- Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion Claim April 8, 2021
- BARDA’s Mask Innovation Challenge – “I don’t pop in peach” April 6, 2021
- Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition April 2, 2021
- New Prescription Drug Price Transparency Law in Virginia April 1, 2021
- FDA Releases Examples of Real-World Evidence Used in Medical Device Decision Making March 31, 2021
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Texas Finalizes Repeal of Medicaid Price Reporting Requirement
May 12, 2016By Alan M. Kirschenbaum –
Last October we reported on a proposed regulation published by the Texas Health and Human Services Commission (HHSC) to repeal a burdensome price reporting requirement for drug manufacturers under Texas Medicaid. HHSC has now finalized the proposed rule without change. See Texas Register of May 6, 2016, at 3298-3300. As we noted in our post last October, the repeal relieves manufacturers of the requirement to calculate and submit updated prices to HHSC for drugs covered under Texas Medicaid, unless an update is requested for specific products by HHSC. Manufacturers that wish to obtain coverage for a new product under Texas Medicaid will continue to be required to submit a Certification of Information Form that includes prices to specified customer categories. The final rule goes into effect on May 15, 2016 (this Sunday).
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- Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion Claim April 8, 2021
- BARDA’s Mask Innovation Challenge – “I don’t pop in peach” April 6, 2021
- Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition April 2, 2021
- New Prescription Drug Price Transparency Law in Virginia April 1, 2021
- FDA Releases Examples of Real-World Evidence Used in Medical Device Decision Making March 31, 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