PREP Act Ninth Amendment – Overview and Audit Guidance for Subcutaneous REGEN-COV

The ninth amendment to the Public Readiness and Emergency Preparedness (PREP) Act was published in the Federal Register on September 14th, 2021, which granted pharmacists the authority to order and administer COVID-19 therapeutics and qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics under the supervision of a pharmacist. The PREP Act only covers COVID-19 therapeutics by subcutaneous, intramuscular, or oral administration—therefore, IV infusion would not be covered under this amendment.

At the time of publishing, only one COVID-19 therapeutic is available for administration under the ninth amendment of the PREP Act. The co-formulated solution, REGEN-COVTM, qualifies because it has FDA emergency use authorization (EUA) for administration via subcutaneous injection in addition to IV infusion. REGEN-COVTM contains two monoclonal antibodies (mAbs), casirivimab and imdevimab, and is authorized for the treatment of certain patients with COVID-19 and for post-exposure prophylaxis in eligible patients.1,2

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proved Use1,2 Coverage Criteria1,2,3,4 Dosage1,2,5
Treatment of COVID-19

ICD-10 Code

U07.1

 ALL MUST APPLY:

  • Mild-to-moderate COVID-19 symptoms within 10 days of onset without requiring hospitalization or oxygen supplementation due to COVID-19 (or requiring more oxygen than baseline)
  • Adult or pediatric patient (≥ 12 years old and ≥ 40 kg)
  • Positive results of direct SARS-CoV-2 viral testing
  • High risk for progressing to severe COVID-19, including hospitalization or death
 600 mg casirivimab + 600 mg imdevimab

IV infusion is preferred, but subcutaneous injection is authorized when infusion is not feasible or would delay treatment.
Post-Exposure Prophylaxis

ICD-10 Code

Z20.822

 ALL MUST APPLY:

  • Adult or pediatric patient (≥ 12 years old and

≥ 40 kg)

  • High risk for progressing to severe COVID-19, including hospitalization or death
  • Not fully vaccinated -OR- not expected to fully respond to vaccine (i.e. immunocompromised)
  • Had close contact with an infected individual per CDC criteria -OR- is at high risk for exposure to an infected individual due to infection in other individuals in same institutional setting
 INITIAL EXPOSURE

600 mg casirivimab + 600 mg imdevimab

REPEAT EXPOSURE

Patients with repeat exposure expected to last more than one month may receive additional doses once every 4 weeks for the duration of the ongoing risk

300 mg of casirivimab + 300 mg of imdevimab

1FDA EUA for REGEN-COVTM, September 9, 2021. https://www.fda.gov/media/145610/download. (Accessed September 13, 2021).

2FDA Fact Sheet for Health Care Providers EUA of REGEN-COVTM (casirivimab and imdevimab). September 2021. https://www.fda.gov/media/145611/download.  (Accessed October 12, 2021).

3NIH Anti-SARS-CoV-2 Monoclonal Antibodies Treatment Guidelines. August 4, 2021. https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/. (Accessed September 27, 2021).

4Close Contact per CDC criteria:  https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/appendix.html#contact. (Accessed September 29, 2021).

5REGEN-COVTM: Subcutaneous Injection Instructions for Healthcare Providers COMBATCOVID.HHS.gov. July 28, 2021. https://www.phe.gov/emergency/events/COVID19/therapeutics/Documents/REGEN-COV-SubQ-FactSheet-July2021-508.pdf?utm_medium=email&utm_source=govdelivery. (Accessed October 12, 2021).

High-Risk Conditions1,2,3
  • Older age (e.g., age ≥65 years old)
  • Obesity or being overweight (adult with BMI >25 kg/m2, or if age 12-17, BMI ≥85th percentile for age and gender based on CDC growth charts)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease or hypertension)
  • Chronic lung diseases (e.g., COPD, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (e.g., cerebral palsy)
  • Conditions with medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])
  • Other conditions/risk factors making the patient high risk for severe COVID-19 (e.g., race, ethnicity) – health care providers should consider the benefit-risk of treatment for each patient

*Additional conditions can be found on the CDC’s COVID-19 Underlying Conditions or People with Certain Medical Conditions webpage

1FDA Fact Sheet for Health Care Providers EUA of REGEN-COVTM (casirivimab and imdevimab). September 2021. https://www.fda.gov/media/145611/download.  (Accessed October 12, 2021).

2CDC. COVID-19 Underlying Medical Conditions. May 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. (Accessed October 12, 2021).

2CDC. COVID-19 People with Certain Medical Conditions. Aug 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. (Accessed October 13, 2021).

When billing REGEN-COVTM, request reimbursement only for the administration fee (aka incentive amount) since the therapeutic agent is provided to the pharmacy at no cost by the federal government. To bill Medicare, the pharmacy must be enrolled as a Part B provider and utilize a medical billing intermediary. For claims billed to plans other than Part B, REGEN-COVTM may or may not be covered by either the pharmacy or medical benefit and cost-sharing is possible. Based on guidance from CMS, below are the billing codes for REGEN-COVTM (NDC 61755-0039-01; 10 mL vial).

sage of casirivimab + imdevimab Medicare Benefit
Drug HCPCS Code Administration HCPCS Code Administration Code Description Incentive Amount*
600 mg + 600 mg

(1,200 mg total)

 Q0244 M0243 Outpatient initial SubQ injection and post-administration monitoring $450
600 mg + 600 mg

(1,200 mg total)

 Q0244 M0244 Home or residence initial SubQ injection and post-administration monitoring in the home or residence $750
300 mg + 300 mg

(600 mg total)

 Q0240 M0240 Outpatient subsequent repeat doses SubQ injection and post-administration monitoring $450
300 mg + 300 mg

(600 mg total)

 Q0240 M0241 Home or residence subsequent repeat doses SubQ injection and post-administration monitoring in the home or residence $750

*This rate covers the administration fee plus the minimum required 1-hour post-injection clinical observation period

PAAS Tips: 

  • Robust documentation is extremely important – be audit-ready by having all the following for each claim:
  1. A placeholder hardcopy
  2. Confirmation of the patient’s eligibility with a signed attestation (COVID-19 treatment also requires valid test results)
  3. An administration log signed and dated by the patient, pharmacist, and staff who administered the therapeutic agent
Sara Hathaway, PharmD
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