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Blog: OIG and HCCA Release Compliance Program Effectiveness Resource Guide

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide...more

4/10/2017  /  Health Care Providers , HHS , OIG

Blog: Comments to Draft Chicago Pharmaceutical Sales Representative License Rules Due April 2, 2017

As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and...more

Blog: FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use...more

3/20/2017  /  FDA , FDCA , Pharmaceutical Industry , PHRMA

Blog: Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance...more

Blog: OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare...more

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

Blog: Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency...

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for...more

Blog: OIG Issues 2017 Work Plan – PAMA, Open Payments, Drug Manufacturer Rebates Among Areas of New Focus

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various...more

Blog: FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders...more

9/2/2016  /  FDA , Medical Devices , PHRMA , Public Comment

Blog: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more

Blog: Open Payments Changes On the Horizon?

The Centers for Medicare & Medicaid Services (CMS) recently announced in the 2017 Physician Fee Schedule proposed rule that since publication and implementation of the Open Payments Final Rule and the 2015 Physician Fee...more

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

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

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

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

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

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

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

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

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

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

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
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