{"id":33351,"date":"2024-10-17T14:16:50","date_gmt":"2024-10-17T18:16:50","guid":{"rendered":"https:\/\/avalere.com\/?p=33351"},"modified":"2024-10-17T14:16:50","modified_gmt":"2024-10-17T18:16:50","slug":"stakeholders-can-engage-usp-during-dc-2025-comment-period","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/stakeholders-can-engage-usp-during-dc-2025-comment-period","title":{"rendered":"Stakeholders Can Engage USP During DC 2025 Comment Period"},"content":{"rendered":"

The US Pharmacopeia Convention (USP)<\/a> is a nonprofit organization that disseminates public compendial quality standards for medicines and develops two drug classification systems: the Medicare Model Guidelines (MMG) for Part D plans and the Drug Classification (DC) for non-Part D plans. The classification systems group eligible drugs into categories and classes that health plans can use in their formulary development process. While there are limited formal requirements regarding how health plans interact with the USP\u2019s classification systems, the USP\u2019s decisions on how drugs are grouped within categories and classes can have a downstream impact on plan formularies, coverage requirements, and patient access.<\/p>\n

The USP Releases Two Classification Sets to Guide Formulary Development<\/h2>\n

The Medicare Prescription Drug Improvement and Modernization Act of 2003 requires the USP, in collaboration with stakeholders, to create a list of categories and classes for Medicare Part D drug formulary development. The Medicare Prescription Drug Benefit Manual<\/a> enables Part D plans to align their formulary structure with the Medicare Managed Care Manual (MMG), without penalties for non-compliance. Part D plans must adhere to specific coverage requirements, however, such as the “two drugs per class” rule and six protected classes,\u00b9 making USP\u2019s organization of drugs in the MMG crucial for patient access.<\/p>\n

The USP updates the MMG every three years, with the latest version (v9.0) finalized in September 2023 for plan years 2025\u20132026. Additionally, the USP MMG influences prescription drug coverage in commercial plans by ensuring that health plans cover either the same number of drugs in each USP category as specified in a state\u2019s Essential Health Benefits (EHB) benchmark plan or at least one drug per class.<\/p>\n

At the request of health plans with other books of business (i.e., non-Medicare Part D plans), the USP launched the first version of the DC in 2019. The DC includes medications beyond those specifically covered under the Medicare Part D benefit\u2014such as drugs used to treat symptomatic relief of cough and cold and to promote fertility\u2014and is more comprehensive than the MMG.\u00b2 Unlike the three-year update cycle of the MMG, the DC is updated annually, which offers stakeholders more opportunities to engage the USP.<\/p>\n

The USP DC 2025 Draft<\/h2>\n

On October 1, the USP released the DC 2025 Draft<\/a>. The draft includes the USP\u2019s suggested classification for drugs approved by the Food and Drug Administration (FDA) from November 2023 to July 2024. The USP will also consider drugs approved between August and October 2024 for the final publication. One clear differentiation from MMG is that DC offers a third level of classification known as pharmacotherapeutic groups (PGs), which the USP defines as an attribute of a drug, providing additional informational groupings on drugs based on therapeutic use or pharmacology. \u200b<\/p>\n

Pending public comment and final approval, the USP DC 2025 Draft proposes the following changes. Drugs approved after October 31 will be addressed in the next version.<\/p>\n

New Classes:<\/p>\n