Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

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Blog: DOJ’s Record Year for FCA Recoveries Includes $2.3 Billion for Health Care Fraud

The Department of Justice (DOJ) announced this week that it recovered a record $5.69 billion in civil False Claims Act (FCA) settlements during fiscal year 2014. This recovery included $2.3 billion for FCA cases involving...more

11/24/2014 - DOJ Enforcement Actions False Claims Act Johnson & Johnson Medicaid Medicare Omnicare TRICARE

Blog: CMS Explains New Data Matching and Resubmission Process During Open Payments Webinar Today

The Centers for Medicare and Medicaid Services (CMS) held a webinar today to address the process for correcting and resubmitting records that were removed from the Open Payments system in August 2014 by CMS due to data...more

11/14/2014 - CMS Health Care Providers Hospitals Open Payments Physicians Webinar

Blog: CMS Exempts CME and Makes Other Sunshine Reporting Changes

Late last week, the Centers for Medicare and Medicaid Services (CMS) issued the 2015 physician payment fee schedule, which includes changes to the Final Rule implementing the federal Sunshine law. ...more

11/5/2014 - CMS Continuing Medical Education Exemptions Physician Fee Schedule Physicians Reporting Requirements Sunshine Act

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

10/27/2014 - DOJ False Claims Act FDA Generic Drugs Government Investigations Kickbacks Medicaid Medtronic Nursing Homes Pharmaceutical Pharmacies Qui Tam Rebates Whistleblowers

Blog: CMS Launches New Search Tool for Open Payments Database; Announces Disputed Payments Reporting Deadline

As we discussed here, the launch of the Centers for Medicare and Medicaid Services (CMS) Open Payments database on September 30, 2014 was met with a high level of criticism from industry, health care professionals, the media...more

10/22/2014 - CMS Databases GPOs Health Care Providers Open Payments

Blog: Sunshine Act Media Coverage and CMS’s Response Today

The Open Payments database has been live for a week now. There has been media coverage, but most has not been the type that many expected. The coverage to date has largely centered on the significant challenges associated...more

10/7/2014 - CMS Health Care Providers Hospitals Media Open Payments Physicians Sunshine Act

Blog: OIG Releases Proposed Rule re: Beneficiary Inducements and Gainsharing Revisions

The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and...more

10/3/2014 - Anti-Kickback Statute CMS Fraud and Abuse Gainsharing HHS Medicare OIG Proposed Regulation Safe Harbors

Blog: CMS Releases First Year Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) promised the government, industry and the public that it would release the first round of data in connection with the Physician Payment Sunshine Act by September 30, 2014,...more

10/1/2014 - CMS Information Reports PPSA

Is CMS Feeling the Sunshine Heat? – Part 3

As we discussed in Part 1 and Part 2 of this ongoing story, the Centers for Medicare & Medicaid Services (CMS) has received significant criticism related to issues with the Open Payments database and its plans to release the...more

9/24/2014 - CMS Healthcare Open Payments Sunshine Act Transparency

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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