News & Analysis as of September 19, 2024

Anti-Kickback Statute › Final Rules

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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

CMS Finalizes New Mandatory Value-Based Payment Initiative: The Transforming Episode Accountability Model

Bass, Berry & Sims PLC on 8/29/2024

On August 28, as part of its Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Final Rule, the Centers for Medicare & Medicaid Services (CMS) finalized the Transforming Episode Accountability Model (TEAM)...more

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

McDermott Will & Emery on 1/15/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more

HHS Finalizes Enhancements to Information Blocking Rules through the HTI-1 Final Rule

Bass, Berry & Sims PLC on 12/19/2023

On December 13, the Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services (HHS), finalized changes to the information blocking rules by...more

Additional Disclosure Required: CMS Implements Substantial Changes to Reporting Skilled Nursing Facility Ownership Information

Goodwin on 12/1/2023

On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that will require skilled nursing facilities (SNFs) to disclose an expanded array of ownership, managerial, and control information...more

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

Quarles & Brady LLP on 9/11/2023

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

Defensibility of a fair market value analysis

Health Care Compliance Association (HCCA) on 8/3/2023

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

PA Changes Anti-Kickback Rules on Co-Location of Medical Assistance Program Providers

Ballard Spahr LLP on 1/18/2023

On January 14, 2023, the state Department of Human Services published a final rule, 53 Pa.B. 376, to amend the Pennsylvania Human Services Code (Code) by removing obstacles that made it harder for providers to share costs....more

Updates in Co-Pay Assistance and Accumulators Legal Developments

Akin Gump Strauss Hauer & Feld LLP on 10/17/2022

Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...more

Final Medicare Advantage and Part D Rule will Likely Require Medicare Advantage Plans to Update 2023 Bids under Maximum...

Mintz - Health Care Viewpoints on 5/5/2022

The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last...more

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

King & Spalding on 3/29/2022

On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

Bass, Berry & Sims PLC on 3/7/2022

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

OIG Publishes New Procedural Process for Advisory Opinions

King & Spalding on 1/17/2022

On January 6, 2022, OIG issued a final rule (Final Rule) that will update the process and procedures that govern advisory opinions in early 2022. The Final Rule will be effective 30 days after its publication in the Federal...more

Stark Regulatory Changes Effective January 1, 2022 Require Modifying Certain Group Practice Compensation Methodologies

Dorsey & Whitney LLP on 5/2/2021

On January 1, 2022, changes to the federal physician self-referral law (“Stark Law” or “Stark”) group practice definition special compensation rule go into effect. Among other things, these changes revise the rule related to...more

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

Miles & Stockbridge P.C. on 4/9/2021

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

Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care

Epstein Becker & Green on 4/8/2021

The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing...more

The New Stark Law Value-Based Exceptions Seek to Advance the Shift from Volume to Value in the Delivery of Health Care in the...

Butler Snow LLP on 3/5/2021

On November 20, 2020, the Department of Health and Human Services (HHS) released final rules, effective as of January 19, 2021 (with limited exception), amending and updating the Stark Law, the Anti-Kickback Statute (AKS),...more

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on 3/3/2021

Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

CMS statement clarifies agency’s view that the Stark Law final rule is effective

McGuireWoods LLP on 2/22/2021

Industry publication BVWire quoted a statement from the Centers for Medicare & Medicaid Services (CMS) that gives healthcare providers more certainty to rely on the much heralded final rule modernizing the physician...more

Potential Delay in Long-Awaited Stark Law and Anti-Kickback Statute Rules

Steptoe & Johnson PLLC on 2/18/2021

A January 20, 2021 memo issued by the Biden Administration may freeze the implementation of the Stark Law and Anti-kickback Statute (“AKS”) final rules that went into effect on January 19, 2021. According to the U.S....more

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to...

Mintz - Health Care Viewpoints on 2/8/2021

In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i)...more

Recent Changes to the Anti-Kickback Statute’s Personal Services Safe Harbor

Jones Day on 2/5/2021

The Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...more

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on 2/4/2021

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

Changes to Stark and Anti-Kickback Regulations Address Technology Advances, Tighten Rules for EHR Contributions, and Promote...

ArentFox Schiff on 2/1/2021

Fraud and abuse regulations have been adapted to meet today’s technology for electronic data, promoting cooperation among health care providers for the exchange of health information and the protection of such information...more

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

Jones Day on 1/21/2021

The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more

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Anti-Kickback Statute › Final Rules

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