Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is DI? 1.39K viewsFDA 0 Votes 1 Ans What is PI? 1.71K viewsFDA 0 Votes 1 Ans Who does the U.S. FDA UDI Rule apply to? 1.62K viewsFDA 0 Votes 1 Ans What is a labeler? 1.57K viewsFDA 0 Votes 1 Ans Section 50.6.4 states that Sponsors may conduct a risk assessment for auditing FDRs. Does this statement apply only when the sponsor has a large number of first tier entities and only audits high-risk first tiers? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans To the extent that Part D sponsors do not use either pharmacists or pharmacy technicians to conduct audits or monitoring activities involving Part D operations (i.e.., formulary administration, coverage determinations, appeals, and grievances, etc.), would this be a potential finding in the compliance area? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans The list in Chapters 9 and 21 provide examples of reports that Sponsors should receive, and seem to be focused on identifying fraud, waste, and abuse. Should the Sponsor receive similar reports from its FDRs as it relates to ongoing compliance with Medicare C/D operational functions (i.e., enrollments, organization/coverage determinations, appeals, grievances, call center compliance, etc.) that have been delegated to a first-tier or downstream entity? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What does the 10 year record retention include? As for the Compliance Program Guidelines, most of our FDRs believe this only pertains to FWA training. They are citing that for any audit conducted of them under 50.6.11, they would only have to retain FWA Training. Should they not be keeping general compliance training and disciplinary actions taken on non-compliance, as well as basically any documents pertaining to day-today operations of their organization? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans A Vision Vendor (first tier) for a Sponsor is required to conduct monthly OIG/GSA verifications on all their employees, temporary employees, volunteers, consultants, etc. However, are they required to carry the requirement forward to their contracted providers, i.e., XYZ’s Optical’s entire organization? Should the Vision Vendor conduct audits of their provider network to ensure the provider’s entire staff is being verified through OIG/GSA on a monthly basis? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans What is “CLIA”? 1.70K viewsClinical Research 0 Votes 1 Ans Why is CLIA important? 1.92K viewsClinical Research 0 Votes 1 Ans What is waived testing? 1.64K viewsClinical Research 0 Votes 1 Ans What does CLIA require of a COW laboratory? 1.66K viewsClinical Research 0 Votes 1 Ans How many laboratories hold a COW? 1.66K viewsClinical Research 0 Votes 1 Ans Why is CMS visiting COW laboratories on site? 1.89K viewsClinical Research 0 Votes 1 Ans What types of COW laboratories will CMS visit? 1.82K viewsClinical Research 0 Votes 1 Ans How many COW laboratories will CMS visit? 1.60K viewsClinical Research 0 Votes 1 Ans How do I register as a user for Clinical Establishments? 1.79K viewsClinical Research 0 Votes 1 Ans What happens if I forget my password of Clinical Establishments account? 1.83K viewsClinical Research 0 Votes 1 Ans What if I do not receive a registration confirmation email? 1.84K viewsClinical Research « Previous 1 2 … 215 216 217 218 219 … 283 284 Next » Question and answer is powered by anspress.net
