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Reportlinker Adds Molecular Diagnostics in Infectious Disease Testing
Date:3/31/2011

ursement Practice 267

6.2.1 Medicare Reimbursement Threats 269

6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease

Using Current Medicare Reimbursement Rules 271

6.3 Trends in Patient Care and Reimbursement 272

6.4 Revenue threats 273

6.4.1 Medicare Payment Exceptions 274

6.4.2 Three Areas for Denial of Claims 275

6.5 Billing Rules 275

6.5.1 Medicare Billing Procedures 276

6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 276

6.5.3 Infectious Disease Billing Strategies 277

7. Regulatory Requirements 279

7.1 U.S. Food and Drug Administration 279

7.2 CLIA Regulations 279

7.3 Clinical Laboratory Improvement Act (CLIA) 281

7.4 State Licensing for Service Laboratories 282

7.5 IVDMIAs 282

7.6 510(k) Clearance 283

7.7 Pre-Market Approval (PMA) 284

7.7.1 Premarket Approval Application 284

7.8 Analyte Specific Reagents (ASRs) 285

7.8.1 Laboratory Developed Tests 286

7.9 What Regulatory Guidance Is Needed for Companion Biomarkers? 287

7.10 U.S. Patent and Trademark Office (USPTO) 288

7.11 IRB Approval in Clinical Trials 288

7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive) 288

7.13 De Novo Classification 289

7.14 Research Use Only Reagents 289

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease

Testing 291

8.1 What are Key Opportunities in Infectious Disease Testing Development and

Commercialization 291

8.2 What are the Current Obstacles for MD Infectious Disease Testing

Implementation? 291

8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD

Strategies? 291

8.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition

Strategies and their Implications for Deal Making? 292'/>"/>

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