Corporate Compliance & Health Care Fraud Investigations Materials
- 20 Key Considerations for Implementing an Effective Corporate Compliance Program
- Key Considerations for Government Health Care Fraud Investigations
- Cooley’s Health Care Fraud Investigation Experience
Federal Agencies
Industry Organizations / Industry Codes
- ACCME
- AdvaMed
- American Hospital Association
- American Medical Association
- BIO
- Healthcare Group Purchasing Industry Initiative
- NAMFCU
- National Governors Association
- PhRMA
Drug & Device Development
- Clinical Investigator Inspection List
- Clinicaltrials.gov
- DailyMed
- Orange Book
- FDA Medical Device Databases
- Orphan Drug Database
- PubMed
Fraud & Abuse
- FHCP Anti-Kickback Statute (42 USC 1320a-7b (prelim))
- FHCP Civil Monetary Penalties Statute (42 USC 1320a-7a (prelim))
- OIG Advisory Opinions
- OIG Compliance Program Guidance For Pharmaceutical Manufacturers
- OIG Safe Harbor Regulations
- Federal Civil False Claims Act (31 USC 3729 et seq. (prelim))
- Federal Sentencing Guidelines
Health Privacy/HIPAA
- OCR HIPAA
- OCR HIPAA FAQs
- OCR Sample Business Associate Agreement Provisions
- FTC Breach Notification Rule
- Cloud Computing in Healthcare: HIPAA and State Law Challenges
Health Reform
- CMS Innovation Center
- Healthcare.gov Marketplace Information
- Kaiser Family Foundation Health Reform
- NCSL Consolidated PPACA/HCERA
- Health Exchanges: Passing the Torch to the Next Phase of Implementation
Drug/Device/Biological Marketing, Transparency & Price Reporting Laws
Federal Sunshine Transparency Law
State Marketing & Transparency Laws
- California
- Connecticut
- DC Detailers Licensure
- DC Marketing Disclosure
- Florida Complimentary Drug Distributors
- Massachusetts
- Minnesota
- Nevada
- Vermont
State Price Reporting Laws
Medicare Part D
- CMS Part D General Information
- CMS Prescription Drug Contracting
- CSSC Operations – PDE reporting
- Coverage Gap Discount Program (CMS site)
- Coverage Gap Discount Program (TPA site)
Prescription Drug Marketing
- FDA Office of Prescription Drug Promotion
- FDA Guidance Documents (Drugs)
- Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Prescription Drug Government Pricing
Medicaid AMP-BP
- Medicaid Drug Rebate Statute (42 USC 1396r-8 (prelim))
- Medicaid Drug Rebate and FUL Regulations
- CMS Drug Rebate Program
- Feb 2012 proposed AMP BP rule
Average Sales Price
340B Drug Discount Program
- 340B Statute (42 U.S.C. 256b (prelim)
- HRSA Office of Pharmacy Affairs
- Covered Entity Database
- 340B Fed. Reg. Notices
- Alternative Methods Demonstration Projects
- 340B Prime Vendor (Apexus)
FSS-VA
