News & Analysis as of September 23, 2024

Anti-Kickback Statute › Proposed Regulation

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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 | July 2024 Recap

McDermott Will & Emery on 9/6/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

OIG’s Favorable Advisory Opinion: Physician Consulting Firm’s Gift Cards to its Clients for Referring New Physician Practices

Harris Beach PLLC on 1/18/2024

This favorable OIG opinion relates to Requestor who provides consulting services to physician practices and the Requestor’s proposed arrangement (“Proposed Arrangement”) to offer its current physician practice customers...more

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

McDermott Will & Emery on 9/1/2023

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

The “Regulatory Sprint to Coordinated Care”

Dorsey & Whitney LLP on 12/3/2020

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

Mintz - Health Care Viewpoints on 6/26/2020

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more

Special Report - Untangling VBEs, ACOs and CINs - What to Know about CMS and OIG's Proposed Regulations - December 2019

McDermott Will & Emery on 12/10/2019

The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more

CMS proposes new Stark Law exception for limited remuneration to a physician

Bricker Graydon LLP on 12/3/2019

On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more

CMS proposes to recalibrate the scope and application of the Stark regulations

Bricker Graydon LLP on 10/23/2019

As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on 10/21/2019

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

HHS tackles barriers to value-based care: Part two – Substantial Stark Law regulatory revisions proposed

Hogan Lovells on 10/21/2019

Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Dorsey & Whitney LLP on 9/10/2019

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

Baker Donelson on 2/5/2019

On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

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

Stinson LLP on 11/21/2018

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

Compliance Concerns Raised Over Proposed Hospital Outpatient Department Rule

McCarter & English, LLP on 9/8/2016

In an August 26, 2016, letter to the Centers for Medicare & Medicaid Services (CMS), the American Hospital Association (AHA) expressed serious concern over the portion of the calendar year 2017 hospital outpatient prospective...more

CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window

Tucker Arensberg, P.C. on 8/20/2015

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available below....more

What You Need To Know About the AKS Proposed Local Transportation Safe Harbor

McGuireWoods LLP on 1/13/2015

On October 3, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule to expand the safe harbors and make other modifications applicable to the federal...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

OIG Proposes New Safe Harbors to the Anti-Kickback Statute and New Exceptions to the Two Civil Monetary Penalty Provisions

Epstein Becker & Green on 10/21/2014

On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more

Proposed Updates to the Civil Monetary Penalties Law for Health Care Providers

K&L Gates LLP on 10/20/2014

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”) that would amend certain rules under the Civil...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

Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

Baker Donelson on 10/16/2014

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,...more

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Mintz - Health Care Viewpoints on 10/10/2014

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...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

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Anti-Kickback Statute › Proposed Regulation

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