News & Analysis as of November 17, 2024

Pharmacies

+ Follow

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 -

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

King & Spalding on 9/5/2024

On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

Arnall Golden Gregory LLP on 2/15/2022

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more

Does HHS’s Elimination of the Safe Harbor for Manufacturer Rebates Leave Manufacturers with Increased Antitrust Risk?

Patterson Belknap Webb & Tyler LLP on 12/15/2020

On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more

New Medicare Part D Demonstration to Address Proposed Changes to Anti-Kickback Safe Harbors

Holland & Knight LLP on 4/10/2019

• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more

HHS OIG Issues Proposed Rule Altering AKS Safe Harbor for Pharmacy Benefit Manager Rebates

McGuireWoods LLP on 3/13/2019

The federal Anti-Kickback Statute (AKS) prohibits the knowing and willful solicitation, receipt, offer or payment of any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for or to...more

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on 2/12/2019

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

Epstein Becker & Green on 2/6/2019

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Dorsey & Whitney LLP on 2/6/2019

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

Skadden, Arps, Slate, Meagher & Flom LLP on 2/5/2019

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

Bass, Berry & Sims PLC on 2/5/2019

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

OIG Report on Topical Compounded Drug Prescribing, Marketing and Billing Practices Signals Heightened Administrative and...

Sheppard Mullin Richter & Hampton LLP on 11/5/2018

When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug program,...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

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

Baker Donelson on 9/26/2017

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

New Anti-Kickback Safe Harbors

Roetzel & Andress on 12/20/2016

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more

OIG Approves Limited, Free Drug Program

Baker Donelson on 8/27/2015

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...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 Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

BakerHostetler on 10/17/2014

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

K&L Gates LLP on 10/13/2014

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

OIG Releases Proposed Rule Adding New Safe Harbors to the Anti-Kickback Statute

King & Spalding on 10/10/2014

Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more

OIG Proposes Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

McDermott Will & Emery on 10/8/2014

On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more

20 Results

View per page

Page: of 1

Anti-Kickback Statute › Medicare Part D › Pharmacies

"My best business intelligence, in one easy email…"