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Proposed Rules Anti-Kickback Statute Department of Health and Human Services (HHS)

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage Remains a Top Enforcement Priority

Medicare Advantage (Medicare Part C) remained a top enforcement priority in 2022, and Medicare Advantage Organizations (MAOs) are the subject of intense scrutiny by the Department of Justice (DOJ); the Office of Inspector...more

Shumaker, Loop & Kendrick, LLP

Stark Law Changes for Group Practices

On December 2, 2020, the Center for Medicare and Medicaid Services (CMS) issued final regulations revising and clarifying regulations, which govern physician referrals for designated health services, commonly known as the...more

Epstein Becker & Green

Stark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for...

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On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final...more

ArentFox Schiff

Investigations Newsletter: HHS Announces Formation of FCA Working Group

ArentFox Schiff on

HHS Announces Formation of FCA Working Group - On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more

Epstein Becker & Green

OIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework

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On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion...more

Butler Snow LLP

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

Butler Snow LLP on

On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more

BakerHostetler

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

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With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more

McDermott Will & Emery

OIG Finalizes Revisions to Safe Harbor Protection for Drug Rebates and Establishes New Safe Harbors for Point-of-Sale Price...

McDermott Will & Emery on

On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more

PilieroMazza PLLC

Healthcare Blog Series: “Safe Harbor” Exceptions, Common Infractions, and Legislative Updates to the Anti-Kickback Statute and...

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This is the second installment in a blog series examining the regulatory environment and key concerns for persons or businesses operating in the healthcare industry. The first installment of this series introduced the...more

Mintz - Health Care Viewpoints

CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform

On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark...more

Chambliss, Bahner & Stophel, P.C.

Providers Push for Implementation of Long-Awaited Changes to Stark and Anti-Kickback Statute

In October 2019, as part of HHS’ Regulatory Sprint to Coordinated Care, long-awaited rules were proposed by HHS and CMS regarding changes to the Stark Law and Anti-Kickback Statute (AKS). These rules were the byproduct of...more

Mintz - Health Care Viewpoints

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

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

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

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

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

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On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Jones Day

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

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The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

Tucker Arensberg, P.C.

It Is Not Illegal to Pay Physicians More Than They Generate

While we are waiting for final disposition of the AKS Safe Harbors and Stark Exceptions proposed in October of 2019, since the comment period expired December 31, 2019 and final rules have not been issued, I thought we should...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

K&L Gates LLP

Triage in 2020: Health Care Topics to Watch in the New Year

K&L Gates LLP on

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement

As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more

BakerHostetler

The Race to Modernize Stark and the AKS: Unpacking the Value-based Proposals in HHS Regulatory Sprint Rulemaking

BakerHostetler on

The U.S. Department of Health & Human Services (HHS) made great strides in its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark), Anti-Kickback Statute (AKS) and...more

K&L Gates LLP

A Giant Leap Forward in Value-Based Innovation or an Avalanche of New Administrative Requirements? An Analysis of the Value-Based...

K&L Gates LLP on

As part of the Department of Health and Human Services’ (“HHS”) “Regulatory Sprint to Coordinated Care,” the following two proposed rules were issued on October 17, 2019, that, if finalized, will markedly change the...more

McDermott Will & Emery

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

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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

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

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In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Nelson Mullins Riley & Scarborough LLP

[Webinar] Stark and Anti-Kickback Proposed Rules: Where Are We Headed Now? - December 5th, 2:00 pm ET

Members of Nelson Mullins' healthcare team will host a 90-minute webinar to discuss the Department of Health and Human Services' and Centers for Medicare & Medicaid Services' new Stark and Anti-Kickback proposed rules, both...more

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