

Masks must be worn:

• In park and forest offices;
• In any other indoor public space, including restrooms; and
• Outdoors when visitors are unable to adequately social distance.

Dunn noted visits to Pennsylvania state parks have increased by more than a million visitors a month since the start of mitigation efforts, and that interest is expected to hold strong through the winter and spring.

To help avoid exposure to COVID-19 and still enjoy the outdoors:

• Don’t hike or recreate in groups – go with those under the same roof, and adhere to social distancing (stay 6 feet apart)
• Take hand sanitizer with you and use it regularly
• Avoid touching your face, eyes, and nose
• Cover your nose and mouth when coughing and sneezing with a tissue or flexed elbow
• If you are sick, stay home

Visitors can help keep state parks and forest lands safe by following these practices:

• Avoid crowded parking lots and trailheads
• Bring a bag and either carry out your trash or dispose of it properly
• Clean up after pets
• Avoid activities that put you at greater risk of injury, so you don’t require a trip to the emergency room

Pennsylvania has 121 state parks and 20 forest districts; all are open year-round.

Information about state parks and forests is available on the DCNR website. Updates also are being provided on DCNR’s Facebook and Twitter accounts.

The Pennsylvania Department of Health notified health care providers that, effective immediately, it has aligned its quarantine guidance for people exposed to COVID-19 with the new guidance from the Centers for Disease Control and Prevention (CDC) announced earlier this week that provides an option for a 10-day quarantine without testing or a seven-day quarantine with a negative test on or after day-five of quarantine.

This guidance does not apply to health care settings or those living in certain congregate settings such as nursing homes or prisons.

“We must stop the spread of this virus and quarantining once you have been exposed is essential,” Secretary of Health Dr. Rachel Levine said. “The incubation period for COVID-19 remains at 14 days and it is still most protective to quarantine for the full two weeks. However, the CDC has affirmed that quarantine can end after 10 days if the person doesn’t develop symptoms, or after seven days if the person tests negative and has no symptoms.”

The department issued a Health Alert Network advisory today for health care providers outlining how to implement the new quarantine guidance. Quarantine may not be shortened to less than seven days. CDC recommends that people who have been exposed monitor their symptoms for the full 14-days after their last exposure.

The recommendation for a 14-day quarantine was based on the incubation period of the virus. CDC’s intention with the option to shorten quarantine is to gain better compliance with quarantine and contact tracing activities.

“If you have been identified as a close contact to someone diagnosed with COVID-19, are in quarantine and have no symptoms, you may get a test as soon as your fifth day of quarantine. If the results are negative you may end your quarantine after the seventh day of quarantine,” Dr. Levine said. “However, you will need to wait for a negative test result to stop quarantining. Providers should know that people seeking tests who are symptomatic should be placed above those seeking tests to shorten their quarantine.”

This recommendation also applies to all quarantine orders, including the travel orders issued on Nov. 25 by Dr. Levine.

Dr. Levine stressed that this does not change the need for Pennsylvanians to continue to wear masks, wash hands, avoid all gatherings and social distance. These efforts must continue to stop the spread of COVID-19.

With hundreds of thousands of workers in Pennsylvania relying on several federal unemployment programs that are set to expire at the end of the month, Governor Tom Wolf sent a letter today to the state’s Congressional delegation urging the federal government to continue the programs through 2021.

“The number of COVID-19 cases is surging now and expected to continue increasing in the weeks to come, endangering both the public and economy,” said Gov. Wolf. “I strongly urge you, our congressional delegation, to consider how important the CARES Act has been to our nation and our state in helping businesses and workers and in preventing further contraction of the economy, and to act swiftly to extend these programs.”

The governor’s letter outlines four recommended actions:

• Extend Pandemic Unemployment Assistance (PUA) Through 2021: PUA provides unemployment benefits to workers who are self-employed, seeking part-time employment, lack sufficient work history, or otherwise do not qualify for regular Unemployment Compensation (UC) or Extended Benefits (EB). PUA has provided more than $6.5 billion to Pennsylvania households and the economy.
• Extend Pandemic Emergency Unemployment Compensation (PEUC) Through 2021: PEUC provides up to 13 weeks of additional unemployment assistance to those who exhausted their benefits. PEUC has added $846.1 million to households in Pennsylvania.
• Renew Federal Pandemic Unemployment Compensation (FPUC): FPUC, which expired on July 31, 2020, provided $16.1 billion to eligible individuals through an additional $600 per week on top of their weekly UC benefit.
• Extend No-interest Loans to the UC Trust Fund Through 2021: Many states are borrowing from the federal government to pay the increased need for UC benefits. Pennsylvania has borrowed $618 million in loans that will begin accruing interest on Jan. 1, 2021 if the no-interest loan program expires. Extending the no-interest loans to states is critical to avoid significant increases in employer taxes and assessments as more Pennsylvanians are expected to need the benefits to afford housing, food and other basic needs.

Since March, the Department of Labor & Industry has paid more than $31.6 billion in total unemployment benefits.