News & Analysis as of September 21, 2024

Office of the Inspector General

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

McDermott Will & Emery on 9/1/2022

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on 7/9/2021

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

New Opportunities in Value-Based Care Part 1: New Opportunities for Provider Collaboration

Nelson Mullins Riley & Scarborough LLP on 5/4/2021

This is the first in a five- part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. At the end of 2020 the Centers for...more

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on 10/11/2019

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

OIG Allows Free and Reduced-Cost Services to Strained Caregivers in Advisory Opinion 18-05

Baker Donelson on 8/2/2018

In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more

Stark Under the Microscope: Congress and HHS Examine Reform of the Stark Law for a Value-Based System

Bass, Berry & Sims PLC on 7/19/2018

On July 17, 2018, the U.S. House of Representatives' Ways and Means Committee Subcommittee on Health ("Subcommittee") expressed its commitment to modernizing the Stark Law during a hearing in which industry and government...more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

McDermott Will & Emery on 4/11/2017

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

New OIG Exclusion Regulations About to Go into Effect

McDermott Will & Emery on 3/3/2017

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

Arnall Golden Gregory LLP on 2/15/2017

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

OIG Expands Exclusionary Authority

Bradley Arant Boult Cummings LLP on 1/31/2017

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

Health Law Insights: January Newsletter

Roetzel & Andress on 1/27/2017

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on 1/13/2017

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Money Talks: Important Takeaways from the OIG’s Civil Monetary Penalties Final Rule

McDermott Will & Emery on 12/22/2016

In a burst of rulemaking in December 2016, the US Department of Health and Human Services, Office of Inspector General, issued two new final rules containing significant changes to OIG’s Civil Monetary Penalty authorities....more

Providers Breathe Sigh of Relief with New Anti-Kickback Safe Harbors and CMP Exceptions

BakerHostetler on 12/20/2016

On December 7, 2016, the HHS Office of Inspector General (OIG) finalized a set of rules first proposed in 2014 adding new anti-kickback law safe harbors and protecting additional conduct from enforcement under the civil...more

Health Update - December 2016

Manatt, Phelps & Phillips, LLP on 12/20/2016

Balancing Gene Therapy’s Promise and Price - Editor’s Note: Exciting advances in science have led to developing treatment breakthroughs, such as gene scripting therapies, that could represent the first potential cures...more

OIG Revises and Adds Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules

Saul Ewing LLP on 12/19/2016

In what may be one of the final federal health care revisions implemented during the Obama Administration, on December 7, 2016 the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”),...more

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Emery on 12/14/2016

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

Mintz - Health Care Viewpoints on 12/12/2016

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

Health Law Pulse - August 2015

Robinson & Cole LLP on 8/18/2015

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more

2014 – The Health Law Year in Review

Bradley Arant Boult Cummings LLP on 12/31/2014

Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more

OIG Announces Proposed AKS and CMP Regulations

Benesch on 10/22/2014

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

Mintz on 10/21/2014

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

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