Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

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Blog: Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the...more

4/24/2015 - Anti-Kickback Statute Clinical Laboratories Enforcement Actions Fraud Alerts OIG Physicians Strategic Enforcement Plan

Blog: OIG Releases New Guidance for Board Oversight of Corporate Compliance Programs

Yesterday, the U.S. Department of Health and Human Services Office of Inspector General (OIG), in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the...more

4/21/2015 - Chief Compliance Officers Health Care Providers Healthcare HHS Human Resources Professionals New Guidance OIG

Blog: West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP)....more

3/31/2015 - Drug Manufacturers Labeling Repeal Reporting Requirements

Blog: On a Roll . . . Vermont Attorney General Posts Two More Enforcement Actions for Gift Ban & Disclosure Law

The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company....more

3/11/2015 - Attorney Generals Conditional Gifts Disclosure Requirements Enforcement Actions Health Care Providers Manufacturers Medical Devices

Blog: CMS Issues Additional Sunshine FAQs

The Centers for Medicare & Medicaid Services (CMS) released this week 5 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing...more

3/11/2015 - CMS GPOs Hospitals Open Payments Physicians Sunshine Act

Blog: Vermont AG Posts Second Enforcement Action of 2015 Related to State Disclosure Law

Last week, the Vermont Attorney General (VT AG) posted its second enforcement action of 2015, this time against a dental products manufacturer. ...more

3/3/2015 - Corporate Gifts Enforcement Actions Manufacturers Reporting Requirements

Blog: FDA Releases Draft Guidance for Reporting Adverse Events Related to HCT/Ps

The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under...more

2/23/2015 - Draft Guidance FDA Healthcare Reporting Requirements

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

2/17/2015 - Enforcement Actions Healthcare Manufacturers Medical Devices Pharmaceutical Pharmaceutical Manufacturers Reporting Requirements

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

2/17/2015 - DOJ Enforcement Actions FDA Funding NIH Pharmaceutical Pharmaceutical Manufacturers Proposed Legislation Settlement Agreements

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

1/13/2015 - Manufacturers Medical Devices Medical Supplies Nurses Pharmaceutical Pharmaceutical Manufacturers Provider Payments Reporting Requirements

Blog: CMS Releases New Video Tutorial for 2014 Sunshine Reporting; Q&A Session Next Week

The Centers for Medicare and Medicaid Services (CMS) released today a 20 minute on-demand video tutorial related to the 2014 Open Payments reporting program. The video provides an overview of the registration, reporting and...more

1/12/2015 - CMS Open Payments Sunshine Act Video Recordings

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

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