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Exclusions Compliance

Foley & Lardner LLP

“Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

Shumaker, Loop & Kendrick, LLP

How Important is Exclusion Screening for Health Care Providers?

Under its exclusion authority, the Department of Health and Human Services Office of Inspector General (OIG) has the power to exclude certain individuals and entities from receiving compensation from federally funded health...more

White and Williams LLP

A Changing Climate: the Rising Tide of ESG Liability and Implications for D&O Coverage

The latest legal buzzword, ESG, represents the environmental, social and governance factors that many corporations are now required to consider and disclose alongside traditional financial information such as operating...more

Holland & Knight LLP

Corporate Transparency Act: A New Regulatory Requirement for Business

Holland & Knight LLP on

The U.S. House of Representatives passed the Corporate Transparency Act of 2019 (HR 2513) by a vote of 249-173, including 25 Republicans, on Oct. 22, 2019. A companion bill is being reviewed by the Senate. The purpose of HR...more

K&L Gates LLP

K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

K&L Gates LLP on

We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more

Skadden, Arps, Slate, Meagher & Flom LLP

"SEC Adopts CEO Pay Ratio Disclosure Requirements"

On August 5, 2015, in a 3-2 vote, the U.S. Securities and Exchange Commission (SEC) adopted final rules implementing the controversial “CEO pay ratio” disclosure requirements that were proposed in 2013 and mandated by...more

Baker Donelson

OIG Proposes Updates to Exclusion and CMP Authority

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The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a pair of proposed regulations to update its exclusion and civil monetary penalty (CMP) authority. The proposed regulations...more

Goodwin

NFA Provides Further Guidance on Bylaw 1101 Obligations of Members Who Do Business with CPOs/CTAs Relying on an Exemption or...

Goodwin on

The National Futures Association (the “NFA”) issued Notice I-14-06 providing guidance to its members regarding their Bylaw 1101 obligation to determine the CFTC registration and NFA membership status of persons with whom they...more

Baker Donelson

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

Baker Donelson on

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

King & Spalding

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

King & Spalding on

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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