Centers for Medicare and Medicaid Services Announces Information Collection Renewals for Medicaid Drug Rebate Programs

On November 3, 2026, the Centers for Medicare and Medicaid Services (CMS), an operating division within the Department of Health and Human Services, published a notice in the Federal Register. The agency announced its intention to collect information from the public regarding specific administrative forms tied to the Medicaid Drug Rebate Program. The public comment period will remain open until January 4, 2027, giving stakeholders an opportunity to evaluate the regulatory burden and operational utility of the proposed actions.

Background and Statutory Framework

The Paperwork Reduction Act of 1995 requires federal agencies to publish notices in the Federal Register before submitting any proposed information collection request to the Office of Management and Budget for review and approval. This statutory mandate ensures that federal agencies minimize the paperwork burden on private entities, local governments, and the public while maximizing the practical utility of collected data. CMS is utilizing this 60-day notice window to invite feedback on burden estimates, collection necessity, and the use of automated technology.

Overview of Information Collections

The notice details two distinct information collection requests slated for extension. The first collection involves the Reconciliation of State Invoice and Prior Quarter Adjustment Statement, utilizing forms CMS-304 and CMS-304a. These forms are used by private sector manufacturers to respond to state rebate invoices for current quarter utilization and to submit necessary adjustments to original data. CMS estimates that 851 respondents account for a total of 5,788 annual responses, amounting to 262,192 annual burden hours.

The second collection covers the Medicaid Drug Rebate Program State Reporting Forms, utilizing forms CMS-368 and CMS-R-144. Form CMS-368 serves as a report of contact for states to identify personnel involved in the program, while form CMS-R-144 is submitted quarterly by states to report drug utilization data. This collection affects 56 state, local, or tribal governments, resulting in 234 total annual responses and 12,325 annual burden hours.

Implications for Stakeholders

For pharmaceutical manufacturers and state agencies, these information collections are critical administrative components of the broader Medicaid Drug Rebate Program. The accuracy of these filings directly affects financial reconciliations between state governments and drug manufacturers. Stakeholders including legal professionals, compliance officers, and policy analysts utilize the public comment period to address potential reporting inefficiencies or regulatory hurdles associated with compliance.

Conclusion and Next Steps

Comments on the proposed information collection extensions must be submitted electronically through regulations.gov or by mail to the CMS Office of Strategic Operations and Regulatory Affairs by January 4, 2027. Following the close of the public comment period, CMS will review the submissions before forwarding the final information collection packages to the Office of Management and Budget for formal approval.