comparemela.com

Latest Breaking News On - Proposed arrangement - Page 15 : comparemela.com

FDA Draft Guidance Instructs Sponsors on Content and Timing of Diversity Plans for Clinical Trials | Troutman Pepper

For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved.

Drug administration safetyOffice of minority healthOffice of inspectorImprove enrollmentUnderrepresented racialEthnic populationsDraft guidanceClinical trialsAffordable care actMinority healthInnovation actAction planDemographic subgroup dataDraft guidance specifiesInvestigational new drugInvestigational device exemption

OIG AO 22-09 Highlights Potential Fraud for Hospital Compensation

OIG for the Department of HHS issued AO No. 22-09, which addresses a proposed arrangement pursuant to which the operator of a network of laboratories would compensate hospitals for certain specimen collection services related to testing performed by the Requestor

Human servicesOffice of inspectorDepartment of healthHealth diagnostics laboratoryUs department of justiceInspector generalAdvisory opinionProposed arrangementAnti kickback statuteSpecimen collectionSpecial fraud alertsSpecial fraud alertClinical laboratory servicesFalse claims actExecutive officerContract hospitals

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09 | Mintz - Health Care Viewpoints

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed.

Human servicesOffice of inspectorDepartment of healthHealth care viewpointsHealth diagnostics laboratoryUs department of justiceInspector generalAdvisory opinionProposed arrangementAnti kickback statuteSpecimen collectionSpecial fraud alertsSpecial fraud alertClinical laboratory servicesFalse claims actExecutive officer

OIG Declines to Impose Sanctions Against Device Manufacturer s Medicare Cost-Sharing Subsidy in Clinical Trial | King & Spalding

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing.

Advisory opinionProposed arrangementAnti kickback statuteCivil monetary penalties

OIG Issues Favorable Decision for Medical Device Manufacturers

Office of the Inspector General for the Department of Health and Human Services issued OIG Advisory Opinion, covering subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices

Department of healthHuman servicesOffice of the inspectorInspector generalProposed arrangementSocial security actBeneficiary inducementsCategoryb investigational device exemptionIg decision for medical device manufacturersDepartment of health and human servicesFfice of the inspector general hhsIg favorable decision for medical device manufacturers

vimarsana © 2020. All Rights Reserved.