News & Analysis as of

Office of the Inspector General Rulemaking Process

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

McDermott Will & Emery

Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

McDermott Will & Emery on

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more

Harris Beach PLLC

NY Medicaid Inspector General Finalizes Rulemaking for Medicaid Program Fraud, Waste and Abuse Prevention

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On December 28, 2022, New York State Register published a summary of the New York State Office of the Medicaid Inspector General’s (“OMIG”) Notice of Adoption for Rulemaking on Medicaid Program Fraud, Waste and Abuse...more

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

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On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

Seyfarth Shaw LLP

CMS Announces Extension on Publishing Final Rule Governing Physician Self-Referrals in Stark Law

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Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

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On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

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In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Bricker Graydon LLP

OIG proposes changes to existing Anti-Kickback Statute safe harbors

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On October 9, 2019, the Office of Inspector General (OIG) released proposed changes interpreting the federal Anti-Kickback Statute (AKS) and its regulatory safe harbors, including changes to several existing safe harbors. ...more

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

Polsinelli on

Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

Bricker Graydon LLP

CMS clarifies the process for correcting mistakes under the Stark Law

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On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) published proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law)....more

Bricker Graydon LLP

CMS and OIG propose three new value-based care exceptions to remove value-based payment barriers

Bricker Graydon LLP on

Part of the Centers for Medicare and Medicaid Services' (CMS) proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), released on October 9, 2019, includes three new exceptions for...more

Bricker Graydon LLP

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

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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

Bricker Graydon LLP

CMS proposes to change the way group practices can pay profit shares to physicians under Stark Law

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Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes to the regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, include changes to the special...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

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Ballard Spahr LLP

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more

Stinson LLP

OIG Proposes Significant Changes to Anti-kickback Statute Safe Harbors to Support Value-Based Arrangements

Stinson LLP on

Last week, the Office of Inspector General (OIG) released a proposed rule that would add a suite of additional safe harbors to the Federal Anti-kickback Statute as well as modify existing safe harbors. These changes are...more

Bricker Graydon LLP

CMS and OIG issue long-awaited rules proposing changes to the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil...

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (HHS-OIG) issued long-awaited proposed changes “to modernize and clarify the...more

Sheppard Mullin Richter & Hampton LLP

CMS Finalizes 2020 Hospice Rule: Big Changes Coming

On August 6, 2019, CMS finalized its 2020 hospice rule, including adopting, without substantial modification, two controversial and material changes to the hospice benefit: Rebasing payment rates to shift about $500...more

PilieroMazza PLLC

Weekly Update Newsletter - February 2019 #4

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GOVERNMENT CONTRACTING - The Government Accountability Office (GAO) sustained a protest filed by Ekagra Partners, LLC challenging the terms of a request for proposal (RFP) issued by the General Services Administration...more

Epstein Becker & Green

Reimbursement Issues Worth Noting: Administrative Law and False Claims Act Implications

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News of two distantly related reimbursement issues with administrative law and False Claims Act (“FCA”) implications is worth noting....more

Ballard Spahr LLP

Updated OIG work plan for CFPB adds new project on sharing complaint data

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Since our last blog post about the Office of Inspector General’s work plan for the CFPB, the work plan has been updated as of July 1, 2017 to add one new planned project....more

Cozen O'Connor

Update on Significant DOT, FAA and Other Federal Agencies’ Aviation-Related Regulatory Actions - February 2016

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This edition of the Cozen O’Connor Aviation Regulatory Update includes the recently signed U.S.-Mexico bilateral agreement that liberalizes air services between the two countries, new Cuba-related regulations loosening...more

Foley & Lardner LLP

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

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The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

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