In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us virtually at HCCA’s Annual Healthcare Enforcement Compliance...more
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more
Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants. On the drug pricing front, the...more
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) issued two final rules to modernize and clarify the Physician...more
A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health...more
On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory...more
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
The Situation: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while also reducing the costs of care. The Action: The Office of Inspector...more
On October 17, 2019, the Department of Health & Human Services (HHS) published proposed rules in the Federal Register that would amend existing and create new exceptions to the physician self-referral law (Stark Law) and safe...more
As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician...more
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
As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more
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
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
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more
On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more
This Client Alert serves as the second in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) as part of its...more
Key Points - On October 17, 2019, the OIG proposed rules to add safe harbor protections for coordinated care and associated value-based arrangements. - The OIG proposed several new safe harbors: value-based...more
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
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
The proposed rules released by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) on Wednesday, October 9, 2019 include new exceptions and safe...more
On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General for the Department of Health and Human Services (“OIG”) announced proposed changes to modernize and clarify the...more
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