News & Analysis as of

Office of the Inspector General Hospitals Safe Harbors

Venable LLP

Contractual Safeguards That Fall Short of a Safe Harbor

Venable LLP on

According to a recent Advisory Opinion from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), a proposed fee arrangement could run afoul of the Federal anti-kickback statute, 42 USC...more

Steptoe & Johnson PLLC

What to Expect, Part III: Modified AKS Safe Harbor for Personal Services & Management Contracts

Steptoe & Johnson PLLC on

The Office of Inspector General’s (“OIG”) new Anti-Kickback Statute (“AKS”) regulations modify the safe harbor for personal services and management contracts (42 CFR § 1001.952(d)) in a manner that allows providers...more

Miles & Stockbridge P.C.

The Stark Law and Anti-Kickback Statute Final Rules: Value-Based Arrangements

The Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) jointly published final rules that expand upon and modify regulatory safe harbors and exceptions to the Anti-Kickback Statute and...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Davis Wright Tremaine LLP

Done Sprinting, but Are We There Yet? The Value-Based Stark Exceptions and AKS Safe Harbors

On December 2, 2020, CMS and OIG finished a two-year sprint to modernize the Stark and Anti-Kickback (AKS) regulations to remove barriers to value-based care and incentivize patient-centered care coordination....more

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

McGuireWoods Consulting

Washington Healthcare Update - December 2019 #1

McGuireWoods Consulting on

This Week in Washington: The House and Senate are back from Thanksgiving recess. Congress is expected to be in session until or about Dec. 20....more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

Womble Bond Dickinson on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that,...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more

McDermott Will & Emery

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

McDermott Will & Emery on

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

Foley & Lardner LLP

ASCs Make Comeback with Multispecialty Ownership Groups

Foley & Lardner LLP on

Ambulatory surgery center (ASC) development and ownership has made a comeback after a number of years of stagnation due to an oversupply of centers and poor income growth. However, with significant changes in payment...more

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

Baker Donelson on

In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Foley & Lardner LLP

Some Helpful Managed Care Guidance Provided in Advisory Opinion 18-11

Foley & Lardner LLP on

Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible...more

Sheppard Mullin Richter & Hampton LLP

How Broad is the Managed Care Safe Harbor?

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Baker Donelson

OIG Advisory Opinion 18-07 Permits GPO Expansion to Serve Wholly Owned Members

Baker Donelson on

In Advisory Opinion No. 18-07, issued July 30, 2018, the OIG permitted a group purchasing organization (GPO) to serve health care facilities owned by the same parent organization as the GPO. While acknowledging that the...more

Baker Donelson

OIG Approves (Again) Another Medigap/PHO Arrangement in Advisory Opinion 18-06

Baker Donelson on

With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more

Baker Donelson

OIG Advisory Opinion 18-04: Another Favorable Medigap/PHO Arrangement

Baker Donelson on

On June 7, 2018, the OIG issued favorable Advisory Opinion 18-04, thereby approving another arrangement between a group of Medicare Supplemental Health Insurance (Medigap) insurers and a preferred hospital organization (PHO)....more

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