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Below is a list of compliance resources all of us routinely use. The initial version of this guide was previewed at the PCF meeting in March 2010, and has been revised and expanded based upon your input and suggestions.
The resource guide will be an ongoing project, and your additional suggestions concerning other resources that should be included are welcomed.
Please feel free to contact me at the email address below or contact the PCF office at info@pharmacomplianceforum.org.
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP
keith.korenchuk@aporter.com
I. Federal Statutes
- Civil Monetary Penalties
- False Claims Act, 31 USC §§3729
- Federal Anti-Kickback Law
- Federal Food, Drug, and Cosmetic Act, Section 352
- Federal Food, Drug, and Cosmetic Act, Section 355
- Federal Public Contract Anti-Kickback Act
- Health Care Fraud Statute
- Lanham Act
- Mandatory and Permissive Exclusion, 42 USC 1320a-7
- Medicaid Rebate Program Statute, 42 USC 1396r-8
- Public Health Services Act, § 340B (42 USC 256b)
- Social Security Act, §1847A (42 USC 1395)
- Stark Law
- Veterans Health Care Act of 1992
II. Federal Regulations/Guidance
- Anti-Kickback Regulatory Safe Harbors, 42 C.F.R. §1001.952
- ASP Data Elements Guide
- CMS Update to Information on Medicare Coding and Payment for Drugs and Biologicals
- CMS; DRA Policy Questions
- Complete Federal Sentencing Guidelines
- Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23,731 (May 5, 2003)
- DRA Final Rule: 42 CFR Part 447 (39142-39190)
- DRA Policy Questions
- DRA: P.L. 109-171
- FDA Guidance (1997) on Medical Education
- FDA Guidance on DTC Broadcast Advertisement
- FDA Guidance on Off-label Drug Promotion
- Federal Sentencing Guidelines 8B2.1, definition of an "effective [corporate] compliance program" (2007)
- General Instructions for Completing the Pharmaceutical Pricing Agreement
- Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, 73 Fed. Reg. 9342
- Guidelines for Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074
- Holder, Thompson, and McNulty Memos:
- HRSA's Patient and Contract Pharmacy Guidance Letter
- Medicaid Rebate Agreements:
- OIG and Health Lawyers Association: An Integrated Approach to Corporate Compliance (July 2004)
- OIG and Health Lawyers Association: Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors (2007)
- OIG Compliance Guidance for the Pharmaceutical Industry
- OIG Fact-Sheet: Federal Anti-Kickback Law and Regulatory Safe Harbors (November 1999)
- OIG Response to Request for Guidance Regarding Certain Physician Investments in the Medical Device Industries (October 2006)
- Part B FAQs:
- Principles of Federal Prosecution of Business Organizations (August 2008)
- Sample Rebate Agreement between the Secretary of HHS and Manufacturer
- Submission of Manufacturer's Average Sales Price Data, 42 CFR Part 414 Sub-part J
III. Settlements/Corporate Integrity Agreements
- Advanced Neuromodulation Systems, Inc. Corporate Integrity Agreement (2007)
- Aventis, Inc. Corporate Integrity Agreement (2007)
- Bayer Corporate Integrity Agreement (2008)
- Biomet, Inc. Corporate Integrity Agreement (2007)
- Biovail Corporation Corporate Integrity Agreement (2009)
- Boston Scientific Corporation Corporate Integrity Agreement (2009)
- Bristol-Myers Squibb Corporate Integrity Agreement (2007)
- Cell Therapeutics, Inc. Corporate Integrity Agreement (2007)
- Cephalon Corporate Integrity Agreement (2008)
- CVS Caremark Corporation Corporate Integrity Agreement (2007)
- DePuy Orthopaedics, Inc. Corporate Integrity Agreement (2007)
- Eli Lilly and Company Corporate Integrity Agreement (2009)
- InterMune Corporate Integrity Agreement (2006)
- Ivax Corporation Corporate Integrity Agreement (2009)
- Jazz Pharmaceuticals Corporate Integrity Agreement (2007)
- King Pharmaceuticals Corporate Integrity Agreement (2005)
- Lawall Prosthetics-Orthotics, Inc. Corporate Integrity Agreement (2005)
- Medicis Pharmaceutical Corporation (2007)
- Medtronic Spine (Kyphon) Corporate Integrity Agreement (2005)
- Medtronic Sofamor Danek USA, Inc. Corporate Integrity Agreement (2009)
- Merck Corporate Integrity Agreement (2008)
- Nationwide Medical Incorporated Corporate Integrity Agreement (2009)
- Neurometrix, Inc. Corporate Integrity Agreement (2009)
- Novartis Corporate Integrity Agreement (2005)
- Otsuka America Pharmaceuticals, Inc. Corporate Integrity Agreement (2008)
- Pfizer, Inc. Corporate Integrity Agreement (2009)
- Purdue Corporate Integrity Agreement (2007)
- Quest Diagnostics Incorporated Corporate Integrity Agreement (2009)
- Smith and Nephew, Inc. Corporate Integrity Agreement (2007)
- Spectranetics Corporation Corporate Integrity Agreement (2009)
- Walgreen Co. Corporate Integrity Agreement (2008)
- Zimmer, Inc. Corporate Integrity Agreement (2007)
IV. Industry Standards
V. Contracts
VI. State Marketing and Reporting Requirements
- California
- Maine
- Massachusetts
- Minnesota
- Nevada
- New Hampshire
- Vermont
- Washington, DC
- West Virginia
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