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Blog: OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace...more

Blog: OIG Releases August Work Plan Items

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The August updates released this week include 4 new Work Plan items:...more

Blog: OIG Work Plan Will Now Be Updated Monthly; 14 New Items Added for July

The Office of Inspector General (OIG) for Health and Human Services (HHS) recently announced that it will begin updating its Work Plan initiatives monthly rather than its previous twice-yearly publications, which was most...more

7/18/2017  /  HHS , Medicaid , Medicare , Medicare Part B , OIG , Work Plans

Blog: CMS Publishes 2016 Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) published today the Open Payments data reported earlier this year by applicable drug, device, biologic and medical supply manufacturers and group purchasing organizations...more

Blog: Maine Enacts Gift Ban Law

Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and...more

Blog: Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit...

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in...more

Blog: FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding...more

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

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