Clinical laboratories are subject to a number of federal regulations pertaining to laboratory quality, oversight and safety requirements.  Laboratories must comply with these standards to be eligible for Medicare and Medicaid reimbursement. AACC regularly monitors and reports on these issues, while working closely with the appropriate regulatory bodies to ensure that the views of professional laboratory scientists are taken into consideration when important decisions are made.  Below are a number of ongoing regulatory issues monitored by the Association.

• SACGHS Releases Pharmacogenomics Report (May 2008)
• FDA Releases Guidance Outlining CLIA Categorization Process  (May 2008)
• SACGHS Releases Final Genetic Testing Recommendations  (April 2008)
• FDA Issues New Policy on Distribution of Off-Label Use Information (February 2008)
• Final CLIA Waiver Guidance (January 2008)
• Final Competitive Bidding Demonstration Bidders Package
• SACGHS Releases Draft Genetics Oversight Document (November 2007)
• Final Physician Fee Schedule Rule
• FDA Revised ASR Frequently Asked Questions Guidance (September 2007)
• FDA Guidance on Pharmacogenomic Data Submissions
• CMS Final Rule on Hospital DRG System Changes (August 2007)
• FDA Revised IVDMIA Guidance (July 2007)
• CMS Draft Competitive Bidding 'Bidders Package' (July 2007)
• OMB Notice on Withdrawal of Excessive Charge Proposed Rule (June 2007)
• CMS Notice Seeking Payment Recommendations for 2008 CPT Codes (June 2007)
• FDA Guidance on Pharmacogenomic and Genetic Tests
• FDA Guidance on QC Material (June 2007)
• OBM Request for Comments on Revised ABN (May 2007)
• New Proposed Hospital DRG System (April 2007)
• New Draft Advanced Beneficiary Notice (February 2007)
• FDA Public Forum on IVDMIAs (February 2007)
• FDA IVDMIA Draft Guidance (September 2006)
• FDA ASR Frequently Asked Questions (September 2006)
• CMS 2007 CPT Payment Recommendations (September 2006)
• FDA Draft Guidance for Informed Consent Exceptions for Emergencyy Research (August 2006)
• CMS Safer Harbor Exception for Health IT (August 2006)
• SACGHS Document on Coverage and Reimbursement of Genetic Tests and Services (February 2006) 
• FDA Excess Specimen/Informed Consent Guidance (April 2006)
• FDA Guidance on Pharmacogenomic Tests and Genetic Tests for Heritable Markers (February 2006)
• CDC Good Lab Practices Document for Waiver Labs (November 2005)
• FDA Guidance on CLIA Waiver Criteria(September 2005)
• NIH Final Ethics Rules (August 2005)
• FDA Draft Drug-Diagnostic Co-Development Concept Paper (April 2005)
• FDA Guidance on Pharmacogenomic Data Submissions (March 2005) 
• NIH Public Access Policy