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Safe Harbors Today's Popular Updates Anti-Kickback Statute

Wilson Sonsini Goodrich & Rosati

Offering Equity to Physicians in an MSO/PC Structure: Key Fraud and Abuse Compliance Considerations

Executive Summary - - Offering equity in MSOs to physicians can be permissible but must be structured to comply with both federal and state laws. Failure to comply with applicable fraud and abuse laws may result in civil...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Jones Day

New Stark Law and Anti-Kickback Statute Protections for Cybersecurity Technology

Jones Day on

The Situation: The adoption of new technologies has been a hallmark of the health care industry in the twenty-first century. While these technologies have helped to improve both industry efficiency and patient outcomes, the...more

McGuireWoods LLP

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

McGuireWoods LLP on

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

Faegre Drinker Biddle & Reath LLP

HHS Issues Final Cybersecurity Safe Harbor and Exception

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each released a final rule (the Final Rules). The Final...more

Davis Wright Tremaine LLP

New Sprint Regulations Encourage Investment in EHR and Cybersecurity Technology

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

Rivkin Radler LLP

New AKS Safe Harbors Finalized

Rivkin Radler LLP on

The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy...more

King & Spalding

HHS Issues Final Rules Implementing Stark Law and Anti-Kickback Statute Reforms

King & Spalding on

On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more

Arnall Golden Gregory LLP

2020 Government Investigations Team Insights - September 2020

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

McDermott Will & Schulte

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

McDermott Will & Schulte on

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

Baker Donelson

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

Baker Donelson on

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

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

Robinson+Cole Health Law Diagnosis

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

Mintz - Health Care Viewpoints

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

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

Akin Gump Strauss Hauer & Feld LLP

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

• 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

Wilson Sonsini Goodrich & Rosati

HHS Announces Overhaul of Kickback and Stark Rules

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

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

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

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....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

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