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Proposed Rules Department of Health and Human Services (HHS) Safe Harbors

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

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On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Seyfarth Shaw LLP

Mental Health Request for Public Comment Spoiler Alert – The Departments Need Help

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Seyfarth Synopsis: The Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans and insurers to cover treatments for mental health and substance use disorders in a manner that is equitable to 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

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 & Schulte

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

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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

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

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

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...

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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 & Schulte

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

Seyfarth Shaw LLP on

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

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 4: Modifications to Key Stark Law Terminology and a New Stark Law...

This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the...more

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

Polsinelli on

Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

McDermott Will & Schulte

[Webinar] Regulatory Sprint To Coordinate Care - November 19th, 21st, and December 5th, 12:30 pm ET

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To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more

Mintz - Employment Viewpoints

Treasury Department and IRS Proposed Individual Coverage HRA Affordability Safe Harbors

As we previously reported, on June 13, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) issued a coordinated set of final regulations (“final rules”) permitting employers...more

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

Tucker Arensberg, P.C. on

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Far-Reaching Proposed Rules to the Federal Stark and Anti-Kickback Laws

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In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark),...more

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