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HHS/CMS | RIN: 0938-AU28 | Publication ID: Spring 2021 |
Title: Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration (CMS 2434) | |
Abstract:
This proposed rule would implement section 6 of the Medicaid Services Investment and Accountability Act of 2019, which created new penalties related to manufacturers’ misclassification of covered outpatient drug products under the Medicaid Drug Rebate Program (MDRP) including civil monetary penalties, suspension of a manufacturer’s drug, and the ability of states to recover unpaid rebates. In addition, it proposes beneficiary protections relating to access to drugs under value-based purchasing programs, as well as MDRP program integrity and administration changes. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: Pub. L. 116–16, sec. 6 42 U.S.C. 1396r-8 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Federal, State |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Cynthia Denemark Deputy Director, Division of Pharmacy Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone:410 786-8764 Email: cynthia.denemark@cms.hhs.gov |