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Final Medicaid Rebate Regulation Clears OMB, Bound for Publication
December 14, 2015By Alan M. Kirschenbaum –
If you’re looking for Holiday reading, CMS has a gift for you!
OMB’s Office of Information Regulatory Affairs (OIRA) has completed its review of a long-awaited CMS final regulation implementing significant changes to the Medicaid Drug Rebate Program. Completion of the review was announced on OIRA’s website here. It typically takes a lengthy regulation from several days to two weeks after OMB release before it is posted for pre-publication review.
We’ll be posting a notice in the FDA Law Blog when the rule is released, and following its release, we’ll be preparing a memo to summarize it. We’ll also be conducting a webinar on the rule in collaboration with KPMG’s government pricing group. The date and other details will be announced on this blog in the near future.
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- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the Table January 11, 2021
- When Will the Emergency End? January 11, 2021
- The Long and Winding Road: DEA Issues Final Marijuana Registration Rule January 8, 2021
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized