What immunocompromising conditions or treatments are considered moderate or severe?

Moderate and severe immunocompromising conditions and treatments include but are not limited to

• Active treatment for solid tumor and hematologic malignancies
• Receipt of solid-organ transplant and taking immunosuppressive therapy
• Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (HCT) (within 2 years after transplantation or taking immunosuppression therapy)
• Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced or untreated HIV infection (people with HIV and CD4 counts < 200 cells/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
• Active treatment with high-dose corticosteroids (i.e., ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory

What steps should pharmacists take to assess that a patient is severely or moderately immunocompromised and recommended to receive an additional COVID-19 vaccine dose?

The patient may self-attest that they are moderately or severely immunocompromised. APhA has several patient attestation documents in our COVID-19 Resources: Know the Facts library. Pharmacists may also refer to the CDC’s prevaccination checklist for COVID-19 vaccination.

To verify that the patient should receive an additional COVID-19 vaccine dose, pharmacists should assess the patients COVID-19 vaccine history by asking for the patient’s COVID-19 vaccination card and/or checking the immunization information system (IIS) to determine which vaccine(s) the patient has received. Pharmacists should look to their state immunization information system for guidance on documenting additional doses.

When might revaccination be considered?

HCT and CAR-T-cell recipients who received doses of COVID-19 vaccine prior to or during treatment with an HCT or CAR-T-cell therapy should be revaccinated with a primary vaccine series at least 3 months (12 weeks) after transplant or CAR-T-cell therapy. An mRNA vaccine is preferred for revaccination with a primary vaccine series.

An additional primary dose of an mRNA COVID-19 vaccine is recommended 28 days after the second dose as part of revaccination for people who continue to be moderately or severely immunocompromised. A patient’s clinical team is best positioned to determine the degree of immune compromise and appropriate timing of vaccination. Consult the patient's hematologist/oncologist regarding any deviations from these guidelines.

When should a patient receive vaccination in relation to immunosuppressive therapies?

When possible, COVID-19 vaccines should be administered at least 2 weeks before starting or resuming immunosuppressive therapies. Timing of COVID-19 vaccination should take current or planned immunosuppressive therapies into consideration. A patient’s clinical team is best positioned to determine the degree of immune compromise and appropriate timing for administration. Serologic or cellular immune testing is not recommended at this time.

What additional considerations should pharmacists counsel on?

Vaccinated people who are immunocompromised should be counseled about the potential for a reduced immune response to COVID-19 vaccines and the need to continue to follow current prevention measures (including wearing a mask, staying 6 feet apart from others they don’t live with, and avoiding crowds and poorly ventilated indoor spaces). Close contacts of immunocompromised patients should also be strongly encouraged to be vaccinated against COVID-19 to protect the immunocompromised patients.

How should the third primary dose (additional dose) be billed for reimbursement?

Moderately or severely immunocompromised individuals should receive a 3-dose primary series as opposed to a 2-dose primary series. To bill for the third primary dose (additional dose) using the pharmacy dispensing system to submit a claim to a PBM, pharmacies should use a submission clarification code value of 7 when the same COVID-19 vaccine product is administered. If a different vaccine product is used for the third primary dose (additional dose) because the product used for the primary series is not available, the new National Drug Code will identify the product administered as a distinct product and a submission clarification code is not needed.

When billing a COVID-19 vaccine through a medical billing pathway, pharmacies can reference AMA’s COVID-19 CPT coding and guidance for appropriate CPT codes, as needed.

Refer to APhA’s “Reimbursement for Administration of COVID-19 Vaccine(s)—What We Know” in the APhA’s COVID-19 Resources: Know the Facts library for an in-depth overview of the medical and pharmacy billing pathways for COVID-19 vaccines.

Last revised on April 22, 2022.