Clinical Research Reimbursement: What You Need to Know to ...
Clinical Research Reimbursement: What You Need to Know to Plan and Execute Trials Without Creating Legal Issues
Amy B. Judge-Prein, Counsel
+1 317 569 4830 amy.judge-prein@
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Laws and Regulations
Regulatory, But Not General Legal Considerations CMS Clinical Trial Policy PPACA PPACA vs. CMS Subject Injury Enforcement Conclusions
2
Regulatory, But Not
Overlap of FDA, CMS, PPACA, State Laws, etc. Clinical trials are just small piece of bigger picture of reimbursement,
Medicare, insurance, etc.
3
General Legal Considerations
False Claims Act Anti-Kickback Statue Inducements Indigent Care
4
Healthcare Billing
Pressures on all involved in clinical research
All want to do the right thing Rules are complex and ever-changing Increasing numbers of clinical trial subjects
are government healthcare beneficiaries Enforcement and oversight of research institutions and billing practices
are increasing So.... CMS is watching closely (NCT#)
Investigator
Institution
Research Sponsor
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