Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

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Blog: OIG Reports Targeting Medicare Part D Fraud Issued on the Heels of National Medicare Fraud Sweep

The Health and Human Services (HHS) Office of Inspector General (OIG) released two reports yesterday related to Medicare Part D fraud. The OIG report, Ensuring the Integrity of Medicare Part D, “synthesizes numerous OIG...more

6/25/2015 - Fraud Healthcare Healthcare Fraud HHS Medicare Medicare Part D OIG

Blog: FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

6/22/2015 - Biologics FDA Healthcare Pharmaceutical Pharmaceutical Manufacturers Pharmacist Physicians Prescription Drugs REMS Websites

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

6/14/2015 - Algorithms Device Manufacturers Draft Guidance FDA General Wellness Products Medical Devices Mobile Apps

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

6/13/2015 - Amarin Clinical Trials FDA First Amendment Off-Label Promotion Pharmaceutical SNDAs

Blog: Key Takeaways from Government Enforcement Panel at ACI Sunshine Conference

Recently, representatives from the United States Attorney’s Office for the Northern District of Georgia, United States Attorney’s Office for the District of New Jersey, and Medicaid Fraud Control Unit (MFCU) for the Office of...more

6/11/2015 - Attorney Generals Chief Compliance Officers Data Mining Enforcement Fraud Government Investigations Health Care Providers Healthcare Healthcare Fraud Medicaid Open Payments Professional Conferences Qui Tam Sunshine Act

Blog: OIG Issues Fraud Alert re: Physician Compensation Arrangements

The U.S. Health and Human Services Office of Inspector General (OIG) released a Fraud Alert today titled Physician Compensation Arrangements May Result in Significant Liability. The OIG directs health care professionals...more

6/10/2015 - Fraud Fraud and Abuse HHS Medicaid Medicare OIG Physician Compensation Arrangements Physicians

Blog: OIG Releases Updated Mid-Year Work Plan: Open Payments, Clinical Laboratory Payments & Opioid Billing Trends Added to Agenda

The Health and Human Services Office of Inspector General (OIG) released last week an updated mid-year Work Plan for FY2015, which removes items that have been completed, postponed, or canceled and includes new items that...more

6/2/2015 - CMS Healthcare Medicare Medicare Part D OIG Work Plans

Blog: Expansion of State False Claims Acts Continues

On May 19, 2015, Vermont’s governor signed into law a state false claims act that largely mirrors the federal False Claims Act, including the ability of a qui tam relator to bring an action on behalf of the state. Vermont...more

6/2/2015 - DOJ False Claims Act Healthcare Healthcare Fraud New Legislation Qui Tam

Blog: Senator Grassley Requests Information Related to Potential Medicare Advantage Fraud

Senator Grassley issued letters this week to the Centers for Medicare and Medicaid Services (CMS) and Department of Justice (DOJ) related to potential fraud in the Medicare Advantage program. Citing news articles, DOJ...more

5/25/2015 - CMS DOJ Fraud GAO Insurance Companies Medicare Medicare Advantage Physician Medicare Reimbursements

Blog: Trend Watch: Government Use Of Data Analytics To Identify Health Care Fraud

Data analytics is not a new concept within the health care industry. However, as data analytics tools become more accessible, government interest in using data analytics to detect health care fraud continues to increase. ...more

5/13/2015 - Congressional Investigations & Hearings Data Analytics Healthcare Healthcare Fraud

Blog: Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to...more

5/11/2015 - 21st Century Cures Initiative CMS Healthcare Innovation

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

5/6/2015 - Annual Reports CMS GPOs Manufacturers Medical Devices Open Payments Pharmaceutical Manufacturers Sunshine Act

Blog: Connecticut Delays Payment Reporting Until 2017

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more

5/6/2015 - APRNs Manufacturers Medical Devices Reporting Requirements

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

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