USP’s objective standards-setting process, longstanding experience in convening experts and stakeholders, and ability to leverage its work on other classification systems uniquely enables USP to lead this effort. This experience and commitment to existing formulary work intuitively aligns with USP’s mission to improve lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines.
Stakeholder feedback indicated that the USP Medicare Model Guidelines (MMG) was being used beyond its intended use. The USP MMG was created specifically for Medicare Part D. Feedback highlighted the need to provide solutions to include prescriptions legally marketed beyond those specifically covered under the Medicare Part D benefit.
Stakeholders identified the following needs for a comprehensive classification system that:
- Includes commercially available prescription drugs
- Extends use beyond Medicare Part D
- Tailors to specific stakeholder uses
- Updates more frequently, at least yearly
- Cross-references other systems
- Makes use of new technologies
USP has received feedback throughout the past 10 years. Examples include:
Public Comment on Medicare Model Guidelines (MMG) v6.0 (2013)
- Participants included patient advocacy groups, manufacturers, and health plans.
- Stakeholder requested categorization of drugs related to obesity and infertility.
- However, comments were out of scope for MMG revision1
USP Stakeholder Meeting (2014)
- Attendees included health plans, PBMs, MedPAC, and health policy analysts.
- Stakeholder feedback identified short- and long-term opportunities.
Stakeholder Interviews (2015)
- Interviews were conducted with health plans, PBMs, drug information knowledge vendors, and pharmacy consultants.
- Stakeholders identified additional features and technology needs.
The chart below details the differences. Highlights of the major differences include:
- Independent USP/stakeholder model
- Revised annually
- Expanded drug placement beyond Medicare Part D eligible drugs in USP Categories and Classes
- Involvement of all stakeholders in public comment period beyond Medicare Part D
- Flexibility for additional features in the system (beyond USP Categories and Classes)
Proposed USP Drug Classification System Compared to USP MMG
| USP Medicare Model Guidelines(USP MMG) | USP Drug Classification System (USP DC) | |
|---|---|---|
| Developed through USP Volunteers, Stakeholder Engagement, and Public Comment Processes |
√ |
√ |
|
Utilizes USP Guiding Principles for establishing Categories and Classes
|
√ | √ |
|
Contains USP Categories and Classes
|
√ | √ |
| Provides Drug Examples | Part D eligible drugs only | Common US outpatient drugs |
|
Implementation Tools: Mapping to RxNorm
|
CMS FRF- MMG Alignment File (triannual) | USP DC- RxNorm Alignment File (annual) |
| Supports Medicare Part D requirements | √ | N/A |
| Stakeholder Focus in Public Comment | Medicare Stakeholders | All Stakeholders |
| Revision Cycle | Tri-annual* | Annual |
| Publication Version | USP MMG v7.0 | Proposed first edition: USP DC 2017 |
| Publication Date | February 1, 2017 | February 1, 2017 |
*Upon request of CMS
The new USP Categories are created to encompass drugs that are included in commercial formularies beyond Medicare Part D. The new Categories created are Anti-obesity Agents, Infertility Agents, and Sexual Disorder Agents. The intended approach to creating new Categories or Classes is that they are broad enough to encompass future mechanism of actions and mindful of therapeutic options.