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Coverage of COVID-19 mAbs Presents Opportunities for Stakeholders

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In November 2020, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to COVID-19 monoclonal antibodies for treatment of mild-to-moderate COVID-19 infection.

In an effort to expand patient access to this newly authorized treatment option, the Centers for Medicare and Medicaid Services (CMS) subsequently issued guidance establishing first-dollar coverage and payment rates for these monoclonal antibodies under the Medicare Part B vaccine benefit through the duration of the public health emergency (PHE). In May 2021, the CMS issued revised guidance increasing the Medicare payment rate for COVID-19 monoclonal antibody administration and establishing a new payment rate  for COVID-19 monoclonal antibody home infusions.

While the CMS has taken steps to accelerate access to new treatment and prevention options over the course of the pandemic, questions remain regarding future coverage and payment of COVID-19 monoclonal antibodies. The CMS may revise its policies toward COVID-19 monoclonal antibodies, which could have coverage, reimbursement, and access implications in a post-PHE environment.

Medicare Coverage of COVID-19 Monoclonal Antibodies Differs from Other Physician-Administered Products

Traditionally, the CMS has covered monoclonal antibodies under the Medicare Part B drug benefit. However, the CMS’s November 2020 memo established Medicare payment for COVID-19 monoclonal antibodies under the Part B vaccine benefit. In its decision to extend first-dollar coverage (i.e. no patient cost sharing)  to therapeutic COVID-19 monoclonal antibodies, the CMS cites Section 3713 of the Coronavirus Aid, Relief, and. Economic Security (CARES) Act, stating that “COVID-19 monoclonal antibody products are considered COVID-19 vaccines” and would therefore be covered and paid for as vaccines under Part B. Notably, Section 3713 of the CARES Act refers to vaccines broadly and does not explicitly mention monoclonal antibodies or treatment.

Currently, all COVID-19 monoclonal antibodies are authorized under an EUA and purchased by the US government. Therefore, providers are reimbursed only for administration and not for the product itself. Additionally, the CARES Act requires Medicare Fee-for-Service to cover COVID-19 vaccines for Medicare Advantage enrollees during the 2021 plan year. This policy also extends to coverage of COVID-19 monoclonal antibodies.

Key Considerations Related to Future Coverage of COVID-19 Monoclonal Antibodies

The CMS’s current coverage policy for COVID-19 monoclonal antibodies is limited to the duration of the PHE, and it is unclear if or when the CMS will reevaluate the policy. Further, as manufacturers begin to pursue FDA approval for these monoclonal antibodies, it is also uncertain when the US government will discontinue purchasing and distributing COVID-19 monoclonal antibodies. Whether the CMS maintains the policy or allows it to expire has implications for payment and access.

Maintaining the existing policy indefinitely or for a period of time beyond the PHE would ensure coverage for COVID-19 monoclonal antibodies under the vaccine benefit. COVID-19 monoclonal antibodies would have first-dollar coverage and providers would be reimbursed at 95% of average wholesale price (AWP) in the physician office setting and at reasonable cost in the hospital outpatient setting. Under this scenario, providers and payers may need to create separate contracts with distributors to account for AWP-based reimbursement as opposed to the more common average sale price (ASP) reimbursement methodology governing other monoclonal antibody treatments.  Manufacturers would also need to consider the extent of patient and provider support services needed for COVID-19 monoclonal antibody treatment, given the distinct reimbursement and first-dollar coverage requirements under the vaccine benefit. Finally, the CMS would need to consider the federal budget implications of keeping COVID-19 monoclonal antibodies under the vaccine benefit.

Alternatively, the CMS could revise its policy and instead reimburse COVID-19 monoclonal antibodies under the Part B drug benefit like other monoclonal antibodies. Under this scenario, reimbursement for COVID-19 monoclonal antibodies would shift to the ASP methodology and patients would be subject to a 20% coinsurance if they lack supplemental insurance. As with other physician-administered products, providers would need to consider the cost implications of these payment shifts to their practices, and manufacturers would need to account for the potential impact of patient cost-sharing on access and utilization when dedicating patient support services.

Given the uncertainty of future COVID-19 monoclonal antibody coverage, manufacturers should plan for both potential coverage scenarios.

  • Manufacturers should consider the effects of these policy scenarios on patient access and patient out-of-pocket burden
  • In addition, given the difference in methodology of reimbursement rates under these scenarios, manufacturers should consider how differing reimbursements could affect sites of care and provider buy-bill dynamics

To learn more about how Avalere can support you in understanding coverage of monoclonal antibodies, connect with us.

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