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HHS/CMS | RIN: 0938-AU28 | Publication ID: Spring 2020 |
Title: ●Misclassification of Drugs Under the Medicaid Drug Rebate Program (CMS-2434) | |
Abstract:
This proposed rule would implement section 6 of the Medicaid Services Investment and Accountability Act of 2019, which clarifies the definitions for single source drug, innovator multiple source drug, and multiple source drug. It would propose additional penalty and compliance authorities with respect to manufacturers that have misclassified a drug product or misreported information about their drugs to the Medicaid Drug Rebate Program. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
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 |