HHS Announces Providers Can Use Provider Relief Fund Payments for Vaccine Distribution

On October 28, 2020, the Department of Health and Human Services (HHS) updated the Provider Relief Fund FAQs on Use of Funds to provide that healthcare providers can use payments received from the Provider Relief Fund to pay for equipment, personnel and transportation costs to be used to support distribution of a COVID-19 vaccine licensed or approved by the Food and Drug Administration. However, these funds cannot be used for expenses and losses related to vaccine distribution that have been reimbursed from other sources that are already obligated to reimburse such expenses, including Medicare, Medicaid, and CHIP (Children’s Health Insurance Program). These new FAQs join other recent guidance from HHS regarding which expenses and losses providers can legally count toward the COVID-19 Provider Relief Fund grants.

HHS Authorizes Qualified Pharmacy Technicians and State-Authorized Pharmacy Technicians to Administer Childhood and COVID-19 Vaccines

On October 21, 2020, the Department of Health and Human Services (HHS) announced that it had authorized qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines (when available), and COVID-19 tests, subject to certain conditions. This guidance expands the HHS September 2020 authorization allowing pharmacists to administer childhood vaccines and COVID-19 vaccines. The requirements applicable to pharmacy technicians and authorized pharmacy interns include, among other things:

  • The vaccination must be ordered by the supervising qualified pharmacist.
  • The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
  • The vaccine must be FDA-authorized or FDA-licensed.
  • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation(s).
  • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
  • The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include a hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
  • The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
  • The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
  • The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the State or local immunization information system (vaccine registry).
  • The supervising pharmacist is responsible for complying with requirements related to reporting adverse events.
  • The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern. 
  • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients when appropriate.

The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Kentucky Publishes Draft COVID-19 Vaccination Plan

person holding injection

On October 16, 2020, the Kentucky Department of Public Health published a first draft vaccination plan for distribution of the COVID-19 vaccine to Kentucky’s local health departments and provider organizations as it becomes available in late 2020 or in 2021. The draft vaccination plan considers the phases of vaccination set out by the Centers for Disease Control and Prevention (CDC) and identifies targeted groups for each phase of equitable access to COVID-19 vaccinations in Kentucky:

Phase 1:        Potentially limited supply of COVID-19 vaccine doses available—initial efforts will focus on critical populations of healthcare personnel and critical infrastructure workers and medically and situationally vulnerable populations, such as congregate care setting and correctional facility residents.

Phase 2:        Large number of vaccine doses available—supplement supply to unvaccinated critical populations (see Phase 1) and expand to essential workers and workers in high public contact jobs, including social service support workers, education personnel, grocery workers, and transportation workers.

Phase 3:        Sufficient supply of vaccine doses for entire population—administer vaccines to vulnerable general population (e.g., age 60+, comorbidities), high-risk children, pregnant women, and other high-risk adults, and critical infrastructure workers not included in previous phases.

Phase 4:        General population.

CMS to Allow Pharmacies to Direct Bill for SNF COVID-19 Vaccinations

person holding injection

On October 16, 2020, CMS announced that it will allow Medicare-enrolled immunizers, including, but not limited to, U.S. pharmacies, to bill and receive direct reimbursement from the Medicare program for vaccinating Medicare beneficiaries residing in skilled nursing facilities (SNFs).  In absence of the exercise of such discretion, the Social Security Act’s Consolidated Billing Provisions would have required SNFs to bill for COVID-19 vaccine administration even when SNFs rely on an outside vendor to perform the service.  CMS stated that the U.S. is facing an unprecedented challenge in meeting the urgent need to vaccinate the most vulnerable citizens in SNFs where about 30 percent of U.S. COVID-19 deaths have occurred.  CMS stated, “Outside immunizers can help fill that urgent need and provide onsite vaccinations at SNFs [but] to do so during this global emergency, Medicare-enrolled vaccinators must be able to bill directly and receive direct reimbursement from the Medicare program.”  

The ability of immunizers to directly bill and receive direct reimbursement will be in effect until the latter of: (1) the last day of the calendar quarter in which the last day of the emergency period occurs; or (2) so long as CMS determines that there is a public health need for mass COVID-19 vaccinations in congregate care settings.

CMS distributed this announcement as a MLNConnects Special Edition email via CMSlists@subscriptions.cms.hhs.gov. . To view a copy of the announcement, click here.

HHS to Allow Pharmacists to Order and Administer COVID Vaccines

On September 9, 2020, the Department of Health and Human Services (HHS) announced that it had published guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to persons age 3 and up, subject to certain requirements.  The authorization preempts any state and local laws that prohibit those who satisfy the HHS requirements from ordering or administering COVID-19 vaccines. These requirements include, among other things:

  • The vaccine must be U.S. Food and Drug Administration (FDA)-authorized or licensed.
  • The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.
  • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
  • The licensed pharmacist must have a current certificate in basic CPR.
  • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
  • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
  • The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
  • The licensed pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Pharmacists Authorized by HHS to Administer Vaccines

On August 19, 2020, the Department of Health and Human Services (HHS) announced that it had amended the March 17, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) concerning the COVID-19 Public Health Emergency to increase accessibility of lifesaving childhood vaccines in order to control preventable outbreaks and diseases and mitigate additional strains on the healthcare system. The directive authorizes state-licensed pharmacists to administer, without a doctor’s prescription, vaccines to children ages 3 to 18, pursuant to certain conditions and restrictions. Twenty-eight states already allow pharmacists to administer vaccinations to children. On August 20th, HHS also announced it was expanding the PREP Act’s liability immunity provisions to protect pharmacists and pharmacy interns from liability for alleged harm arising from their administration of vaccines to children.

The amended Declaration can be reviewed here. The American Academy of Pediatrics published an announcement opposing the HHS action, calling it “incredibly misguided” and arguing that pediatricians are the best and safest administrators of childhood vaccinations.