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Final Medicaid Best Price Changes Encourage Value Based Purchasing but Discourage Copay Assistance
January 5, 2021By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui —In the New Year’s Eve edition of the Federal Register, CMS published a final rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. The variety of topics covered in this rule include:
- Best price changes and other and other measures to encourage value based arrangements in Medicaid
- New regulations to implement the alternative rebate for line extensions, including definitions of “new formulation” and “oral dosage form”
- A new, difficult hurdle for claiming the best price exceptions for manufacturer coupon and other patient savings programs
- Clarification of the average manufacturer price (AMP) and best price treatment of rebates to Medicaid Managed Care plans that are not pursuant to a CMS-approved supplemental rebate program.
- Implementation of statutory amendments to exclude sales of authorized generics from the brand AMP, redefine single source and innovator source drugs to remove references to “original NDAs”; and redefine multiple source drugs to include OTC drugs that are covered outpatient drugs.
Hyman, Phelps & McNamara, P.C. has prepared a memo summarizing this wide-ranging final rule (available here).
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- A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING Act May 25, 2022
- FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs May 25, 2022
- FDA Issues Flurry of Warning Letters Regarding Adulterated Dietary Supplements May 24, 2022
- HP&M’s Sara Koblitz to Present at DC Bar’s FDA for IP Lawyers Webinar May 23, 2022
- Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act May 19, 2022
- 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