Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

Contact  |  View Bio  |  RSS

Latest Publications


Blog: OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and...more

11/4/2015 - Drug Pricing Healthcare HHS HIPAA Medicare OIG OMB Prescription Drugs Work Plans

Blog: BEWARE: DOJ Announces New Policy to Increase Prosecutions of Individuals Involved in Corporate Fraud

Earlier this week, Deputy Attorney General (AG) Sally Quillian Yates issued a memorandum to Department of Justice (DOJ) attorneys discussing the need to hold individuals accountable for corporate wrongdoing in both civil and...more

9/14/2015 - Criminal Prosecution DOJ Enforcement Actions Government Investigations Health Care Providers Life Sciences Personal Liability Willful Misconduct Yates Memorandum

Blog: Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...more

8/13/2015 - Celebrity Endorsements FDA Kim Kardashian Prescription Drugs Social Networks Warning Letters

Blog: First Court Decision Interpreting the Overpayment Rule Issued This Week

Earlier this week, a key decision denying defendants’ motion to dismiss was issued in the case, Kane v. Healthfirst Inc., et al. and United States v. Continuum Health Partners Inc., et al. (case no. 1:11-cv-02325, S.D.N.Y.)....more

8/10/2015 - Affordable Care Act CMS False Claims Act (FCA) Hospitals Medicaid Medicare Mistake Overpayment Overpayment Recovery Time Limits

Blog: Significant Court Decision Issued Today re: Off-Label Promotion

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this...more

8/10/2015 - First Amendment Government Investigations Misbranding Off-Label Use Pharmaceutical Industry Preliminary Injunctions

Blog: Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon,...more

7/24/2015 - Cephalon Compliance Corporate Integrity Agreement False Claims Act (FCA) Health Care Providers Healthcare HHS Kickbacks Off-Label Promotion OIG Qui Tam

Blog: CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more

7/21/2015 - CME CMS Medicaid Medicare New Guidance Open Payments Pharmaceutical Industry Physician Fee Schedule Reporting Requirements Sunshine Act

Blog: CMS Announces that Data Analytics has Prevented $820M in Improper Medicare Payments

The Office of Inspector General (OIG) recently certified the “positive return on investment” from the FPS and recommended its continued operation, although the OIG determined that it was not feasible at this time to expand...more

7/20/2015 - CHIP CMS Fraud GAO Healthcare Healthcare Fraud Medicaid OIG

Blog: 2014 Open Payments Infographic

Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49...more

7/15/2015 - CMS Open Payments Pharmaceutical Industry Physicians Teaching Hospitals

Blog: JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed

JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005....more

7/15/2015 - Conflicts of Interest IRB

Blog: Minimal Media Interest to Date in Recently-Released Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released last week the 2014 Open Payments data, the first release of data reported by applicable manufacturers and group purchasing organizations (GPO) for a full calendar...more

7/8/2015 - CMS Health Care Providers Hospitals Open Payments Pharmaceutical Industry Physicians

Blog: OIG Announces New Special Litigation Team

The Office of Inspector General (OIG) announced this week that it will launch a special litigation team devoted solely to Civil Money Penalty (CMP) and Exclusion cases. The announcement was made by representatives of the...more

7/6/2015 - CMP Law Healthcare OIG

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 Industry 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 Draft Guidance FDA 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 Industry 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 (FCA) 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 Industry 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 - Analytics Congressional Investigations & Hearings 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 Industry 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

56 Results
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.