{"id":29231,"date":"2023-05-26T10:58:58","date_gmt":"2023-05-26T14:58:58","guid":{"rendered":"https:\/\/avalere.com\/?p=29231"},"modified":"2024-05-09T11:02:35","modified_gmt":"2024-05-09T15:02:35","slug":"mdrp-proposal-will-impact-vaccine-and-novel-immunization-landscape","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/mdrp-proposal-will-impact-vaccine-and-novel-immunization-landscape","title":{"rendered":"MDRP Proposal Will Impact Vaccine and Novel Immunization Landscape"},"content":{"rendered":"

Background<\/strong><\/h2>\n

To date, no statutory or regulatory definition of \u201cvaccine\u201d exists for the purposes of the Medicaid Drug Rebate Program (MDRP), creating uncertainty about product classification. Under the MDRP, manufacturers enter agreements with the Centers for Medicare and Medicaid Services (CMS) to provide mandatory rebates in exchange for product Medicaid coverage. Only products that meet the definition of a covered outpatient drug (COD), as defined in Section 1927(k)(2) of the Social Security Act, participate in the MRDP. Vaccines are explicitly excluded from the COD definition and are therefore excluded from the MDRP. As a result, states historically have not been required to cover vaccines for all Medicaid populations, though Medicaid-eligible children can access vaccines free of cost through the Vaccines for Children (VFC) program. For adults, the Inflation Reduction Act requires<\/a> state Medicaid programs to cover adult vaccines without cost-sharing starting in October 2023. These pathways are intended to provide patient coverage without cost-sharing for all recommended vaccines. However, it is currently unclear to what extent these requirements apply to therapeutic vaccines, such as those used to treat cancer and infectious diseases, and novel, passive immunizations, which deliver antibodies created outside of an individual’s body to stimulate a disease-specific immune response.<\/p>\n

Proposed Rule Would Define \u201cVaccine\u201d for Purposes of the MDRP<\/h2>\n

On May 26, CMS issued a proposed rule<\/a> to address drug classification and implement a variety of other programmatic updates in the MDRP. In the rule, CMS proposes defining \u201cvaccine\u201d for the purposes of the MDRP as \u201ca product that is administered prophylactically to induce active, antigen-specific immunity for the prevention of one or more specific infectious diseases and is included in a current or previous [Food and Drug Administration] FDA-published list of vaccines licensed for use in the United States.\u201d<\/p>\n

As vaccines are explicitly excluded from the MDRP, any product that does not fall under the finalized definition of a vaccine would be included in the MDRP. CMS\u2019s proposed definition excludes products that provide passive immunization, such as preventive immunoglobulins, as well as therapeutic immunizations (e.g., cancer vaccines). If this definition is finalized as proposed, it would have significant market implications for these novel products, including those currently on the market and the growing pipeline of products anticipated to launch in coming years.<\/p>\n

Key Questions About the MDRP Rule and Vaccines<\/h2>\n

CMS requests comment on the proposed definition, soliciting feedback on whether it appropriately distinguishes between preventive and therapeutic vaccines as well as potential indirect consequences. Comments are due by July 25.<\/p>\n

As stakeholders assess the impact of the proposed rule and develop a comment strategy, it will be important to consider key questions related to:<\/p>\n