Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

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DOJ Announces Recently Implemented Procedure for Reviewing False Claims Act Suits for Criminal Prosecution

During a speech at the annual Taxpayers Against Fraud Education Fund conference this week, Assistant Attorney General Leslie R. Caldwell announced that the U.S. Department of Justice’s (DOJ) Criminal Division “recently...more

9/22/2014 - Criminal Prosecution DOJ False Claims Act Qui Tam

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more

9/22/2014 - Co-payments Healthcare HHS Medicare Part D OIG Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

Is CMS Feeling the Sunshine Heat? – Part 2

As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...more

9/10/2014 - CMS Grants Medical Research Open Payments Pharmaceutical Physicians Sunshine Act

NIH Releases Final Guidance on Genomic Data Sharing

The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy). The GDS Policy applies to all NIH-funded research, regardless of the level of...more

9/5/2014 - DNA Genetic Materials Human Genes

Is CMS Feeling the Sunshine Heat?

As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more

9/2/2014 - CMS GPOs Healthcare Healthcare Reform Sunshine Act

CMS Reopens Open Payments System After Rejecting One-Third of Reported Payments

The Centers for Medicare & Medicaid Services (CMS) announced last week that the Open Payments system was available again after it was taken off-line on August 3, 2014 to “resolve a data integrity issue.” Because the Open...more

8/19/2014 - CMS Open Payments

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

7/16/2014 - Advertising Disclosure Requirements FDA Final Guidance Medical Devices Pharmaceutical Pharmaceutical Manufacturers Social Networks

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014. This is the process that allows physicians and teaching hospitals to review...more

7/15/2014 - CMS Hospitals Medical Devices Pharmaceutical Physicians Provider Payments Sunshine Act

CMS Announces Dates for Sunshine Payment Review, Dispute & Correction Process

The Centers for Medicare & Medicaid Services (CMS) announced today that the Open Payments review, dispute and correction process will begin on Monday, July 14, 2014 and continue through September 11, 2014. ...more

7/14/2014 - CMS Healthcare Medicaid Medicare Sunshine Act

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs...more

5/23/2014 - Anti-Kickback Statute Charitable Organizations Civil Monetary Penalty HHS Medicare Part D OIG Patient Assistance Programs Pharmaceutical Manufacturers

CMS Releases Open Payments Registration Information For Physicians And Teaching Hospitals; Phase 2 Timeline For Manufacturers And...

The Centers for Medicare & Medicaid Services (CMS) released today information regarding registration in the Open Payments system for physicians and teaching hospitals interested in reviewing and verifying data reported by...more

5/1/2014 - CMS GPOs Open Payments Pharmaceutical Physicians Teaching Hospitals

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