News & Analysis as of

Health Information Technologies Anti-Kickback Statute

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Morrison & Foerster LLP

Artificial Intelligence in Healthcare: New Avenues for Liability

Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

Quarles & Brady LLP

Million Dollar Maybe: Enforcement of Cures Act Information Blocking Prohibitions Begins

Quarles & Brady LLP on

As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

Health Care Compliance Association (HCCA)

[Event] 26th Annual Compliance Institute - March 28th - 31st, Phoenix, AZ

The primary educational and networking event for healthcare compliance professionals - As our flagship healthcare compliance conference, HCCA’s Compliance Institute (CI) has been providing educational resources and...more

Rivkin Radler LLP

EHR Company In $3.8M Kickback Settlement

Rivkin Radler LLP on

The U.S. Department of Justice recently announced that CareCloud Health, a Florida-based developer of electronic health records software, agreed to pay $3.8 million to resolve a whistleblower’s allegations that it paid...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

K&L Gates LLP

White Paper: OIG Finalizes New and Revises Existing AKS Safe Harbors and Creates New CMP Law Exception

K&L Gates LLP on

On 2 December 2020, the Office of Inspector General (OIG) in the U.S. Department of Health & Human Services (HHS) issued a long-awaited final rule (the Final Rule or Rule). The Final Rule adds multiple new safe harbors,...more

BakerHostetler

The HHS Regulatory Sprint Removes Some Stark and AKS Hurdles for Donating Healthcare Technology

BakerHostetler on

This is the second in a series of client alerts on the collaborative effort between the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS), which...more

Manatt, Phelps & Phillips, LLP

New HHS Regulations Create Opportunities for Digital Health Partnerships

On November 20, 2020, the Department of Health and Human Services (HHS) finalized a set of sweeping changes to the regulatory framework that governs fraud and abuse in the Medicare and Medicaid programs. Among other changes,...more

Tucker Arensberg, P.C.

Cybersecurity AKS Safe Harbor and Stark Exception

Tucker Arensberg, P.C. on

EHR Safe Harbor Permanent - The existing electronic health records items and services Safe Harbor in 42 CFR Section 1001.952(y) was amended by deleting the sunset provision, thereby making the protection permanent....more

ArentFox Schiff

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

ArentFox Schiff on

In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...more

McDermott Will & Emery

Questions Remain for the EHR Industry as a Second EHR Vendor, Greenway Health, Settles False Claims Act Allegations

McDermott Will & Emery on

On February 6, 2019, the DOJ announced a settlement agreement with Greenway Health, a vendor of EHR software, under which Greenway agreed to pay approximately $57 million to resolve allegations that it caused its health care...more

Stinson LLP

AdvaMed Proposes New Safe Harbors to the Anti-Kickback Statute for Value-Based Pricing Arrangements

Stinson LLP on

AdvaMed, the trade association representing manufacturers of medical devices, diagnostic products, digital health technologies and health information systems, proposed three new safe harbors to the Anti-Kickback Statute...more

Farrell Fritz, P.C.

The Doctor Is In – From a Distance; Telemedicine Caveats

Farrell Fritz, P.C. on

While there has been discussion of the potential proliferation of telemedicine for quite some time, telemedicine is finally positioned to take off thanks to the latest federal budget. ...more

McDermott Will & Emery

OCR Explains How Information Blocking Violates HIPAA

McDermott Will & Emery on

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

King & Spalding

OIG Warns Information Blocking May Affect Safe Harbor Protection

King & Spalding on

In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more

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