On December 18, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Moderna COVID‑19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older. Review Moderna’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when the vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage

The Pennsylvania Department of Banking and Securities (DoBS) responded to nearly 5,000 complaints and inquiries about financial transactions, companies, or products in fiscal year 2019-2020 according to its recently released Consumer Services Annual Report.

The department saw an 18 percent increase in inquiries over last year, largely a result of consumers impacted by COVID-19, including questions about mortgage forbearance, payment deferrals, and scams, highlighted in the report. Of the 4,970 inquiries, the most common (28 percent) complaint or inquiry was related to bank account/services, especially withdrawals, and the second most prevalent complaint (20 percent) was mortgage issues, especially with processing and underwriting. On average, department staff helped resolve consumer issues in fewer than five days. The report also highlights aspects of financial caregivers’ fiduciary responsibility and increased activity with social payments.

“The department remains committed to protecting consumers when it comes to financial services,” said Tim Arthun, Deputy Secretary for Financial Services. “The uptick in calls and emails to our office about financial products, services, and scams is not surprising given the ongoing challenges of the COVID-19 pandemic. I commend our staff for their diligence in helping consumers navigate these complex issues while adapting to remote work.”

The department’s outreach staff offered 320 presentations across 56 counties and reached more than 27,000 consumers during the fiscal year. These events, which are typically held in person, moved entirely online beginning in March to help protect public health.

“I am continually impressed by the department’s entire staff who have remained steadfast in upholding the department’s mission and vision throughout the pandemic,” added Secretary of Banking and Securities Richard Vague. “With the assistance of the Office of Administration’s IT staff who helped seamlessly transition staff to telework, our Financial Services for Consumers and Business Deputate has been unwavering in its commitment to supporting consumers and helping to resolve their financial complaints and inquiries.”

The department’s Investor Education and Consumer Outreach is part of the governor’s Consumer Financial Protection Initiative. The staff works with state and local government agencies, service providers, community and trade organizations, the General Assembly, the military community, schools, and other partners to help Pennsylvanians across the commonwealth become well-informed about the financial marketplace. There are a variety of free, non-commercial programs and presentations available, or a program can be tailored to a specific group’s needs.

Anyone can ask questions or file complaints about financial transactions, companies, or services online or by calling 1-800-PA-BANKS (800-600-0007). Members of the public can stay informed about fraud and scams by following the Department of Banking and Securities on Facebook or Twitter or by subscribing to the department newsletter. Use #GovWolfCFPI to follow the Consumer Financial Protection Initiative on Twitter.

The Pennsylvania Department of Health announced a new tool called the Connect & Protect Form where contact tracers will now reach out to 19- through 64- year-old residents within the department’s jurisdiction to gather a digital case investigation. This process will allow public health professionals to reach more cases in an efficient time frame to gather information relating to where the case went or who they came in contact with to support both case investigation and contact tracing efforts.

Between Sunday, December 6 and Saturday, December 12, there were 71,341 COVID-19 cases statewide, an increase of 8,648 cases compared to the previous seven-day period weekly numbers. Case investigations are being prioritized to address those cases that present the highest likelihood of leading to an outbreak. Of the 71,341 newly reported cases, 13 percent, or 9,274 cases, had a case investigation started within 24 hours of receiving the positive report. Public health professionals will continue calling to complete the case investigation after the 24-hour period. An additional four percent, or 2,853 cases, had a case investigation started within 48 hours.

Although public health professionals may call to start the case investigation, not all cases to obtain additional information are successful. The Department of Health leaves voicemails, texts, and sends a letter to the home requesting a return call. There were 6,420 people, or 9 percent of cases, in this reported week that were successfully contacted by a public health professional statewide.

After the initial case investigation is complete, contact tracing begins. Within the same time period of December 6 to December 12, there were 1,675 contact tracing staff working with local and county health entities, partner organizations and the Regional Response Health Collaboration Program within the Department of Human Services as well as volunteers from Co-County Wellness in Berks County and Penn Medicine Lancaster General Health. These staff monitored 8,197 contacts who were identified during the case investigations, an increase of 1,844 additional close contacts monitored compared to last week.

Currently, all of the allotted 1,090 people have been hired through Insight Global. Some of these staff have been promoted to perform case investigations to meet the immediate needs of increased caseloads. There are 50 case investigators, 40 supervisors, and 10 resource coordinators who will help to refer Pennsylvanians to services during quarantine across the commonwealth. An additional 50 contact tracers will be promoted and trained to become case investigators over the next two weeks.

Since the implementation of the Contact Tracing Management System in early October through December 12 in those areas of the state where Pennsylvania Department of Health is responsible for contact tracing, there have been:

• 62,700 contacts have been processed for areas where PA DOH has jurisdiction;
• 47,800 people, or 76 percent of the total contacts identified, have been effectively reached to communicate their quarantine status and offer ongoing symptom monitoring;
• 11,900 people, or about 19 percent of the total contacts, were not reached; and
• 1,700 were still in the process of being contacted.

On September 22, the department launched COVID Alert PA, a free mobile app that uses Bluetooth technology to let a person know that they have been exposed to COVID-19 without compromising the identity or location of either the person using the app, or of the person to whom they may have been exposed.

The Department of Health has made updates the COVID Alert PA app to include 13- through 17-year-old residents with parental consent to download the app and four new languages. This app is interoperable with 16 other states that also utilize the same notification exposure app technology.

In addition to the traditional case investigations and contact tracing process, there have been 527 cases that confirmed their positivity and uploaded their random ID’s through the app. These uploads generated 253 exposure alerts to persons who have downloaded the app on their phones and who were in close contact (six feet for 15 minutes or more) to the case. Of those who received the alerts, 41 individuals requested a call back for further assistance from a trained contact tracer.

As the contact tracing program expands, the Department of Health continues to work in partnership with over 150 organizations, in addition to the county and municipal health departments, through regional partnerships to help gather and answer questions, identify problems and find solutions to improve contact tracing efforts within the region.

Each regional partnership has met at least once, and includes public health staff, health providers, academic institutions, community organizations, and other stakeholders interested in helping to coordinate and engage around contact tracing efforts.

Organizations and entities interested in partnering in these efforts should reach out to RA-DHCONTACTTRACING@pa.gov.

You can find more information on the state’s contact tracing efforts at the Department of Health’s website here.

Pennsylvania hospitals began receiving shipments of the Pfizer-BioNTech COVID-19 vaccine the week of December 14. Through December 20:

• 97 hospitals have received 97,500 vaccine doses.
• 17,700 doses of the vaccine have been administered.

A spreadsheet of facilities that have received vaccine can be found here.

Links to updated guidance and Frequently Asked Questions can be found below:

Frequently Asked Questions for Businesses Operating During the COVID-19 Disaster Emergency: https://www.governor.pa.gov/covid-19/business-faq/

Guidance for Businesses in the Construction Industry Permitted to Operate During the COVID-19 Disaster Emergency: https://www.governor.pa.gov/covid-19/construction-industry-guidance/

Guidance for Businesses in the Restaurant Industry Permitted to Operate During the COVID-19 Disaster Emergency to Ensure the Safety and Health of Employees and the Public: https://www.governor.pa.gov/covid-19/restaurant-industry-guidance/

COVID-19 Guidance for Businesses: https://www.governor.pa.gov/covid-19/business-guidance/

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

COVID-19 Care Site-Specific Call

CMS-CDC Nursing Home Stakeholder Call

When: December 22, 2020; 1-2pm ET

Where: Participant Line: (833) 614-0820   (Conference ID: 7979889)

Overview: Please join CDC and CMS for this call with Nursing Homes focused on COVID 19 vaccination among residents and staff. During this call, you’ll receive:

• Updates on Pharmacy Partnership for Long-Term Care Program;
• Critical clinical, safety, and infection prevention and control considerations associated with implementation;
• Communication resources you can use to address resident and staff questions and concerns; and
• General reminders for the holiday season.

A questions and answer session will follow updates.

Acute Hospital at Home Q&A Session

When: Tuesday, December 22, 2020 10:30 AM-11:00 AM

Where: Participant Line: (833) 614-0820  (Conference ID: 3985903)

Join CMS for an Acute Hospital Care at Home Q&A Session. This call provides an opportunity for health systems interested in participating as well as hospitals currently enrolled in the program to seek clarification from CMS subject matter experts.  Prior to the call, please review the publicly posted FAQs to verify if an answer to your question is available. Acute hospital care at home FAQs (PDF)

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.

The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 18 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

A link to the full FDA press release is here. The press release also provides information and discussion on available safety and effectiveness data.

You can review the full Moderna COVID-19 Vaccine EUA Letter of Authorization here.

In addition to the EUA letter, below are links to fact sheets from the FDA:

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers)

Fact Sheet for Recipients and Caregivers

Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex M Azar II and Acting Secretary of Defense Christopher C. Miller have issued statements on this next step, and they can be viewed here.

For more information on COVID-19 vaccines, the EUA process, and guidance to industry for developing a COVID-19 vaccine please visit:

COVID-19 Vaccines

Emergency Use Authorization for Vaccines Explained

Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry

Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry