News & Analysis as of September 25, 2024

Anti-Kickback Statute › EHR

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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 -

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement – Part II

White & Case LLP on 2/10/2021

For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...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

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on 1/13/2021

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

New Sprint Regulations Encourage Investment in EHR and Cybersecurity Technology

Davis Wright Tremaine LLP on 12/4/2020

On December 2, 2020, under the Trump Administration's "Regulatory Sprint to Coordinated Care" initiative, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final...more

Cybersecurity AKS Safe Harbor and Stark Exception

Tucker Arensberg, P.C. on 12/3/2020

EHR Safe Harbor Permanent - The existing electronic health records items and services Safe Harbor in 42 CFR Section 1001.952(y) was amended by deleting the sunset provision, thereby making the protection permanent....more

$145 Million Settlement Shows the Depth of Government’s Effort to Combat Opioid Crisis and its Interest in Fraud Actions Against...

Dorsey & Whitney LLP on 3/5/2020

Less than a year after United States Attorney Christina E. Nolan warned electronic health records (“EHR”) companies in a DOJ press release that they “should consider themselves on notice” following a $57.25 million FCA...more

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

Manatt, Phelps & Phillips, LLP on 2/5/2020

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

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

Bass, Berry & Sims PLC on 2/4/2020

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

Robinson+Cole Health Law Diagnosis on 1/31/2020

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more

Stark Law and Anti-Kickback Statute Proposed Rules Would Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on 11/22/2019

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

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on 11/13/2019

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Anti-Kickback EHR and Cybersecurity Safe Harbor

Tucker Arensberg, P.C. on 11/11/2019

As another part of the Regulatory Sprint to Coordinated Care, OIG proposed revisions to the existing EHR Anti-Kickback Safe Harbor and added a cybersecurity component. The initial EHR Safe Harbor was developed in response...more

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on 11/4/2019

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

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

Epstein Becker & Green on 10/31/2019

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

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

Bass, Berry & Sims PLC on 10/30/2019

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

Sprint Regulations: EHR and Cybersecurity Proposals

Davis Wright Tremaine LLP on 10/29/2019

Consistent with the Administration’s broader effort to reduce regulatory burdens within the healthcare industry, the Sprint Regulations include proposals designed to remove barriers to the widespread adoption of cybersecurity...more

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

Mintz - Health Care Viewpoints on 10/22/2019

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

HHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules

Epstein Becker & Green on 10/22/2019

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

OIG Proposes to Add and Expand AKS Safe Harbors

Katten Muchin Rosenman LLP on 10/22/2019

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

CMS Proposes Changes to Physician Self-Referral Regulations to Promote Value-Based Health Care

Akin Gump Strauss Hauer & Feld LLP on 10/18/2019

• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more

HHS Office of Inspector General Proposes Modifications to Anti-Kickback Statute Safe Harbors to Promote Value-Based Care

Akin Gump Strauss Hauer & Feld LLP on 10/18/2019

• On Oct. 9, 2019, the U.S. Department of Health and Human (HHS) Services Office of Inspector General (OIG) has issued its proposed rule to reform the Anti-Kickback Statute’s (AKS) regulatory safe harbors to address...more

HHS Announces Overhaul of Kickback and Stark Rules

Wilson Sonsini Goodrich & Rosati on 10/18/2019

On October 9, 2019, the U.S. Department of Health and Human Services' (HHS') Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) announced plans for sweeping changes to rules policing health...more

HHS Releases Proposed Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law Reforms

Proskauer Rose LLP on 10/15/2019

On October 9, 2019, the Department of Health and Human Services ("HHS") issued proposed changes to the regulations implementing the Physician Self-Referral Law (the "Stark Law"), the Anti-Kickback Statute (the "AKS"), and the...more

New Proposed Cybersecurity and EHR Donation Rules

Faegre Drinker Biddle & Reath LLP on 10/11/2019

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...more

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Anti-Kickback Statute › EHR

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