COVID-19: Additional Guidance on Pharmacy Vaccine Administration

The Food and Drug Administration (FDA) issued emergency use authorization for three vaccines to protect against COVID-19.  While these long-awaited vaccines have provided tremendous hope for the nation in looking for a pathway out of the pandemic, the vaccines also present many questions (and opportunities) for pharmacies in the role that they might play in the distribution of the vaccines.  For the pharmacies that have signed up to participate in their states’ vaccine rollout plans or are considering administering the vaccines in the future, questions abound about their ability to administer the vaccines as pharmacies and how they might seek reimbursement for those activities. Federal guidance and state law provide insight to pharmacies considering their role in vaccine distribution.

   

   

The Centers for Medicare and Medicaid and state legislators have updated their COVID-19 guidance to address questions raised on a pharmacy’s ability to administer and collect reimbursement on the vaccine. CMS’s guidance creates flexibility for the administration of the COVID-19 vaccine and a mechanism for payment.

   

As a threshold matter, it is essential to note that the vaccine itself will be paid for through funding authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, but administration of the vaccine by a provider will be paid for by the payer (for example, the private insurance company, Medicare in the case of a Medicare Advantage plan, or the Provider Relief Fund).

   

To expand vaccine capability, independent pharmacies should register for vaccine administration. For example, West Virginia sets a significant standard in leading the country’s vaccine distribution because of its partnership with local independent pharmacies.

   

   

Pharmacies can enroll under Medicare as mass immunizers to offer COVID-19 vaccines to Medicare beneficiaries under roster billing, similar to flu and pneumococcal vaccines. As we await more information about state and private reimbursement plans, pharmacies can prepare for Medicare reimbursement by registering as a Medicare mass immunizer, if not already enrolled as such, or a Medicare provider. However, a party enrolled only as a mass immunizer may not bill Medicare for any services other than flu vaccines, pneumococcal vaccines, COVID-19 vaccines, and their administration.

   

Pharmacies wishing to administer the vaccine will bill private and public insurance for the vaccine administration fee. Independent pharmacies that want to participate in the Federal Retail Pharmacy Program may sign up with an existing network administrator partner to provide COVID-19 vaccination as part of the program. 1 Pharmacies not enrolled with the CDC as COVID-19 vaccination providers can register directly with a state or territory’s immunization program to offer vaccination in their communities. 2 

   

Consumers enrolled in a non-grandfathered group or individual health insurance coverage will receive the vaccine and its administration free of charge from a network provider. 3 During the COVID-19 public health emergency, patients will also receive the vaccine and its administration free of charge from an out-of-network provider. This fee will be reimbursed for uninsured patients through the Health Resources and Services Administration’s Provider Relief Fund.

   

Medicare payment rates for COVID-19 vaccine administration will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of 2 or more doses, the initial dose(s) administration payment rate will be $16.94 and $28.39 for administering the final dose in the series. These rates recognize the costs of administering the vaccine, including the additional resources involved with required public health reporting, conducting important outreach and patient education, and spending extra time with patients answering any questions they may have about the vaccine.

   

CMS issued toolkits to provide health care providers not enrolled in Medicare with the information needed to administer and bill vaccines to Medicare beneficiaries and information related to coverage of the vaccine for several different programs and payers.

   

COVID-19 vaccination providers participating in the CDC COVID-19 Vaccination Program must sign a CDC COVID-19 Vaccination Program Provider Agreement. 4 COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction as soon as practicable and no later than 72 hours after administration.

   

If you have any questions regarding how to best position your pharmacy or anything related to COVID-19, please contact us to speak to an attorney today. We also have a specific team of Frier Levitt attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and are prepared to assist clients.