The BackPage - September/October 2020

Virtual Site Visits

CDC has granted approval for awardees to begin conducting compliance, storage & handling, and IQIP site visits virtually. Consultants will begin reaching out to providers to schedule virtual site visits in August. Consultants must utilize a virtual platform with screen-sharing functionality for document/record review. The platform used by Virginia is GoToWebinar and GoToMeeting which are HIPAA compliant. Once consultants are able to return to the field, Virginia will transition to hybrid visits where a portion of the visit will be completed virtually and the remainder will be completed in-person.

Digital Data Logger (DDL) Recalibration Guidance

Considering both fiscal operational challenges providers and manufactures may be currently experiencing, awardees may extend the calibration period by one additional year, at their discretion, to reduce the burden on providers with expiring calibration certificates. This guidance only applies for certificates expiring this calendar year. For example, a certificate set to expire 6/30/2020 could be extended to 6/30/2021. However, a certificate set to expire 2/1/2021 would still need to be recalibrated prior to the due date as of now.

FDA expands license for Gardasil 9 to include preventing oropharyngeal and other head-and-neck cancers caused by relevant HPV types

On June 12, the FDA approved a supplemental biologics licensure application (sBLA) to add a new indication for Gardasil 9 (Merck): prevention of oropharyngeal and other head-and-neck cancers caused by human papillomavirus (HPV) types targeted by the vaccine.

Accelerated approval regulations require a post-licensure confirmatory study to verify and describe the clinical benefit for the indication. To satisfy this requirement, Merck is conducting a study to evaluate the efficacy of Gardasil 9 in men 20 through 45 years of age. FDA has accepted the prevention of oral persistent infection as an intermediate surrogate endpoint to predict the prevention of oropharyngeal and other head and neck cancers caused by HPV.

Gardasil 9 remains approved for use in individuals 9 through 45 years of age, with no other changes to the previously approved age-specific dosing regimens.

Annual Provider Agreement Renewals

Each year enrolled providers are required to submit an updated Provider Agreement. Updated Agreements must be complete including verification of site name, address, telephone and fax numbers, contact information for the current primary and back-up coordinator, signature of the medical director or equivalent (this must be a physician unless a NP signing the form has an autonomous medical license), verification of vaccine shipping hours, and a completed patient profile. Vaccine orders cannot be filled if a Provider Agreement becomes overdue. Submitting an incomplete Agreement may delay vaccine order requests.

Flu Vaccine is Available

The first shipments of flu vaccine have arrived at the CDC depots. Please notify Susan Kocen if you are ready to begin administering flu vaccine. The interim VISs can be found here: https://www.cdc.gov/vaccines/hcp/vis/current-vis.html?deliveryName=USCDC_11_1-DM6726

Flu Prevention

CDC recommends a yearly flu vaccine as the first and most important step in protecting against flu viruses. Getting a flu vaccine during 2020-2021 will be more important than ever. Flu vaccines will not prevent COVID-19, but they will reduce the burden of flu illnesses, hospitalizations and deaths on the health care system and conserve scarce medical resources for the care of people with COVID-19. For more information about flu prevention visit: https://www.cdc.gov/flu/prevent/prevention.htm

Hepatitis A Vaccine Information Statement (VIS)

The updated interim hepatitis A vaccine information statement has been posted on the VIS website. We encourage providers to begin using this VIS immediately, but previous editions may be used until they run out. For more information, please visit: https://www.cdc.gov/vaccines/hcp/vis/current-vis.html?deliveryName=USCDC_11_1-DM6726

Adult Vaccine Update

The Virginia Department of Health has received supplemental funding from the Centers for Disease Control and Prevention (CDC) to increase flu activities and vaccine distribution for adults during the 2020-2021 influenza season.

CDC is providing a one-time special allowance during the 2020-2021 flu season to allow 317-purchased flu vaccine to be administered to all adults regardless of insurance status. This is the same allowance being provided for the supplemental adult vaccine. Priority, for both the 317 flu vaccine and the supplemental adult flu vaccine, should be given to individuals without other means of receiving flu vaccine, and screening for insurance is recommended if the vaccine is administered in an office setting.

CDC recommends that providers reduce any financial barriers to the administration of this vaccine, and recommends that people not be turned away for an inability to pay. While administration fees are allowable, CDC recommends that any administration fee is capped at the maximum fee allowable for the administration of VFC vaccine, which is $21.24 per injection in Virginia.