Extending Medicare Reimbursement in Clinical Trials (2000) / Chapter Skim
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67 APPENDIX A Glossary, Acronyms, and Abbreviations GLOSSARY blinding (synonym: masking) Keeping secret group assignment (e.g., to treatment or control)
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS68 the basis for inpatient payment under the Medicare prospective payment system (PPS)
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APPENDIX A 69 permitting evaluation of the drug in human beings in specified studies under specified conditions. In some cases, INDs may also be needed to allow study of already-approved drugs for new ("unlabelled")
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS70 phase 3 trial Compares intervention with the current standard or placebo to assess dosage effects, effectiveness, and safety. Almost always uses random allocation to assign treatment.
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APPENDIX A 71 ASCO American Society of Clinical Oncology CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CMP competitive medical plan CT computerized tomography DHHS Department of Health and Human Services DoD Department of Defense DRG diagnosis-related group FDA Food and Drug Administration GAO General Accounting Office GCRC General Clinical Research Center GHC Group Health Cooperative of Puget Sound HCFA Health Care Financing Administration HCPP health care prepayment plan HHA Home Health Agency HMO health maintenance organization IDE Investigational Device Exemption IND Investigational New Drug Exemption IOM Institute of Medicine IRB institutional review board KPNC Kaiser Permanente of Northern California LVRS lung volume reduction surgery MRA magnetic resonance angiography NCI National Cancer Institute NHLBI National Heart, Lung and Blood Institute NIDDK National Institute of Diabetes and Digestive and Kidney Diseases NIH National Institutes of Health NLM National Library of Medicine OIG Office of the Inspector General ONDS optic nerve decompression surgery OPRR Office of Protection from Research Risks PDQ Physician Data Query PET positron-emission tomography PI principal investigator
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS72 PPS prospective payment system PRO Peer Review Organization ProPAC Prospective Payment Assessment Commission PTCA percutaneous transluminal coronary angioplasty SNF skilled nursing facility SPN solitary pulmonary nodule VA Department of Veterans Affairs
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