News & Analysis as of September 19, 2024

Anti-Kickback Statute › Medical Devices › Centers for Medicare & Medicaid Services (CMS)

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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... more +

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 -

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on 4/2/2024

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Sheppard Mullin Richter & Hampton LLP on 1/31/2024

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

McDermott Will & Emery on 9/26/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

McDermott Will & Emery on 3/30/2023

After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Emery on 3/9/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

Mintz - Health Care Viewpoints on 10/11/2022

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

OIG Approves Physician-Owned Medical Device Company

Mintz - Health Care Viewpoints on 4/28/2022

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on 4/4/2022

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on 2/17/2022

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on 11/5/2021

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...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

Pharmaceutical and Medical Device Manufacturers Be Advised: Sunshine Act / Open Payments Enforcement is on the Rise

Mintz - Health Care Viewpoints on 5/28/2021

Pharmaceutical and medical device manufacturers should be advised that the government is using its enforcement authority under the Open Payments Program (otherwise known as the Sunshine Act) in conjunction with the...more

Is 2021 The Value-Based And Shared Savings Revolution?

MoFo Life Sciences on 4/22/2021

By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more

Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor

Faegre Drinker Biddle & Reath LLP on 12/3/2020

Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more

OIG Issues Warning About Speaker Programs Sponsored by Drug and Device Companies

King & Spalding on 12/1/2020

On November 16, 2020, OIG issued a significant Special Fraud Alert that warns about certain “inherent” fraud and abuse risks raised by speaker programs sponsored by pharmaceutical and medical device companies. OIG expressed...more

HHS Issues Final Rules Implementing Stark Law and Anti-Kickback Statute Reforms

King & Spalding on 11/30/2020

On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more

HHS Finalizes Sweeping Changes to Stark Law, Anti-Kickback Statute Regulations

McDermott Will & Emery on 11/25/2020

On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more

OIG Issues Special Fraud Alert On Speaker Programs

Rivkin Radler LLP on 11/23/2020

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose...more

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on 11/13/2020

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Report on Medicare Compliance Volume 29, Number 39. News Briefs: November 2020

Health Care Compliance Association (HCCA) on 11/9/2020

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - Medtronic USA Inc., a medical device maker, has agreed to pay $8.1 million to settle allegations it violated the False Claims Act by paying kickbacks to induce...more

DOJ Announces the First Open Payments Program / Sunshine Act Enforcement Action

Mintz - Health Care Viewpoints on 11/3/2020

On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more

Healthcare Law Update: October 2019

Holland & Knight LLP on 10/15/2019

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

McDermott Will & Emery on 2/6/2019

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

Healthcare Law Update: December 2018

Holland & Knight LLP on 12/20/2018

Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more

Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities

Mintz - Health Care Viewpoints on 10/25/2018

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which...more

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