- Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes January 22, 2021
- FDA Continues Discussion of AI/ML Software Medical Devices January 21, 2021
- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- 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
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Updated Version of HP&M Fraud and Abuse Outline Covers Devices as Well as Drugs
January 5, 2014By Alan M. Kirschenbaum –
Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to cover devices as well as drugs. It provides an overview of the Federal health care program antikickback law, the Federal False Claims Act, and other federal and state fraud and abuse laws and related laws, identifying noteworthy cases and OIG precedents that interpret these laws. The outline also discusses the major enforcement risk areas for which drug and device companies have been targeted in recent years, including the offer of free goods and services, bundled discounts, consulting fees, grants, post-marketing studies, inflation of reported prices, off-label promotion, and other areas, citing relevant OIG guidance and examples of enforcement actions and settlements in each area.
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- Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes January 22, 2021
- FDA Continues Discussion of AI/ML Software Medical Devices January 21, 2021
- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- 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
- 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