Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs
medicaid · Centers for Medicare and Medicaid Services · Rule · Published 2019-04-01 · Effective 2019-04-01 · 84 FR 12130
Document
Document number
2019-06274
Federal Register citation
84 FR 12130
CFR reference
42 CFR 447
Type
Rule
Action
Final rule and interim final rule with comment period.
Category
medicaid
Sub-agency
Centers for Medicare and Medicaid Services
Publication date
2019-04-01
Effective date
2019-04-01
HHS docket
CMS-2345-F2 and 2345-IFC2
Abstract
This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, we also are issuing a final rule which responds to comments on the definition and identification of line extension drugs for which we requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.