With the surge in COVID-19 cases continuing, starting Monday, Dec. 7, the Pennsylvania Capitol Complex will close to the public until further notice. All operations of the Governor’s Office and General Assembly will continue, but access to the Capitol Complex will be limited to employees and people with badge keycard credentials.

The cancelation of visits and events applies to all interior venues in the Capitol Complex and will affect rallies, school or group tours, choir performances, receptions, and other public gatherings. The Capitol Complex includes, but is not limited to, the Main Capitol Rotunda, East Wing Rotunda, Keystone Building Atrium, Forum Auditorium and The State Museum of Pennsylvania.

To further support public health, the Department of General Services is encouraging Pennsylvanians to add their phone to the fight against COVID-19 by downloading the COVID Alert PA app. The free and voluntary mobile app can notify those who opt-in if you have had a potential exposure to someone who tested positive for COVID-19. In addition, the app provides timely alerts that can help you get advice on how to help yourself and protect others as well as determine when to get testing. It can help reduce your risk of unknowingly spreading the virus to your friends, family, and larger community. The free app can be found in the Google Play Store Opens In A New Window and the Apple App Store Opens In A New Window by searching for “covid alert pa.”

On December 3, Pennsylvania Governor Tom Wolf announced that U.S. Specialty Formulations (USSF), LLC, a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new, high-paying positions at the site.

“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.

There is currently a global shortage of pharmaceutical manufacturing capacity, further exacerbated by the COVID-19 pandemic, and very limited capacity for clinical investigators to obtain appropriately documented clinical grade materials. USSF has been able to address both of these market challenges. USSF has also partnered with fellow Ben Franklin Technology Partners company VaxForm, LLC, to adapt an emergent oral vaccine platform technology to act as a vaccine for SARS-CoV-2 (COVID-19).

This oral platform was originally designed and has been successfully tested to show that it produces the antibodies required to generate immunity to Diphtheria, Tetanus (Lockjaw) and Pertussis (Whooping cough). After the COVID-19 genomic structure was identified, this oral platform was modified to generate the appropriate proteins to produce the proper immune response in mammals. USSF will be providing clinical materials from its Allentown plant for the human phase one clinical safety trials scheduled to begin in February 2021.

USSF received a funding proposal from the Department of Community and Economic Development (DCED) for a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan. The company has committed to invest at least $5.2 million into the project and company will create 97 new, high-paying jobs and retain 14 more positions.

The project was coordinated by the Governor’s Action Team, an experienced group of economic development professionals who report directly to the governor and work with businesses that are considering locating or expanding in Pennsylvania.

“Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral Vaccine Platforms. As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world,” said USSF CEO Dr. Kyle Flanigan. “This is expected to have a dramatic positive impact on world health. The jobs created focus on biotechnology and advanced manufacturing capabilities, which are resilient to economic downturn. Further, the strategic location of this facility also allows USSF to support other vaccine formulation companies as the industry focuses on bringing this pandemic under control.”

The company also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program to support the rapid advancement of vaccines, treatments and therapies by qualified biotechnology entities in response to the COVID-19 pandemic. The program, announced in July, was made available to Pennsylvania-based entities that demonstrate both a financial need and a well-defined pathway to the accelerated commercialization of a new vaccine, treatment or therapy in direct response to fight against COVID-19.

“We are pleased to welcome USSF to the growing life sciences sector in the Lehigh Valley,” said Don Cunningham, president and CEO of the Lehigh Valley Economic Development Corporation (LVEDC). “USSF is on the front lines of the fight against COVID-19 and we’re glad to be home to its expanding operations. We appreciate the work of Governor Wolf and the Commonwealth to support the growth of this important company.”

USSF was founded in 2013 and produces a variety of pharmaceuticals in a state-of-the-art facility that exceeds quality standards outlined in U.S. Pharmacopeia (USP) and FDA guidelines, and adheres to the Current Good Manufacturing Practice (cGMP) and thereby lowers the total risk of using Outsourced Facility pharmaceuticals. The company utilizes a small batch disposable model to support healthcare providers and investigational new drug sponsors on a global scale. By registering some formulations under its FDA Outsourced Facility designation, USSF addresses the need caused by interruptions in the availability of specialty pharmaceuticals. USSF focuses on high-value formulations, allowing the company to provide a much larger portfolio of products to customers at both global and regional levels. USSF’s portfolio has expanded to include injectables and nasal presentations as well as tropical pharmaceuticals as a response to customer demands. The company is also the global single source of four prescription medications.

For more information about the Governor’s Action Team or DCED, visit dced.pa.gov, and be sure to stay up to date with all of our agency news on Facebook, Twitter, and LinkedIn.

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”

You can read the full press release here

CMS hosts varied recurring stakeholder engagement sessions to share information related to the agency’s response to COVID-19. These sessions are open to members of the healthcare community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.

Call details are below. Conference lines are limited so we highly encourage you to join via audio webcast, either on your computer or smartphone web browser. You are welcome to share this invitation with your colleagues and professional networks. These calls are not intended for the press.

Calls recordings and transcripts are posted on the CMS podcast page at: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts

CMS COVID-19 Office Hours Calls (twice a month on Tuesday at 5:00 – 6:00 PM Eastern)

Office Hour Calls provide an opportunity for hospitals, health systems, and providers to ask questions of agency officials regarding CMS’s temporary actions that empower local hospitals and healthcare systems to:

• Increase Hospital Capacity – CMS Hospitals Without Walls;
• Rapidly Expand the Healthcare Workforce;
• Put Patients Over Paperwork; and
• Further Promote Telehealth in Medicare

Next Office Hours:Tuesday, December 8^th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 3129517

Audio Webcast link: https://engage.vevent.com/rt/cms2/index.jsp?seid=2766

Tuesday, December 22nd at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 3968359

Audio Webcast link: https://engage.vevent.com/rt/cms2/index.jsp?seid=2771

For the most current information including call schedule changes, please click here

To keep up with the important work the White House Task Force is doing in response to COVID-19 click here: https://protect2.fireeye.com/url?k=36fa2226-6aae0b0d-36fa1319-0cc47a6d17cc-2d06c219f858d641&u=http://www.coronavirus.gov/. For information specific to CMS, please visit the Current Emergencies Website.

To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance. Through the exercise of this discretion, we will allow Medicare-enrolled immunizers working within their scope of practice and subject to applicable state law, including, but not limited to, pharmacies working with the United States, as well as infusion centers, and home health agencies, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare Part A SNF residents. This enforcement discretion, and accordingly the ability for entities other than the SNF to submit claims for these monoclonal antibody products and their administration furnished to Medicare Part A SNF residents, is limited to the period described in the above-cited enforcement discretion notice.

The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, casirivimab and imdevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) , EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Additional Resources:

• List COVID-19 monoclonal antibody infusion billing codes, payment allowances and effective dates
• Monoclonal Antibody COVID-19 Infusion Program Instruction
• CMS COVID-19 Vaccine Provider Toolkit

In line with USDA’s unwavering promise to serve America’s children well through school meal programs, the department today announced it will publish a proposed rule maintaining flexibility for schools to serve tasty meals their kids will be eager to eat. These proposed changes respond directly to the needs of nutrition professionals who are the experts on-the-ground, hearing from our children every day.

The proposed rule would maintain flexibility in USDA child nutrition program meal requirements related to milk, grains, and sodium, by:

• Allowing flavored, low-fat milk in the Child Nutrition Programs;
• Allowing half of the weekly grains offered through the school meal programs to be whole grain-rich; and
• Providing schools more time for gradual sodium reduction by retaining Sodium Target 1 through the end of SY 2023-2024, continuing to Target 2 in SY 2024-2025, and eliminating the Final Target.

Yesterday, USDA issued a separate rule as an administrative step to ensure the department’s procedural compliance with a court ruling regarding its 2018 final rule on child nutrition program flexibilities. Today’s rule proposes to restore the flexibilities included in the 2018 final rule. Despite this procedural formality, schools do not have to change their meals, thanks to the  meal pattern flexibilities USDA has already provided in all child nutrition programs through June 30, 2021, in response to the COVID-19 national emergency.

The proposed rule announced today will publish in the Federal Register on Nov. 25th, followed by a 30-day public comment period. USDA is committed to listening to and collaborating with customers, partners, and stakeholders to make these reforms as effective as possible, and encourages all those who are interested in school meals to share their comments and recommendations for improvement through regulations.gov.

For information on food insecurity in Pennsylvania throughout the pandemic, visit agriculture.pa.gov/foodsecurity.

Pennsylvania Agriculture Secretary Russell Redding announced that the CARES Act-funded Dairy Indemnity Program has distributed $7.6 million in direct relief payments to 1,550 dairy farmers in the commonwealth. Any dairy farmer who experienced losses due to discarded or displaced milk during the COVID-19 pandemic was eligible to apply.

“Early in the pandemic in Pennsylvania, many of our dairy farmers were forced to dump milk and faced extreme uncertainty due to rapidly changing markets,” said Redding. “In this season of thanks, we are grateful that the legislature saw and met the needs of Pennsylvania’s dairy farmers with this program. These dollars don’t stop at the farm gate. They come back in your communities through grocery stores, schools, food banks, and more.”

Senators Judy Schwank and Elder Vogel, chairs of the Senate Agriculture and Rural Affairs Committee, championed this CARES-Act funding for Pennsylvania’s dairy farmers and joined today’s announcement.

“The dairy indemnity program, funded by the CARES Act, was a great program to help 1,550 of our farmers weather COVID-19,” Schwank said. “But there are nearly 7,000 dairy farms in the Commonwealth. We have to recommit ourselves to doing everything we can to strengthen the industry.”

“During this difficult time, there was an even greater appreciation for the role dairy farmers plays in our economy and to the families of Pennsylvania,” said Vogel. “It is the Commonwealth’s most essential industry and providing the necessary state funding at this time is more critical than ever.”

To qualify for direct relief payments, farmer’s losses must have occurred between March 6, 2020 and September 30, 2020. Farmers were eligible for an immediate $1,500 in direct relief upon applying, followed by additional relief dollars with the remaining funds in the program.

Pennsylvania is home to nearly 7,000 dairy farms with an economic impact of $12 billion and more than 52,000 jobs. The commonwealth’s more than 500,000 cows produce more than 10.2 billion pounds of milk annually, ranking Pennsylvania seventh in the nation for total milk production.

Reminder: December 11 Deadline for 2021 Dairy Safety-Net Enrollment

The U.S. Department of Agriculture reminds dairy producers that the deadline to enroll in Dairy Margin Coverage (DMC) for calendar year 2021 is Friday, Dec. 11, 2020. USDA’s Farm Service Agency (FSA) opened DMC signup in October to help producers manage economic risk brought on by milk price and feed cost disparities.

For DMC enrollment, producers must certify with FSA that the operation is commercially marketing milk, sign all required forms, and pay the $100 administrative fee unless the dairy operation qualifies for a limited resource, beginning, socially disadvantaged, or military veteran farmers and ranchers waiver.

Producers interested in DMC have the option to select a $4.00 catastrophic level of coverage with no premium fee or they can choose to buy-up coverage where the premium is based on margin triggers between $4.50 and $9.50 on 5 to 95 percent of established production history.

To determine the appropriate level of DMC coverage for a specific dairy operation, producers can utilize the recently updated online dairy decision tool. The decision tool is designed to demonstrate the historical performance of DMC and assist producers with calculating total premium costs and administrative fees associated with participation in DMC. An informational video is available, too.

For more information, visit farmers.gov DMC webpage, or contact your local USDA Service Center. To locate your local FSA office, visit farmers.gov/service-center-locator.

The Centers for Medicare & Medicaid Services (CMS) outlined unprecedented steps to increase the capacity of the American health care system to provide care to patients outside a traditional hospital setting amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the country.

In March 2020, CMS announced the Hospitals Without Walls program, which provides broad regulatory flexibility that allowed hospitals to provide services in locations beyond their existing walls. Today, CMS is expanding on this effort by executing an innovative Acute Hospital Care At Home program, providing eligible hospitals with unprecedented regulatory flexibilities to treat eligible patients in their homes. CMS believes that treatment for more than 60 different acute conditions, such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD) care, can be treated appropriately and safely in home settings with proper monitoring and treatment protocols.

As part of Hospital Without Walls, CMS also previously announced regulatory flexibility that allowed Ambulatory Surgical Centers (ASCs) – facilities that normally provide same-day surgical care – the ability to be temporarily certified as hospitals and provide inpatient care for longer periods than normally allowed. Today, CMS is announcing an update to that regulatory flexibility, clarifying that participating ASCs need only provide 24-hour nursing services when there is actually one or more patients receiving care onsite.

A press release is attached and available here.

Frequently asked questions (FAQs) on the Acute Hospital Care At Home program are attached and available here.

FAQs on the ASC flexibilities announced today are attached and available here.

As part of NIOSH’s efforts to keep our stakeholders up to date on the CDC and NIOSH COVID-19 response, here is a summary of new information available.

• A new scientific brief highlights evidence that cloth masks help to block virus-carrying respiratory droplets from reaching others when the wearer has COVID-19. Cloth masks can also help block the amount of virus-carrying droplets that a mask wearer inhales if someone nearby is infected.
• The workplaces and businesses webpage was updated to provide one central location for all work-related COVID-19 resources.
• A new infographic provides tips to ensure that employers and employees are prepared to assist when a COVID-19 case is identified in the workplace. The infographic is a part of the recommendations provided for COVID-19 Case Investigation and Contact Tracking in Non-Healthcare Workplaces: Information for Employers.
• The critical infrastructure sector response planning webpage as updated to reflect new scientific evidence, evolving epidemiology, and the need to simplify the assessment of risk.

New school resources are also available:

The Cleaning, Disinfection, and Hand Hygiene in Schools toolkit is now available to aid school administrators as they consider how to protect the health, safety, and wellbeing of students, teachers, other school staff, families, and communities and prepare for educating students.

The school health personnel webpage provides information and resources to help school nurses and other healthcare personnel perform these new roles and responsibilities during the COVID-19 pandemic. Resources for self-care are also included.