Sarah diFrancesca

Sarah diFrancesca

Cooley LLP

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Blog: OIG Releases Criteria For Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the...more

4/25/2016 - CMS Guidance Update HHS OIG Social Security Act

Blog: Final Medicare 60-Day Overpayment Rule Provides Reasonable Framework For Providers

Published today in the Federal Register was a long-awaited Final Rule implementing a requirement from the 2010 Affordable Care Act requiring Medicare Part A and B providers and suppliers to report and return overpayments to...more

2/15/2016 - Affordable Care Act CMS False Claims Act (FCA) Medicare Part A Medicare Part B Overpayment Recovery Time Limits

Blog: CMS Releases Improved Open Payments Website, Refreshed Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) announced today that it had released an improved Open Payments website. The website has been enhanced with a homepage tool for searching by doctor name, a “snapshot” of Open...more

1/19/2016 - CMS GPOs Open Payments

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

1/7/2016 - Biotechnology Compliance Continuing Legal Education Events Life Sciences Medical Devices Pharmaceutical Industry Popular

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

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