News & Analysis as of

Department of Health and Human Services (HHS) Office of the Inspector General Social Security Act

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Drug Cost Subsidies for Certain Low-Income Medicare Enrollees

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Foley & Lardner LLP

DOJ Antitrust Division and HHS OIG Enter into Partnership to Increase Coordination and Enforcement in Health Care

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On December 9, 2022, the U.S. Department of Justice Antitrust Division (DOJ) and Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced they had entered a Memorandum of Understanding...more

Morgan Lewis - Health Law Scan

OIG Launches New Resource Page Featuring Telehealth

Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more

King & Spalding

OIG Updates COVID-19 Administrative Enforcement FAQs With Question Regarding Ambulance Providers’ Waiver or Discount of Certain...

King & Spalding on

On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

Baker Donelson

OIG's List of Excluded Individuals/Entities – What Employers Need to Know

Baker Donelson on

OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Holland & Knight LLP

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

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Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

Saul Ewing LLP

U.S. Department of Health and Human Services Updates Criteria for Permissive Exclusion Under Section 1128(b)(7) of the Social...

Saul Ewing LLP on

The HHS-OIG issued new guidelines on April 18, 2016 regarding the Secretary's exercise of the Department's permissive exclusion authority pursuant to Section 1128(b)(7) of the Social Security Act. The HHS-OIG's new guidance...more

Cooley LLP

Blog: OIG Releases Criteria For Implementing Exclusion Authority

Cooley LLP on

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the...more

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